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Park SC, Jung J, Kwon YE, Baeg SI, Oh DJ, Kim DH, Lee YK, Choi HM. Constipation and risk of death and cardiovascular events in patients on hemodialysis. Kidney Res Clin Pract 2025; 44:155-163. [PMID: 39815794 PMCID: PMC11838856 DOI: 10.23876/j.krcp.24.174] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2024] [Revised: 10/02/2024] [Accepted: 10/24/2024] [Indexed: 01/18/2025] Open
Abstract
BACKGROUND Constipation is a common gastrointestinal disorder and is often accompanied by alteration in the gut microbiota. Recently, several studies have disclosed its association with an increased risk of cardiovascular disease and mortality in the general population. Despite the high prevalence of constipation, data on the clinical impact of constipation in patients with chronic kidney disease are limited. We aimed to explore the prevalence of constipation and its association with cardiovascular disease in chronic kidney disease using a nationally representative cohort of hemodialysis patients. METHODS This study used hemodialysis quality assessment and health insurance claims data from patients undergoing maintenance hemodialysis in South Korea. Chronic constipation was defined using the total number of laxatives prescribed during the 1-year baseline period. The primary outcome was a composite of acute ischemic stroke, hemorrhagic stroke, myocardial infarction, or all-cause death. Secondary outcomes were the individual components of the primary outcome. RESULTS Among 35,230 patients on hemodialysis, 9,133 (25.9%) were identified as having constipation. During a median follow-up of 5.4 years, patients with constipation had a 15% higher incidence of the composite outcome, 16% higher incidence of ischemic stroke, and 14% higher all-cause mortality, after multivariate adjustment. CONCLUSION Chronic constipation requiring laxatives was associated with a higher risk of the composite outcome of cardiovascular events or all-cause death in patients on hemodialysis. Further studies are needed to confirm whether constipation is an independent predictor or a possible causal factor of cardiovascular disease.
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Affiliation(s)
- Sang Cheol Park
- Artificial Intelligence and Robotics Laboratory, Myongji Hospital, Goyang, Republic of Korea
| | - Juyoung Jung
- Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
| | - Young Eun Kwon
- Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
| | - Song In Baeg
- Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
| | - Dong-Jin Oh
- Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
| | - Do Hyoung Kim
- Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea
| | - Young-Ki Lee
- Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea
| | - Hye Min Choi
- Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
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Li C, Wu R, Xie D. Association Between Indices of Thyroid Hormone Resistance and Constipation Prevalence in the US Population: NHANES 2007-2010. J Clin Gastroenterol 2024:00004836-990000000-00382. [PMID: 40261665 DOI: 10.1097/mcg.0000000000002107] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/15/2024] [Accepted: 10/21/2024] [Indexed: 04/24/2025]
Abstract
BACKGROUND Chronic constipation is a common and complex condition that significantly impairs the quality of life and health care costs. Identifying the underlying cause is crucial for effective management, and hypothyroidism is frequently implicated. Nevertheless, extensive studies are scarce regarding this correlation. The research aims to examine the association between indices of thyroid hormone resistance, particularly the Thyroid Feedback Quantile-based Index of Free Thyroxine (TFQIFT4), and the occurrence of constipation among the population of the United States. METHODS The analysis examined data collected from 6354 participants in the National Health and Nutrition Examination Survey (NHANES) conducted between 2007 and 2010. Chronic constipation was determined as the Bristol Stool Form Scale (BSFS) types of 1 to 2 or <3 bowel movements weekly. Thyroid hormone resistance was assessed using various indices. The statistical analysis comprised weighted logistic regression, restricted cubic splines (RCS), subgroup analysis, and sensitivity analysis. RESULTS Chronic constipation was diagnosed in 10% of participants, displaying distinct characteristics. A nonlinear association between TFQIFT4 and constipation was observed, with inflection points at -0.25 and 0.376. Above a TFQIFT4 value of -0.25, a significantly negative association with constipation was found, primarily in females (OR=0.21; 95% CI: 0.10-0.44). No such association was found in males. CONCLUSIONS The study elucidates a complex correlation between thyroid hormone resistance, particularly TFQIFT4, and constipation. Gender-specific correlations were evident, with TFQIFT4 demonstrating a negative association with constipation, primarily in females. These findings underscore the need for further investigation into the underlying mechanisms involving central thyroid resistance and constipation across genders.
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Affiliation(s)
- Cheng Li
- Department of General Surgery, Fuzhou First General Hospital Affiliated with Fujian Medical University
| | - Ruozhen Wu
- Department of Gastrointestinal Surgery, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian Province, China
| | - Diya Xie
- Department of General Surgery, Fuzhou First General Hospital Affiliated with Fujian Medical University
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Shi L, Shi L, Wei M, Zhang M, Zhang Y, Li J, Maimaiti P. Prevalence, risk factors, impact and management of constipation among adults in Urumqi, China: a cross-sectional survey. Front Nutr 2024; 11:1451527. [PMID: 39555186 PMCID: PMC11563834 DOI: 10.3389/fnut.2024.1451527] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2024] [Accepted: 10/23/2024] [Indexed: 11/19/2024] Open
Abstract
Constipation, a prevalent gastrointestinal disorder, significantly impacts quality of life. This study aimed to investigate the prevalence, risk factors, and implications of constipation in Urumqi City. A cross-sectional survey was conducted from July to August 2023, involving 1,386 participants aged 20-80 years. Data were collected via a self-administered questionnaire, with constipation severity assessed using the Patient Assessment of Constipation Symptoms (PAC-SYM) scale. Key findings indicated that various factors, including residing in rural areas, outdoor work, and sleep disorders, were positively correlated with higher PAC-SYM scores. Conversely, higher daily water intake and certain dietary patterns showed negative correlations. Additionally, increased constipation severity was associated with greater physiological strain and psychosocial concerns (all p < 0.05), emphasizing the disorder's profound effect on quality of life. These findings underscore the need for comprehensive management strategies in Urumqi, considering its diverse lifestyle and dietary factors.
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Affiliation(s)
- Lingyun Shi
- School of Nursing, Xinjiang Medical University, Urumqi, China
- Xinjiang Medical University, Urumqi, China
- The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China
| | - Li Shi
- The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China
| | - Minghui Wei
- School of Nursing, Xinjiang Medical University, Urumqi, China
| | - Mengke Zhang
- School of Nursing, Xinjiang Medical University, Urumqi, China
| | - Yuan Zhang
- School of Nursing, Xinjiang Medical University, Urumqi, China
| | - Jiaxue Li
- School of Nursing, Xinjiang Medical University, Urumqi, China
| | - Palida Maimaiti
- School of Nursing, Xinjiang Medical University, Urumqi, China
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Ota T, Kuratani S, Masaki H, Ishizaki S, Seki H, Takebe T. Impact of chronic constipation symptoms on work productivity and daily activity: A large-scale internet survey. JGH Open 2024; 8:e70042. [PMID: 39502164 PMCID: PMC11532788 DOI: 10.1002/jgh3.70042] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/16/2024] [Revised: 08/07/2024] [Accepted: 09/30/2024] [Indexed: 11/08/2024]
Abstract
Background and Aim Chronic constipation negatively impacts work productivity and patients' quality of life. This retrospective study assessed the correlation between symptoms of chronic constipation and work/activity impairment with and without the use of laxative treatment. Methods This cross-sectional, observational, web-based survey was conducted using the Work Productivity and Activity Impairment-Chronic Constipation Questionnaire and included Japanese patients with chronic constipation receiving prescribed medication. Outcomes of interest included total work productivity and activity impairment and their correlation with constipation symptoms. Results Among the 2351 analyzed patients (mean [SD] age, 51.7 [13.8] years), 80.7% were females, 63.3% had a disease duration of ≥10 years, and 1424 were working. The averages of total activity impairment, total work productivity impairment, presenteeism, and absenteeism were 39.2%, 33.9%, 31.2%, and 5.0%, respectively. The annual work productivity loss per patient was estimated to be 1.343 million Japanese Yen. Symptoms that had a statistically significant positive correlation with total work impairment (P < 0.05) were abdominal discomfort/nausea, abdominal pain, abdominal bloating, and unpredictable defecation timing. Total activity impairment was significantly (P < 0.05) affected by abdominal discomfort/nausea, abdominal bloating, abdominal pain, incomplete defecation, unpredictable defecation timing, loss of defecation desire, and straining. Work productivity and daily activity had improved in 71.2% and 72.6% of patients, respectively, after they received treatment. Conclusion Symptoms of constipation, particularly abdominal symptoms and unpredictable defecation timing, can have a negative impact on work productivity and daily activity. Treatment focused on these symptoms may reduce the socio-economic burden of chronic constipation in Japan.
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Affiliation(s)
- Takumi Ota
- Medical Affairs DepartmentMochida Pharmaceutical Co., Ltd.Shinjuku‐kuTokyoJapan
| | - Shinji Kuratani
- Medical Affairs DepartmentMochida Pharmaceutical Co., Ltd.Shinjuku‐kuTokyoJapan
| | - Hisanori Masaki
- Medical Science Group, Medical DepartmentEA Pharma Co., Ltd.Chuo‐kuTokyoJapan
| | - Sonoko Ishizaki
- Medical Science Group, Medical DepartmentEA Pharma Co., Ltd.Chuo‐kuTokyoJapan
| | - Haruhiko Seki
- Value and Access DepartmentINTAGE Healthcare Inc.Chiyoda‐kuTokyoJapan
| | - Takahiro Takebe
- Medical Affairs DepartmentMochida Pharmaceutical Co., Ltd.Shinjuku‐kuTokyoJapan
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Yamamoto S, Ohashi W, Yamaguchi Y, Igari H, Koshino A, Sugiyama T, Nagao K, Tamura Y, Izawa S, Mano M, Ebi M, Usami J, Hamano K, Izumi J, Wakita Y, Funaki Y, Ogasawara N, Sasanabe R, Sasaki M, Maekawa M, Kasugai K. Factors Associated with Defecation Satisfaction among Japanese Adults with Chronic Constipation. J Clin Med 2024; 13:3216. [PMID: 38892926 PMCID: PMC11172833 DOI: 10.3390/jcm13113216] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/24/2024] [Revised: 05/16/2024] [Accepted: 05/16/2024] [Indexed: 06/21/2024] Open
Abstract
Background: Constipation causes substantial morbidity worldwide. Methods: This survey assessed constipation-related factors in Japan using the Japanese version of the Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) instrument. We also examined the relationship among laxative type, Bristol Stool Form Scale (BSFS) scores, and treatment cost. Finally, we examined differences in satisfaction scores according to laxative type, treatment type, treatment cost, and BSFS score. Results: IBS-QOL-J was higher among those taking salt and/or irritation laxatives. Those paying >JPY 5000 (USD 50.00) had the lowest IBS-QOL-J. IBS-QOL-J was significantly lower among those with a BSFS score of 1 or 2 (severe constipation). Conclusions: This study's findings suggest that a variety of factors, including treatment type and cost, are associated with defecation satisfaction. Those who had hard stools, used multiple laxatives, or spent more on treatment were less satisfied. Future strategies should target therapies that do not require multiple laxatives with lower treatment costs. Adequate defecation with a small number of appropriate laxatives at minimal cost appears to improve defecation satisfaction. It is desirable to identify appropriate laxatives and improve dietary habits and exercise routines. It is also necessary to stop blindly increasing laxative usage and properly diagnose constipation disorders such as anatomical abnormalities other than functional constipation.
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Affiliation(s)
- Sayuri Yamamoto
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
- Division of General Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Wataru Ohashi
- Division of Biostatistics, Clinical Research Center, Aichi Medical University, Nagakute 480-1195, Japan
| | - Yoshiharu Yamaguchi
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Hiroki Igari
- Division of General Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Akira Koshino
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Tomoya Sugiyama
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Kazuhiro Nagao
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Yasuhiro Tamura
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Shinya Izawa
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Mamiko Mano
- Division of Sleep Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Masahide Ebi
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Jun Usami
- Division of General Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Koichi Hamano
- Division of General Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Junko Izumi
- Division of General Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Yoshinori Wakita
- Division of General Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Yasushi Funaki
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Naotaka Ogasawara
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Ryujiro Sasanabe
- Division of Sleep Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Makoto Sasaki
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
| | - Masato Maekawa
- Division of General Medicine, Aichi Medical University, Nagakute 480-1195, Japan
| | - Kunio Kasugai
- Division of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Japan
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Xiong Z, Ma P, Zhang H, Liu C, Liu B, Liu Z, Yan S. Placebo response to sham electroacupuncture in patients with chronic functional constipation: A secondary analysis. Neurogastroenterol Motil 2024; 36:e14770. [PMID: 38361038 DOI: 10.1111/nmo.14770] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/27/2023] [Revised: 01/30/2024] [Accepted: 02/08/2024] [Indexed: 02/17/2024]
Abstract
BACKGROUND Chronic severe functional constipation is a common disease that requires novel and effective treatment strategies. Acupuncture might constitute a promising therapeutic approach for chronic constipation, but it reportedly engenders an enhanced placebo response. Herein, we aimed to determine the magnitude of the placebo responses to electroacupuncture for constipation and identify its influencing factors. METHODS In this secondary analysis of a multicenter randomized trial, patients were randomized to a sham electroacupuncture group, which was administered for 8 weeks in 24 sessions of superficial needling at nonacupoints. The placebo response rates were assessed using three responder criteria: ≥3 complete spontaneous bowel movements per week (CSBMs/week), overall CSBM, and sustained CSBM. Logistic regression with backward selection method was employed to identify the potential factors that affected the placebo response. KEY RESULTS Overall, 539 patients were included in the study. The placebo response rate was 10.58%, 9.46%, and 9.09% according to the three aforementioned criteria, respectively. Those who exhibited more CSBMs/week at baseline were more likely to respond to sham electroacupuncture. Among patients with more than one CSBM per week at baseline, the response rates for achieving the criteria of ≥3 CSBMs per week, overall CSBM, and sustained CSBM were 25.40%, 30.16%, and 22.22%. CONCLUSIONS AND INFERENCE Electroacupuncture did not demonstrate a large placebo response in functional constipation treatment. The number of CSBMs at baseline may be a moderator of the placebo response to sham electroacupuncture. Thus, superficial needling sham acupuncture may be considered an ideal sham control for clinical trials of chronic constipation.
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Affiliation(s)
- Zhiyi Xiong
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
| | - Peihong Ma
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
| | - Haoran Zhang
- College of Preschool Education, Beijing Youth Politics College, Beijing, China
| | - Cunzhi Liu
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
| | - Baoyan Liu
- China Academy of Chinese Medical Sciences, Beijing, China
| | - Zhishun Liu
- Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
| | - Shiyan Yan
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
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Lin YC, Yan HT. Impact of dietary sodium restriction on falls among middle-aged and older adults: Results of an 8-year longitudinal study. Geriatr Gerontol Int 2024; 24 Suppl 1:292-299. [PMID: 37718504 DOI: 10.1111/ggi.14669] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2023] [Revised: 08/14/2023] [Accepted: 08/30/2023] [Indexed: 09/19/2023]
Abstract
AIM This study aimed to understand the relationship between dietary sodium restriction (DSR) and falling experiences in middle-aged and older adults. METHODS The 8-year follow-up data from the Taiwan Longitudinal Study on Aging, covering 5131 individuals aged ≥50 years, were analyzed using random-effects panel logit models. Participants were asked to indicate whether they were told by a physician to reduce or avoid sodium intake from food and whether they had had fall experiences during the past year. We modelled falling experiences as a function of DSR (independent variable), involuntary body weight loss and walking difficulty (mediators), and chronic diseases (moderator), adjusting for individual-level characteristics. RESULTS Individuals with DSR were at a higher risk of falls compared with those with no DSR (adjusted odds ratio [AOR] = 1.30, 95% confidence interval [CI] = 1.11-1.53). This effect was more prevalent in individuals with a history of stroke (AOR = 1.85, 95% CI = 1.19-2.87). Those told to reduce sodium intake by a physician were likely to lose weight involuntarily (AOR = 1.20, 95% CI = 1.05-1.36) and had difficulty walking up two or three flights of stairs alone (AOR = 2.38, 95% CI = 1.73-3.27), which mediated the effect of DSR on increased fall risk (AOR = 1.15, 95% CI = 0.95-1.38). We found a temporal effect: participant reactions to short- and mid-term DSR were significant. CONCLUSIONS DSR was associated with a greater likelihood of falls among middle-aged and older adults, particularly those with a history of stroke. Geriatr Gerontol Int 2024; 24: 292-299.
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Affiliation(s)
- Yu-Chun Lin
- Department of Chinese Medicine, China Medical University Hospital, Taichung City, Taiwan
- Graduate Institute of Integrated Medicine, China Medical University, Taichung City, Taiwan
| | - Huang-Ting Yan
- Institute of Political Science, Academia Sinica, Taipei City, Taiwan
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Phung TH, Pitt E, Alexander K, Bradford N. Non-pharmacological interventions for chemotherapy-induced diarrhoea and constipation management: A scoping review. Eur J Oncol Nurs 2024; 68:102485. [PMID: 38104513 DOI: 10.1016/j.ejon.2023.102485] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/18/2023] [Revised: 11/16/2023] [Accepted: 11/26/2023] [Indexed: 12/19/2023]
Abstract
PURPOSE Chemotherapy-induced diarrhoea (CID) and constipation (CIC) are among the most common and severe gastrointestinal symptoms related to chemotherapy. This review aimed to identify and describe the evidence for non-pharmacological interventions for the management of CID and CIC. METHODS The scoping review was based on the Joanna Briggs Institute methodology and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Evidence from five databases were included: CINAHL, MEDLINE, Embase, PubMed, and APA PsycInfo. Data were systematically identified, screened, extracted and synthesised narratively to describe the evidence for non-pharmacological interventions and their effects on CID and CIC. RESULTS We included 33 studies, of which 18 investigated non-pharmacological interventions for CID management, six for CIC management, and nine for both CID and CIC management. Interventions were categorized into five groups, including (1) digital health interventions, (2) physical therapies, (3) diet and nutrition therapies, (4) education, and (5) multimodal. Diet and nutrition therapies were the most common to report potential effectiveness for CID and CIC outcomes. Most of the interventions were implemented in hospitals under the supervision of healthcare professionals and were investigated in randomised control trials. CONCLUSIONS The characteristics of non-pharmacological interventions were diverse, and the outcomes were inconsistent among the same type of interventions. Diet and nutritional interventions show promise but further research is needed to better understand their role and to contribute to the evidence base. Nurses are well placed to assess and monitor for CIC and CID, and also deliver effective non-pharmacological interventions.
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Affiliation(s)
- Thi Hanh Phung
- School of Nursing, Faculty of Health, N block, Queensland University of Technology, Kelvin Grove, 4059, Australia; Faculty of Nursing and Midwifery, Hanoi Medical University, Hanoi, Viet Nam.
| | - Erin Pitt
- School of Nursing, Faculty of Health, N block, Queensland University of Technology, Kelvin Grove, 4059, Australia; Cancer and Palliative Care Outcomes Centre, Centre for Healthcare Transformation, Queensland University of Technology, X block, 66 Musk Avenue, Kelvin Grove, 4059, Australia; Cancer Nurses Society of Australia, 165 Sovereign Hill Drive, Gabbadah, Western Australia, 6041, Australia
| | - Kimberly Alexander
- School of Nursing, Faculty of Health, N block, Queensland University of Technology, Kelvin Grove, 4059, Australia; Cancer and Palliative Care Outcomes Centre, Centre for Healthcare Transformation, Queensland University of Technology, X block, 66 Musk Avenue, Kelvin Grove, 4059, Australia; Cancer Nurses Society of Australia, 165 Sovereign Hill Drive, Gabbadah, Western Australia, 6041, Australia; Centre for Children's Health Research, Children's Health Queensland Hospital and Health Services, South Brisbane, 4101, Australia
| | - Natalie Bradford
- School of Nursing, Faculty of Health, N block, Queensland University of Technology, Kelvin Grove, 4059, Australia; Cancer and Palliative Care Outcomes Centre, Centre for Healthcare Transformation, Queensland University of Technology, X block, 66 Musk Avenue, Kelvin Grove, 4059, Australia; Cancer Nurses Society of Australia, 165 Sovereign Hill Drive, Gabbadah, Western Australia, 6041, Australia; Centre for Children's Health Research, Children's Health Queensland Hospital and Health Services, South Brisbane, 4101, Australia
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Yang J, Guo J, Yang X, Chen J, Bai T, Liu S. Nocebo effects and influencing factors in the randomized clinical trials of chronic constipation: A systematic review and meta-analysis. Neurogastroenterol Motil 2024; 36:e14708. [PMID: 37936549 DOI: 10.1111/nmo.14708] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2022] [Revised: 09/22/2023] [Accepted: 10/26/2023] [Indexed: 11/09/2023]
Abstract
BACKGROUND Nocebo effects are unavoidable in randomized clinical trials. We aimed to assess the magnitude of nocebo effects and explore the influencing factors in chronic constipation. METHODS We searched the PubMed, Embase, and Cochrane Library databases up to July 2022. Randomized, placebo-controlled trials investigating interventions in chronic constipation were included. We conducted a random effects meta-analysis of the proportion of adverse events (AEs) in placebo-treated participants and evaluated the effect of trial characteristics on nocebo effects. KEY RESULTS We identified 20,204 studies from the databases, of which 61 were included in the final analysis. The pooled placebo AE rate was 30.41%, and AE-related withdrawal rate was 1.53%. The most commonly reported AEs were headache (5.67%), diarrhea (4.45%), abdominal pain (3.98%), nasopharyngitis (3.39%), nausea (3.36%), and flatulence (2.95%). The placebo AE rate was lower in trials conducted in Asia compared to those in Europe, North America, and international trials. It was also lower in trials diagnosed by Rome III compared to clinician's opinion and Rome II. Additionally, the placebo AE rate was lower in single-center trials compared to multicenter trials, lower in 5-8 weeks therapy compared to 9-12 weeks therapy, lower in participants with FC compared to those with IBS-C and CC, lower in trials with 2 arms compared to 3 arms, and higher in trials with prokinetic drugs compared to secretagogues and laxatives. CONCLUSIONS & INFERENCES The placebo AE rate was 30.41% in patients with chronic constipation. Based on our findings, we recommend that researchers take the nocebo effects into consideration when designing and conducting clinical trials and adopt specific measures to mitigate the negative influence of nocebo effects.
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Affiliation(s)
- Jingze Yang
- Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Jinlu Guo
- Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Xin Yang
- Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Jie Chen
- Department of Pathology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Tao Bai
- Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Shi Liu
- Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
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10
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Ishibashi K, Urabe Y, Vu NTH, Miyauchi S, Nakamura T, Konishi H, Mizuno J, Fukuhara M, Takigawa H, Yuge R, Quach DT, Oka S, Hiyama T. Clinical factors associated with stable treatment of chronic constipation in Japanese patients. BMC Gastroenterol 2024; 24:52. [PMID: 38287249 PMCID: PMC10823644 DOI: 10.1186/s12876-024-03140-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2023] [Accepted: 01/17/2024] [Indexed: 01/31/2024] Open
Abstract
BACKGROUND/AIMS Chronic constipation (CC) is one of the most common gastrointestinal disorders in the general population. Although there are many treatment options, achieving a stable treatment for CC remains one of the challenges in clinical practice. This study aimed to evaluate the clinical factors associated with stable treatment for CC in Japanese patients. METHODS A retrospective, cross-sectional, and multicenter study was carried out. Patients were eligible for inclusion if they fulfilled the Rome IV criteria for diagnosing CC and had been treated for at least one and a half years. Patients with up to two prescription modifications for CC in one year were defined as the stable treatment group, whereas those with three or more prescription changes were defined as the unstable treatment group. Univariate and multivariate analyses were carried out to identify factors associated with CC. RESULTS A total of 114 patients have been recruited. There were 82 patients (77.0%) in the stable treatment group and 32 patients (23.0%) in the unstable treatment group. Based on multivariate likelihood analysis, only using acid-suppressive drugs contributed to stability treatment in CC patients (odds ratio: 2.81, 95% confidence interval: 1.12-7.08, p = 0.03). CONCLUSION Administration of acid-suppressive drugs was the only factor related to the stability of CC treatment. Further studies are needed to validate the results as well as clarify the causes.
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Affiliation(s)
- Kazuki Ishibashi
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Yuji Urabe
- Department of Gastrointestinal Endoscopy and Medicine, Hiroshima University Hospital, Hiroshima, Japan
| | - Nhu Thi Hanh Vu
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
- Department of Internal Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh, Vietnam
| | - Shunsuke Miyauchi
- Health Service Center, Hiroshima University, 1-7-1 Kagamiyama, 739-8514, Higashihiroshima, Japan
| | - Takeo Nakamura
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Hirona Konishi
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Junichi Mizuno
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Motomitsu Fukuhara
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Hidehiko Takigawa
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Ryo Yuge
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Duc Trong Quach
- Department of Internal Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh, Vietnam
| | - Shiro Oka
- Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Toru Hiyama
- Health Service Center, Hiroshima University, 1-7-1 Kagamiyama, 739-8514, Higashihiroshima, Japan.
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11
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He M, Ding G, Yang Y, Zhong J. Bowel habits were associated with mortality in chronic kidney disease: results from a nationwide prospective cohort study. Ren Fail 2023; 45:2292150. [PMID: 38093521 PMCID: PMC10732187 DOI: 10.1080/0886022x.2023.2292150] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/05/2023] [Accepted: 12/03/2023] [Indexed: 12/18/2023] Open
Abstract
PURPOSE Bowel habits may affect the prognosis in the chronic kidney disease (CKD) patients. This study aimed to explore the association of bowel habits with cardiovascular and all-cause mortality in CKD. METHODS 2460 CKD patients in the National Health and Nutrition Examination Survey (NHANES) from 2005 through 2010 without missing data for bowel habits and mortality were enrolled. Bowel habits including bowel movements (BMs) per week and stools consistency were obtained by standard interview. Mortality status and cause of death were determined by NHANES-linked National Death Index records through 31 December 2015. Cox proportional hazard models and Kaplan-Meier analysis were used to evaluate the association of bowel habits with cardiovascular and all-cause mortality. RESULTS A total of 2460 CKD patients with an average age of 60.80 ± 0.57 years were enrolled. During an average follow-up of 87.47 ± 0.98 months, 144 cardiovascular and 669 all-cause deaths were documented. Reporting 3 or fewer BMs per week was associated with cardiovascular (HR = 1.83, 95% CI: 1.06, 3.17) and all-cause mortality (HR = 1.71, 95% CI: 1.20, 2.43). More than 10 BMs per week also increased the risk of all-cause mortality (HR = 1.21, 95% CI: 1.01, 1.45). Hard stools consistency increased the risk of all-cause mortality (HR= 2.00, 95% CI: 1.48, 2.70) compared with those reporting normal stools. CONCLUSION Low stool frequency and hard stool consistency were associated with an increased risk of mortality in patients with CKD.
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Affiliation(s)
- Meng He
- Department of Nephrology, Mingguang People’s Hospital, Chuzhou, China
| | - Guanggui Ding
- Department of Nephrology, Mingguang People’s Hospital, Chuzhou, China
| | - Yongbiao Yang
- Department of Nephrology, Mingguang People’s Hospital, Chuzhou, China
| | - Jie Zhong
- Department of Nephrology, Mingguang People’s Hospital, Chuzhou, China
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12
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Borges NA, Sahiun E, Ribeiro-Alves M, Regis B, Mafra D. Effects of Polydextrose Supplementation on Intestinal Function in Hemodialysis Patients: A Double-Blind, Randomized, Placebo-Controlled Trial. J Ren Nutr 2023; 33:747-754. [PMID: 37321430 DOI: 10.1053/j.jrn.2023.06.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2023] [Revised: 06/05/2023] [Accepted: 06/06/2023] [Indexed: 06/17/2023] Open
Abstract
OBJECTIVES Intestinal constipation is a frequent complication in hemodialysis (HD) patients. Polydextrose (PDX), a nondigestible oligosaccharide, has been reported as a fermentable fiber with potential benefits. This study aimed to investigate the possible influence of PDX supplementation on intestinal function in HD patients. METHODS This randomized, double-blind, placebo-controlled trial included 28 patients who received daily oral supplementation with 12 g of PDX or placebo (corn starch) for 2 months. ROME IV criteria were used to define constipation and questionnaires were applied to patient assessment of constipation symptoms (PAC-SYM) and their impact on the patient assessment of constipation quality of life. The Bristol scale was used to assess stool consistency. Commercial Enzyme-Linked Immuno Sorbent Assay kits were used to evaluate the interleukin-6 and tumor necrosis factor-α plasma levels. RESULTS 25 patients completed the study; 16 in the PDX group [7 females, 48.5 years (IQR = 15.5)] and 9 in the control group [3 females, 44.0 years (IQR = 6.0)]. According to ROME IV criteria, 55% of patients were diagnosed with constipation. PAC-SYM faecal symptoms domain was reduced after 2 months of PDX supplementation (P = .004). We also observed a significant reduction in the PAC-QoL-concerns domain (P = .02). The average values for PAC-SYM and patient assessment of constipation quality of lifewere reduced significantly after intervention with PDX. There were no significant changes after the intervention period concerning biochemical variables, food intake, and inflammation markers. No adverse effects were observed during the supplementation period. CONCLUSIONS The results of the present study suggest that short-term PDX supplementation may have favourable results on intestinal function and the quality of life of chronic kidney disease patients in HD.
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Affiliation(s)
- Natalia Alvarenga Borges
- Postgraduate Program in Food, Nutrition and Health - Institute of Nutrition, State University of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil
| | - Elaine Sahiun
- Postgraduate Program in Food, Nutrition and Health - Institute of Nutrition, State University of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil
| | - Marcelo Ribeiro-Alves
- HIV/AIDS Clinical Research Center, National Institute of Infectious Diseases Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil
| | - Bruna Regis
- Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Rio de Janeiro, Brazil
| | - Denise Mafra
- Graduate Program in Biological Sciences - Physiology, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro (RJ), Brazil.
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Wu Y, Ying Q, He Y, Xie X, Yuan X, Wang M, Fei X, Yang X. Effect of external therapies of traditional Chinese medicine on constipation in patients with CRF: A meta-analysis. PLoS One 2023; 18:e0291968. [PMID: 37796899 PMCID: PMC10553223 DOI: 10.1371/journal.pone.0291968] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2023] [Accepted: 09/10/2023] [Indexed: 10/07/2023] Open
Abstract
OBJECTIVE The purpose of this study was to evaluate the curative effect of external therapies of traditional Chinese medicine on constipation in patients with chronic renal failure and to provide scientific theoretical basis for clinical practice. METHOD We searched the English database of PubMed, EMBASE, the Cochrane Library and the Web of Science and Chinese database of CNKI, Wan fang database, VIP Database and China Biomedical Literature Database up to December 2022. Randomized controlled trials (RCTs) involving constipation in patients with CRF that compared external therapies of traditional Chinese medicine and routine treatment to routine treatment were eligible for the analysis. A meta-analysis of the outcome indicators including total efficiency, weekly defecation times, defecation time, defecation difficulty score, patient-assessment of constipation quality of life and adverse events of treatment were performed. The analysis was performed by using Review Manager version 5.3. RESULT A total of 23 studies were included, with 1764 patients. Meta-analysis results showed that compared with the control group, the test group could significantly increase weekly defecation times(MD = 0.94, 95%CI(0.70, 1.18), Z = 7.74, P < 0.00001), reduce defecation time(MD = -2.92, 95%CI(-3.69, -2.16), Z = 7.49, P < 0.00001), reduce defecation difficulty score(MD = -1.92, 95%CI(-2.45, -1.39), Z = 7.11, P < 0.00001), improve the quality of life in patients with constipation(MD = -7.57, 95%CI(-10.23, -4.91), Z = 5.58, P < 0.00001) and obtain a higher total effective rate of treatment(OR = 4.53, 95%CI(3.27, 6.29), Z = 9.07, P < 0.00001). In terms of safety, there was no statistical significance in the incidence of adverse events between two groups(OR = 0.35, 95%CI(0.04, 2.95), Z = 0.96, P = 0.34). CONCLUSION The combination of external therapies of traditional Chinese medicine and routine treatment could achieve an excellent curative effect, and there was no specific adverse event. However because of the limited level of current evidence, more high-quality trials are needed in the future.5.
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Affiliation(s)
- Yu Wu
- Department of Nephrology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Qisu Ying
- Department of Nephrology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Yajing He
- Department of Nephrology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Xiangcheng Xie
- Department of Nephrology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Xiao Yuan
- Department of Nursing, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Ming Wang
- Department of Nephrology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Xiao Fei
- Department of Nephrology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Xiu Yang
- Department of Nephrology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
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Lee VV, Lau NY, Blasiak A, Siah KTH, Ho D. Involving patients in the process: Development of a constipation patient-reported outcome measure for symptoms and quality of life. Comput Struct Biotechnol J 2023; 22:41-49. [PMID: 37822352 PMCID: PMC10563011 DOI: 10.1016/j.csbj.2023.09.034] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/21/2023] [Revised: 09/26/2023] [Accepted: 09/27/2023] [Indexed: 10/13/2023] Open
Abstract
Objective Patient-reported outcome measures (PROMs) are useful standardized tools to measure current patient health status and well-being. While there are existing constipation-related PROMs, the majority of PROMs were not developed with adequate patient involvement and few examined content validity. Accordingly, the current study aimed to develop a constipation PROM with multiple phases of patient and clinician involvement. Methods To generate PROM items, 15 patients with chronic constipation (age range =28-79 years, 10 females) underwent a qualitative interview exploring their experiences with chronic constipation. Following that, eight clinical experts completed the content validity index (CVI) ratings of all the items generated to assess content validity. Based on results of the content validity assessment, relevant items were maintained and 12 participants with chronic constipation were re-interviewed to obtain feedback about comprehensibility, comprehensiveness and relevance. Results Six themes and 25 sub-themes emerged from the qualitative interview, and an initial list of 33 symptom items and 18 quality of life (QoL) items were generated. Based on the CVIs calculated, 11 symptom items and nine QoL items were maintained with the scale-content validity index indicating excellent content validity. Overall, participants indicated the PROM to be relevant, comprehensive and easy to understand however, minor amendments were made to improve the three qualities of interest. Conclusion The current study developed a constipation PROM that measures both symptom severity and constipation-related QoL, with supporting evidence for relevance, comprehensiveness and comprehensibility. Further prioritization should be given to validating and exploring new digital modalities of PROM administration.
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Affiliation(s)
- V Vien Lee
- The N.1 Institute for Health, National University of Singapore, Singapore
- The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore
| | - Ni Yin Lau
- The N.1 Institute for Health, National University of Singapore, Singapore
- The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore
| | - Agata Blasiak
- The N.1 Institute for Health, National University of Singapore, Singapore
- The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore
- Department of Biomedical Engineering, College of Design and Engineering, National University of Singapore, Singapore
- Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
| | - Kewin Tien Ho Siah
- Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital, Singapore
- Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
| | - Dean Ho
- The N.1 Institute for Health, National University of Singapore, Singapore
- The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore
- Department of Biomedical Engineering, College of Design and Engineering, National University of Singapore, Singapore
- Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
- Bia-Echo Asia Centre for Reproductivity Longevity and Equality (ACRLE), Yong Loo Lin School of Medicine, National University of Singapore, Singapore
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Tardy AL, Marguet S, Costantino H, Stewart A, Mackie D, Saba G, Amand C. Profile and quality of life of the adult population in good health according to the level of vitality: European NHWS cross sectional analysis. BMC Public Health 2023; 23:1061. [PMID: 37277779 DOI: 10.1186/s12889-023-15754-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/07/2022] [Accepted: 04/13/2023] [Indexed: 06/07/2023] Open
Abstract
BACKGROUND The World Health Organization's definition of health highlights the importance of mental and physical wellbeing and not only disease state. However, lack of awareness on the burden of impaired vitality and its impact on the quality of life of the general healthy population prevents healthcare providers from delivering appropriate solutions and advice. This study aims to better characterize this population in Europe and identify the profile and the health reported outcomes associated with impaired vitality. METHODS This retrospective observational study included National Health and Wellness Survey (NHWS) data collected in healthy participants aged 18-65 years from five European Union countries in 2018. Socio-demographic and lifestyle characteristics, comorbidities, attitudes towards healthcare systems, Patient Activation Measure, health-related quality of life outcomes (EQ-5D), and work productivity and activity impairment were analysed according to SF-12 vitality score subgroups (≥ 60, 50- < 60, 40- < 50, < 40). RESULTS A total of 24,295 participants were enrolled in the main analysis. Being a female, younger, having a lower income and being obese or having sleep and mental disorders was associated with an increased risk of impaired vitality. This was associated with a higher consumption of healthcare resources along with having a weak patient-physician relationship. Participants who were disengaged in the self-management of their health were 2.6 times more likely to have a low level of vitality. For participants in the lowest vitality group, odds of mobility problems increased by 3.4, impairment of usual activity by 5.8, increased of pain and discomfort by 5.6 and depression and anxiety by 10.3, compared with participants in the highest vitality group. Also, odds of presenteeism increased by 3.7, overall work impairment by 3.4 and daily activity losses by 7.1. CONCLUSION Evidence-based trends facilitate the identification of a healthy population with impaired vitality in real-world practice. This study highlights the actual burden of low vitality on daily life activities, particularly on mental health and reduced work productivity. Additionally, our results underline the importance of self-engagement in the management of vitality impairment and highlights the need to implement strategies to address this public health concern in the affected population (HCP-patient communication, supplements, meditation).
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Affiliation(s)
| | | | | | - Andrew Stewart
- Science Hub, Sanofi Consumer Healthcare Cambridge, Cambridge, MA, USA
| | | | | | - Caroline Amand
- Science Hub, Sanofi Consumer Healthcare, Gentilly, France.
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Nojkov B, Baker JR, Chey WD, Saad R, Watts L, Armstrong M, Collins K, Ezell G, Phillips C, Menees S. Age- and Gender-Based Differences in Anorectal Function, Gastrointestinal Symptoms, and Constipation-Specific Quality of Life in Patients with Chronic Constipation. Dig Dis Sci 2023; 68:1403-1410. [PMID: 36173584 DOI: 10.1007/s10620-022-07709-z] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2022] [Accepted: 09/21/2022] [Indexed: 12/09/2022]
Abstract
BACKGROUND The effect of age and gender differences on anorectal function, symptoms severity, and quality of life (QoL) in patients with chronic constipation (CC) is not well studied. This study examines the impact of age and gender on anorectal function testing (AFT) characteristics, symptoms burden, and QoL in patients with CC. METHODS This is a retrospective analysis of prospectively collected data from 2550 adults with CC who completed AFT. Collected data include demographics, sphincter response to simulated defecation during anorectal manometry (ARM), balloon expulsion testing (BET), and validated surveys assessing constipation symptoms and QoL. DD was defined as both the inability to relax the anal sphincter during simulated defecation and an abnormal BET. RESULTS 2550 subjects were included in the analysis (mean age = 48.6 years). Most patients were female (81.6%) and Caucasian (82%). 73% were < 60 years old (mean = 41) vs. 27% ≥ 60 years old (mean = 69). The prevalence of impaired anal sphincter relaxation on ARM, abnormal BET, and DD in patients with CC was 48%, 42.1%, and 22.9%, respectively. Patients who were older and male were significantly more frequently diagnosed with DD and more frequently had impaired anal sphincter relaxation on ARM, compared to patients who were younger and female (p < 0.05). Conversely, CC patients who were younger and female reported greater constipation symptoms severity and more impaired QoL (p ≤ 0.004). CONCLUSION Among patients with CC referred for anorectal function testing, men and those older than 60 are more likely to have dyssynergic defecation, but women and patients younger than 60 experience worse constipation symptoms and QoL.
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Affiliation(s)
- Borko Nojkov
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA.
| | - Jason R Baker
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - William D Chey
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - Richard Saad
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - Lydia Watts
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - Moira Armstrong
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - Kristen Collins
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - Gabrielle Ezell
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - Cari Phillips
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
| | - Stacy Menees
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, University of Michigan Health System, 3912 Taubman Center, 1500 E. Medical Center Dr. SPC 5362, Ann Arbor, MI, 48109, USA
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Effects of Bowel Training and Defecation Posture on Chronic Constipation in Older Adults With Dementia: A Randomized Controlled Trial. Am J Gastroenterol 2023; 118:531-538. [PMID: 36066478 DOI: 10.14309/ajg.0000000000001986] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/19/2022] [Accepted: 08/16/2022] [Indexed: 12/11/2022]
Abstract
INTRODUCTION Chronic constipation (CC), which can cause behavioral and psychiatric symptoms of dementia and related caregiver distress, is common in older adults admitted to care facilities with dementia. This study aimed to examine the effect of defecation care on CC and related problems. METHODS This study compared bowel training and defecation posture intervention (intervention group) with general care (control group) as the treatment of CC among older adults with dementia in 6 long-term care facilities. The primary outcomes were the number of spontaneous bowel movements (SBMs) and complete SBMs. The secondary outcomes were Patient Assessment of Constipation Quality of Life Questionnaire, Constipation Scoring System, constipation symptoms, and Neuropsychiatric Inventory Nursing Home Version scores. The differences were analyzed using 2-way ANOVA with repeated measures. RESULTS The data of 30 patients (14 in the intervention group, 16 in the control group) were analyzed. Weekly mean complete SBMs increased from 0.53 times at baseline to 1.58 times at 8 weeks in the intervention group compared with a change from 0.56 to 0.43 times in the control group (interaction P < 0.001). The Patient Assessment of Constipation Quality of Life Questionnaire, Constipation Scoring System, behavioral and psychiatric symptoms of dementia, and caregiver distress scores showed significant improvement after 8 weeks of defecation care intervention. DISCUSSION Defecation care, including bowel training and appropriate defecation posture, is effective for CC among older adults with dementia, improving patient mental health and reducing burden on caregivers.
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Ito M, Yoshimoto J, Maeda T, Ishii S, Wada Y, Kishi M, Koikeda T. Effects of high-fiber food product consumption and personal health record use on body mass index and bowel movement. J Funct Foods 2023. [DOI: 10.1016/j.jff.2023.105443] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/12/2023] Open
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Kon R, Ikarashi N, Onuma K, Yasukawa Z, Ozeki M, Sakai H, Kamei J. Effect of partially hydrolyzed guar gum on the expression of aquaporin-3 in the colon. Food Sci Nutr 2023; 11:1127-1133. [PMID: 36789055 PMCID: PMC9922137 DOI: 10.1002/fsn3.3150] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2022] [Revised: 10/29/2022] [Accepted: 11/08/2022] [Indexed: 11/19/2022] Open
Abstract
In recent years, the development of functional foods targeting gastrointestinal disorders has been in progress. Partially hydrolyzed guar gum (PHGG), which is a water-soluble dietary fiber, is known to have a constipation-improving effect. However, many aspects of the mechanism remain unclear. In this study, we investigated the role of aquaporin-3 (AQP3), which regulates the water content of feces in ameliorative effect of PHGG on constipation. Rats were allowed to freely consume a normal diet or a diet containing 5% PHGG for 14 days, and defecation parameters were measured. We also analyzed the expression levels of genes involved in water transport in the colon. The defecation frequency and volume of rats treated with PHGG were not different from those from the control group, but the fecal water content was significantly increased, and soft stools were observed. The expressions of claudin-1, tight junction protein-1, and cadherin-1, which are involved in tight junctions or adherens junctions, were almost the same in the PHGG-treated group and the control group. The expression level of AQP3 in the colon was significantly decreased in the PHGG-treated group. In this study, PHGG decreased the colonic AQP3 expression, thereby suppressing water transport from the luminal side to the vascular side and improving constipation.
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Affiliation(s)
- Risako Kon
- Department of Biomolecular PharmacologyHoshi UniversityTokyoJapan
| | | | - Kazuhiro Onuma
- Department of Biomolecular PharmacologyHoshi UniversityTokyoJapan
| | - Zenta Yasukawa
- Department of Nutrition, Faculty of NutritionKanazawa Gakuin UniversityIshikawaJapan
| | | | - Hiroyasu Sakai
- Department of Biomolecular PharmacologyHoshi UniversityTokyoJapan
| | - Junzo Kamei
- Advanced Research Institute for Health ScienceJuntendo UniversityTokyoJapan
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Ishimaru K, Kakuto H, Yukumi S, Akita S, Ogi Y, Kikuchi S, Yoshida M, Koga S, Egi H, Watanabe Y, Ono Y, Watanabe H. Imaging Classification of Constipation. J Anus Rectum Colon 2023; 7:25-29. [PMID: 36743467 PMCID: PMC9876606 DOI: 10.23922/jarc.2022-039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/26/2022] [Accepted: 10/05/2022] [Indexed: 01/25/2023] Open
Abstract
Objectives The diagnosis of patients with chronic constipation is very complicated. This study aimed to develop a simple imaging classification for the diagnosis of chronic constipation by abdominal computed tomography (CT). Methods Sixty-two patients who underwent abdominal CT in our hospital between January and June 2022 were enrolled. The CT values of the stool in the rectum and cecum were measured in patients with chronic constipation (C group) and in those without (non-C group). Results A strong correlation was observed between the Bristol Stool Form Scale (BSFS) and the CT value of rectal stool. Furthermore, the rectal stool CT value was significantly higher in patients with chronic constipation than in those without. The CT value of cecal stool did not differ between the two groups. The cecal stool CT value was significantly higher in patients with severe constipation (BSFS 1) than in those with BSFS 2-6. A cutoff CT value of 100 was selected as the optimal value for indicating chronic constipation. Conclusions Abdominal CT was useful in the diagnosis of chronic constipation. If the patient had constipation, the optimal cutoff CT value was 100.
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Affiliation(s)
- Kei Ishimaru
- Department of Minimally Invasive Gastroenterology, Ehime University Graduate School of Medicine, Toon, Japan
| | | | - Shungo Yukumi
- Department of Surgery, National Hospital Organization Ehime Medical Center, Toon, Japan
| | - Satoshi Akita
- Department of Minimally Invasive Gastroenterology, Ehime University Graduate School of Medicine, Toon, Japan
| | - Yusuke Ogi
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, Toon, Japan
| | - Satoshi Kikuchi
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, Toon, Japan
| | - Motohira Yoshida
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, Toon, Japan
| | - Shigejiro Koga
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, Toon, Japan
| | - Hiroyuki Egi
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, Toon, Japan
| | - Yuji Watanabe
- Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, Toon, Japan
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Li F, Wang M, Shah SHA, Jiang Y, Lin L, Yu T, Tang Y. Clinical Characteristics of Adult Functional Constipation Patients with Rectoanal Areflexia and Their Response to Biofeedback Therapy. Diagnostics (Basel) 2023; 13:diagnostics13020255. [PMID: 36673065 PMCID: PMC9857652 DOI: 10.3390/diagnostics13020255] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2022] [Revised: 01/08/2023] [Accepted: 01/09/2023] [Indexed: 01/11/2023] Open
Abstract
Background: The London Classification for anorectal physiological dysfunction specifically proposes rectoanal areflexia (RA), which means the absence of a rectoanal inhibitory reflex (RAIR) based on a manometric diagnosis. Although RA is not observed in healthy people, it can be found in adult patients with functional constipation (FC). This study describes the clinical manifestations of adult patients with FC and RA and their response to biofeedback therapy (BFT). Methods: This retrospective study reviewed the reports of high-resolution anorectal manometry (HR-ARM) and the efficacy of BFT in adult patients with FC. In addition, the Constipation Scoring System (CSS) scale, Patient Assessment of Constipation Symptoms (PAC-SYM) scale, Patient Assessment of Constipation Quality of Life (PAC-QOL) scale, Zung’s Self-Rating Anxiety Scale (SAS), Zung’s Self-Rating Depression Scale (SDS), balloon expulsion test (BET), and the use of laxatives were assessed. Results: A total of 257 adult patients diagnosed with FC were divided into the RA group (n = 89) and the RAIR group (n = 168). In the RA and RAIR groups, 60 (67.4%) and 117 (69.6%) patients, respectively, had dyssynergic defecation (DD) during simulated defecation. Type II pattern of dyssynergia was most frequently observed in both groups. Compared with the RA group, the RAIR group showed a higher CSS score, physical discomfort score, and prevalence of inadequate relaxation of the anal sphincter (p < 0.001, p = 0.036, and p = 0.017, respectively). The anxiety and depression scores were not different between the two groups. The proportion of patients using volumetric and stimulant laxatives and their combination was significantly higher in FC patients with RA, whereas the efficacy of BFT was significantly lower (p = 0.005, p < 0.001, p = 0.045, and p = 0.010, respectively). Conclusion: Adult FC patients with RA may suffer more severe constipation and have a lower efficacy of BFT compared with those with RAIR.
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Affiliation(s)
| | | | | | | | | | - Ting Yu
- Correspondence: (T.Y.); (Y.T.)
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22
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Yagi S, Furukawa S, Miyake T, Yoshida O, Shiraishi K, Tange K, Hashimoto Y, Kitahata S, Ninomiya T, Hanayama M, Suzuki S, Shibata N, Murakami H, Ohashi K, Tomida H, Yamamoto Y, Takeshita E, Ikeda Y, Hiasa Y. Aging is Associated With Constipation in Japanese Patients With Ulcerative Colitis: A Post Hoc Analysis. Gerontol Geriatr Med 2023; 9:23337214231215637. [PMID: 38035264 PMCID: PMC10683382 DOI: 10.1177/23337214231215637] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2023] [Revised: 10/21/2023] [Accepted: 11/05/2023] [Indexed: 12/02/2023] Open
Abstract
Aim: Age is a risk factor for constipation. Constipation is common in patients with ulcerative colitis (UC) and has been positively associated with disease activity, but evidence is limited. This study aimed to assess the association between disease activity and constipation in patients with UC. Methods: The study subjects consisted of 290 Japanese UC patients. The definition of constipation was based on Rome I criteria and/or medication for constipation. Information on and lifestyle habits was obtained from a self-administered questionnaire. Mucosal healing (MH) was defined as Mayo endoscopic subscore 0. Clinical remission (CR) was defined as both the absence of rectal bleeding and no abnormally high stool frequency (<3 times per day). Results: The prevalence of constipation is not associated with MH, CR, duration of UC and disease extent of UC. The prevalence of constipation among age groups, <40, 40-49 years, 50-59 years, 60-69 years, and >70 years was 10.0%, 5.8%, 15.7%, 11.8%, and 25.6%, respectively. >70 years was independently and positively associated with the prevalence of constipation (adjusted odds ratio 3.64 [95% confidence interval 1.26, 10.95], p for trend: .001). Conclusions: Aging was independently and positively associated with the prevalence of constipation in UC.
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Affiliation(s)
- Sen Yagi
- Saiseikai Imabari Hospital, Matsuyama, Ehime, Japan
| | | | - Teruki Miyake
- Ehime University Graduate School of Medicine, Toon, Japan
| | - Osamu Yoshida
- Ehime University Graduate School of Medicine, Toon, Japan
| | - Kana Shiraishi
- Ehime University Graduate School of Medicine, Toon, Japan
| | - Kazuhiro Tange
- Ehime University Graduate School of Medicine, Toon, Japan
| | - Yu Hashimoto
- Ehime University Graduate School of Medicine, Toon, Japan
| | | | | | | | | | | | | | - Katsuhisa Ohashi
- OHASHI Clinic Participate in Gastro-Enterology and Ano-Proctology, Niihama, Japan
| | | | | | - Eiji Takeshita
- Ehime University Graduate School of Medicine, Toon, Japan
| | | | - Yoichi Hiasa
- Ehime University Graduate School of Medicine, Toon, Japan
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23
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Fernández-Gutiérrez DÁ, Brito-Brito PR, Darias-Curvo S, Cabrera-de-León A, Martínez-Alberto CE, Aguirre-Jaime A. Cross-mapping medical records to NANDA-I to identify nursing diagnoses in a vulnerable population. Int J Nurs Knowl 2023; 34:42-54. [PMID: 35451572 PMCID: PMC10084389 DOI: 10.1111/2047-3095.12371] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2021] [Accepted: 04/03/2022] [Indexed: 01/11/2023]
Abstract
PURPOSE To assess the association between vulnerable populations and nursing care needs, using NANDA-I diagnostics, in the population of the Canary Islands, Spain. METHODS Nursing social epidemiology study. Cross Mapping of Medical Records to NANDA-I to Identify Nursing Diagnoses in a Population usinga medical, epidemiological follow-up study of a cohort of 7,190 people. The level of vulnerability of the participants was assigned, among those who were also assigned nursing diagnoses, using the "ICE index" to calculate the expected associations. FINDINGS The most prevalent nursing diagnosis in our sample was Sedentary lifestyle (60.5%), followed by Ineffective health self-management (33.8%) and Risk-prone health behaviour (28.7%). Significant differences were found by sex, age group and social class, with the nursing diagnoses included in the study being more prevalent among the most socio-economically disadvantaged social class. CONCLUSIONS The cross-mapping method is useful to generate diagnostic information in terms of care needs, using the NANDA-I classification. The expected associations between high social vulnerability and care needs have been verified in a comprehensive and representative sample of the Canarian population (Spain). IMPLICATIONS FOR NURSING PRACTICE From an epidemiological perspective, identifying nursing diagnoses at the population level allows us to find the most prevalent needs in the different community groups and to focus appropriate nursing interventions for their implementation and impact assessment.
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Affiliation(s)
- Domingo Ángel Fernández-Gutiérrez
- Associate Professor in the Nursing Department, Universidad de La Laguna, and Health Care Information Systems Facilitator and Blended-Learning Advisor in Primary Health Care Management, Servicio Canario de la Salud. Member of the University Study Center for Social Inequalities and Governance, CEDESOG Universidad de La Laguna, Tenerife, Canary Islands, Spain
| | - Pedro Ruymán Brito-Brito
- Associate Professor in the Nursing Department, Universidad de La Laguna, and Research Nurse in Primary Care Management, Servicio Canario de la Salud, Tenerife, Canary Islands, Spain
| | - Sara Darias-Curvo
- Full Professor in the Nursing Department, Universidad de La Laguna, Tenerife. Member of the University Study Center for Social Inequalities and Governance, CEDESOG., Canary Islands, Spain
| | - Antonio Cabrera-de-León
- Research Physician in the Research Unit of Ntra. Sra. de Candelaria Hospital, Tenerife. Full professor of Preventive Medicine and Public Health, Universidad de La Laguna, Canary Islands, Spain
| | - Carlos Enrique Martínez-Alberto
- Associate Professor in the Nursing Department, European University of the Canary Islands, Laureate International Universities, and Research Nurse in Primary Care Management, Servicio Canario de la Salud, Tenerife, Canary Islands, Spain
| | - Armando Aguirre-Jaime
- Research Advisor, Care Research Institute, Colegio de enfermeros de Santa Cruz de Tenerife Department of Public Health, European University of the Canary Islands, Laureate International Universities, Tenerife, Canary Islands, Spain
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24
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Cui Z, Zou P, Lin Z, Cao Y, Luo Y. Gender Differences in Excessive Screen Time among Chinese High School Students in Henan Province. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022; 20:721. [PMID: 36613042 PMCID: PMC9819855 DOI: 10.3390/ijerph20010721] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/21/2022] [Revised: 12/21/2022] [Accepted: 12/27/2022] [Indexed: 06/17/2023]
Abstract
In a technology-driven society, adolescents are particularly vulnerable to the effects of excessive screen time, and gender disparities are notable. However, evidence on the gender difference in excessive screen time among Chinese high school students is scarce. This study examined gender differences in excessive screen time and its impact on mental health and urinary incontinence among 15,055 high school-aged adolescents, including 7514 (49.9%) males and 7541 (50.1%) females with the mean age of 16.72 (SD 0.88) in Henan Province, China. A stratified two-stage cluster sampling design was applied. Mental Health Inventory of Middle School Students and International Consultation on Incontinence Questionnaire-Short Form was used to collect data about mental health and urinary incontinence status. The percentage of students reporting excessive screen time was 9.4%, predominantly male (15.3% versus 3.5%; p < 0.001). Physical disease, living on campus, and cigarette or alcohol consumption were common factors associated with excessive screen time in both genders. Students in their second or third year showed significantly lower rates of excessive screen time than their peers. In males, younger age, active sexual behavior, chronic constipation, and having a mother with a Ph.D. degree were factors associated with a higher probability of reporting excessive screen time, while females living in a rural-urban continuum or whose mothers have a junior college degree were associated with higher odds of reporting excessive screen times. Excessive screen time was significantly positively correlated with mental health problems and urinary incontinence (p < 0.05). Results suggests the need to address excessive screen time and to focus separately on the mechanisms influencing excessive screen time in males and females.
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Affiliation(s)
- Zhenti Cui
- School of Nursing, Sias University, Zhengzhou 451100, China
- Health Science Center, Xi’an Jiaotong University, Xi’an 710061, China
| | - Ping Zou
- Scholar Practitioner Program, School of Nursing, Faculty of Education and Professional Studies, Nipissing University, Toronto, ON M5T 1V4, Canada
| | - Zihan Lin
- Health Science Center, Xi’an Jiaotong University, Xi’an 710061, China
| | - Yingdong Cao
- School of Nursing, Sias University, Zhengzhou 451100, China
| | - Yan Luo
- Health Science Center, Xi’an Jiaotong University, Xi’an 710061, China
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25
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Almehmadi M, Halawi M, Kamal M, Jawaid T, Asif M. Laxative Effects and Phytochemical Analysis of Perilla frutescens Seed Oil by Using Gas Chromatography: A Good Source of Omega Fatty Acids. Pharm Chem J 2022. [DOI: 10.1007/s11094-022-02781-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
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Wang D, Li Y, Shi Y, Hu Z. U-shaped association between sleep duration with chronic constipation and diarrhea: A population-based study. Chronobiol Int 2022; 39:1656-1664. [PMID: 36322395 DOI: 10.1080/07420528.2022.2139713] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
To examine the association between sleep duration with chronic constipation and diarrhea, we collected demographic and questionnaire data of participants from The National Health and Nutrition Examination Survey in the period 2005 to 2010. A restricted cubic spline curve function was used to determine the association between sleep duration and chronic constipation or diarrhea. Multivariate logistic regression models were used to estimate the association between sleep duration groups and chronic constipation or diarrhea. 14,054 eligible participants were included in this study. Among all sleep durations, 7 hours sleep per day had the highest percentage of normal stool forms (86.3%, P < .001), while people with ≤4 hours sleep had a higher number of bowel movements per week (P < .001). RCS models demonstrated a significant nonlinear association between sleep duration and risk of chronic constipation (P < .001). The inflection points of the U-shaped association curve corresponded to 7 hours of sleep per day. Multivariate logistic regression indicated that compared to participants with 7 hours daily sleep duration, participants with ≤4 hours and ≥10 hours sleep duration had a 54% (95%CI: (1.16-2.04), P = .002) and 90% (95%CI: (1.33-2.72), P < .001) higher risk of constipation, respectively. There is a non-linear association between sleep duration and the risk of chronic constipation. Our findings indicate that both shorter and longer sleep duration are associated with an increased risk of constipation.
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Affiliation(s)
- Dongyan Wang
- Department of Gastroenterology, Shanghai Pudong New Area Gongli Hospital, Shanghai, China
| | - Yan Li
- Department of Gastroenterology, Shanghai Tenth People's Hospital, Affiliated to Tongji University School of Medicine, Shanghai, China
| | - Yihai Shi
- Department of Gastroenterology, Shanghai Pudong New Area Gongli Hospital, Shanghai, China
| | - Zhengyu Hu
- Department of General Surgery, Shanghai Tenth People's Hospital, Affiliated to Tongji University School of Medicine, Shanghai, China
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Arslan NÇ, Gündoğdu A, Tunali V, Topgül OH, Beyazgül D, Nalbantoğlu ÖU. Efficacy of AI-Assisted Personalized Microbiome Modulation by Diet in Functional Constipation: A Randomized Controlled Trial. J Clin Med 2022; 11:jcm11226612. [PMID: 36431088 PMCID: PMC9698233 DOI: 10.3390/jcm11226612] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2022] [Revised: 11/02/2022] [Accepted: 11/07/2022] [Indexed: 11/09/2022] Open
Abstract
Background: Currently, medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. Methods: Between December 2020−December 2021, 50 patients fulfilling the Rome IV criteria for functional constipation were randomized into two groups. The control group received sodium picosulfate plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake). The study group underwent microbiome analysis and received an individualized diet with the assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul). Differences in patient assessment constipation−quality of life (PAC-QoL) scores and complete bowel movements per week (CBMpW) were compared between groups after 6-weeks of intervention. Results: The mean age of the overall cohort (n = 45) was 31.5 ± 10.2 years, with 88.9% female predominance. The customized diet developed for subjects in the study arm resulted in a 2.5-fold increase in CBMpW after 6-weeks (1.7 vs. 4.3). The proportion of the study group patients with CBMpW > 3 was 83% at the end of the study, and the satisfaction score was increased 4-fold from the baseline (3.1 to 10.7 points). More than 50% improvement in PAC-QoL scores was observed in 88% of the study cohort compared to 40% in the control group (p = 0.001). Conclusion: The AI-assisted customized diet based on individual microbiome analysis performed significantly better compared to conventional therapy based on patient-reported outcomes in the treatment of functional constipation.
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Affiliation(s)
- Naciye Çiğdem Arslan
- Department of General Surgery, School of Medicine, Medipol University, Istanbul 34214, Turkey
| | - Aycan Gündoğdu
- Department of Microbiology and Clinical Microbiology, Faculty of Medicine, Erciyes University, Kayseri 38280, Turkey
| | - Varol Tunali
- Department of Emergency Medicine, Eşrefpaşa Municipality Hospital, Izmir 35170, Turkey
- Department of Parasitology, Faculty of Medicine, Celal Bayar University, Manisa 45040, Turkey
- Correspondence:
| | - Oğuzhan Hakan Topgül
- Department of General Surgery, School of Medicine, Medipol University, Istanbul 34214, Turkey
| | | | - Özkan Ufuk Nalbantoğlu
- Department of Computer Engineering, Faculty of Engineering, Erciyes University, Kayseri 38280, Turkey
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28
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Zeng Y, Chen F. Efficacy of Electroacupuncture Compared With Transcutaneous Electrical Stimulation for Severe Chronic Constipation: A Randomized Controlled Pilot Trial. J Clin Gastroenterol 2022; 56:875-880. [PMID: 34907924 DOI: 10.1097/mcg.0000000000001645] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/17/2021] [Accepted: 10/15/2021] [Indexed: 12/10/2022]
Abstract
BACKGROUND To treat severe chronic constipation, both electroacupuncture (EA) therapy and transcutaneous electrical stimulation (TES) are safe and effective, but there is a lack of comparison between the 2 treatments. We sought to compare the therapeutic effect of EA relative to TES for the treatment of severe chronic constipation. METHODS We conducted a pilot randomized controlled trial. Seventy participants with severe chronic constipation were randomly allocated to the EA group or TES group. The acupoints in both groups are bilateral Tianshu (stomach 25), Fujie (spleen 14), and Shangjuxu (stomach 37). Each participant received 24 sessions of EA or TES during the treatment period of 8 weeks. Outcome measures were the proportion of participants with an increase from baseline of 1 or more complete spontaneous bowel movements (CSBMs) at week 8 and changes in the number of CSBMs and spontaneous bowel movements, stool character, difficulty in defecation, Patient Assessment of Constipation Quality of Life (PAC-QOL); the proportion of participants using rescue medicine and adverse reactions. Participants were followed for 24 weeks after the treatment. RESULTS Sixty of the 70 eligible participants completed the whole trial, 32 participants (91.43%) in the EA group and 28 participants (80.00%) in the TES group. There were 10 participants (14.29%) who dropped out during the whole study, 3 (8.57%) in the EA group, and 7 (20.00%) in the TES group. At weeks 20 and 32, 22 of 32 (68.75%) and 19 of 32 (59.38%) in the EA group met the clinical outcome of an increase of 1 or more CSBMs from the baseline, compared with 10 of 28 (35.71%) and 9 of 28 (32.14%) in the TES group ( P =0.019 and 0.042, respectively). At the same time, the proportions of participants having 3 or more CSBMs per week were 18 of 32 (56.25%) and 15 of 32 (46.88%) in the EA group, respectively, compared with 6 of 28 (21.43%) and 5 of 28 (17.86%) in the TES group ( P =0.008 and 0.027, respectively). Statistical differences between the 2 groups were maintained in the change from baseline in CSBMs during the follow-up period ( P =0.007 and 0.013, at week 20 and 32, respectively) and in the change from baseline in spontaneous bowel movements at week 20 ( P =0.007). Statistical significance was also observed in the decrease of PAC-QOL score after 8 weeks of treatment (mean±SD, EA: 19.06±14.41 vs. TES: 12.48±9.13, P =0.031). No significant difference was noted between the 2 groups in defecation difficulty, stool character, and the use of rescue medicine. CONCLUSIONS For the treatment of severe chronic constipation, EA performed better than TES in long-term follow-up and improving the quality of life. TES could be a better choice for patients with severe chronic constipation who are afraid of acupuncture because it is noninvasive. Well-designed and more rigorous clinical trials with larger sample sizes are needed.
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Affiliation(s)
- Yuxiao Zeng
- Department of Acupuncture, Wangjing Hospital, China, Academy of Chinese Medical Sciences, Beijing, China
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29
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Yoshihara T, Kessoku T, Takatsu T, Misawa N, Ashikari K, Fuyuki A, Ohkubo H, Higurashi T, Iwaki M, Kurihashi T, Nakatogawa M, Yamamoto K, Terada I, Tanaka Y, Nakajima A. Exploratory, multicenter, open-label study to evaluate the effects of linaclotide in patients with chronic constipation with an insufficient response to magnesium oxide: A study protocol. Contemp Clin Trials Commun 2022; 30:101019. [DOI: 10.1016/j.conctc.2022.101019] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2022] [Accepted: 10/26/2022] [Indexed: 11/06/2022] Open
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30
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Andresen V, Becker G, Frieling T, Goebel-Stengel M, Gundling F, Herold A, Karaus M, Keller J, Kim M, Klose P, Krammer H, Kreis ME, Kuhlbusch-Zicklam R, Langhorst J, Layer P, Lenzen-Großimlinghaus R, Madisch A, Mönnikes H, Müller-Lissner S, Rubin D, Schemann M, Schwille-Kiuntke J, Stengel A, Storr M, van der Voort I, Voderholzer W, Wedel T, Wirz S, Witzigmann H, Pehl C. Aktualisierte S2k-Leitlinie chronische Obstipation der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) und der Deutschen Gesellschaft für Neurogastroenterologie & Motilität (DGNM) – April 2022 – AWMF-Registriernummer: 021–019. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2022; 60:1528-1572. [PMID: 36223785 DOI: 10.1055/a-1880-1928] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Affiliation(s)
- V Andresen
- Medizinische Klinik, Israelitisches Krankenhaus, Hamburg, Deutschland
| | - G Becker
- Klinik für Palliativmedizin, Freiburg, Deutschland
| | - T Frieling
- Medizinische Klinik II, Helios-Klinikum Krefeld, Krefeld, Deutschland
| | | | - F Gundling
- Medizinische Klinik II (Gastroenterologie, Gastroenterologische Onkologie, Hepatologie, Diabetologie, Stoffwechsel, Infektiologie), Klinikum am Bruderwald, Bamberg, Deutschland
| | - A Herold
- Sozialstiftung Bamberg, End- und Dickdarm-Zentrum Mannheim, Mannheim, Deutschland
| | - M Karaus
- Abt. Innere Medizin, Evang. Krankenhaus Göttingen-Weende, Göttingen, Deutschland
| | - J Keller
- Medizinische Klinik, Israelitisches Krankenhaus, Hamburg, Deutschland
| | - M Kim
- Klinik und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie (Chirurgische Klinik I) des Universitätsklinikums, Zentrum Operative Medizin (ZOM), Würzburg, Deutschland
| | - P Klose
- Universität Duisburg-Essen, Medizinische Fakultät, Essen, Deutschland
| | - H Krammer
- Sozialstiftung Bamberg, End- und Dickdarm-Zentrum Mannheim, Mannheim, Deutschland
| | - M E Kreis
- Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Deutschland
| | | | - J Langhorst
- Knappschafts-Krankenhaus, Essen, Deutschland
| | - P Layer
- Medizinische Klinik, Israelitisches Krankenhaus, Hamburg, Deutschland
| | | | - A Madisch
- Klinik für Gastroenterologie, interventionelle Endoskopie und Diabetologie, Klinikum Siloah-Oststadt-Heidehaus, Hannover, Deutschland
| | - H Mönnikes
- Klinik für Innere Medizin, Martin-Luther-Krankenhaus, Berlin, Deutschland
| | | | - D Rubin
- Klinik für Innere Medizin Schwerpunkt Gastroenterologie, DRK Kliniken Berlin Mitte, Berlin, Deutschland.,Klinik für Innere Medizin mit Schwerpunkt Gastroenterologie, Vivantes Klinikum Spandau, Spandau, Deutschland
| | - M Schemann
- Lehrstuhl für Humanbiologie, TU München, Freising, Deutschland
| | - J Schwille-Kiuntke
- Innere Medizin VI Psychosomat. Medizin u. Psychotherapie, Universitätsklinikum Tübingen, Tübingen, Deutschland.,Institut für Arbeitsmedizin, Sozialmedizin und Versorgungsforschung, Universitätsklinikum Tübingen, Tübingen, Deutschland
| | - A Stengel
- Medizinische Klinik mit Schwerpunkt Psychosomatik, Charité - Universitätsmedizin Berlin, Berlin, Deutschland
| | - M Storr
- Zentrum für Endoskopie, Starnberg, Deutschland
| | - I van der Voort
- Klinik für Innere Medizin Gastroenterologie und Diabetologie, Jüdisches Krankenhaus Berlin, Berlin, Deutschland
| | | | - T Wedel
- Anatomisches Institut, Universität Kiel, Kiel, Deutschland
| | - S Wirz
- Cura Krankenhaus Bad Honnef, Bad Honnef, Deutschland
| | - H Witzigmann
- Klinik für Allgemein- und Viszeralchirurgie, Krankenhaus Dresden-Friedrichstadt, Dresden, Deutschland
| | - C Pehl
- Medizinische Klinik, Krankenhaus Vilsbiburg, Vilsbiburg, Deutschland
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Bulbul E, Cepken T, Caliskan F, Palabiyik B, Sayan C, Kazancioglu R. The quality of life and comfort levels of hemodialysis patients with constipation: A descriptive and cross-sectional study. Hemodial Int 2022; 26:351-360. [PMID: 35451169 DOI: 10.1111/hdi.13009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2021] [Revised: 01/24/2022] [Accepted: 03/24/2022] [Indexed: 11/30/2022]
Abstract
INTRODUCTION This study was conducted to determine the constipation-related quality of life, bowel habits, and comfort levels of constipated hemodialysis patients. It is known that the prevalence of constipation is high in hemodialysis patients. METHODS This was a cross-sectional and correlational study. The study included 164 hemodialysis patients who were determined to have constipation by examining the constipation statuses of 385 patients based on the Rome-IV criteria. The study was reported according to the STrengthening the Reporting of OBservational studies in Epidemiology Declaration. FINDINGS It was determined that as the constipation-related quality of life of the patients increased, their comfort levels also increased. Constipation-related quality of life increased in parallel with an increasing Bristol Stool Scale (BSS) score and an increasing number of bowel movements. The BSS scores of the patients were found to have a significant positive correlation with the patients' bowel movement frequencies and a significant negative correlation with their constipation frequencies. There was a negative correlation between years of dialysis and bowel movement frequencies. The presence of a previous gastrointestinal system complaint, the presence of an impact of constipation on the patient's dialysis session, and comfort levels were determined to be significant predictors of constipation-related quality of life that explained 26.3% of the total variance in constipation-related quality of life. DISCUSSION In patients receiving hemodialysis treatment, constipation is an important and frequently encountered problem. Constipation leads to a reduction in quality of life and hemodialysis-related comfort.
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Affiliation(s)
- Elif Bulbul
- Hamidiye Faculty of Nursing, Internal Medicine Nursing Department, University of Health Sciences Turkey, Istanbul, Turkey
| | | | | | | | - Canan Sayan
- Hemodialysis Center, Bezmialem Vakif University, Istanbul, Turkey
| | - Rumeyza Kazancioglu
- Faculty of Medicine, Division of Nephrology, Bezmialem Vakif University, Istanbul, Turkey
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Kayaoglu SA, Sert OZ. Constipation in the period of limited isolation during COVID-19 pandemic. REVISTA DA ASSOCIACAO MEDICA BRASILEIRA (1992) 2022; 68:196-201. [PMID: 35239881 DOI: 10.1590/1806-9282.20211007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/08/2021] [Accepted: 11/20/2021] [Indexed: 11/21/2022]
Abstract
OBJECTIVE COVID-19 outbreak has become widespread globally and caused a new global chaos. This outbreak that completely affected the lifestyle of individuals resulted in periods of isolation. Here, we evaluated the effects of lifestyle changes with isolation on constipation. METHODS A survey on constipation was performed during the 12-week isolation period starting in March 2020 in Turkey. Data of 390 individuals who participated in the survey through the social media and who were actively employed prior to isolation were analyzed. Rome IV criteria were used to evaluate constipation. RESULTS Among the participants in the study, 253 (64.9%) were women with the mean age of 39.5±9.5 years. A statistically significant association was found between the decreased water consumption during the isolation period and constipation after the isolation (p=0.020; p<0.05). A significant association was found between the changes in physical activity and constipation after the isolation (p=0.013; p<0.05). New development of constipation during the isolation or declaration of increased constipation was found to be statistically associated with post-isolation constipation according to Rome criteria (p=0.000; p<0.05). CONCLUSION The data of this present study demonstrated that isolation period was effective on the newly developed constipation. Decreased physical activity and water consumption are also effective on constipation.
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Affiliation(s)
- Sevcan Alkan Kayaoglu
- Haydarpasa Numune Training and Research Hospital, Department of General Surgery - Istanbul, Turkey
| | - Ozlem Zeliha Sert
- Haydarpasa Numune Training and Research Hospital, Department of General Surgery - Istanbul, Turkey
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Hayashi T, Miwa H. Treatment Satisfaction With Current Medications for Chronic Constipation: An Internet Survey of Japanese Patients. J Clin Gastroenterol 2022; 56:e64-e70. [PMID: 33337642 PMCID: PMC8647691 DOI: 10.1097/mcg.0000000000001473] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Accepted: 11/01/2020] [Indexed: 12/13/2022]
Abstract
GOALS This survey aims to determine relevant patient characteristics, treatment satisfaction, and bothersome symptoms in Japanese patients with chronic constipation (CC) treated at medical institutions. BACKGROUND Epidemiological surveys of Japanese patients with CC are limited. STUDY This internet survey, conducted in 2017, included 500 adults (selected from 589 respondents to match age composition ratio in Japan) who experienced constipation-like symptoms for ≥6 months, were treated at medical institutions for symptoms, and were taking any prescribed medication. RESULTS Of 500 patients, 65.6% were female and 62.6% had experienced constipation for >10 years. Abdominal bloating, infrequent bowel movement, hard consistency of stool, and difficulty of defecation were the most frequently reported and most bothersome symptoms in males and females. Overall, 29% of patients were satisfied with treatment (36% of males, 26% of females); the individual major CC symptom with the highest level of treatment satisfaction was infrequent bowel movement (31% of total, 45% of males, 26% of females). The level of treatment satisfaction for most individual major CC symptoms was lower in females than in males, and overall treatment satisfaction by therapeutic categories ranged from 16% to 46%. Mean overall treatment satisfaction, as well as mean treatment satisfaction for each major symptom, decreased with increasing number of treatments. CONCLUSIONS The survey results suggest that conventional treatment options were not effective enough to improve bothersome symptoms or treatment satisfaction. Treatment selection that is tailored to individual symptoms and takes patient characteristics into consideration may be key to improving patients' treatment satisfaction.
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Affiliation(s)
| | - Hiroto Miwa
- Department of Internal Medicine, Division of Gastroenterology, Hyogo College of Medicine, Hyogo, Japan
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Walter S, Jones MP, Sjödahl J, Stjernman H, Hjortswang H, Andreasson A. Measuring the impact of gastrointestinal inconvenience and symptoms on perceived health in the general population - validation of the Short Health Scale for gastrointestinal symptoms (SHS-GI). Scand J Gastroenterol 2021; 56:1406-1413. [PMID: 34521305 DOI: 10.1080/00365521.2021.1974087] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVES Gastrointestinal (GI) symptoms are intimately related to our wellbeing. The Short Health Scale for GI symptoms (SHS-GI) is a simple questionnaire to measure the impact of GI inconvenience and symptoms on quality of life. The aim was to validate the SHS-GI in a general population sample and to compare it with SHS-data across different patient groups. METHOD A subsample of 170 participants from a population-based colonoscopy study completed the Rome II questionnaire, GI diaries, psychological questionnaire (hospital anxiety and depression scale) and SHS-GI at follow-up investigation. Psychometric properties of SHS-GI as an overall score were determined by performing a confirmatory factor analysis (CFA). Spearman correlation between SHS total score and symptoms was calculated in the general population sample. SHS-GI data was compared with SHS data from patients with inflammatory bowel disease (IBD) and fecal incontinence (FI). RESULTS As expected, the general population rated their impact of GI inconvenience on quality of life as better than the patient populations in terms of all aspects of the SHS-GI. The CFA showed a good model fit meeting all fit criteria in the general population. Cronbach's alpha for the total scale was 0.80 in the general population sample and ranged from 0.72 in the FI sample to 0.88 and 0.89 in the IBD samples. CONCLUSIONS SHS-GI demonstrated appropriate psychometric properties in a sample of the normal population. We suggest that SHS-GI is a valid simple questionnaire suitable for measuring the impact of GI symptoms and inconvenience on quality of life in both general and patient populations.
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Affiliation(s)
- Susanna Walter
- Department of Biomedical and Clinical Sciences (BKV), Division of Inflammation and Infection, Linkoping University, Linkoping, Sweden.,Department of Gastroenterology, Linköping University Hospital, Linkoping, Sweden
| | - Michael P Jones
- School of Psychological Sciences, Macquarie University, North Ryde, Australia
| | - Jenny Sjödahl
- Department of Gastroenterology, Linköping University Hospital, Linkoping, Sweden
| | - Henrik Stjernman
- Department of Internal Medicine, Ryhov Hospital Jönköping, Jönköping, Sweden
| | - Henrik Hjortswang
- Department of Gastroenterology, Linköping University Hospital, Linkoping, Sweden
| | - Anna Andreasson
- School of Psychological Sciences, Macquarie University, North Ryde, Australia.,Department of Psychology, Stress Research Institute, Stockholm University, Stockholm, Sweden.,Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
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Yamamoto S, Kawamura Y, Yamamoto K, Yamaguchi Y, Tamura Y, Izawa S, Nakagawa H, Wakita Y, Hijikata Y, Ebi M, Funaki Y, Ohashi W, Ogasawara N, Sasaki M, Maekawa M, Kasugai K. Internet Survey of Japanese Patients With Chronic Constipation: Focus on Correlations Between Sleep Quality, Symptom Severity, and Quality of Life. J Neurogastroenterol Motil 2021; 27:602-611. [PMID: 34642281 PMCID: PMC8521473 DOI: 10.5056/jnm20135] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/16/2020] [Revised: 09/14/2020] [Accepted: 02/18/2021] [Indexed: 12/13/2022] Open
Abstract
Background/Aims Chronic constipation and lifestyle factors can affect sleep quality. We evaluated the relationship between chronic constipation and sleep in the Japanese population. Methods This cross-sectional internet-based survey included 3000 subjects with constipation, classified according to sleep status (good/poor). Primary endpoints were Bristol stool form scale (BSFS) score and correlations between sleep disorder criteria of the Pittsburgh Sleep Quality Index (PSQI) and sleep status (good/poor sleep). Secondary endpoints included correlations between quality of life (QOL) and mood, medical, lifestyle, and sleep factors. Results The proportion of participants with BSFS category 4 (normal stool) was significantly higher in the good sleep group (P < 0.001). Sleep disturbance (P < 0.05), sleep quality, and duration, use of hypnotic medication, and daytime dysfunction of PSQI (all P < 0.001) significantly correlated with poor sleep. In the poor sleep group, QOL was significantly worse and anxiety and depression levels were significantly higher (all P < 0.001) compared with the good sleep group. Anemia and smoking (both P < 0.05), recent body weight increases, and poor eating habits (all P < 0.001) were significantly higher in the poor sleep group. Male sex, onset associated with change in frequency of stools, sensation of incomplete evacuation for at least 25% of defecations, and manual maneuvers to facilitate at least 25% of defecations correlated with poor sleep. Conclusions Subjects with constipation and poor sleep experienced severe symptoms and had poor QOL. These data support the need for a multifocal treatment approach, including lifestyle advice and pharmacotherapy.
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Affiliation(s)
- Sayuri Yamamoto
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Yurika Kawamura
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Kazuhiro Yamamoto
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Yoshiharu Yamaguchi
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Yasuhiro Tamura
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Shinya Izawa
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Hiroaki Nakagawa
- Division of General Medicine, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Yoshinori Wakita
- Division of General Medicine, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Yasutaka Hijikata
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Masahide Ebi
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Yasushi Funaki
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Wataru Ohashi
- Division of Biostatistics, Clinical Research Center, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Naotaka Ogasawara
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Makoto Sasaki
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Masato Maekawa
- Division of General Medicine, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
| | - Kunio Kasugai
- Division of Gastroenterology, Aichi Medical University School of Medicine, Yazakokarimata, Nagakute, Aichi, Japan
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Evaluating the Impact of Cost on the Treatment Algorithm for Chronic Idiopathic Constipation: Cost-Effectiveness Analysis. Am J Gastroenterol 2021; 116:2118-2127. [PMID: 34388141 DOI: 10.14309/ajg.0000000000001403] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/29/2021] [Accepted: 07/19/2021] [Indexed: 12/11/2022]
Abstract
INTRODUCTION Chronic idiopathic constipation (CIC) is a common and burdensome illness. We performed a cost-effectiveness analysis of the US Food and Drug Administration-approved CIC drugs to evaluate and quantify treatment preferences compared with usual care from insurer and patient perspectives. METHODS We evaluated the subset of patients with CIC and documented failure of over-the-counter (OTC) osmotic or bulk-forming laxatives. A RAND/UCLA consensus panel of 8 neurogastroenterologists informed model design. Treatment outcomes and costs were defined using integrated analyses of registered clinical trials and the US Centers for Medicare and Medicaid Services-supported cost databases. Quality-adjusted life years (QALYs) were calculated using health utilities derived from clinical trials. A 12-week time horizon was used. RESULTS With continued OTC laxatives, CIC-related costs were $569 from an insurer perspective compared with $3,154 from a patient perspective (considering lost wages and out-of-pocket expenses). CIC prescription drugs increased insurer costs by $618-$1,015 but decreased patient costs by $327-$1,117. Effectiveness of CIC drugs was similar (0.02 QALY gained/12 weeks or ∼7 healthy days gained/year). From an insurer perspective, prescription drugs (linaclotide, prucalopride, and plecanatide) seemed less cost-effective than continued OTC laxatives (incremental cost-effectiveness ratio >$150,000/QALY gained). From a patient perspective, the cost-effective algorithm started with plecanatide, followed by choosing between prucalopride and linaclotide starting at the 145-μg dose (favoring prucalopride among patients whose disease affects their work productivity). The patient perspective was driven by drug tolerability and treatment effects on quality of life. DISCUSSION Addressing costs at a policy level has the potential to enable patients and clinicians to move from navigating barriers in treatment access toward truly optimizing treatment choice.
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Kim S, Lee HA, Jang SB, Lee H. A population pharmacokinetic-pharmacodynamic model of YH12852, a highly selective 5-hydroxytryptamine 4 receptor agonist, in healthy subjects and patients with functional constipation. CPT Pharmacometrics Syst Pharmacol 2021; 10:902-913. [PMID: 34085769 PMCID: PMC8376136 DOI: 10.1002/psp4.12664] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2021] [Revised: 04/20/2021] [Accepted: 04/22/2021] [Indexed: 12/15/2022] Open
Abstract
YH12852, a novel, highly selective 5-hydroxytryptamine 4 (5-HT4 ) receptor agonist, is currently under development to treat patients with functional constipation. In this study, we aimed to develop a pharmacokinetic (PK)-pharmacodynamic (PD) model that adequately described the time courses of the plasma concentrations of YH12852 and its prokinetic effect as assessed by the Gastric Emptying Breath Test (GEBT) and to predict the prokinetic effect of YH12852 at higher doses through PD simulation. We used the plasma concentrations of YH12852 from patients with functional constipation and healthy subjects and the GEBT results from healthy subjects obtained from a phase I/IIa trial. The PK-PD modeling and covariate analysis were performed using NONMEM software. The prokinetic effect of YH12852 was described using a semimechanistic multicompartment PD model and an empirical model by Ghoos et al. A two-compartment model with first-order absorption adequately described the observed concentration-time profiles of YH12852. The semimechanistic multicompartment PD model and the revised Ghoos model with two slope parameters adequately described the observed kPCDt (the percent dose of 13 C excreted in the exhaled air at minute t after completing the test meal, multiplied by 1000) values. YH12852 accelerated gastric emptying even at low doses of 0.05-0.1 mg, and its prokinetic effect was greater in subjects suffering from more severe functional constipation. The PD simulation experiments revealed that the change from baseline in the half time for gastric emptying induced by YH12852 increased in a dose-dependent manner at 0.05-5 mg although the results at doses >0.1 mg were extrapolated. We also showed that the empirical Ghoos model is a special case of the general semimechanistic multicompartment PD model for gastric emptying.
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Affiliation(s)
- Siun Kim
- Department of Applied Biomedical EngineeringGraduate School of Convergence Science and TechnologySeoul National UniversitySeoulKorea
- Department of Molecular Medicine and Biopharmaceutical SciencesGraduate School of Convergence Science and TechnologySeoul National UniversitySeoulKorea
| | - Hyun A. Lee
- Department of Applied Biomedical EngineeringGraduate School of Convergence Science and TechnologySeoul National UniversitySeoulKorea
- Department of Molecular Medicine and Biopharmaceutical SciencesGraduate School of Convergence Science and TechnologySeoul National UniversitySeoulKorea
| | - Seong Bok Jang
- Clinical Development DepartmentResearch & Development DivisionYuhan CorporationSeoulKorea
| | - Howard Lee
- Department of Applied Biomedical EngineeringGraduate School of Convergence Science and TechnologySeoul National UniversitySeoulKorea
- Department of Molecular Medicine and Biopharmaceutical SciencesGraduate School of Convergence Science and TechnologySeoul National UniversitySeoulKorea
- Department of Clinical Pharmacology and TherapeuticsSeoul National University College of Medicine and HospitalSeoulKorea
- Department of Clinical Pharmacology and TherapeuticsSeoul National University HospitalSeoulKorea
- Center for Convergence Approaches in Drug DevelopmentSeoul National UniversitySeoulKorea
- Advanced Institute of Convergence TechnologySuwonKorea
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Corrigendum to "Positive Effect of Electro-Acupuncture Treatment on Gut Motility in Constipated Mice Is Related to Rebalancing the Gut Microbiota". EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE 2021. [PMID: 34061119 DOI: 10.1155/2021/6652017] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
[This corrects the article DOI: 10.1155/2021/6652017.].
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Tomita T, Kazumori K, Baba K, Zhao X, Chen Y, Miwa H. Impact of chronic constipation on health-related quality of life and work productivity in Japan. J Gastroenterol Hepatol 2021; 36:1529-1537. [PMID: 33047825 DOI: 10.1111/jgh.15295] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2020] [Revised: 09/09/2020] [Accepted: 10/07/2020] [Indexed: 12/20/2022]
Abstract
BACKGROUND AND AIM The impact of chronic constipation on health-related quality of life (HRQoL), work productivity, and healthcare resource use in Japan is not well understood. This study aimed to evaluate and compare the humanistic burden of respondents with chronic constipation to respondents without chronic constipation and to respondents with type 2 diabetes mellitus (T2DM), irritable bowel syndrome (IBS), and gastroesophageal reflux disease (GERD), respectively. METHODS This cross-sectional study collected demographic and general health data and HRQoL data as measured by the Short Form 12-Item (Version 2) Health Survey and EuroQol 5-dimension health surveys. Health impacts on employment-related activities and indirect costs were measured using the Work Productivity and Activity Impairment questionnaire. Propensity score matching was used to identify a control group without chronic constipation. Multivariate generalized linear models were used to identify potential factors that may impact the outcomes of respondents. RESULTS A total of 30 001 individuals responded to the Japan National Health and Wellness Survey 2017, whereof 3373 (11.2%) reported having chronic constipation; 963 were physician diagnosed. Compared with matched controls, patients with physician-diagnosed chronic constipation had lower mean HRQoL scores and higher mean absenteeism, presenteeism, total Work Productivity and Activity Impairment, and indirect costs. Physician-diagnosed chronic constipation was associated with a higher health burden than T2DM, IBS, and GERD. CONCLUSIONS Chronic constipation is associated with a considerable health burden, which is higher compared with T2DM, IBS, and GERD. These results suggest an urgent need for effective treatment of Japanese patients with chronic constipation to improve their quality of life.
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Affiliation(s)
- Toshihiko Tomita
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
| | | | - Kenji Baba
- Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan
| | | | | | - Hiroto Miwa
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
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Zhao X, Fang Y, Ye J, Qin F, Lu W, Gong H. A meta-analysis of randomized controlled trials of a traditional Chinese medicine prescription, modified RunChang-Tang, in treating functional constipation. Medicine (Baltimore) 2021; 100:e25760. [PMID: 34011036 PMCID: PMC8137032 DOI: 10.1097/md.0000000000025760] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/24/2020] [Accepted: 04/13/2021] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND Modified Runchang-Tang (MRCT), a Chinese herbal medicine, is widely used to treat functional constipation (FC), which is a common digestive system disease. However, its efficacy has not been evaluated systematically and objectively. Thus, a meta-analysis was conducted to assess the efficacy and safety of MRCT for treating functional constipation. METHODS We searched for relevant publications from Embase, Medline, The Cochrane Library, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chinese Scientific Journals Database, and Wanfang Data for relevant literature. The timeframe of retrieval was set from the founding date of each database to July 15, 2020. RESULT A total of 26 randomized controlled trials with 2103 individuals were included in this meta-analysis. All trials were conducted in mainland China and were written in Chinese. The results showed that MRCT monotherapy provided better symptom relief in FC patients compared to prokinetic agent monotherapy (odds ratio, [OR] = 4.06), osmotic laxatives (OR = 4.39) and stimulant laxatives (OR = 2.99). Additionally, there were no obvious adverse effects in MRCT group compared with control group. CONCLUSION MRCT treatment is an efficient and safe treatment for FC. However, considering the limitations of this study, further well-designed randomized controlled trials are required to validate this conclusion.
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Affiliation(s)
- Xiankun Zhao
- Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu
| | - Yuxiao Fang
- Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu
| | - Jing Ye
- Department of Respiratory Medicine, Mianyang Hospital of T.C.M, Mianyang
| | - Feng Qin
- Andrology Laboratory, Department of Urology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
| | - Wenzhu Lu
- Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu
| | - Hanlin Gong
- Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu
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Shapiro A, Bradshaw B, Landes S, Kammann P, Bois De Fer B, Lee WN, Lange R. A novel digital approach to describe real world outcomes among patients with constipation. NPJ Digit Med 2021; 4:27. [PMID: 33594206 PMCID: PMC7887258 DOI: 10.1038/s41746-021-00391-x] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2020] [Accepted: 01/11/2021] [Indexed: 12/20/2022] Open
Abstract
Understanding day-to-day variations in symptoms and medication management can be important in describing patient centered outcomes for people with constipation. Patient Generated Health Data (PGHD) from digital devices is a potential solution, but its utility as a tool for describing experiences of people with frequent constipation is unknown. We conducted a virtual, 16-week prospective study of individuals with frequent constipation from an online wellness platform that connects mobile consumer digital devices including wearable monitors capable of passively collecting steps, sleep, and heart rate data. Participants wore a Fitbit monitoring device for the study duration and were administered daily and monthly surveys assessing constipation symptom severity and medication usage. A set of 38 predetermined day-level behavioral activity metrics were computed from minute-level data streams for steps, sleep and heart rate. Mixed effects regression models were used to compare activity metrics between constipation status (irregular or constipated vs. regular day), medication use (medication day vs. non-medication day) and the interaction of medication day with irregular or constipation days, as well as to model likelihood to treat with constipation medications based on daily self-reported symptom severity. Correction for multiple comparisons was performed with the Benjamini-Hochberg procedure for false discovery rate. This study analyzed 1540 enrolled participants with completed daily surveys (mean age 36.6 sd 10.0, 72.8% female, 88.8% Caucasian). Of those, 1293 completed all monthly surveys and 756 had sufficient Fitbit data density for analysis of activity metrics. At a daily-level, 22 of the 38 activity metrics were significantly associated with bowel movement or medication treatment patterns for constipation. Participants were measured to have fewer steps on irregular days compared to regular days (-200 steps, 95% CI [-280, -120]), longer periods of inactivity on constipated days (9.1 min, 95% CI [5.2, 12.9]), reduced total sleep time on irregular and constipated days (-2.4 min, 95% CI [-4.3, -0.4] and -4.0 min, 95% CI [-6.5, -1.4], respectively). Participants reported greater severity of symptoms for bloating, hard stool, difficulty passing, and painful bowel movements on irregular, constipation and medication days compared to regular days with no medication. Interaction analysis of medication days with irregular or constipation days observed small increases in severity compared to non-medication days. Participants were 4.3% (95% CI 3.2, 5.3) more likely to treat with medication on constipated days versus regular. No significant increase in likelihood was observed for irregular days. Daily likelihood to treat increased for each 1-point change in symptom severity of bloating (2.4%, 95% CI [2.0, 2.7]), inability to pass (2.2%, 95% CI [1.4, 3.0]) and incomplete bowel movements (1.3%, 95% CI [0.9, 1.7]). This is the first large scale virtual prospective study describing the association between passively collected PGHD and constipation symptoms and severity at a day-to-day granularity level. Constipation status, irregular or constipated, was associated with a number of activity metrics in steps and sleep, and likelihood to treat with medication increased with increasing severity for a number of constipation symptoms. Given the small magnitude of effect, further research is needed to understand the clinical relevance of these results. PGHD may be useful as a tool for describing real world patient centered experiences for people with constipation.
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Affiliation(s)
| | | | - Sabine Landes
- Sanofi-Aventis, Consumer Healthcare, Frankfurt am Main, Germany
| | - Petra Kammann
- Sanofi-Aventis, Consumer Healthcare, Frankfurt am Main, Germany
| | - Beatrice Bois De Fer
- Sanofi-Aventis Groupe, Global CHC Scientific & Clinical Platforms, Gentilly, France
| | | | - Robert Lange
- Sanofi-Aventis, Consumer Healthcare, Frankfurt am Main, Germany.
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Li H, Chen J, Ren X, Yang C, Liu S, Bai X, Shan S, Dong X. Gut Microbiota Composition Changes in Constipated Women of Reproductive Age. Front Cell Infect Microbiol 2021; 10:557515. [PMID: 33552996 PMCID: PMC7859112 DOI: 10.3389/fcimb.2020.557515] [Citation(s) in RCA: 26] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2020] [Accepted: 12/03/2020] [Indexed: 12/12/2022] Open
Abstract
Background Chronic constipation is one of the most prevalent functional gastrointestinal disorders, yet its etiology is multifactorial, and the pathophysiological mechanism is still unclear. Previous studies have shown that the gut microbiota of constipated patients differs from healthy controls; however, many discrepancies exist in the findings, and no clear link has been confirmed between chronic constipation and changes in the gut microbiota. Growing evidence indicates that age, gender, and hormone levels can affect the composition of gut microbiota. The aim of this study is to examine the overall changes in gut microbiota within a specific sub-population of patients, namely, constipated women of reproductive age. Methods We carried out a cross-sectional study comparing the fecal microbial composition of 30 healthy women and 29 constipated women using 16S rRNA gene sequencing. Only women of reproductive age were recruited to reduce the effects of age, gender, and hormone levels on the microbiome, and to prevent conflating the impact of these factors with the effects of constipation. Results There were obvious differences in the gut microbiota in constipated women of reproductive age compared with the healthy controls, manifesting mainly as a significant increase in the abundance of Bacteroides (p < 0.05) and a significant decrease in the abundance of Proteobacteria (p < 0.01). The overall composition of the gut microbiota in each group was different, which was reflected in the ratios of Firmicutes to Bacteroidetes (F/B), which was 1.52 in the constipated group vs. 2.21 in the healthy group. Additionally, there was a significant decrease in butyrate-producing bacteria, like Roseburia and Fusicatenibacter (p < 0.01). Conclusion The overall composition of the gut microbiota changed in constipated women of reproductive age, characterized by a loss in Proteobacteria and an increase in Bacteroidetes. Furthermore, the abundance of some butyrate-producing bacteria also reduced. These changes may reflect the unique interactions between host and some bacteria, or some bacterial metabolic products, which may be important targets for future studies to explore the pathogenesis of constipation.
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Affiliation(s)
- Hongxia Li
- Department of General Surgery, Bethune Hospital Affiliated to Shanxi Medical University, Taiyuan, China
| | - Jianwei Chen
- Department of General Surgery, Bethune Hospital Affiliated to Shanxi Medical University, Taiyuan, China
| | - Xiaojing Ren
- Key Laboratory of Chemical Biology and Molecular Engineering of National Ministry of Education, Institute of Biotechnology, Shanxi University, Taiyuan, China
| | - Chuanli Yang
- Key Laboratory of Chemical Biology and Molecular Engineering of National Ministry of Education, Institute of Biotechnology, Shanxi University, Taiyuan, China
| | - Shuai Liu
- Department of General Surgery, Bethune Hospital Affiliated to Shanxi Medical University, Taiyuan, China
| | - Xinshu Bai
- Department of General Surgery, Bethune Hospital Affiliated to Shanxi Medical University, Taiyuan, China
| | - Shuhua Shan
- Key Laboratory of Chemical Biology and Molecular Engineering of National Ministry of Education, Institute of Biotechnology, Shanxi University, Taiyuan, China
| | - Xiushan Dong
- Department of General Surgery, Bethune Hospital Affiliated to Shanxi Medical University, Taiyuan, China
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FUYUKI A, HIGURASHI T, KESSOKU T, ASHIKARI K, YOSHIHARA T, MISAWA N, IWAKI M, KOBAYASHI T, OHKUBO H, YONEDA M, USUDA H, WADA K, NAKAJIMA A. Efficacy of Bifidobacterium bifidum G9-1 in improving quality of life in patients with chronic constipation: a prospective intervention study. BIOSCIENCE OF MICROBIOTA, FOOD AND HEALTH 2021; 40:105-114. [PMID: 33996367 PMCID: PMC8099630 DOI: 10.12938/bmfh.2020-073] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 10/09/2020] [Accepted: 12/08/2020] [Indexed: 12/26/2022]
Abstract
Chronic constipation is a functional disorder that decreases a patient's quality of life (QOL). Because dysbiosis has been associated with constipation, we aimed to investigate the efficacy of Bifidobacterium bifidum G9-1 (BBG9-1) in improving QOL in patients with constipation. This was a prospective, single-center, non-blinded, single-arm feasibility trial. A total of 31 patients with constipation and decreased QOL received BBG9-1 treatment for 8 weeks, followed by a 2-week washout period. The primary endpoint was change in the overall Japanese version of the patient assessment of constipation of QOL (JPAC-QOL) score after probiotic administration relative to that at baseline. Secondary endpoints included changes in gut microbiota, stool consistency, frequency of bowel movement, degree of straining, sensation of incomplete evacuation, and frequency of rescue drug use. The overall JPAC-QOL scores and frequency of bowel movement significantly improved after BBG9-1 administration from those at baseline (p<0.01 and p<0.01, respectively). There were no statistically significant changes in other clinical symptoms. Subset analysis revealed that patients with initial Bristol Stool Form Scale stool types of <4 had improvements in stool consistency, a significant increase in the frequency of bowel movements, and a significant alleviation in the degree of straining, following BBG9-1 administration. At the genus and species levels, Sarcina and Sarcina maxima were significantly increased. Functional analysis showed that butanoate metabolism increased significantly, whereas methane metabolism decreased significantly. We concluded that BBG9-1 is safe and improves QOL in patients with constipation. The underlying improvements may be due to changes in stool consistency.
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Affiliation(s)
- Akiko FUYUKI
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Takuma HIGURASHI
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Takaomi KESSOKU
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Keiichi ASHIKARI
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Tsutomu YOSHIHARA
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Noboru MISAWA
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Michihiro IWAKI
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Takashi KOBAYASHI
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Hidenori OHKUBO
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Masato YONEDA
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
| | - Haruki USUDA
- Department of Pharmacology, Shimane University Faculty of
Medicine, 89-1 Enyacho, Izumo, Shimane 693-0021, Japan
| | - Koichiro WADA
- Department of Pharmacology, Shimane University Faculty of
Medicine, 89-1 Enyacho, Izumo, Shimane 693-0021, Japan
| | - Atsushi NAKAJIMA
- Department of Gastroenterology and Hepatology, Yokohama City
University School of Medicine, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa 236-0004,
Japan
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The Combined Effects of Magnesium Oxide and Inulin on Intestinal Microbiota and Cecal Short-Chain Fatty Acids. Nutrients 2021; 13:nu13010152. [PMID: 33466274 PMCID: PMC7824761 DOI: 10.3390/nu13010152] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2020] [Revised: 12/31/2020] [Accepted: 01/03/2021] [Indexed: 12/12/2022] Open
Abstract
Constipation is a common condition that occurs in many people worldwide. While magnesium oxide (MgO) is often used as the first-line drug for chronic constipation in Japan, dietary fiber intake is also recommended. Dietary fiber is fermented by microbiota to produce short-chain fatty acids (SCFAs). SCFAs are involved in regulating systemic physiological functions and circadian rhythm. We examined the effect of combining MgO and the water-soluble dietary fiber, inulin, on cecal SCFA concentration and microbiota in mice. We also examined the MgO administration timing effect on cecal SCFAs. The cecal SCFA concentrations were measured by gas chromatography, and the microbiota was determined using next-generation sequencing. Inulin intake decreased cecal pH and increased cecal SCFA concentrations while combining MgO increased the cecal pH lowered by inulin and decreased the cecal SCFA concentrations elevated by inulin. When inulin and MgO were combined, significant changes in the microbiota composition were observed compared with inulin alone. The MgO effect on the cecal acetic acid concentration was less when administered at ZT12 than at ZT0. In conclusion, this study suggests that MgO affects cecal SCFA and microbiota during inulin feeding, and the effect on acetic acid concentration is time-dependent.
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Abstract
Primary care physicians frequently evaluate patients with constipation. The history is crucial in uncovering warning symptoms and signs that warrant colonoscopy. Particular elements in the history and rectal examination also can provide clues regarding the underlying etiology. Regardless of etiology, lifestyle modifications, fiber, and laxatives are first-line therapies. Patients who fail first-line therapies can be offered second-line treatments and/or referred for testing of defecatory function. In those with severely refractory symptoms, referrals to a gastroenterologist and a surgeon should be considered.
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Affiliation(s)
- David B Snell
- Division of Gastroenterology & Hepatology, Department of Medicine, New York University, 550 First Avenue, New York, NY 10016, USA.
| | - Saamia Faruqui
- Division of Gastroenterology & Hepatology, Department of Medicine, New York University, 550 First Avenue, New York, NY 10016, USA
| | - Brian P Bosworth
- Department of Medicine, New York University, 550 First Avenue, HCC 3-15, New York, NY 10016, USA
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Senna Versus Magnesium Oxide for the Treatment of Chronic Constipation: A Randomized, Placebo-Controlled Trial. Am J Gastroenterol 2021; 116:152-161. [PMID: 32969946 DOI: 10.14309/ajg.0000000000000942] [Citation(s) in RCA: 30] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/03/2020] [Accepted: 08/17/2020] [Indexed: 12/11/2022]
Abstract
INTRODUCTION This is the first prospective, double-blinded, randomized, placebo-controlled trial to evaluate the safety and efficacy of a stimulant laxative compared with an osmotic agent for the treatment of chronic idiopathic constipation. METHODS Patients were randomly administered stimulant laxative (senna, 1.0 g), osmotic agent (magnesium oxide [MgO], 1.5 g), or placebo for 28 consecutive days. The primary endpoint was overall symptom improvement. Secondary endpoints were spontaneous bowel movement (SBM), complete SBM, and patient assessment of constipation quality of life (QOL). RESULTS Ninety patients (mean age, 42 years; 93% women; mean duration of symptoms, 9.9 years) were enrolled; all completed the study. The response rate for overall improvement was 11.7% in the placebo group, 69.2% in the senna group, and 68.3% in the MgO group (P < 0.0001). Change in SBM was significantly greater in the senna and MgO groups than that in the placebo group (P < 0.001). Similarly, change in complete SBM was significantly greater in the senna and MgO groups than that in the placebo group (P < 0.01). On the patient assessment of constipation QOL, significant improvements were seen in the senna and MgO groups compared with those in the placebo group (senna, P < 0.05; MgO, P < 0.001). The frequency of severe treatment-related adverse events was 0%. DISCUSSION Senna and MgO significantly improved the frequency of bowel movements and QOL score and seem to be effective in the treatment of constipation.
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Hamatani T, Shibue Y, Sawada N, Takagaki T, Hashimoto M, Nakada Y, Kakuyama H. Pharmacokinetics, safety and metabolite profiling of minesapride, a novel 5-HT 4 receptor partial agonist, in healthy elderly and young subjects. Drug Metab Pharmacokinet 2020; 35:563-570. [PMID: 33189559 DOI: 10.1016/j.dmpk.2020.09.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2020] [Revised: 08/13/2020] [Accepted: 09/25/2020] [Indexed: 10/23/2022]
Abstract
Minesapride is a novel 5-hydroxytryptamine 4 (5-HT4) receptor partial agonist that is expected to show efficacy in patients with irritable bowel syndrome with predominant constipation and functional constipation. An open-label study was conducted to evaluate pharmacokinetics (PK) and safety of minesapride. Japanese subjects, 12 elderly and 12 young, received a single oral dose of minesapride 40 mg/day in the fasted state. Metabolite profiles were also investigated in this clinical study and in an in vitro study using cryopreserved hepatocytes. Clinical results showed that minesapride was rapidly absorbed (Cmax: 2302.1 ng/mL in the elderly group, 2117.5 ng/mL in the young group), and the plasma concentration then decreased with half-life of approximately 7 h. There were no notable PK differences between elderly and young groups. No serious adverse events (AEs) were observed. The only AE that occurred in 2 or more subjects was diarrhea. Metabolite profiles in plasma and urine were similar between elderly and young groups. No major metabolites exceeded 10% of unchanged minesapride, and results of the in vitro study suggested that there were no human-specific metabolites. From the viewpoints of PK and metabolite profiling, no dose adjustment of minesapride is warranted in elderly population without renal or hepatic impairment.
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Affiliation(s)
- Tatsuto Hamatani
- Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.
| | - Yuta Shibue
- Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan
| | - Naoyuki Sawada
- Preclinical Research Unit, Research Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan
| | - Takeshi Takagaki
- Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan
| | - Masayo Hashimoto
- Preclinical Research Unit, Research Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan
| | - Yosuke Nakada
- Data Science, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan
| | - Hiroyoshi Kakuyama
- Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan
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Odaka T, Tominaga K. Uncontrolled, Open-Label Pre-Dinner Administration of Elobixibat in Japanese Adults with Chronic Constipation: A Retrospective Chart Review. CURRENT THERAPEUTIC RESEARCH 2020; 93:100616. [PMID: 33320111 PMCID: PMC7723766 DOI: 10.1016/j.curtheres.2020.100616] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/11/2020] [Revised: 10/27/2020] [Accepted: 11/07/2020] [Indexed: 12/18/2022]
Abstract
BACKGROUND Elobixibat has been approved as a new therapeutic drug for chronic constipation. Only the pharmacological efficacy and safety profile of pre-breakfast administration of elobixibat had been previously demonstrated. OBJECTIVE We evaluated the efficacy and safety profile of pre-dinner administration of elobixibat in patients with functional constipation in a retrospective observational study. METHODS Patients aged 20 years or older diagnosed with functional constipation by the Rome IV criteria from June 1, 2018, to January 17, 2019. The evaluation time points were at the start and 1, 2, 4, and 8 weeks after treatment. The primary end point was frequency of spontaneous bowel movements per week. The secondary end points were changes in Bristol Stool Form Scale score, onset time required for spontaneous defecation after administration, percent of patients with spontaneous defecation within 24 hours and 48 hours after the first administration, improvement of abdominal pain or abdominal bloating evaluated by a visual analog scale, and total score and each subscore of the Japanese-Translated Version of Patient Assessment of Constipation Quality of Life Questionnaire. RESULTS Pre-dinner administration of elobixibat was associated with significantly increased frequency of spontaneous bowel movements and improved Bristol Stool Form Scale score at 1, 2, 4, and 8 weeks after treatment. The mean onset time until spontaneous defecation after treatment was 4 to 5 hours, which was earlier than that by conventional constipation treatment drugs and almost constant within an individual during the treatment period. Spontaneous defecation was achieved by 85.4% within 24 hours and 90.2% within 48 hours after the first administration. Elobixibat also improved patients' quality of life, which was evaluated by the Japanese-Translated Version of Patient Assessment of Constipation Quality of Life Questionnaire without adverse events. CONCLUSIONS Pre-dinner administration of elobixibat improved constipation, abdominal pain and bloating, and patient quality of life by management of fixed defecation. (Curr Ther Res Clin Exp. 2020; 81:XXX-XXX).
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Affiliation(s)
- Takeo Odaka
- Odaka Internal and Gastrointestinal Clinic, Narashino, Chiba, Japan
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Ahn Y, Hong GS, Lee JH, Lee CW, Kim SO. Ischemic colitis after enema administration: Incidence, timing, and clinical features. World J Gastroenterol 2020; 26:6442-6454. [PMID: 33244204 PMCID: PMC7656214 DOI: 10.3748/wjg.v26.i41.6442] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/03/2020] [Revised: 09/05/2020] [Accepted: 10/01/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Enema administration is a common procedure in the emergency department (ED). However, several published case reports on enema-related ischemic colitis (IC) have raised the concerns regarding the safety of enema agents. Nevertheless, information on its true incidence and characteristics are still lacking.
AIM To investigate the incidence, timing, and risk factors of IC in patients receiving enema.
METHODS We consecutively collected the data of all adult patients receiving various enema administrations in the ED from January 2010 to December 2018 and identified patients confirmed with IC following enema. Of 8320 patients receiving glycerin enema, 19 diagnosed of IC were compared with an age-matched control group without IC.
RESULTS The incidence of IC was 0.23% among 8320 patients receiving glycerin enema; however, there was no occurrence of IC among those who used other enema agents. The mean age ± standard deviation (SD) of patients with glycerin enema-related IC was 70.2 ± 11.7. The mean time interval ± SD from glycerin enema administration to IC occurrence was 5.5 h ± 3.9 h (range 1-15 h). Of the 19 glycerin enema-related IC cases, 15 (79.0%) were diagnosed within 8 h. The independent risk factors for glycerin-related IC were the constipation score [Odds ratio (OR), 2.0; 95% confidence interval (CI): 1.1-3.5, P = 0.017] and leukocytosis (OR, 4.5; 95%CI: 1.4-14.7, P = 0.012).
CONCLUSION The incidence of glycerin enema-related IC was 0.23% and occurred mostly in the elderly in the early period following enema administration. Glycerin enema-related IC was associated with the constipation score and leukocytosis.
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Affiliation(s)
- Yura Ahn
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine & Asan Medical Center, Seoul 05505, South Korea
| | - Gil-Sun Hong
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine & Asan Medical Center, Seoul 05505, South Korea
| | - Ju Hee Lee
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine & Asan Medical Center, Seoul 05505, South Korea
| | - Choong Wook Lee
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine & Asan Medical Center, Seoul 05505, South Korea
| | - Seon-Ok Kim
- Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, South Korea
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50
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Taylor DCA, Abel JL, Martin C, Doshi JA, Essoi B, Korrer S, Reasner DS, Carson RT, Hunter AG. Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR). J Med Econ 2020; 23:1072-1083. [PMID: 32696684 DOI: 10.1080/13696998.2020.1799816] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
AIMS To characterize a US population of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) using CONTOR, a real-world longitudinal research platform that deterministically linked administrative claims data with patient-reported outcomes data among patients with these conditions. METHODS Patients with IBS-C or CIC were identified using diagnosis and treatment codes from administrative claims. Potential respondents received a mailed survey followed by 12 monthly online follow-up surveys and 2 mailed diaries. Surveys collected symptom severity, treatment use, quality of life, productivity, and condition/treatment history. Comorbidities and healthcare costs/utilization were captured from claims data. Diaries collected symptoms, treatments, and clinical outcomes at baseline and 12 months. Data were linked to create a patient-centric research platform. RESULTS Baseline surveys were returned by 2,052 respondents (16.8% response rate) and retention rates throughout the study were high (64.8%-70.8%). Most participants reported burdensome symptoms despite having complex treatment histories that included multiple treatments over many years. More than half (55.3%) were dissatisfied with their treatment regimen; however, a higher proportion of those treated with prescription medications were satisfied. LIMITATIONS The study sample may have been biased by patients with difficult-to-treat symptoms as a result of prior authorization processes for IBS-C/CIC prescriptions. Results may not be generalizable to uninsured or older populations because all participants had commercial insurance coverage. CONCLUSIONS By combining administrative claims and patient-reported data over time, CONTOR afforded a deeper understanding of the IBS-C/CIC patient experience than could be achieved with 1 data source alone; for example, participants self-reported burdensome symptoms and treatment dissatisfaction despite making few treatment changes, highlighting an opportunity to improve patient management. This patient-centric approach to understanding real-world experience and management of a chronic condition could be leveraged for other conditions in which the patient experience is not adequately captured by standardized data sources.
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Affiliation(s)
| | - Jessica L Abel
- Health Economics and Outcomes Research, AbbVie, Madison, NJ, USA
| | - Carolyn Martin
- Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA
| | - Jalpa A Doshi
- Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Breanna Essoi
- Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA
| | - Stephanie Korrer
- Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA
| | - David S Reasner
- Data Science, Ironwood Pharmaceuticals, Inc, Boston, MA, USA
- Data Science and Analytics, Imbria Pharmaceuticals, Boston, MA, USA
| | - Robyn T Carson
- Patient-Centered Outcomes Research, AbbVie, Madison, NJ, USA
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