Efficacy and safety of endoscopic gastroplasty for treatment of obesity: An overview of comparative meta-analyses

Table 1 Characteristics of included studies

No.	Ref.	Country	Eligibility/inclusion criteria	Search characteristics		Number of studies and total number of patients
				Databases searched	Search period and limitations
14	Singh et al[9], 2020	United States	Inclusion criteria: P: Patients underwent EBMT for obesity; I: ESG; C: IGB; O: %TWL, %EWL and adverse events; SD: All RCTs and observational studies with a minimal follow-up of 12 months; studies with more than one treatment arm, patients who underwent ESG or IGB alone with or without lifestyle modification	MEDLINE (PubMed), Scopus, Cochrane Register of Controlled Trials, and Web of Science databases	Inception to August 2019; restricted to observational and RCTs	28 studies; 1 study with direct comparison (n = 58)
			Exclusion criteria: Patients with prior or sequential EBMTs or bariatric surgery; Case reports and study with < 25 patients; studies with endoscopic gastroplasty techniques using devices other than the OverStitch endoscopic suturing system; studies with IGBs not approved by the United States Food and Drug Administration; Letters, editorials, expert opinions, and reviews without original data and studies with overlapping patient cohorts
42	Jaruvongvanich et al[11], 2020	United States	Inclusion criteria: P: Adults aged 18 years or older with obesity; I: ft-TORe or APMC-TORe to manage weight regain after RYGB; C: Any; O: TBWL; SD: case-control studies, cohort studies, RCTs	Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, and Daily, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus	Inception to February 10, 2020, limited to the English language and excluding animal studies	16 studies; 1625 participants
43	Mohan et al[13], 2020	United States	Inclusion criteria: P: Patients with moderate to severe obesity; I: ESG; C: LSG on published 2013; O: Pooled and difference in %TWL, %EWL and BMI with ESG at 1, 6, and 12 months; and adverse events; SD: All studies were included irrespective of the study sample-size, inpatient/outpatient setting, and geography as long as they provided data needed for the analysis	PubMed, EMBASE, Google-Scholar, Scopus, and Web of Science databases	Inception to August 2019; restricted to studies in human subjects and published in English language in peer-reviewed journals	15 studies; 3994 patients
			Exclusion criteria: Studies on LSG published until December 31, 2012; studies on LSG published as abstracts; studies on robot-assisted LSG; studies that did not report outcomes on weight loss, in terms of total weight loss and/or excess weight loss and/or BMI; studies that did not report first 12 months’ outcome data; studies done exclusively in elderly and/or geriatric population (age > 60 years); studies done in a pediatric population (age < 18 years); and studies not published in English language
50	Jalal et al[10], 2020	Australia	Inclusion criteria: P: Adult patient study populations greater or equal to 20 with obesity; I: ESG; C: LSG; O: Weight loss potential of ESG, ESG complications, rates of conversion to surgery and cost; SD: English studies as Case-control, cohort and RCTs	PubMed/MEDLINE, Cochrane Library, EMBASE/OVID, and the World Wide Web	NR	2 studies; 348 participants
			Exclusion criteria: Case reports or case series; Articles that did not have extractable ESG data; Same centre studies or studies with cross over patient populations; Patient cohort less than 20
56	Madruga-Neto et al[4], 2018	Brazil	Inclusion criteria: P: Patients with obesity (BMI > 30 kg/m2); I: EG with full-thickness suture or plication devices; C: sham or diet and lifestyle changes; O: AWL, %EWL, responder rate (%TWL ≥ 5%), and potential complications in 6 and 12 months; SD: Only RCTs without restrictions on language or publication year	MEDLINE [PubMed], Embase, Cochrane Central, and LILACS/BIREME	Inception to November 2017	3 studies; 459 patients
			Exclusion criteria: studies with follow-up periods < 1 month, those involving revision endoscopic procedures after bariatric surgery, and those involving patients who were overweight (BMI: 25-30 kg/m2)
57	Brunaldi et al[14], 2018	Brazil	Inclusion criteria: P: Patients with RYGB who presented with weight regain; I: Endoscopic therapy for weight regain following RYGB; C: Any comparator; O: AWL, EWL, and TBWL; SD: RCT, observational cohort studies, and case series and Conference abstracts if they met the eligibility criteria	MEDLINE, Embase, Scopus, Web of Science, Cochrane, OVID, CINAHL/EBSCo, LILACS/Bireme, and gray literature	Inception to October 31, 2016	15 studies; 882 patients
			Exclusion criteria: Reviews, editorials, case-control studies, studies using non-human subjects, articles without English translation, did not describe the endoscopic method clearly; follow-up weight or BMI less than 1 month; with endoscopic treatment for other indications besides weight regain, such as dumping syndrome or fistula closure; did not report baseline BMI; included patients with weight regain who had already undergone other endoscopic or surgical treatment of weight regain

APMC-TORe: Argon plasma mucosal coagulation alone; AWL: Absolute weight loss; BMI: Body mass index; C: Comparator; EBMT: Endoscopic bariatric and metabolic therapies; EG: Endoscopic gastroplasty; ESG: Endoscopic sleeve gastroplasty; EWL: Excess weight loss; I: Intervention; ft-TORe: Full-thickness suturing plus argon plasma mucosal coagulation; IGB: Intragastric balloon; LSG: Laparoscopic sleeve gastroplasty; NR: Not reported; O: Outcome; P: Participants; RCT: Randomized controlled trial; RYGB: Roux-en-Y Gastric Bypass; SD: Study design; TORe: Endoscopic transoral outlet reduction; TWL: Total weight loss.

Table 2 Risk of bias assessment, heterogeneity, and limitations in the included studies

Ref.	Country	Quality assessment/risk of bias	Author reported factors affecting the quality	Heterogeneity in the analysis	Author reported limitations in the review
Singh et al[9], 2020	United States	NOS; Score of 8	NR	Considerable	Limited quality of the included studies, lack of controlled ESG studies, lack of long-term follow-up data, lack of clarify the concomitant use of weight loss medication, considerable heterogeneity, lack of standardized definition for SAE
Jaruvongvanich et al[11], 2020	United States	RCTs: Cochrane Collaboration risk assessment tool; high quality (1), low to medium quality (2); Observational studies: National Institutes of Health quality assessment scale for pre-post Studies; high quality (7) and low to medium quality (6)	Reporting bias, inappropriate patient selection, blinding of personals and outcome assessors, loss to follow-up	High (0%-87%)	Small sample size, limited follow-up duration, small number of studies in each analysis, low to moderate methodological quality of the included studies, the small number of comparative trials between the 2 techniques, substantial heterogeneities, influence of concomitant pharmacotherapy, limiting generalizability of findings, reporting bias
Mohan et al[13], 2020	United States	NOS; 3 were high quality and the rest were medium quality	Included studies were not entirely representative of the general population and community practice, selection bias, inadequate follow-up	NR	Effect of additional confounding factors, included studies were not entirely representative of the general population and community practice, retrospective nature of studies, selection bias, lack of subgroup data based on the presence of comorbidities, lack of data on success/failure of procedure
Jalal et al[10], 2020	Australia	NR: Limited quality	High loss to follow-up rates	Low (19%)	Lack of studies, retrospective nature of cohort studies, lack of control groups, heterogeneity, lack of long-term study data, high loss to follow-up rates
Madruga-Neto et al[4], 2018	Brazil	JADAD quality score: 3; GRADE standards: Very low to moderate	Inappropriate randomization, inappropriate blinding	Moderate (I2: 50% to 68%)	Biases, heterogeneity, inadequate data
Brunaldi et al[14], 2018	Brazil	Joanna Briggs Institute Checklist; very low	Selection bias, unclear reporting of information	NR	Lack of RCT, bias, heterogeneity, low methodological quality, lack of comparative studies

ESG: Endoscopic sleeve gastroplasty; NR: Not reported; RCT: Randomized controlled trial; SAE: Serious adverse event.

Table 3 The effect of endoscopic gastroplasty vs other interventions on total body weight loss

Ref.	Country	Number of studies & participants	Intervention and comparator	Effect measure	Effect size (95%CI)	Interpretation with respect to intervention
3 months
Brunaldi et al[14], 2018	Brazil	8 studies; 320 participants	FTS-APC vs FTS-alone	% mean	FTS-APC: 25.0 ± 1.99; FTS-alone: 15.3 ± 9.88	The FTS-APC group and demonstrated significantly a greater weight loss compared to FTS alone (P < 0.001)
Jaruvongvanich et al[11], 2020	United States	2 studies	ft-TORe vs APMC-TORe	% mean difference	-0.1 (-4.6 to 4.4)	There was no significant difference between two treatments
Jaruvongvanich et al[11], 2020	United States	2 studies	TORe vs TORe-gastroplasty	% mean difference	2.6 (0.5 to 4.7)	The TORe group and demonstrated significantly a greater weight loss compared to TORe-gastroplasty
6 months
Singh et al[9], 2020	United States	1 study; 58 participants	ESG vs IGB	% mean difference	3.07 (1.46–4.67)	ESG achieved significantly (P = 0.002) superior weight loss compared to IGB
Jalal et al[10], 2020	Australia	2 studies; 348 participants	ESG vs LSG	% mean difference	8.52 (6.35–0.69)	LSG appeared to have a significantly (P < 0.00001) superior weight loss compared to ESG
Jaruvongvanich et al[11], 2020	United States	3 studies	ft-TORe vs APMC-TORe	% mean difference	0.3 (-5.5 to 6.0)	There was no significant difference between two treatments
Jaruvongvanich et al[11], 2020	United States	2 studies	TORe vs TORe-gastroplasty	% mean difference	0.8 (-2.3 to 3.9)	There was no significant difference between two treatments
12 months
Singh et al[9], 2020	United States	1 study; 58 participants	ESG vs IGB	% mean difference	7.33 (5.22-9.44)	ESG achieved significantly (P = 0.0001) superior weight loss compared to IGB
Mohan et al[13], 2020	United States	9 studies	ESG vs LSG	% mean	ESG: 17.08 (15.05-19.10); LSG: 30.5 (27.4-33.5)	LSG appeared to have a significantly (P = 0.001) superior weight loss compared to ESG
Madruga-Neto et al[4], 2018	Brazil	2 studies; 376 participants	EG vs Sham	% mean difference	4.8 (1.1-8.51)	The difference between the groups was significantly (P = 0.01) higher in the intervention group than in the control group
18-24 months
Singh et al[9], 2020	United States	1 study; 58 participants	ESG vs IGB	% mean difference	11.51 (5.33-17.69)	ESG achieved significantly (P = 0.0003) superior weight loss compared to IGB

APC: Argon plasma coagulation; APMC-TORe: Argon plasma mucosal coagulation alone; ESG: Endoscopic Sleeve Gastroplasty; ft-TORe: Full-thickness suturing plus argon plasma mucosal coagulation; FTS: Full-thickness suturing; IGB: Intragastric balloon; LSG: Laparoscopic sleeve gastroplasty; TORe: Endoscopic transoral outlet reduction.

Table 4 The effect of endoscopic gastroplasty vs other interventions on excessive weight loss

Ref.	Country	Number of studies & participants	Intervention and comparator	Effect measure	Effect size (95%CI)	Interpretation with respect to intervention
6 months
Singh et al[9], 2020	United States	1 study; 58 participants	ESG vs IGB	% mean difference	20.80 (12.50-29.10)	ESG achieved significantly (P = 0.0001) superior weight loss compared to IGB
Madruga-Neto et al[4], 2018	Brazil	2 studies; 127 participants	EG vs CT	% mean difference	17.87 (-1.8 to 37.54)	There was no significant (P = 0.07) difference between the groups, although the EG group presented higher effect than the control group
12 months
Singh et al[9], 2020	United States	1 study; 58 participants	ESG vs IGB	% mean difference	30.99 (22.81-39.16)	ESG achieved significantly (P = 0.0001) superior weight loss compared to IGB
Mohan et al[13], 2020	United States	9 studies	ESG vs LSG	% pooled mean	ESG: 62.3 (51.3-74.6); LSG: 69.3 (60.1-78.4)	There was no significant (P = 0.4) difference between LSG and ESG
Madruga-Neto et al[4], 2018	Brazil	2 studies; 127 participants	EG vs CT	% mean difference	16.01 (-1.48 to 33.5)	There was no significant (P = 0.07) difference between the groups, although the EG group presented higher effect than the control group
Brunaldi et al[14], 2018	Brazil	14 studies; 619 participants	FTS-APC vs FTS-alone	% mean difference	FTS-APC: 27.0 ± 2.91; FTS-alone: 17.8 ± 15.3	The FTS-APC group and demonstrated significantly a greater weight loss compared to FTS alone (P < 0.001)
18-24 months
Singh et al[9], 2020	United States	1 study; 58 participants	ESG vs IGB	% mean difference	43.78 (35.98-51.58)	ESG achieved significantly (P = 0.0001) superior weight loss compared to IGB
Brunaldi et al[14], 2018	Brazil	10 studies; 455 participants	FTS-APC vs FTS-alone	% mean difference	FTS-APC: 24.2 ± 0.84; FTS-alone: 11.7 ± 21.6	The FTS-APC group and demonstrated significantly a greater weight loss compared to FTS alone (P < 0.001)

CT: Conservative therapy; EG: Endoscopic gastroplasty; ESG: Endoscopic sleeve gastroplasty; IGB: Intragastric balloon; LSG: Laparoscopic sleeve gastroplasty; FTS: Full-thickness suturing; APC: Argon plasma coagulation.

Table 5 The effect of endoscopic gastroplasty vs other interventions on Absolute Weight Loss

Ref.	Country	Number of studies & participants	Intervention and comparator	Effect measure	Effect size (95%CI)	Interpretation with respect to intervention
6 months
Madruga-Neto et al[4], 2018	Brazil	2 studies; 127 participants	EG vs CT	% mean difference	7.05 (3.83 to 10.28)	There was significant (P < 0.0001) weight reduction in the EG group than the control group
12 months
Mohan et al[13], 2020	United States	11 studies	ESG vs LSG	% pooled mean	ESG: 29.3 (27.6-32.3) LSG: 29.3 (27.1-31.4)	There was no significant (P = 0.65) difference between LSG and ESG
Madruga-Neto et al[4], 2018	Brazil	2 studies; 127 participants	EG vs CT	% mean difference	4.99 (0.52 to 9.46)	There was a significant (P = 0.03) weight reduction in EG group than the control group

CT: Conservative therapy; EG: Endoscopic gastroplasty; ESG: Endoscopic sleeve gastroplasty; LSG: Laparoscopic sleeve gastroplasty.

Table 6 Adverse Events following the treatment endoscopic gastroplasty vs other interventions

Ref.	Country	Number of studies & participants	Intervention and comparator	Adverse events reported
Singh et al[9], 2020	United States	1 study; 58 participants	ESG vs IGB	3 (2 upper gastrointestinal bleeding, 1 peri gastric fluid collection)
Mohan et al[13], 2020	United States	15 studies	ESG vs LSG	All ADRs: ESG: 2.9 % (1.8-4.4); LSG: 11.8 % (8.4-16.4); P = 0.001; Bleeding: ESG: 1.1 % (0.7-1.8); LSG: 2.6 % (1.9-3.7); P = 0.005; GERD: ESG: 0.4 % (0.1-1.1); LSG: 5.8 % (3.5-9.3, 73); P = 0.001
Madruga-Neto et al[4], 2018	Brazil	3 studies; 459 patients	ESG vs CT	The total rate of adverse events in the EG group was 52.9%-77.8%, of which 5.0%-5.2% of the events were severe
Jaruvongvanich et al[11], 2020	United States	16 studies; 1625 participants	ft-TORe vs APMC-TORe	APMC-TORe: GI bleeding (1); Overall AE rates: ft-TORe: 9.3% (8-17.8); APMC-TORe: 6.4% (1.9-10.9); stricture rates: ft-TORe: 3.3% (1.4-5.3); APMC-TORe: 4.8% (2.3-7.2)

EG: Endoscopic gastroplasty; ESG: Endoscopic sleeve gastroplasty; IGB: Intragastric balloon; LSG: Laparoscopic sleeve gastroplasty; APMC-TORe: Argon plasma mucosal coagulation alone; CT: Conventional therapy; ft-TORe: full-thickness suturing plus argon plasma mucosal coagulation.