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Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. May 28, 2014; 20(20): 6031-6043
Published online May 28, 2014. doi: 10.3748/wjg.v20.i20.6031
Table 1 Characteristics and primary outcomes of randomized, double-blind, placebo controlled clinical trials in irritable bowel syndrome patients
Ref.IBS populationSelection criteriaTreatmentDoseDurationOutcome
Mitchell et al[46]All subtypesModified RomeAlverine citrate vs placebo120 mg tid12 wkNo significant difference compared to placebo
Wittmann et al[48]All subtypesRome IIIAlverine citrate +60 mg tid +4 wkSignificantly reduced abdominal pain and discomfort compared to placebo
simethicone vs placebo300 mg tidMore therapy responders, regardless of stool pattern, compared to placebo
Connel et al[52]All subtypesMebeverine vs placebo100 mg qid12 wkSuperior in controlling IBS symptoms compared to placebo
Kruis et al[58]All subtypesMebeverine vs placebo vs Wheat bran400 mg daily16 wkNo significant difference compared to placebo
Enck et al[59]All subtypesMebeverine vs placebo vs Dietary fiber16 wkTherapy response rate lower than placebo
Everitt et al[61]All subtypesRome IIIMebeverine vs135 mg tid6 wkNo significant difference between drugs
methylcellulose vs placebo with/without cognitive behavioral therapy web site (assisted or not)3 tbl. bidSignificantly increased enablement at 6 and 12 wk in website group compared to no website group, significantly more participants scored their subjective assessment of global relief as improved at 12 wk in website group compared to no website group.
Baldi et al[69]Abdominal pain predominantOtilonium bromide vs placebo40 mg tidNo significant difference in abdominal pain, bloating and general well-being compared to placebo, but significantly reduced sigmoid motility
Battaglia et al[70]All subtypesDrossmanOtilonium bromide vs placebo40 mg tid15 wkSignificantly better compared to placebo in reduction of abdominal pain frequency, global score improvement of abdominal pain and discomfort, therapy responder rate, reduced tenderness of the sigmoid colon, higher general well-being and global judgement of investigators; superior in improving severity of diarrhea/constipation, number of evacuations and mucus in stool; more effective in treating diarrhea, but not constipation
Clave et al[72]All subtypesRome IIOtilonium bromide vs placebo40 mg tid15 wkReduced abdominal pain frequency and bloating and improved stool frequency and patient global assessment compared to placebo; lower symptom recurrence after treatment
Awad et al[85]All subtypesPinaverium bromide vs placebo50 mg tidSignificantly reduced post-prandial rectal spike amplitude plus frequency and spontaneous recto-anal inhibitory reflex frequency compared to placebo
Chassany et al[98]All subtypesRome IIPhloroglucinol + trimethylphloroglucinol vs placebo62.2 mg + 80 mg tid1 wkSignificantly higher relative decrease of pain intensity and responder rate in the phloroglucinol plus trimethylphloroglucinol group compared to placebo; persisting treatment effect in a higher percent of patients treated with phloroglucinol plus trimethylphloroglucinol
Cha et al[99]IBS-DRome IIIPhloroglucinol vs placebo80 mg tid2 wkSignificantly improved subjects' global assessment and decreased stool frequency