4 mg QHS; 3 wks RCT double-blind Global Improvement:
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1 Web supplement Table 1. Placebo-Controlled Trials of IBS s Loperamide 7 N=60; males and 4 mg QHS; 3 wks Global Improvement: Abdominal Pain: Significant decrease in days with colicky pain in subgroup of N=21 with IBS-A and abdominal pain Stool Form/Consistency: in stool in subgrps of N=16 IBS-painless diarrhea and N=21 with IBS-A and abdominal pain in stool frequency in 1
2 subgrps of N=16 IBS-painless diarrhea and N=21 with IBS-A and abdominal pain Loperamide 8 N=28; males and 2 mg BID, then Stool Form/Consistency, Urgency, Frequency, titrate to max 12 crossover Borborygmi: mg; 5 wks (mean dose dose ~ 4.8 mg/d) Loperamide 9 N=90; males and 2 mg QHS, then Stool Form/Consistency, titrate to max 6 mg; 5 wks (mean dose dose ~ 3 mg/d) Loperamide 47 N=25; males and 2 mg QHS, titrated RCT double blind Global Improvement, Abdominal Pain, Stool females; IBS-D Qwk to max 8 mg Form/Consistency, Urgency : 2
3 QHS; 13 wks Frequency, Flatulence, Borborygmi: No Ispaghula husk 10 N=80; males and 3.6 gm sachet TID; Global Improvement: 12 wks Significant decrease in days with no bowel movement Ispaghula husk 11 N=20; males and 30 gm QD; 4 wks Global Improvement: crossover; 7-10 d washout No improvement Ispaghula N=80; males and 3 gm sachet BID; 4 Global Improvement: 3
4 husk/poloxamer wks No significant difference in resolution or improvement in symptoms Ispaghula husk 13 Ispaghula husk 14 N=12; males and N=77; males and 3.5 gm BID; 16 wks Global Improvement: 6.4 gm TID; 8 wks Global Improvement, Abdominal Pain, or Stool Form/Consistency: Psyllium or Bran 15 N=275; males and 1) 10 gm psyllium, Global Improvement: Psyllium-Significant split BID, or 2) 10 improvement in symptom severity at month 3 only; gm bran split BID; Bran-No improvement 12 wks Abdominal Pain: Psyllium-Significant relief at months 1 and 2 only, but no change in severity; Bran-Significant relief at month 3 only, but no 4
5 change in severity Lubiprostone 45 N=193; males and 8, 16, or 24 mcg ; Global Improvement: females; IBS-C BID; 12 wks dose ranging; 2 wk at 28 days with 24 mcg follow-up BID dose Adominal Pain: Significant trend for improvement in abdominal pain at 28 days; trend not significant at 3 mos Bloating: Significant trend for improvement; trend not significant at 3 mos Stool Form/Consistency: limited to 24 mcg BID after 1 mo 5
6 Amitriptyline 16 N=40; Males and 25 mg x 1 wk Global Improvement, Abdominal Pain: titrated to 50 mg x 1 wk, then 75 mg Frequency, Flatulence: QHS; 12 wks Amitriptyline 17 N=33 adolescents; kg:10 mg; ; 3 Global Improvement: males and females; 50-80kg:20 mg; wk follow-up Abdominal Pain: IBS-All >80kg 30 mg QHS; in pain relief isolated to 8 wks periumbilical and right lower quadrant areas; No improvement in abdominal pain intensity and frequency Amitriptyline 48 N=54; Males and 10 mg QHS; 8 wks Global Improvement, Stool Form/Consistency, 6
7 Trimipramine 18 females; IBS-D N=61; males and Incomplete Evacuation: Abdominal Pain, Flatulence, Mucus Passage: No improvement 50 mg QD; 4 wks Mucus: Trimipramine 19 N=428; males and 50 mg QHS, 10 mg Abdominal Pain: QAM plus 40 mg limited to doses of 50 QPM, 35 mg QPM, mg QHS and 10 mg QAM plus 40 mg QPM 10 mg TID; > 6wks Imipramine 23 N=51; males and 25 mg x 2 weeks, Global Improvement, Abdominal Pain, then 50 mg QHS; 7
8 12 weeks Desipramine 21 N=28; males and 50 mg a 1 wk, 100 Global Improvement: mg x 1 wk, then 150 crossover; 2 wk Improvement, significance not reported mg QHS; 6 wks washout Abdominal Pain: in IBS-D subgroup Desipramine 22 N=31; males and depressed 150 mg QHS; 8 wks Abdominal Pain: Doxepin 20 N=44; males and 75 mg QHS; 6 wks ; 4 Global Improvement, Abdominal Pain, wk follow-up Incomplete Evacuation: 8
9 Citalopram 23 N=51; males and 20 mg x 2 weeks, Global Improvement, Abdominal Pain, then 40 mg QAM; 12 weeks Citalopram 24 N=23; males and 20 mg x 3 wks, then RCT crossover; 3 wk Global Improvement, Bloating, Urgency, 40 mg QD x 3 wks; washout Incomplete Evacuation, Abdominal Pain: non-depressed 6 wks Fluoxetine 25 N=40; males and non-depressed 20 mg QHS; 6 wks Global Improvement, Abdominal Pain, Urgency, Incomplete Evacuation, Bloating, Flatulence: No improvement Fluoxetine 26 N=44; males and 20 mg QD; 12 wks ; 4 Bloating, Stool Form/Consistency, females; IBS-C wk follow-up Paroxetine 27 N=72; males and 12.5 mg titrated to Global Improvement: 9
10 non-depressed 50 mg QD as tolerated; 12 weeks Abdominal Pain: No improvement Hyoscine butylbromide 13 Dicyclomine 46 N=12; males and N=97; males and females; IBS-C 10 mg QID; 16 wks Global Improvement: 40 mg QID; 2 wks Global Improvement, Abdominal Pain: Peppermint Oil 28 N=50; males and 550 mg QD; 4 wks ; 4 Global Improvement, Abdominal Pain, wk follow-up Bloating, Urgency, Incomplete Evacuation: Peppermint Oil 29 N=110; males and 187 mg TID or Abdominal Pain, Frequency, Flatulence, QID; 4 wks Borborygmi: 10
11 Rifaximin 31 N=87; males and 400 mg TID x 10 Bloating: days; 10 days placebo; 10 wk follow up Rifaximin 49 N=388; males and 550 mg BID x 14 ; 12 Bloating: females; IBS-D days; 14 days wk follow up in bloating during treatment and maintained for 12 weeks following treatment Pregabalin 32 N=26; males and 50 mg TID x 3 days Abdominal Pain: titrated to 100 mg in sensory threshold of without psychiatric TID x 4 days, 150 abdominal pain; No difference in sensory threshold disorders mg TID x 4 days, of moderate abdominal; Urgency: then 200 mg TID; 3 in sensory threshold wks 11
12 Gabapentin 30 N=40; males and 100 mg TID x 3 Abdominal Pain, Bloating: females IBS-D days titrated to 200 sensory threshold mg TID x 2 days; 6 days Clonidine 50 N=44; males and 0.1 mg BID; 4 wks ; Global Improvement: females; IBS-D dose-ranging; pilot in wks with relief; study in proportion of wks with relief Stool Form/Consistency, Octreotide 51 N=46; males and 20 mg IM q4wks; 8 Global Improvement, Abdominal Pain, females; IBS-D and wks Frequency, Bloating, Flatulence, Incomplete A Evacuation: 12
13 Stool Form/Consistency: Probiotics: N=40; males and 2x10 9 cfu BID; 4 Abdominal Pain, L. acidophilus 15 wks Incomplete Evacuation: Stool Form/Consistency, Probiotics: N=362; males and 10 8 cfu QD; 4 wks ; Global Improvement, Abdominal Pain, B. infantis 33 dose-ranging; 2 wk Bloating, Incomplete Evacuation, Flatulence: follow-up Urgency, Mucus: 13
14 Probiotics: N=298; males and 0.75 ml TID x 1 wk, Global Improvement, Abdominal Pain, E. coli 34 then 1.5 ml TID Stool Form/Consistency, Bloating: ( x10 7 cfu/ml ); 8 wks Probiotics: N=297; males and 0.75 ml TID x 1 wk, Global Improvement, Abdominal Pain: E. coli and E. 1.5 ml TID x 2 wks, Significant faecalis 35 then 2.25 ml TID (3-9x10 7 cfu/1.5 ml); 8 wks Probiotics: N=40; males and 5x10 7 cfu BID; 4 Global Improvement, Abdominal Pain: L. plantarum 36 weeks Probiotics:BLLS*** N=100; males and 1x10 10 cfu QD; 4 Global Improvement: 14
15 37 wks Abdominal Pain: between wks 1 and 4; No significant improvement in satisfactory relief Flatulence: in the IBS-C subgroup Probiotics: N=44; males and 8 x 10 9 cfu QD; 8 Abdominal Pain, Bloating: B. coagulans 38 females; IBS-D wks Probiotics:LBP* 39 N=86; males and 1.2 dl QD (1.7 x ; 3 Abdominal Pain, Borborygmi: 10 7 cfu of each wk follow-up strain/ml); 20 wks Flatulence: 15
16 Probiotics: N=75; males and cfu QD; 8 wks; Abdominal Pain, Incomplete Evacuation: B. infantis 40 4 wk follow up Bloating: Probiotics:LBP* 41 N=81; males and 8-9 x 10 9 cfu QD; Abdominal Pain: 24 wks ; significant improvement in % of pts with dec abdominal pain Urgency, Incomplete Evacuation, Borborygmi: Flatulence: ; significant improvement in % of pts with decreased flatulence Probiotics:BLS** 42 N=48; males and 4.5x10 6 cfu QD; 4 Abdominal Pain, 16
17 wks Bloating, Urgency: Flatulence: Probiotics: L. N=54; males and 10 8 cfu, 4 tabs daily Global Improvement, Abdominal Pain, reuteri 43 x 7 d, then 2 tabs Bloating, Incomplete Evacuation, Flatulence: QD; 22 wks Probiotics: L. GG 44 N=50; males and children cfu BID; 6 wks Global Improvement, Abdominal Pain: *LBP: L. rhamnosus, B. breve and P. freudenreichii **BLS:Bifidobacterium, Lactobacillus, S. salivarius ***BLLS:B. longum, L. acidophilus, L. lactis, S. thermophilus 17
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