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. 2015 Aug 5;2015:0413.
Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review
People (>90% aged >16 years) with idiopathic chronic constipation (modified Rome II criteria and negative investigations)
3 RCTs in this analysis
Total number of adverse events
with lubiprostone
with placebo
Absolute results not reported

RR 1.79
95% CI 1.21 to 2.65
NNH = 4
95% CI 3 to 6
Small effect size placebo

Systematic review
People (>90% aged >16 years) with idiopathic chronic constipation (modified Rome II criteria and negative investigations)
3 RCTs in this analysis
Diarrhoea
with lubiprostone
with placebo
Absolute results not reported

RR 4.46
95% CI 1.28 to 15.48
Moderate effect size placebo

Systematic review
People (>90% aged >16 years) with idiopathic chronic constipation (modified Rome II criteria and negative investigations)
3 RCTs in this analysis
Nausea
with lubiprostone
with placebo
Absolute results not reported

RR 7.27
95% CI 3.76 to 14.06
Large effect size placebo

RCT
4-armed trial
People, average age about 40 years, with idiopathic chronic constipation At least 1 adverse event
17/44 (39%) with highest-dose lubiprostone
13/43 (30%) with middle-dose lubiprostone
1/41 (2%) with lowest-dose lubiprostone
2/42 (5%) with placebo

P value among groups not reported

RCT
4-armed trial
People, average age about 40 years, with idiopathic chronic constipation Diarrhoea
8/44 (18%) with highest-dose lubiprostone
4/43 (9%) with middle-dose lubiprostone
0/41 (0%) with lowest-dose lubiprostone
0/42 (0%) with placebo

P value among groups not reported
Incidence of diarrhoea significantly higher in highest-dose arm v placebo (P = 0.0037) and middle dose arm v placebo (P = 0.0429)
No other pairwise analysis reported
Effect size not calculated placebo compared with highest-dose and middle-dose lubiprostone

RCT
4-armed trial
People, average age about 40 years, with idiopathic chronic constipation Nausea
7/44 (16%) with highest-dose lubiprostone
3/43 (7%) with middle-dose lubiprostone
0/41 (0%) with lowest-dose lubiprostone
0/42 (0%) with placebo

P value among groups not reported
Incidence of nausea significantly higher in highest-dose arm v placebo (P = 0.007)
No other pairwise analysis reported
Effect size not calculated placebo compared with highest-dose lubiprostone