| Methods |
Cross‐over randomised controlled trial. |
| Participants |
10 adults (7 men and 3 woman)
Dropouts:
Inclusion: obese people on orlistat 120 mg 3x/day; BMI > 30; negative pregnancy test
Exclusion: elderly (age > 55 years); postnatal women; continence problems; gastrointestinal disease; psychological problems; abnormal laboratory results
Age: mean 46 years (range 27 to 54)
BMI: 35.7 (30.2 to 43.6) |
| Interventions |
A: loperamide 2 mg + placebo x 2
B: loperamide 2 mg x2 (= 4 mg) + placebo x 1
C: loperamide 2 mg x3 (= 6 mg) + no placebo
Each block of active treatment for 2 weeks
Washout: 2 weeks between each block |
| Outcomes |
No effect on stool frequency
Trend for increased stool consistency from median (IQR) score 0.7 (0.5 to 0.9) with placebo to 0.4 (0.3 to 0.6) with 6 mg dose (0 = all hard, 1 = all liquid)
Continence problems (fecal spotting and incontinence) reduced with loperamide vs placebo, P < 0.05
Significant positive dose‐response relationship with increasing dose of loperamide (reduced FI with 2 mg dose, and almost no FI with 4 mg and 6 mg doses)
Adverse effects: none (specifically no severe constipation with the highest doses) |
| Notes |
Study aim was to reduce the adverse effects of orlistat treatment for obesity (oily stools, increased faecal frequency and urgency and 'fecal spotting' (= faecal incontinence) in order to increase compliance with orlistat
No useable data |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"The hospital pharmacy dispensed medication according to a computer generated randomization list." |
| Allocation concealment (selection bias) |
Low risk |
"The sequence was concealed until the study was completed". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Reported as "double‐blind study", however it is not specified who was blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Reported as "double‐blind study", however it is not specified who was blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No incomplete outcome data |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Was use of a cross over design appropriate? |
Low risk |
Each participant received placebo and two of the three doses of loperamide for 2 weeks, each separated by a 2‐week washout. The sequence was concealed until the study was completed. |
| Is it clear that the order of receiving treatment was randomised? |
Low risk |
"The hospital pharmacy dispensed medication according to a computer generated randomization list." |
| Can it be assumed that the trial was not biased from carry over effects? |
Low risk |
Each participant received placebo and two of the three doses of loperamide for 2 weeks, each separated by a 2‐week washout. |
