Skip to main content
. 2016 Aug 22;2016(8):CD003424. doi: 10.1002/14651858.CD003424.pub4

Robinson 1990.

Methods Randomised, double‐blind, placebo‐controlled cross‐over trial for 2 successive 3‐week treatment periods.
Participants 17 children with CF (11 males, 6 females), mean age 6.2 years, range 0.5 ‐ 13.8 years.
Interventions 2 groups:
1. usual enzyme therapy plus placebo 4x daily;
2. usual enzyme therapy plus misoprostol 100 mcg 4x daily.
Outcomes Faecal fat.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised, but no details of method given.
Allocation concealment (selection bias) Low risk Randomisation carried out at the pharmacy in the hospital.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Described as double‐blinded, participants each given 2 bottles of identical looking medication at start of trial (1 bottle of active misoprostol and 1 bottle of inert placebo).
Parents of 5 out of 15 children were reported to be able to identify the misoprostol treatment period by improvements in symptoms such as abdominal pain and bulky bowel movements.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 withdrawals, 1 aged 6 months due to marked diarrhoea while taking misoprostol and 1 because of poor compliance.