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. |
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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. |