Emery 1983.
Methods | Double‐blind parallel group with stratified random sampling | |
Participants | 8 boys with DMD aged 4 years 8 months to 9 years 6 months. Diagnosed according to clinical findings, serum enzymes, muscle biopsy; and EMG in some | |
Interventions | Verapamil 40 mg twice daily or placebo for 12 months | |
Outcomes | Vignos score (0 to 10). Motor ability (0 to 40). Muscle force in 10 bilateral muscle groups by MRC scale and ergometry. CK. 24 hr creatine. 24 hr creatinine. Assessed as difference from baseline | |
Notes | 1 in verapamil arm developed prolonged PR interval. Study preceded by a trial of verapamil with 4 participants, of whom 2 developed prolonged PR interval | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: ‘..then randomly assigned ‘. Comment: does not describe how randomly assigned |
Allocation concealment (selection bias) | Low risk | Quote: ‘then randomly assigned to either the active drug ... or placebo by a pharmacist..who was not involved in assessing the effects of the drug’ Comment: suggests a central pharmacy allocation |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: ‘ The effects of treatment were assessed ..........without any knowledge of the results of previous assessments or of any of the biochemical findings’ |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcome data were complete |
Selective reporting (reporting bias) | Low risk | Comment: no evidence of selective reporting |
Other bias | High risk | Quote: ‘the criteria of selection were that they should live within easily travelling distance of this hospital...’ Comment: ‘this may have introduced bias because of differences in socioeconomic status and in ability to travel |