Medhi 2009.
Methods | Randomised, double‐blind, active control, 2 parallel groups. Duration 4 weeks | |
Participants | Randomised n=110; intervention n=55, control n=55. Completed n=100; intervention n=50, control n=50. Age 40+ years. OA knee (not ACR criteria), knee pain, knee swelling | |
Interventions | Tradename not provided. Ricinus officinalis. Castor oil, 2.7ml (3 x 0.9ml), capsule Active control: diclofenac sodium, 150mg (3 x 50mg), capsule Concurrent intervention permitted: all participants encouraged to have physiotherapy |
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Outcomes | Pain VAS 0‐100 | |
Notes | Exploratory study design; power, effect, and sample size not determined a priori. Reported ethics committee approval. Results favour diclofenac over castor oil for improvement in osteoarthritic knee pain. Pain improved in both intervention and active control groups, but improvement was greater in the diclofenac group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, method not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. Participants "selected from outpatients" may imply that allocation was unconcealed, or that participation in the study was not voluntary (unclear risk) |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as double‐blind, method incompletely reported. Assume active intervention and placebo not distinguished by look, taste, smell or packaging |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reported withdrawals (low risk) Per‐protocol analysis only (unclear risk) Five participants withdrew due to "efficacy failure", which may confound results |
Selective reporting (reporting bias) | Unclear risk | Clinical outcome data reported as percentages and P values only, insufficient for extraction (unclear risk) Reported adverse events (low risk) |
Other bias | Unclear risk | Diagnosis / assessment not consistent with ACR criteria (unclear risk) |