Blotman 1997.
Methods | Randomised, double‐blind, placebo control, 2 parallel groups, multicentre (n not specified). Duration 90 days (˜12 weeks) | |
Participants | Completed n=163. Mean age 63 yrs. M:F 55:108. Inclusion: OA knee (n=101) or hip (n=62) (ACR criteria), Kellgren grade IB‐III, pain requiring NSAIDs for 3 months | |
Interventions | Piascledine 300*: Persa gratissma and Glycine max, avocado / soyabean unsaponifiables, 300mg / 600mg, OD, tablets Placebo control: ingredients not reported Rescue medication permitted: one of 7 predefined NSAIDs taken by all participants for first 45 days. Resumption of same NSAID allowed during second 45 days |
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Outcomes | Resumption of NSAIDS, time off NSAIDS, NSAID use (diclofenac equivalents), Lequesne index, pain VAS 0‐100, patient global 0‐4, physician global 0‐4 | |
Notes | Confirmatory study design, power 80%, alpha 0.05. Reported compliance with Helsinki Declaration and ethics committee approval. Results favour intervention for reduced use of NSAIDs, but pain scores are similar in the two groups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Described as randomised, in blocks of four, stratified according to site of arthritis (hip or knee), to one of two groups, using a table of random numbers |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Described as double‐blind. 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) Included per protocol analysis only (unclear risk) |
Selective reporting (reporting bias) | Low risk | Reported adverse events |
Other bias | Low risk | Diagnosis and assessment consistent with ACR criteria |