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. 2014 May 22;2014(5):CD002947. doi: 10.1002/14651858.CD002947.pub2

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
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