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

Mills 1996.

Methods Randomised, double‐blind, placebo control, 2 parallel groups. Duration 2 months (˜8 weeks)
Participants Randomised n=82 (all participants, OA and RA), Completed n=52 (plus RA n=20). Mean age (all participants, OA and RA) 62 yrs. Gender data not reported. Inclusion: Self‐identified arthritis pain, subsequently assessed by rheumatologist (ACR criteria), AIMS2 pain score of at least 3, not using prescribed salicylates, NSAIDs, or analgesics
Interventions Reumalex: polyherbal mixture including extracts of willow bark, guaiacum resin, black cohosh, sarsparilla, and poplar bark, 2 "at a time", tablets.
Placebo control: calcium phosphate, tablets
Concurrent medication permitted: stable self‐prescribed analgesics
Outcomes Pain AIMS 2, modified Ritchie index, analgesic use (diary)
Notes Exploratory study design; power, effect, and sample size not determined a priori. Reported ethics committee approval. Results equivocal; medium effect size improvements in pain, but no reduction in analgesic use.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised, but participants allocated directly to groups on order of enrolment into the trial (quasi‐randomised): "Assigned by accession to pre‐set lists of allocations randomised for equalisation in every ten, and after stratification by clinical condition, to one of two groups"
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 interventions, active control, and placebo not distinguished by look, taste, smell or packaging
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Reported withdrawals (low risk)
Per‐protocol analysis only (unclear risk)
Selective reporting (reporting bias) Low risk Reported adverse events (low risk)
Other bias Low risk Diagnosis/assessment consistent with ACR criteria