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 |
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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 |