Schadler 1988.
Methods | Randomised, double blind, placebo control, 2 group crossover. Duration 14 days (˜2 weeks); 2 x 7 days (˜1 week) intervention, no washout period | |
Participants | Randomised n=30, Completed n=30. Mean age 66 yrs, range 45‐81 yrs. M:F 7:23. Inclusion: OA knee, hip, thumb, shoulder (criteria not specified) | |
Interventions | PhytodolorRN: standardised extract mixture of ash bark, aspen leaf, aspen bark, golden rod herb, 3 x 40 drops, tincture Placebo control: ingredients not reported |
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Outcomes | Diclofenac use, pain at rest 0‐3, pressure pain 0‐3, pain with mvt 0‐3, mobility impairment (scale not reported) | |
Notes | Exploratory study design; power, effect, and sample size not determined a priori. Did not report ethical oversight or compliance with guidelines. Results favour intervention (reduced used of diclofenac only, results equivocal for other outcomes). | |
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 |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as double blind, method not reported. In other studies of PhytodolorRN, active intervention and placebo not distinguished by look, taste, smell or packaging |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported 100% compliance, no withdrawals: likely in intervention over 7 days Intention‐to‐treat analysis can be assumed |
Selective reporting (reporting bias) | Unclear risk | Reported adverse events (low risk) |
Other bias | Unclear risk | Criteria for diagnosis of OA not specified (unclear risk) |