Bernhardt 1991.
Methods | Randomised, double‐blind, placebo control, active control (unblinded), 3 parallel groups. Duration 4 weeks | |
Participants | Randomised n=108; intervention n=36, placebo n=36, piroxicam n=36. Completed n=108. Mean age 52 yrs. M:F 22:50. Inclusion: OA (criteria not specified), acute or recurrent degenerative arthritic complaints | |
Interventions | PhytodolorRN: standardised extract mixture of ash bark, aspen leaf, aspen bark, golden rod herb, 3 x 30 drops, tincture Active control: piroxicam (Feldene 20), 20mg, OD Placebo control: ingredients not reported Concurrent treatment permitted: balneology (thermal baths), and physiotherapy |
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Outcomes | Pain with movement 0‐3, enduring pain 0‐3, mobility impairment 0‐3, finger‐ground distance, grip strength, PGA 0‐6, patient perception efficacy 0‐3 | |
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. Some outcome measures (eg: finger‐ground distance) are non‐specific and may be of limited use in rheumatological assessment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised to one of three 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 | Unclear risk | Described as double‐blind. In PhytodolorRN and placebo groups, active intervention and placebo not distinguished by look, taste, smell or packaging (low risk) Piroxicam group not blinded (unclear risk) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported no withdrawals (low risk) Intention‐to‐treat analysis can be assumed |
Selective reporting (reporting bias) | Unclear risk | Most outcome data reported as change scores, percentages, graphs and p values only, insufficient for extraction (unclear risk) Reported adverse events (low risk) |
Other bias | High risk | Diagnosis not based on ACR criteria. Non‐homogenous sample (any degenerative arthropathy, any site) (high risk) Unvalidated outcome measures (unclear risk) |