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

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
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)