Baer 2005.

Methods	R, DB, PC, parallel groups Assessed at baseline, 6 weeks
Participants	Primary OA of at least 1 knee A flare of pain after withdrawal of prior therapy with either NSAID or paracetamol N = 216 (212 for efficacy) M 94, F 122 Mean age 65 years Mean baseline pain 13/20
Interventions	(1) Diclofenac sodium 1.5% (with DMSO, Pennsaid®), n = 107 (2) Placebo (vehicle carrier), n = 109 Medication (40 drops) applied around affected knee (front, back, and sides) without massage, 4 times daily for 6 weeks Rescue medication: paracetamol (maximum 1500 mg daily) except during washout and week before final assessment
Outcomes	≥ 50% PR (provided by author) PGE: 5‐point scale (responder = "good" or "very good") OMERACT‐OARSI responder Adverse events Withdrawals
Notes	Oxford Quality Score: R2, DB2, W1. Total = 5
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer‐generated"
Allocation concealment (selection bias)	Low risk	"randomisation schedule was concealed from the investigators, their support staff, study participants and the sponsor's clinical research personnel"
Blinding (performance bias and detection bias) All outcomes	Low risk	"two study solutions were identical clear, colourless liquids packaged in opaque bottles"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Primary outcome using BOCF imputation supplied by author. "Other" attrition greater in placebo arm (11%)
Study duration	Low risk	6 weeks
Size	Unclear risk	50 to 200 participants per treatment arm