Cao 2005.
Methods | Randomised, unblinded, active control, 2 parallel groups, two centres. Duration 4 weeks | |
Participants | Randomised n=120, intervention (n=60; n=30 at x centres), Chinese control n=30, Western control n=30. Completed n=116. Inclusion: OA knee (ACR criteria), at least 5 days on NSAIDs, adverse events with NSAIDs, pain with walking at least 20mm (VAS 0‐100) in the previous 48h | |
Interventions | Tradename not provided. Chinese herbal mixture (blood‐nourishing, hard‐softening; BNHS), 3150mg Active control (Chinese): Chinese mixture to counter osteophytes, 5250mg, capsules Active control (Western): Viatril‐s 2250mg (crystalline glucosamine sulphate 1884mg equivalent to glucosamine sulphate 1500mg, sodium chloride 384mg) Rescue medication permitted: paracetamol (acetominophen), up to 4000mg daily, PRN; and aspirin, up to 100mg daily in a stable dose |
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Outcomes | WOMAC‐VAS (normalised scores), pain during walking 0‐100 VAS, patient global 0‐4, physician global 0‐4 | |
Notes | Exploratory study design; power, effect, and sample size not determined a priori. Reported ethics committee approval and compliance with ICH GCP guidelines. Improvements occured in all groups over time. Results indicate that BNHS is not inferior to counter osteophyte Chinese mixture or Viatril‐s. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, method inadequately reported: "sealed envelope method" |
Allocation concealment (selection bias) | Low risk | Allocation concealment can be inferred: "sealed envelope method" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as blinded, method inadequately reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported withdrawals Included intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | Reported adverse events (low risk) |
Other bias | Low risk | Diagnosis and assessment consistent with ACR criteria |