Oben 2009.
Methods | Randomised, double blind, placebo control, 4 parallel groups (2 x normal weight patients, 2 x overweight patients). Duration 8 weeks | |
Participants | Randomised n=80, Completed n=45. Age range 25‐60 yrs (mean age not reported). Gender data not reported. OA knee (ACR criteria) in adults of normal weight and overweight | |
Interventions | NP 06‐1: mixture of Phellodendron amurense tree bark extract with 50% berberine and Citrus sinensis peel extract a minimum of 30% polymethoxylated flavones, 1480mg (2 x 2 x 370mg), capsules Placebo control: ingredients not reported, capsules |
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Outcomes | Lequesne index, BMI, CRP, ESR | |
Notes | Exploratory study design; power, effect, and sample size not determined a priori. Reported university oversight, but unclear whether a formally consistuted human research ethics committee approved the research design. Results favour intervention. In the overweight intervention group, weight loss during the intervention period may have contributed to improvement. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number sequence |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Active intervention and placebo not distinguished by look, taste, smell, packaging, or medication regimen |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reported withdrawals (low risk) Per protocol analysis only (unclear risk) |
Selective reporting (reporting bias) | Unclear risk | Incompletely reported adverse events |
Other bias | Unclear risk | Diagnosis / assessment consistent with ACR criteria (low risk) Possible confounder: the berberine component of the intervention may have contributed to weight loss |