Winther 2005.
| Methods | Randomised, placebo control, 2 group crossover. Duration 6.5 months; 14 days run‐in, 2 x 3 months (˜12 weeks) intervention, no washout period | |
| Participants | Randomised n=94, Completed stage 1 n=94, Completed stage 2 n=80. Mean age 66 yrs. M:F 40:54. Inclusion: aged 35+ years, primary OA hip or knee, radiographic verification (ACR criteria), mild to moderate pain | |
| Interventions |
LitoZin: Rosa canina lito (rosehip and seed), 5000mg (2 x 5 x 500mg), equivalent to 1.5mg galactolipid, capsules Placebo control: ingredients not reported, "inactive powder of similar taste, smell, and colour", capsules |
|
| Outcomes | WOMAC‐VAS | |
| Notes | Exploratory study design; power, effect, and sample size not determined a priori. Reported ethics committee approval. Results moderately favour intervention. Evidence of carryover effect in the group receiving the intervention prior to the placebo. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised in blocks of four, to one of two groups, using a computer generated allocation schedule |
| Allocation concealment (selection bias) | Low risk | Adequate allocation concealment can be inferred1 |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Active intervention and placebo not distinguished by look, taste, smell, or packaging |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported withdrawals. Included intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Unclear risk | Reported adverse events (low risk) Subgroup analyses published separately (unclear risk) |
| Other bias | Low risk | Diagnosis / assessment consistent with ACR criteria |
Unless otherwise stated, all oral medications are reported as total daily doses, which may have been administered in single or divided doses.
Unless subscales are named, outcome measures (eg: WOMAC, HAQ, COAT) were used in entirety. Unless specified, all outcome measures were administered, scored, and scaled according to Osteoarthritis Research Society International (OARSI) standards.
1. Reported compliance with ICH GCP guidelines (ICH 2004) anchored in European law, or ethics committee oversight that would require the same, so adequate randomisation, allocation concealment, and blinding can be assumed.
2. Indicates that the tradename was not provided in the manuscript, but has been determined through communication with the manufacturing company noted in the acknowledgements.