PD536 - USING DOSE–RESPONSE CORRELATION RE-ANALYZING TO DISTINGUISH PLACEBO FROM STANDARDIZED ROSE-HIP POWDER (LITO) IN A CLINICAL TRIAL ON OSTEOARTHRITIS WHERE DATA INITIALLY LOOKED IDENTICAL
PD536
USING DOSE–RESPONSE CORRELATION RE-ANALYZING TO DISTINGUISH PLACEBO FROM STANDARDIZED ROSE-HIP POWDER (LITO) IN A CLINICAL TRIAL ON OSTEOARTHRITIS WHERE DATA INITIALLY LOOKED IDENTICAL
A. Motawei1,*, K. M. Warholm 2, K. W. winther3
1food sciences department, faculty of agriculture, Mansoura, Egypt, 2 Oslo University Hospital, Division of Orthopedic Surgery,, oslo, Norway, 3preventive and clinical nutrition, nutrition and exercise institute, Copenhagen , Denmark
Rationale: positive placebo responses are common in clinical trials and pose a major challenge when evaluating different treatments. Standard between-group comparisons may fail to detect true effects when placebo improvements are significant. We aimed to demonstrate how a simple dose–response correlation method can help differentiate positive responses from those experienced with placebo through secondary analysis of a randomized controlled clinical trial of powdered Rosa-canina fruits.
Methods: Data were reanalyzed from a multicenter, double-blind, randomized, placebo-controlled trial (N = 120) evaluating the effects of standardized Rosa-canina powder in hip and knee osteoarthritis (OA). Participants received fixed doses, leading to variability in mg/kg exposure due to different body weights. Pearson correlations between dose/kg and changes in WOMAC pain and function at 6 and 12 weeks were calculated separately for the active and placebo groups. Standard between-group comparisons were performed.
Results: Both groups showed significant improvement, over 50%, with no statistically significant differences between them in WOMAC pain or function. the active group, which received a food supplement, exhibited a consistent negative correlation between body weight and symptom improvement at 6 and 12 weeks, suggesting greater benefit with a higher dose for body weight. No dose–response relationship was observed in the placebo recipients.
Conclusion: Dose–response correlation analysis uncovered positive effects of Rosa-canina as a nutrient that were not detectable through standard between-group comparisons. this low-cost, easy-to-implement method may help distinguish active effects from placebo responses in trials with large nonspecific improvements.
Disclosure of Interest: None declared