Clusters of Responders and Predictive Factors for Response to Supplementation With Boswellia, Turmeric, and Red Algae Extracts in Painful Knee Osteoarthritis: A Prospective Observational Study Using an Arsenal of Patient Centred-measures [post]

Samira Ait-Abdellah, Caroline Gal, Anne Leblanc, Anne-Priscille Trouvin, Serge Perrot
2020 unpublished
Background: Knee osteoarthritis (KOA) is a common, painful condition. This open-label, observational, longitudinal study evaluated the use of a fixed combination of boswellia, turmeric, and red algae extracts in patients with painful KOA. Given the growing interest in patient-centred care in osteoarthritis, effects were assessed by an arsenal of patient-reported outcome measures (PROMs): Patient Acceptable Symptom Scale (PASS), Minimal Clinically Important Improvement (MCII), Patient Global
more » ... Patient Global Impression of Change (PGIC), and Lequesne algofunctional index (LAFI). Patients also completed a list of 17 items on pain quality.Methods: Patients with painful unilateral or bilateral KOA were included. They had to take 1-4 capsules per day of a dietary supplement containing boswellia, turmeric, and red algae extracts (Cartimotil Fort®, PiLeJe Laboratoire, Paris, France) for 90 days. Patients completed PROMs on Days 0 (baseline), 10, 20, 30, 60, and/or 90. Results: From March 2017 to March 2019, 118 patients [female: 69.5%; age: 62.9 (9.5) years, mean (SD); BMI: 26.4 (4.0) kg/m²; DN4 <4: 90.7%] were included in the study and took at least one capsule. Mean (SD) follow-up duration was 100.7 (54.9) days. Pain relief was maximal on Day 90: 64.5% of patients were responders (positive PASS); 68.8% and 58.4% had MCII and PGIC scores indicating positive effect (score ≥3) or global improvement (score ≥5); 73.3% (versus 47.5% at baseline) were mildly/moderately disabled (LAFI score <8); 55.2% had meaningful decrease (-30%) in pain intensity (VAS), 35.1% (versus 59.2% at baseline) took analgesics as supplementary treatment. Median time to first PASS change was 34 days. Pain intensity (VAS) as well as two pain characteristics (i.e., "Stabbing pain" and "Widespread pain") were independent factors associated with non-response on Day 30. Four clusters of responders were isolated according to pain characteristics, with one cluster exhibiting a higher responder rate. Treatment compliance and safety were satisfactory.Conclusions: This study showed that the fixed combination of boswellia, turmeric, and red algae extracts improved KOA patients. Further studies are needed to confirm the observations. Beyond these results, this study showed the importance of PROs and specific pain qualitative descriptors for accurate evaluation of dietary supplement approaches in painful conditions. Trial registration details: ClinicalTrials.gov, NCT02977936. Registered 30 November 2016, https://clinicaltrials.gov/ct2/show/NCT02977936
doi:10.21203/rs.3.rs-51794/v1 fatcat:i25hrxxic5hqxhe3o7l42vxe2y