Ait Abdellah Samira, Gal Caroline, Leblanc Anne, Trouvin Anne-Priscille, Perrot Serge
Clinical Research Department, PiLeJe Laboratoire, Paris, France.
Applied Research Department, PiLeJe Laboratoire, Paris, France.
Open Access Rheumatol. 2021 Jan 8;13:1-13. doi: 10.2147/OARRR.S287078. eCollection 2021.
This observational study evaluated a combination of boswellia, turmeric, and red algae extracts in patients with knee osteoarthritis (KOA). Given the growing interest in patient-centered 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 Impression of Change (PGIC), and Lequesne algofunctional index (LAFI). Patients also completed a list of 17 items on pain quality.
Patients with painful unilateral or bilateral KOA had to take 1-4 capsules per day of a dietary supplement containing boswellia, turmeric, and red algae extracts for 90 days. Patients completed PROMs on Days 0 (baseline), 10, 20, 30, 60, and/or 90.
A total of 118 patients [female: 69.5%; age: 62.9 (9.5) years, mean (SD)] 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 the first PASS change was 34 days. Pain intensity (VAS), as well as two pain characteristics (ie, "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.
The results of this preliminary study suggest that the combination of boswellia, turmeric, and red algae extracts tested could improve KOA patients. Beyond these results, this study showed the importance of PROMs and specific pain qualitative descriptors for the accurate evaluation of dietary supplement approaches in painful conditions.
这项观察性研究评估了乳香、姜黄和红藻提取物的组合对膝骨关节炎（KOA）患者的疗效。鉴于骨关节炎患者对以患者为中心的护理的兴趣日益增加，通过一系列患者报告结局指标（PROMs）来评估疗效：患者可接受症状量表（PASS）、最小临床重要改善（MCII）、患者整体变化印象（PGIC）和勒凯斯内功能指数（LAFI）。患者还完成了一份关于疼痛性质的17项清单。
单侧或双侧疼痛性KOA患者每天必须服用1 - 4粒含有乳香、姜黄和红藻提取物的膳食补充剂，持续90天。患者在第0天（基线）、第10天、第20天、第30天、第60天和/或第90天完成PROMs评估。
共有118例患者[女性：69.5%；年龄：62.9（9.5）岁，均值（标准差）]纳入研究并至少服用了一粒胶囊。平均（标准差）随访时间为100.7（54.9）天。疼痛缓解在第90天达到最大程度：64.5%的患者为反应者（PASS阳性）；68.8%和58.4%的患者MCII和PGIC评分表明有积极效果（评分≥3）或整体改善（评分≥5）；73.3%（与基线时的47.5%相比）为轻度/中度残疾（LAFI评分<8）；55.2%的患者疼痛强度（VAS）有显著降低（-30%），35.1%（与基线时的59.2%相比）将镇痛药作为辅助治疗。首次PASS变化的中位时间为34天。疼痛强度（VAS）以及两种疼痛特征（即“刺痛”和“广泛疼痛”）是与第30天无反应相关的独立因素。根据疼痛特征分离出四组反应者，其中一组表现出更高的反应率。
这项初步研究的结果表明，所测试的乳香、姜黄和红藻提取物的组合可能改善KOA患者的病情。除了这些结果，本研究还表明了PROMs和特定疼痛定性描述符对于准确评估疼痛状况下膳食补充剂方法的重要性。
