RESUMO
Background: Osteoarthritis (OA) management needs a combination of nonpharmacological and pharmacological modalities. However, as in many chronic conditions, the main concern with OA therapy is the difficulty in obtaining good medication compliance over a long period. The PREDOA study aimed to investigate the predictive factors of adherence to treatment in patients with OA treated with glucosamine sulfate (GS)-copper sulfate-ginger root (GCu), a symptomatic slow-acting drug for OA. Methods: Ambulatory patients with a clinical diagnosis of OA were included in a prospective (6 months) multicenter open-label observational study. All patients received two capsules of GS-GCu once daily for 6 months. Demographics, disease features (OA location, symptom duration, concomitant therapies, comorbidities), and patient self-assessment of pain (0-10) were obtained at baseline. At month 6, the investigator collected patient self-assessments of treatment observance, reasons for nonadherence, pain scores, patient perceptions of treatment efficacy, changes in analgesic intake, and occurrence of adverse events. Predictors of observance were studied in univariate and multivariate analyses. Results: A total of 2,030 patients were included in the study. At baseline, the average pain score was 6.4±1.7. Observance was good in 80% of patients. It was weaker in active than retired patients (P=0.005) in patients not taking concomitant treatment (P=0.008) or who had never been treated for OA (P=0.001). Observance was correlated with pain decrease (P<0.0001) and with lack of adverse effects (P<0.001). Age, sex, pain level at baseline, OA location, and number of painful joints were not related to treatment compliance. Conclusion: Medication compliance with GS-GCu depends both on the safety-efficacy balance and several patient related-factors. To improve adherence, detailed information about therapeutic objectives is necessary in active patients who do not get any other medications and for whom it is their first treatment for OA. Clinical trial identifier: CCTIRS 14-371 B.
RESUMO
BACKGROUND: Devil's claw (Harpagophytum procumbens), turmeric (Curcuma longa), and bromelain are nutraceuticals that have demonstrated anti-inflammatory and analgesic properties and may be potential solutions in the treatment of acute or chronic joint pain. Their analgesic effect, however, is generally considered mild to moderate, and the relevance of their clinical use remains subject to discussion. OBJECTIVES: The aim of the study was to evaluate the clinical relevance of the efficacy of a marketed complex of 3 plant extracts-H procumbens, C longa, and bromelain (AINAT, 650 mg)-in the treatment of degenerative joint pain. METHODS: A multicenter, observational, prospective, open-label survey was conducted in 8 rheumatology centers. The study included 2 groups, 1 group with participants suffering from chronic osteoarthritis (OA) pain and 1 group suffering from acute OA pain. SETTING: The research team carried out the study under daily practice conditions. PARTICIPANTS: A total of 42 patients (36 women; mean age = 67 y) suffering from acute or chronic, degenerative spine or joint pain participated. INTERVENTION: Two 650-mg capsules of AINAT were administered 3 ×/d to patients with acute pain and 2 ×/d to patients with chronic pain. OUTCOME MEASURES: At baseline, and during a follow-up visit at 15 d for the acute pain group and 60 d for the chronic pain group, the research team obtained each participant's global assessment (PGA) and each rheumatologist's global assessment (RGA), as well as each participant's pain score, using for each of them a 100-mm visual analogue scale (VAS). The clinical relevance of the efficacy was evaluated by comparing the outcome measures at endpoint to the values defining the patient acceptable symptom state (PASS) and by comparing the variations (in mm and %) between baseline and endpoint to those defining the minimal clinically important improvement (MCII). Tolerance was also assessed by collecting adverse events at each visit and by using a 4-point scale (very good to bad) at the endpoint. RESULTS: At baseline, the VAS pain score (standard deviation) was 69.1 mm (15.4) and 68.0 mm (18.2) for patients with acute and chronic pain, respectively. At the endpoint, the scores decreased to 42.1 mm (21.1) and 37.8 mm (25.9), respectively. This reduction of pain, as a percentage as well as an absolute value, corresponds to the required definition of MCII, particularly in patients with chronic joint pain. At the endpoint, most of the patients in both groups reached the level of pain defined as the PASS. No withdrawals occurred due to treatment side effects. CONCLUSION: The improvement of joint pain was clinically relevant in patients treated with AINAT for both acute and chronic OA pain. Considering its excellent tolerance profile, the tested complex of 3 plant extracts with antiinflammatory properties may be a valuable and safe alternative to NSAIDs in patients suffering from degenerative joint diseases.
