BCM-95® (CURCUGREEN®), 28 Mar 2022

Rizaldy Taslim Pinzon, Rosa De Lima Renita Sanyasi, Esdras Ardi Pramudita
& Septian Dewi Periska

Chronic pain is the major complaint in subjects with osteoarthritis (OA). Non- steroid anti inflammatory drug (NSAID) is still the drug of choice in Indonesia to treat OA patients. The prolonged consumption of NSAID may lead to many adverse events (AE). Some previous studies showed the extract of Curcuma longa and Boswellia serrata is a promising potential as therapeutic interventions against OA. This study aimed to evaluate the effectiveness and safety of CB extract to relieve symptoms in patients with OA. This was a randomized controlled trial (RCT) in OA patients. The treatment used in this trial were CB extract (350 mg of Curcuma longa and 150 mg Boswellia serrata) and NSAID (400 mg ibuprofen or 50 mg diclofenac sodium). Subjects were randomized to 3 different groups (Group 1: CB extract and NSAID; group 2: CB extract; group 3: NSAID). Each medication was taken two times per day for four weeks. Paracetamol tablet 500 mg gave to each subject as a rescue medication. Each subject would be followed up three times: baseline (visit I), two weeks after baseline (visit II), and four weeks after baseline (visit III). The measurement was using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). There were 105 subjects at the beginning of the study dominated by a female with mean aged 63 years and have osteoarthritis with KL grade II. Seven subjects were lost to follow up, and three subjects excluded from the study due to adverse event. Ninety-five subjects (group 1: 36; group 2: 29, group 3: 30) remained for complete analysis. Delta (Δ) WOMAC score defined as the result of subtraction between WOMAC score at a visit I and WOMAC score at visit III. The highest mean of the WOMAC score was in group 1. However, group 1 showed the greatest reduction of WOMAC score after four weeks of treatment (ΔWOMAC = 12.08 ± 18.6). Group 3 has the least WOMAC score reduction (ΔWOMAC = 6.9 ± 16). There was no statistically different ΔWOMAC score between groups (p = 0.367). The highest consumption of rescue medication was in group 3, whereas the least consumption was in group 2. There was no statistical different of rescue medication consumption between groups (p: 0.346). Group 3 was the most frequently group with reported AE, whereas group 2 has the least reported AE. There were no statistically difference from the prevalence of AE between groups at the visit II (p: 0.119) and the visit III (p: 0.767). CB extract is effective for OA treatment and also has a better safety profile compared to NSAID. [Rizaldy Taslim Pinzon, Rosa De Lima Renita Sanyasi, Esdras Ardi Pramudita & Septian Dewi Periska; A Randomized Controlled Trial of Curcuma Longa and Boswellia Serrata Extract in Osteoarthritis; Global Journal of Medical Research (H) Volume XIX, Issue III, Version I , Year 2019]