AB1005 EFFICACY AND SAFETY OF GARCINIA KOLA (CLUSIACEAE) IN KNEE OSTEOARTHRITIS: A PILOT STUDY

Abstract

BackgroundAdministration of supplements to strengthen the joint cartilage matrix have become popular not only for pain relief but also for joint preservation. Reports have suggested anti-inflammatory and analgesic properties of Garcinia kola (GK) extracts in knee osteoarthritis (KOA)1,2.ObjectivesTo evaluate the non-inferiority of GK compared to Diclofenac in patients with KOA.MethodsRandomized, double-blind, controlled trial (1:1) in outpatients aged 18 to 70 years followed at the Douala General Hospital, Cameroon for KOA with Kellgren-Lawrence grade ≥ 2. Patients with pain on the visual analog scale (VAS) > 5 and who had not taken non-steroidal anti-inflammatory drugs or corticosteroids in the previous 15 days were included. Paracetamol, tramadol, and codeine were accepted as analgesics. The trial was approved by the institutional ethics committee.Patients were divided into 2 groups: Garcinia kola (400 mg/12hours per os) and Diclofenac (50 mg/8hours per os). The primary endpoint was the per-protocol change in ultrasensitive CRP (CRPus) measured at D0 and D15. Secondary endpoints were the decrease in VAS pain with clinical relevance if decrease ≥ 20%, and safety. Statistical significance was set at p<0.05.ResultsForty-seven patients (33 women) were randomized (GK, n = 24 and Diclofenac, n = 23). There were no differences (p > 0.05) in sociodemographic, clinical, and radiographic characteristics between the two groups [Table 2]. Between D0 and D15, there was no difference in CRPus variation between patients in the GK and Diclofenac groups (p > 0.05) [Table 2]. The same was true for pain VAS (p > 0.05), with an effect considered clinically relevant. Adverse events were mild to moderate in severity, including 2 cases of epigastralgia (Diclofenac) and 3 cases of increased libido (GK). No significant changes in seric level of liver transaminases, creatinine, and fasting blood sugar were observed.Table 1.Main baseline patient characteristicsVariablesGarcinia kola, n = 24Diclofenac, n = 23Age, years57 ± 1258 ± 11Female gender, n (%)19 (79.1)17 (73.9)BMI, Kg/m227 ± 1027 ± 12Duration of osteoarthritis, years4 ± 24 ± 1Kellgren-Lawrence ≥ 2, n (%)20 (83.3)20 (86.9)VAS pain, mm, mean72 ± 1770 ± 15CRPus, mg/L4.8 ± 0.74.2 ± 0.5Table 2.Assessment of the evaluation criteria: CRPusand VAS painGarcinia kola (G.K)DiclofenacCRPus*Day 04.84.2Day 153.12.6Variation, n (%)-1.7 (35,4)-1.6 (38,1)p-Valuep = 0.003p < 0.001VAS pain**Day 07270Day 155453Variation, n (%)-1.8 (25.0)-1.7 (24.3)p-Valuep < 0.001p < 0.001*GK vs. Diclofenac: p > 0.05; **GK vs. Diclofenac: p > 0.05ConclusionGarcinia kola (GK) was non-inferior to Diclofenac in reducing CRPus and VAS pain in patients with KOA. The safety was good. GK would be a promising alternative to explore in the future management of osteoarthritis.