Clinical evaluation of the efficacy of JT-2000 * in the management of osteoarthritis : A double-blind placebo-controlled trial

ABSTRACT Osteoarthritis (OA), degenerative arthritis is one of the most common forms of arthritis. NSAIDs are the preferred choice for the management of OA. However, the use of NSAIDs in OA is causally associated with various short and long term adverse effects. The present study was aimed to evaluate the efficacy and safety of JT-2000, a polyherbal drug, in patients suffering from OA of knee. This was a randomized placebo-controlled clinical trial conducted on 100 patients of either sex, with clinical and radiological evidence of OA of the knee. Patients with established hypertension, renal, hepatic or cardiac failure, on long-term steroid treatment, or with evidence of rheumatoid arthritis and gout were excluded from the study. All the patients were randomized into drug and placebo groups of 50 patients each. A detailed medical history of all patients was recorded and symptomatic evaluation was done using the scoring system followed by clinical, radiological and blood chemistry examination. All patients were followed up for 6 months. The predefined primary outcome measure for efficacy was a decrease in the total sign-and-symptom score at the end of 6 months; secondary outcome measures were short- and long-term safety, assessed by incidence of adverse events, patient compliance to therapy and improvement in laboratory parameters. All adverse events predefined as unrelated, possible and probable, reported by the patients, were recorded. Statistical analysis was done according to intention-totreat principles. The minimum level of significance was fixed at 95% confidence limit and a 2- sided p value of less than 0.05 was considered significant. Patients ranged from 20-80 years and there were thrice as many female as males. No significant changes were observed in any of the biochemical parameters in both groups. The reduction in the mean of number of joints involved in the JT-2000 group was highly significant (t=17.32, p<0.0001), while the results were not significant in the placebo group. (t=1.56, p=0.1208). There was a significant reduction in the average swelling score and pain scores and mean secondary muscle weakness score, in the JT-2000 group compared to the placebo group. At the end of 6 months treatment, patients in the JT-2000 group had a significant reduction in difficulty in climbing, compared to the placebo group. In the JT-2000 group, there was a significant decrease in subchondral sclerosis, osteophytes, cartilage proliferation, fibrosis, synovial fluid viscosity and crystal deposition at the end of 6 months of treatment. The unaltered blood chemistry, liver and renal function parameters suggested long-term safety of the drug. In this study, there was an excellent relief from pain at the end of the therapy and an overall improvement in quality of life of the JT-2000 group. This study indicates that JT-2000 is a more effective and safer alternative for long-term use in the management of mild to moderate OA than NSAIDs.