The Clinical Efficacy and Safety of the Sahastara Remedy versus Diclofenac in the Treatment of Osteoarthritis of the Knee: A Double-Blind, Randomized, and Controlled Trial

الملخص EN

Introduction.

The Sahastara (SHT) remedy is a Thai traditional medicine that has been acknowledged in the Thai National List of Essential Medicine and has been used as an alternative medicine to treat knee osteoarthritis.

Although SHT remedies have been used in Thai traditional medical practices for a long period of time, there are few reports on their clinical trials.

Aim of the Study.

To investigate the clinical efficacy and safety of the SHT remedy in treating OA of the knee when compared to diclofenac.

Methods.

A phase 2, double-blind, randomized, and controlled trial study with a purpose to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee osteoarthritis.

Sixty-six patients, ages between 45 and 80 years of age, were randomly allocated into 2 groups.

The SHT group received 1,000 mg of SHT powdered capsules 3 times per day, orally before meals, while another group received 25 mg of diclofenac sodium capsules 3 times a day, orally after meals for 28 days.

All patients were followed up at 14 and 28 days for the evaluation of the efficacy and safety by using clinical examinations, blood tests, a visual analogue scale (VAS) for pain, and the 100-meter walktime test.

Improvement on the quality of life was also assessed by the WOMAC index.

Results.

There were 31 and 30 patients in SHT and diclofenac groups, respectively, who had completed the study.

Both medications have shown to significantly reduce the VAS for pain, and significantly improve the 100-meter walktime test and the WOMAC index score.

However, there were no differences in the efficacy between the two groups.

The blood chemistry showed no toxicity on renal and/or liver functions after taking SHT for 28 days but the patients who took diclofenac showed significant increases in their AST, ALT, and ALP.

Systolic and diastolic blood pressure slightly increased in the diclofenac group but the SHT group did not effect on blood pressure.

Conclusions.

The SHT remedy is similar to diclofenac in all evaluating symptoms of OA knee.

However, the SHT remedy has shown to be a good alternative treatment for OA knee with less systemic side effects when it was compared with diclofenac.