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Session 2: Clinical studies and clinical application of traditional & indigenous medicine

Efficacy and Safety of the Sahastara remedy versus Diclofenac in

the Treatment of Osteoarthritis of the Knee: A Double Blind,
Randomized Controlled Trial

,
Puritat Kanokkangsadal*, Piya Pinsornsak**, Arunporn Itharat*****
*Department of Orthopedics, Faculty of Medicine, **Department of Applied Thai Traditional Medi-
cine, ***Center of Excellence on Applied Thai Traditional Medicine Research (CEATMR), Faculty of
Medicine, Thammasat University, Pathumthani, 12120, Thailand

Background and Rationale: The Sahastara (SHT) remedy is a Thai traditional medicine
that has been acknowledged in the Thai National List of Essential Medicines and has been
used as an alternative medicine to treat knee osteoarthritis (OA). 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.
Objective: 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 controlled trial study was conducted to
determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treat-
ment of knee OA. Sixty six patients, ages between 45›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. Both groups received placebos to maintain the double-
blind conditions and Omeprazole 20 mg, twice daily, orally before meals for GI prophylaxis. 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 walk-time 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 improve the VAS for
pain, the 100 meter walk-time test and the WOMAC index score. However, there were no
differences in the efficacy between the two groups. Abdominal discomfort was the most
frequent adverse event found in both groups. The blood chemistry showed no toxicity on renal
and/or liver functions but the patients taking diclofenac showed significant increases in their
AST, ALT, and ALP. Systolic and diastolic blood pressures slightly increased in the diclofenac
group but were not altered in the SHT group.
Conclusions: The SHT remedy similar to diclofenac in all evaluating symptoms of knee
OA. However, the SHT remedy has shown to be a good alternative treatment for knee OA with
less systemic side effects when it was compared with diclofenac.
Key words: Sahastara remedy, OA knee, diclofenac, alternative medicine, Thai tradi-
tional medicine