Abstract
Sahastara (SHT) remedy is a Thai traditional medicine described in the Thai National List of Essential Medicine (NLEM) for the relief of muscle pain. The purpose of this study was to investigate the efficacy and safety of SHT remedy extract capsule for treating primary OA. A phase 2, double-blind, randomized, and controlled trial study was used to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee OA. The outcome of reduce pain was measured from VAS, 100 meter time walk, and the WOMAC score of day 14 and day 28 which should reduce significantly when compared with day 0 and should be equal with or better than diclofenac. Blood pressure and blood chemistry values at day 14 and day 28 did not change when compared with day 0. The results found that SHT remedy ethanolic extract capsule can reduce all OA knee scores at day 14 and day 28 significantly when compared with day 0 and also no significant difference with diclofenac (P > 0.05). The SHT also showed safety values on blood pressure and blood chemistry. The SHT was observed that it had no serious side effect. The results of this study are the first report of using the SHT ethanolic extract capsule in the treatment of primary osteoarthritis of the knee. It can be recommended as an anti-inflammatory herbal drug for reducing pain in knee osteoarthritis patients.
Highlights
Osteoarthritis (OA) is the most common joint disease which occurs more frequently in males before the age of 45 and more frequently in females after 55 years of age
66 patients were chosen for the study, but only 63 (95.45%) patients completed the study (32 in the SHT group and 31 in the diclofenac group). ree patients dropped out at the follow-up visits with unrelated intervention and nonserious reasons (Figure 1)
Comparison of all criteria (WOMAC scores on all physical index and 100 meters walk) between SHT ethanolic extract capsule and diclofenac showed no significant difference (P > 0.05), but the visual analogue scale (VAS) score of SHT at day 28 was higher than diclofenac and was significantly different (P 0.01)
Summary
Osteoarthritis (OA) is the most common joint disease which occurs more frequently in males before the age of 45 and more frequently in females after 55 years of age. Osteoarthritis commonly occurs in the hands, feet, spine, and large weight-bearing joints, such as hips and knees. OA with no known cause is referred to as primary osteoarthritis. When the cause is known, it is referred to as secondary osteoarthritis. E pain is an important clinical complaint [1]. E oral and topical NSAIDs are most commonly used to relieve pain in OA knee patients. NSIADs were used for OA treatment but alternative medicine was commonly used, including acupuncture, ai massage, sesame oil, yellow oil, and herbal medicine [3,4,5]
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