Phase II clinical trial of Ayurved Siriraj Wattana Recipe for symptomatic relief in patients with osteoarthritis of the knee.

Abstract

BACKGROUND:

Osteoarthritis of the knee is one of the most common public health problems in Thailand and throughout the world. It causes disability, with pain and loss of function. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common treatment modality to relieve pain for OA, but can cause undesirable adverse effects. Effective and safer alternative treatments for OA are urgently needed. Among the many kinds, Ayurved Siriraj Wattana Recipe has been widely used in humans for a long time. The components of the recipe probably were related with many systems of the body such as the immune system and the gastrointestinal system and it may have anti-inflammatory activity as well as anti-oxidative capacity.

OBJECTIVE:

Determine the efficacy of Ayurved Siriraj Wattana Recipe for knee osteoarthritis in a randomized, open-label, diclofenac-controlled trial for 12 weeks. The trial has been approved from Siriraj Institutional Review Board (SIRB), Faculty of Medicine, Siriraj Hospital, Mahidol University.

MATERIAL AND METHOD:

Analyze the 12-item Oxford, defined as 5-point Likert scales of pain and functional activity. The secondary assessment included 10-cm VAS pain assessment tool as well as, patients' and physician's global efficacy assessment.

RESULTS:

"12-Item Oxford" revealed that patients had mild problems in terms of function and pain with an average function score observed between groups (p = 0.6). The average pain score at 12 weeks' follow-up was not significantly different in the Wattana group compared with the diclofenac group (p = 0.3). Responses with no differences included the mean 10-cm VAS that assessed pain at 12 weeks' follow-up in both groups. There were no significant differences in the patients' and physician's global efficacy assessment with patients in both groups. There were no differences in the frequent of adverse events between groups. In addition, there were no significant differences in the patients' and physician's global safety assessment between groups.

CONCLUSION:

The present, diclofenac-controlled trial concludes that Ayurved Siriraj Wattana Recipe treatment could be an effective treatment of pain in knee OA at 12 weeks.

• Authors: Thanyaporn Pengkhum, Somruedee Chatsiricharoenkul, Pravit Akarasereenont, Keerati Charoencholvanich
• Journal: Journal of the Medical Association of Thailand = Chotmaihet thangphaet (J Med Assoc Thai) Vol. 95 Issue 3 Pg. 452-60 (Mar 2012) ISSN: 0125-2208 [Print] Thailand
• PMID: 22550847 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Diclofenac

Topics

• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Diclofenac (therapeutic use)
• Female
• Humans
• Male
• Medicine, Ayurvedic
• Middle Aged
• Osteoarthritis, Knee
• Pain Measurement
• Phytotherapy (methods)
• Plants, Medicinal
• Treatment Outcome