The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study

Abstract

Background. Gumiganghwal-tang (GMGHT) is a traditional herbal medicine consisting of nine different herbs. GMGHT inhibits the mRNA expression and production of inflammatory cytokines tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), and TNF-beta on lipopolysaccharide-(LPS-) stimulated peritoneal macrophages in a dose-dependent manner. It is empirically used for the treatment of inflammatory disease, but there are few reports of clinical trials that investigate its efficacy and safety. The current study aimed to investigate the clinical efficacy and safety of GMGHT in patients with knee osteoarthritis (OA). Methods. This was a multicenter, two-armed, double-blinded, randomized, placebo controlled study of GMGHT over 6 weeks. Eligible patients who fulfilled theAmericanCollege of Rheumatology criteria for OA were randomized to receive eitherGMGHT or the placebo. Clinical assessments includedmeasurement of knee pain and function using theWesternOntario andMcMasterUniversities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2weeks. Results. Atotal of 128 patientswere enrolled (91.4% female; mean age, 58.7 +/- 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 +/- 1.4, resp. 71.3 +/- 1.6 (treatment, resp. placebo group, p= 0.84), and total WOMAC score was 55.2 +/- 1.6, resp. 55.6 +/- 1.5 (p = 0.84). After 6 weeks, the pain VAS was 43.0 +/- 2.5, resp. 61.6 +/- 2.5 (p < 0.01) and the totalWOMAC score was 34.1 +/- 2.4, resp. 46.9 +/- 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edemawere comparable between both groups. Conclusions. Treatment withGMGHTresulted in significant improvement in pain, function, and global assessment, and it was generally safe and well tolerated in patients with OA.