Background/Purpose:

Traditional Chinese Medicine (TCM), which includes the use of herbal medicines, is widely used to treat osteoarthritis (OA) of the knee in Asian societies; furthermore, many persons with OA in the United States use TCM therapies. The scientific basis for the use of TCM in the treatment of OA, however, is relatively sparse. Huo-Luo-Xiao-Ling (HLXL) Dan is a Chinese herbal compound that is used for the treatment of arthritis and Bi syndrome in Asia and has been shown to have anti-inflammatory and immunomodulatory properties in preclinical models of rheumatoid arthritis. The primary objective of this study was to examine the efficacy and safety of a proprietary formulation of HLXL Dan in patients with osteoarthritis (OA) of the knee who continued to have symptoms despite receiving standard analgesic and/or anti-inflammatory treatment.

Methods: A randomized, double-blind, placebo-controlled phase II clinical trial was conducted at two sites: the University of Maryland Center for Integrative Medicine and the Chinese University of Hong Kong. Patients with symptomatic radiographic knee OA who fulfilled ACR classification criteria and had moderate or greater frequent knee pain in one or both knees despite receiving background analgesic and/or anti-inflammatory medicines were randomized to receive either HLXL Dan at a dose of 5,180 mg/day (15 capsules in 3 divided doses) or matching placebo for 8 weeks. Clinical assessments were performed at baseline and weeks 2 and 8 including measurement of knee pain and function with the WOMAC OA Index, patient global assessment (PGA) and PGA of response to therapy (PGART) at end of study. Safety assessments were performed at each visit. Data were analyzed using an intent-to-treat protocol; statistical significance was inferred if P <= 0.05.

Results: A total of 92 patients were enrolled: 53 in the U.S. and 39 in Hong Kong. Overall, the mean age was 60 years, 65 (71%) were women and 64 (70%) were of Asian ethnicity. Mean (SD) baseline WOMAC pain and function score was 4.3 (1.5) and 4.2 (1.6), respectively, and PGA was 2.2 (0.8). There were no significant differences between HLXL- and placebo-treated groups in baseline variables. While both groups had significant improvement in all outcome measures after 8 weeks, there were no significant differences between the HLXL- and placebo-treated groups. At 8 weeks, about two-thirds of subjects noted that they were better based on PGART responses; there was no difference between treatment groups. In mixed models repeated measures analysis, there were no significant differences in WOMAC pain or function scores or PGA between groups; furthermore, there was no interaction between clinical site and degree of improvement. Average adherence exceeded 80 percent and was similar between clinical sites. Finally, there was a significantly greater rise in mean ALT levels in the HLXL-treated group compared with the placebo-treated group (3.8 [10.4] vs 0.1 [5.8] U/l) but no significant difference in either AST or γGT levels.

Conclusion:

These data fail to demonstrate that a proprietary form of the Chinese herbal compound HLXL Dan is efficacious for treating the symptoms of knee OA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-the-chinese-herbal-compound-hou-lou-xiao-ling-dan-in-patients-with-osteoarthritis-of-the-knee-results-of-a-phase-ii-international-study/