• L Lao, M Hochberg, D Y W Lee, A M K Gilpin, FongH H SHHSDepartment of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: hfong@uic.edu., P Langenberg, K Chen, E K Li, L S Tam, and B Berman.
• Center for Integrative Medicine, School of Medicine, University of Maryland, Baltimore, USA; School of Chinese Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China. Electronic address: lxlao1@hku.hk.
• Osteoarthr. Cartil. 2015 Dec 1; 23 (12): 2102-2108.

ObjectiveTo examine the efficacy and safety of Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine (TCM), in patients with knee osteoarthritis (OA).DesignA multi-site, randomized, double-blind, placebo-controlled phase II dose-escalation clinical trial was conducted. Eligible patients who fulfilled American College of Rheumatology criteria were randomized to receive either HLXL or placebo. Clinical assessments included measurement of knee pain and function with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. A Data and Safety Monitoring Board (DSMB) was established to review the data for ensuring the quality of the trial.ResultsIn the first stage, 28 participants were randomized to receive either low-dose HLXL-Dan (2400 mg/day) or placebo for 6 weeks. The results showed no statistical difference between the two groups. The study was then re-designed following the recommendation of DSMB. Ninety-two patients were enrolled in the second stage and were randomized to receive either high-dose HLXL-Dan (4000 mg/day for week 1-2, and 5600 mg/day for week 3-8) or placebo for 8 weeks. All outcome assessments showed significant improvements for both groups after 8 weeks but no significant between-group differences. The change (mean ± SD) of WOMAC pain and WOMAC function scores of HLXL and placebo group after 8 weeks were -1.2 ± 1.7 vs -1.4 ± 1.5, and -1.1 ± 1.6 vs -1.3 ± 1.5 respectively. No serious adverse events were reported.ConclusionAlthough safe to use, an 8-week treatment of HLXL-Dan was not superior to placebo for reduction in pain or functional improvement in patients with knee OA.Clinical Trial Registration NumberClinicaltrials.gov (NCT00755326).Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

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