Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine, for patients with
osteoarthritis of the knee: a multi-site, randomized, double-blind,
placebo-controlled phase II clinical trial.
Author(s): Lao L(1), Hochberg M(2), Lee DY(3), Gilpin AM(4), Fong HH(5), Langenberg P(6),
Chen K(7), Li EK(8), Tam LS(9), Berman B(10).
Affiliation(s): Author information:
(1)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.
(2)Division of Rheumatology & Clinical Immunology, Department of Medicine, School
of Medicine, University of Maryland, Baltimore, USA. Electronic address:
mhochber@medicine.umaryland.edu. (3)Mailman Research Center, McLean Hospital,
Harvard Medical School, Belmont, MA 02478, USA. Electronic address:
dlee@mclean.harvard.edu. (4)Department of Epidemiology and Public Health, School
of Medicine, University of Maryland, Baltimore, USA. Electronic address:
adele.gilpin@gmail.com. (5)Department of Medicinal Chemistry and Pharmacognosy,
College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA.
Electronic address: hfong@uic.edu. (6)Department of Epidemiology and Public
Health, School of Medicine, University of Maryland, Baltimore, USA. Electronic
address: PLANGENB@epi.umaryland.edu. (7)Department of Family and Community
Medicine, School of Medicine, University of Maryland, Baltimore, USA. Electronic
address: KChen@som.umaryland.edu. (8)Department of Medicine and Therapeutics,
Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong Special
Administrative Region, China. Electronic address: edmundli@cuhk.edu.hk.
(9)Department of Medicine and Therapeutics, Prince of Wales Hospital, Chinese
University of Hong Kong, Hong Kong Special Administrative Region, China.
Electronic address: lstam@cuhk.edu.hk. (10)Center for Integrative Medicine,
School of Medicine, University of Maryland, Baltimore, USA. Electronic address:
BBerman@som.umaryland.edu.
Publication date & source: 2015, Osteoarthritis Cartilage. ,
OBJECTIVE: To examine the efficacy and safety of Huo-Luo-Xiao-Ling (HLXL)-Dan, a
Traditional Chinese Medicine (TCM), in patients with knee osteoarthritis (OA).
DESIGN: A 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.
RESULTS: In 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.
CONCLUSION: Although 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 NUMBER: Clinicaltrials.gov (NCT00755326).
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