Abstract
BackgroundDuhuo Jisheng Wan (DJW) is perhaps the best known and most widely used Chinese herbal recipe for arthralgia, but the clinical study to verify its efficacy is lacking. The purpose of this study was to compare the efficacy of DJW versus diclofenac in symptomatic treatment of osteoarthritis (OA) of the knee.MethodsThis study was a randomized, double-blind, double-dummy, controlled trial. The 200 patients suffering from OA of the knee, were randomized into the DJW and diclofenac group. The patients were evaluated after a run-in period of one week (week 0) and then weekly during 4 weeks of treatment. The clinical assessments included visual analog scale (VAS) score that assessed pain and stiffness, Lequesne's functional index, time for climbing up 10 steps, as well as physician's and patients' overall opinions on improvement.ResultsNinety four patients in each group completed the study. In the first few weeks of treatment, the mean changes in some variables (VAS, which assessed walking pain, standing pain and stiffness, as well as Lequesne's functional index) of the DJW group were significantly lower than those of the diclofenac group. Afterwards, these mean changes became no different throughout the study. Most of the physician's and patients' overall opinions on improvement at each time point did not significantly differ between the two groups. Approximately 30% of patients in both groups experienced mild adverse events.ConclusionDJW demonstrates clinically comparable efficacy to diclofenac after 4 weeks of treatment. However, the slow onset of action as well as approximately equal rate of adverse events to diclofenac might limit its alternative role in treatment of OA of the knee.
Highlights
Duhuo Jisheng Wan (DJW) is perhaps the best known and most widely used Chinese herbal recipe for arthralgia, but the clinical study to verify its efficacy is lacking
Since few patients withdrew from the trial, the results were not substantially affected, whether the statistical method was performed by an intention to treat (ITT) analysis or an analysis on available completers
We found that oral administration of the ethanol extract of DJW possessed both central and peripheral analgesic activities in animal model, even when the DJW extract was given in the equivalent dose used in human [to be published data]
Summary
Duhuo Jisheng Wan (DJW) is perhaps the best known and most widely used Chinese herbal recipe for arthralgia, but the clinical study to verify its efficacy is lacking. The purpose of this study was to compare the efficacy of DJW versus diclofenac in symptomatic treatment of osteoarthritis (OA) of the knee. A clinical manifestation of OA of the knee is pain in and around the joint that is typically worse with weight-bearing and at night. Long-term use of NSAIDs is directly related to many side effects, including gastrointestinal bleeding, hypertension, congestive heart failure, hyperkalemia, and renal insufficiency [8]. Some of these disadvantages can be avoided by using paracetamol or selective cyclooxygenase II (COX-II) inhibitors, long-term use of paracetamol possibly leads to hepatotoxicity and chronic renal impairment [9,10]. The relatively high cost of selective COX-II inhibitors seems to be unsuitable for Thailand's present socio-economic status
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