Page 86 - journal-7-2-S-Full

Journal of Thai Traditional & Alternative Medicine Vol. 7 No. 2 May-August (Supplement) 2009 ˜˜

OP-16

Chinese herbal recipe versus diclofenac in treatment of osteoarthritic knee:

From animal models to clinical trial.

1 1 1 1
Supanimit Teekachunhatean , Puongtip Kunanusorn , Ampai Panthong , Chaichan Sangsee ,
1 2 3 4
Noppamas Rojanasthien , Kanit Sananpanich , Suwalee Pojchamarnwiputh , Sumalee Pruksakorn ,
5
Sorasak Lhieochaiphunt
1
Department of Pharmacology
2
Department of Orthopedics
3
Department of Radiology
4
Department of Microbiology, Faculty of Medicine, Chiang Mai University 50200, Thailand, 5Division of Pharmaceutical
Sceinces, Faculty of Pharmacy, Chiang Mai University 50200, Thailand.

Rationale: 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.

Objectives: To investigate the analgesic and anti-inflammatory activities of DJW in animal models and to
compare the clinical efficacy of DJW versus diclofenac in patients suffering from osteoarthritis (OA) of the knee.
Methodology: In animal models, the analgesic activity of crude extract of DJW (250, 1,000 and 4,000 mg

/ kg) was investigated by using formalin test in mice, whereas the acute inflammatory activity of the same
doses was investigated by using carrageenin-induced hind paw edema in rat. In clinical trial, a randomized,
double-blind, double-dummy, controlled trial was conducted in 200 patients suffering from OA of the knee. The

patients were randomized into either DJW or diclofenac group (100 patients / group), and were evaluated after
a run-in period of one week (week 0 or baseline) and again at the end of the study (week 4). The clinical
assessments included visual analog scale (VAS) score assessing pain and stiffness, Lequesneûs functional index,

as well as physicianûs and patientsû overall opinions on improvement.
Results: In animal models, DJW demonstrated marked analgesic activity in formalin test. However, it did

not reveal anti-inflammatory activity in the carrageenin-induced hind paw edema. In clinical trial, 94 patients in
each group completed the study. At the end of the study, the mean changes from baseline values in VAS
assessing pain and stiffness, as well as Lequesneûs functional index did not significantly differ between DJW

and diclofenac groups. In addition, there were no statistical differences in the physicianûs and patientsû overall
opinions on improvement at week 4 between the two groups. The majority of patients in both groups (approxi-

mately 70 %) experienced no adverse events. All adverse events reported were mild in intensity in both groups.
Conclusion: In animal models, crude extract of DJW demonstrates significant analgesic activity. How-
ever, the lack of anti-inflammatory activity in the carrageenin-induced hind paw edema suggests that its

mechanism of action might not be predominantly due to inhibition of prostaglandin synthesis. In clinical trial,
DJW demonstrates clinically comparable efficacy to diclofenac after 4 weeks of treatment.