Analysis of fufang duzhong jiangu keli in improvement of knee joint function in 400 cases of knee osteoarthritis

Heming WANG; Jirong GE; Haibo YIN; Xinghua FENG; Liguo ZHU; Jun ZHANG; Zhenjiang GUO; Tao LUO

ABSTRACT

BACKGROUND:

According to the thrust of document issued by State Drug Administration, the clinical experiment was carried onfufang duzhongjiangu keli (compound) (Bo Si Zhuang) in treatment of knee joint osteoarthritis.

OBJECTIVE:

To evaluate the improvement of the compound in treatment of knee joint osteoarthritis and its safety.

DESIGN:

Zhuanggu guanjie wan (bolus) was taken as controlled drug and double blind, double-simulation randomized method was designed.

SETTING:

Fujian Institute of Chinese Medicine, Guananmen Hospital of China Academy of Traditional Chinese Medicine, Institute of Orthopedics and Traumatology of China Academy of Traditional Chinese Medicine and Beijing Hospital of Chinese Medicine.

PARTICIPANTS:

Clinical experiment Ⅱ was performed since December 19, 1999, in which, 200 cases of knee joint osteoarthritis were observed and divided into compound group (100 cases) and bolus group (100 cases).From December 1999 to March 2000, clinical experiment Ⅲ was performed to observe 400 cases of knee joint osteoarthritis, in which, 300cases were divided in compound group and 100 cases in bolus group. All of cases were diagnosed by X-ray test and differentiated in Chinese medicine as insufficiency of liver and kidney and stasis of tendons and vessels. All of patients were in the known of experiment.

METHODS:

In compound group, fufang duzhong zhuanggu keli (1bag/time, 3 times/day) + simulated dosage of zhuanggu guanjie wan were administrated. In bolus group, fufang duzhong zhuanggu keli simulated dosage + zhuanggu guanjie wan (1bag/time, twice/day) were administrated.Double blind and double-simulation randomized control experiment was given in one-month treatment to observe clinical therapeutic effects.MAIN OUTCOME

MEASURES:

Evaluation on clinical indexes of joint function ,clinical therapeutic effect, syndrome score in Chinese medicine and adverse reaction.

RESULTS:

Totally 600 cases employed had all accomplished datum collections, no dropped-off case. ① The total effective rate of compound group was superior remarkably to bolus group (92.%, 82%). ② The result of joint function in compound group was superior remarkably to that of bolus group. ③ Concerning to improvement of syndromes in Chinese medicine, the result in compound group was superior to that of bolus group (the decreased integrals were 7.03±3.38 and 5.43±3.16 respectively). ④No obvious harmful effect presented during experiment.

CONCLUSION:

Fufang duzhong jiangu keli improves the symptoms of osteoarthritis of knee safely and effectively.