OBJECTIVE: To observe the clinical efficacy of Wangbi Tablet (WT) on the treatment of knee osteoarthritis (KOA), and to study its treatment program by integrative medicine. METHODS: The randomized, parallel control, and multi-center clinical observation method was used. 160 KOA patients of Gan-Shen deficiency complicated with stasis-blood blockade syndrome were assigned to three groups. Group A (72 cases) was treated by WT, Group B (42 cases) was treated by Votalin Tablet, and Group C (46 cases) was treated by WT + Votalin Tablet. All patients were treated for two months. Before and after treatment the clinical symptoms, the knee function activity, adverse reactions were observed and recorded. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) of each patient were respectively detected, statistically analyzed and compared. RESULTS: After eight weeks of treatment significant difference was shown in the time of morning stiffness in joints, joint tendemess, swelling, pain, joint functional activities, ESR, and CRP between Group A and Group B (P<0.01). Besides, better effects were obtained in Group C (P<0.01). Improvement of ESR and CRP: They were obviously improved in the three groups after treatment (P<0.01). As for the markedly effective rate, better effects were obtained in Group C (P<0.05). CONCLUSIONS: In the treatment of KOA, WT showed favorable effects with no obvious adverse reaction. The combination of WT and Voltaren Tablet was significantly superior to use of WT or Votalin Tablet alone. It could reduce the dosage of Voltaren Tablet and avoid adverse reactions of the gastrointestinal tract.
RCT Entities:
OBJECTIVE: To observe the clinical efficacy of Wangbi Tablet (WT) on the treatment of knee osteoarthritis (KOA), and to study its treatment program by integrative medicine. METHODS: The randomized, parallel control, and multi-center clinical observation method was used. 160 KOA patients of Gan-Shen deficiency complicated with stasis-blood blockade syndrome were assigned to three groups. Group A (72 cases) was treated by WT, Group B (42 cases) was treated by Votalin Tablet, and Group C (46 cases) was treated by WT + Votalin Tablet. All patients were treated for two months. Before and after treatment the clinical symptoms, the knee function activity, adverse reactions were observed and recorded. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) of each patient were respectively detected, statistically analyzed and compared. RESULTS: After eight weeks of treatment significant difference was shown in the time of morning stiffness in joints, joint tendemess, swelling, pain, joint functional activities, ESR, and CRP between Group A and Group B (P<0.01). Besides, better effects were obtained in Group C (P<0.01). Improvement of ESR and CRP: They were obviously improved in the three groups after treatment (P<0.01). As for the markedly effective rate, better effects were obtained in Group C (P<0.05). CONCLUSIONS: In the treatment of KOA, WT showed favorable effects with no obvious adverse reaction. The combination of WT and Voltaren Tablet was significantly superior to use of WT or Votalin Tablet alone. It could reduce the dosage of Voltaren Tablet and avoid adverse reactions of the gastrointestinal tract.