| Aim:1. To review the current status of knee osteoarthritis in Malaysia.2.To observe the clinical efficacy of Chinese herbal comobidity medicine Qiang Gu Bao(???)in the treatment of knee osteoarthritis in Malaysia.3. To analyze the safety profile of Qiang Gu Bao in clinical application.4. To analyze the active ingredients of Qiang Gu Bao as antioxidant agents.Methods:60 participants were recruited into the study. Eligible participants were to receive oral Chinese herbal medicine Qiang Gu Bao (Fructus Psoraleae 15g, Rhizoma Drynariae 15g, Radix Notoginseng 3g, Radix Glycyrrhizae 6g) daily in 2 divided doses, half an hour after meals, over 8 weeks, with every 2 weeks follow-up. Each subject attended a total of five clinic visits including the screening visit. At each visit, heart rate, blood pressure, laboratory tests(full blood picture, liver and renal function tests, and urine test) were conducted. Safety monitoring by 12-lead electrocardiogram (ECG) was carried out at visit 1 (screening visit) and 4(end of 6th week). Final assessment of the therapeutic effects were carried out at the end of visit 5 (end of 8th week). Through out the trial period, the clinical efficacy. VAS pain score, knee swelling parameter, WOMAC indices and Karnofsky performance scale index were recorded and compared using the previous indices as baseline to conduct the within group analyses.Results:1. The average age in the study group was 56 years old with an average of having OA at the age of 53.98. The average BMI was 23.77 kg/m2. Among 60 patients, 88.30% were Chinese,48.30% of their educational level was 1-6 years;71.70% was married,78.30% was house wife,45% had no comobidity, most of them had OA symptoms lasted for 2 years.2. During 8 weeks trials, the heart rate, blood pressures and ECG of all candidates remained within normal limits.3. Through VAS pain score analysis, comparing visit 1 and visit 2, there was no significance in pain relieving (P= 0.289>0.05). Comparing visit 2 and visit 3, there was significance reduction in pain score(P<0.05). Observing visit 3 and visit 4; visit 4 and visit 5, there were significant reduction in pain score (P<0.05) indicating that the medicine could help to relief pain.4. Through the observation of knee joint swelling parameter:comparing visit 1 and visit 2,visit 2 and visit 3, there was not much reduction in the joint swelling (P>0.05, P>0.05); comparing visit 3 and visit 4, visit 4 and visit 5, there was significant reduction in knee joint swelling(P<0.05, P<0.05).5.Through WOMAC indices, comparing visit 1 and visit 2, there was reduction in pain, stiffness of kneejoint and physical activities respectively (P=0.017, P=0.013, P=0.042). Comparing visit 2 and visit 3, visit 3 and visit 4, there was significant improvement in the pain score, stiffness of joint and physical activities(P<0.05). The same was also observed in visit 4 and visit 5 (P<0.050). From the beginning till the end of the treatment, the pain score, joint stiffness and physical functions were all improved (p<0.05). 6. According to Karnofsky performance scale index, comparing visit 1 and visit 2, there was no significant improvement in quality of life(P>0.05);comparing visit 2 and visit 3, visit 3 and visit 4, visit 4 and visit 5, all of them were having significant improvements(P<0.05, P<0.05, P<0.05),showing that the patients'quality of life had improved significantly at the end of the treatment.7. Through free radical scavenging activity of the extracts evaluated by DPPH, the average antioxidant effect of Qiang Gu Bao was 74.1% indicating that active ingredients in Qiang Gu Bao had an high antioxidant property.Conclusions:The Chinese herbal medicine formula Qiang Gu Bao had significant therapeutic effect in Malaysian OA population. It helped to improve the symptoms of knee OA, better knee function, reduce joint pain, improved quality of life of the patients, delayed as well as controlled the progression of the disease. It was safe and no unwanted adverse effects were observed. |
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