A randomized, parallel control and multicenter clinical trial of evidence-based traditional Chinese medicine massage treatment VS External Diclofenac Diethylamine Emulgel for the treatment of knee osteoarthritis.

BACKGROUND: Both massage and topically administered NSAIDs are safe and effective treatments for knee osteoarthritis (KOA); however, different massage technique sects in China caused assessment difficulties for the treatment of KOA. In order to standardize the massage techniques and procedures, we organized multi-disciplinary experts in China to acquire an evidence-based traditional Chinese medicine massage treatment of knee osteoarthritis. The purposes of this study will be to provide clinicians a complementary and alternative therapy for patients and to evaluate the efficacy and safety of evidence-based traditional Chinese medicine massage treatment of KOA compared to External Diclofenac Diethylamine Emulgel. METHODS AND DESIGN: A randomized controlled trial in which 300 participants diagnosed with KOA will be recruited and randomly allocated to either the experimental group or the control group in a ratio of 2:1. Two hundred participants will receive evidence-based traditional Chinese medicine massage 2 sessions per week for 10 weeks as the experimental group, and 100 participants will receive External Diclofenac Diethylamine Emulgel 3-4 times per day for 10 weeks as the control group. The patients in the two groups will receive follow-up at two time points at 5 weeks and 10 weeks from the beginning of treatment, respectively. The MRI scans and X-ray will be performed at baseline and at the end of the intervention. The primary outcome will be the changes in the Western Ontario and McMaster Osteoarthritis Index (WOMAC). Secondary outcomes will be measured by the PRO scale for knee osteoarthritis based on the concept of traditional Chinese medicine (Chinese scale for knee osteoarthritis (CSKO)), X-ray evaluation, and MRI scan evaluation. The data of WOMAC and CSKO will be analyzed at the baseline, 5 weeks, and 10 weeks from the beginning of treatment. The data from MRI scans and X-rays will be analyzed at baseline and at the end of the intervention. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. DISCUSSION: This study will provide clinicians with much-needed knowledge for the treatment of KOA through a controlled trial. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800014400 . Registered on 10 January 2018.

Research Progress on Pharmacological Effect of Astragali Radix-Angelicae Sinensis Radix on Invigorating Qi and Activating Blood / 中国实验方剂学杂志

Astragali Radix-Angelicae Sinensis Radix （AA） is a basic pair of drugs mainly targeting the syndrome characteristics of Qi and blood diseases. LI Dong-yuan's Danggui Buxuetang （DBT） is composed of AA， which is mainly used to tonify Qi and generate blood， with main indications of Qi deficiency and blood deficiency， blood heat and so on. It is favored by doctors because of its refined prescription and remarkable curative effect. However， there are many compatibility ratios of AA in different prescriptions in ancient books， and their efficacy and indications are also slightly different. This research showed that DBT also had the effect of invigorating Qi and activating blood， and the previous study of the group showed that 3∶1 compatibility ratio of the two herbs in the total amount of 36 g had more obvious effect of invigorating Qi and activating blood. By consulting the relevant literature， it was found that the drug pair had a certain effect of invigorating Qi and activating blood in various compatibility ratios such as 1∶1， 3∶1， 1∶5， 3∶2， 2∶1， 5∶1. The corresponding pharmacological effect mainly included regulating the energy metabolism of substances， regulating immune function， reducing blood viscosity， anti-oxidation stress， anti-inflammation， lowering blood lipids， lowering blood sugar， protecting heart function， protecting blood vessel wall， intervening angiogenesis， fighting against organ tissue fibrosis and so on. Regardless of the AA single-medicine's activating blood effect and the theory that "Qi circulation leads to blood circulation" or the drug pair's manifestation in modern pharmacological effects， all of these have confirmed that AA's effect of invigorating Qi and activating blood does exist， and the difference of action performance caused by different ratios of AA is closely related to dosage and proportion， which needs further study. Based on the study focusing on the effect of tonifying Qi and generating blood， it is easy to ignore the effect of invigorating Qi and activating blood， which limits the clinical application of the latter. Therefore， the tonifying Qi and activating blood circulation effect of the drug pair is reviewed in this paper， so as to provide a theoretical basis for its clinical rational drug use and related research.

Clinical observation of jianpi bushen formula to prevent collapse of osteonecrosis of femoral head / 中国中药杂志

To observe the clinical effect of Jianpi Bushen formula to prevent the collapse of osteonecrosis of femoral head (ONFH) of type phlegm and blood stasis obstructing the collaterals. 50 cases (including 73 hips) of non-collapse ONFH (ARCO I, II, III a) were selected from the out-patient department of orthopedic in Guang'anmen Hospital attached to China Academy of Chinese Medical Science. All the cases fit for diagnostic criteria were given Jianpi Bushen formula and followed up. Staging criteria was ARCO classification. Harris score evaluated the hip function. The mean follow-up time was 4.2 years (3-5.4 years). After a mean of 4.2 years (3-5.4 years) followed-up, 12 hips collapse occurred while 61 hips not (the non-collapse rate was 83.56%). Collapse did not occurred among the all 7 hips at stage ARCO I (the non-collapse rate was 100%). Among the 49 hips at stage ARCO II, 9 hips collapse occurred while 40 hips not (the non-collapse rate was 81.63%). Among the 17 hips at stage ARCO III a, 3 hips collapse occurred while 14 hips not (the non-collapse rate was 82.35%). Kaplan-Meier analysis showed the average survival time of non-collapse was 5 years (4. 8-5.2 years). The 3 year survival rate of non-collapse was 92.5%. The 4 year survival rate was 74% and the condition tended to be stability trend. The Harris score was 71.93 +/- 11.25 before treatment and 81.63 +/- 12.16 after treatment, significantly different. These results suggest that: Jianpi Bushen formula is an effective method for treating ONFH of type phlegm and blood stasis obstructing the collaterals. It can delay or prevent the collapse of femoral head and significantly improve the hip function.

Meta-analysis on efficacy and safety of external use of tradition Chinese medicines and western medicines in treating knee osteoarthritis / 中国中药杂志

<p><b>OBJECTIVE</b>To assess the efficacy and safety of the external use of tradition Chinese medicine (TCM) in treating knee osteoarthritis.</p><p><b>METHOD</b>By computer retrieval of MEDLINE, CNKI and VIP database on data from the establishment of database to May 2011,all of the randomized controlled trials on the external use of TCMs in treating knee osteoarthritis with western medicines as the control drugs were collected to screen out literatures in line with the inclusion standards. The quality of the included literatures was strictly assessed, and a meta-analysis was conducted by RevMan 5.1 software.</p><p><b>RESULT</b>Totally 25 RCTs involving 2 159 patients were included [1152 patients in the TCM group (TCMG), 1007 patients in the western medicine group (WMG)], in which 21 articles were brought into the analysis on efficacy. The results of meta-analyses showed that the efficient rates of the TCMG and the WMG were 92.35% (941/ 1019) and 81.19% (712/877), respectively, OR = 2.88 [2.16-3.83], with a hypothesis testing on total effect of Z = 7.20 (P < 0.00001)], suggesting that the external use of TCMs had a better efficacy than the WMG. A total of 25 literatures were brought into the analysis on adverse effect. The adverse effects rate of the TCMG and the WMG were 1.30% (15/1 152) and 5.36% (54/1007), respectively, OR = 0.40 [0.11-1.38], Z = 1.46 (P = 0.15)], indicating no significant difference between them. The sub group analysis shows that compared with the external use of western medicines,the adverse effect rate of the two groups are similar [(1.87% (11/589): 1.60% (9/564)], OR = l.12 [0.48-2.58], Z = 0.26 (P = 0.80). But as for inhibitors NSAIDS and COX-2 for oral,the adverse effect rate of the TCMG was lower than that of the WMG [(1.07% (4/375): 15.46% (45/291)], OR = 0.11 [0.01-0.87], Z = 2.09 (P = 0.04).</p><p><b>CONCLUSION</b>The efficacy of the external use of TCMs in treating OA is better than that of western medicines. The adverse effect rates of the external use of TCMs is equivalent to that of western medicines, and significantly lower than that of oral western medicines. But because of the poor quality of the included literatures, the final conclusion for the efficacy of TCMs in treating knee osteoarthritis could not be reached only based on this Meta-analysis and remain to be proved with the results of high-quality clinical studies.</p>