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.

Study on the Distribution of Constitutions of Chinese Medicine in Patients with Osteonecrosis of Femoral Head / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the distribution of constitution types of Chinese medicine (CM) in patients with osteonecrosis of femoral head (ONFH).</p><p><b>METHODS</b>Totally 130 ONFH patients were recruited. Constitution types of CM were identified in all patients. Distribution features of constitution types of CM in ONFH patients were observed. The differences of distribution in gender, age, single or bilateral hips, course of disease, staging, cause, and region were also analyzed.</p><p><b>RESULTS</b>Seventy patients were of complicated constitutions, while 60 patients were of single constitution. Among the 60 single constitution cases, yang-deficiency constitution [18 (13.9%)], damp-heat constitution [10 (7.7%)], blood-stasis constitution [7 (5.4%)], and qi-deficiency constitution [7 (5.4%)] were mainly distributed. Of the complicated constitutions, yang-deficiency dominated constitution occupied the top ratio [30 (23.1%)], followed by blood-stasis dominated constitution [15 (11.5%)], damp-heat dominated constitution [9 (6.9%)]. By putting them together, yang-deficiency constitution occupied the top constitution of CM [48 (36.9%)], followed by blood-stasis constitution [ 22 (16.9%)] and damp-heat constitution [19 (14.6%)]. The aforesaid three constitutions accounted for 68.5% of the total. There were no statistical distribution differences in gender, age, single or bilateral hips, course of disease, staging, or cause.</p><p><b>CONCLUSION</b>Yang-deficiency constitution, damp-heat constitution, and blood-stasis constitution were liable constitutions of CM in ONFH patients.</p>

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.

Case-control study on arthroscopy and manipulation for the treatment of derangement of patellofemoral joint / 中国骨伤

<p><b>OBJECTIVE</b>To compare the therapeutic effects of arthroscopy and manipulation of Traditional Chinese medicine (TCM) in the treatment of patellofemoral joint disease.</p><p><b>METHODS</b>The patients met with the criteria of patellofemoral joint disease were divided into manipulation of TCM group and arthroscopy group randomly, 31 patients in each group. There were 31 patients in manipulation of TCM group, including 4 males and 27 females, with an average age of (52.83 +/- 5.79) years old; and the patients were treated with manipulation. There were 31 patients in arthroscopy group, including 8 males and 23 females, with an average age of (54.14 +/- 6.12) years old; the patients were treated with arthroscopy. The HSS knee joint score, fitness angle of patellofemoral joint and lateral angle of patellofemoral joint in X-ray were compared in each group and between the two groups before and after treatment respectively.</p><p><b>RESULTS</b>The two therapeutics had equally efficacious in which improved HSS score significantly. After treatment, the HSS scores in manipulation of TCM group and arthroscopy group were 94.80 +/- 7.26 and 88.65 +/- 5.79 separately, the score in manipulation of TCM group was higher than that of arthroscopy group. Comparing with the arthroscopy group, lateral angle of patellofemoral joint with weight-hearing position were improved significantly in manipulation of TCM group.</p><p><b>CONCLUSION</b>Arthroscopy and manipulation of TCM have equally efficacious in the treatment of patellofemoral joint disease, but manipulation has advantage of minimal trauma, and is better to treat patella extraversion.</p>

Research on the distribution difference of MRI signals in osteonecrosis of the femoral head patients of different TCM syndrome types / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the distribution difference of magnetic resonance imaging (MRI) signals in osteonecrosis of the femoral head (ONFH) patients of different TCM syndrome types.</p><p><b>METHODS</b>Recruited 29 ONFH patients were assigned to the tendon and vessel stagnation group (14 cases) and the Gan-Shen deficiency group (15 cases) according to TCM syndrome typing. The distribution difference of their MRI signals of MRIT1WI, T2WI + fs, T1 and T2 combined signal were compared.</p><p><b>RESULTS</b>There was statistical difference in T1W1 signal distribution between the two TCM syndrome types (P = 0.04). There was no statistical difference in T2WI + fs or T1 and T2 combined signal between the two TCM syndrome types (P = 0.42, P = 0.15). MRI signals in the tendon and vessel stagnation group were mainly manifested as fat-like signals,while they were mainly manifested as mixed signals in the Gan-Shen deficiency group.</p><p><b>CONCLUSION</b>Distribution difference of MRI signals exists between ONFH patients of different TCM syndrome types.</p>

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>