Improving acupuncture research: progress, guidance, and future directions / 中国针灸

This paper makes an interpretation of the collection Acupuncture: how to improve the evidence base published by BMJ & BMJ Open. Studies show that the quality of randomized controlled trial (RCT) of acupuncture is low, and multivariable Meta-regression analysis fails to confirm most factors commonly believed to influence the effect of acupuncture. The methodological challenges in design and conduct of RCT in acupuncture were analyzed, and a consensus on how to design high-quality acupuncture RCT was developed. The number of acupuncture systematic reviews was huge but the evidence was underused in clinical practice and health policy, and a large number of western clinical practice guidelines recommended acupuncture therapy, but the usefulness of recommendations needed to be improved. In view of the problems in clinical research on acupuncture mentioned in this collection, combined with the analysis of the purpose of clinical research on acupuncture, perspectives, study types, as well as the relationship between evidence and clinical decision-making, a five-stage study paradigm of clinical research on acupuncture is proposed.

Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine / 中国中药杂志

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial / 中国结合医学杂志

BACKGROUND@#The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients' adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula (, JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer.@*METHODS@#A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy.@*DISCUSSION@#This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518).

Acupuncture for Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis

PURPOSE: To assess the effectiveness and safety of acupuncture for erectile dysfunction (ED). MATERIALS AND METHODS: We searched six major English and Chinese databases included randomized controlled trials (RCTs) testing acupuncture alone or in combination for ED. Dichotomous data were presented as risk ratio (RR) and continuous data were presented as mean difference (MD) both with 95% confidence interval (CI). The Revman (v.5.3) was used for data analyses. Quality of evidence across studies was assessed by the online GRADEpro tool. RESULTS: We identified 22 RCTs, fourteen of them involving psychogenic ED. Most of the included RCTs had high or unclear risk of bias. There was no difference between electro-acupuncture and sham acupuncture with electrical stimulation on the rate of satisfaction and self-assessment (RR, 1.50; 95% CI, 0.71–3.16; 1 trial). Acupuncture combined with tadalafil appeared to have better effect on increasing cure rate (RR, 1.31; 95% CI, 1.00–1.71; 2 trials), and International Index of Erectile Function-5 scores (MD, 5.38; 95% CI, 4.46–6.29; 2 trials). When acupuncture plus herbal medicine compared with herbal medicine alone, the combination therapy showed significant better improvement in erectile function (RR, 1.68; 95% CI, 1.31–2.15; 7 trials). Only two trials reported facial red and dizziness cases, and needle sticking and pruritus cases in acupuncture group. CONCLUSIONS: Low quality evidence shows beneficial effect of acupuncture as adjunctive treatment for people mainly with psychogenic ED. Safety of acupuncture was insufficiently reported. The findings should be confirmed in large, rigorously designed and well-reported trials.

Auxiliary treatment of HBV correlated hepatic failure by Chinese herbs: a systematic review of randomized controlled trials / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the effectiveness and safety of Chinese herbs as an adjuvant treatment for hepatitis virus B (HBV)-related hepatic failure.</p><p><b>METHODS</b>Data were retrieved through the Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, PubMed, CNKI, VIP, Wanfang Database, and ChiCTR by key words or free words such as hepatic failure, severe hepatitis, HBV, Chinese medicine, randomization, and control. Appendix references of related papers were taken as supplementary indices. According to requirement for Cochrane systematic evaluation, randomized clinical trials on assessing the effectiveness and safety of Chinese herbs as main or adjuvant treatment in treating HBV-related hepatic failure were methodologically assessed, data extracted and analyzed.</p><p><b>RESULTS</b>Totally 21 trials on Chinese herbal medicine therapy versus standard medical therapy (involving 1 881 patients) were included. Most trials had unclear risk bias. In 5 studies on the mortality, 3 trials showed that the mortality was lower in the test group than in the control group [RR 0.40, 95% CI (0.20, 0.79), P = 0.0002]. In 6 randomized control trials, totally 20 papers reported the control of complications. Eight results showed Chinese herbal medicine therapy had better effect in controlling complications. The recurrence rate and assessment of the survival quality were reported. Considering secondary indicators, four trials showed Chinese herbal medicine therapy had better effect in lowering the ineffective rate, decreasing total bilirubin (TBIL), and elevating prothrombin activity (PTA). Other prescriptive analyses found that the overall effect on secondary indicators was better in the test group than in the control group, but not all the indicators were statistically different. Adverse reactions were only reported in two papers, showing no severe adverse reaction.</p><p><b>CONCLUSION</b>According to present evidence, till now, we could not judge whether Chinese herbs, as an adjuvant treatment, could do any favor for lowering the incidence and recurrence of hepatic failure patients, and improving their survival qualities.</p>

Expertise-based randomized controlled trials and its application in acupuncture clinical research / 中国针灸

Through introduction of the methodological mechanism and comparison with classic randomized controlled trial, the status and the applicability of the expertise-based randomized controlled trials in clinic are explored, and its characteristics in acupuncture clinical application are analyzed. It is held that expertise-based randomized controlled trial is more suitable for the acupuncture clinical research, especially for acupuncture practice which emphasizes manipulations and different schools.

Treatment of diabetic nephropathy by integrative medicine: a multi-center prospective cohort study / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To assess the efficacy and safety of integrative medicine (IM) treatment for diabetic nephropathy (DN), and to explore the medication laws by Chinese medicine (CM) syndrome typing.</p><p><b>METHODS</b>One hundred and seventy outpatients or inpatients with DN at Dongfang Hospital of Beijing University of Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences, and China-Japan Friendship Hospital of the Ministry of Health were recruited from March 2008 to July 2009. They were allocated into the IM group (116 cases) or the Western medicine group (54 cases) according to whether or not they were willing to receive CM syndrome typing. The incidence of endpoint events and secondary outcome measures [such as body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), urinary albumin excretion rate (UAER), 24 h urinary protein (24 hU), serum creatinine (SCr), fasting blood glucose (FBG), and glycosylated hemoglobin (HbA1c)] of two groups were observed at 3, 6, 12, 18, and 24 months respectively during the follow-ups. Patients in the IM group were syndrome typed. The CM recipes were collected to calculate the frequency of Chinese materia medica used. The liver function, blood routines, and ECG were observed and compared during the follow-ups.</p><p><b>RESULTS</b>The follow-up period was 3 to 24 months with the mean of 14 months. Data suitable for analysis mainly covered the 3rd, 6th, 12th and 18th month of the follow-up. Both PPS and FAS analysis showed that there were no significant difference in the incidence of endpoint between two groups (11.2% vs 7.4%, P>0.05). The level of body mass index (BMI) [(25.0 +/- 3.1) kg/m2] and fasting blood glucose (FBG) [(7.9 +/- 1.5) mmol/L] in the IM group were lower than those of the Western medicine group [(28.6 +/- 4.4) kg/m2 and (8.8 +/- 2.9) mmol/L respectively] at the 6-month follow-up (P<0.05). The levels of FBG [(7.9 +/- 1.4) mmol/L] and HbA1c [(7.8 +/- 1.4)%] in the IM group were lower than those of the Western medicine group [(9.6 +/- 2.8) mmol/L and (8.5 +/- 1.6)% respectively] at the 12-month follow-up (P<0.05). There was no significant difference in other indices between the two groups at the 3- or 12-month follow-ups. The level of SCr in the IM group and the Western medicine group before follow-up were (96.8 +/- 35.2) micromol/L and (80.5 +/- 24.6) micromol/L respectively, showing statistical difference (P<0.01). There were no significance difference in SCr between the two groups at 3, 6, 12, 18-month follow-ups for center 2 (Xiyuan Hospital of China Academy of Chinese Medical Sciences) and center 3 (China-Japan Friendship Hospital of the Ministry of Health), while the level of SCr in the IM group [(82.4 +/- 25.7) micromol/L, (78.1 +/- 25.9) micromol/L, (80.3 +/- 24.0) micromol/L, respectively] were lower than that of the Western medicine group [(101.4 +/- 37.2) micromol/L, (96.5 +/- 34.1) micromol/L, (93.9 +/- 25.9) micromol/L, respectively] for center 1 (Dongfang Hospital of Beijing University of Chinese Medicine) at 3, 6, 12-month follow-ups (P<0.05). The top ten drugs used most frequently in the 237 prescriptions collected was astragali (68.4%), ophiopogonis tube (67.5%), rehmannia dried rhizome (67.1%), danshen root (49.4%), Codonopsis pilosula (41.8%), figwort root (35.4%), Chinese magnolia-vine fruit (29.5%), safflower (27.9%), peach seed (26.2%), and angelica root (25.3%). There was no abnormal liver function, blood abnormalities, and serious adverse events in two groups during the follow-ups.</p><p><b>CONCLUSIONS</b>CM treatment based on syndrome typing in combination with routine Western medicine for DN could reduce the levels of BMI, FBG, HbA1c, and SCr at partial time points, showing favorable safety. Chinese medicinals applied in treatment based on syndrome typing for DN covered mainly supplementing qi, nourishing yin, and activating blood circulation to remove blood stasis.</p>

Application of qualitative research method in clinical study on acupuncture and moxibustion / 中国中西医结合杂志

Clinical qualitative research on acupuncture has turned into one of the overseas attentive points in medical research, and up to now nearly one hundred papers have been published, covering various pivotal aspects of clinical acupuncture itself, such as therapeutic effect evaluation, experience and expectation of patients as well as understanding and experience of acupuncturists on the treatment. Currently, the qualitative research on the holistic therapeutic mode and efficacy evaluation of acupuncture has become the focus of research in foreign countries. Compared with the condition abroad, there is almost no relavent paper published in China. In this paper, the development status, focal field and main direction of overseas qualitative research on acupuncture are introduced, the characteristics of the research proposed in China is analyzed, and its future application in China is looked forward to.

Herbal CONSORT statement and standardization of reporting traditional Chinese drug trials / 中国中药杂志

Based on detailed explanation of the herbal CONSORT statement, and the consideration of the character of traditional Chinese drugs, to discuss the standardization of reporting traditional Chinese drug trials. The standards of reporting traditional Chinese drug trials are not consolidated yet. In the year 2006, Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement was developed by the CONSORT group and published. This herbal CONSORT statement includes 5 parts, and totally 22 items, in which the items of participant criteria, intervention, control setting and outcomes, et al. are elaborated to be adaptable to herbal intervention trials. This herbal CONSORT statement has provided valuable basis for the development of standards of reporting traditional Chinese drug trials, though it is not completely adaptive to be the reporting standards in consideration of the background theory and the animal drugs and mineral drugs that traditional Chinese drugs contain. The proper reporting standards of traditional Chinese drug trials should take the different types of drugs and the different purposes of trials into consideration. The trial reports of drugs that must be applied under the instruction of traditional Chinese medicine (TCM) theory should report participant criteria that include TCM syndrome differentiation and other important characters of TCM interventions.

Bibliometrics study on dominant diseases in modern acupuncture clinic / 中国针灸

<p><b>OBJECTIVE</b>To find out the dominant diseases in the clinic of modern acupuncture.</p><p><b>METHODS</b>By means of bibliometrics, clinical acupuncture study literatures from 1978 to 2004, searched from CBM database, were sorted and counted to show the different clinical utilizing quantities and developing trends of different disease groups in the acupuncture clinic.</p><p><b>RESULTS</b>Obviously dominant type: nervous system diseases; mature type: motor system diseases; developing type: 3 kind of diseases including psychosis; premature type: diseases related with surgery; steady type: 3 kind of diseases including digestive system diseases (diseases of liver and gallbladder are not included); pre-developing diseases: 5 kind of diseases including otorhinolaryngologic diseases.</p><p><b>CONCLUSION</b>Among all these types, obvious advantage type and mature type are the most distinguishing. Developing type has the most significant ascending trend. Premature type has relatively strong developing potentiality.</p>