[Design, manufacture and evaluation of a multi-parameter controllable automatic fire-acupuncture instrument].

A multi-parameter controllable automatic fire-acupuncture instrument was developed by integrating traditional fire needling with modern medical device technology. A gun-like appearance was designed for easy hand-held operation, the electromagnetic induction was for heating needle body, a scale knob was for controlling the needle insertion depth, the combination of electromagnetic ejection and spring return was for the precise control of the needle retention time; and the changeable single ste-rile needle or multiple needles were adopted to meet individual demand, obtain high efficiency and prevent infection. All of these designs are associated with the overall process control system to ensure the exact controllability of needle body temperature, needling density, insertion depth and needle retention time. Besides, this device is advantageous at handy and aseptic operation with high efficiency, conformability and visualization. In this research, this instrument was tested in animals for the impacts of automatic fire needling on skin damage and fur growth. It is found that the accurate control of each parameter is of the significant advantage in the safety and effectiveness of treatment, which lays a solid foundation for the subsequent systematic review on safety and effectiveness.

[Chinese medicine clinical trial protocol design and report specifications].

Clinical trial protocol is the document that illustrates the background of a clinical trial, theoretic basis, objective, design, methods, and organization, as well as statistical calculating, implement, and conditions for completion. Clinical trial protocol is the basic measure for ensuring the validity of scientific results and reducing bias. In order to optimize the design of clinical trial protocol, we generalize main problems in Chinese medicine clinical trials, key points of clinical trial protocol, as well as report standards.

Traditional Chinese medicine for chronic fatigue syndrome: a systematic review of randomized clinical trials.

BACKGROUND: There is no curative treatment for chronic fatigue syndrome (CFS). Traditional Chinese medicine (TCM) is widely used in the treatment of CFS in China. OBJECTIVE: To evaluate the effectiveness and safety of TCM for CFS. METHODS: The protocol of this review is registered at PROSPERO. We searched six main databases for randomized clinical trials (RCTs) on TCM for CFS from their inception to September 2013. The Cochrane risk of bias tool was used to assess the methodological quality. We used RevMan 5.1 to synthesize the results. RESULTS: 23 RCTs involving 1776 participants were identified. The risk of bias of the included studies was high. The types of TCM interventions varied, including Chinese herbal medicine, acupuncture, qigong, moxibustion, and acupoint application. The results of meta-analyses and several individual studies showed that TCM alone or in combination with other interventions significantly alleviated fatigue symptoms as measured by Chalder's fatigue scale, fatigue severity scale, fatigue assessment instrument by Joseph E. Schwartz, Bell's fatigue scale, and guiding principle of clinical research on new drugs of TCM for fatigue symptom. There was no enough evidence that TCM could improve the quality of life for CFS patients. The included studies did not report serious adverse events. CONCLUSIONS: TCM appears to be effective to alleviate the fatigue symptom for people with CFS. However, due to the high risk of bias of the included studies, larger, well-designed studies are needed to confirm the potential benefit in the future.

Chinese herbal medicine Guizhi Fuling Formula for treatment of uterine fibroids: a systematic review of randomised clinical trials.

BACKGROUND: Guizhi Fuling Formula is widely applied for uterine fibroids in China. Many clinical trials are reported. This study assessed the efficacy and safety of Guizhi Fuling Formula for the treatment of uterine fibroids. METHODS: PubMed, Cochrane CENTRAL, EMBASE, and four Chinese databases were searched through May 2013. We included randomised controlled trials (RCTs) that tested Guizhi Fuling Formula for uterine fibroids, compared with no intervention, placebo, pharmaceutical medication, or other Chinese patent medicines approved by the State Food and Drug Administration of China. Authors extracted data and assessed the quality independently. We applied RevMan 5.2.0 software to analyse data of included randomised trials. RESULTS: A total of 38 RCTs involving 3816 participants were identified. The methodological quality of the included trials was generally poor. Meta-analyses demonstrated that Guizhi Fuling Formula plus mifepristone were more effective than mifepristone alone in reducing the volume of fibroids (in total volume of multiple fibroids, MD -19.41 cm(3), 95% CI -28.68 to -10.14; in average volume of multiple fibroids, MD -1.00 cm(3), 95% CI -1.23 to -0.76; in average volume of maximum fibroids, MD -3.35 cm(3), 95% CI -4.84 to -1.87, I(2) = 93%, random effects model). Guizhi Fuling Formula significantly improved symptoms of dysmenorrhea either when it was used alone (RR 2.27, 95% CI 1.04 to 4.97) or in combination with mifepristone (RR 2.35, 95% CI 1.15 to 4.82). No serious adverse events were reported. CONCLUSIONS: Guizhi Fuling Formula appears to have additional benefit based on mifepristone treatment in reducing volume of fibroids. However, due to high risk of bias of the trials, we could not draw confirmative conclusions on its benefit. Future clinical trials should be well-designed and avoid the issues that are identified in this study.

Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study.

BACKGROUND: Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications. OBJECTIVE: To describe the characteristics of TCM trials, estimate bias risk and outcome-reporting bias in clinical trials. DATA SOURCES AND STUDY SELECTION: Fifteen trial registries were searched from their inception to July 2012 to identify randomised trials on TCM including Chinese herbs, acupuncture and/or moxibustion, cupping, tuina, qigong, etc. DATA EXTRACTION: We extracted data including TCM specialty and treated disease/conditions from the registries and searched for subsequent publications in PubMed and Chinese databases. We compared information in the registries of completed trials with any publications focusing on study design, sample size, randomisation, bias risk including reporting bias from the register protocol. RESULTS: 1096 registered randomised trials were identified evaluating TCM, of which 505 were completed studies (46.1%). The most frequent conditions were pain (13.3%), musculoskeletal (11.7%), nervous (8.7%), digestive (7.1%), circulatory (6.5%), respiratory (6.3%), mental and behavioural disorders (6.2%) and cancer (6.0%). The trial register data identified parallel, phase II/III randomised trials with sample size estimations and blinding, but limited information about randomisation (sequence generation and allocation concealment). Comparing trial registration data of 115 completed trials (22.8%) with their subsequent 136 publications, inconsistencies were identified in one or more of the following: sample size (11%), outcome assessor blinding (37.5%), primary outcomes (29%) and safety (28%) reporting. CONCLUSIONS: Increasing numbers of clinical trials investigating a variety of TCM interventions have been registered in international trial registries. The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos. However, selective outcome reporting is widespread and similar to conventional medicine and therefore study conclusions should be interpreted with caution.

Chinese herbal medicine for gout: a systematic review of randomized clinical trials.

Patients with gout referring to Chinese herbal medicine are not rare in China, and a great number of clinical trials on herbal medicine have been published. However, there has not been a systematic review to summarize the evidence of Chinese herbal medicine for gout. The aim of this study is to evaluate the evidence for the effectiveness and safety of Chinese herbal medicine for gout. We searched for randomized clinical trials on Chinese herbal medicine for gout till December 2012. Cochrane risk of bias tool was used to assess the methodological quality. RevMan 5.2 was used to synthesize the results. We included 57 trials involving 4,527 gout patients. The quality of trials was generally poor. No trial reported health-related quality of life in patients. There is not enough evidence showing that herbal medicine was statistically more effective than conventional medications in pain relief [mean difference (MD), -0.03; 95% confidence interval (CI), -0.06, 0.00], but herbal medicine combined with conventional medicines may have better effectiveness (MD, -0.33; 95% CI, -0.59, -0.07). Trials that reported function limitation relief found herbal medicine more effective than conventional medications (MD, -0.23; 95% CI, -0.32, -0.15). There was no evidence showing that herbal medicine prevents gout recurrence better. Twenty-five out of 41 trials, involving 23 different herbal prescriptions, found statistical significance in lowering serum uric acid level, and the overall effect from Chinese herbal medicine in inflammation relief is better than conventional therapies in 19 trials with 17 different prescriptions. The current data show that herbal medicine leads to fewer side reactions compared to conventional therapies [risk ratio (RR), 0.11; 95% CI, 0.08 to 0.15]. Chinese herbal medicine may have clinical effectiveness for functional recovery in patients with gout, and lead to a safe control of serum uric acid level and inflammation severity. Due to low quality of trials, trials with higher methodological quality and less heterogeneity are needed in the future.

Acupoint Stimulation for Acne: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: Acupoint stimulation-including acupuncture, moxibustion, cupping, acupoint injection, and acupoint catgut embedding-has shown a beneficial effect for treating acne. However, comprehensive evaluation of current clinical evidence is lacking. OBJECTIVE: The aim of this review was to assess the effectiveness and safety of all acupoint stimulation techniques used to treat acne vulgaris. DESIGN: A systematic review was conducted. It included only randomized controlled trials on acupoint stimulation for acne. Six electronic databases were searched for English and Chinese language studies. All searches ended in May 2012. Studies were selected for eligibility and assessed for quality. RevMan 5.1 software was used for data analysis with an effect estimate presented as risk ratios (RR) or mean difference (MD) with a 95% confidence interval (CI). PATIENTS: Studies with subjects who were diagnosed with acne vulgaris, or papulopustular, inflammatory, adolescent, or polymorphic acne-regardless of gender, age, and ethnicity-were included. INTERVENTION: Interventions included any acupoint stimulation technique-such as acupuncture, moxibustion, cupping, acupoint injection, and acupoint catgut embedding-compared with no treatment, placebo, or conventional pharmaceutical medication. MAIN OUTCOME MEASURE: Reduction of signs and symptoms and presence of adverse effects were examined. RESULTS: Forty-three trials involving 3453 patients with acne were included. The methodological quality of trials was generally poor in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed significant differences in increasing the number of cured patients between acupuncture plus herbal medicine and herbal medicine alone (RR: 1.60; 95% CI: 1.19-2.14; P=0.002), and between acupuncture plus herbal facial mask and herbal facial mask alone (RR: 2.14; 95% CI: 1.29-3.55; P=0.003). Cupping therapy was significantly better than pharmaceutical medications for increasing the number of cured patients (RR: 2.11; 95% CI: 1.45-3.07; P<0.0001). Serious adverse events were not reported in all included trials. CONCLUSIONS: Acupoint stimulation therapies combined with other treatments appears to be effective for acne. However, further large, rigorously designed trials are needed to confirm these findings.

[Reporting specification of systematic reviews on Chinese medicine and methodological evaluation].

Currently, the number of systematic reviews on Chinese medicine (CM) increases gradually. However, the quality of the reviews varied, which resulted in great limitations in guiding clinical practice. This article refers to the Cochrane Handbook and PRISMA Statement to introduce the reporting specification of the systematic review, including asking a research question, review methods, presentation of the results, discussion and conclusion. We analyzed the methodology issues in the published systematic reviews on CM in order to improve the quality of future reviews.

[Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

BACKGROUND: Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. OBJECTIVE: To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. SEARCH STRATEGY: Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. INCLUSION CRITERIA: RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. DATA EXTRACTION AND ANALYSIS: Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. RESULTS: The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report concealment of random numbers, 5% used placebo, 10% reported outcome attrition bias and no study employed the analysis of intention-to-treat and 98% reported the diagnostic criteria for type 2 diabetes. The participants mainly consisted of outpatients without complications (76%). The minimum and maximum sample size was 40 and 300 (106 ± 60), respectively. CONCLUSION: The inclusion and exclusion criteria and outcome measures did not match the purposes and contents of post-marketing research in the included studies. They also failed to reflect the basic principles of traditional Chinese medicine in the process of diagnosis and treatment. The demographic characteristics of the patients, the indications for medicine and the syndrome differentiation process were not reported sufficiently and transparently. In order to improve the post-marketing research and promote the rational use of Chinese patent drugs, it is recommended that phase IV clinical trials should establish clear research purpose as well as hypothesis first, and choose scientific and evidence-based study design and outcome measures. In addition, guidelines for implementation of post-marketing research should be developed.