The concept and the background of pragmatic randomized controlled trials are introduced in this article, and the differences between pragmatic randomized controlled trials and explanatory randomized trials are also described.The methodological features of pragmatic randomized controlled trials are further explored by means of some typical cases study of pragmatic clinical trials.
The history of the World Federation of Acupuncture-Moxibustion Societies (WFAS) was reviewed through summarizing the background and process of the establishment of WFAS. The establishment background was explained in different aspects, named the recovery of acupuncture-Moxibustion in the world, the successive setup of world acupuncture-Moxibustion organizations, the divergences of International Association of Acupuncture-Moxibustion, striding forward of China reform and opening policy as well as the attention of the World Health Organization (WHO), etc. The establishment of WFAS was introduced on the proposal from eight countries, the important time of the development of acupuncture and moxibustion in China, 1984, divergences and consensus as well as the final phase. The official establishment of WFAS represents the global benefits of acupuncture-Moxibustion colleagues. It is the international organization of acupuncture and moxibustion, contributing to the promotion of acupuncture and moxibustion in the world.
The standardized reports of simulated acupuncture control are conductive to understanding and replicating the control method for researchers and readers. At present, the reporting quality of the simulated control in the clinical research of acupuncture is low and there is not a guideline, specification or standard specifically for the report of simulated acupuncture control. In this article, we compared in-depth the checklists between STRICTA (standards for reporting interventions in clinical trials of acupuncture) and TIDieR-Placebo (a guide and checklist for reporting placebo and sham controls), and assessed their applicability in acupuncture clinical research. The checklist of STRICTA is a particular standard for reporting acupuncture intervention measures, including the items of acupuncture control, especially the reporting of the details in acupuncture control; while, the checklist of TIDieR-Placebo is for the comprehensive reporting of placebo or sham control, covering a wider range of content. It specifies the overall reporting of the placebo control setting, intervention delivery and blindness assessment. Although both of the checklists provide a certain reference for reporting simulated acupuncture, they are not applicable for adequately reporting the simulated acupuncture control. Therefore, it is urgent to develop a specific guideline for reporting simulated acupuncture control so as to improve the reporting quality.规范的模拟针刺对照报告有助于研究者、读者对该对照方式的理解与重复。目前部分针刺临床研究中模拟针刺对照报告质量较差，且尚无专门针对模拟针刺对照报告的指南、规范或标准。本文对模拟针刺对照相关报告规范——针刺临床试验干预措施报告标准(STRICTA)及安慰剂和假对照报告指南与清单(TIDieR-Placebo)进行深入地比较分析，并评价其在针刺临床研究中的适用性。STRICTA清单是专门针对针刺干预措施报告的规范，同时也包括对针刺对照内容的规范，侧重于针刺细节的报告；TIDieR-Placebo清单则是针对安慰剂对照或假干预普适性的报告标准，涵盖内容更广，从安慰对照设置、实施与盲法评价方面进行整体报告内容的规定。两者均对模拟针刺对照报告有一定的借鉴意义，但又不完全适用。故亟需制订专门针对模拟针刺对照报告的指南、标准或规范，以提高其报告质量。.
Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control. Methods This study consists of a multi-centre (two centres in Korea and two centres in China), randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group). The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching) from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping). The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure. Trial registration Current Controlled Trials ISRCTN90807007
Background: Various types of sham acupuncture are used in acupuncture clinical trials, and the placebo response of sham acupuncture have substantial impact on the study outcomes. However, the magnitude of the placebo response and whether it differs across different types of sham acupuncture is unclear. Hence, we conducted a meta analysis to investigate the magnitude of the placebo response of sham acupuncture and whether different types of sham acupuncture have different responses in the studies of acupuncture for nonspecific low back pain (LBP).Methods: PubMed, Embase, MEDLINE, and the Cochrane Library was searched, and randomized clinical trials (RCTs) were included if they randomized patients to receive acupuncture or sham acupuncture treatment. The outcomes included the change in pain intensity, back-specific function and quality of life etc. Random-effects models was used to synthesize the results, standardized mean differences (SMDs, Hedges’ g) were applied to estimate the effect size.Findings: In total, 17 RCTs were included in this meta-analysis, sham acupuncture showed a noteworthy pooled placebo response (SMD −1 · 50, 95% CI −2·03 to −0·96, I2 = 88%) in pain intensity. A significant placebo response was also shown in back-specific functional status, but not in quality of life. Trials in which the sham acupuncture penetrated the skin, performed with regular needles had a significantly higher placebo response, but other variables such as the location of sham acupuncture did not have a significantly impact on the placebo response.Interpretation: Sham acupuncture is associated with large placebo response in pain intensity, and researchers should be aware that the types of sham acupuncture applied may influence the results of trials.Trial Registration Details: The study protocol was registered at https://www.crd.york.ac.uk/prospero/display_record.php? RecordID=304416. Funding Information: The National Natural Science Foundation of China (82174234).Declaration of Interests: The authors have no conflicts of interest to declare.
Purpose . To analyze and compare the clinical registration information about acupuncture and moxibustion for intervention characteristics. Methods . Clinical trials from the International Clinical Trials Registry Platform of the World Health Organization in acupuncture and moxibustion were comprehensively collected from 2013 to 2015; data were independently screened and extracted by two retrievers, and relevant data involving either basic descriptions or intervention characteristics were analyzed. Results . 425 acupuncture and moxibustion registered clinical trials were included; 88.00% (374/425) were designed as controlled studies, among which 38.59% (164/425) had sham acupuncture as the control group. The most common diseases were pain-related at approximately 19.29% (82/425) of trials. Reports on the intervention information in these acupuncture and moxibustion clinical studies were not sufficiently presented; these reports included the reporting of names of points (39.8%), the method of needle stimulation (32.5%), needle type (29.6%), needle retention time (34.1%), the number of treatment sessions (22.4%), and the frequency and duration of treatment sessions (38.1%). Conclusion . The registration information for the clinical trials of acupuncture and moxibustion was quite low according to this investigational study. Steps should be taken to improve the quality of acupuncture and moxibustion registration information.
Objective To establish and promote the non-contact doctor-patient interactive diagnosis and treatment mode based on mobile internet for the treatment of coronavirus disease 2019 (COVID-19) with moxibustion therapy, and to observe the feasibility and effectiveness of the model in the pandemic. Methods A total of 43 first-line medical staff and 149 suspected and confirmed cases with COVID-19 [18 cases in medical observation period, 17 cases of mild type (cold dampness and stagnation in the lung), 24 cases of ordinary type (cold-dampness accumulated in the lung) and 90 cases in recovery period (qi deficiency of spleen and lung)] were included. A non-contact doctor-patient interactive diagnosis and treatment platform was established for the treatment of COVID-19 with indirect moxibustion plaster based on mobile internet. By the platform, the patients were instructed to use indirect moxibustion plaster in treatment. For the first-line medical staff and patients in the medical observation period, Zusanli (ST 36), Qihai (CV 6) and Zhongwan (CV 12) were selected. For the mild cases (cold dampness and stagnation in the lung) and the cases of ordinary type (cold-dampness accumulated in the lung), Hegu (LI 4), Taichong (LR 3), Zusanli (ST 36) and Guanyuan (CV 4) were selected. In the recovery period (qi deficiency of spleen and lung), Dazhui (GV 14), Feishu (BL 13), Geshu (BL 17), Zusanli (ST 36) and Kongzui (LU 6) were used. The treatment was given once daily for 40 min each time. The intervention lasted for 10 days. After intervention, the infection rate and the improvement in the symptoms and psychological status of COVID-19 were observed in clinical first-line medical staff and COVID-19 patients. Results In 10 days of intervention with indirect moxibustion plaster, there was zero infection among medical staff. Of 43 first-line physicians and nurses, 33 cases had some physical symptoms and psychological discomforts, mainly as low back pain, poor sleep and anxiety. After treatment, regarding the improvements in the symptoms and psychological discomforts, the effective rate was 78.8% (26/33) and the curative rate was 36.4% (12/33). Regarding the improvements in psychological discomforts, the effective rate was 58.3% (14/24) and the curative rate was 37.5 (9/24). Of 149 patients, 133 cases had the symptoms and psychological discomforts. After treatment, regarding the improvements in the symptoms and psychological discomforts, the effective rate was 81.2% (108/133) and the curative rate was 34.6% (46/133). Regarding the improvements in psychological discomforts, the effective rate was 76.5% (52/68) and the curative rate was 57.4 % (39/68). Conclusion It is feasible to apply the indirect moxibustion plaster technique based on mobile internet to the treatment COVID-19. This mode not only relieves the symptoms such as cough and fatigue, improves psychological state, but also possibly prevents the first-line medical staff from COVID-19.
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