Available online 9 September 2023

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Randomized controlled trial (RCT) is the golden standard for evaluation of clinical evidence. To assess the effect of acupuncture, due to the specificity of acupuncture intervention, the blinding and control methods are the difficulties in study design. It is not practical to blind investigators, participants and evaluators simultaneously. At present, blinding is generally conducted for the participants and evaluators in clinical trial. We took a comparative study of manual acupuncture and electroacupuncture for menopausal hot flush as an example to explore a new way with the reference of double-dummy design in new drug study. A single-blind and double-dummy clinical trial model of acupuncture was established. Based on individual acupuncture intervention in each group, the placebo intervention was combined to ensure the form consistency of two groups. Such a study design may eliminate non-specific effect of acupuncture, and can be conductive to comparing the specific effect of acupuncture and can provide the references and regimens for study design.

摘要

随机对照试验是评价临床证据的“金标准”.在针灸临床疗效评价中, 因针灸治疗操作上的特殊性, 盲法和对照方法的选择是临床研究设计的难点, 对研究者,研究对象和评价者同时设盲是不切实际的, 目前临床研究普遍的做法是针对研究对象和评价者设盲.笔者以“手针和电针治疗绝经烘热疗效比较”为例, 探讨借助临床新药研究中双模拟的思路, 建立了单盲双模拟针灸临床研究模式, 在两组不同针刺干预基础上, 分别联合安慰干预, 使两组在治疗形式上保持一致.这样的研究设计可消除针刺非特异性治疗因素的影响, 有助于比较不同针刺特异性的治疗效果, 为针灸临床的设计提供了可参考的思路和方案.

Section snippetsCommon designs for control intervention in acupuncture RCT

According to the study purpose, the blank control, placebo control or positive drug control is optional in acupuncture clinical trial. Some studies in western countries choose the waiting cohort as the blank control and the basic treatment can be involved considering the ethical issue. Acupuncture trial in China also selects the effective drugs or measurements internationally recognized, i.e. positive drug control. However, acupuncture and medication are different in the intervention procedure,

Origins of the design for the single-blind and double-dummy acupuncture clinical trial

To assess the effect of acupuncture, the trial should be designed appropriately according to the study objective so that the efficacy specificity of different acupuncture therapies can be compared [12]. In comparison of clinical efficacy between manual acupuncture (MA) and EA, the results of previous studies have proved that EA can relieve the clinical symptoms of patients with menopausal syndrome and positively regulates the serum sex hormones [20,21]. The clinical practice of MA has been

Designing the single-blind and double-dummy acupuncture clinical trial

In 2014, supported by the First Affiliated Hospital of Hunan University of Chinese Medicine, First Affiliated Hospital of Bengbu Medical College, Shaanxi Chinese Medicine Hospital, Wuhan Integrative Chinese and Western Medicine Hospital, Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Yueyang Hospital Affiliated to Hunan University of Chinese Medicine and Changsha Chinese Medicine Hospital, we conducted the "the twelfth five-year" the National Key Technology R&D Program

Significance of the single-blind and double-dummy design in acupuncture clinical trial

The single-blind and double-dummy model of acupuncture clinical trial was established on the base of the double-dummy idea of clinical new drug research. The different placebo interventions were combined in two groups simultaneously. The sham EA and sham MA designed in the trial avoid the differences from the exterior between the intervention group and the control group, which minimizes the impacts of non-specific treatment factor such as psychological factors of the patients in two groups.

Uncited References

[7]

Author contributions

Wei ZHANG had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Wen-ying SHI, Wei ZHANG

Acquisition, analysis, or interpretation of data: Wen-ying SHI, Wei ZHANG

Drafting of the manuscript: Wen-ying SHI

Critical revision of the manuscript for important intellectual content: Wei ZHANG

Obtained funding: Wen-ying SHI, Wei ZHANG

Administrative, technical, or material support: Wei ZHANG

Study

Role of the funding source

The study sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

State of human rights

The intervention conformed to the ethical criteria.

Data sharing statement

You can contact the corresponding author for the data.

Declaration of Competing Interest

The authors declare that there is no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References (26)YX Li et al.Overviews of meta-analysis on acupuncture for trigeminal neuralgia

Liaoning J Tradit Chin Med

(2018)

XJ Wang et al.Controlling methods of clinical research on acu-moxibustion commonly used of abroad

Chin J Integr Tradit West Med

(2006)

H Zheng et al.Features of acupuncture randomised controlled trials published in the top four journals

Chin Acupunct Moxibust

(2010)

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