Dataset Information

Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China.

ABSTRACT:

Background

Acupuncture is effective in symptom and quality of life improvement of chronic asthma, but the efficacy differences between different acupoints are uncertain. In terms of the theory of Meridian-viscera Association, the study aims to investigate the different effectiveness between acupoints in Lung meridian and the acupoints in Heart meridian, so as to provide the evidence to develop a better prescription of the acupuncture treatment of chronic persistent asthma.

Methods

This study is a multicentral randomized controlled trial. A total of 68 chronic persistent asthma patients will be randomly allocated into two groups: the Lung meridian group and the Heart meridian group. This trial will include a 2-week baseline period, a 4-week treatment period with 12 sessions' acupuncture, and an 8-week follow-up period. The primary outcome is the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes are the Asthma Control Test (ACT), Peak Expiratory Flow (PEF), and Forced Expiratory Volume in 1?s (FEV1). The AQLQ and ACT will be collected at baseline, week 4, week 8, and week 12 after randomization. PEF, FEV1, the Self-rating Anxiety Scale (SAS), and the Self-rating Depression Scale (SDS) will be assessed at baseline and week 4.

Discussion

The results will provide evidence for acupuncture prescription selection and the clinical efficacy improvement. The results of this trial will also be used to determine whether or not a full definitive trial will go ahead, which will further confirm the theory of Meridian-viscera Association.

Trial registration

Chinese Clinical Trial Registry ( http://www.chictr.org.cn/showproj.aspx?proj=43803 ) ChiCTR1900027284. Registered on 7 November 2019.

SUBMITTER: Cheng S

PROVIDER: S-EPMC7789474 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China.

Cheng Shirui S Dong Xiaohui X Lan Lei L He Zhaoxuan Z Yu Siyi S Yang Yi Y Zhang Chuantao C Chen Mei M Yang Jun J Chu Haoran H Liu Yalan Y Wang Menglin M Huang Qingsong Q Zeng Fang F

Trials 20210106 1

<h4>Background</h4>Acupuncture is effective in symptom and quality of life improvement of chronic asthma, but the efficacy differences between different acupoints are uncertain. In terms of the theory of Meridian-viscera Association, the study aims to investigate the different effectiveness between acupoints in Lung meridian and the acupoints in Heart meridian, so as to provide the evidence to develop a better prescription of the acupuncture treatment of chronic persistent asthma.<h4>Methods</h4 ...[more]

PMID: 33407788

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Project description:BackgroundAsthma is a common chronic disease in both adults and children. Inhaled corticosteroids (ICS) and β2-agonists are the major medications treating asthma with many side effects. Acupuncture has been used in many diseases including asthma. We aim to assess the efficacy and safety of acupuncture for asthma.MethodsThe following electronical databases will be searched from inception to January 1, 2017: Medline, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), SinoMed, the China National Knowledge Infrastructure Database (CNKI), the Chinese Scientific Journal Database (VIP database), and the Wanfang database. We will also search reference lists of identified studies, potential gray literatures, relevant conference abstracts, and registers of clinical trials. Two reviewers will independently undertake study selection, data extraction, and quality assessment. Data will be synthesized by either the fixed-effects or random-effects model according to a heterogeneity test. Changes in lung function will be assessed as the primary outcome. The level of control, medication usage, quality of life, exacerbations, symptoms, adverse events will be evaluated as the secondary outcomes. The RevMan V.5.3.5 will be employed for meta-analysis. Continuous outcomes will be presented as mean difference or standard mean difference, while dichotomous data will be expressed as relative risk.ResultsThis study will provide a high-quality synthesis of current evidence of acupuncture for asthma from several aspects including lung function, the level of control, medication usage, quality of life, exacerbations, symptoms and adverse events.ConclusionThe conclusion of our study will provide updated evidence to judge whether acupuncture is an effective intervention for children with asthma.Ethics and disseminationIt is not necessary for ethical approval because individuals cannot be identified. The protocol will be disseminated in a peer-reviewed journal or presented at a relevant conference.Prospero registration numberPROSPERO CRD42017054562.

Project description:BackgroundMigraine is a highly prevalent neurological disorder. It is the third most prevalent disorder and the seventh highest cause of disability worldwide. Acupuncture may be a viable prophylactic treatment option for frequent or uncontrolled migraine. Clinical studies comparing acupuncture and placebo acupuncture have not reached a consistent conclusion in confirming whether acupuncture is effective in migraine prophylaxis. The effect of acupuncture mainly depends on acupoints and needles operation. We found that the design of the placebo acupuncture in previous studies included shallow needling at sham acupoints, non-penetrating needling at sham acupoints, and needling at inactive acupuncture points to achieve the inert effect of control group, but the non-penetrating needling at true acupoints was ignored. This randomized controlled trial aims to use true acupoints for non-penetrating acupuncture as control to evaluate the efficacy of manual acupuncture for the prophylaxis of migraine without aura (MWoA).Methods/designThis is a single-blinded, randomized, controlled, prospective, multi-center trial with two parallel treatment groups. A total of 198 eligible patients with MWoA will be randomly divided into two groups (1:1 allocation ratio). The intervention group will receive manual acupuncture and the control group will receive placebo acupuncture (non-penetrating). Patients will receive three acupuncture treatment sessions per week for 4 consecutive weeks. All patients will then receive a 12-week follow-up.DiscussionIn this study, we are evaluating the efficacy and safety of manual acupuncture in the prophylaxis of MWoA. The placebo control is using non-penetrating needling verum acupoints. It is essential to determine an appropriate control method to ensure the methodological quality of a randomized controlled trial.Trial registrationThe trial has been registered in the Chinese Clinical Trial Registry (approval no. ChiCTR2000032308 ) in April 2020.

Dataset Information

Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China.

Background

Methods

Discussion

Trial registration

Publications

Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China.

Similar Datasets

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