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Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial.

ABSTRACT: Although asthma symptoms can be temporarily controlled, it is recommended to use effective low-risk, non-drug strategies to constitute a significant advance in asthma management. Acupuncture has been traditionally used to treat asthma; however, the evidence for the efficacy of this treatment is still lacking. Previous clinical trials of acupuncture in treating asthma were limited by methodological defects; therefore, high-quality research is required.This trial is designed as a multi-center, randomized, double-blind, parallel-group controlled trial. Patients with mild to moderate asthma will be randomly allocated to either a verum acupuncture plus as-needed salbutamol aerosol and/or prednisone tablets group or a sham acupuncture plus as-needed salbutamol aerosol and/or prednisone tablets group. Acupoints used in the verum acupuncture group are GV14 (Da Zhui), BL12 (Feng Men), BL13 (Fei Shu) and acupoints used in the sham acupuncture group are DU08 (Jin Suo), BL18 (Gan Shu), BL19 (Dan Shu). After a baseline period of 1 week, the patients in both groups will receive verum/sham acupuncture once every other day with a total of 20 treatment sessions in 6 weeks and a 3-month follow-up. The primary outcome will be measured by using the asthma control test and the secondary outcomes will be measured by using the percentage of symptom-free days, the average dosage of salbutamol aerosol and/or prednisone tablets, lung functions, daily asthma symptom scores, asthma quality of life questionnaire, and so on.This trial will assess the effect of acupuncture on asthma and aims to provide reliable clinical evidence for the efficacy of acupuncture in treating asthma.ClinicalTrials.gov Identifier: NCT01931696 , registered on 26 August 2013.

SUBMITTER: Yin LM

PROVIDER: S-EPMC4581041 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial.

Yin Lei-Miao LM Wang Yu Y Fan Lei L Xu Yu-Dong YD Wang Wen-Qian WQ Liu Yan-Yan YY Feng Jun-Tao JT Hu Cheng-Ping CP Wang Pei-Yu PY Zhang Tie-Feng TF Shao Su-Ju SJ Yang Yong-Qing YQ

Trials 20150923

<h4>Background</h4>Although asthma symptoms can be temporarily controlled, it is recommended to use effective low-risk, non-drug strategies to constitute a significant advance in asthma management. Acupuncture has been traditionally used to treat asthma; however, the evidence for the efficacy of this treatment is still lacking. Previous clinical trials of acupuncture in treating asthma were limited by methodological defects; therefore, high-quality research is required.<h4>Methods/design</h4>Thi ...[more]

PMID: 26399399

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Project description:Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain.A total of 640 participants (160 in each of four arms) between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM) acupuncture needling (individualized or standardized), a "control" group (simulated acupuncture), or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for most pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount.Results of this trial will help clarify the value of acupuncture needling as a treatment for chronic low back pain.Clinical Trials.gov NCT00065585.

Project description:BackgroundChronic urticaria (CU) is a refractory skin disease with long duration and a high recurrence rate. Acupuncture has been widely used for the treatment of CU in clinical practice in China. However, until now, there has been no appropriately designed randomized controlled trial (RCT) to provide explicit evidence about the effectiveness of acupuncture for the treatment of CU worldwide. Therefore, we plan to conduct a pilot study to explore its effectiveness and safety and determine the feasibility of studying acupuncture in a future, full-scale, RCT of CU.Methods/designThis randomized, sham-controlled, participant-blinded and assessor-blinded pilot trial is underway in China. A total of 60 participants with CU will be randomly assigned to two groups in a 1:1 ratio: one treated with real acupuncture and the other with sham acupuncture, for 10?sessions over 2?weeks. The experimental group will receive acupuncture on a fixed prescription of acupoints, whereas the control group will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The primary outcome will be the urticaria activity score (UAS). The secondary outcomes will include a visual analogue scale (VAS) score for itching intensity, the Dermatology Life Quality Index (DLQI), the Hamilton Depression Scale (HAMD), the Hamilton Anxiety Scale (HAMA), the humoral immunity index, serum total IgE, and adverse events. The UAS, VAS for itching and the DLQI will be conducted at baseline and at 1, 2, 3, and 4?weeks after randomization. The HAMD, HAMA, humoral immunity index, and serum total IgE will be assessed at baseline and at 2?weeks after randomization. Adverse events will be summarized at 1 week and 2 weeks after randomization.DiscussionThe pilot study mainly aims to investigate trial feasibility, and confirm basic information about its effects and safety. Results of this trial will help clarify whether the acupuncture treatment is beneficial for symptom improvement in patients with CU. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for CU.Trial registrationAcupuncture-Moxibustion Clinical Trial Registry, AMCTR-ICR-18000190 . Registered on 19 June 2018.

Project description:BACKGROUND:Bell's palsy is the most frequent cause of unilateral peripheral facial palsy, a common condition that third of patients can have inadequate recovery and subsequent physical and social impairments. The largely ineffective and even controversial nature of the various medical and surgical treatment options means that novel, alternative approaches are needed. In preclinical and clinical evidence, low-level laser therapy (LLLT) has demonstrated the ability to regenerate peripheral nerves. Laser acupuncture treatment (LAT), the stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation, is a common treatment modality, but its efficacy in chronic Bell's palsy is undetermined. This study aims to evaluate the efficacy of LAT in patients experiencing inadequate recovery from Bell's palsy. METHODS:This 2-armed, parallel, randomized, subject-assessor-blinded, single-center, sham-controlled pilot trial will randomly assign 32 eligible patients into either a real LAT group (n?=?16) or a sham LAT group (n?=?16). The real LAT group will receive 3 LAT sessions each week for 6 weeks (a total of 18 sessions), delivered to acupoints corresponding with the affected side of the face. The sham LAT group will receive the same treatment as the real LAT group, but with a sham laser device. The primary outcome measure will be the change from baseline at week 6 in the Facial Disability Index score. Secondary outcomes will monitor changes during treatment in the House-Brackmann and Sunnybrook facial nerve grading systems and stiffness scale, at weeks 1, 3, and 6. DISCUSSION:To the best of our knowledge, this double-blind, randomized, sham-controlled trial is the first such investigation into the efficacy of LAT in chronic Bell's palsy. Clinical trials using LLLT have shown positive therapeutic effects in acute Bell's palsy, although as yet, the feasibility and efficacy of LAT remain unclear in patients experiencing inadequate recovery from Bell's palsy. TRIAL REGISTRATION:This trial protocol has been approved by the Research Ethics Committee of the China Medical University Hospital, Taichung, Taiwan (Protocol ID: CMUH107-REC1-030) also registered at ClinicalTrials.gov (identifier no. NCT03592797).

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Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial.

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Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial.

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