RESUMEN
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.
Asunto(s)
Terapia por Acupuntura , Asma , Meridianos , Terapia por Acupuntura/efectos adversos , Asma/diagnóstico , Asma/terapia , China , Humanos , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , VíscerasRESUMEN
BACKGROUND: Acupuncture has long been used to treat chronic stable angina pectoris (CSAP), but the acupuncture prescription for CSAP varies. This trial will compare the therapeutic effects between the acupoints on the Heart Meridian and the acupoints on the Lung Meridian for treating CSAP, so as to provide a better prescription for acupuncture treatment of CSAP. METHODS: This is a multicenter randomized controlled trial. A total of 148 CSAP patients will be randomly allocated into two groups through central randomization in a 1:1 ratio. This trial will include a 2-week screening period, a 4-week treatment period, and a 4-week follow-up period. The primary outcome is the frequency of angina attacks from baseline to 4 weeks after inclusion. Secondary outcomes include the frequency of angina attacks from baseline to 4 weeks after acupuncture treatment, the pain intensity of angina, total ischemia burden, heart rate variability, QT dispersion, the score of Seattle Angina Questionnaire, and the score of Short-Form of McGill Pain Questionnaire. These outcome measures will be evaluated at baseline, at the end of acupuncture treatment, and at the end of follow-up. DISCUSSION: We hypothesize that the effectiveness of puncturing at acupoints on the Heart Meridian will not be the same as those on the Lung Meridian. The results will provide further evidence of Meridian-Viscera Association theory and references for acupoints selection in the clinical practice. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900025804 . Registered on September 9, 2019.