Randomized trial of acupoints herbal patching in Sanfu Days for asthma in clinical remission stage

BACKGROUND Although China has a long history of using acupoints herbal patching (acupoints herbal patching means applying herbal patch on special acupoints to stimulate skin to form blisters, hyperemia, and even suppuration) in Sanfu Days (Sanfu Days are supposed to be the three hottest days in a year which is calculated by the ancient calendar) for the treatment of asthma, there is insufficient evidence to support its effectiveness and safety issues. This study investigated the efficacy and safety of acupoints herbal patching compared with placebo in participants with asthma in clinical remission stage. METHODS We enrolled participants with asthma in clinical remission stage, above 13 years old and both genders in a randomized, double-blind and placebo-control trial at clinical center, School of Chinese Medicine, The University of Hong Kong to assess the effectiveness and safety of acupoints herbal patching, as compared with placebo, when added to guidelines-based therapy. The trial was conducted for three times (these three times were 19 July, 29 July and 8 August 2010), and the primary outcome was pulmonary function test. Secondary outcome was self-made questionnaire which were designed based on Traditional Chinese Medicine theory and clinical experience summary. RESULTS Three hundred and twenty three eligible participants were enrolled, they were randomly assigned to acupoints herbal patching group (n = 165), placebo control group (n = 158). There was no significant difference in primary and secondary outcome as compared with placebo group at the end of 3rd treatment and four times follow ups. But sub-analysis of secondary outcome in four times follow ups showed that acupoints herbal patching significantly reduced the proportion of participants who didn't need medical treatment when they had a small rise in asthma-related symptoms increased from 6-15 % at 1st follow up and 0-7 % at 3rd follow up (P < 0.05). It indicated that the proportion of participants who can spontaneous resolution of an asthma attack increased through acupoints herbal patching. In addition, acupoints herbal patching was significantly superior to placebo in reducing the percentage of participants who were susceptibly waken up by asthma symptoms from 27-14 %, and the percentage of participants who had the symptom of running nose and sneezing before onset from 18-8 % at 2nd follow up (P < 0.05). Improvements also occurred with treatment group, it reduced the proportion of participants who were spontaneous sweating at 3rd follow up (P < 0.05). CONCLUSIONS There was no significant difference between acupoints herbal patching and placebo in pulmonary function test in this study. Self-made questionnaire showed that the lasting effect of acupoints herbal patching was significantly better than placebo in reducing the need for medications to control asthma and the proportion of susceptible symptoms in participants with asthma in clinical remission stage. It showed that the low quality of life caused by asthma-related symptoms was significantly improved through acupoints herbal patching in Sanfu Days. Besides, acupoints herbal patching was as safe as placebo for chronic stable asthma. TRIAL REGISTRATION NUMBER HKUCTR-1128, Registration date 22 Jul 2010.