Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial

Abstract

Background: Bronchial asthma is one of the most common inflammatory airway disorders. As one of the main non-drug therapies, the Sanfu herbal patch (SHP) has been widely used to treat bronchial asthma, although the evidence for its efficacy and associated mechanism are inconclusive. The objective of this trial is to clarify the clinical efficacy and safety of the SHP in the treatment of bronchial asthma in the chronic persistent or clinical remission stage and to provide high-quality data for further research. Methods: We propose a multicentre, double-blinded, parallel, randomized, placebo-controlled clinical trial involving 4 study hospitals in China. A total of 72 eligible participants will be randomized into an SHP group and a placebo group. They will receive an SHP for 3 treatment sessions. The primary outcome will be changes in forced expiratory volume in 1 s after 3 treatment sessions. Secondary outcomes will include the following: (1) the Asthma Quality of Life Questionnaire, Asthma Control Test, and Asthma Long-term Follow-up Scale; (2) levels of Metallothionein-2 and Transgelin-2 in blood and urine; and (3) levels of IL-5, IL-13, IL-23, IL-25, and thymic stromal lymphopoietin in blood. Analysis of the data will be performed at baseline, at the end of the 2nd and 3rd treatment sessions, and at the 24week follow-up. The safety of the SHP will be evaluated at each treatment session. Discussion: The aims of this trial are to determine whether the SHP is more effective than placebo in the treatment of patients with bronchial asthma, as well as whether the SHP works by reducing airway inflammation and reversing bronchoconstriction.

Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial

“…The outcomes of this trial include the change in forced expiratory volume in the first second (FEV1) from the beginning of baseline to the end of 3 treatment sessions (TSs) as the primary outcome; the questionnaire survey and laboratory indicators will be secondary outcomes. Although the specific details have been explained in the published protocol [ 14 ], we briefly discuss them here.…”

“…We will screen BA participants according to rigid inclusion and exclusion standards. The specific standards have been described in detail in the published protocol [ 14 ]. Randomisation will be performed by Strategy Applications (SAS, version 9.2, SAS Institute, Inc., Cary, USA) by generating random permuted blocks.…”

“…Groups 1 and 2 will represent the SHP and placebo groups, respectively. The researcher will label the tubes “group 1” or “group 2.” Participants will receive a treatment card from the independent researcher to ensure blindness to the treatment assignment results [ 14 ]. After obtaining the consent of the participants, we will randomly assign 72 eligible subjects (1:1) to the SHP group or the placebo group, and they will receive three courses of SHP treatment or placebo treatment, respectively, and then 24 weeks of follow-up evaluation (Figs.…”

“…The operating assistants will prepare identical-looking SHP patches and placebo patches using tubes marked with the same names on the treatment cards. In addition, the acupuncturists, operating assistants and nurses will be asked not to communicate their possible assignments with the participants, and the participants will have to wait in the room for 120 minutes and remove the patches while facing away from the nurses [ 14 ].…”

“…The trial protocol was previously published [ 14 ], with additional detailed information on the trial principles, qualification criteria and intervention measures. The purpose of this statistical analysis plan is to detail and prespecify how the data collected in this trial will be used and analysed to minimise reporting deviation and make the test as transparent as possible.…”