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Huatan Dingji Decoction intervening in atrial fibrillation: protocol for a randomized double-blind single-simulated
Ying Xiao1,2, Xinyi Wang1,2, Jin Yang1,2
1Department of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 Wanping South Road, Shanghai, 200032, China.
Insights
This study evaluates the efficacy of HTDJ, a Traditional Chinese Medicine, combined with Western medicine for atrial fibrillation. The research aims to provide evidence for integrated treatment approaches.
Area of Science:
- Integrative Medicine
- Cardiology
- Traditional Chinese Medicine (TCM)
Background:
- Atrial fibrillation (AF) is a common arrhythmia with serious health implications.
- Western medicine treatments for AF have limitations.
- Traditional Chinese Medicine (TCM) offers potential advantages in AF management, including fewer side effects and better compliance.
Purpose of the Study:
- To evaluate the efficacy and safety of HTDJ combined with Western medicine for treating atrial fibrillation (AF).
- To provide clinical evidence for the integrated use of TCM and Western medicine in AF management.
- To lay the foundation for further clinical development and application of HTDJ in AF treatment.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- Participants received either HTDJ plus Western medicine or placebo plus Western medicine for 1 month.
- Follow-up evaluations occurred at weeks 4 and 12, assessing clinical efficacy, safety, and secondary outcomes like echocardiography and quality of life surveys.
Main Results:
- This section is to be filled after the study results are available.
- The study is designed to collect data on the primary and secondary outcomes to determine the efficacy and safety of the intervention.
- Adverse events will be monitored throughout the trial.
Conclusions:
- The study will assess the short-term and medium-term clinical efficacy and safety of HTDJ plus Western medicine for AF.
- Findings are expected to support the integration of TCM and Western medicine for AF treatment.
- This research aims to provide robust medical evidence for the clinical application of HTDJ.
Background:
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and can lead to heart failure (HF), stroke, pulmonary embolism (PE), and other complications, seriously affecting people's quality of life and health. Western medicine is limited in the treatment of AF, while Traditional Chinese Medicine (TCM) has unique advantages, such as less side effects, low toxicity, long effect duration, and high compliance. The prescription of HTDJ is a common prescription for the treatment of atrial fibrillation in Longhua Hospital, Shanghai University of Traditional Chinese Medicine. It has been used for many years and has a large number of clinically effective cases. It has a good clinical application prospect, but there is a lack of effective evaluation of its clinical efficacy.
Method:
This study adopts a randomized double-blind, single-simulated, placebo-controlled research method. Participants were randomly assigned in a 1:1 ratio through a centrally controlled, computer-generated, simple randomization schedule. Participants would take the medicine for 1 month, and the curative effect would be evaluated. Subsequently, the participants would not take TCM and only receive western medicine treatment. They would be followed up for another 8 weeks, and a clinical evaluation would be conducted. The secondary outcomes include echocardiography, Hamilton Anxiety Scale, Hamilton Depression Scale, rate of increase and decrease of anti-arrhythmia western medicine, the MOS 36-item short-form health survey, N-terminal-pro hormone B-type natriuretic peptide level, and integral TCM syndrome score. Adverse events will be monitored throughout the trial. Cases are from outpatient and inpatient with atrial fibrillation in the Cardiology Department of Longhua Hospital. Evaluations will be conducted at baseline and at weeks 4 and 12 after randomization.
Discussion:
In this study, the efficacy and safety of HTDJ plus western medicine in the treatment of atrial fibrillation (qi deficiency and phlegm opacities) will be evaluated, so as to provide medical evidence of short-term and medium-term clinical efficacy for the treatment of atrial fibrillation with integrated traditional and western medicine and lay a foundation for further clinical development and application.
Trial Registration:
ClinicalTrials.gov ChiCTR2000030517 . Registered on March 5, 2020, with the Chinese Clinical Trial Registry.
