Anshen Buxin Liuwei Pill for the treatment of cardiac neurosis (heyisheng-type palpitation): a randomized, double-blind clinical trial.

BACKGROUND: Cardiac neurosis is a common functional cardiovascular disorder in clinical practice worldwide, and its clinical harm cannot be ignored. A randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy and safety of Anshen Buxin Liuwei Pill in the treatment of patients with clinical symptoms of cardiac neurosis (heyisheng-type palpitation). Guided by traditional Mongolian medical theories, this study takes clinical symptom improvement of cardiac neurosis (excessive Hey pattern palpitation) as the primary endpoint evaluated by the corresponding Mongolian medicine scale. Secondary outcomes cover Anshen Buxin Liuwei Pills' effects on concomitant anxiety, depression and insomnia as well as its safety. The study intends to clarify the drug's clinical value and advantages, generate clinical evidence for treating cardiac neurosis under Mongolian medicine system, and promote its application in cardiovascular care. METHODS: This randomized, double blind, placebo controlled clinical trial enrolled 200 patients diagnosed with cardiac neurosis between June 2021 and December 2022. Participants were randomly assigned at a 1:1 ratio into either a Anshen Buxin Liuwei Pill treatment group or a placebo control group via stratified block randomization. Both groups received continuous intervention for 8 weeks and were followed up until the 12th week. For quantitative data conforming to a normal distribution, the t-test or Wilcoxon rank-sum test was applied. Categorical data were analyzed with the Chi-squared test, Fisher exact test, Wilcoxon rank-sum test, and the Cochran-Mantel-Haenszel test. RESULTS: A total of 182 participants (91 per group) were enrolled. Baseline characteristics including demographics, cardiac neurosis-related scales, high-sensitivity C-reactive protein (hs-CRP) and 5-hydroxytryptamine (5-HT) were comparable between groups (all P>0.05). Nine patients withdrew in each group. The intervention group had seven voluntary withdrawals, one aggravated cerebral infarction and one loss to follow-up; the control group had eight voluntary withdrawals and one dropout related to hypertension adverse event. Anshen Buxin Liuwei Pill yielded short-term improvements in Cardiac Neurosis Self-Rating Scale, with longer-term benefits in anxiety, depression and sleep quality. At week 8, the effective rate for heyisheng-type palpitations was 83.00% (95% CI: 75.32-90.68%) in the experimental group versus 34.80% (95% CI: 25.07-44.53%) in controls, a between-group difference of 48.20% (95% CI: 36.05-60.35%). The experimental group achieved significantly better symptom, mood and sleep scores at weeks 2, 8 and 12. No significant intergroup differences were found in hs-CRP and 5-HT throughout follow-up. CONCLUSIONS: This study confirmed that Anshen Buxin Liuwei Pill can effectively treat cardiac neurosis, alleviate depression and anxiety, and ameliorate sleep disorders. Moreover, the drug exhibited a favorable safety profile for clinical application. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100044412.