Objective: To evaluate the efficacy of Tongyang Fumai decoction (, TYFM) on the quality of life (QOL) as a complementary therapy for sick sinus syndrome (SSS).
Methods: This randomized controlled study involved 224 patients with symptomatic SSS. Patients were randomly assigned to either the TYFM group or the control group (receiving theophylline sustained-release tablets). The primary endpoints included changes in average heart rate, the longest R to R (RR) interval, and the occurrences of long RR intervals. Secondary endpoints comprised the Short Form (SF)-36 questionnaires, the Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS).
Results: TYFM significantly improved average heart rate (TYFM: 6 bpm vs control: 3 bpm, P < 0.01), shortened longest RR interval (TYFM: －0.20 s vs control: －0.0027 s, P < 0.05), and reduced numbers of long RR (TYFM: －99 vs control: －59, P < 0.01). In SF-36, TYFM enhanced physical and mental components (P < 0.01), outperforming the control group. TYFM also improved eight SF-36 dimensions significantly (P < 0.05 or P < 0.01). Regarding SAS and SDS, TYFM reduced scores significantly (P < 0.01), while SAS improved in the control group (P < 0.01), with no change in SDS. Statistically significant differences (P < 0.01) were observed in SAS and SDS between TYFM and control groups post-intervention.
Conclusions: TYFM emerges as a promising alternative strategy for treating SSS, demonstrating favorable therapeutic effects and significant improvements in the quality of life for patients with SSS.
Keywords: Tongyang Fumai decoction; quality of life; randomized controlled trial; sick sinus syndrome; treatment outcome.