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Journal of Traditional Chinese Medicine >

2024 , Vol. 44 >Issue 6: 1247 - 1253

DOI: https://doi.org/10.19852/j.cnki.jtcm.2024.06.010

Research Articles

Compound Tongyang Fumai decoction (通阳复脉方) improves quality of life in sick sinus syndrome: a randomized controlled study

  • Qiaomin WU ,
  • Xuanke GUAN ,
  • Jinfeng LIU ,
  • Yanli WANG ,
  • Xing CHANG ,
  • Zhiming LIU ,
  • Ruxiu LIU
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  • Cardiovascular Department, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China

Received date: 2023-01-11

  Accepted date: 2023-04-10

  Online published: 2024-11-12

Supported by

Beijing Clinical Application Research Project: Evaluation of the Therapeutic Efficacy of Tongyang Huoxue Decoction based on the Heart-Kidney Simultaneous Treatment for Sick Sinus Syndrome(Z181100001718184);Academic Inheritance and Communication Project of China Academy of Chinese Medical Sciences: Academic Experience Inheritance of Liu Zhiming(CI2022E012XB);High Level Chinese Medical Hospital Promotion Project: In-Hospital Pharmaceutical Preparation based on the Experience of Renowned Traditional Chinese Medicine Physicians(HLCMHPP2023053);Fundamental Research Funds for the Central Public Welfare Research Institutes: Mechanism of 'Kidney Tonifying, Yang Activating, and Blood Circulating' Chinese Medicine in Improving Sinoatrial Node Injury Under Hypoxic Stress(ZZ17-XRZ-028)

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Abstract

OBJECTIVE: To evaluate the efficacy of Tongyang Fumai decoction (通阳复脉方, 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.

Key words： sick sinus syndrome; treatment outcome; quality of life; randomized controlled trial; Tongyang Fumai decoction

Cite this article

Qiaomin WU , Xuanke GUAN , Jinfeng LIU , Yanli WANG , Xing CHANG , Zhiming LIU , Ruxiu LIU . Compound Tongyang Fumai decoction (通阳复脉方) improves quality of life in sick sinus syndrome: a randomized controlled study[J]. Journal of Traditional Chinese Medicine, 2024 , 44(6) : 1247 -1253 . DOI: 10.19852/j.cnki.jtcm.2024.06.010

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