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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Therapeutic Efficacy of Shexiang Baoxin Pill Combined with Exercise in Patients with Heart Failure with Preserved Ejection Fraction: A Single-Center, Double-Blind, Randomized Controlled Trial.

  • 2022-12-09
  • Chinese journal of integrative medicine 29(2)
    • Si-Pei Liu
    • Jian-Guan Zhou
    • Yan Jin
    • Yan Guo
    • Shi-Wei Zhou
    • Mei-Lan Lin
    • Jun Zhang
    • Xiao-Nv Wang
    • Xia-Fei Guan
    • Lei Wang

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 20
Population
60 patients with HFpEF
Methods
Patients were randomly divided into three groups: group A received Shexiang Baoxin Pill combined with home-based exercise training plus conventional drugs; group B received conventional drugs plus home-based exercise training; group C received conventional drugs only. Intervention lasted 12 weeks.
Duration
12 weeks

Objective

To evaluate the therapeutic efficacy of Shexiang Baoxin Pill combined with exercise in heart failure patients with preserved ejection fraction (HFpEF).

Methods

Sixty patients with HFpEF were randomly divided into group A (n=20), receiving Shexiang Baoxin Pill combined with home-based exercise training based on conventional drugs for 12 weeks; group B (n=20), receiving conventional drugs combined with home-based exercise training for 12 weeks; and group C (n=20), receiving conventional drug treatment only. Peak oxygen uptake (peakVO2), anaerobic threshold (AT), 6-min walking test (6MWT), Pittsburgh Sleep Quality Index (PSQI), and SF-36 questionnaire (SF-36) results before and after treatment were compared among groups.

Results

After the 12-week intervention, patients in group C showed significant declines in peakVO2, AT, 6MWT, PSQI, and SF-36 compared with pre-treatment (P<0.01), while groups A and B both showed significant improvements in peakVO2, AT, 6MWT, PSQI, and SF-36 results compared with pre-treatment (P<0.01). Compared with group C, patients in groups A and B showed significant improvements in peakVO2, AT, 6MWT, PSQI, and SF-36 (P<0.01). In addition, patients in group A showed more significant improvements in physical function, role-physical, vitality, and mental health scores on the SF-36 questionnaire, and PSQI scores than those in group B (P<0.01).

Conclusions

Exercise training improved exercise tolerance, sleep quality and quality of life (QoL) in patients with HFpEF. Notably, Shexiang Baoxin Pill played an active role in sleep quality and QoL of patients with HFpEF. (The trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2100054322)).

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