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

doi:10.19852/j.cnki.jtcm.2024.06.010

Abstract

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

WU Qiaomin, GUAN Xuanke, LIU Jinfeng, WANG Yanli, CHANG Xing, LIU Zhiming, LIU Ruxiu. 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.

Figures/Tables 5

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Characteristic	Control group (n = 112)	TYFM group (n = 112)	P value
Age (years)	63.05±12.01	61.95±11.09	0.477^a
Male [n (%)]	35 (31.25)	49 (43.75)	0.053^b
Course of SSS (years)	6.64±8.09	6.86±8.69	0.950^a
Body temperature (℃)	36.26±0.22	36.22±0.20	0.194^a
Respiratory rate (breaths/min)	17.86±1.51	18.71±6.53	0.177^a
Heart rate (beats/min)	54.60±9.48	53.04±6.94	0.161^a
Longest RR interval (s)	1.95±0.53	2.02±0.54	0.327^a
Number of long RR during 24 h	190.55±687.97	136.98±431.68	0.486^a
Hypertension [n (%)]	55 (49.1)	51 (45.5)	0.688^b
Ischemic heart disease [n (%)]	22 (19.6)	25 (22.3)	0.743^b
Dyslipidemia [n (%)]	45 (40.2)	37 (33.0)	0.332^b
Diabetes [n (%)]	19 (17.0)	9 (8.0)	0.069^b

Characteristic	Control group (n = 112)	TYFM group (n = 112)	P value
Age (years)	63.05±12.01	61.95±11.09	0.477^a
Male [n (%)]	35 (31.25)	49 (43.75)	0.053^b
Course of SSS (years)	6.64±8.09	6.86±8.69	0.950^a
Body temperature (℃)	36.26±0.22	36.22±0.20	0.194^a
Respiratory rate (breaths/min)	17.86±1.51	18.71±6.53	0.177^a
Heart rate (beats/min)	54.60±9.48	53.04±6.94	0.161^a
Longest RR interval (s)	1.95±0.53	2.02±0.54	0.327^a
Number of long RR during 24 h	190.55±687.97	136.98±431.68	0.486^a
Hypertension [n (%)]	55 (49.1)	51 (45.5)	0.688^b
Ischemic heart disease [n (%)]	22 (19.6)	25 (22.3)	0.743^b
Dyslipidemia [n (%)]	45 (40.2)	37 (33.0)	0.332^b
Diabetes [n (%)]	19 (17.0)	9 (8.0)	0.069^b

Item	Control group (n = 95)			TYFM group (n = 103)			P value
Item	Baseline	Week 4	Difference (95% CI)	Baseline	Week 4	Difference (95% CI)	P value
PF	45±10	46±9	1.5 (－0.2, 3.1)	46±9	50±7^a	5 (3, 6)	0.001
RP	33±21	44±20^a	12 (7, 16)	34±23	55±12^a	20 (16, 25)	<0.001
BP	46±7	49±7^a	3 (1, 4)	47±7	54±7^a	8 (6, 9)	<0.001
GH	36±12	36±11	－0.7 (－3, 1.7)	37±11	45±10^a	8(6, 10)	<0.001
VT	52±9	54±9^b	2.1 (0.4, 3.8)	51±9	58±7^a	7 (5, 9)	<0.001
SF	53±11	56±11^a	3 (1, 5)	54±9	62±7^a	8 (6, 10)	<0.001
RE	42±24	49±20^a	7 (2, 12)	45±22	56±10^a	12 (7, 16)	0.002
MH	51±9	52±10	1.3 (－0.3, 3.0)	49±11	55±9^a	6 (6, 7)	0.024
PCS	39±10	44±10^a	4 (2, 6)	41±10	51±6^a	10 (8, 12)	<0.001
MCS	52±13	54±12	2.3 (－0.3, 4.8)	52±14	58±8^a	6 (4, 8)	0.014

Item	Control group (n = 95)			TYFM group (n = 103)			P value
Item	Baseline	Week 4	Difference (95% CI)	Baseline	Week 4	Difference (95% CI)	P value
PF	45±10	46±9	1.5 (－0.2, 3.1)	46±9	50±7^a	5 (3, 6)	0.001
RP	33±21	44±20^a	12 (7, 16)	34±23	55±12^a	20 (16, 25)	<0.001
BP	46±7	49±7^a	3 (1, 4)	47±7	54±7^a	8 (6, 9)	<0.001
GH	36±12	36±11	－0.7 (－3, 1.7)	37±11	45±10^a	8(6, 10)	<0.001
VT	52±9	54±9^b	2.1 (0.4, 3.8)	51±9	58±7^a	7 (5, 9)	<0.001
SF	53±11	56±11^a	3 (1, 5)	54±9	62±7^a	8 (6, 10)	<0.001
RE	42±24	49±20^a	7 (2, 12)	45±22	56±10^a	12 (7, 16)	0.002
MH	51±9	52±10	1.3 (－0.3, 3.0)	49±11	55±9^a	6 (6, 7)	0.024
PCS	39±10	44±10^a	4 (2, 6)	41±10	51±6^a	10 (8, 12)	<0.001
MCS	52±13	54±12	2.3 (－0.3, 4.8)	52±14	58±8^a	6 (4, 8)	0.014

Item	Control group (n = 95)			TYFM group (n = 103)			P value
Item	Baseline	Week 4	Difference (95% CI)	Baseline	Week 4	Difference (95% CI)	P value
SAS	42±9	38±9^a	5 (3-6)	43±9	32±8^a	11 (10-13)	< 0.001
SDS	41±11	39±10	2 (0-3)	43±11	34±9^a	9 (8-11)	< 0.001

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