[Clinical intervention research on mental stress-induced myocardial ischemia].

OBJECTIVE: To observe the impact of Xinkeshu on top of standard medication on psychological stress-related emotional and biophysiological parameters in patients with mental stress-induced myocardial ischemia (MSIMI).

METHODS: A randomized controlled clinical trial was conducted on 40 patients with MSIMI and patients were randomized into treatment group (n = 21) and control group (n = 19) by random number table method. Patients in the treatment group received Xinkeshu (12 capsules/d) on top of standard therapy, and the control group received placebo on top of standard therapy. Serum homocysteine (Hcy), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) were compared between the groups at baseline and after 8 weeks therapy.

RESULTS: (1) Baseline data were similar between the 2 groups (all P > 0.05). (2) After 8 weeks, LVFS was significantly increased (from (34.62 ± 5.76)% to (35.90 ± 4.99) %, P = 0.027) and serum Hcy (from (18.08 ± 1.81) µmol/L to (16.06 ± 10.10) µmol/L), PHQ-9 (from 8.14 ± 3.98 to 6.28 ± 2.87) and GAD-7 (from 9.52 ± 4.98 to 6.48 ± 3.84) were significantly reduced in treatment group (all P < 0.05) compared to baseline. In the control group, only GAD-7 was significantly reduced (from 8.89 ± 5.06 to 6.74 ± 4.80, P = 0.003) after 8 weeks therapy compared to baseline (P < 0.05) while other parameters remained unchanged (all P > 0.05).

CONCLUSION: Xinkeshu on the top of standard therapy can improve the emotional state and left ventricular systolic function in patients with MSIMI.