ObjectiveTo observe the
clinical efficacy of the Modified Tongmai Anshen Formula (通脉安神方加减, MTAF) in the
treatment of
stable angina pectoris (SAP) with
sleep disorders. MethodsA total of 148
patients suffering from SAP with
sleep disorder were included and randomly divided into
control group and
treatment group, with 74
patients in each group. The
control group received conventional western
medicine, and the
treatment group additionally received MTAF (1
dose per day), both for 4 weeks. The changes in
angina pectoris symptoms,
traditional Chinese medicine (TCM)
syndromes,
sleep quality,
quality of life, serological
indicators including
serum intercellular adhesion molecule-1 (
ICAM-1) and
vascular cell adhesion molecule-1 (
VCAM-1),
brain-derived
nerve growth factor (
BDNF) and
tyrosine kinase receptor B (TrkB) were compared between groups before and
after treatment, and the
safety was evaluated. ResultsIn the
treatment group and the
control group, the total effective rates of TCM
syndromes(82.43% vs 52.70%),
angina pectoris (79.73% vs 64.86%) and
sleep (89.19% vs 68.92%) showing significant difference (P<0.001).
After treatment, the total TCM
syndrome score, primary symptom score,
secondary symptom score, and
secondary symptoms
sleeplessness,
restlessness, tiredness and
fatigue individual score,
angina pectoris score, PSQI total score and each item score were all significantly reduced in both groups, while the SF-36 single item score significantly increased (P<0.05). The total TCM
syndromes and primary symptom scores, secon-dary symptoms
sleeplessness,
restlessness, tiredness and
fatigue individual score,
angina pectoris score,
time to fall asleep,
sleep quality,
hypnotic medication,
sleep disturbance, daytime dysfunction score and PSQI total score were significantly lower in the
treatment group than those in the
control group after treatment (P<0.05), while the
somatic pain,
general health status,
social functioning, emotional functioning,
mental health, and
health change were significantly higher in the
treatment group (P<0.05).
After treatment,
ICAM-1 and
VCAM-1 level significantly decreased (P<0.05), and
BDNF and TrkB levels increased (P<0.05) in the
treatment group, while
BDNF level significantly decreased in the
control group (P<0.05). The TrkB level was significantly higher in the
treatment group compared to the
control group after treatment (P<0.05). A total of four adverse events occurred during the
treatment, none of which were considered to be related to this study. ConclusionMTAF can significantly improve
angina pectoris symptoms, TCM
syndromes,
sleep quality and
quality of life in
patients suffering from SAP with
sleep disorders, the mechanism of which may be related to the
protection of vascular endothelial function and central
neurons.