Effect of Qingxuan Granule () on blood pressure variability of hypertensive patients with and without obstructive sleep apnea.

Objective: To observe the effect of Qingxuan Granule () on blood pressure variability of hypertensive patients with and without obstructive sleep apnea (OSA).

Methods: This study was a stratified, randomized, doubled-blind, placebo-controlled clinical trial. Ninety mild and moderate hypertensive patients with yin deficiency and yang hyperactivity syndrome were enrolled. Each patient received portable sleep monitoring for OSA diagnosis and 24-h ambulatory blood pressure monitoring (ABPM) for blood pressure diagnosis. According to the OSA diagnosis, the hypertensive patients were assigned to two subgroups, one with OSA (group A), the other without OSA (group B); and in each subgroup, the patients were randomly assigned to the treatment group (group A1 or group B1) and control group (group A2 or group B2). All of the patients were treated by Amlodpine Besylate, in addition, Qingxuan Granule was given to the treatment group (group A1 or group B1), and placebo was given to the control group (group A2 or group B2), respectively. After a 2-month treatment, each patient received portable sleep monitoring and 24-h ABPM again, the difference (D-value) of the blood pressure, and OSA index between pre-treatment and post-treatment were analyzed by covariance analysis in a generalized linear model. In this model, D-value was accepted as dependent variable Y, which was affected by treatment method (considered as factor a), the base level of all indices before treatment (considered as factor b), and OSA condition (considered as factor c).

Results: The following indices declined more in total treatment groups (groups A1+B1) than in total control groups (groups A2+B2, P <0.05): 24-h systolic blood pressure (SBP) standard deviation (SD), daytime SBP SD, night time SBP SD, 24-h diastolic blood pressure (DBP) SD, 24-h DBP coefficient variation (CV), daytime DBP SD, night time DBP SD, and heart rate; the following indices declined less in the patients with OSA than those without OSA (P <0.05): night time SBP, 24-h SBP SD, daytime SBP SD, night time SBP SD, 24-h DBP SD, 24-h DBP CV, daytime DBP SD, night time DBP SD, night time DBP CV, and heart rate; and the following indices increased less in the patients with OSA than those without OSA (P <0.05): night time SBP fall rate, night time DBP fall rate. No significant difference was found in OSA' indices after taking Qingxuan Granule (P>0.05), with the exception that hypopnea index decreased and hypopnea improved (P<0.05).

Conclusions: For hypertensive patients, Qingxuan Granule could improve the blood pressure variability, and this effect could be weakened by OSA; also Qingxuan Granule could improve hypopnea in OSA patients.