Efficacy of Hawthorn fruit extract on blood pressure and quality of sleep in patients with hypertension along with sleep disorders: A randomized double-blind controlled trial

Objective: This study aimed to investigate the effect of Crataegus monogyna (C.monogyna) on controlling the blood pressure in patients with hypertension along with sleep disorder. Methods: This was a parallel double-blind, placebo-controlled trial study from May, 2018 to December, 2019. Total of 60 patients with hypertension and sleep disorder were randomly assigned to C.monogyna and placebo groups. The groups received C.monogyna and placebo capsules twice-daily for 8 weeks. The primary outcomes were the changes of systolic and diastolic blood pressure and Pittsburgh questionnaire’s scores from baseline measurements. The secondary outcomes were changes in serum biochemical markers from baseline. Results: Before treatment, there was no significant difference between study groups in terms of demographic data and outcomes (P>0.05) except body mass index (P=0.02). After treatments, the intervention group had a significant improvement in systolic and diastolic blood pressure compared to placebo ((118.14±6.76 vs 129.76±8.28, 95% CI: 7.54 – 15.69, P<0.001 and 77.14±5.32 vs 83.57±6.73, 95% CI: 3.17 – 9.68, P<0.001, respectively) analysis revealed no significant difference observed between study groups in terms of baseline characteristics and pre-and posttreatment laboratory tests. Also, none of the groups had superiority in terms of the Pittsburgh questionnaire’s scores (P=0.44); however, the intragroup analysis revealed significant improvements in the intervention group (P= 0.001). Conclusion: C.monogyna fruit extract as a supplementary medication has beneficial effects on controlling blood pressure and quality of sleep in patients with hypertension along with sleep disorders.