Self-Designed Ningxin Anshen Formula for Treatment of Post-ischemic Stroke Insomnia: A Randomized Controlled Trial

Ning Dai; Yuanyuan Li; Jing Sun; Feng Li; Hang Xiong

doi:10.3389/fneur.2020.537402

Self-Designed Ningxin Anshen Formula for Treatment of Post-ischemic Stroke Insomnia: A Randomized Controlled Trial

Front Neurol. 2020 Nov 9:11:537402. doi: 10.3389/fneur.2020.537402. eCollection 2020.

Authors

Ning Dai¹, Yuanyuan Li², Jing Sun³, Feng Li¹, Hang Xiong³

Affiliations

¹ College of Traditional Chinese Medicine, Beijing University of Traditional Chinese Medicine (TCM), Beijing, China.
² Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Traditional Chinese Medicine (TCM), Beijing, China.
³ Department of Medical Neurology, Tongzhou District of Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine (TCM), Beijing, China.

Abstract

This study aimed to assess the efficacy and safety of self-designed Ningxin Anshen (NXAS) Formula for post-ischemic stroke insomnia of blood-deficient and liver-heat syndrome. Ninety patients were randomized into NXAS group, Placebo group and Zopiclone group. Patients in the NXAS group, Placebo group and Zopiclone group were treated with Ningxin Anshen Formula, placebo and zopiclone for 4 weeks, respectively. The scores of the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and traditional Chinese Medicine (TCM) Syndromes of self-designed scale and the number of adverse events (AEs) were determined. Results showed that the overall effective rate in the NXAS group and Placebo group was 76.67 and 30.00%, respectively, showing significant difference (P < 0.01). There was no marked difference between Zopiclone group (80.00%) and NXAS group. In both NXAS group and Zopiclone group, the scores of PSQI, ISI, and TCM Syndromes of self-designed scale after 4-week treatment were significantly different from those before treatment (P < 0.01). After 4-week treatment, the scores of PSQI, ISI, and TCM Syndromes of self-designed score were comparable between NXAS group and Zopiclone group (P > 0.05). Only one patient in the NXAS group developed gastrointestinal discomfort, which resolved without treatment discontinuation. In conclusion, self-designed NXAS Formula is effective and safe and has little adverse effect in treating post-stroke insomnia of blood-deficient and liver-heat syndrome.

Keywords: Insomnia Severity Index; Ningxin Anshen Formula; Pittsburgh Sleep Quality Index; post-stroke insomnia; randomized controlled trial.