Modified Suanzaoren decoction in treating post-stroke cognitive impairment with comorbid insomnia symptoms: A clinical trial

Abstract

Background: Cognitive impairment and insomnia are common complications for stroke patients, and often coexist without effective therapy. Modified Suanzaoren decoction (M-SZRD), derived from a famous classic prescription, has been used as an alternative treatment for these patients. The objective of this study is to investigate the effectiveness of M-SZRD in treating post-stroke cognitive impairment with comorbid insomnia symptoms. Methods: A total of 80 participants were randomly assigned into 2 groups to 40 cases in the treatment group (treated with modified Suanzaoren decoction) and 40 cases in the control group (treated with zolpidem). The intervention period was 4 weeks. Cognitive function, sleep quality, depression, and anxiety disorders were evaluated in both groups before and after treatment. Clinical assessment of patients with stroke included National Institutes of Health Stroke Scale and Barthel Index evaluations. Hormone levels of the hypothalamic-pituitary-adrenal and hypothalamus-pituitary-thyroid axis were also measured. Results: Out of the total 80 participants, 5 withdrew during the experiment and did not complete the study, leaving 75 patients for analysis to 38 in the treatment group and 37 in the control group. The findings showed that M-SZRD was more effective than the control group in improving cognitive function (P = .006). However, both groups were found to have a similar effect in improving insomnia (P = .323). There was no significant difference between the 2 groups in terms of activities of daily living and National Institutes of Health Stroke Scale improvement. M-SZRD was superior to the control group in improving depression state (P = .034), but when including dropouts in the intention-to-treat analysis, the difference was not statistically significant (P = .150). Furthermore, the M-SZRD group was better than the control group in reducing cortisol levels (P = .036), and the improvement in serum-free triiodothyronine (FT3) levels was also more significant in the M-SZRD group than in the control group (P = .0007). Conclusion: M-SZRD is a more effective treatment for improving cognitive function in patients with post-stroke cognitive impairment and comorbid insomnia symptoms, possibly by regulating the cortisol levels of the hypothalamic-pituitary-adrenal axis and FT3 levels of the hypothalamus-pituitary-thyroid axis.