Medicine · 5 authors, 3 centres
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This randomized controlled trial compared modified Suanzaoren decoction to zolpidem in 80 post-stroke patients with cognitive impairment and insomnia. The results show that M-SZRD was superior to zolpidem in improving cognitive function after 4 weeks of treatment, while both treatments were similarly effective for improving insomnia.
Participants were assigned to receive either modified Suanzaoren decoction (n=38) or zolpidem (n=37). Both groups showed similar significant improvements in insomnia symptoms (P = .323). M-SZRD also showed a statistically significant advantage in reducing cortisol levels (P = .036) and improving free triiodothyronine (FT3) levels (P = .0007). The study found no significant between-group differences in activities of daily living or stroke severity (NIHSS) improvement. While M-SZRD was superior for depression in the per-protocol analysis (P = .034), this difference was not significant in the intention-to-treat analysis (P = .150). Safety was acceptable, with mild adverse events (diarrhea in the M-SZRD group, daytime fatigue in the zolpidem group). Limitations include the short 4-week duration, small sample size, and lack of blinding.
