Combination of Alprazolam and Bailemian Capsule Improves the Sleep Quality in Patients With Post-Stroke Insomnia: A Retrospective Study

When the hell will your doctor create a sleep protocol?

Combination of Alprazolam and Bailemian Capsule Improves the Sleep Quality in Patients With Post-Stroke Insomnia: A Retrospective Study

Jian Wang^1†, Zhiqiang Wang^2†, Xiaoyan Wang², Guo Du², Bo Zheng¹, Yuxia Li² and Qingsong Wang^2*

• ¹Department of Neurology, Yaan People’s Hospital, Yaan, China
• ²Department of Neurology, The General Hospital of Western Theater Command, Chengdu, China

Insomnia is often ignored in the diagnosis and treatment of patients of stroke. The present study aimed to evaluate the efficacy of alprazolam (ALP) combined with Bailemian capsule (BC, a traditional Chinese patent medicine) in the treatment of post-stroke insomnia (PSI). A total of 231 stroke patients involved in this retrospective study were treated with ALP, BC, or ALP + BC for 3 weeks. The quality of sleep was evaluated by the Pittsburgh Sleep Quality Index (PSQI) and polysomnography (PSG), while self-care ability was monitored by the modified Rankin Scale (mRS) before and after treatment. Compared with the baseline, the self-care ability of patients in each group was significantly improved after treatment (P < 0.01). The PSQI data showed a significant improvement in all patients in all of the subjective PSQI items and global score (P < 0.05). Notably, ALP + BC administration had a significantly greater effect on sleep latency, quality, disturbance, and efficiency, as well as daytime dysfunction and global PSQI than the use of ALP or BC alone (P < 0.05). The PSG data showed that ALP significantly improved the sleep efficiency and decreased the arousal times, rapid eye movement (REM) sleep, and sleep latency (P < 0.05), while BC significantly improved the sleep efficiency, total sleep time, and the duration of N3 (P < 0.05). Strikingly, ALP + BC achieved the effect of both ALP and BC (P < 0.05). Importantly, the effect of the combination of ALP and BC was greater than the use of ALP or BC alone, which was consistent with the result of PSQI. In conclusion, the sleep quality and self-care ability of patients with PSI were improved by ALP and BC, thereby supporting the potential advantages of ALP combined with BC in the treatment of patients with PSI.

Introduction

Stroke is the second most common cause of deaths worldwide (1) as well as the leading cause of long-term disability (2, 3). Post-stroke insomnia (PSI) is a common symptom but often underestimated and is even ignored in the diagnosis and treatment (4). Up to 70% of the patients with acute stroke have sleep disorders including excessive daytime sleepiness, insomnia, hypersomnia, and fatigue (5). PSI affects the functional recovery of the nervous system, aggravates the existing diseases such as hypertension and diabetes, and deteriorates the quality of life (6). Accumulating evidence demonstrated that poor quality of sleep could be detrimental to the immune system (7), delay the recovery (8), increase pain sensitivity (9), lead to depression and anxiety (10), and affect the functional well-being (11). Although the consequences of PSI and the potential clinical impact are severe, the condition is not well treated.

Reportedly, alprazolam (ALP) was the most commonly used Western drug in China due to its effectiveness on generalized anxiety, panic attacks with or without agoraphobia, and depression (12). ALP is a derivative of benzodiazepine, and the mechanism underlying the activity of the drug and the side effects have been described previously (13). Notably, ALP presents excessive side effects when more than 0.5 mg was used each time (14).

Drugs for stroke from traditional Chinese medicine have been developed (15, 16). According to clinical and basic research in traditional Chinese medicine, these drugs were beneficial in the prevention and treatment of stroke. BC is a traditional Chinese patent medicine. It can improve sleep quality and alleviate insomnia by elevating the level of brain contents 5-HT and GABA (17, 18). Previous studies have shown that sleep disorders were closely related to the decreased content of 5-HT and gamma-aminobutyric acid (GABA) in the central nervous system (19). The data were monitored, which showed that this drug might cause nausea, abdominal pain, rash, and itching. Despite mild adverse reactions, BC can alleviate PSI and anxiety, resulting in the improvement of life quality (20).

In this retrospective study, we evaluated the effect of BC, ALP, and BC combined with ALP on sleep quality and stroke outcome (self-care ability) in PSI patients.