Clinical efficacy and safety of 16 Chinese patent medicines in combination with benzodiazepines/non-benzodiazepines for the treatment of chronic insomnia in adults: A multiple-treatment meta-analysis

Abstract

Introduction

Chronic insomnia in adults affects the health and quality of life of patients. Chinese patent medicines (CPMs) combined with benzodiazepines/non-benzodiazepines (BZDs/N-BZDs) are used frequently in routine clinical practice. However, evidence on the efficacy and safety of these combined interventions is lacking. A multiple treatment meta-analysis (MTMA) was conducted to evaluate the comparative efficacy and safety of 16 CPMs combined with BZDs/N-BZDs for the treatment of chronic insomnia in adults.

Methodology

We systematically reviewed 171 randomized controlled trials (RCTs) involving 16,874 participants (8506 in intervention groups and 8368 in control groups) from the inception of several databases to 2023. This review encompassed electronic databases, regulatory-agency websites, and international registers of published trials involving adult patients with chronic insomnia who received CPM + BZDs/N-BZDs therapies. A random-effects MTMA was undertaken using Stata/MP17, RevMan (5.3), and R. Outcome measures were the Pittsburgh Sleep Quality Index (PSQI), overall efficacy rate, as well as the incidence of dry mouth, dizziness, and somnolence.

Results

Our MTMA showed that BZD/N-BZD therapy as a co-intervention for Tianmengjiaonang (TMJN) was likely to be the optimal option for improving the PSQI (surface under the cumulative sorting curve (SUCRA) = 95.00 %), whereas shensongyangxinjiaonang (SSYXJN) had the highest probability of improving overall effectiveness (SUCRA = 88.20 %). Jiaotaiwan (JTW), Bailemian (BLMJN), and Wulinjiaonang (WLJN) had the highest probability of reducing the incidence of somnolence (SUCRA = 90.00 %), dry mouth (SUCRA = 72.90 %), and dizziness (SUCRA = 84.40 %).

Conclusions

All CPMs in combination with BZDs/N-BZDs were more efficacious and safer than using BZDs/N-BZDs alone in adults with chronic insomnia. SSYXJN + BZDs/N-BZDs and TMJN + BZDs/N-BZDs are likely to be optimal CPMs because they improve overall efficacy and sleep quality and reduce the risk of adverse effects. However, the effects of these interventions may vary from person to person. Hence, patients, carers, and clinicians should carefully consider the efficacy, safety, and risk–benefit profile of all active interventions for patients with insomnia based on real-world data.