Efficacy and safety of commercial Chinese polyherbal preparations combined with biomedicine for elderly patients with primary insomnia: a systematic review and meta-analysis of randomized controlled trials
4 affiliations
- 1Department of Traditional Chinese Medicine, School of Changchun University of Chinese Medicine
- 2Department of Graduate Student Administration Office, Affiliated Hospital of Changchun University of Chinese Medicine
- 3Department of Neurology, Affiliated Hospital of Changchun University of Chinese Medicine
- 4Department of Rehabilitation, Nanguan District Hospital of Traditional Chinese Medicine
Abstract
Introduction: The prevalence of primary insomnia among the elderly is steadily increasing; however, robust evidence supporting the efficacy and safety of combining commercial Chinese polyherbal preparations (CCPPs) with biomedicine therapy remains insufficient. This study aimed to systematically evaluate the efficacy and safety of CCPPs combined with biomedicine versus biomedicine therapy for primary insomnia in elderly patients, and to assess the certainty of the evidence via the GRADE framework and P-curve analysis.
Methods: Seven biomedical databases were searched (before November 2025) for randomized controlled trials (RCTs) involving elderly patients with primary insomnia. Risk of bias was assessed using Cochrane RoB 2 by two researchers independently. Meta-analysis was performed using R software. Outcomes included Pittsburgh Sleep Quality Index (PSQI), total clinical effectiveness rate, Sleep Dysfunction Rating Scale (SDRS), and adverse events. Robustness was evaluated via sensitivity, subgroup, and P-curve analyses.
Results: Meta-analysis suggested that combined therapy was associated with a lower PSQI score (MD = −2.09, 95% CI -2.62 to −1.57) and higher total clinical effectiveness rate (RR = 1.21, 95% CI 1.15–1.27) relative to monotherapy. The combination group also showed a lower risk of adverse events (RR = 0.47, 95% CI 0.36–0.61). However, P-curve analysis revealed notable discrepancies across outcomes: PSQI exhibited sufficient evidential value (Power = 99%), whereas the total clinical effectiveness rate lacked adequate evidential value (Power = 9%), implying potential publication bias. Subgroup analyses showed that heterogeneity decreased within the subgroup of patients with disease duration <1 year, although the between-subgroup difference did not reach statistical significance. The certainty of evidence was rated as “Moderate” for adverse events but “Low” to “Very Low” for efficacy outcomes.
Conclusion: In elderly patients with primary insomnia, combined treatment of CCPPs and biomedicine may help improve sleep quality and may reduce adverse events reported in clinical trials. However, due to methodological limitations, high heterogeneity and potential publication bias among the included trials, the certainty of the available evidence remains limited. Given insufficient evidential value, the reliability of the total clinical effectiveness rate is questionable, and clinicians should place greater emphasis on outcomes assessed using validated scales such as the Pittsburgh Sleep Quality Index (PSQI). Further large-scale, multicenter, double-blind, placebo-controlled randomized controlled trials (RCTs) are needed to further verify these preliminary findings.
Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251186213 , identifier: CRD420251186213.
Related
- The efficacy and safety of combining different commercial Chinese polyherbal preparations with conventional Western drugs in the treatment of diabetic osteoporosis: a network meta-analysis
- Clinical Evidence of Orally Administered Herbal Preparations for Supportive Cancer Care: A PRISMA Systematic Review of Randomized Clinical Trials (1990–2026)
- Commercial Goat Cheeses Show No Differences in Postprandial Satiety During Caloric Restriction: A Randomized Controlled Pilot Trial
- Berberine and Berberine-Containing Alkaloid Preparations in Preclinical Models of Endometriosis and Adenomyosis: A Systematic Review
- Efficacy of Epimedii Folium and related preparations in experimental osteoporosis: a systematic review and meta-analysis
BibTeX
@article{wu2026efficacy,
title = {{Efficacy and safety of commercial Chinese polyherbal preparations combined with biomedicine for elderly patients with primary insomnia: a systematic review and meta-analysis of randomized controlled trials}},
author = {Yang Wu and Fang Liu and Mengqi Shi and Lan Yu and Ying Zhang and Huijing Cui and Ruonan Zhang and Peng Xu and Hongmei Nan},
journal = {Frontiers in Pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1841014},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1841014/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Efficacy and safety of commercial Chinese polyherbal preparations combined with biomedicine for elderly patients with primary insomnia: a systematic review and meta-analysis of randomized controlled trials
AU - Yang Wu
AU - Fang Liu
AU - Mengqi Shi
AU - Lan Yu
AU - Ying Zhang
AU - Huijing Cui
AU - Ruonan Zhang
AU - Peng Xu
AU - Hongmei Nan
PY - 2026
DA - 2026/10/23
JO - Frontiers in Pharmacology
DO - 10.3389/fphar.2026.1841014
UR - https://www.frontiersin.org/articles/10.3389/fphar.2026.1841014/full
AB - Introduction: The prevalence of primary insomnia among the elderly is steadily increasing; however, robust evidence supporting the efficacy and safety of combining commercial Chinese polyherbal preparations (CCPPs) with biomedicine therapy remains insufficient. This study aimed to systematically evaluate the efficacy and safety of CCPPs combined with biomedicine versus biomedicine therapy for primary insomnia in elderly patients, and to assess the certainty of the evidence via the GRADE framework and P-curve analysis. Methods: Seven biomedical databases were searched (before November 2025) for randomized controlled trials (RCTs) involving elderly patients with primary insomnia. Risk of bias was assessed using Cochrane RoB 2 by two researchers independently. Meta-analysis was performed using R software. Outcomes included Pittsburgh Sleep Quality Index (PSQI), total clinical effectiveness rate, Sleep Dysfunction Rating Scale (SDRS), and adverse events. Robustness was evaluated via sensitivity, subgroup, and P-curve analyses. Results: Meta-analysis suggested that combined therapy was associated with a lower PSQI score (MD = −2.09, 95% CI -2.62 to −1.57) and higher total clinical effectiveness rate (RR = 1.21, 95% CI 1.15–1.27) relative to monotherapy. The combination group also showed a lower risk of adverse events (RR = 0.47, 95% CI 0.36–0.61). However, P-curve analysis revealed notable discrepancies across outcomes: PSQI exhibited sufficient evidential value (Power = 99%), whereas the total clinical effectiveness rate lacked adequate evidential value (Power = 9%), implying potential publication bias. Subgroup analyses showed that heterogeneity decreased within the subgroup of patients with disease duration <1 year, although the between-subgroup difference did not reach statistical significance. The certainty of evidence was rated as “Moderate” for adverse events but “Low” to “Very Low” for efficacy outcomes. Conclusion: In elderly patients with primary insomnia, combined treatment of CCPPs and biomedicine may help improve sleep quality and may reduce adverse events reported in clinical trials. However, due to methodological limitations, high heterogeneity and potential publication bias among the included trials, the certainty of the available evidence remains limited. Given insufficient evidential value, the reliability of the total clinical effectiveness rate is questionable, and clinicians should place greater emphasis on outcomes assessed using validated scales such as the Pittsburgh Sleep Quality Index (PSQI). Further large-scale, multicenter, double-blind, placebo-controlled randomized controlled trials (RCTs) are needed to further verify these preliminary findings. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251186213 , identifier: CRD420251186213.
SN - 1663-9812
ER -