Efficacy and safety of Kami Guibi-tang in elderly patients with insomnia and memory complaints: A randomized, double-blind, placebo-controlled trial
Poster Session E - Monday, March 31, 2025, 2:30 – 4:30 pm EDT, Back Bay Ballroom/Republic Ballroom
Seung-Yeon Cho1, Kyeonghwa Lee1, Seong-Uk Park1, Jung-Mi Park1, Chang-Nam Ko1; 1Kyung Hee University, Seoul, Republic of Korea
Introduction: Insomnia is prevalent among elderly individuals and is often associated with cognitive decline and a poor quality of life. While pharmacological treatments are available, they pose risks of dependency and adverse effects, particularly in older populations. Kami Guibi-tang (KGT), a traditional herbal medicine, may improve sleep quality and cognitive function, but its efficacy and safety in elderly patients with insomnia remain underexplored. Methods: This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of KGT in improving sleep quality, cognitive function, and quality of life in elderly patients with insomnia. Thirty-four elderly participants were randomly assigned to receive either KGT or a placebo for 12 weeks. The primary outcome was the change in Pittsburgh Sleep Quality Index-Korean (PSQI-K) scores. Secondary outcomes included the Insomnia Severity Index-Korean (ISI-K), the Seoul Neuropsychological Screening Battery-Dementia (SNSB-D), the Short-Form 36 Health Survey (SF-36), and the Short-Form Geriatric Depression Scale (S-GDS). Safety was monitored through vital signs, laboratory tests, electrocardiograms (ECGs), and reports of adverse events. Results: Both the KGT and placebo groups showed significant improvements in sleep quality (PSQI-K, ISI-K). However, the KGT group demonstrated greater cognitive gains, particularly in memory and executive function. Depression scores (S-GDS) also improved in the KGT group. No adverse events were associated with KGT. Conclusion: KGT is a potentially effective and safe treatment for improving sleep and cognition in elderly patients with insomnia. Larger studies are needed to confirm these findings and to explore the long-term effects of KGT.
Topic Area: OTHER