| 英文摘要 |
Among the most prevalent sleep disorders, insomnia compromise quality of life while maintaining bidirectional causal relationships with anxiety, depression, and cardiometabolic disease. Because public recognition of insomnia as a clinical disorder remains limited, and because concerns persist regarding the adverse effects and dependence liability of hypnotics, nutritional supplements marketed as natural and harmless have emerged as a popular alternative. International evidence-based guidelines, however, remain broadly reserved toward nutritional interventions for insomnia. The 2017 American Academy of Sleep Medicine guideline explicitly recommends against melatonin, tryptophan, and valerian for the treatment of insomnia. The 2023 European guideline, despite examining a wider range of herbal and compound traditional Chinese medicine preparations, likewise withheld recommendation on the basis of pervasive methodological shortcomings. Indeed, most commercially available products are multi-ingredient formulations that are seldom validated as end products. Even where trials exist, the most frequently cited limitations include imprecise inclusion criteria, outcome assessment weighted toward subjective questionnaires with a corresponding lack of objective data, insufficient sample sizes and trial durations, and the frequent under-reporting of adverse events. Because natural compounds also lack patent protection, research funding is constrained and replication is difficult to achieve. Objectively, therefore, nutritional interventions for insomnia cannot be deemed ineffective; rather, robust evidence of efficacy is not yet available. Yet the factors driving patients' treatment choices extend beyond efficacy and are not wholly grounded in objective evidence. Prior research indicates that users of complementary and alternative medicine are predominantly middle-aged individuals of higher educational and income status, particularly those who endorse holistic conceptions of health and seek to address the root cause of their condition. The authors' recently completed randomized controlled trial of banana peel extract was designed to address the methodological deficiencies outlined above and to contribute more rigorous evidence. Beyond scientific considerations, the regulatory framework constitutes a further determinant. The most recent American Academy of Sleep Medicine guideline now includes combined cognitive behavioral therapy for insomnia and pharmacotherapy as a conditional recommendation, reflecting a shift from adjudicating the relative superiority of pharmacological versus non-pharmacological approaches toward personalized integration. If future work can accumulate evidence through more rigorous designs incorporating biomarkers alongside both subjective and objective assessment, with concurrent regulatory adaptation, nutritional interventions may secure a legitimate place in the clinical management of insomnia—one that honors both scientific evidence and patients' autonomous preferences and psychological needs. |