JMIR Publications

ABSTRACT

Background:

Menopausal syndrome (MPS) is a common condition caused by declining ovarian function and fluctuating estrogen levels during the menopausal transition, typically presenting with vasomotor symptoms, psychological disturbances, and metabolic abnormalities that impair quality of life in middle-aged women. Current treatments, including hormone replacement therapy and nonhormonal medications, are limited by safety concerns and adverse effects. Liuwei Dihuang (LWDH) pill is a classical multi-herb formulation in traditional Chinese medicine(TCM), widely used for kidney yin deficiency and menopausal symptoms such as hot flashes, insomnia, depression, and anxiety. Preliminary studies suggest favorable efficacy and safety; however, robust real-world evidence, particularly in combination with conventional Western therapy, remains insufficient.

Objective:

We designed this study to evaluate the real -world effectiveness and safety of LWDH in combination with conventional Western therapy for MPS.

Methods:

This prospective, multicenter, real-world, observational cohort study will be performed at eight designated centers in China from March 9,2025 to Septemper 30,2025. A total of 1000 patients with menopausal syndrome from 8 institutions in a genuine clinical setting will be allocated to either the exposure group (patients receiving LWDH treatment) or the non-exposed group (patients not receiving LWDH treatment). The main observation indicators will be changes in the Modified Kupperman Scale and sex hormone levels. The secondary outcomes encompass alterations in the Menopause Quality of Life Scale, improvement in TCM Syndrome Scale, and variations in blood glucose and lipid levels. In addition, metabolomics analyses will be conducted to explore potential mechanisms of action. Adverse events or clinically significant abnormalities in vital signs and laboratory parameters, irrespective of severity, will be documents during the trial to evaluated the safety of LWDH. Assessments will be performed at baseline, 2 weeks and 4 weeks after enrollment,with a subsequent 2-week follow-up. Propensity score–based inverse probability of treatment weighting will be applied to balance baseline covariates, with comparative analyses conducted using weighted regression models.

Results:

The recruiting and enrollment of participants began in March 2025. It is expected that by December 2026, 1,000 participants will have been recruited. At present, patient recruitment is ongoing, and preliminary organization and analysis of medical-record data are underway. Blood-sample collection for metabolomics analysis is also in progress. Final data collection is expected to be completed in March 2027. We expected to generate evidence to support clinical decision-making, with results anticipated to be published in esteemed, peer-reviewed health research journals by around December 2027.

Conclusions:

This study will assess the clinical effectiveness, safety, and potential mechanisms of LWDH in the treatment of MPS in real-world settings, providing a scientific basis for its use in clinical practice. Clinical Trial: ClinicalTrials.gov NCT06874738; https://clinicaltrials.gov/study/NCT06874738.