JMIR Publications

ABSTRACT

Background:

Background:

Liuwei Dihuang (LWDH) pill, an adaptation of Chinese herbal medicine, is commonly employed to alleviate menopausal symptoms. Experimental and randomized controlled trials indicated that LWDH pill was advantageous for patients with menopausal syndrome (MPS). However, the pertinent scientific evidence of LWDH in the real clinical practice remains insufficient.To systematically evaluate the effectiveness and safety of LWDH pill in the treatment of MPS under real-world clinical conditions, thereby providing high-quality evidence for rational clinical use.

Objective:

Objective:

To systematically evaluate the effectiveness and safety of LWDH pill in the treatment of MPS under real-world clinical conditions, thereby providing high-quality evidence for rational clinical use.

Methods:

Methods:

This prospective, multicenter, real-world, observational cohort study will be performed at six designated centers in China from March 9,2025 to Septemper 30,2025. A total of 1000 patients with menopausal syndrome will be allocated to either the exposure group (patients receiving LWDH treatment) or the non-exposed group (patients not receiving LWDH treatment), mostly based on patient desire in a genuine clinical setting. The main observation indicators will be changes in the modified kupperman scale and sex hormone levels.The secondary outcomes encompass alterations in the Menopausal quality of life scale, improvement in TCM syndrome scale, and variations in blood glucose and lipid levels.In addition, the multi-omics integrated analysis technique is employed to explore the 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. Data will be analyzed using a combination of artificial intelligence and traditional statistical methods.

Results:

Results:

This study will, for the first time, systematically evaluate the clinical efficacy and safety of LWDH under real-world conditions, and quantitatively assess improvements in menopausal syndrome using multiple outcome measures.

Conclusions:

Conclusion: This real-world cohort study is expected to provide important evidence regarding the clinical efficacy and safety of LWDH in treating menopausal syndrome, offering a scientific basis for its standardized use in clinical practice.