The efficacy and safety of Chinese herbal medicine Guizhi Fuling capsule combined with low dose mifepristone in the treatment of uterine fibroids: a systematic review and meta-analysis of 28 randomized controlled trials

Abstract

Objective Guizhi Fuling Capsule (GZFL), a classic traditional Chinese medicine prescription, is often recommended for the treatment of uterine fibroids (UFs). However, the efficacy and safety of GZFL in combination with low-dose mifepristone (MFP) remains controversial. Materials and methods We searched eight literature databases and two clinical trial registries for randomized controlled trials (RCTs) of the efficacy and safety of GZFL combined with low-dose MFP in the treatment of UFs from database inception to April 24, 2022. Data analysis was performed using the Meta package in RStudio and RevMan 5.4. GRADE pro3.6.1 software was used for the assessment of evidence quality. Results Twenty-eight RCTs were included in this study, including a total of 2813 patients. The meta-analysis showed that compared with low-dose MFP alone, GZFL combined with low-dose MFP significantly reduced follicle stimulating hormone (p < 0.001), estradiol (p < 0.001), progesterone (p < 0.001), luteinizing hormone (p < 0.001), uterine fibroids volume (p < 0.001), uterine volume (p < 0.001), menstrual flow (p < 0.001) and increased clinical efficiency rate (p < 0.001). Meanwhile, GZFL combined with low-dose MFP did not significantly increase the incidence of adverse drug reactions compared with low-dose MFP alone (p = 0.16). The quality of the evidence for the outcomes ranged from “very low” to “moderate.” Conclusion This study suggests that GZFL combined with low-dose MFP is more effective and safe in the treatment of UFs, and it is a potential treatment for UFs. However, due to the poor quality of the included RCTs formulations, we recommend a rigorous, high-quality, large-sample trial to confirm our findings.

Advancements and Emerging Therapies in the Medical Management of Uterine Fibroids: A Comprehensive Scoping Review

“…A recent meta-analysis suggested the potential superiority of combined therapy involving mifepristone and Guizhi Fuling capsules, compared with mifepristone alone. However, authors emphasized the low quality of available data and underscored the need for high-quality randomized trials to prove initial findings [ 45 ].…”

“…Alternative therapies, such as Chinese herbal preparations, phytochemicals, and novel drug delivery systems, show promising initial results. However, the majority of studies identified in this scoping review were conducted in an in vitro or ex vivo setting [44][45][46][47][48][49][50]. Randomized studies involving large cohorts of patients are necessary to assess the safety, efficacy, and clinical utility of potential new therapies.…”