Evidence map›Paper›PMID 41849092›Full record

ArticleInternational journal of clinical pharmacy2026

Effectiveness, safety, and pharmacoeconomic profile of Sophora flavescens film in the treatment of postpartum vaginal dysbiosis: a non-randomized controlled trial.

Jiaojiao Zhao, Xiaorang Li, Songsong Tan, Ye Pan, Zhihao Yang, Shuimei Sun, Junjie Lan, Rui Zhang, Huaye Zhao, Linfang Hu and 6 more

Abstract readControlled Clinical Trial
In one paragraph

Article in International journal of clinical pharmacy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Jiaojiao Zhao *School of Pharmacy, Guizhou University, Guiyang, China.
Xiaorang Li *Department of Scientific Education, Jinsha County People's Hospital, Bijie, China.
Songsong TanOffice of Health Insurance Administration, Guizhou Provincial People's Hospital, Guiyang, China.
Ye PanDepartment of Obstetrics and Gynecology, Guizhou Provincial People's Hospital, Guiyang, China.
Zhihao YangDepartment of Health Services Management, Guizhou Medical University, Guiyang, China.
Shuimei SunDepartment of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
Junjie LanDepartment of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
Rui ZhangDepartment of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
Huaye ZhaoDepartment of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
Linfang HuDepartment of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
Jiaxue WangDepartment of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
Wenyi ZhengCollege of Pharmacy, Chongqing Medical University, Chongqing, China.
Rui HeDepartment of Personnel, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Chang XuProof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China.
Xiaoling ZengDepartment of Obstetrics and Gynecology, Guizhou Provincial People's Hospital, Guiyang, China.
Jiaxing ZhangSchool of Pharmacy, Guizhou University, Guiyang, China. zjx19870619@126.com.

Funding

Guizhou Provincial Administration of Traditional Chinese Medicinet of China QZYY-2024-065Guizhou Provincial Department of Science and Technology Qiankehe Support (2025) General 109
6 · The paper itself

Abstract

introductionSophora flavescens film (SFF), a topical traditional Chinese medicine that primarily contains matrine, has been approved in China since 2009 for chronic gynecological inflammation. However, evidence regarding its clinical value in the management of postpartum vaginal dysbiosis (PVD) remains limited.

aimThis study aimed to evaluate the effectiveness, safety, and pharmacoeconomic profile of SFF as an adjunct to conventional therapy in women with PVD.

methodThis single-center, open-label, non-randomized controlled trial was conducted among postpartum women (6-8 weeks after delivery) diagnosed with PVD. Participants were self-selected into either the SFF group (SFF plus conventional therapy) or the control group (conventional therapy alone). The primary outcome was the overall therapeutic effectiveness based on composite vaginal ecosystem indicators. Secondary outcomes included Vaginal Health Index Score (VHIS), Vaginal Inflammation Score (VIS), EQ-5D-5L health utility, EQ-VAS, and adverse events (AEs). Pharmacoeconomic evaluation was performed using a decision tree model to estimate the incremental cost-effectiveness ratio (ICER). Statistical analyses incorporated logistic regression and analysis of covariance (ANCOVA) with directed acyclic graph (DAG)-based confounder adjustments.

resultsIn total, 126 participants (63 per group) completed the study. The SFF group demonstrated a significantly higher overall effectiveness than the control group (adjusted odds ratio = 3.68, 95% confidence interval [CI]: 1.49-9.09, P = 0.005). Significant post-treatment improvements were observed in VHIS (mean difference [MD] = 2.420, 95% CI: 1.808-3.032, P < 0.001, η

conclusionWhen combined with conventional care, SFF significantly improved clinical, symptomatic, and quality-of-life outcomes in women with PVD, with favorable tolerability and short-term cost-effectiveness. These results support its potential clinical utility. However, confirmation through multicenter, double-blind, randomized controlled trials is warranted.

Indexed as

Drugs, Chinese HerbalDysbiosisSophora flavescensVaginaAdultCost-Benefit AnalysisCost-Effectiveness AnalysisEconomics, PharmaceuticalFemaleHumansPostpartum PeriodTreatment OutcomeDrugs, Chinese HerbalCost-effectivenessEffectivenessPostpartum vaginal dysbiosisSafetySophora flavescens film

Identifiers

PMID41849092
PMCPMC13176005

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.