Evidence map›Paper›PMID 39046647›Full record

Trial reportChinese journal of integrative medicine2024

Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain: A Multicenter, 3:1 Randomized, Double-Blind, Placebo-Controlled Trial.

Jin-Hua Leng, Hua Duan, Zheng Guan, Ying-Fang Zhou, Hong Qu, Kai-Hong Xu, Shao-Fen Zhang, Qin Zhang, Xin Wang, Kai-Qing Lin and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Chinese journal of integrative medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02031523 (A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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.

NCT02031523 phase4unknown statusnot on this map

A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain

TypeinterventionalSponsorJiangsu Kanion Pharmaceutical Co., LtdRan2013 to 2015Enrolled400ConditionsDysmenorrheaArmsSanjie analgesic capsule, placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

11 authors.

Jin-Hua LengDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, 100730, China.
Hua DuanDepartment of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100006, China.
Zheng GuanDepartment of Gynecology, Chinese PLA General Hospital, Beijing, 100039, China.
Ying-Fang ZhouDepartment of Gynecology, Peking University First Hospital, Beijing, 100034, China.
Hong QuDepartment of Gynecology, Beijing Chao-yang Hospital, Beijing, 100020, China.
Kai-Hong XuDepartment of Gynecology, Womens Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang Province, 310006, China.
Shao-Fen ZhangDepartment of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200090, China.
Qin ZhangDepartment of Gynecology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, 310007, China.
Xin WangDepartment of Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110032, China.
Kai-Qing LinDepartment of Gynecology, Womens Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang Province, 310006, China.
Jing-He LangDepartment of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, 100730, China. langjh@vip.163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of Sanjie Analgesic Capsule (SAC) in Chinese patients with endometriosis-associated pain.

methodsThis was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 15 centers between November 2013 and July 2017 in China. Eligible 323 patients with endometriosis were randomized at a 3:1 ratio to the SAC group (241 cases) and placebo group (82 cases) by stratified block randomization. Patients in the SAC or placebo groups were given SAC or placebo 1.6 g 3 times per day, orally, respectively since the first day of menstruation for 3 consecutive menstrual cycles. The primary endpoint was clinical response to dysmenorrhea evaluated using a 10-point Visual Analogue Scale at 3 and 6 months. The secondary endpoint was the pain score evaluated by VAS (chronic pelvic pain, defecation pain, and dyspareunia) at 3 and 6 months, and the pain recurrence rate at 6 months. Adverse events (AEs) were recorded during the study.

resultsA total of 241 women were included in the SAC group, and 82 were in the placebo group. Among these women, 217 (90.0%) and 71 (86.6%) completed the intervention, respectively. At 3 months, overall response rate (ORR) was significantly higher in women administered SAC (80.1%) compared with those who received a placebo (30.5%, P<0.01). Six months after treatment, the ORR for dysmenorrhea was 62.7% in the SAC group and 31.7% in the placebo group (P<0.01). Chronic pelvic pain and defecation pain were significantly improved by SAC compared with placebo (both P<0.05). The incidence rates of total AEs events in the SAC and placebo groups were 6.6% and 9.8%, respectively, and no significant difference was shown between the two groups (P=0.339).

conclusionSAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain. (Trial registration: ClinicalTrials.gov, No. NCT02031523).

Indexed as

AnalgesicsCapsulesDrugs, Chinese HerbalEndometriosisAdultDouble-Blind MethodDysmenorrheaFemaleHumansPainPain MeasurementPelvic PainPlacebosTreatment OutcomeYoung AdultAnalgesicsCapsulesDrugs, Chinese HerbalPlacebosChinese medicineendometriosispainrandomized controlled trialSanjie Analgesic Capsule

Identifiers

PMID39046647

What OpenQuestion holds

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Registered trials

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.