Evidence map›Paper›PMID 33452912›Full record

Trial reportWorld journal of urology2021

The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.

Kai Zhang, Run-Qi Guo, Shan-Wen Chen, Bin Chen, Xin-Bo Xue, Shan Chen, Jian Huang, Ming Liu, Ye Tian, Li Zuo and 2 more

Open access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in World journal of urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.3field-weighted citation impact, top 8% of its field
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

5 citing papers in PubMed, 17 citations in OpenAlex.

  1. Nutrients · 2024
    Trial
  2. Trial
  3. Article
  4. The Efficacy of FlogofilmJournal of clinical medicine · 2023
    Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 1 country.

Kai Zhang *Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing, 100034, China.
Run-Qi Guo *Minimally Invasive Tumor Therapies Center, Beijing Hospital, National Center of Gerontology, Beijing, China.
Shan-Wen ChenDepartment of Urology, Huashan Hospital of Fudan University, Shanghai, China.
Bin ChenDepartment of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Xin-Bo XueDepartment of Urology, The Second Affiliated Hospital, Soochow University, Suzhou, China.
Shan ChenDepartment of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Jian HuangDepartment of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.
Ming LiuDepartment of Urology, Beijing Hospital, Beijing, China.
Ye TianDepartment of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Li ZuoDepartment of Urology, Changzhou No. 2 People's Hospital Affiliated to Nanjing Medical University, Changzhou, Jiangsu, China.
Ming ChenDepartment of Urology, Zhongda Hospital, Southeast University, Nanjing, 210000, Jiangsu, China. mingchen6308@163.com.ORCID http://orcid.org/0000-0002-3500-7224
Li-Qun ZhouDepartment of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing, 100034, China. zhoulqmail@sina.com.
Beijing Tongren Hospital · CNPeking University · CNBeijing Hospital · CNCapital Medical University · CNChangzhou No.2 People's Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNRenji Hospital · CNSoochow University · CNSun Yat-sen University · CNZhongda Hospital Southeast University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo perform a placebo-controlled trial to evaluate the efficacy and safety of Serenoa repens extract (SRE) for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

methodsWe conducted a double-blind, randomized, placebo-controlled, multicenter, clinical phase 4 study of 221 patients with CP/CPPS across 11 centers. Participants were randomly assigned in a 2:1 ratio to receive SRE or placebo for 12 weeks. The primary efficacy endpoint was the change in total score on the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Secondary efficacy endpoints included improvements within each domain of NIH-CPSI, clinical response rate, and International Index of Erectile Function 5 items (IIEF-5).

resultsIn total, 226 patients were enrolled and randomized between January 2017 and June 2018. Of these 221 patients were included in the intent-to-treat analysis: 148 in the SRE group and 73 patients in the placebo group. Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores. The significant improvements of NIH-CPSI scores were established after 2 weeks from the first dose, and continued to the end of the treatment. Furthermore, a significantly higher rate of patients achieved a clinical response in the SRE group compared with that in the placebo group (73.0% vs 32.9%, P < 0.0001). Only minor adverse events were observed across the entire study population.

conclusionsSRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered.

Indexed as

AdultDouble-Blind MethodHumansMalePlant ExtractsProstatitisSerenoaTreatment OutcomePlant ExtractsProstasanChronic pelvic pain syndromeChronic prostatitisEfficacySafetySerenoa repens

Identifiers

PMID33452912
PMCPMC8510895
OpenAlexW3124026966

What OpenQuestion holds

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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.