Evidence map›Paper›PMID 33674256›Full record

SynthesisEuropean urology focus2022

Placebo Response in Patients with Oral Therapy for Overactive Bladder: A Systematic Review and Meta-analysis.

Hadi Mostafaei, Florian Janisch, Keiichiro Mori, Fahad Quhal, Benjamin Pradere, Sakineh Hajebrahimi, Claus G Roehrborn, Shahrokh F Shariat

Registry-linked trialAbstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in European urology focus, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06508944 (Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.0field-weighted citation impact, top 6% 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.

NCT06508944 phase4completednot on this mapstarted 2024, after this paper: background citation

Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women: A Randomized Double-Blind, Placebo-Controlled Study

TypeinterventionalSponsorMahidol UniversityRan2024 to 2024Enrolled86ConditionsLower Urinary Tract Symptoms, Female Genitourinary Disease, Urinary Stress Incontinence, Urinary Urge IncontinenceArmsvaginal 17 beta-estradiol, Placebo, Behavioral modifications
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 22 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 11 countries.

Hadi MostafaeiDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Research Center for Evidence Based Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Florian JanischDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Medical University of Hamburg, Hamburg, Germany.
Keiichiro MoriDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Fahad QuhalDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; King Fahad Specialist Hospital-Dammam, Dammam, Saudi Arabia.
Benjamin PradereDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, CHRU Tours, Francois Rabelais University, Tours, France.
Sakineh HajebrahimiResearch Center for Evidence Based Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Claus G RoehrbornDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Shahrokh F ShariatDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Institute for Urology and Reproductive Health, I.M. Sechenov First Moscow State Medical University, Moscow, Russia; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Department of Urology, Weill Cornell Medical College, New York, NY, USA; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria; Department of Urology, University of Jordan, Amman, Jordan; European Association of Urology Research Foundation, Arnhem, The Netherlands. Electronic address: sfshariat@gmail.com.
Medical University of Vienna · ATEuropean Association of Urology · NLJikei University School of Medicine · JPTabriz University of Medical Sciences · IRThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextThe role of a placebo response in the management of overactive bladder (OAB) remains unclear.

objectiveThe aim of this review is to methodically study the placebo response extracted from the control arms of randomized clinical trials assessing therapy in patients with OAB. EVIDENCE ACQUISITION: Medline (PubMed), The Cochrane Library, EMBASE, and Scopus were searched to identify randomized controlled trials (RCTs) published until September 2019. Randomized placebo-controlled trials investigating oral drug therapy for OAB were included. The articles were critically appraised by two reviewers. The primary outcomes were the placebo response in the main patient-reported urinary outcomes together with assessing the impact of patient demographic factors on the placebo response. EVIDENCE SYNTHESIS: The initial search resulted in 1982 records after reviewing the titles and abstracts, and reference lists of other systematic reviews; 57 studies with an overall estimated 12 901 patients were included in the meta-analysis. The included studies were of overall high/acceptable quality. The standardized mean difference was -0.45 (95% confidence interval [CI] -0.51 to -0.40; p<0.001) for daily micturition episodes, -0.33 (95% CI -0.42 to -0.24; p<0.001) for daily nocturia episodes, -0.46 (95% CI -0.55 to -0.37; p<0.001) for urgency urinary incontinence episodes, -0.50 (95% CI -0.61 to -0.39; p<0.001) for daily urgency episodes, -0.51 (95% CI -0.60 to -0.43; p<0.001) for daily incontinence episodes, and 0.25 (95% CI 0.211-0.290; p<0.001) for volume voided per micturition. The meta-regression of age-related impact of the placebo response on nocturia showed a slope of -0.02 (p<0.001).

conclusionsPlacebo has a statistically significant effect on improving symptoms and signs associated with OAB; this effect is age dependent. However, there is no consensus on what change of OAB symptoms and signs is clinically meaningful for the affected patient. Taken together, the placebo response seems to be non-negligible in OAB, supporting the need for placebo control in RCTs. PATIENT SUMMARY: Placebo is an inert treatment method often used in clinical research for comparison with active treatment. However, studies show that placebo has an effect of its own. A placebo response means the total improvement resulting from receiving a placebo. In our study, placebo had a significant role in improving the symptoms of overactive bladder.

Indexed as

NocturiaUrinary Bladder, OveractiveHumansPlacebo EffectRandomized Controlled Trials as TopicOveractive bladderPlacebo responseSystematic review

Identifiers

PMID33674256
OpenAlexW3135630396

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.