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JAMA Network Open Mar 2020Placebo responses in the treatment of erectile dysfunction (ED) are poorly described in the literature to date. (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Placebo responses in the treatment of erectile dysfunction (ED) are poorly described in the literature to date.
OBJECTIVE
To quantify the association of placebo with ED outcomes among men enrolled in placebo-controlled, phosphodiesterase 5 inhibitor (PDE5I) trials.
DATA SOURCES
For this systematic review and meta-analysis, a database search was conducted to identify double-blind, placebo-controlled studies using PDE5Is for the treatment of ED published from January 1, 1998, to December 31, 2018, within MEDLINE, Embase, Cochrane Library, and Web of Science. Only articles published in the English language were included.
STUDY SELECTION
Double-blind, placebo-controlled randomized clinical trials of PDE5Is for ED were included. Studies were excluded if they did not provide distribution measures for statistical analysis. Study selection review assessments were conducted by 2 independent investigators. A total of 2215 studies were identified from the database search, and after review, 63 studies that included 12 564 men were analyzed.
DATA EXTRACTION AND SYNTHESIS
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed in abstracting data and assessing validity. Data were extracted from published reports by 2 independent reviewers. Quality assessment was performed using the Jadad scale. Data were pooled using a random-effects model.
MAIN OUTCOMES AND MEASURES
The main outcome was improvement in the erectile function domain of the International Index of Erectile Function questionnaire in the placebo arm of the included studies. Effect size was reported as bias-corrected standardized mean difference (Hedges g). The hypothesis was formulated before data extraction.
RESULTS
A total of 63 studies that included 12 564 men (mean [SD] age, 55 [7] years; age range, 36-68 years) were included. Erectile function was significantly improved among participants in the placebo arm, with a small to moderate effect size (Hedges g [SE], 0.35 [0.03]; P < .001). Placebo effect size was larger among participants with ED associated with posttraumatic stress disorder (Hedges g [SE], 0.78 [0.32]; P = .02) compared with the overall analysis. No significant difference was found between placebo and PDE5Is for ED after prostate surgery or radiotherapy (Hedges g [SE], 0.30 [0.17]; P = .08).
CONCLUSIONS AND RELEVANCE
In this study, placebo was associated with improvement of ED, especially among men with ED-related posttraumatic stress disorder. No difference was found between placebo and PDE5I among men treated for ED after prostate surgery.
Topics: Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Placebos; Randomized Controlled Trials as Topic; Urological Agents
PubMed: 32196105
DOI: 10.1001/jamanetworkopen.2020.1423 -
Journal of the American Medical... Dec 1955
Topics: Humans; Placebos
PubMed: 13271123
DOI: 10.1001/jama.1955.02960340022006 -
Anaesthesia Feb 2011
Topics: Anesthesia, Conduction; Humans; Placebos; Randomized Controlled Trials as Topic; Research Design
PubMed: 21254979
DOI: 10.1111/j.1365-2044.2010.06602.x -
Revue Medicale de Bruxelles 2006There are many papers devoted to placebo and placebo effects. The present article tries to provide a precise definition of these concepts and to take stock of our... (Review)
Review
There are many papers devoted to placebo and placebo effects. The present article tries to provide a precise definition of these concepts and to take stock of our knowledge on this topic. Considering that most of the publications dealing with this phenomon are of poor scientific quality, some authors deny its existence. However recent findings in neuroscience show that it is a reality and explain its mechanisms.
Topics: Humans; Placebo Effect; Placebos; Reproducibility of Results
PubMed: 17256416
DOI: No ID Found -
Anaesthesia and Intensive Care May 2010
Topics: Humans; Placebo Effect; Placebos
PubMed: 20514948
DOI: 10.1177/0310057X1003800303 -
PLoS Medicine Sep 2020Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their...
BACKGROUND
Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions.
METHODS AND FINDINGS
We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator.
CONCLUSIONS
We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.
Topics: Checklist; Humans; Placebos; Research Design; Research Personnel; Research Report; Surveys and Questionnaires
PubMed: 32956344
DOI: 10.1371/journal.pmed.1003294 -
Wiener Klinische Wochenschrift Oct 1987Nonspecific drug actions result from the social interaction between physician and patient and the medical environment. Positive (therapeutic) placebo effects are... (Review)
Review
Nonspecific drug actions result from the social interaction between physician and patient and the medical environment. Positive (therapeutic) placebo effects are produced in approximately 30-35% of treated patients, especially in cases of vegetative and psychic disturbances. There appears to be no distinct group of individuals with specific personality features that can be classified as "placebo responders". Negative (toxic) placebo effects, which are usually minor, are reported in 4-50% of treated patients. The occurrence of side effects may cause the patient to assume treatment with an active agent, thus increasing the therapeutic efficiency of the treatment (placebo amplification by side effects). On the other hand, the lack of a certain side effect may diminish the therapeutic effect of an active drug. The notion that placebo-induced analgesia is endorphin-mediated is not established. Hence at present psychological mechanisms have to be assumed for the placebo effect. The conscious use of a placebo as a therapeutic agent is problematic for ethical reasons, whereas the placebo component of drugs with specific actions should be exploited to enhance their therapeutic efficiency.
Topics: Humans; Placebos; Psychophysiologic Disorders; Somatoform Disorders
PubMed: 3318148
DOI: No ID Found -
Movement Disorders : Official Journal... Aug 2018
Topics: Humans; Movement Disorders; Placebos
PubMed: 30230628
DOI: 10.1002/mds.27476 -
Complementary Therapies in Medicine Apr 2013
Topics: Humans; Placebo Effect; Placebos; Randomized Controlled Trials as Topic; Research Design
PubMed: 23497807
DOI: 10.1016/j.ctim.2013.01.006 -
Perspectives in Biology and Medicine 1999
Review
Topics: Bioethics; Clinical Medicine; Complementary Therapies; Germany; Health Knowledge, Attitudes, Practice; Humans; Placebo Effect; Placebos
PubMed: 10432640
DOI: 10.1353/pbm.1999.0055