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Medicina Clinica Jun 1987
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The New England Journal of Medicine Oct 2001
Topics: Humans; Meta-Analysis as Topic; Pain Management; Placebo Effect; Placebos; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 11680452
DOI: No ID Found -
Archives of Internal Medicine
Clinical Trial Randomized Controlled Trial Review
Topics: Adolescent; Adult; Aged; Asthma; Child; Double-Blind Method; Drug Utilization; Ethics; Helsinki Declaration; Humans; Middle Aged; Placebos; Treatment Outcome
PubMed: 12153369
DOI: 10.1001/archinte.162.15.1673 -
Schizophrenia Bulletin Nov 2013Fluphenazine, a phenothiazine derivative, was one of the first drugs to be classed as an "antipsychotic" and was approved by the Food and Drug Administration in 1959. In... (Comparative Study)
Comparative Study Review
Fluphenazine, a phenothiazine derivative, was one of the first drugs to be classed as an "antipsychotic" and was approved by the Food and Drug Administration in 1959. In Britain, it was first used for the relief of anxiety. The American reports, however, were the first to indicate its value in psychotic illness. Fluphenazine is an inexpensive and widely accessible antipsychotic drug that has been available to treat people with schizophrenia for five decades. We updated our original search (from September 2006) using The Cochrane Schizophrenia Group Trials register (May 2012); we found no new relevant studies. Seven randomized controlled trials (RCTs) were included with a total of N = 439 participants. Results, based on this small selection of studies, suggested that there was no significant difference between oral fluphenazine and placebo for most outcomes, including global state and leaving the study early. Results did suggest a statistically significant effect favoring oral fluphenazine in the short term for levels of relapse (n = 38, 1 RCT, RR 0.25 CI 0.06-1.03) with levels of extrapyramidal adverse effects more frequent with oral fluphenazine. The findings in this review confirm much that clinicians and recipients of care already know, but they provide quantification to support clinical impression. In this review, for perhaps the first time, we objectively quantified the effects of oral administration of fluphenazine in comparison with placebo. It is indeed a potent antipsychotic but with considerable adverse effects. Other drugs may well be preferable.
Topics: Antipsychotic Agents; Fluphenazine; Humans; Placebos; Schizophrenia
PubMed: 24072807
DOI: 10.1093/schbul/sbt140 -
Progress in Neuro-psychopharmacology &... May 2006The use of placebos as reference agents in randomised controlled trials for psychiatric disorders has come under question for ethical reasons. Alternative methods for... (Review)
Review
The use of placebos as reference agents in randomised controlled trials for psychiatric disorders has come under question for ethical reasons. Alternative methods for validating the efficacy of new treatments exist, but may not be as reliable as placebo. In this paper we examine arguments for and against the ongoing use of placebo agents in the development of new treatments for obsessive compulsive disorder in the context of evidence from randomised controlled trials.
Topics: Controlled Clinical Trials as Topic; Humans; Obsessive-Compulsive Disorder; Placebo Effect; Placebos
PubMed: 16413647
DOI: 10.1016/j.pnpbp.2005.11.012 -
The Lancet. Gastroenterology &... Jun 2021Clinical trials in irritable bowel syndrome are associated with high placebo response rates. We aimed to identify the magnitude of the placebo response and the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Clinical trials in irritable bowel syndrome are associated with high placebo response rates. We aimed to identify the magnitude of the placebo response and the contributing factors to this occurrence.
METHODS
We did a systematic review and meta-analysis with a search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials between April 1, 1959, and April 30, 2020. We included all randomised controlled trials that compared an active pharmacotherapeutic agent with placebo and had a dichotomous outcome of response to therapy (in terms of global improvement or improvement in abdominal pain) in adults (aged ≥18 years) with irritable bowel syndrome. Exclusion criteria were trials reporting on treatment satisfaction as a dichotomous outcome of response to therapy or clinician-reported outcomes and a treatment duration of less than 4 weeks. Our main outcome was identification of the magnitude of the pooled placebo response rate for the following endpoints: global improvement, abdominal pain, and US Food and Drug Administration (FDA) endpoints. We extracted information from published reports and pooled proportions through meta-analysis with random effects. The study was registered with PROSPERO, CRD42020170908.
FINDINGS
Of the 6863 publications identified, 70 articles describing 73 randomised controlled trials were included in our analysis. The pooled placebo response rate was 27·3% (95% CI 24·3-30·9) using the global improvement endpoint, 34·4% (31·2-37·8) using the abdominal pain endpoint, and 17·9% (15·2-21·0) using the composite FDA endpoint responder definition, all with substantial heterogeneity between the trials. Studies published before 2006, and those done in Europe, with a parallel design, a run-in period of 2 weeks or less, a dose schedule of three times a day or more, or a smaller sample size of the control group were significantly associated with an increased pooled placebo response rate.
INTERPRETATION
More than a quarter of patients with irritable bowel syndrome had a placebo response in terms of global improvement, with multiple associated moderators. We recommend future trials apply a run-in period of at least 2 weeks and dose once or twice a day to minimise the placebo response rate.
FUNDING
None.
Topics: Abdominal Pain; Adult; Case-Control Studies; Europe; Female; Humans; Irritable Bowel Syndrome; Male; Placebo Effect; Placebos; Randomized Controlled Trials as Topic; Severity of Illness Index; United States; United States Food and Drug Administration
PubMed: 33765447
DOI: 10.1016/S2468-1253(21)00023-6 -
Journal of Medical Ethics Apr 2013Over the decades of experimentation on the placebo effect, it has become clear that it is driven largely by expectation, and that strong expectations of efficacy are...
Over the decades of experimentation on the placebo effect, it has become clear that it is driven largely by expectation, and that strong expectations of efficacy are more likely to give rise to the experience of benefit. No wonder the placebo effect has come to resemble a self-fulfilling prophecy. However, this resemblance is considerably exaggerated. The placebo effect does not work as strongly as it is advertised to do in some efforts to elicit it. Half-truths about the placebo effect are now in circulation, reinforced by a number of other equivocations that it seems to attract. As the deceptive use of placebos has fallen into discredit, the use of half-truths and exaggerations-neither of which is technically a deception-becomes an ever more inviting possibility. However, there are risks and costs associated with the half-truth that the doctor possesses the power to make his or her words come true by the alchemy of the placebo effect.
Topics: Deception; Drugs, Generic; Humans; Pain; Placebo Effect; Placebos; Truth Disclosure
PubMed: 23250230
DOI: 10.1136/medethics-2012-101057 -
JAMA May 1985
Topics: Attitude; Clinical Trials as Topic; Humans; Placebos; Research Design
PubMed: 3981774
DOI: No ID Found -
Survey of Ophthalmology 2000
Topics: Controlled Clinical Trials as Topic; False Positive Reactions; Humans; Observer Variation; Placebo Effect; Placebos
PubMed: 10667446
DOI: 10.1016/s0039-6257(99)00123-x -
South African Medical Journal =... Dec 1979
Topics: Humans; Placebos
PubMed: 550433
DOI: No ID Found