How Sound Is the Double-Blind Design for Evaluating Psychotropic Drugs?

Fisher, Seymour; Greenberg, Roger P.

doi:10.1097/00005053-199306000-00002

Cited by 117 publications

(86 citation statements)

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“…Specifically, patients are randomly assigned to either receive the best standard treatment (without being asked) or to be asked if they will take part in the experimental treatment (where those who decline will receive the standard treatment). While this design avoids any potential disappointment among the control group as they do not even know they 6 In double-blind trials of antidepressant drugs, the vast majority of patients and their clinicians have been found to break the blind early on (most likely due to their monitoring of side effects); see Fisher and Greenberg (1993) and Margraf et al (1991).…”

Section: Randomisation Bias In the Clinical Literaturementioning

confidence: 99%

‘Randomisation bias’ in the medical literature: a review

Sianesi¹

2016

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Abstract:Randomised controlled or clinical trials (RCTs) are generally viewed as the most reliable method to draw causal inference as to the effects of a treatment, as they should guarantee that the individuals being compared differ only in terms of their exposure to the treatment of interest. This 'gold standard' result however hinges on the requirement that the randomisation device determines the random allocation of individuals to the treatment without affecting any other element of the causal model. This 'no randomisation bias' assumption is generally untestable but if violated would undermine the causal inference emerging from an RCT, both in terms of its internal validity and in terms of its relevance for policy purposes. This paper offers a concise review of how the medical literature identifies and deals with such issues. JEL codes: C18, C21, C90, 19

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Section: Randomisation Bias In the Clinical Literaturementioning

confidence: 99%

‘Randomisation bias’ in the medical literature: a review

Sianesi¹

2016

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“…Fisher and Greenberg (1993) conducted a comprehensive literature search of psychotropic drug trials using double-blind procedures. They reported that in 23 of 26 articles, patients and/or physicians differentiated active from placebo conditions at a rate significantly greater than chance.…”

Section: Introductionmentioning

confidence: 99%

Independent Evaluator Knowledge of Treatment in a Multicenter Comparative Treatment Study of Panic Disorder

Roll

Ray

Marcus

et al. 2003

Neuropsychopharmacol

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The purpose of this study was to examine independent evaluators' (IEs) blindness to treatment condition during a Multicenter Comparative Treatment Study of Panic Disorder. IEs were 15 doctoral-and masters-level clinicians in psychology, social work, and medicine. They conducted three post-treatment assessments with each patient. Immediately after each assessment interview, IEs completed a form indicating which of the five possible treatments they believed the patient had received and any specific information that provided IEs with information about a patient's treatment condition. These forms were completed for 170 patients. Analyses were conducted to determine the accuracy of guesses about treatment condition by IEs during post-treatment assessments, the relationship between accuracy of IE guessing and actual treatment assignment, the relationship between accurate guessing and outcome ratings, and contributors to the breaking of the blind. A significant relationship was found between IE guesses and actual treatment at all three assessment points, across individual IEs, treatment sites, and IE professional affiliations. IEs were no more accurate in their guessing about patients taking medication than those receiving behavior therapy. Patients and project staff inadvertently provided information to IEs that enhanced the rates of accurate guessing. Implications of these findings on interpretation of the treatment study are discussed, and recommendations are made for improving blindness procedures.

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“…What we talk about is actually alexithymia.Coles et al (15) believes that people suffering from stomatopyrosis have hidden energy as a psychical disturbance, as this is what the test he conducted revealed. Domb and Chole (3) studied the possibility of cancerophobia being a mental etiological factor with respondents suffering from stomatopyrosis and the results he obtained showed a high percentage of the interrelatedness between cancerophobia and stomatopyrosis.Greenberg et al (16,17,18) concluded that psychotherapy and psychopharmacotherapy are very successful in treating BMS which has occurred as a result of a mental disturbance.Botha (19) dealt with people suffering from stomatopyrosis in whose etiology there was a psychogenic factor. He concluded that psychotherapy and psychopharmacotherapy gave excellent results.…”

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confidence: 99%

Anxiolytics, Antidepressants and Autogenous training in the therapy of burning mouth syndrome

Pokupec¹

2013

iosrphr

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How Sound Is the Double-Blind Design for Evaluating Psychotropic Drugs?

Cited by 117 publications

References 0 publications

‘Randomisation bias’ in the medical literature: a review

‘Randomisation bias’ in the medical literature: a review

Independent Evaluator Knowledge of Treatment in a Multicenter Comparative Treatment Study of Panic Disorder

Anxiolytics, Antidepressants and Autogenous training in the therapy of burning mouth syndrome

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