Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? A protocol for a meta-epidemiological study of PDE-5 inhibitors
| Autor: | Kavita Singh, Geertruida E Bekkering, Dirk Devroey, Frederik Feys |
|---|---|
| Přispěvatelé: | Family Medicine and Chronic Care |
| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Male
medicine.medical_specialty Blinding Nocebo medicine.drug_mechanism_of_action Phosphodiesterase Inhibitors Medicine (miscellaneous) lcsh:Medicine Placebo law.invention Phosphodiesterase-5 inhibitor Expectancy Randomized controlled trial Erectile Dysfunction Bias law medicine Protocol Humans Randomized Controlled Trials as Topic business.industry PDE-5 lcsh:R Placebo Effect Crossover study Clinical trial Nocebo Effect Review Literature as Topic Research Design Physical therapy business Phosphodiesterase 5 inhibitor |
| Zdroj: | Systematic Reviews, Vol 1, Iss 1, p 54 (2012) Systematic Reviews Vrije Universiteit Brussel |
| ISSN: | 2046-4053 |
| Popis: | Background Patients’ expectations of treatment effects may contribute to positive (placebo) and negative (nocebo) outcomes. The effect of patient expectations may be pronounced in subjectively assessed conditions, such as male erectile dysfunction. The aim of this project is to examine the magnitude of expectancy in trials of phosphodiesterase-5 inhibitors. We hypothesize that randomized controlled trials with inadequate blinding will report enhanced placebo effects for intervention groups and nocebo effects for placebo groups, compared with adequately blinded studies. Methods/design We will quantify the magnitude of expectancy by comparing the effect estimates of trials with inadequate and adequate blinding. Blinding will be assessed using four domains from the Cochrane ‘risk-of-bias’ tool: allocation concealment; blinding of patient; caregiver; and outcome assessor. Our secondary aim is to identify factors that can modify expectations, such as prior experience with the intervention and drug side effects. We will perform an electronic search using a combination of controlled vocabulary and free text words in the following databases: MEDLINE, EMBASE, CENTRAL, and a clinical trials register. We will include randomized controlled trials, with either parallel or crossover design, that compare one phosphodiesterase-5 inhibitor with a placebo. The study’s primary aim should be to investigate the efficacy of phosphodiesterase-5 inhibitors for treating male erectile dysfunction. Screening will take place at two levels: abstracts and titles, followed by full text reports. Two reviewers will independently extract data on the primary outcome and assess risk of bias. We will meta-analyze treatment effects, if appropriate, to assess the magnitude of enhanced placebo effects and nocebo effects in intervention and placebo groups, respectively. We will explore possible mediators of placebo and nocebo effects with subgroup and meta-regression analyses. Discussion Treatments may confer significant costs and risk of adverse effects; it is important, therefore, to determine whether the effects of treatments are larger than expectancy alone. If treatment expectations can be used in a non-deceptive way to produce clinically advantageous outcomes, then it may be possible to incorporate such mechanisms into evidence-based healthcare decision-making. |
| Databáze: | OpenAIRE |
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