Placebos: Honest fakery

Marchant, Jo

doi:10.1038/535s14a

Cited by 14 publications

(13 citation statements)

References 11 publications

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“…Second, this study was conducted with only male patients with IBS-D. Third, psychosocial factors may have affected to the response to the drug. Especially, expectations of the drug efficacy, which differs among patients, is likely to affect the drug effects [26]. The effect of expectations can be tested by use of placebo [26].…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea

Ida

Nishida

Akiho

et al. 2017

BioPsychoSocial Med

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BackgroundPrevious studies have indicated that ramosetron, a 5-hydroxytryptamine-3 receptor antagonist, achieves global improvement in irritable bowel syndrome (IBS) symptoms in male patients with IBS with diarrhea (IBS-D). However, in addition to global assessment it was deemed important to assess “clinically meaningful improvements, focusing on the patient’s chief complaint and the severity of major IBS symptoms”. We performed a randomized, placebo-controlled, phase IV pilot study to explore and examine efficacy variables that allow such evaluation of ramosetron in male patients with IBS-D.MethodsWe performed a prospective study of 115 male outpatients with IBS-D (according to the Rome III criteria), from June 2009 to December 2009 at 25 centers in Japan. After a one-week baseline period, subjects received either 5 μg of ramosetron (n = 47) or placebo (n = 51) once daily for 12 weeks. To evaluate “clinically meaningful improvements focusing on the severity of major IBS symptoms,” the Japanese version of the IBS severity index (IBSSI-J) was used.ResultsChange in IBSSI-J overall score from baseline was −133.5 ± 110.72 in the ramosetron 5 μg group and −108.2 ± 94.44 in the placebo group (P = 0.228) at the last evaluation point. Differences in responder rates for at least a 50% reduction from baseline in IBSSI-J between the ramosetron 5 μg group and the placebo group were over 10%, except Month 1. The monthly responder rate for global assessment of relief of overall IBS symptoms in the ramosetron 5 μg group showed a statistically significant improvement compared to placebo at the second month (44.4% vs 18.4%, P = 0.012). The proportion of patients who had a ≥ 50% reduction in IBSSI-J overall score was 24/37 (64.9%) in the responder group on global assessment and 18/54 (33.3%) in the non-responder group at Week 12.ConclusionsFurther examination will be needed before IBSSI-J can be used in clinical trials of agents for IBS-D. However, this study revealed that response on global assessment was correlated with improvement in the IBSSI-J, suggesting that global assessment reflects improvement of the symptom severity of patients with IBS-D. (Clinicaltrials.gov ID: NCT00918411 Registered 9 June 2009).

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Section: Discussionmentioning

confidence: 99%

“…Especially, expectations of the drug efficacy, which differs among patients, is likely to affect the drug effects [26]. The effect of expectations can be tested by use of placebo [26]. Therefore, the drug effect seen in clinical trials are supposed to be a summation of placebo effects and real pharmacological effects.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea

Ida

Nishida

Akiho

et al. 2017

BioPsychoSocial Med

View full text Add to dashboard Cite

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“…Sham stimulation is a form of placebo control in which patients are delivered an inert stimulus in a blinded manner. Shamstimulation controls for nonspecific outcomes such as placebo responses and placebo effects (12,13). Placebo responses, defined as changes in response following placebo administration, account for the natural disease progression, fluctuation in symptoms, and regression to the mean (12,13).…”

Section: Introductionmentioning

confidence: 99%

Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis

Tan

Wells

Dinning

et al. 2020

Neuromodulation: Technology at the Neural Interface

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“…This review systematically describes the findings of the past 15 years regarding how a response to being treated can cause neurobiological reactions in the brain of the PD patient. Emphasis is placed on the identification of reliable biomarkers as predictors of the placebo response for future therapies.…”

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confidence: 99%

Neurobiology of placebo effect in Parkinson's disease: What we have learned and where we are going

et al. 2018

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The placebo effect is a phenomenon produced when an inert substance administered like a regular treatment improves the clinical outcome. Parkinson's disease (PD) is one of the main clinical disorders for which the placebo response rates are high. The first evidence of the neurobiological mechanisms underlying the placebo effect in PD stems from 2001, when de la Fuente-Fernandez and colleagues demonstrated that a placebo injection led to the release of dopamine in the striatal nuclei of PD measured with positron emission tomography technology. Since then, several studies have been conducted to investigate the neurobiological underpinnings of placebo responses. This article presents a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Of an initial yield of 143 papers, 19 were included. The lessons learned from these studies are threefold: (i) motor improvement is dependent on the activation of the entire nigrostriatal pathway induced by dopamine release in the dorsal striatum; (ii) the magnitude of placebo-induced effects is modulated by an expectancy of improvement, which is in turn related to the release of dopamine within the ventral striatum; (iii) the functioning of the neural pathways underlying the placebo response can be tuned by prior exposure and learning strategies. In conclusion, although the neural network underlying the placebo effect in PD has been largely confirmed and accepted, what remains to be established is how, when, and where the expectation of reward (mediated by the ventral striatum) interacts with the primary motor system (mediated by the dorsal striatum) to induce clinical improvement in motor symptoms. © 2018 International Parkinson and Movement Disorder Society.

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Placebos: Honest fakery

Cited by 14 publications

References 11 publications

Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea

Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea

Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis

Neurobiology of placebo effect in Parkinson's disease: What we have learned and where we are going

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