“Pre-Cebo”: An Underrecognized Issue in the Interpretation of Adequate Relief During Irritable Bowel Syndrome Drug Trials

Kim, Sharon E.; Chua, Kathleen; Amichai, Meridythe M.; Kubomoto, Scott; Pimentel, Mark

doi:10.1016/s0016-5085(11)62545-6

Cited by 8 publications

(10 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This perception could be the reason for rather low placebo responses in more recent trials (after 2000) with drugs, for example, rifaximin, which have lower adverse event rates. 53 Another interpretation of the same phenomenon of low placebo response and high drug efficacy in rifaximin trials in IBS was proposed by Kim et al 54 Patient responses to mock informed consent forms of trials, testing either an antidepressant (desipramine), a prokinetic (alosetron), or a local antibiotic (rifaximin) were evaluated. Patients expected the highest efficacy for treatments they were familiar with (antibiotics), which the authors called a 'pre-cebo' effect.…”

Section: Placebo Response and Trial Durationmentioning

confidence: 96%

“…Patients expected the highest efficacy for treatments they were familiar with (antibiotics), which the authors called a 'pre-cebo' effect. 54 The increased use of social media by patients enrolled in RCTs might also corrupt true blinding and a fair assessment of drug efficacy. Through these networks, patients communicate with other patients, and exchange information about drugs and their adverse effects; it has been noted 55 that this information informs patients about their group assignment and so unblinds drug studies.…”

Section: Placebo Response and Trial Durationmentioning

confidence: 99%

See 1 more Smart Citation

Placebo effects and their determinants in gastrointestinal disorders

Elsenbruch

Enck²

2015

Nat Rev Gastroenterol Hepatol

150

112

View full text Add to dashboard Cite

Placebo effects in clinical trials have sparked an interest in the placebo phenomenon, both in randomized controlled trials (RCTs) and in experimental gastroenterology. RCTs have demonstrated similar short-term and long-term placebo response rates in gastrointestinal compared to other medical diagnoses. Most mediators and moderators of placebo effects in gastrointestinal diseases are also of similar type and size to other medical diagnoses and not specific for gastrointestinal diagnoses. Other characteristics such as an increase in the placebo response over time and the placebo-enhancing effects of unbalanced randomization were not seen, at least in IBS. Experimental placebo and nocebo studies underscore the 'power' of expectancies and conditioning processes in shaping gastrointestinal symptoms not only at the level of self-reports, but also within the brain and along the brain-gut axis. Brain imaging studies have redressed earlier criticism that placebo effects might merely reflect a response bias. These findings raise hope that sophisticated trials and experiments designed to boost positive expectations and minimize negative expectations could pave the way for a practical and ethically sound use of placebo knowledge in daily practice. Rather than focusing on a 'personalized' choice of drugs based on biomarkers or genes, it might be the doctor-patient communication that needs to be tailored.

show abstract

Section: Placebo Response and Trial Durationmentioning

confidence: 96%

Section: Placebo Response and Trial Durationmentioning

confidence: 99%

Placebo effects and their determinants in gastrointestinal disorders

Elsenbruch

Enck²

2015

Nat Rev Gastroenterol Hepatol

150

112

View full text Add to dashboard Cite

show abstract

“…Finally, placebo responses may also be driven by pretrial beliefs in the drug being tested: In the mock informed-consent forms of three putative trials testing either an antidepressant (desipramine), a prokinetic (alosetron), or a local antibiotic (rifaximin), IBS patients expected the highest efficacy from treatments with which they were familiar (i.e., antibiotics), which the authors called a "pre-cebo" effect, i.e., preconceived notions from being familiar with the drug class (Kim et al, 2012).…”

Section: A Randomized Clinical Trialsmentioning

confidence: 99%

Neuro-Bio-Behavioral Mechanisms of Placebo and Nocebo Responses: Implications for Clinical Trials and Clinical Practice

Schedlowski¹,

Enck²,

Rief³

et al. 2015

Pharmacological Reviews

268

257

View full text Add to dashboard Cite

“…It is a common clinical observation that patients with more positive attitudes toward their treatment appear to have better outcomes, and this is now being backed up by a growing body of research evidence (Kim, Kubomoto, Chua, Amichai, & Pimentel, 2012;Michael, Garry, & Kirsch, 2012). Perhaps somewhat surprisingly, this eff ect can occur with medication, but it is even more important in relation to behavioural treatments, especially as these are time consuming and relatively expensive to provide.…”

Section: Discussionmentioning

confidence: 99%

The Manchester Colour Wheel: Enhancing its Utility

Carruthers

Whorwell

2013

Percept Mot Skills

View full text Add to dashboard Cite

The Manchester Colour Wheel was developed to investigate the role of colour in the perception of illness in gastroenterology. During validation it was found that positive, neutral, or negative connotations of the shade of a colour were more important than the colour itself. However, when asked to relate mood to a colour, the response rate was greater in individuals with mood disorders than healthy controls. This study assessed whether response rate could be made more uniform by changing the wording of the question. Mood/colour choice was compared, using two slightly different questions, in 105 and 203 healthy volunteers, resulting in response rates of 39% and 95% respectively, with the latter not associated with increased false positive responses. These results show that adjustment of the wording of a mood-related question may allow equal response rates irrespective of the mood status of participants.

show abstract

“Pre-Cebo”: An Underrecognized Issue in the Interpretation of Adequate Relief During Irritable Bowel Syndrome Drug Trials

Cited by 8 publications

References 0 publications

Placebo effects and their determinants in gastrointestinal disorders

Placebo effects and their determinants in gastrointestinal disorders

Neuro-Bio-Behavioral Mechanisms of Placebo and Nocebo Responses: Implications for Clinical Trials and Clinical Practice

The Manchester Colour Wheel: Enhancing its Utility

Contact Info

Product

Resources

About