Increasing placebo responses over time in U.S. clinical trials of neuropathic pain
@article{Tuttle2015IncreasingPR, title={Increasing placebo responses over time in U.S. clinical trials of neuropathic pain}, author={Alexander H. Tuttle and Sarasa Tohyama and Tim Ramsay and Jonathan Kimmelman and Petra Schweinhardt and Gary J. Bennett and Jeffrey S. Mogil}, journal={PAIN}, year={2015}, volume={156}, pages={2616–2626} }
Abstract Recent failures of clinical trials of novel analgesics designed to treat neuropathic pain have led to much speculation about the underlying reasons. One often discussed possibility is that the placebo response in these trials has increased in recent years, leading to lower separation between the drug and placebo arms. Whether this has indeed occurred has not yet been adequately addressed. Here, we extracted data from published randomized controlled trials (RCTs) of drugs for the…
158 Citations
Additional considerations for increasing placebo response.
- Psychology, MedicinePain
- 2016
The authors report an increase placebo response over time and hypothesize that the United States studies would be associated with a lower risk of bias (ie, higher quality), and suggest that study quality assessment be included in future iterations of the analyses.
Increasing uncertainty in CNS clinical trials: the role of placebo, nocebo, and Hawthorne effects
- Psychology, MedicineThe Lancet Neurology
- 2016
Can knowledge of Placebo and Nocebo Mechanisms Help Improve Randomized Clinical Trials?
- MedicineInternational review of neurobiology
- 2018
Size does matter, but it isn't everything: the challenge of modest treatment effects in chronic pain clinical trials.
- Medicine, PsychologyThe journal of pain : official journal of the American Pain Society
- 2019
Meta-analysis comparing placebo responses in clinical trials of painful HIV-associated sensory neuropathy and diabetic polyneuropathy
- Medicine, PsychologyScandinavian journal of pain
- 2020
A meta-analysis of the magnitude of placebo response and the proportion of placebo responders between trials of systemic pharmacological intervention in HIV-SN and a comparable neuropathic condition, diabetic polyneuropathy, found no significant difference.
Placebo response in neuropathic pain after spinal cord injury: a meta-analysis of individual participant data
- Medicine, PsychologyJournal of pain research
- 2018
The current meta-analysis of individual patient data demonstrated the importance of sex and baseline pain intensity on changes in pain ratings in the placebo arm of SCI central neuropathic pain randomized controlled clinical trials, indicating that placebo responses occur independent of injury characteristics.
How May Placebo Mechanisms Influence Orofacial Neuropathic Pain?
- Psychology, MedicineJournal of dental research
- 2019
The new definitions, magnitude, and social, psychological, neurobiologic, and genetic mechanisms of placebo effects in pain, especially neuropathic pain, are reviewed to illustrate that placebo effects are not simply response bias but psychoneurobiological phenomena that can be measured at many levels of the neuroaxis.
Pain, placebo, and test of treatment efficacy: a narrative review.
- Medicine, PsychologyBritish journal of anaesthesia
- 2019
Oral pharmacotherapeutics for the management of peripheral neuropathic pain conditions – a review of clinical trials
- MedicineExpert opinion on pharmacotherapy
- 2020
This narrative review presents the results of different prospective, randomized controlled trials, systematic reviews and meta-analyses assessing the effects of different oral medications in the management of various peripheral neuropathic pain conditions and concludes that none of them were significantly superior.
Consideration in Randomized Placebo-Controlled Trial on Neck Pain to Avoid the Placebo Effect in Analgesic Action
- Medicine, PsychologyFrontiers in Pharmacology
- 2022
Logistic regression analysis finds neck pain patients with shorter disease duration are more likely to overscore their pain severity, because of their less experience in pain perception, tolerance, and analgesia expectation.
References
SHOWING 1-10 OF 43 REFERENCES
Clinical trial outcome in neuropathic pain
- Medicine, PsychologyNeurology
- 2008
The results suggest that study characteristics may contribute to the outcomes of clinical trials of treatments for neuropathic pain and provide an impetus for investigating strategies for decreasing placebo response rates and thereby possibly increasing the likelihood of positive outcomes in trials of efficacious treatments.
Predictors of the placebo analgesia response in randomized controlled trials of chronic pain: a meta-analysis of the individual data from nine industrially sponsored trials
- Medicine, PsychologyPain
- 2015
It is thought that patients' perception of treatment allocation and expectations toward treatment efficacy could potently predict outcomes of RCTs, supporting the expectancy hypothesis.
Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain
- Psychology, MedicineNeurology
- 2005
There is little evidence that decreasing the placebo response rate makes it more likely that superiority of active vs. placebo treatment will be demonstrated, and analyses of neuropathic pain clinical trial databases should be conducted to examine factors associated with trial outcomes.
Placebo response changes depending on the neuropathic pain syndrome: results of a systematic review and meta-analysis.
- Medicine, PsychologyPain medicine
- 2012
The placebo response for a decline in pain intensity and responder rate was smaller in trials that assessed central pain and postherpetic neuralgia (PHN) and larger in Trials that assessed HIV pain.
Placebo response in studies of major depression: variable, substantial, and growing.
- Medicine, PsychologyJAMA
- 2002
The response to placebo in published trials of antidepressant medication for MDD is highly variable and often substantial and has increased significantly in recent years, as has the response to medication.
Systematic review: Placebo response in drug trials of fibromyalgia syndrome and painful peripheral diabetic neuropathy—magnitude and patient-related predictors
- Medicine, PsychologyPAIN®
- 2011
Placebo response in antipsychotic clinical trials: a meta-analysis.
- Medicine, PsychologyJAMA psychiatry
- 2014
The average treatmentChange associated with placebo treatment in antipsychotic trials increased since 1960, while the change associated with medication treatment decreased, indicating that the average drug-placebo difference significantly decreased over time, with decreasing baseline severity and with increasing study duration.
Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder.
- Psychology, MedicineThe American journal of psychiatry
- 2009
OBJECTIVE
The authors examined characteristics and predictors of response to placebo in all available reports of short-term randomized controlled trials of antidepressants for pediatric major…