Is Placebo Response Responsible for Many Phase III Failures?

Dumitrescu, Teodora Pene; McCune, Jeanine; Schmith, Virginia D.

doi:10.1002/cpt.1632

Cited by 8 publications

(2 citation statements)

References 26 publications

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“…25 Future study designs could consider a placebo runin phase with a variable duration or comparison of multiple dosing schedules. 26 Consistent with the published literature, appetite improved with dexamethasone. 27 Interestingly, fatigue did not improve despite administration of high doses of dexamethasone, 15 although patients were not specifically enrolled for this symptom and Edmonton Symptom Assessment System fatigue as a measure has shown little responsiveness in other clinical trials.…”

Section: Average Unpleasantnesssupporting

confidence: 85%

Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial

Hui¹,

Puac²,

Shelal³

et al. 2022

The Lancet Oncology

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Section: Average Unpleasantnesssupporting

confidence: 85%

Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial

Hui¹,

Puac²,

Shelal³

et al. 2022

The Lancet Oncology

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“…We currently lack validated outcome measures that account for both dyspnea and activity while being responsive to change [27]. Finally, a large placebo effect may be related to regression to the mean, obsequiousness bias, co-interventions, or spontaneous improvement [28].…”

Section: Clinical Trialsmentioning

confidence: 99%

The role of corticosteroids in the palliation of dyspnea in cancer patients: an evidence-based review

Hui,

Yennurajalingam

2023

Current Opinion in Supportive &Amp; Palliative Care

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Purpose of review To provide an evidence-based review on the use of corticosteroids for dyspnea in cancer patients. Recent findings Corticosteroids are commonly used for palliation of dyspnea; however, there is wide variation in how they are prescribed due to the paucity of high-quality evidence. Some clinicians would offer corticosteroids routinely regardless of the causes of dyspnea, while others would only prescribe corticosteroids selectively for specific indications, such as lymphangitic carcinomatosis, upper airway obstruction, superior vena cava obstruction, and cancer treatment-induced pneumonitis. Few mechanistic studies have been conducted to support the use of corticosteroids in cancer patients. Two double-blind, placebo-controlled randomized trials have examined the routine use of high-dose dexamethasone for dyspnea in cancer patients. A pilot study suggested some benefits, but the larger confirmatory trial revealed no improvement compared to the placebo and significantly more adverse events. The selective use of corticosteroids use is only based on observational studies such as case series. Summary The unfavorable risk:benefit ratio of high-dose dexamethasone suggests that it should not be routinely prescribed for dyspnea in cancer patients. More research is needed to assess the selective use of corticosteroids and identify patients most likely be benefit from corticosteroid use.

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CORRIGENDUM: Is Placebo Response Responsible for Many Phase III Failures?

2020

Clin Pharma and Therapeutics

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Is Placebo Response Responsible for Many Phase III Failures?

Cited by 8 publications

References 26 publications

Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial

Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial

The role of corticosteroids in the palliation of dyspnea in cancer patients: an evidence-based review

CORRIGENDUM: Is Placebo Response Responsible for Many Phase III Failures?

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