Trial reportThe Journal of allergy and clinical immunology2009
Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.
Trial report in The Journal of allergy and clinical immunology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04129931 (PrecISE), which is not on this map. Cited by 57 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
Who cites it
57 citing papers in PubMed, 9 syntheses or guidelines pooled it, 109 citations in OpenAlex.
- Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2023Pooled it
- How do they add up? The interaction between the placebo and treatment effect: A systematic review.British journal of clinical pharmacology · 2022Pooled it
- Meta-analysis of pain and function placebo responses in pharmacological osteoarthritis trials.Arthritis research & therapy · 2019Pooled it
- Effects of empathic and positive communication in healthcare consultations: a systematic review and meta-analysis.Journal of the Royal Society of Medicine · 2018Pooled it
- Leukotriene-receptor antagonists versus placebo in the treatment of asthma in adults and adolescents: a systematic review and meta-analysis.Annals of internal medicine · 2015Pooled it
- Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies.International journal of epidemiology · 2014Pooled it
- Sex differences in asthma symptom profiles and control in the American Lung Association Asthma Clinical Research Centers.Respiratory medicine · 2013Pooled it
- Interventions to modify health care provider adherence to asthma guidelines: a systematic review.Pediatrics · 2013Pooled it
- Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children.The Cochrane database of systematic reviews · 2012Pooled it
- Pharmacogenomics and Placebo Response in a Randomized Clinical Trial in Asthma.Clinical pharmacology and therapeutics · 2019Trial
- Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.International forum of allergy & rhinology · 2019Trial
- Trial
- Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study.International journal of behavioral medicine · 2018Trial
- Factors associated with depressive symptoms in uncontrolled asthmatics.The Journal of asthma : official journal of the Association for the Care of Asthma · 2018Trial
- Trial
- Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder.Journal of psychiatric research · 2017Trial
- Effect of Continuous Positive Airway Pressure on Airway Reactivity in Asthma. A Randomized, Sham-controlled Clinical Trial.Annals of the American Thoracic Society · 2016Trial
- Obesity and symptoms of depression contribute independently to the poor asthma control of obesity.Respiratory medicine · 2014Trial
- Altered placebo and drug labeling changes the outcome of episodic migraine attacks.Science translational medicine · 2014Trial
- Once-daily indacaterol 75 μg in moderate- to-severe COPD: results of a Phase IV study assessing time until patients' perceived onset of effect.International journal of chronic obstructive pulmonary disease · 2014Trial
Corrections and comments
- Commented on by
Authors and funding
11 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundInformation that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit.
objectiveThe study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit.
methodsA randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control.
resultsPeak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect.
conclusionsOptimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.