O’Brien A, Russo-Magno P, Karki A, et al. Effects of withdrawal of inhaled steroids in men with severe irreversible airflow obstruction. American Journal of Respiratory and Critical Care Medicine 2001;164:365-71.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/11500334
| Methods | Study design: Randomized double-blind placebo-controlled study with a crossover design
Number of groups: Two groups |
| Participants | Number of participants: 24 randomized, 15 completed
Age: 66.9 ± 1. 9 years, range 40 to 79 years Sex: 0 female, 24 male Participants with dementia: No Inclusion criteria · Used beclomethasone dipropionate measured dose inhaler inhaler · Lung volume and diffusing capacity of the lungs for carbon monoxide measurement obtained within 2 years · Baseline spirometry pre- and post- bronchodilator with <12% reversibility of forced expiratory volume and forced vital capacity Exclusion criteria: · Not described Country: United States of America Setting: Community – out-patient pulmonary department of a university-affiliated Veterans Administration Medical Center in Providence |
| Interventions | Medicine: Inhaled corticosteroids
Withdrawal schedule: Not described Comparator: Placebo compared to continued treatment |
| Outcomes | Exacerbations
Chronic Respiratory Disease Questionnaire Exercise capacity measured using the Borg scale, oxygen saturation, and mean distance walked Spirometry Sputum analysis |
| Dates | Dates: Not described
Follow-duration: 12 weeks |
| Funding sources | VA Merit Review and a VA/Department of Defense Collaborative Research Grant (S. Rounds) |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | “Randomization was performed by the clinical pharmacist who randomized an odd number dice roll to placebo and an even number dice roll to drug.” |
| Allocation concealment (selection bias) | Low risk | Method not described but probably done as randomization performed by pharmacist separate to physician. Patients given placebo inhalers |
| Blinding of participants and personnel (performance bias) | Low risk | “The subject and the pulmonary physician were blinded to the treatment regimen.”
“Placebo and drug metered-dose-inhaler (MDI) canisters were identical, and the placebo mist was flavored to make the treatments indistinguishable.” |
| Blinding of outcome assessment (detection bias) | Low risk | As above |
| Incomplete outcome data (attrition bias) | High risk | “Data were analyzed only from patients who completed both stages of the study, i.e., those who followed protocol; no patient data were analyzed according tointention-to-treat.” |
| Selective reporting (reporting bias) | Unclear risk | There was no pre-published protocol. However, the stated objectives were reported.
CRQ |
| Other bias | Unclear risk | Unclear how/where the participants were recruited. Limited detail. |
Leave a Reply