TY - JOUR
T1 - A meta-analysis of sleep changes associated with placebo in hypnotic clinical trials
AU - McCall, William Vaughn
AU - D'Agostino, Ralph
AU - Dunn, Aaron
PY - 2003/1
Y1 - 2003/1
N2 - Objectives: The effects associated with placebo (EAP) have been incompletely described in clinical trials of insomnia treatment. We conducted a meta-analysis of insomnia medication trials for the purpose of estimating the magnitude of sleep EAP. Method: We reviewed Medline for 1966 through 2000 for the meta-analysis. The subject heading of insomnia restricted to the subheading of drug therapy was crossed against the results of a search on the subjects heading placebo and text word placebo. We selected only papers that examined primary insomnia, incorporating both placebo and active medication therapies in a randomized, double-blind, parallel-group design. We required that results be reported for 1, 2, 3, or 4 weeks of treatment, and that outcomes be reported in hours/minutes. Results: Five papers satisfied our requirements for eligibility, comprising 213 patients receiving placebo for a 2-week interval. Subjective sleep latency demonstrated a significant reduction (mean ± S.E.) of 13.1 ± 2.0 min (95% confidence interval (CI) 9.2, 17.0) for the placebo group after combining the data across studies. Subjective total sleep time demonstrated a significant increase of 13.5 ± 5.4 min (95% CI 2.9, 24.0). Polysomnographic (PSG) sleep latency demonstrated a non-significant reduction of 2.5 ± 4.3 min (95% CI -5.9, 10.9). Conclusions: The confirmation of EAP in insomnia clinical trials argues for the retention of a placebo control in future insomnia clinical trials.
AB - Objectives: The effects associated with placebo (EAP) have been incompletely described in clinical trials of insomnia treatment. We conducted a meta-analysis of insomnia medication trials for the purpose of estimating the magnitude of sleep EAP. Method: We reviewed Medline for 1966 through 2000 for the meta-analysis. The subject heading of insomnia restricted to the subheading of drug therapy was crossed against the results of a search on the subjects heading placebo and text word placebo. We selected only papers that examined primary insomnia, incorporating both placebo and active medication therapies in a randomized, double-blind, parallel-group design. We required that results be reported for 1, 2, 3, or 4 weeks of treatment, and that outcomes be reported in hours/minutes. Results: Five papers satisfied our requirements for eligibility, comprising 213 patients receiving placebo for a 2-week interval. Subjective sleep latency demonstrated a significant reduction (mean ± S.E.) of 13.1 ± 2.0 min (95% confidence interval (CI) 9.2, 17.0) for the placebo group after combining the data across studies. Subjective total sleep time demonstrated a significant increase of 13.5 ± 5.4 min (95% CI 2.9, 24.0). Polysomnographic (PSG) sleep latency demonstrated a non-significant reduction of 2.5 ± 4.3 min (95% CI -5.9, 10.9). Conclusions: The confirmation of EAP in insomnia clinical trials argues for the retention of a placebo control in future insomnia clinical trials.
KW - Ethics
KW - Hypnotics
KW - Meta-analysis
KW - Placebo
KW - Sleeping pills
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U2 - 10.1016/s1389-9457(02)00242-3
DO - 10.1016/s1389-9457(02)00242-3
M3 - Article
C2 - 14592361
AN - SCOPUS:12244295469
SN - 1389-9457
VL - 4
SP - 57
EP - 62
JO - Sleep Medicine
JF - Sleep Medicine
IS - 1
ER -