Evidence Table 8b

Quality assessment of randomized controlled trials (new for Update #2)

AuthorYearRandomization method described?Allocation concealment method described?Groups similar at baseline?CommentsInclusion criteria specified?Exclusion criteria specified?Outcome assessors masked?Care provider masked?Patients masked?Attrition reported?Loss to fu differential or high?CommentsITT analysis?CommentPost-randomization exclusions ?CommentWithdrawal rate differential or high?CommentHandling of carryover effects (for crossover studies only)Funding
Berry2006Method not describedMethod not describedYesYesNRNRNRYesNoUnable to determineNoNo
Fava2006Method not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYes50/545 (9.2%), not differentialYes543/545 analyzed (99.6%)Yes40 for protocol violation, did not meet entry criteria, or “other”Yes172/545 (31.6%)Sepracor
Kryger2007Method not describedMethod not describedNRNot reported by order of randomizationYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoYesNoNono dropoutswashoutTakeda
Krystal 20082008Method not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesYes77/1018 (7.6%)Yes1016/1025 analyzed (99.1%)Yes43 for poor complianceYes405/1018 (39.8%)Sanofi- Aventis
McCall2006Method not describedMethod not describedYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesNoUnable to determineNoNo9/264 (3.4%)Sepracor
Rosenberg2007Method not describedMethod not describedNRNot reported by order of randomizationYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoYesYes1 excluded for protocol violationNo1/22 (4.5%)washoutSepracor
Roth 20072007Method not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoYesNoNoNo dropoutswashoutTakeda
Soares2006Method not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNo4/410 (1%)YesYes13 for protocol violation, did not meet entry criteria, or otherNo51/410 (12.4%)Sepracor
Walsh2008Method not describedYesNoNumber of awakenings and sleep quality higher in placebo group (different directions)YesYesYesUnclear, reported as double blindYesYesNoYes199/205 analyzed (97.1%)Yes1 for poor complianceNo7/205 (3.4%)Sanofi- Aventis
Walsh (eszopiclone)2007Method not describedMethod not describedYesYesYesYesYesYesYesNo9.6%Yes548/550 analyzedYes35 discontinued for protocol violation; 20 for other reasonsYesMore placebo patients discontinued (52% vs 37%) 80/830 discontinued overall (9.6%)Sepracor
Zammit (ramelteon)2007Method not describedYesNoDifferences in weight and sex at baselineYesYesYesYesYesNo1/405NoYes6 for protocol deviation, 1 for noncomplianceNo34/405 withdrew (8.4%); not reported by groupTakeda

From: Evidence Tables

Cover of Drug Class Review: Newer Drugs for Insomnia
Drug Class Review: Newer Drugs for Insomnia: Final Report Update 2 [Internet].
Carson S, McDonagh MS, Thakurta S, et al.
Portland (OR): Oregon Health & Science University; 2008 Oct.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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