AuthorYearQuality ratingRandomization method adequate?Allocation concealment method adequate?Groups similar at baseline?CommentsInclusion criteria specified?Exclusion criteria specified?Outcome assessors masked?Care provider masked?Patients masked?Attrition reported?Adherence reported?Contamination reported?Loss to followup differential or high?CommentsIntention to treat analysis?CommentsPost- randomization or post- enrollment exclusions?CommentsFunding
Akhila2006POORMethod not describedMethod not describedYesNoNoNRNoNoYesNoNoYesNo88/116 analyzed (75.9%)Unable to determineNot reported
Almeida2006FAIRYesYesYesYesYesYesUnclear, reported as double blindYesYesNoNoNoYesall analyzed, LOCFNoFoundation
Arrenbrecht2004POORMethod not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoNoUnable to determineNo80.1% analyzedUnable to determineNot reported
Baksu2005FAIRMethod not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoNoNoNoCompleters only analyzedUnable to determineNot reported
Crisafulli2004FAIRYesMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoNoNoYesUnable to determineNot reported
Dayal2005FAIRYesMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoNoNoYesYes8 women withdrew prior to receiving medicationBerlex
Ettinger, Diem 20062004FAIRYesMethod not describedNoLumbar spine BMD lower in placebo groupYesYesYesYesYesYesNoNoNoYesLOCFNoBerlex; one author holds a patent on the study drug
Gambacciani2005POORMethod not describedMethod not describedYesYesYesNRNRNRNoNoUnable to determineUnable to determineUnable to determineNot reported
Greenspan (A)2003FAIR- GOODYesYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesYesNoNoYesNoNIH, Merck, and Wyeth
Greenspan (B)2005FAIRYesMethod not describedYesYesYesYesYesUnclear, reported as double blindYesNoNoNoYesYes3 excluded for medical contraindicationNIH; Wyeth and Merck provided study medication
Greenwald2005FAIR- POORMethod not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoNoNoYesLOCFUnable to determineNovo Nordisk
Heikkinen2004POORYesYesYesYesYesNoNoNoYesNoNoUnable to determineNo316/464 analyzed (68.1%); Only completers and those without missing data were analyzedYes52 women excluded because of missing data, poor quality of BMD scans, or presence of bone deformitiesSchering AG
Heinrich2005POORNot randomizedNot randomizedNRGroups balanced for age, BMI and verbal IQYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoNoNoNo35/51 analyzed (68.6%), compliant subjects not analyzedYes5/51 for non complianceFoundation
Joffe2006FAIRMethod not describedMethod not describedYesYesYesYesYesYesYesNoNoNoYesNoPfizer; Berlex provided study medication
Levine2005FAIRMethod not describedMethod not describedNRYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoNoUnable to determineUnable to determineUnclear how many patients analyzedUnable to determineNot reported
Liu2005FAIRMethod not describedYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesYesNoUnable to determineYesUnable to determineNIH (National Institute of Aging)
Newton2006FAIRYesYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesYesNoNoYes95% analyzed at 3m, 92% at 12mNoNIH
Odmark2004FAIRYesMethod not describedYeslower DBP and higher BMI in starters vs switchersYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoNoNoNosymptom scores on 208/249 (83.5%)Yes1 excluded due to loss of diary card and rating scales; 2 never started treatmentWyeth
Pornel2005POORMethod not describedMethod not describedNRReported for efficacy evaluable population onlyYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesYesNoUnable to determineNoReport main outcome on 476/1143 patients only. Number in ITT population not reportedUnable to determineNot reported
Reddy2006FAIRYesMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesYesNoNoYesYes2/60 for non complianceNIH; Pfizer provided gabapentin; one author has patent on gabapentin for hot flushes
Reid2004FAIRMethod not describedMethod not describedYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoNo28/619 (4.5%)YesYes6/619 (0.9%) patients never received study drug; additionally, 5.0% discontinue d for protocol violation.Lilly
Schiff2005FAIR- POORYesYesNRYesYesNRNRNRYesYesNoNoNo19/24 analyzed (79.2%)Yes2/24 excluded for lack of complianceMerck
Schurmann2004FAIRMethod not describedMethod not describedNRYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoNoNoYesNoSchering
Serrano2006FAIRYesYesYesYesYesNoNoNoYesNoNoNoNo184/226 (81.4%) analyzedNoSusan G. Komen
Foundation and Italian
Foundation for Cancer Research
Speroff (A)2006FAIRYesMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesYesNoNoYes289/293 analyzed (98.6%)NoWarner Chilcott
Speroff (B)2000FAIRMethod not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoNoNoUnable to determineUnclear how many analyzedUnable to determine
Utian2005FAIRYesYesNofewer women in EA group had dyspareunia (27.6% vs 38% in estradiol and 36.6% in CEE groups)YesYesUnclear, reported as double blindUnclear, reported as double blindYesYesYesNoNoYesYes1 woman who never took study drugWarner Chilcott
Warming (A)2004FAIR- POORMethod not describedYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoNoNoNoAppears that only completers analyzed (180/240) (states ITT)NoNot reported; one author from Wyeth
Warming (B)2005FAIRMethod not describedMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesYesNoNoNoYesUnable to determine4% other Table 4Not reported
Weisberg2005FAIRYesNoYesYesYesPartial (for some outcomes)NoNoYesYesNoUnable to determineNo155/185 analyzed (83.8%)Unable to determinePharmacia Upjohn
Wolf2005POORNot randomizedNot randomizedYesYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindYesNoNoNoNo35/51 analyzed = 69%YesGovernmen
Yaffe2006FAIRMethod not describedMethod not describedYesYesYesYesYesYesYesYesNoNoYes417 analyzed, but not clear how missing data handledNoBerlex and National Institute on Aging

From: Appendix G. Quality assessment of trials added for Update #3

Cover of Drug Class Review: Hormone Therapy for Postmenopausal Women or Women in the Menopausal Transition Stage
Drug Class Review: Hormone Therapy for Postmenopausal Women or Women in the Menopausal Transition Stage: Final Report Update # 3 [Internet].
Nelson HD, Nygren P, Freeman M, et al.
Portland, (OR): Oregon Health & Science University; 2007 Oct.
Copyright © 2007, Oregon Health & Science University, Portland, Oregon.

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