Evidence Table 4

Quality assessment of randomized-controlled trials in patients with migraine

Internal Validity
Author, YearRandomization adequate?Allocation concealment adequate?Groups similar at baseline?Eligibility criteria specified?Outcome assessors masked?Care provider masked?Patient masked?Reporting of attrition, crossovers, adherence, and contaminationAttrition: differential/highIntention-to-treat (ITT) analysisQuality RatingFunding
Anthony, 1972NoNoNot reportedYesNot reportedNot reportedNot reportedYes -attrition, adherence
No -crossovers, contamination
Yes - differential. Non- completers:
10% (8/79) prindolol
11% (8/73) clonidine
24% (12/51)
carbamazepine
YesPoorBoehringer
Ingelheim Pty
Ltd and Gelgy
Ltd (Australia)
Bartolini, 2005Not reportedNot reportedYesYesNo, open-labelNo, open-labelNo, open- labelYes - attrition, adherence
No - crossovers, contamination
No
Non-completers: 12% (6/49) total, with 3 drop-outs in each drug group
Unclear (49 randomized, 6 drop- outs, results on 44-- 89.9% analyzed)PoorNot reported
Diener, 2007YesYesYesYesNot reportedYesYesYes - attrition, adherence
No - crossovers, contamination
No
Non-completers (double-blind phase):
20% (52/259) placebo
18% (45/255) topiramate
YesGoodJanssen-Cilag
EMEA
Dodick, 2007YesUnclearYesYesNot reportedAssumed - stated double- blind designAssumed - stated double-blind designNot reportedNot reportedNoPoorOrtho-McNeil
Jansson
Scientific Affairs, LLC
Gutpa 2007YesYesYesYesYesYesYesYes - attrition, adherence
No - crossovers, contamination
No
Non-competers: 7% (4/60) for each condition
YesGoodNot reported
Mei, 2006Not reportedNot reportedYesYesNot reportedAssumed - stated double- blind designAssumed - stated double-blind designYes - attrition, adherence
No - crossovers, contamination
No
Non-completers:
30% (9/30) drug
30% (9/30) placebo
Reported as ITT but 70% were analyzedFairNot reported
Millan-Guerrero,
2007
Not reportedNot reportedYesYesNot reportedYesYesYes - attrition
No - adherence, crossovers, contamination
No
Non-completers:
13% (6/46) sodium valproate
11% (5/46) histamine
NoFairNot reported
Silberstein, 2006Not reportedNot reportedYesYesYesYesAssumed - stated double-blind designYes - attrition, adherence
No - crossovers, contamination
Yes - differential
Non-completers:
31% (43/140) topiramate
18% (13/73) placebo
Yes with LOCFFairOrtho-McNeil
Neurologics, Inc, NJ
Silberstein, 2007Does not clearly meet standardDoes not clearly meet standardYesYesNot reportedAssumed - stated double- blind designAssumed - stated double-blind designYes - attrition, adherence
No - crossovers, contamination
Yes - high loss
Non-completers:
44% (73/165) topiramate
45% (73/163) placebo
YesFairOrtho-McNeil
Neurologics, Inc, NJ
Silberstein, 2008Does not clearly meet standardDoes not clearly meet standardYesYesYesYesYesYes - attrition, adherence
No - crossovers, contamination
Yes - differential
Non-completers:
38% (32/85) oxcarbazepine
21% (18/85) placebo
YesFairNovartis Pharmaceuticals Corporation
Silvestrini, 2003Not reportedNot reportedYesYesNot reportedNot reportedYesYes - attrition
No - adherence, crossovers, contamination
No
Non-completers:
7% (1/14) topriamate 50 mg/d
0% (0/14) placebo
YesFairNot reported

From: Evidence Tables

Cover of Drug Class Review: Antiepileptic Drugs for Indications Other Than Epilepsy
Drug Class Review: Antiepileptic Drugs for Indications Other Than Epilepsy: Final Report Update 2 [Internet].
McDonagh M, Peterson K, Lee N, et al.
Portland (OR): Oregon Health & Science University; 2008 Oct.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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