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Evidence Table 9Original report: Quality assessment of included trials

Author
Year
Country
Quality ratingRandomization adequateAllocation concealment adequateGroups similar at baselineEligibility criteria specifiedOutcome assessors maskedCare provider maskedPatients maskedReporting of attrition crossover adherence and contaminationCarryover effects handling (if crossover design)Withdrawal rate high (>85%)Loss to follow-up
Differential or high
Intent-to-treat analysis (at least 95% analyzed)Post randomization or post enrollment exclusionsNumber Screened
Eligible Enrolled
Exclusion criteria specifiedFunding
Backonja
1998
US
FairYesMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
16.7% gabapentin, 19.8% placebo
NoYes
<5% not analyzed
Yes
lack of compliance (n=6 total)
Screened: 232
Eligible: 221
Enrolled: 165
YesParke-Davis
Beydoun
2006
US
FairYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYesNoYes
Used LOCF, but number analyzed not clear
NoScreened: NR
Eligible: NR
Enrolled: 347
YesNovartis
Bone
2002
UK and Ireland
FairYesYesNR
Only baseline pain levels reported as NSD between groups
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
WashoutYes
5/19 (26.3%) withdrew
NoYesNoScreened: 33
Eligible: 27
Enrolled: 19
YesPfizer provided study medication
Campbell
1966
England
PoorYesMethod not describedNo
6% of carbamazepine first group vs 29% of placebo first group had been injected for pain; otherwise similar
NoNRNRYesAttrition: Yes
Crossover: Yes
Adherence: No
Contamination: No
NoNoNo
70/76 analyzed
Yes
7/77 post- randomization exclusions
Screened: NR
Eligible: NR
Enrolled: 77
NoNot reported (Geigy Pharmaceuticals supplied carbamazepine)
Cardenas
2002
US
FairMethod not describedYesYesYesYesYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NANo
11/84 (13.1%)
NoYesNoScreened: 282
Eligible: 157
Enrolled: 84
YesGovernment funded (NIH and Dept of Education)
Chandra
2006
India
FairYesYesYesYesYesYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NANo
7.9% overall (2/38 nortriptyline, 4/38 gabapentin)
NoNo
70/76 analyzed (92.1%)
NoScreened: 110
Eligible: 79
Enrolled: 76
YesPfizer (partly)
Dalessio
1966
US
PoorMethod not describedMethod not describedNRNoUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NoneYes
20%
NoYesNoScreened: NR
Eligible: NR
Enrolled: 10
NoGeigy provided study drug, otherwise NR
Dallocchio
2000
Italy
FairMethod not describedMethod not describedYesYesNoNoNoAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NANoNoYesNoScreened: NR
Eligible: NR
Enrolled: 25
YesNot reported
Dogra
2005
US
FairYesMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
40/146
NoYesNoScreened: 289
Eligible: 156
Enrolled: 146
YesNovartis
Drewes
1994
Denmark
FairMethod not describedMethod not describedNR
Crossover
YesYesUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutNoNoYesYes
1/20
Screened: NR
Eligible: NR
Enrolled: 20
YesRhone-Poulenc
Rorer A/S
Dworkin
2003
US
FairYesYesYesYesYesYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
34.8% pregabalin, 11.9% placebo
NoYes
LOCF
excluded for lack of efficacy (n=6)Screened: 245
Eligible: 188
Enrolled: 173
YesPfizer
Eisenberg
2001
Israel
FairYesMethod not describedNo
duration of sx's longer in lamotrigine arm
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
13/59 (22%)
NoNoNoScreened: 160
Eligible: NR
Enrolled: 59
YesGlaxo-Wellcome
Finnerup
2002
Denmark
FairYesYesNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
WashoutYesNoNo
22/30 analyzed
NoScreened: 436
Eligible: 100
Enrolled: 30
YesFoundation and government; Glaxo provided medication
Freynhagen
2005
Multiple European
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
129/338 (38.2%)
NoYes
2/338 not analyzed (<1%)
Yes
7.3% for lack of compliance of other reason
Screened: 503
Eligible: NR
Enrolled: 338
YesPfizer
Galer (A)
2002
US
PoorMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: No
Crossover: No
Adherence: No
Contamination: No
NAUnable to determineUnable to determineNo
Only analyzed those with final data; Number randomized NR (only number analyzed)
Unable to determineScreened: 150
Eligible: NR
Enrolled: NR
NoEndo Pharmaceuticals
Galer (B)
1999
US
FairMethod not describedMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NRNoNoYesNo
<5% (1 patient who had a stroke)
Screened: NR
Eligible: NR
Enrolled: 33
YesHind Health Care, Inc.
Gilron (A)
2005
Canada
FairMethod not describedYesYesYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
AnalysisYes
Attrition 16/57
Unable to determineUnable to determine
Not clear-states no patients excluded for missing data, but number analyzed not explicit, and 16 withdrawals
Unable to determine
Reasons for withdrawal NR (13/57)
Screened: 86
Eligible: 70
Enrolled: 57
YesGovernment (Canadian Institutes of Health Research). Study medication provided by Pfizer and Aventis-Pharma
Gilron (B)
2001
US
PoorMethod not describedMethod not describedYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutNoNoYesNoScreened: NR
Eligible: NR
Enrolled: 3
YesGovernment (NIH) and Ortho-McNeil
Goldstein
2005
US
FairYesYesYes
More women in placebo group (48.7% vs 35%, p=0.033); otherwise similar
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYesNoNo
347/457 analyzed for primary outcome
Yes
17 subjects in total due to sponsor decision or protocol violation
Screened: 763
Eligible: 457
Enrolled: 457
YesEli Lilly and PRN Consulting
Gorson
1999
FairMethod not describedMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: No
Crossover: No
Adherence: No
Contamination: No
WashoutNoNoYesNoScreened: NR
Eligible: NR
Enrolled: 40
YesWarner-Lambert (Parke-Davis Pharmaceuticals)
Hahn
2004
Germany
FairMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
19%
NoNo
24/26 analyzed (92.3%)
NoScreened: NR
Eligible: NR
Enrolled: 26
YesPfizer
Hammack
2002
US
FairBalanced allocationNot applicableYesYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
WashoutNoNoYes
Imputation for missing data
Yes
6/57
Screened: NR
Eligible: NR
Enrolled: 57
Yes
Kalso
1996
Finland
FairMethod not describedYesNRYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
Yes
5/20 (25%)
NoNoYes
1/20 excluded due to noncompliance
Screened: NR
Eligible: NR
Enrolled: 20
YesAcademy of Finland, Paulo Foundation, Centre for International Mobility
Kieburtz
1998
US
FairYesYesYesYesYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
35/145 (24%)
NoNoNoScreened: NR
Eligible: NR
Enrolled: 145
YesGovernment (NIH); medication provided by Boehringer-Ingelheim.
Killian
1968
US
PoorMethod not describedMethod not describedNRYesUnclear, reported as double blindYesYesAttrition: No
Crossover: No
Adherence: No
Contamination: No
NAUnable to determineUnable to determineNo
36/42 analyzed
Unable to determineScreened: NR
Eligible: NR
Enrolled: 42
Kishore-Kumar
1990
US
PoorMethod not describedMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NoneYes
7/26
NoNo
19/26 (73%)
NoScreened: NR
Eligible: NR
Enrolled: 26
YesNot reported
Kochar (A)
2002
India
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NANoNoNoYesScreened: 60
Eligible: NR
Enrolled: 57
YesNot reported
Kochar (B)
2004
India
FairMethod not describedMethod not describedNR
Baseline characteristics reported on 39/43 analyzed
YesYesUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NANoNoNoNoScreened: 48
Eligible: 44
Enrolled: 43
YesNot reported
Kochar (C)
2005
India
FairMethod not describedMethod not describedYes
Baseline data reported for 40/45 completers only
YesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NANoNoNoNoScreened: 48
Eligible: 45
Enrolled: 45
YesNot reported
Kvinesdal
1984
Denmark
FairMethod not describedMethod not describedNR
Crossover
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NoneYesNoNoNoScreened: NR
Eligible: NR
Enrolled: 15
YesNot reported (tablets provided by Dumex Ltd)
Leijon
1989
Sweden
FairMethod not describedMethod not describedNRYesYesYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutNoNoNoNoScreened: 27
Eligible: 15
Enrolled: 15
YesGovernment and foundation (County Council of Ostergotland and Swedish Association of the Neurologically Disabled)
Lesser
2004
US
FairMethod not describedYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NANoNoYesNoScreened: 578
Eligible: NR
Enrolled: 338
YesPfizer
Levendoglu
2004
Turkey
FairMethod not describedMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutNoNoYesNoScreened: NR
Eligible: NR
Enrolled: 20
YesNo funds received
Max (A)
1987
US
FairMethod not describedMethod not describedNRYesYesYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NoneYesNoNoUnable to determineScreened: NR
Eligible: NR
Enrolled: 37
YesNot reported
Max (B)
1991
US
FairMethod not describedMethod not describedNRYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NoneYes
16.7% withdrew
NoNo
20/24 analyzed (83.3%)
NoScreened: NR
Eligible: NR
Enrolled: 24
YesNot reported
Max (C)
1988
US
FairMethod not describedMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutYes
21/62 (34%)
NoNo
41/62 who completed both arms (partial sensitivity analysis on 11/21)
Unable to determineScreened: NR
Eligible: NR
Enrolled: NR
Yes
McCleane
1999
UK
PoorYesMethod not describedNR
Data only reported for 74/100 patients completing trial
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYesNoNo
74/100 analyzed
Unable to determineScreened: NR
Eligible: NR
Enrolled: 100
YesNot reported
Meier
2003
Germany and Switzerland
PoorYesMethod not describedNRYesYesYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: Yes
WashoutYes
18/58 (31%)
NoNo
40/58 analyzed (69%)
Yes
3/58 excluded for non-permitted medications
Screened: 67
Eligible: 61
Enrolled: 58
YesIBSA (Pambio- Noranco, Switzerland)
Morello
1999
US
FairMethod not describedNRYesNoYesYesAttrition: Yes
Crossover: Yes
Adherence: Yes
Contamination: No
WashoutYesNoNoNo
3/28 pre- randomization exclusions
Screened: NR
Eligible: 28
Enrolled: 25
YesNot reported
Otto
2004
Denmark
FairYesYesNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NRNoNoNoYesScreened: 95
Eligible: 63
Enrolled: 37
YesNot reported
Panerai
1990
Italy
PoorMethod not describedMethod not describedNR
No baseline data on drop-outs
YesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutYesNoNo
24/39 (62%) analyzed
NoScreened: NR
Eligible: NR
Enrolled: 39
YesNot reported
Raja
2002
US
FairYesYesNR
Crossover
YesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutYesUnable to determineUnable to determineYesScreened: 103
Eligible: 85
Enrolled: 76
YesNIH
Raskin (A)
2004
US
FairYesMethod not describedNo
weight higher in topiramate group (101.4 vs 95.7 kg, p=0.028
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYesNoYesNoScreened: 553
Eligible: NR
Enrolled: 323
YesOrtho-McNeil
Raskin (B)
2005 and 2006
US
FairYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NANoNoYes
340/348 randomized analyzed for primary endpoint
Yes
1.8 and 2.6% due to physician decision or protocol violation
Screened: 475
Eligible: NR
Enrolled: 348
YesEli Lilly
Rice
2001
UK
FairYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
18.6%
NoNo
306/334 were analyzed=91.6%
Yes
2.4% withdrew because of "other" reason, not specified
Screened: 411
Eligible: 359
Enrolled: 334
YesPfizer
Richter
2005
US
FairYesMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NANo
Attrition P: 15%, I1: 5%, I2: 12%
NoYes
3 patients in placebo group not analyzed (<5%)
NoScreened: 396
Eligible: 261
Enrolled: 246
YesPfizer
Robinson
2004
US
FairMethod not describedYesYesYesYesYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NANoNoNoNoScreened: 457
Eligible: 218
Enrolled: 39
YesGovernment (NIH)
Rockliff
1966
US
PoorMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: No
Crossover: No
Adherence: No
Contamination: No
NoneUnable to determineUnable to determineUnable to determineUnable to determineScreened: NR
Eligible: NR
Enrolled: NR
YesGeigy Pharmaceuticals
Rosenstock
2004
US
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NANoNoYesYes
lack of compliance (n=5)
Screened: 225
Eligible: 165
Enrolled: 146
YesPfizer
Rowbotham (A)
1996
US
FairMethod not describedMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
WashoutNo
35/40 completed
NoNo
35/40 (87.5%) analyzed
Yes
2/40 (5%)
Screened: NR
Eligible: NR
Enrolled: 40
YesHarry Hind and NIH
Rowbotham (B)
2004
US
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYes
42/245 withdrew (17.1%)
NoYes
Analyzed has >=1 dose, 3 FU measures, and used LOCF
Yes
3/245 for protocol violation
Screened: NR
Eligible: NR
Enrolled: 245
YesWyeth
Rowbotham (C)
1998
US
FairYesMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
19.7%
NoYesYes
excluded for lack of compliance (n=3 overall)
Screened: 292
Eligible: NR
Enrolled: 229
YesParke-Davis
Rull
1969
Mexico
FairMethod not describedMethod not describedNRYesYesYesYesCrossover: No
Adherence: No
Contamination: No
NRNoUnable to determineUnable to determineUnable to determineNoNot reported
Sabatowski
2004
Multiple European and Australia
FairYesMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYesNoYes
TT population was 238/253 (94.1%) randomized and received one dose of study medication
Yes
3.8%
Screened: 307
Eligible: 253
Enrolled: 238
YesParke-Davis/Pfizer
Serpell
2002
UK and Republic of Ireland
FairYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYes
23.8%
No
I 5%, P 6%
Unable to determine
Number analyzed for efficacy not reported
NoScreened: 351
Eligible: 327
Enrolled: 307
YesParke-Davis
Shlay
1998
US
FairMethod not describedYesYesYesYesUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYes
48/136 (35%)
NoYesNoScreened: NR
Eligible: NR
Enrolled: 136
YesNational Institute of Allergy and Infectious Disease
Siddall
2006
Australia
FairYesMethod not describedYesYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYes
51/137 (37.2%)
NoYes
136/137 analyzed (99.3%)
NoScreened: 165
Eligible: 143
Enrolled: 137
YesPfizer
Simpson (A) Part 1
2001
US
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NANoNoNo
54/60 analyzed
Unable to determineScreened: NR
Eligible: NR
Enrolled: 60
YesNot reported
Simpson (A) Part 2
2001
US
FairMethod not describedMethod not describedNR
Yes for pain score, other characteristics NR
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NANoNoYesNoEligible: 12
Enrolled: 11
YesNot reported
Simpson (B)
2003
US
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYesNoYesNoScreened: NR
Eligible: NR
Enrolled: 227
YesGlaxoSmithKline
Simpson (C)
2000
US
FairYesYesNo
CD4 count higher in lamotrigine group (p=0.01); baseline characteristics reported for
YesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYesNoYesNoScreened: NR
Eligible: NR
Enrolled: 42
YesGlaxo Wellcome
Sindrup (A)
1989
Denmark
PoorMethod not describedMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NRYesNoNo
9/13 analyzed (69.2%)
Yes
1/13 (MI)
Screened: NR
Eligible: NR
Enrolled: 13
YesResearch Foundation of Vejle County, Denmark. Medication and placebo provided by Ciba-Geigy.
Sindrup (B)
1990
Denmark
PoorMethod not describedMethod not describedNRYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutYes
7/26 (26.9%) withdrew
NoNo
19/26 (73.1%) analyzed
Unable to determineScreened: NR
Eligible: NR
Enrolled: 26
Danish Diabetes Association; Ciba- Geigy provided medications and placebo tablets.
Sindrup (C)
2003
Denmark
FairYesYesNRYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: Yes
WashoutYesNoYesYes
1/40 excluded due to high concentration of tramadol
Screened: 70
Eligible: 20
Enrolled: 40
YesGovernment and hospital research foundation, medication provided by Wyeth and Nycomed.
Tai
2002
US
PoorYesMethod not describedNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
WashoutYes
50%
No
2/14 (14.2%)
No
7/14 (50%) not analyzed
Yes
1/14 excluded for lack of compliance
Screened: NR
Eligible: NR
Enrolled: 14
YesAmerican Academy of Physical Medicine and Rehabilitation and Eastern Paralyzed Veterans Association
Tasmuth
2002
Finland
FairYesMethod not describedNR
Baseline characteristics not reported by order of randomization
YesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
WashoutNo
2/15 (13.3%) withdrew
NoNo
13/15 patients enrolled analyzed (86.7%)
Yes
1 patient excluded for non-compliance
Screened: 45
Eligible: NR
Enrolled: 15
YesHelsinki University Central Hospital Research Funds;
Thienel
2004
Multiple
FairYesYesYesYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
41–58%
NoUnable to determine 1259/1269 in safety population analyzed; # randomized unclearUnable to determine
See above
Screened: NR
Eligible: NR
Enrolled: 1269
YesJohnson & Johnson
van Seventer
2006
US and Multiple European
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindUnclear, reported as double blindUnclear, reported as double blindAttrition: Yes
Crossover: No
Adherence: Yes
Contamination: No
NAYes
35.1%
NoYes
368/370 (99.5%) analyzed
NoScreened: 435
Eligible: 387
Enrolled: 370
YesPfizer
Vestergaard
2001
Denmark
FairYesYesNRYesUnclear, reported as double blindUnclear, reported as double blindYesAttrition: Yes
Crossover: Yes
Adherence: No
Contamination: Yes
WashoutYesNoNo
27/30 (85%)
NoScreened: NR
Eligible: NR
Enrolled: 30
YesDanish Medical Research Council and Danish Pain Research Center. Glaxo Wellcome provided medication and technical support and patient transport costs.
Vrethem
1997
Sweden
FairMethod not describedMethod not describedNRYesYesYesYesAttrition: No
Crossover: No
Adherence: No
Contamination: No
WashoutYes
7/37 (19%)
Unable to determineNoUnable to determineScreened: NR
Eligible: NR
Enrolled: 37
Yes
Watson
1982
Canada
FairMethod not describedMethod not describedNRNoUnclear, reported as double blindYesYesAttrition: No
Crossover: No
Adherence: No
Contamination: No
WashoutNoNoUnable to determineUnable to determineScreened: NR
Eligible: NR
Enrolled: 24
NoNot reported
Wernicke
2006
US
FairYesYesNo
Higher BPI average interference score in duloxetine 120 mg group; otherwise similar
YesYesYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
NAYesNoYes
327/334 randomized analyzed
Yes
12/334 excluded
Screened: 561
Eligible: NR
Enrolled: 334
YesEli Lilly
Zakrzewska
1997
UK
FairMethod not describedMethod not describedYesYesUnclear, reported as double blindYesYesAttrition: Yes
Crossover: No
Adherence: No
Contamination: No
WashoutNoNoYesNoScreened: NR
Eligible: NR
Enrolled: 14
YesGlaxo Wellcome

From: Evidence Tables

Cover of Drug Class Review: Neuropathic Pain
Drug Class Review: Neuropathic Pain: Final Update 1 Report [Internet].
Selph S, Carson S, Fu R, et al.
Portland (OR): Oregon Health & Science University; 2011 Jun.
Copyright © 2011 by Oregon Health & Science University.

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