Gabapentin (Epilepsy)

All congenital malformations (majors, minors, majors and minors, or unspecified)

R analysis
id Study   Lib. in paper Exposition period    Study type  Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S7650
R26788
Tomson (Gabapentin), 2018 Malformed Offspring at least 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 0.94 [0.13;6.97] C 1/36   74/2,514 75 36
ref
S7048
R19906
Miškov (Gabapentin) (Controls unexposed, disease free), 2016 Congenital anomalies during pregnancy (anytime or not specified) prospective cohort unexposed, disease free excluded Adjustment: No 765.00 [11.05;52971.87] C
excluded (control group)
1/2   0/128 1 2
ref
S7410
R21805
Miškov (Gabapentin) (Controls unexposed, sick), 2016 Congenital anomalies during pregnancy (anytime or not specified) excluded prospective cohort unexposed, sick Adjustment: No 21.00 [0.27;1646.32] C
excluded (exposition period)
1/2   0/4 1 2
ref
S6252
R26783
Arkilo (Gabapentin), 2015 Major malformations during pregnancy (anytime or not specified) excluded retrospective cohort exposed to other treatment, sick Adjustment: No 47.00 [0.38;5814.69] C
excluded (exposition period)
0/1   0/24 0 1
ref
S6379
R35197
Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick), 2013 Fetal malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.83 [0.05;14.66] C
excluded (control group)
0/14   13/315 13 14
ref
S6370
R35198
Vajda (Gabapentin) (Controls unexposed, sick), 2013 Fetal malformations at least 1st trimester prospective cohort unexposed, sick Adjustment: No 0.95 [0.05;18.18] C 0/14   5/147 5 14
ref
S8274
R26784
Mawer (Gabapentin) (Controls exposed to Lamotrigine, sick), 2010 Major malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 4.60 [0.15;144.69] C
excluded (control group)
0/2   2/37 2 2
ref
S8276
R26787
Mawer (Gabapentin) (Controls unexposed, disease free), 2010 Major malformations 1st trimester prospective cohort unexposed, disease free excluded Adjustment: No Matched 14.28 [0.53;384.83] C
excluded (control group)
0/2   6/285 6 2
ref
S8278
R26786
Mawer (Gabapentin) (Controls unexposed, sick), 2010 Major malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 8.78 [0.24;318.70] C 0/2   1/41 1 2
ref
S6060
R26785
Morrow (Gabapentin) (Controls exposed to Lamotrigine, sick), 2006 Major congenital malformation 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.99 [0.13;7.64] C
excluded (control group)
1/31   21/647 22 31
ref
S6059
R26789
Morrow (Gabapentin) (Controls unexposed, sick), 2006 Major congenital malformation 1st trimester prospective cohort unexposed, sick Adjustment: No 0.91 [0.11;7.55] C 1/31   8/227 9 31
ref
S6682
R18560
Dean (Gabapentin), 2002 Congenital malformations (major and minor) at least 1st trimester retrospective cohort unexposed, sick Adjustment: No 4.07 [0.07;222.16] C 0/1   7/38 7 1
ref
Total 5 studies 1.34 [0.42;4.34] 97 84
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Tomson (Gabapentin), 2018Tomson, 2018 1 0.94[0.13; 6.97]753634%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Vajda (Gabapentin) (Controls unexposed, sick), 2013Vajda, 2013 2 0.95[0.05; 18.18]51416%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Mawer (Gabapentin) (Controls unexposed, sick), 2010Mawer, 2010 3 8.78[0.24; 318.70]1211%ROB confusion: criticalROB selection: moderateROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Morrow (Gabapentin) (Controls unexposed, sick), 2006Morrow, 2006 4 0.91[0.11; 7.55]93131%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Dean (Gabapentin), 2002Dean, 2002 5 4.07[0.07; 222.16]719%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (5 studies) I2 = 0% 1.34[0.42; 4.34]97840.220.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Gabapentin; 2: Gabapentin) (Controls unexposed, sick; 3: Gabapentin) (Controls unexposed, sick; 4: Gabapentin) (Controls unexposed, sick; 5: Gabapentin;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.34[0.42; 4.34]97840%NATomson (Gabapentin), 2018 Vajda (Gabapentin) (Controls unexposed, sick), 2013 Mawer (Gabapentin) (Controls unexposed, sick), 2010 Morrow (Gabapentin) (Controls unexposed, sick), 2006 Dean (Gabapentin), 2002 5 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 1.62[0.38; 6.86]22480%NAVajda (Gabapentin) (Controls unexposed, sick), 2013 Mawer (Gabapentin) (Controls unexposed, sick), 2010 Morrow (Gabapentin) (Controls unexposed, sick), 2006 Dean (Gabapentin), 2002 4 exposed to other treatment, sickexposed to other treatment, sick 0.94[0.13; 6.97]7536 -NATomson (Gabapentin), 2018 1 Tags Adjustment   - No  - No 1.34[0.42; 4.34]97840%NATomson (Gabapentin), 2018 Vajda (Gabapentin) (Controls unexposed, sick), 2013 Mawer (Gabapentin) (Controls unexposed, sick), 2010 Morrow (Gabapentin) (Controls unexposed, sick), 2006 Dean (Gabapentin), 2002 5 All studiesAll studies 1.34[0.42; 4.34]97840%NATomson (Gabapentin), 2018 Vajda (Gabapentin) (Controls unexposed, sick), 2013 Mawer (Gabapentin) (Controls unexposed, sick), 2010 Morrow (Gabapentin) (Controls unexposed, sick), 2006 Dean (Gabapentin), 2002 50.220.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.85.12.4490.000Tomson (Gabapentin), 2018Vajda (Gabapentin) (Controls unexposed, sick), 2013Mawer (Gabapentin) (Controls unexposed, sick), 2010Morrow (Gabapentin) (Controls unexposed, sick), 2006Dean (Gabapentin), 2002

Asymetry test p-value = 0.0806 (by Egger's regression)

slope=-2.0248 (0.9268); intercept=1.8001 (0.6934); t=2.5962; p=0.0806

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 6060, 8274, 8276, 6379, 7048

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale14.28[0.53; 384.83]62 -NAMawer (Gabapentin) (Controls unexposed, disease free), 2010 1 unexposed, sick controlsunexposed, sick controls 1.62[0.38; 6.86]22480%NAVajda (Gabapentin) (Controls unexposed, sick), 2013 Mawer (Gabapentin) (Controls unexposed, sick), 2010 Morrow (Gabapentin) (Controls unexposed, sick), 2006 Dean (Gabapentin), 2002 4 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.14[0.34; 3.77]112830%NATomson (Gabapentin), 2018 Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick), 2013 Mawer (Gabapentin) (Controls exposed to Lamotrigine, sick), 2010 Morrow (Gabapentin) (Controls exposed to Lamotrigine, sick), 2006 40.510.01.0