Phenobarbital (All indications) updated on 04-22-2025

Oro-facial clefts

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.
S10172
R46498		 Blotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Oro-facial clefts 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 4.18 [0.22;78.35] C
excluded (control group) 		0/80   4/2,997 4 80
ref
S10042
R46489		 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Oro-facial clefts 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 4.18 [0.26;67.49] C 0/80   2,815/1,875,733 2,815 80
ref
S9151
R31459		 Tomson (Phenobarbital), 2018 Cleft lip or palate at least 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 2.86 [0.30;27.55] C 1/294   3/2,514 4 294
ref
S9118
R31329		 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Orofacial clefts throughout pregnancy population based cohort retrospective exposed to other treatment, sick Adjustment: No 10.46 [0.42;262.81] C 0/27   1/833 1 27
ref
S9107
R31285		 Hernández-Díaz (Phenobarbital) (Epilepsy), 2012 Oral clefts 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No Controls: mixed indications 4.56 [1.32;15.71] C 4/199   7/1,562 11 199
ref
Total 4 studies 4.46 [1.70;11.72] 2,831 600
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 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019Blotière, 2019 1 4.18[0.26; 67.49]2,8158012%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Tomson (Phenobarbital), 2018Tomson, 2018 2 2.86[0.30; 27.55]429418%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014Veiby, 2014 3 10.46[0.42; 262.81]1279%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Hernández-Díaz (Phenobarbital) (Epilepsy), 2012Hernández-Díaz, 2012 4 4.56[1.32; 15.71]1119961%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (4 studies) I2 = 0% 4.46[1.70; 11.72]2,8316000.950.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Phenobarbital) (Controls unexposed NOS) (Mixed indications; 2: Phenobarbital; 3: Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications; 4: Phenobarbital) (Epilepsy;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 4.46[1.70; 11.72]2,8316000%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Tomson (Phenobarbital), 2018 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Hernández-Díaz (Phenobarbital) (Epilepsy), 2012 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 4.18[0.26; 67.49]2,81580 -NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1 exposed to other treatment, sickexposed to other treatment, sick 4.50[1.61; 12.61]165200%NATomson (Phenobarbital), 2018 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Hernández-Díaz (Phenobarbital) (Epilepsy), 2012 3 Tags Adjustment   - No  - No 4.46[1.70; 11.72]2,8316000%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Tomson (Phenobarbital), 2018 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Hernández-Díaz (Phenobarbital) (Epilepsy), 2012 4 Controls   - mixed indications  - mixed indications 4.56[1.32; 15.71]11199 -NAHernández-Díaz (Phenobarbital) (Epilepsy), 2012 1 All studiesAll studies 4.46[1.70; 11.72]2,8316000%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Tomson (Phenobarbital), 2018 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Hernández-Díaz (Phenobarbital) (Epilepsy), 2012 40.550.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.95.41.9740.000Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019Tomson (Phenobarbital), 2018Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014Hernández-Díaz (Phenobarbital) (Epilepsy), 2012

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 10172

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 4.18[0.26; 67.49]2,81580 -NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 4.47[1.69; 11.80]206000%NABlotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Tomson (Phenobarbital), 2018 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Hernández-Díaz (Phenobarbital) (Epilepsy), 2012 40.510.01.0