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

Psychomotor developmental disorders/delay

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.
S16617
R69695		 Thomas b (Phenobarbitone) (Epilepsy) (Controls exposed to LTG), 2022 Delayed motor development quotient (< 84, i.e one SD of the mean) - The developmental assessment scale for Indian infants (DASII) - Between 12-24 months of age (mean (SD): 15.3 (3.9) months)) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 5.51 [0.69;43.95] C
excluded (control group) 		15/83   1/26 16 83
ref
S16618
R69696		 Thomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 The motor development quotient (MODQ) - The developmental assessment scale for Indian infants (DASII) - Between 12-24 months of age (mean (SD): 15.3 (3.9) months)) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No extrapolated (cont. endpoint) 1.36 [0.81;2.29] -/83   -/110 - 83
ref
S9179
R31634		 Shankaran (Phenobarbital) (Other indications), 2002 The psychomotor developmental index ≤84 (PDI) (Bayley) days before delivery excluded randomized controlled trial unexposed, sick Adjustment: Randomisation 0.79 [0.51;1.22] C
excluded (exposition period) 		59/206   61/181 120 206
ref
S9167
R31544		 Koch (Phenobarbital), 1996 Minor neurological dysfunction (at age 6) (Touwen) during pregnancy (anytime or not specified) prospective cohort unexposed (general population or NOS) Adjustment: No Matched 0.94 [0.04;21.31] C 0/4   4/34 4 4
ref
Total 2 studies 1.35 [0.81;2.25] 4 87
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 Thomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022Thomas b, 2022 1 1.36[0.81; 2.29]-8397%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Koch (Phenobarbital), 1996Koch, 1996 2 0.94[0.04; 21.31]443%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 0% 1.35[0.81; 2.25]4870.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Phenobarbitone) (Epilepsy) (Controls unexposed, sick; 2: Phenobarbital;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.35[0.81; 2.25]4870%NAThomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 Koch (Phenobarbital), 1996 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.94[0.04; 21.31]44 -NAKoch (Phenobarbital), 1996 1 unexposed, sickunexposed, sick 1.36[0.81; 2.29]-83 -NAThomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 1 Tags Adjustment   - No  - No 1.35[0.81; 2.25]4870%NAThomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 Koch (Phenobarbital), 1996 2 extrapolated (cont. endpoint)extrapolated (cont. endpoint) 1.36[0.81; 2.29]-83 -NAThomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 1 MatchedMatched 0.94[0.04; 21.31]44 -NAKoch (Phenobarbital), 1996 1 All studiesAll studies 1.35[0.81; 2.25]4870%NAThomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 Koch (Phenobarbital), 1996 20.25.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

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

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 16617

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.94[0.04; 21.31]44 -NAKoch (Phenobarbital), 1996 1 unexposed, sick controlsunexposed, sick controls 1.36[0.81; 2.29]-83 -NAThomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 5.51[0.69; 43.95]1683 -NAThomas b (Phenobarbitone) (Epilepsy) (Controls exposed to LTG), 2022 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Veroniki b (NMA) (Psychomotor developmental delay)Veroniki b (NMA) (Psychomotor developmental delay) 0.96[0.39; 2.29]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT-9 metaPregmetaPreg 1.35[0.81; 2.25]0%87----Thomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022 Koch (Phenobarbital), 1996 20.510.01.0