Primidone AND Phenobarbital (Epilepsy) 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.
S19461
R82970		 Straub (Controls exposed to LTG) (Phenobarbital) (Epilepsy), 2026 Coordination disorders - ICD-10 codes: F82 - Mean follow up (full cohort): 3.4 years during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick Adjustment: No 0.21 [0.01;3.51] C 0/249   30/3,273 30 249
ref
S16789
R70472		 Thomas b (Phenobarbitone) (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
S16790
R70473		 Thomas b (Phenobarbitone) (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
S8711
R29400		 Koch (Phenobarbital or Primidone), 1996 Minor neurological dysfunction (at age 6) (Touwen) during pregnancy (anytime or not specified) prospective cohort unexposed (general population or NOS) Adjustment: No Matched 1.15 [0.19;7.11] C 2/15   4/34 6 15
ref
Total 3 studies 1.27 [0.78;2.08] 36 347
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 Straub (Controls exposed to LTG) (Phenobarbital) (Epilepsy), 2026Straub, 2026 1 0.21[0.01; 3.51]302493%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate Thomas b (Phenobarbitone) (Controls unexposed, sick), 2022Thomas b, 2022 2 1.36[0.81; 2.29]-8390%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Koch (Phenobarbital or Primidone), 1996Koch, 1996 3 1.15[0.19; 7.11]6157%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (3 studies) I2 = 0% 1.27[0.78; 2.08]363470.25.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls exposed to LTG) (Phenobarbital) (Epilepsy; 2: Phenobarbitone) (Controls unexposed, sick; 3: Phenobarbital or Primidone;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.27[0.78; 2.08]363470%NAStraub (Controls exposed to LTG) (Phenobarbital) (Epilepsy), 2026 Thomas b (Phenobarbitone) (Controls unexposed, sick), 2022 Koch (Phenobarbital or Primidone), 1996 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.15[0.19; 7.11]615 -NAKoch (Phenobarbital or Primidone), 1996 1 unexposed, sickunexposed, sick 1.36[0.81; 2.29]-83 -NAThomas b (Phenobarbitone) (Controls unexposed, sick), 2022 1 exposed to other treatment, sickexposed to other treatment, sick 0.21[0.01; 3.51]30249 -NAStraub (Controls exposed to LTG) (Phenobarbital) (Epilepsy), 2026 1 Tags Adjustment   - No  - No 1.27[0.78; 2.08]363470%NAStraub (Controls exposed to LTG) (Phenobarbital) (Epilepsy), 2026 Thomas b (Phenobarbitone) (Controls unexposed, sick), 2022 Koch (Phenobarbital or Primidone), 1996 3 extrapolated (cont. endpoint)extrapolated (cont. endpoint) 1.36[0.81; 2.29]-83 -NAThomas b (Phenobarbitone) (Controls unexposed, sick), 2022 1 MatchedMatched 1.15[0.19; 7.11]615 -NAKoch (Phenobarbital or Primidone), 1996 1 All studiesAll studies 1.27[0.78; 2.08]363470%NAStraub (Controls exposed to LTG) (Phenobarbital) (Epilepsy), 2026 Thomas b (Phenobarbitone) (Controls unexposed, sick), 2022 Koch (Phenobarbital or Primidone), 1996 30.15.01.0

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 16789

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.15[0.19; 7.11]615 -NAKoch (Phenobarbital or Primidone), 1996 1 unexposed, sick controlsunexposed, sick controls 1.36[0.81; 2.29]-83 -NAThomas b (Phenobarbitone) (Controls unexposed, sick), 2022 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.25[0.05; 29.85]4633270%NAStraub (Controls exposed to LTG) (Phenobarbital) (Epilepsy), 2026 Thomas b (Phenobarbitone) (Controls exposed to LTG), 2022 20.510.01.0