Primidone AND 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.
S19462
R82976
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
S16791
R70477
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
S16792
R70478
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
S9559
R33805
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
S9590
R33958
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) (Epilepsy) (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) (Epilepsy) (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) (Epilepsy) (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) (Epilepsy) (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) (Epilepsy) (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) (Epilepsy) (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) (Epilepsy) (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 16791

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) (Epilepsy) (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) (Epilepsy) (Controls exposed to LTG), 2022 20.510.01.0