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

Neonatal intracranial hemorrhage

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.
S9570
R33888		 Burja (Phenobarbital or Primidone) (Controls unexposed, disease free), 2006 Intracranial hemorrhage during pregnancy (anytime or not specified) retrospective cohort (registry) unexposed, disease free excluded Adjustment: No 12.45 [0.45;341.34] C
excluded (control group) 		0/2   5/211 5 2
ref
S9568
R33878		 Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 Intracranial hemorrhage during pregnancy (anytime or not specified) retrospective cohort (registry) unexposed, sick Adjustment: No 3.93 [0.12;124.06] C 0/2   2/32 2 2
ref
S9559
R33808		 Shankaran (Phenobarbital) (Other indications), 2002 Intracranial Hemorrhage (all grade) days before delivery randomized controlled trial unexposed, sick Adjustment: Randomisation 1.00 [0.64;1.57] C 51/225   47/207 98 225
ref
S9488
R33385		 D'Souza (Phenobarbital) (Controls unexposed, disease free), 1991 Periventricular haemorrhage (germinal layer) throughout pregnancy prospective cohort unexposed, disease free excluded Adjustment: No Matched 17.57 [0.30;1024.08] C
excluded (control group) 		0/4   0/62 0 4
ref
S9489
R33414		 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Periventricular haemorrhage (germinal layer) throughout pregnancy prospective cohort unexposed, sick Adjustment: No 2.14 [0.03;131.94] C 0/4   0/8 0 4
ref
Total 3 studies 1.03 [0.66;1.61] 100 231
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 Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006Burja, 2006 1 3.93[0.12; 124.06]222%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Shankaran (Phenobarbital) (Other indications), 2002Shankaran, 2002 2 1.00[0.64; 1.57]9822597%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA D'Souza (Phenobarbital) (Controls unexposed, sick), 1991D'Souza, 1991 3 2.14[0.03; 131.94]041%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (3 studies) I2 = 0% 1.03[0.66; 1.61]1002310.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Phenobarbital or Primidone) (Controls unexposed, sick; 2: Phenobarbital) (Other indications; 3: Phenobarbital) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 3.06[0.22; 43.15]260%NABurja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 2 case control studiescase control studies 0 RCTRCT 1.00[0.64; 1.57]98225 -NAShankaran (Phenobarbital) (Other indications), 2002 1 Type of controls unexposed, sickunexposed, sick 1.03[0.66; 1.61]1002310%NABurja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 Shankaran (Phenobarbital) (Other indications), 2002 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 3 Tags Adjustment   - No  - No 3.06[0.22; 43.15]260%NABurja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 2   - Randomisation  - Randomisation 1.00[0.64; 1.57]98225 -NAShankaran (Phenobarbital) (Other indications), 2002 1 All studiesAll studies 1.03[0.66; 1.61]1002310%NABurja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 Shankaran (Phenobarbital) (Other indications), 2002 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 30.210.01.0

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 9488, 9570

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale14.29[1.10; 186.14]560%NABurja (Phenobarbital or Primidone) (Controls unexposed, disease free), 2006 D'Souza (Phenobarbital) (Controls unexposed, disease free), 1991 2 unexposed, sick controlsunexposed, sick controls 1.03[0.66; 1.61]1002310%NABurja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 Shankaran (Phenobarbital) (Other indications), 2002 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 30.510.01.0