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

Cleft lip with or without cleft palate

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.
S10043
R36326		 Blotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Cleft lip with or without cleft palate 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 7.53 [0.36;158.21] C
excluded (control group) 		0/80   2/2,997 2 80
ref
S10044
R36349		 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Cleft lip with or without cleft palate 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 7.20 [0.45;116.14] C 0/80   1,637/1,875,733 1,637 80
ref
S9582
R33936		 Lowe (Phenobarbital or Primidone) (Controls unexposed, disease free), 1973 Cleft lip and/or cleft palate 1st trimester population based cohort retrospective unexposed, disease free excluded Adjustment: No 11.51 [1.56;84.81] C
excluded (control group) 		1/57   49/31,632 50 57
ref
S9583
R33938		 Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 Cleft lip and/or cleft palate 1st trimester population based cohort retrospective unexposed, sick Adjustment: No 5.97 [0.24;149.03] C 1/57   0/111 1 57
ref
Total 2 studies 6.65 [0.81;54.48] 1,638 137
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 7.20[0.45; 116.14]1,6378057%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973Lowe, 1973 2 5.97[0.24; 149.03]15743%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 0% 6.65[0.81; 54.48]1,6381370.920.01.0ROB: 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 or Primidone) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 6.65[0.81; 54.48]1,6381370%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 7.20[0.45; 116.14]1,63780 -NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1 unexposed, sickunexposed, sick 5.97[0.24; 149.03]157 -NALowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 1 Tags Adjustment   - No  - No 6.65[0.81; 54.48]1,6381370%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 2 All studiesAll studies 6.65[0.81; 54.48]1,6381370%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 20.520.01.0

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 9582, 10043

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 9.81[1.94; 49.68]1,6871370%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Lowe (Phenobarbital or Primidone) (Controls unexposed, disease free), 1973 2 unexposed, sick controlsunexposed, sick controls 5.97[0.24; 149.03]157 -NALowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 7.53[0.36; 158.21]280 -NABlotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 10.510.01.0