Valproate (All indications)

Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation

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.
S9450
R33187
Rihtman (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013 Children: withdrawal symptoms after birth at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No Controls: epilepsy indication 0.46 [0.02;11.63] C
excluded (control group)
0/30   1/42 1 30
ref
S9451
R33222
Rihtman (Valproate) (Controls unexposed, NOS) (Mixed indications), 2013 Children: withdrawal symptoms after birth at least 1st trimester excluded prospective cohort unexposed (general population or NOS) Adjustment: No 1.75 [0.03;90.31] C
excluded (exposition period)
0/30   0/52 0 30
ref
S9290
R32266
Burja (Valproate) (Controls unexposed, disease free), 2006 Withdrawal symptoms during pregnancy (anytime or not specified) retrospective cohort (registry) unexposed, disease free excluded Adjustment: No 1263.00 [18.27;87332.99] C
excluded (control group)
1/2   0/211 1 2
ref
S9292
R32276
Burja (Valproate) (Controls unexposed, sick), 2006 Withdrawal symptoms during pregnancy (anytime or not specified) retrospective cohort (registry) unexposed, sick Adjustment: No 189.00 [2.70;13229.55] C 1/2   0/32 1 2
ref
S9299
R32358
Dean (Valproate), 2002 Neonatal withdrawal features at least 1st trimester excluded retrospective cohort unexposed, sick Adjustment: No 11.63 [1.43;94.83] C
excluded (exposition period)
11/46   1/38 12 46
ref
Total 1 studies 189.00 [2.70;13229.55] 1 2
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 (Valproate) (Controls unexposed, sick), 2006Burja, 2006 1 189.00[2.70; 13229.55]120%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA0.9500.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Valproate) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 189.00[2.70; 13229.55]12 -NABurja (Valproate) (Controls unexposed, sick), 2006 1 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 189.00[2.70; 13229.55]12 -NABurja (Valproate) (Controls unexposed, sick), 2006 1 Tags Adjustment   - No  - No 189.00[2.70; 13229.55]12 -NABurja (Valproate) (Controls unexposed, sick), 2006 1 All studiesAll studies 189.00[2.70; 13229.55]12 -NABurja (Valproate) (Controls unexposed, sick), 2006 10.51000.01.0

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 9290, 9450

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale1263.00[18.27; 87332.99]12 -NABurja (Valproate) (Controls unexposed, disease free), 2006 1 unexposed, sick controlsunexposed, sick controls Out of scale189.00[2.70; 13229.55]12 -NABurja (Valproate) (Controls unexposed, sick), 2006 10.510.01.0