Nitrazepam (Psy and mixed indications) updated on 02-10-2025

Major congenital malformations

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.
S15591
R64159		 Källén, 2013 Relatively severe malformations early pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: No BZD Coexposure: Not specified 0.23 [0.03;1.66] C 1/134   49,499/1,575,847 49,500 134
ref
S17864
R75432		 Eros, 2002 Major congenital anomalies during pregnancy (anytime or not specified) excluded case control unexposed (general population or NOS) Adjustment: No BZD Coexposure: Yes (with psychiatric (ATD and/or psychotropics) medications) Matched 1.60 [0.80;3.00]
excluded (exposition period) 		18/37   22,847/60,979 22,865 37
ref
Total 1 studies 0.23 [0.03;1.66] 49,500 134
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 Källén, 2013Källén, 2013 0.23[0.03; 1.66]49,5001340%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate0.22.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.23[0.03; 1.66]49,500134 -NAKällén, 2013 1 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.23[0.03; 1.66]49,500134 -NAKällén, 2013 1 Tags Adjustment   - No  - No 0.23[0.03; 1.66]49,500134 -NAKällén, 2013 1 BZD Coexposure   - Not specified  - Not specified 0.23[0.03; 1.66]49,500134 -NAKällén, 2013 1 All studiesAll studies 0.23[0.03; 1.66]49,500134 -NAKällén, 2013 10.110.01.0

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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale0.23[0.03; 1.66]49,500134 -NAKällén, 2013 10.510.01.0