Naratriptan

All congenital malformations (majors, minors, majors and minors, or unspecified)

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.
S3553
R11389		 Yusuf (Control exposed to Sumatriptan), 2018 Major birth defects 1st trimester retrospective cohort (claims database) exposed to other treatment, sick Adjustment: No 0.13 [0.01;2.07] C 0/93   65/1,608 65 93
ref
S3523
R11387		 Spielmann (Control mainly exposed other treatments, sick), 2017 Major birth defects during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.85 [0.11;6.68] C
excluded (control group) 		1/42   12/429 13 42
ref
S3524
R11388		 Spielmann (Control unexposed, disease free), 2017 Major birth defects during pregnancy (anytime or not specified) excluded prospective cohort unexposed, disease free Adjustment: No 0.82 [0.11;6.11] C
excluded (exposition period) 		1/42   44/1,526 45 42
ref
S3489
R11386		 Ephross (Naratriptan versus Sumatriptan), 2014 Major birth defects (live birth, fetal death and induced abortions) 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 0.51 [0.07;3.88] C 1/46   20/478 21 46
ref
S3503
R6832		 Källén (control exposed to ergots), 2011 Any congenital malformations 1st trimester population based cohort propective exposed to other treatment, sick excluded Adjustment: No 1.15 [0.15;8.94] C
excluded (control group) 		1/22   21/527 22 22
ref
S3496
R6821		 Källén (control unexposed, disease free), 2011 Any congenital malformations 1st trimester population based cohort propective unexposed, disease free Adjustment: No 0.98 [0.13;7.32] C 1/22   56,759/1,229,901 56,760 22
ref
Total 3 studies 0.50 [0.14;1.77] 56,846 161
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 Yusuf (Control exposed to Sumatriptan), 2018Yusuf, 2018 1 0.13[0.01; 2.07]659321%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Ephross (Naratriptan versus Sumatriptan), 2014Ephross, 2014 2 0.51[0.07; 3.88]214639%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Källén (control unexposed, disease free), 2011Källén, 2011 3 0.98[0.13; 7.32]56,7602240%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (3 studies) I2 = 0% 0.50[0.14; 1.77]56,8461610.02.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Control exposed to Sumatriptan; 2: Naratriptan versus Sumatriptan; 3: control unexposed, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.50[0.14; 1.77]56,8461610%NAYusuf (Control exposed to Sumatriptan), 2018 Ephross (Naratriptan versus Sumatriptan), 2014 Källén (control unexposed, disease free), 2011 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.98[0.13; 7.32]56,76022 -NAKällén (control unexposed, disease free), 2011 1 exposed to other treatment, sickexposed to other treatment, sick 0.31[0.06; 1.63]861390%NAYusuf (Control exposed to Sumatriptan), 2018 Ephross (Naratriptan versus Sumatriptan), 2014 2 Tags Adjustment   - No  - No 0.50[0.14; 1.77]56,8461610%NAYusuf (Control exposed to Sumatriptan), 2018 Ephross (Naratriptan versus Sumatriptan), 2014 Källén (control unexposed, disease free), 2011 3 All studiesAll studies 0.50[0.14; 1.77]56,8461610%NAYusuf (Control exposed to Sumatriptan), 2018 Ephross (Naratriptan versus Sumatriptan), 2014 Källén (control unexposed, disease free), 2011 30.010.01.0

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 3503, 3523

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.98[0.13; 7.32]56,76022 -NAKällén (control unexposed, disease free), 2011 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.52[0.14; 1.88]1081610%NAYusuf (Control exposed to Sumatriptan), 2018 Ephross (Naratriptan versus Sumatriptan), 2014 Källén (control exposed to ergots), 2011 30.510.01.0