Sumatriptan

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.
S3552
R11395		 Yusuf (Control exposed to Naratriptan), 2018 Major birth defects 1st trimester retrospective cohort (claims database) exposed to other treatment, sick Adjustment: No 7.86 [0.48;127.94] C 65/1,608   0/93 65 1,608
ref
S3512
R11393		 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 0.55 [0.17;1.72] C
excluded (control group) 		4/258   12/429 16 258
ref
S3511
R11394		 Spielmann (Control unexposed, disease free), 2017 Major birth defects during pregnancy (anytime or not specified) excluded prospective cohort unexposed, disease free Adjustment: No 0.53 [0.19;1.49] C
excluded (exposition period) 		4/258   44/1,526 48 258
ref
S3488
R11390		 Ephross (Control exposed to Naratriptan), 2014 Major birth defects (live birth, fetal death and induced abortions) 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 1.97 [0.26;14.99] C 20/478   1/46 21 478
ref
S3581
R7145		 Nezvalová-Henriksen (Control unexposed, disease free), 2013 Congenital malformations (any) 1st trimester population based cohort retrospective unexposed, disease free excluded Adjustment: Yes 1.29 [0.88;1.90]
excluded (control group) 		28/415   9,136/178,565 9,164 415
ref
S3582
R7163		 Nezvalová-Henriksen (Control unexposed, sick), 2013 Congenital malformations (any) 1st trimester population based cohort retrospective unexposed, sick Adjustment: No 0.98 [0.56;1.72] C 28/415   25/364 53 415
ref
S3502
R6828		 Källén (Controls exposed to ergots), 2011 Any congenital malformations 1st trimester population based cohort propective exposed to other treatment, sick excluded Adjustment: No 1.20 [0.74;1.93] C
excluded (control group) 		107/2,257   21/527 128 2,257
ref
S3495
R6817		 Källén (Controls unexposed, disease free), 2011 Any congenital malformations 1st trimester population based cohort propective unexposed, disease free Adjustment: No 0.99 [0.91;1.21] 107/2,257   56,759/1,229,901 56,866 2,257
ref
S3490
R11391		 Shuhaiber (Control exposed to other treatments), 1998 Major congenital malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 1.10 [0.07;17.86] C
excluded (control group) 		1/82   1/90 2 82
ref
S3491
R11392		 Shuhaiber (Control unexposed, disease free), 1998 Major congenital malformations at least 1st trimester prospective cohort unexposed, disease free Adjustment: No 1.11 [0.07;18.06] C 1/82   1/91 2 82
ref
Total 5 studies 1.00 [0.87;1.14] 57,007 4,840
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 Naratriptan), 2018Yusuf, 2018 1 7.86[0.48; 127.94]651,6080%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Ephross (Control exposed to Naratriptan), 2014Ephross, 2014 2 1.97[0.26; 14.99]214780%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Nezvalová-Henriksen (Control unexposed, sick), 2013Nezvalová-Henriksen, 2013 3 0.98[0.56; 1.72]534156%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Källén (Controls unexposed, disease free), 2011Källén, 2011 4 0.99[0.91; 1.21]56,8662,25793%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Shuhaiber (Control unexposed, disease free), 1998Shuhaiber, 1998 5 1.11[0.07; 18.06]2820%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (5 studies) I2 = 0% 1.00[0.87; 1.14]57,0074,8400.220.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Control exposed to Naratriptan; 2: Control exposed to Naratriptan; 3: Control unexposed, sick; 4: Controls unexposed, disease free; 5: Control unexposed, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.00[0.87; 1.14]57,0074,8400%NAYusuf (Control exposed to Naratriptan), 2018 Ephross (Control exposed to Naratriptan), 2014 Nezvalová-Henriksen (Control unexposed, sick), 2013 Källén (Controls unexposed, disease free), 2011 Shuhaiber (Control unexposed, disease free), 1998 5 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.99[0.86; 1.14]56,8682,3390%NAKällén (Controls unexposed, disease free), 2011 Shuhaiber (Control unexposed, disease free), 1998 2 unexposed, sickunexposed, sick 0.98[0.56; 1.72]53415 -NANezvalová-Henriksen (Control unexposed, sick), 2013 1 exposed to other treatment, sickexposed to other treatment, sick 3.18[0.61; 16.41]862,0860%NAYusuf (Control exposed to Naratriptan), 2018 Ephross (Control exposed to Naratriptan), 2014 2 Tags Adjustment   - No  - No 1.00[0.87; 1.14]57,0074,8400%NAYusuf (Control exposed to Naratriptan), 2018 Ephross (Control exposed to Naratriptan), 2014 Nezvalová-Henriksen (Control unexposed, sick), 2013 Källén (Controls unexposed, disease free), 2011 Shuhaiber (Control unexposed, disease free), 1998 5 All studiesAll studies 1.00[0.87; 1.14]57,0074,8400%NAYusuf (Control exposed to Naratriptan), 2018 Ephross (Control exposed to Naratriptan), 2014 Nezvalová-Henriksen (Control unexposed, sick), 2013 Källén (Controls unexposed, disease free), 2011 Shuhaiber (Control unexposed, disease free), 1998 50.220.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.33.31.7080.000Yusuf (Control exposed to Naratriptan), 2018Ephross (Control exposed to Naratriptan), 2014Nezvalová-Henriksen (Control unexposed, sick), 2013Källén (Controls unexposed, disease free), 2011Shuhaiber (Control unexposed, disease free), 1998

Asymetry test p-value = 0.1749 (by Egger's regression)

slope=-0.0646 (0.0574); intercept=0.6475 (0.3659); t=1.7698; p=0.1749

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 3490, 3502, 3581, 3512

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.02[0.89; 1.17]66,0322,7540%NANezvalová-Henriksen (Control unexposed, disease free), 2013 Källén (Controls unexposed, disease free), 2011 Shuhaiber (Control unexposed, disease free), 1998 3 unexposed, sick controlsunexposed, sick controls 0.98[0.56; 1.72]53415 -NANezvalová-Henriksen (Control unexposed, sick), 2013 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.29[0.82; 2.03]2164,4250%NAYusuf (Control exposed to Naratriptan), 2018 Ephross (Control exposed to Naratriptan), 2014 Källén (Controls exposed to ergots), 2011 Shuhaiber (Control exposed to other treatments), 1998 40.510.01.0