Triptans

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.
S3510
R6888
Spielmann (Control mainly exposed other treatments, sick), 2017 Major birth defects 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.88 [0.36;2.18] C
excluded (control group)
8/323   12/429 20 323
ref
S3509
R6864
Spielmann (Control unexposed, disease free), 2017 Major birth defects 1st trimester prospective cohort unexposed, disease free Adjustment: No 0.86 [0.40;1.83] C 8/323   44/1,526 52 323
ref
S3492
R6764
Nezvalová-Henriksen (Control unexposed, disease free), 2013 Congenital malformations (major) 1st trimester population based cohort retrospective unexposed, disease free excluded Adjustment: Yes 1.14 [0.84;1.55]
excluded (control group)
43/1,210   5,292/178,565 5,335 1,210
ref
S851
R6746
Nezvalová-Henriksen (Control unexposed, sick), 2013 Congenital malformations (major) 1st trimester population based cohort retrospective unexposed, sick Adjustment: No 0.77 [0.51;1.17] C 43/1,210   50/1,095 93 1,210
ref
S850
R6554
Bérard, 2012 Major congenital malformations during pregnancy (anytime or not specified) excluded nested case control unexposed, disease free Adjustment: Yes 1.49 [0.89;2.52]
excluded (exposition period)
18/139   4,698/59,568 4,716 139
ref
S3494
R6811
Källén (control exposed to ergots), 2011 Relatively severe malformations 1st trimester population based cohort propective exposed to other treatment, sick excluded Adjustment: No 1.03 [0.61;1.74] C
excluded (control group)
92/2,777   17/527 109 2,777
ref
S849
R6543
Källén (control unexposed, disease free), 2011 Relatively severe malformations 1st trimester population based cohort propective unexposed, disease free Adjustment: Yes 1.04 [0.84;1.28] 92/2,777   38,818/1,229,901 38,910 2,777
ref
S3595
R7303
Shuhaiber - Sumatriptan (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
S3596
R7307
Shuhaiber - Sumatriptan (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 4 studies 0.97 [0.81;1.17] 39,057 4,392
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 Spielmann (Control unexposed, disease free), 2017Spielmann, 2017 1 0.86[0.40; 1.83]523236%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Nezvalová-Henriksen (Control unexposed, sick), 2013Nezvalová-Henriksen, 2013 2 0.77[0.51; 1.17]931,21019%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Källén (control unexposed, disease free), 2011Källén, 2011 3 1.04[0.84; 1.28]38,9102,77775%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998Shuhaiber - Sumatriptan, 1998 4 1.11[0.07; 18.06]2820%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 0% 0.97[0.81; 1.17]39,0574,3920.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Control unexposed, disease free; 2: Control unexposed, sick; 3: control unexposed, disease free; 4: Control unexposed, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.97[0.81; 1.17]39,0574,3920%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, sick), 2013 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.03[0.84; 1.26]38,9643,1820%NASpielmann (Control unexposed, disease free), 2017 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 3 unexposed, sickunexposed, sick 0.77[0.51; 1.17]931,210 -NANezvalová-Henriksen (Control unexposed, sick), 2013 1 Tags Adjustment   - No  - No 0.79[0.55; 1.14]1471,6150%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, sick), 2013 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 3   - Yes  - Yes 1.04[0.84; 1.28]38,9102,777 -NAKällén (control unexposed, disease free), 2011 1 All studiesAll studies 0.97[0.81; 1.17]39,0574,3920%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, sick), 2013 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 40.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.33.31.7070.000Spielmann (Control unexposed, disease free), 2017Nezvalová-Henriksen (Control unexposed, sick), 2013Källén (control unexposed, disease free), 2011Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 3595, 3494, 3492, 3510

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.06[0.89; 1.25]44,2994,3920%NASpielmann (Control unexposed, disease free), 2017 Nezvalová-Henriksen (Control unexposed, disease free), 2013 Källén (control unexposed, disease free), 2011 Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 4 unexposed, sick controlsunexposed, sick controls 0.77[0.51; 1.17]931,210 -NANezvalová-Henriksen (Control unexposed, sick), 2013 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.99[0.63; 1.55]1313,1820%NASpielmann (Control mainly exposed other treatments, sick), 2017 Källén (control exposed to ergots), 2011 Shuhaiber - Sumatriptan (Control exposed to other treatments), 1998 30.510.01.0