Topiramate (All indications)

Spina bifida

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.
S10173
R37179		 Blotière (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Spina bifida 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 1.93 [0.08;47.52] C
excluded (control group) 		0/517   1/2,997 1 517
ref
S10048
R36430		 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Spina bifida 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 2.94 [0.18;47.19] C 0/517   616/1,875,733 616 517
ref
S8594
R28607		 Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Spina bifida throughout pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 17.53 [0.34;893.01] C
excluded (control group) 		0/48   0/833 0 48
ref
S8596
R28617		 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Spina bifida throughout pregnancy population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 11.34 [0.58;222.54] C 0/48   3/3,773 3 48
ref
Total 2 studies 5.51 [0.72;41.94] 619 565
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 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019Blotière, 2019 1 2.94[0.18; 47.19]61651754%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014Veiby, 2014 2 11.34[0.58; 222.54]34846%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 0% 5.51[0.72; 41.94]6195650.950.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Topiramate) (Controls unexposed NOS) (Mixed indications; 2: Topiramate) (Controls unexposed, sick) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 5.51[0.72; 41.94]6195650%NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.94[0.18; 47.19]616517 -NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 1 unexposed, sickunexposed, sick 11.34[0.58; 222.54]348 -NAVeiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 1 Tags Adjustment   - No  - No 5.51[0.72; 41.94]6195650%NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 2 Controls   - epilepsy indication  - epilepsy indication 11.34[0.58; 222.54]348 -NAVeiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 5.51[0.72; 41.94]6195650%NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 20.550.01.0

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 8594, 10173

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.94[0.18; 47.19]616517 -NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 1 unexposed, sick controlsunexposed, sick controls Out of scale11.34[0.58; 222.54]348 -NAVeiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 4.66[0.39; 55.76]15650%NABlotière (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 20.510.01.0