Quantitative benefit-risk assessment of methylprednisolone in multiple sclerosis relapses

BMC Neurology

Table 3 Details of included study arms for the estimation of risk for non-serious adverse effects

Intervention	Study	Cumulative dose	Route	Duration	Follow-up	Fraction with at least one adverse event
High-dose methylprednisolone	Abbruzzese 1983 [39]	8400 mg^a	IV	15 days	Not stated	3/30^b
	Durelli 1986^c [31]	7035 mg^a	IV	15 days	15 days	9.2/13^d
	Thompson 1989 [40]	3000 mg	IV	3 days	84 days	1/29
	Sellebjerg 1998 [34]	3676 mg	PO	15 days	56 days	23/26
	La Mantia 1994 [27]	5750 mg	IV	14 days	14 days	0/10
	Soelberg-Sorensen 2004 [41]	3000 mg^e	IV	3 days	182 days	30/40^f
	Martinelli 2009 [42]	5000 mg	IV	5 days	28 days	11/20
	Martinelli 2009 [42]	5000 mg	PO	5 days	28 days	15/20
	Ramo-Tello 2013 [36]	3000 mg	IV	3 days	28 days	24/24
	Ramo-Tello 2013 [36]	3750 mg	PO	3 days	28 days	24/25
	Shaygannejad 2013 [43]	3000-5000 mg + taper	IV	13–20 days	90 days	58/64
Placebo	Rose 1970 [38]	-	IM	14 days	28 days	8/94^b
	Durelli 1986^c [31]	-	IV	15 days	15 days	5.0/10^d
	Sellebjerg 1998 [34]	-	PO	15 days	56 days	8/25

IV intravenous, PO per oral, IM intramuscular
^a Based on a weight of 70 kg
^b Patients were given antacids
^c Only the 15 days controlled period of this trial is considered here
^d Counts were reported per adverse event term; the number displayed here is based on an independence assumption
^e Patients also received 0.1 % human albumin
^f Includes multiple sclerosis as an adverse event

ISSN: 1471-2377