Skip to main content
. 2013 Sep;12(9):857–865. doi: 10.1016/S1474-4422(13)70159-5

Table 3.

Summary of main results

Dronabinol (n=329) Placebo (n=164) Estimated treatment effect (95% CI) p value
First EDSS score progression event, number of events (number of first progression events per patient-year*) 145 (0·24) 73 (0·23) HR 0·92 (0·68 to 1·23) 0·57
MSIS-29-PHYS score, yearly change 0·62 (3·29) 1·03 (3·74) −0·91 (−2·01 to 0·19) 0·11
MSFC score, yearly change −0·17 (0·28) −0·16 (0·30) −0·03 (−0·19 to 0·09) 0·72
MSWS-12 score, yearly change 0·37 (2·33) 0·52 (2·68) −0·19 (−0·97 to 0·60) 0·74
RMI, yearly change −0·58 (0·96) −0·72 (1·08) 0·04 (−0·24 to 0·32) 0·76
MRI n=182 n=91
PBVC, yearly change −0·68 (0·95) −0·66 (0·98) −0·01% (−0·26 to 0·24) 0·94
New or enlarging T2 lesions 60 (37%) 34 (40%) OR 0·89 (0·50 to 1·58)§ 0·70
New or enlarging T1 lesions 54 (34%) 28 (33%) OR 1·05 (0·59 to 1·88)§ 0·87

Data are n (%) or mean (SD) unless otherwise specified. EDSS=expanded disability status scale. HR=hazard ratio. MSIS-29-PHYS=29-item multiple sclerosis impact scale, physical impact subscale. MSFC=multiple sclerosis functional composite. MSWS-12=multiple sclerosis walking scale. RMI=Rivermead mobility index. PBVC=percentage brain volume change. OR=odds ratio.

*

Assuming progression events occur at the midpoint of the 6 months between follow-ups.

HR (dronabinol/placebo) according to Cox regression analysis (losses to follow-up regarded as censored observations); sensitivity analysis (losses to follow-up regarded as progression events) resulted in HR 1·11 (0·86–1·44), p value=0·41.

Estimated between-group difference (dronabinol–placebo) according to multilevel model.

§

Estimated OR according to logistic regression model (dronabinol/placebo).