studies were restricted to subjects with MDD
(three in mild-moderate MDD, three in moderatesevere
MDD). All 14 studies enrolled only adults;
no placebo-controlled studies of SAM-e in pediatric
patients with depression were identified. Only one
study included an active comparator arm (imipramine).114
Eleven of the 14 studies were conducted
in Europe and three were conducted in the United
States. All 14 studies were short-term, ranging
from 2-6 weeks. No placebo-controlled studies
were identified that assessed the long-term
antidepressant efficacy of SAM-e.
Five of the nine studies in mild-to-moderate
depressives were “positive”, i.e., they reported
statistically significant results favoring SAM-e on
the prospectively defined primary endpoint. Two
other studies in mild-to-moderate depression also
produced numerically favorable results for SAM-e;
however, a statistical comparison between groups
was not provided. !e mean treatment effect size
in the positive studies was 1.0 (range 0.33-1.6), by
convention a large effect size.
Four of the five SAM-e studies in subjects with
more severe symptoms were also positive. !e
mean effect size for these studies was 0.87 (median
0.79), again consistent with a large effect size. In
the study with an active comparator, SAM-e
produced a reduction in HAM-D score that was
essentially equivalent to the reduction produced by
imipramine. As previously noted, all SAM-e studies
identified were methodologically flawed to some
extent. !ese shortcomings are briefly summarized
in Table 8.
studies were restricted to subjects with MDD(three in mild-moderate MDD, three in moderatesevereMDD). All 14 studies enrolled only adults;no placebo-controlled studies of SAM-e in pediatricpatients with depression were identified. Only onestudy included an active comparator arm (imipramine).114Eleven of the 14 studies were conductedin Europe and three were conducted in the UnitedStates. All 14 studies were short-term, rangingfrom 2-6 weeks. No placebo-controlled studieswere identified that assessed the long-termantidepressant efficacy of SAM-e.Five of the nine studies in mild-to-moderatedepressives were “positive”, i.e., they reportedstatistically significant results favoring SAM-e onthe prospectively defined primary endpoint. Twoother studies in mild-to-moderate depression alsoproduced numerically favorable results for SAM-e;however, a statistical comparison between groupswas not provided. !e mean treatment effect sizein the positive studies was 1.0 (range 0.33-1.6), byconvention a large effect size.Four of the five SAM-e studies in subjects withmore severe symptoms were also positive. !emean effect size for these studies was 0.87 (median0.79), again consistent with a large effect size. Inthe study with an active comparator, SAM-eproduced a reduction in HAM-D score that wasessentially equivalent to the reduction produced byimipramine. As previously noted, all SAM-e studiesระบุ flawed ถูก methodologically ไปขอบเขตการ ! แสดงความเร็วจะสรุปสั้น ๆในตาราง 8
การแปล กรุณารอสักครู่..