SAM-e E"cacy
Fourteen English language citations of placebocontrolled
studies of SAM-e monotherapy for the
treatment of depressive symptoms were identi-
fied.107-120 Study quality was a common issue; no
study met all of the study selection criteria
outlined, with most being deficient in regards to
more than one selection criterion. Nevertheless,
because these studies represent the only placebocontrolled
data identified by the searches, they
were utilized for this efficacy examination.
Nine of 14 identified studies included subjects
with mild-to-moderate depressive symptoms
(Table 6) and five included subjects with moderateto-severe
symptoms (Table 7). Only six of the 14
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.
SAM-e E"cacyFourteen English language citations of placebocontrolledstudies of SAM-e monotherapy for thetreatment of depressive symptoms were identi-fied.107-120 Study quality was a common issue; nostudy met all of the study selection criteriaoutlined, with most being deficient in regards tomore than one selection criterion. Nevertheless,because these studies represent the only placebocontrolleddata identified by the searches, theywere utilized for this efficacy examination.Nine of 14 identified studies included subjectswith mild-to-moderate depressive symptoms(Table 6) and five included subjects with moderateto-severesymptoms (Table 7). Only six of the 14studies 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.
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