Premenstrual Syndromes : PMS and PMDD - Rutuja :: The site ...

sertraline compared with placebo was evident by the
second randomized treatment cycle on four of seven
SAS factors, the Q-LES-Q and the three DRSP functioning
items. Functional improvement as measured by
the SAS and Q-LES-Q measures correlated with emotional
and physical symptom improvement. Women who
remitted (a Clinical Global Impressions-Improvement
score of 1 after three cycles of sertraline treatment) had
significantly higher premenstrual functioning at baseline
compared with non-remitters as evidenced by the
SAS total and factor scores, the Q-LES-Q scores, and
the three DRSP functioning items (all p � 0.001). 67
Halbreich and colleagues further compared baseline
luteal SAS and Q-LES-Q scores of this same group of
243 women with PMDD participating in the sertraline
trial 65 with baseline measures of women who participated
in dysthymia (N � 175) and chronic MDD (MDD
without remission or MDD and dysthymia, N � 124)
sertraline trials. 25 Again, the pretreatment SAS and
Q-LES-Q scores of women with PMDD and dysthymia
did not significantly differ, except for significantly
worse scores on the parental SAS factor in women with
PMDD. Functional impairment in women with PMDD
was not as severe as women with chronic MDD, overall,
although the parental and social/leisure SAS factors
demonstrated non-significant increased impairment
with PMDD.
Halbreich and colleagues reported on a multisite trial
of flexible-dose sertraline or placebo administered in
the luteal phase over three menstrual cycles in 229
women with PMDD. 66 Functioning was assessed by the
SAS and the three DRSP items during the follicular and
luteal phases at baseline and during the luteal phase of
each of three treatment cycles. Quality of life was assessed
with the Q-LES-Q at baseline and during each treatment
cycle. Significant improvement with sertraline compared
with placebo was evident on the total and on four of
seven SAS factor scores, the Q-LES-Q, and the three
DRSP functioning items. The social/leisure and family
unit SAS factor scores significantly improved with sertraline
in both the daily dosing and luteal phase dosing
studies.
A study in 167 women compared full-cycle sertraline,
luteal phase sertraline, and placebo for 3 months. 68
This study utilized the DSR for prospective confirmation
of premenstrual symptoms; 60% of the 167 women
met strict criteria for PMDD and 40% met criteria for
severe PMS. Global Ratings of Functioning assessed
family life, work, and social activity functioning with
ratings from 0 to 4, with 4 signifying ‘severe disruption’.
The Global Ratings of Functioning scores at baseline
ranged from 2.1 to 2.7 in the 167 women. Results
demonstrated that both dosing regimens of sertraline
were significantly superior to placebo in improving
PREVALENCE, IMPACT ON MORBIDITY, AND DISEASE BURDEN 43
family relationships and social activities, but not work
functioning. 68 An earlier study by this research group
had utilized the DSR, Global Ratings of Functioning,
and the Q-LES-Q in a study comparing full-cycle sertraline,
desipramine, and placebo for three cycles. 69 In this
study, 74% of 167 women met criteria for PMDD and
26% met criteria for severe PMS. At baseline, the Global
Ratings of Functioning scores ranged from 2.37 to 2.81,
and the Q-LES-Q averaged 45. Sertraline was more
effective than both desipramine and placebo in improving
family life, work, and social activity functioning.
Sertraline was also more effective than placebo in
improving quality of life as measured by the Q-LES-Q.
Paroxetine trials
Two multisite studies have been published reporting on
the comparison of daily dosing of paroxetine controlled
release (CR) 25 mg, paroxetine CR 12.5 mg, and placebo
in women with PMDD. 70,71 In both studies the diagnosis
of PMDD was determined by VAS ratings, and functioning
was assessed with the SDS. In the first study,
baseline values of the work, social/leisure, and family
life SDS item scores for the sample of 313 women with
PMDD at baseline were not provided. After three
cycles of treatment, paroxetine CR 25 mg daily was significantly
superior to placebo in each SDS domain,
whereas 12.5 mg daily was superior to placebo in the
improvement of social/leisure and family life functioning
only. 70 In the second study, the ranges of SDS item
scores at baseline in 371 women with PMDD were
work (4.9–5.4), social life (5.7–6.0), and family life
(6.5–6.9). Paroxetine CR 25 mg daily was significantly
superior to placebo in each SDS domain, whereas
12.5 mg daily was superior to placebo in the improvement
of family life functioning only. 71
A multisite study of the luteal phase administration
of paroxetine CR 25 mg, paroxetine 12.5 mg, and
placebo was conducted in 366 women with PMDD. 72
Diagnosis of PMDD was determined by VAS ratings,
and functioning was assessed with the SDS. The total
SDS score ranged from 16.8 to 17.6 in the 366 women
at baseline. Both doses of paroxetine CR were significantly
superior to placebo after three cycles of treatment
in improving functioning as reflected by
reductions in the total SDS score.
Escitalopram trial
A recent small trial compared luteal phase dosing of escitalopram
with symptom-onset dosing of escitalopram
over three cycles in 27 women with PMDD. 73 There
was no placebo condition. Diagnosis of PMDD was