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

42 THE PREMENSTRUAL SYNDROMES
health provider visits than controls. 57 Further analysis
demonstrated that women with PMS were 2–3 times
more likely to miss at least 2 days of work per month
and were 4–6 times more likely to report at least a 50%
reduction in work productivity compared with women
without PMS. 58 Women with PMS in both cycles showed
significantly greater decrease in work productivity compared
to women with one cycle of PMS and women not
meeting PMS criteria. Women who met criteria for PMS
in one or both cycles were significantly more likely to
use calcium, vitamins, and other non-prescription
medications (p � 0.02), and to use antidepressants,
antianxiety medications, and other prescription medications
(p � 0.03) for premenstrual symptoms than
controls. 58
The largest data available describing the functioning
and quality of life in women with prospectively confirmed
PMDD comes from women presenting for multisite
clinical trials. Although women with PMDD seeking
treatment may not be the same as women with PMDD
in the community who do not seek treatment, the baseline
evaluation of women seeking treatment in these
studies has been systematic and comprehensive. In
addition to baseline assessments, recent treatment trials
have also examined the effect of treatment on functioning
and quality of life as secondary outcome measures.
Fluoxetine trials
The largest multisite fluoxetine trial assessed the diagnosis
of late luteal phase dysphoric disorder (now PMDD)
with VAS in 313 women. 59 In later analyses, 8 items
from the Premenstrual Tension Syndrome – Self Report 60
corresponding to work functioning were examined in
304 women. 61 At baseline, each of the 8 items were
endorsed by a significantly larger percent of women
during the luteal phase than in the follicular phase (each
p � 0.001). Both fluoxetine 20 mg daily and 60 mg daily
for 6 months were significantly better than placebo in
improving the 8-item summed score, and the improvement
occurred during the first cycle of treatment.
A multisite study compared luteal-phase fluoxetine
20 mg, fluoxetine 10 mg, and placebo in 260 women
with PMDD diagnosed with the DRSP. 62 Both 20 mg
(p � 0.033) and 10 mg (p � 0.021) fluoxetine for three
cycles were significantly superior to placebo in improving
the three DRSP functioning items. Another multisite
study compared fluoxetine 90 mg administered 14
and 7 days before expected menses, placebo 14 days
before, and fluoxetine 90 mg 7 days before expected
menses, and placebo both 14 and 7 days before expected
menses in 257 women with PMDD diagnosed with the
DRSP. 63 The work, social life, and family life subscales
of the SDS at luteal baseline were 4.8–5.2, 5.2–5.5, and
5.5–6.0, respectively, in the three treatment groups.
The administration of fluoxetine 90 mg twice weekly
before expected menses, but not once before expected
menses, was significantly superior to placebo on improving
the work (p � 0.001), social life (p � 0.037), and
family life (p � 0.005) scores of the SDS and the sum of
the three DRSP functioning items (p � 0.035). A crossover
study of flexible-dose fluoxetine and placebo, each
administered for three cycles, in 20 women with
PMDD reported superiority of fluoxetine over placebo
for a composite social isolation and work efficiency
score. 64
Sertraline trials
A recent study 41 reported on a post-hoc analysis of the
pretreatment Q-LES-Q scores of 437 women with
prospectively confirmed PMDD by DRSP ratings who
had participated in clinical trials of sertraline treatment.
65,66 The sum of items 1–14 correlated with the
overall satisfaction and contentment item 16 (r � 0.78,
p � 0.0001), suggesting that the broad set of functioning
domains assessed by the Q-LES-Q individual items
are related to the overall sense of quality of life. Thirtyone
percent of women with PMDD were considered to
have severe quality of life impairment, defined as two
or more standard deviations below the community
norm. Illness-specific symptom measures accounted for
26% of the variance in quality of life for women with
PMDD, suggesting that quality of life assessment should
be part of the diagnostic evaluation and treatment plan
for women with PMDD in addition to specific premenstrual
symptoms. 41
Three studies have reported on the effect of sertraline
and placebo on the functioning and quality of life in 243
women with PMDD who participated in a multisite
trial of daily flexible-dose sertraline for three cycles. 65
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 treatment
cycle. Quality of life was assessed with the Q-LES-Q at
baseline and during each treatment cycle. The initial
study reported that sertraline was significantly superior
to placebo in improving functioning as measured by the
three DRSP functioning items and the SAS scores. 65
Pearlstein and colleagues further examined the data. 67
Significant luteal phase impairment was evident compared
with the follicular phase during the baseline cycle
on the total and factor SAS scores, and on items 1–14
and the overall assessment score of the Q-LES-Q (all
p � 0.001). Overall, the luteal impairment noted
with SAS total and factor scores was similar to
cohorts of women with dysthymia, but milder than
women with MDD. Significant improvement with