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

with placebo in 450 women. 21 Mood symptoms (e.g.
depression, anxiety, mood swings, irritability), behavioral
symptoms (difficulty concentrating, sleep disturbance),
and physical symptoms (e.g. fatigue, increased
appetite, breast tenderness, headaches) were all significantly
reduced with the OCP compared with placebo.
It is particularly significant that active treatment was
associated with a 49% reduction in premenstrual
depression, as OCPs have been thought by some to
worsen or cause symptoms of depression. 28,29
The differences in estrogen dose and shortened drugfree
interval between the Yonkers 21 and the Freeman 20
studies may explain the more favorable results in the
former study. The Freeman study 20 used a higher dose
of estradiol than the Yonkers study 21 (e.g. 30 �g rather
than 20 �g), and the active drug was given for 21
rather than 24 days in a 28-day cycle.
In addition to their effect on premenstrual symptoms,
there are numerous health advantages afforded
by intake of OCPs. They provide effective, reversible
contraception but also have other known benefits,
including prevention of bone loss, decreased risks for
HORMONAL THERAPIES OVERVIEW 111
ovarian and endometrial cancer, anemia, abnormal
uterine bleeding, uterine myomata, endometriosis,
pelvic inflammatory disease, as well as complications
of unplanned pregnancy, such as ectopic pregnancy and
molar gestation. 9,18 The most bothersome physical side
effects of OCPs are bloating and breast tenderness, and
these symptoms are, at least in part, attributable to
water retention, probably related to their estrogenic
component. 9,18
Currently, the evidence suggests that OCPs should be
considered if premenstrual symptoms are primarily
physical, and the newer OCPs containing antiandrogenic
progestins may be effective in treating mood symptoms
as well. More controlled studies are needed to confirm
the efficacy of continuous vs cyclical oral contraceptives
in ameliorating premenstrual symptoms. 30 The newer
OCPs with lower-dose estrogen and drospirenone may
have a unique role in women who both desire contraception
and suffer from symptoms of PMDD.
Table 12.2 lists the evidence supporting the efficacy
and safety of OCPs as well as the other hormonal
therapies to be discussed in this chapter.
Table 12.2 Evidence-based guidelines on the use of hormonal treatments in PMS/PMDD
Treatment Strength of Quality of Efficacy c Adverse events d
recommendation a evidence b
Oral contraceptives A Ib A A
Estradiol patches and implants B IIb C C
Progesterone suppositories and
micronized tablets
A Ia D A
Danazol A Ib A C
GnRH agonists A Ia A C
Ovariectomy B IIb C C
Chasteberry (Vitex agnus-castus) A Ib C D
Black cohosh (Cimicifuga racemosa) C IV C D
aStrength of recommendation A = At least one randomized controlled trial as part of a body of literature of overall good
quality and consistency addressing the specific recommendation. B = Well-controlled clinical studies available but no
randomized clinical trials on the topic of recommendations. C = Evidence obtained from expert committee reports or
opinions and/or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies
of good quality.
bQuality of evidence Ia = Evidence obtained from a meta-analysis of randomized controlled trials. Ib = Evidence
obtained from at least one randomized controlled trial. IIb = Evidence obtained from at least one other type of welldesigned
quasi-experimental study. III = Evidence obtained from well-designed non-experimental descriptive studies, such
as comparative studies, correlation studies, and case studies. IV = Evidence obtained from expert committee reports or
opinions and/or clinical experience of respected authorities.
cEfficacy A = Effective. B = Conflicting data. C = Insufficient data. D = Ineffective.
dAdverse effects A = Minimal/mild. B = Moderate. C = Major. D = Unknown.