Background
Premenstrual syndrome is characterized by the cyclic occurrence of physical, behavioral
and psychological symptoms during the luteal phase of the menstrual cycle disappearing
within a few days of the onset of menstruation. Generally symptoms are mild, but 5–8%
of women suffer from severe PMS. Apart from conventional drugs, like serotonin reuptake
inhibitors and oral contraceptives, complementary and alternative medicines such as
Vitex agnus castus are used by many women experiencing PMS.
Objective
Our objective was to determine the efficacy, tolerability, and acceptability of Vitex agnus castus preparations for treatment of premenstrual syndrome.
Study Design
All journals in the Ovid software from inception through January 2016 were searched,
including the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and
PsycINFO. Gray literature was searched by Google Scholar and manufacturers of Vitex agnus castus preparations were contacted for information about unpublished trials. We included
randomized controlled trials with Vitex agnus castus in women with premenstrual syndrome and/or premenstrual dysphoric disorder with a
minimal duration of 2 menstrual cycles. The eligibility of the manuscripts was assessed
by 2 reviewers independently. The data abstracted included characteristics of the
study design, characteristics of the patient population, intervention details, type
of comparator, method of diagnosis, and outcome measures. We adhered to the PRISMA
guidelines.
Results
We found 17 randomized controlled trials of Vitex agnus castus in the treatment of premenstrual syndrome. Fourteen of these could be included in
the quantitative analysis. Thirteen of 14 studies with placebo, dietary supplements,
or herbal preparations as controls reported positive effects of Vitex agnus castus on total premenstrual syndrome symptoms. Unfortunately most of the trials are associated
with a high risk of bias. The pooled effect of Vitex agnus castus in placebo-controlled trials was large (Hedges g, –1.21; 95% confidence interval,
–1.53 to –0.88), but heterogeneity was extremely high (I2, 91%). We were unable to single out factors that could explain this heterogeneity
satisfactorily. The funnel plot and Egger tests suggest the presence of publication
bias.
Conclusion
Although meta-analysis shows a large pooled effect of Vitex agnus castus in placebo-controlled trials, the high risk of bias, high heterogeneity, and risk
of publication bias of the included studies preclude a definitive conclusion. The
pooled treatment effects should be viewed as merely explorative and, at best, overestimating
the real treatment effect of Vitex agnus castus for premenstrual syndrome symptoms. There is a clear need for high-quality trials
of appropriate size examining the effect of standardized extracts of Vitex agnus castus in comparison to placebo, selective serotonin reuptake inhibitors, and oral contraceptives
to establish relative efficacy.
Key words
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Article info
Publication history
Published online: February 23, 2017
Accepted:
February 15,
2017
Received in revised form:
February 5,
2017
Received:
November 21,
2016
Footnotes
Author Saskia Verkaik began the work on this review when she was in between jobs, and is currently employed by Acerta Pharma B.V., a biotechnology company not active in the field of premenstrual syndrome. The company had no involvement in any part of this study. The other three authors of the review have no potential conflicts to disclose.
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