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The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

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Abstract

Introduction

A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal® (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome (PMS).

Methods

Femal, 160 mg twice-daily, was given for four menstrual cycles to 50 women, and placebo to 51 women. PSD were evaluated on a visual analogue scale prior to and after the four cycles. The effect on overall PMS symptoms was assessed with the Steiner premenstrual tension syndrome (PMTS) self-rating questionnaire. The results were analysed statistically based on intention to treat.

Results

Femal treatment resulted in a significant reduction in PSD (P<0.05) whereas placebo had no significant effect (P>0.05). In a subgroup analysis of women with irritability as their main PMS symptom cluster, the reduction of PSD was even more pronounced (P<0.001). There was no significant difference in overall degree of PMS symptom reduction between Femal and placebo when all participating women were evaluated (P>0.05). However, in women with irritability as their main PMS symptom cluster, Femal treatment resulted in a significant reduction of the Steiner score (P<0.05). The frequency of adverse events was not significantly different in women on Femal compared to women on placebo (P>0.05). No serious adverse events were recorded.

Conclusion

Femal treatment reduced PSD to a significant degree, particularly in women with irritability as their main PMS symptom. Femal treatment also reduced overall PMS symptoms in women with irritability (but not dysphoria) as their main PMS symptom. The safety of Femal and its efficacy in PSD and other symptoms in women with irritability as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS.

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Authors and Affiliations

  1. Greverud Legesenter, Flåtestadveien 3, 1415, Oppegård, Norway

    Gerhard Gerhardsen

  2. Faculty of Life Sciences, University of Copenhagen, Copenhagen, Denmark

    Anne V. Hansen

  3. Fartein Valens vej 45, Kolbotn, Norway

    Marianne Killi

  4. Medical Centre, Amager Hospital, Copenhagen, Denmark

    Gitte Gleerup Fornitz

  5. Herning Hospital, Herning, Denmark

    Frank Pedersen

  6. Department of Clinical Biochemistry, Copenhagen County Hospital in Gentofte, University of Copenhagen, Hellerup, Denmark

    Signe Barfod Roos

Authors
  1. Gerhard Gerhardsen
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  2. Anne V. Hansen
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  3. Marianne Killi
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  4. Gitte Gleerup Fornitz
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  5. Frank Pedersen
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  6. Signe Barfod Roos
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Correspondence to Gerhard Gerhardsen.

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Gerhardsen, G., Hansen, A.V., Killi, M. et al. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study. Adv Therapy 25, 595–607 (2008). https://doi.org/10.1007/s12325-008-0072-4

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  • DOI: https://doi.org/10.1007/s12325-008-0072-4

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