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

G. Gerhardsen; A.V. Hansen; M. Killi; F. Pedersen; S.B. Roos; Gitte Gleerup Fornitz

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

G. Gerhardsen, A.V. Hansen, M. Killi, F. Pedersen, S.B. Roos, Gitte Gleerup Fornitz

14 Citations (Scopus)

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 (R) (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. Conclusions: 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
Udgivelsesdato: 2008/6

Original language	English
Journal	Advances in Therapy
Volume	25
Issue number	6
Pages (from-to)	595-607
Number of pages	12
ISSN	0741-238X
Publication status	Published - 2008

Cite this

@article{b8016420873c11de8bc9000ea68e967b,

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

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 (R) (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. Conclusions: 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 Udgivelsesdato: 2008/6",

author = "G. Gerhardsen and A.V. Hansen and M. Killi and F. Pedersen and S.B. Roos and Fornitz, {Gitte Gleerup}",

note = "Times Cited: 0ArticleEnglishGerhardsen, GGreverud Legesenter, Flatestadveien 3, Oppegard 1415, NorwayCited References Count: 16322QNSPRINGER233 SPRING ST, NEW YORK, NY 10013 USANEW YORK",

year = "2008",

language = "English",

volume = "25",

pages = "595--607",

journal = "Advances in Therapy",

issn = "0741-238X",

publisher = "Adis International Ltd",

number = "6",

}

TY - JOUR

T1 - The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

AU - Gerhardsen, G.

AU - Hansen, A.V.

AU - Killi, M.

AU - Pedersen, F.

AU - Roos, S.B.

AU - Fornitz, Gitte Gleerup

N1 - Times Cited: 0ArticleEnglishGerhardsen, GGreverud Legesenter, Flatestadveien 3, Oppegard 1415, NorwayCited References Count: 16322QNSPRINGER233 SPRING ST, NEW YORK, NY 10013 USANEW YORK

PY - 2008

Y1 - 2008

N2 - 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 (R) (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. Conclusions: 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 Udgivelsesdato: 2008/6

AB - 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 (R) (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. Conclusions: 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 Udgivelsesdato: 2008/6

M3 - Journal article

SN - 0741-238X

VL - 25

SP - 595

EP - 607

JO - Advances in Therapy

JF - Advances in Therapy

IS - 6

ER -