Femal对经前综合征女性的疗效：一项随机、双盲、平行组、安慰剂对照的多中心研究。

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

作者信息

Gerhardsen Gerhard, Hansen Anne V, Killi Marianne, Fornitz Gitte Gleerup, Pedersen Frank, Roos Signe Barfod

机构信息

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

出版信息

Adv Ther. 2008 Jun;25(6):595-607. doi: 10.1007/s12325-008-0072-4.

DOI:10.1007/s12325-008-0072-4

PMID:18568441

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.

摘要

引言

开展了一项双盲、安慰剂对照、随机、平行组、多中心研究，以评估一种基于花粉的草药产品Femal（英国莱斯特郡海邦有限公司）对经前综合征（PMS）女性经前睡眠障碍（PSD）的影响。

方法

50名女性每天服用两次160毫克Femal，持续四个月经周期，51名女性服用安慰剂。在四个周期前后，通过视觉模拟量表评估PSD。使用施泰纳经前紧张综合征（PMTS）自评问卷评估对整体PMS症状的影响。基于意向性分析对结果进行统计学分析。

结果

Femal治疗使PSD显著降低（P<0.05），而安慰剂无显著效果（P>0.05）。在以易怒为主要PMS症状群的女性亚组分析中，PSD的降低更为明显（P<0.001）。在评估所有参与女性时，Femal和安慰剂在PMS症状减轻的总体程度上无显著差异（P>0.05）。然而，在以易怒为主要PMS症状群的女性中，Femal治疗使施泰纳评分显著降低（P<0.05）。与服用安慰剂的女性相比，服用Femal的女性不良事件发生率无显著差异（P>0.05）。未记录到严重不良事件。