Efficacy of a Herbal Formulation Based on Foeniculum Vulgare in Oligo/Amenorrhea: A Randomized Clinical Trial
Authors: Falahat Farnoush , Ayatiafin Sedigheh , Jarahi Lida , Mokaberinejad Roshanak , Rakhshandeh Hasan , Feyzabadi Zohre , Tavakkoli Mandana 
Published: October 2018

Background:

The aim of this study was to evaluate the efficacy of the herbal tea based on
Foeniculum vulgare, on inducing regular bleeding in women with oligomenorrhea and secondary amenorrhea(
oligo/amenorrhea).

Methods:

Forty women aged 18- 40 with oligo/amenorrhea were enrolled in this randomized controlled
clinical trial and were allocated to two groups equally. The women in the first group were treated by
Fomentex (Foeniculum vulgare / Mentha longifolia / Vitex agnus-castus) herbal tea 11.2 g/day in 2 divided
doses for 2 weeks and the second group were treated by medroxy progesterone acetate (MP)10
mg/day for the last 10 days of their menstrual cycles. The intervention was repeated in three cycles of
menstruation in both groups. Bleeding pattern was documented by the patient on diary cards. The occurrence
(yes/no) of bleeding, the regularity of bleeding pattern, the interval of cycles, the duration of
bleeding, the volume of blood flow, the hormonal parameters (total testosterone, free testosterone luteinizing
hormone and follicle-stimulating hormone), and the endometrial thickness in sonography before
and after the intervention were evaluated and compared as outcomes.

Results:

The number of women with bleeding during the first cycle was in the Fomentex group and the
MP group 83.3% and 94.1% respectively (p = 0.61). The regularity of bleeding did not significantly
differ in patients treated with Fomentex from those given MP (66.7% vs. 94.1%; p = 0.088). Mean interval
of cycles decreased in both groups after intervention (p<0.001). Mean duration decreased significantly
in MP group after the intervention but it was not different in patients treated with Fomentex. The
difference between 2 groups was not significant (P=0.705).

:

Volume of blood flow, with regard to Pictorial Blood Assessment Chart (PBAC), increased significantly
in MP group after the intervention (P=0.001) and it was not different in patients treated with Fomentex
(P=0.757); however, difference between 2 groups was not significant (P=0.063). The percentage of patients
with on time menstruation in the next (drug-free) episode, was higher in the Fomentex group compared
with the MP group (50% vs. 23.5%; p = 0.105). Secondary outcomes such as dysmenorrhea, acne
and hirsutism reduced in the Fomentex group (P≤0.05), while they increased in the MP group (P=0.007).
At the end of the treatment, there was a significant decrease in luteinizing hormone, total testosterone and
free testosterone in patients taking Fomentex. The decrease of endometrial thickness, was significant in
both groups after the intervention (P=0.001), but the difference between 2 groups was not significant
(P=0.58). No notable complication or side effect was reported in relation to Fomentex.

Conclusion:

Fomentex herbal tea is a safe, well-tolerated, and effective choice in inducing bleeding
and maintaining regular bleeding in women with oligo/amenorrhea.