Printer Friendly

New international research confirms dose dependant efficacy of Vitex agnus-castus extract Ze 440 (Premular[R]) in relieving symptoms of PMS: Michelle Boyd, herbalist, and head of practitioner education at Flordis, focuses on a most effective herbal remedy for the treatment of premenstrual syndrome (PMS).

2011 systematic review of Vitex agnus-castus (VAC) evaluated the efficacy of this herb in alleviating symptoms of PMS and highlighted the only (better than placebo) benefits were derived from the use of European dosage forms. (1) Further, of the studies identified in this review, only one extract of VAC has received recognition for 'well established use' classification from the Committee on Herbal Medicinal products of the European Medicine Agency (EMA), namely Ze 440. (2,3)

Most recently (2012), new international research, published in the International Journal of Phytotherapy and Phytopharmacology, Phytomedicine, confirms that this unique VAC extract (Ze 440), is the most effective dosage and preferred option to relieve the symptoms of PMS in women. (4) This multicentre, double-blind, placebo-controlled, parallel-group study included 162 females aged 18 to 45 years with PMS. Participants were randomised to receive either placebo or one of three different doses of Ze 440 over three menstrual cycles. The patients' symptom severity was assessed for the main symptoms of PMS identified as irritability, mood alteration, anger, headache, bloating and breast fullness. Study results showed the improvement for the group on the normal dosage for Premular of one tablet per day was superior in the reduction of all six individual symptom scores, compared to the placebo and smaller dosage groups. Interestingly, a higher dose demonstrated no significant difference in reducing symptom severity compared to the normal Premular dose. Importantly, after treatment with the normal Premular dose, nearly half (49%) of all patients had no symptoms and 31% had mild symptoms. The tolerability rating for Premular was also noted as very good by over two-thirds of patients (69%) and good by almost one-third (31%), with no serious adverse events occurring in the study. (4)

Prior chronic use of oral contraceptives was allowed in this study, with the dose remaining unchanged throughout the study period. Oral contraceptives are known to affect premenopausal symptoms; however the researchers noted no statistically significant effect of oral contraceptives on either total or individual symptom scores. (4)

On the basis of these findings, the study authors conclude that, for patients suffering from PMS, Premular (Ze 440) once-daily should be the preferred option. (4)

The clinical evidence from this study supports the dose recommendation provided by both the European Scientific Cooperative of Phytotherapy (E/S/C/O/P 2003) and the Committee on Herbal Medicinal products of the EMA's 'well established use' classification for Ze 440 (Premular). (2,3)

This study also adds to an already established body of clinical evidence to support Premular's efficacy and safety. In previous clinical trials, Premular has also shown to be significantly (p<0.001) better than placebo in reducing PMS symptoms such as irritability, anger and headache. (6,7)

Premular is one of a pedigree of European herbal medicines, developed and currently produced by Swiss company Zeller. Zeller has over 130 years of experience in the development and manufacture of herbal medicines.

References: (1.) Dante, G. Facchinetti, F. (2011) 'Herbal treatments for alleviating premenstrual symptoms: a systematic review', J Psycosom Obst Gynaecol 32(1): 42-51. (2.) European Medicines Agency: Evaluation of Medicines for Human Use, 17 September 2009. 'Committee on Herbal Medicine Products, Draft Assessment Report on Vitex Agnus-castus L., Fructus', Doc. Ref.: EMEA/HMPC/144003/2009. (3.) European Medicines Agency: 25 November 2010, 'Committee on Herbal Medicinal Products, Community herbal monograph on Vitex agnus-castus L., fructus Final', Doc.Ref.: EMEA/HMPC/144006/2009. (4.) Schellenberg, R., et al. (2012) Dose-dependent efficacy of Vitex agnus castuis extract Ze 440 in patients suffering premenstrual syndrome. Phytomedicine http://dx.doi.oig/10.1016/j.phymed.2012.08.006. (5.) Schellenbeig, R. (2001) 'Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study', BMJ 322(7279):134-7. (6.) Berber D., et al. (2000) 'Efficacy of Vitex agnus castus L. extract Ze 440 in patients with pre-menstrual syndrome (PMS)', Arch Gynecol Obstet 264:150-153.
COPYRIGHT 2012 National Herbalists Association of Australia
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2012 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Author:Boyd, Michelle
Publication:Australian Journal of Herbal Medicine
Geographic Code:4E
Date:Dec 1, 2012
Previous Article:SJW and psoriasis.
Next Article:Anesthesia and cognitive deficits in children.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters