Evidence Based Medicines

UHI’s physicians and pharmacologists created Zenstral PMS™ using the principles of evidence based medicine (EBM) and the results of university clinical trials worldwide.

Evidence based medicine researchers evaluate a broad spectrum of evidence—such as meta-analyses, systematic reviews of existing research, randomized controlled trials, cohort studies, and other methods of inquiry—to make decisions about patient care and treatment.

Below is a representative sample of the scientific evidence used in formulating patent-pending Zenstral PMS™:

Vitex Agnus Castus Extract (VAC)

A recent double-blind, randomized controlled trial published in the British Medical Journal (BMJ) demonstrated a 52 percent reduction in PMS symptoms with treatment with dry extract of agnus castus fruit.1 Similar results were obtained in another recent study published in the Archives of Gynecology and Obstetrics.²

Another recent study found that Vitex agnus castus extract had efficacy equal to fluoxetine for the treatment of PMDD, which is a more severe form of PMS. In this same study, the authors found that 57.9 percent of patients responded to VAC extract in the treatment of this disorder. The study also found that VAC extract was more effective than fluoxetine for treatment of the physical symptoms of PMDD.³

German health authorities have approved the use of chasteberry for three gynecological conditions: menstrual cycle irregularity, premenstrual syndrome (PMS), and mastodynia (breast pain).⁴

Magnesium

A recent randomized, double-blind crossover study concluded that magnesium works synergistically with vitamin B6 in the treatment of anxiety symptoms associated with PMS.7

Vitamin B6

The British Medical Journal did a meta-analysis of vitamin B6 in the treatment of PMS and concluded that it was likely to be of benefit in treating premenstrual symptoms and premenstrual depression.⁸

Zenstral PMS Mechanism of Action

Many different causes have been proposed for PMS. These include nutritional deficiencies in magnesium and/or vitamin B6.9,10 In addition, hormonal changes, neurotransmitter activity, diet, and stress have all been implicated in the etiology of PMS.^9,10

Vitex Agnus Castus Extract (VAC)

VAC acts on the hypothalamic-pituitary-adrenal (HPA) axis, which accounts for some of its efficacy11. Part of this compound’s PMS-relieving properties results from its dopamine agonist properties, which reduces stress-induced prolactin levels.11 VAC also elevates both beta-endorphin and opiod levels.^12,13

Magnesium

Low levels of red-cell magnesium have been correlated with symptoms of PMS.14 This is the rationale for supplementation with magnesium and has resulted in a number of studies on magnesium supplementation in women suffering from PMS.

Vitamin B6 The PMS-relieving properties result from its positive effect on neurotransmitter systems: serontonin, norepinephrine, histamine, dopamine, and taurine.¹⁵

Zenstral PMS™ Safety and Contraindications

Data from clinical trials, postmarketing surveillance studies, spontaneous reporting systems, manufacturers, and herbalist organizations indicate that the compounds in Zenstral PMS™ are generally well tolerated, and that any adverse events following VAC treatment are mild and reversible.16 Possible side effects include nausea, gastrointestinal discomfort, headache and pruritus.^{1,2,3,6,7,8,16}

Consult a physician if you experience any of these side effects or use this product longer than six months. Discontinue use if an allergic reaction occurs.

Zenstral PMS should not be used by women who are pregnant or lactating, taking birth control pills, or have a hormone-sensitive condition such as breast cancer.

No drug interactions have been reported, but theoretically VAC may interfere with dopamine agonists.16 Consult a physician before use if you are taking dopamine-related medications.

References

1. Schellenberg, et al. Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomized, placebo controlled study. BMJ. 2001;322;134-7.
2. Berger D, Schaffner W, Schrader E, Meier B, Brattstrom A. Efficacy of Vitex agnus castus L. extract Ze 440 in patients with pre-menstrual syndrome (PMS). Arch Gynecol Obstet. 2000; 264:150-53.
3. Atmaca M, Selahattin K, Texcan E. Fluoxetine versus Vitex agnus castus extract in the treatment of premenstrual dysphoric disorder. Human Psychopharmacol Clin Exp. 2003;18:191-5.
4. Blumenthal M, Busse WR, Goldberg A, et al. The complete German Commission E. monographs: therapeutic guide to herbal medicines. Austin TX. American Botanical Council. 1998, p1694.
5. Proctor M, Murphy P. Herbal dietary therapies for primary and secondary dysmenorrhoea (Cochrane review). The Cochrane Library, Issue 2, 2002. Oxford: update software.
6. Walker A, De Souza M, Vickers M, Abeyasekera S, Collins M, Trinca L. Magnesium supplementation alleviates premenstrual symptoms of fluid retention. Journal of Women’s Health. 1998 Nov;7(9):1157-65.
7. De Souza M, Walker A, Robinson P, Bolland K. A synergistic effect of daily supplement for 1 month of 200mg magnesium plus 50mg vitamin B6 for the relief of anxiety-related premenstrual symptoms: a randomized, double-blind, crossover study. Journal of Womens Health & Gender-Based Medicine. 2000 Mar;9(2)131-3.
8. Wyatt K, Dimmock P, Jones P, Shaughn O’brien PM. Efficacy of vitamin B-6 in the treatment of premenstrual syndrome: systemic review. BMJ. 1999; 318:1375-81.
9. Mortola J. Premenstrual syndrome-pathophysiologic considerations. N Engl J Med. 1998; 338:256-7.
10. Chrousos GP, Torpy DJ, Gold PW. Interactions between the hypothalamic-pituitary-adrenal axis and the female reproductive system: Clinical implications. Ann Intern Med. 1998;129:229-40.
11. Merz PG, Gorkow C, Schordter A, Rietbrock S, Sider C, Loew D, Dericks–Tan JSE, Taubert HD. The effects of special Agnus castus extract (BP 109E1) on prolactin secretion in healthy male subjects. Exp Clin Endocrinol Diabetes. 1996;104:447-53.
12. Brugisser R, Burkard W, Simmen U, Schaffner W. Untersuchungen an Opiod-Rezeptorin mit Vitex agnus-castus L. Z Phytother. 1999;20:140-58.
13. Samochowic L, Glaesmer R, Samochowic J. EifluBvon Monchspfeffer auf die konzentration von beta-Endorphin im Serum weiblicher Ratten. Arztez Naturheilverfahren. 1998;39:213-215.
14. Rosenstein DL, Elin RJ, Hosseini JM, et al. Magnesium measures across the menstrual cycle in premenstrual women. Biol Psychiatry. 1994;35:557-61.
15. Schindler R, Thoni H, Classen HG. The role of magnesium in the generation and therapy of benign muscle cramps. Combined in-vivo/invitro studies on rat phrenic nerve-diaphragm preparations. Arneimittel-Forschung. 1998;48:161-66.
16. Daniele C, Thompson J, Pittler MH, Ernst E. Vitex agnus castus: a systematic review of adverse events. Drug Saf. 2005;28(4):319-32.