Mind and Body Solution for PMS
A Patient’s guide to the latest knowledge about Premenstrual Syndrome (PMS) from University Health Industries
Part 1: About PMS
- What are PMS and PMDD?
- What causes PMS?
- What are the symptoms of PMS?
- What are the risks of PMS and PMDD?
- How can I tell if I have PMS?
- What can I do to manage my symptoms?
- What medical treatments are available?
- How effective are Selective Serotonin Reuptake Inhibitors (SSRIs) for the treatment of PMS?
- What is the effectiveness of gonadotropin releasing hormone analogues (GnRHa) therapy in treating PMS?
- Is bright light therapy effective for treating the depression associated with premenstrual dysphoric disorder?
Part 2: About Zenstral
- What is Zenstral PMS™?
- Who should take Zenstral PMS™?
- What are the ingredients?
- How does Zenstral PMS™ work?
- What is evidence based medicine?
- What is a meta-analysis?
- What scientific evidence was used in formulating Zenstral PMS™?
- What other nutraceuticals are available from UHI?
- Who should not take Zenstral PMS™?
- How much should I take?
- When will it start to work?
- What are the possible side effects?
- What is the NPA TruLabel Program?
- What is your guarantee?
- Who is University Health Industries, Inc.
Understanding PMS is one of the most important things you can do to manage your symptoms. In this booklet, we present the known facts about PMS, an overview of treatment options, and current independent research that supports the use of Zenstral PMS™ for relieving PMS and PMDD.
What are PMS and PMDD?
Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD), a more severe form of PMS, are both very common and potentially debilitating conditions from which many women suffer. Hormonal changes following ovulation trigger a group of disruptive symptoms that appear approximately 14 days before your period. PMS and PMDD affect an estimated 40 million women in the United States, with more than 5 million requiring medical treatment.
What causes PMS?
Though the exact cause of PMS is not completely understood, it appears that the hormones progesterone, estrogen and testosterone are involved, along with changes in the level of the brain chemical serotonin. Nutritional deficiencies in magnesium or vitamin B6, hormonal changes, neurotransmitter activity, diet, and stress have all been implicated in the etiology of PMS.1,2
What are the symptoms of PMS?
Most women feel some discomfort before their periods. But if you have PMS, you may feel so anxious, depressed, or uncomfortable that you can't cope at home or at work. Common symptoms of PMS include:
Physical Symptoms
- Breast tenderness (mastodynia)
- Cramping
- Swollen hands or feet
- Weight gain
- Headaches
- Bloated abdomen
- Constipation
- Joint pain
- Fatigue
- Acne
Psychological Symptoms
- Irritability
- Angry outbursts
- Low self-esteem
- Anxiety
- Confusion
- Difficulty concentrating
- Mood swings
- Crying spells
- Decreased libido
- Depression
What are the risks of PMD and PMDD?
PMS and PMDD are not mere inconveniences. These conditions can adversely impact a woman’s personal, professional, and financial success. Women suffering from PMS are at increased risk of depression, absenteeism from work, strained relationships, reduced productivity, and worsening of medical conditions such as epilepsy, asthma, fibromyalgia, multiple sclerosis, or migraine headache during specific phases of their menstrual cycles.
How can I tell if I have PMS?
According the American College of Obstetricians and Gynecologists (ACOG), you may have PMS if
* Your PMS symptoms occur only during the last two weeks of your cycle.
* the symptoms are sufficiently uncomfortable to impair your quality of life.
* other disorders that may be mistaken for PMS have been excluded.
If you suspect you have PMS, ACOG recommends keeping a daily log of your symptoms for two or three consecutive months to help in diagnosis. It’s important to talk with your doctor to confirm your diagnosis and rule out other possible causes of your symptoms, such as depression, migraine headaches, seizure disorders, irritable bowel syndrome, chronic fatigue syndrome, or allergies.
What can I do to manage my PMS symptoms?
Women can often manage the symptoms of premenstrual syndrome by making changes in the way they eat, exercise, and approach their daily lives. To reduce your discomfort, try implementing as many of the suggestions below as you can.
Dietary Tips for Controlling PMS
* Eat smaller, more frequent meals to reduce bloating and the sensation of fullness.
* Eat complex carbohydrates such as whole grain breads, pasta, and cereals.
* Cut back on sugar and fat in your diet.
* Avoid salt for the last days before your period to reduce bloating and fluid retention.
* Avoid caffeine intake to feel less tense and irritable.
* Choose foods rich in calcium.
* Increase consumption of dietary fiber.
Lifestyle Tips for Controlling PMS
* Get aerobic exercise. Regular daily exercise will help improve your overall health and can alleviate symptoms such as fatigue and a depressed mood.
* Ensure adequate sleep—about eight hours per night.
* Attempt to schedule stressful events for the week after your period.
* Maintain a regular schedule of meals, bedtime, and exercise.
* Practice deep-breathing exercises to help reduce headaches, anxiety, or trouble sleeping.
* Avoid smoking cigarettes.
What medical treatments are available for PMS and PMDD?
There are four types of prescription drugs used for PMS/PMDD:
1. Antidepressants that act on serotonin, including fluoxetine, sertraline, and paroxetine.The FDA has recently ordered makers of several antidepressants to issue black box warnings that patients on these medications should be closely monitored for “clinical worsening, suicidality, or unusual changes in behavior.”
2. Agents that suppress ovulation, such as danazol, transdermal estradiol patches, and some oral contraceptives. These medications carry risks for serious side effects and can be very expensive.
3. Other psychotropics to reduce anxiety, such as alprazolam and other anxiolytic benzodiazepines. Since alprazolam has a very short half-life, there is a risk of addiction for patients who are started on this medication.
4. Spironolactone, a diuretic that is only available by prescription. It has proven effective in reducing premenstrual fluid retention, but doesn’t address the other symptoms of PMS.
How effective are selective serotonin reuptake inhibitors (SSRI’s) for the treatment of PMS?
SSRI’s are a class of drugs used in the treatment of depression, anxiety, and personality disorders. Patients can experience many side effects from the use of these medications including weight changes, increase in anxiety, suicidal thoughts, and sexual dysfunction. A study published in the Cochrane Database concluded that there is very good evidence to support the use of selective serotonin reuptake inhibitors in the management of severe PMS. However, withdrawals due to side effects were 2.5 times more likely to occur in the treatment group than in the placebo group.3
What is the effectiveness of using gonadotropin releasing hormone analogues (GnRHa) to treat PMS?
GnRH analogues work to stop menstrual periods by decreasing estrogen production. A recent meta-analysis published in the British Journal of Obstetrics and Gynecology concluded that GnRHa treatment appears to be an effective option in the management of PMS.4 Unfortunately, patients who take these analogues can experience several serious side effects, including menopausal type symptoms such as hot flashes, mood swings, vaginal dryness, and increased LDL cholesterol and bone loss.
Is bright light therapy effective for treating the depression associated with premenstrual dysphoric disorder?
Light therapy consists of exposure to full-spectrum light for a prescribed amount of time. A recent meta-analysis of bright light therapy published in the American Journal of Obstetrics and Gynecology concluded that “the current evidence justifies neither enthusiastic dissemination nor confident rejection of this therapeutic modality.”5 Essentially, this suggests that more research is required to study the potential benefit of this treatment for PMS.
Part 2: About Zenstral PMS ™
Zenstral PMS from University Health Industries
[Testimonial]
“I want to thank you for all of your help. I have had the most terrible PMS with every symptom possible. Zenstral PMS has made all the difference! I have none of the symptoms: no headache, cramps, irritability, mood swings, or aches. This works! Thanks so much for this product!"
- Debbie W, North Carolina.
What is Zenstral PMS™?
Zenstral PMS™ is an innovative blend of natural compounds that are scientifically proven to reduce the symptoms of premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Unlike other PMS treatments, Zenstral addresses both the physical and psychological symptoms of PMS/PMDD in one convenient product, without the risk of dangerous side effects.
Using the principles of evidence based medicine, our physicians and pharmacologists formulated Zenstral PMS™ after months of reviewing the results of university research studies worldwide. The result is a powerful nutraceutical that is as effective as other PMS remedies—and safer.†
Who should take Zenstral PMS™?
Zenstral PMS™ is recommended for women suffering from
* general PMS-related symptoms
* cyclical mood symptoms of PMS including irritability, tension, depression
* lower back and joint pain associated with PMS
* fluid retention associated with PMS
* breast tenderness associated with PMS
What are the ingredients in Zenstral PMS™?
Each caplet contains 20 mg of Vitex agnus castus (.3% casticin), 200 mg of magnesium oxide (MgO), and 50 mg of vitamin B6 (pyroxidine)..
The Vitex agnus castus (VAC) compound used in Zenstral is casticin, a flavonoid from the chasteberry. This is the same substance used in the clinical studies that show Vitex agnus castus to be effective. Nearly all other products on the market standardize to agnuside, a terpene compound from the chasteberry tree.
How does Zenstral PMS™ work?
The natural compounds in Zenstral work on many of the biochemical mechanisms that contribute to PMS:†
1. Vitex Agnus Castus Extract (VAC): VAC acts on the hypothalamic-pituitary-adrenal (HPA) axis, a set of complex interactions between three hormone-producing organs. It also reduces stress-induced prolactin levels by simulating the effects of dopamine in the brain (dopamine agonist).6 In addition, VAC has been found to elevate beta-endorphin and opiod levels, naturally occurring substances that decrease pain and create a feeling of calm and well-being.7,8
2. Magnesium: Low levels of red-cell magnesium have been correlated with symptoms of PMS.9 This is the rationale for supplementation with magnesium and has resulted in a number of studies on magnesium supplementation in women suffering from PMS.
3. Vitamin B6: Also called pyroxidine, vitamin B6 has a positive effect on levels of neurotransmitters such as serontonin, norepinephrine, histamine, dopamine, and taurine.10
What is evidence-based medicine?
Evidence based medicine (EBM) involves examining 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.
EBM is rapidly becoming the new paradigm in health care, replacing the older authority-based model where the value of a medical treatment (and sometimes its availability) was based on the work of a limited number of experts.
To learn more about evidence based medicine, a non-profit organization called the Cochrane Collaboration (www.cochrane.org) is an excellent place to begin.
What is a meta-analysis?
A meta-analysis involves collecting data from many similar research studies, then analyzing the pooled data for statistical significance.
What evidence was used in formulating Zenstral PMS™?
Below is a representative sample of the scientific evidence used in formulating Zenstral PMS™:
Vitex Agnus Castus Extract (VAC)
A recent double-blind, randomized controlled trial published in the British Medical Journal demonstrated a 52 percent reduction in PMS symptoms in women treated with dry extract of agnus castus fruit.11 Similar results were obtained in another study published in the Archives of Gynecology and Obstetrics.12
Another recent study found Vitex agnus castus extract to be as effective as fluoxetine for the treatment of PMDD, a more severe form of PMS. The authors reported that 57.9 percent of patients responded to VAC extract in the treatment of this disorder, and also found that VAC extract was more effective than fluoxetine in treating the physical symptoms of PMDD.13
German health authorities have approved the use of chasteberry for three gynecological conditions: menstrual cycle irregularity, premenstrual syndrome (PMS), and mastodynia (breast pain).14
Magnesium
A recent randomized, double-blind crossover study concluded that magnesium works synergistically with vitamin B6 to relieve anxiety symptoms associated with PMS.15
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 beneficial in treating premenstrual symptoms and premenstrual depression.16
Who should not take Zenstral PMS™?
Consult a physician before use if you are pregnant, nursing, taking birth control pills, have a hormone-sensitive medical condition such as breast cancer, or are taking dopamine-related medications.
How much should I take?
The typical dosage is one caplet twice daily. Take Zenstral™ every day of the month, not only when you’re having symptoms. It needs to reach and maintain therapeutic levels in the body to work.
When will it start to work?
With daily use, Zenstral™ will reach therapeutic levels in your system within three to four weeks, so you should feel relief by the second cycle. In contrast, prescription antidepressants take at least a month to start working and don’t address the physical symptoms of PMS.
What are the possible side effects?
No serious side effects have been reported for the ingredients in Zenstral PMS™. Data from clinical trials, post-marketing 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.17 Possible side effects include nausea, gastrointestinal discomfort, headache, or pruritus.11,12,13,15,16,17,18
Consult a physician if you experience any of these side effects or use this product longer than six months. Discontinue use and consult a physician if an allergic reaction occurs.
No drug interactions have been reported. However, because of Zenstral’s mode of action, consult your physician before use if you are taking dopamine-related medications.
What is the NPA TruLabel Program?
The Natural Products Association (NPA) TruLabel program is the industry's most expansive and successful self-regulatory program.
University Health Industries and other NPA members voluntarily pay for random monitored tests of their products by independent laboratories. If a test reveals any deficiency in product quality or accuracy in labeling, NPA immediately alerts the member company and expects it to take corrective action. NPA revokes the membership of any company that does not comply.
What is your guarantee?
University Health Industries’ products are backed by our 100% money-back guarantee for first-time orders. If for any reason you are not completely satisfied with your order, simply return it within 30 days and we'll issue you a full refund of your purchase price, less shipping and handling.
Who is University Health Industries, Inc?
Every year, research labs around the globe identify and test natural compounds with the potential to improve human health—yet more than 98% of these discoveries are never commercialized for the benefit of the public.
University Health Industries, Inc. (OTC:UVHI), in collaboration with universities worldwide, researches natural compounds with clinically proven efficacy, identifies those with the greatest potential for enhancing human life, then develops them into patented nutraceutical products for treating common chronic ailments.
Our mission is to make the latest clinical discoveries in natural compounds available to consumers, delivered in patented pharmaceutical-grade formulations with guaranteed quality and potency.
UHI is a proud American company with offices and manufacturing facilities in Boca Raton, Florida. All of our products are GMP-approved and made in the United States to ensure they adhere to standards the American public can trust.
What other nutraceuticals are available from UHI?
UHI will introduce three new products in the coming weeks , each developed with the same quality and efficacy standards as Zenstral PMS™:
* Arthroleve ULT™ for bone and joint pain †
* Premium SAMe ULT™ for mood support†
* Cold & Flu RMD™ for immune system support and relief from the common cold†
Our physicians and pharmacologists are hard at work creating additional evidence-based nutraceutical products. Visit the UHI Web site at universityhealthindustries.com for updates, or request new product announcements by email at zenstralpms.com.
We welcome your feedback. Please contact us at 1 888 575 1700 or send an email to customercare@arthroleve.com with your suggestions, questions, and comments.
References
1. Mortola J. Premenstrual syndrome-pathophysiologic considerations. N Engl J Med. 1998; 338:256-7.
2 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.
3 Wyatt KM, Dimmock PW, O’Brien PM. Selective serotonin reuptake inhibitors for premenstrual syndrome. Cochrane Database Syst Rev. 2002;(4):CD 001396.
4 Wyatt KM, Dimmock PW, Ismail KM, Jones PW, O’brien PM. The effectiveness of GnRHa with and without ‘add-back’ therapy in treating premenstrual syndrome: a meta analysis. BJOG, 2004 Jun;111(6):585-93.
5 Krasnik C, Montori VM, Guyatt GH, Heels-Ansdell D, Brusse JW; Medically Unexplained Syndromes Study Group. The effect of bright light therapy on depression associated with premenstrual dysphoric disorder. Am J Gynecol. 2005 Sep;193(3 Pt 1):658-61.
6 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.
7 Brugisser R, Burkard W, Simmen U, Schaffner W. Untersuchungen an Opiod-Rezeptorin mit Vitex agnus-castus L. Z Phytother. 1999;20:140-58.
8 Samochowic L, Glaesmer R, Samochowic J. EifluBvon Monchspfeffer auf die konzentration von beta-Endorphin im Serum weiblicher Ratten. Arztez Naturheilverfahren. 1998;39:213-215.
9 Rosenstein DL, Elin RJ, Hosseini JM, et al. Magnesium measures across the menstrual cycle in premenstrual women. Biol Psychiatry. 1994;35:557-61.
10 Schindler R, Thoni H, Classen HG. The role of magnesium in the generation and therapy of benign muscle cramps. Combined in vivo/in vitro studies on rat phrenic nerve-diaphragm preparations. Arneimittel-Forschung. 1998;48:161-66.
11 Schellenberg, et al. Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomized, placebo controlled study. BMJ. 2001;322;134-7
12 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.
13 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.
14 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.
15 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.
16 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.
17 Daniele C, Thompson J, Pittler MH, Ernst E. Vitex agnus castus: a systematic review of adverse events. Drug Saf. 2005;28(4):319-32.
18 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.
19 Proctor M, Murphy P. Herbal dietary therapies for primary and secondary dysmenorrhoea (Cochrane review). The Cochrane Library, Issue 2, 2002. Oxford: update software.
† These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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