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H-Regulator: A Safe & Effective Alternative

The terms ‘PMS’ and ‘menopause’ are often met with raised eyebrows. Both are mediated by changes in women’s hormonal levels. Both may result in mood swings, irritability, dysphoria (unhappiness), tension and anxiety. Both have scourged relationships between wives and their husbands, mothers and their children, and sisters and their siblings, the world over. While these conditions are exclusive to women, brave individuals have often commented that it’s not just women that suffer. It’s everyone!

Menstrual Cycle Conditions
Menstruation involves the discharge of blood and fragments of endometrium (uterine lining) from the vagina every month in females of childbearing age. The menstrual cycle can cause many women distressing symptoms. Those symptoms characterising the lead up to menstruation may be referred to as Pre-Menstrual Syndrome (PMS). Disruption of the menstrual cycle itself can lead to a variety of ailments, such as amenorrhea (no menstruation), dysmenorrhea (painful menstruation), luteal phase defects, menorrhagia (long, heavy menstruation), oligomenorrhea (infrequent menstruation) and polymenorrhea (overly frequent menstruation). The following is a brief discussion on some of these problems.

Pre-Menstrual Syndrome (PMS)
Pre-menstrual syndrome is characterised by a collection of physical and psychological symptoms occurring prior to menstruation. 95% of women experience some form of PMS, while 40% of women have symptoms severe enough to disrupt their lifestyle, and 5% are incapacitated by their symptoms (this condition is termed Premenstrual Dysphoric Disorder, or PMDD) [1].

While symptoms vary widely between individuals, common physical symptoms include abdominal pain, bloating, headache or migraine, back pain, swelling and breast tenderness.  Psychological symptoms may include irritability, tension, depression, aggression, dysphoria, fatigue, insomnia, food cravings and reduced libido [2,3,4]. In short, PMS can cause considerable physical and emotional discomfort. 

The exact causes of PMS remain elusive, although its relationship to the luteal phase of the menstrual cycle strongly suggests the involvement of sex hormones such as oestrogen  and progesterone.  Currently, popular theory posits central nervous system neurotransmitter interactions with sex hormones are at play, with altered levels of 5-Hydroxytryptamine (serotonin) commonly observable during the occurrence PMS. 

Painful Menstruation (Dysmenorrhoea)
Painful menstruation is caused by severe spasmodic cramping experienced in the lower back and lower abdominal pain which peaks just before or during the first day of menstrual bleeding.  Other symptoms associated with the pain include nausea, vomiting and diarrhoea. 60% of adolescent females suffer terrible menstrual pain at some stage, while 14% of these girls regularly miss school because of the severe pain experienced [8].

Menstrual Migraine
Menstrual migraines are severe headaches that can occur before, during or after menstruation [8]. Among the 19% of women suffering from migraine, 60% relate it to their menstrual cycles.  Menstrual migraine has the same symptoms as migraine, however the pain is stronger, lasts longer, and occurs more frequently [10]. The causes of the condition are not yet fully understood, but it may be linked to menstrual related overproduction of prostaglandins, or triggered by the fall in oestrogen levels.  , , 

Irregular Menstruation (Oligomenorrhea) & Absent Menstruation (Amenorrhoea)
The causes of irregular or absent menstruation are diverse.  Absence of menstruation could be caused by anatomical abnormalities involving the ovaries, the pituitary gland or the hypothalamus. The sudden stop of normal menstruation may be explained by a number of reasons, most commonly stress, significant weight loss, regular strenuous exercise or depression. Pregnancy may also cause periods to stop unexpectedly.
 
Menopause
Menopause denotes the cessation of women’s menstrual cycles and fertility, usually around 45-55 years of age.  During menopause, the ovaries begin to function erratically. A woman’s monthly cycle becomes less predictable, periods begin to skip and, eventually, cease altogether as the ovaries effectively cease to produce progesterone and the oestrogens, oestradiol and oestriol. The resultant fluctuations in hormonal balance may then lead to a host of unwanted side effects.

During menopause, around two-thirds of women will experience vasomotor symptoms such as hot flushes and night sweats. Other common symptoms include accelerated bone loss, urogenital atrophy, urinary tract infections, incontinence, increased cardiovascular risk, vaginal dryness, sleep and mood disturbances, sexual dysfunction, decreased libido and loss of skin elasticity [14, 15]. In particular, mood and sleep disturbances can have a significant negative impact on the overall quality of life for a large proportion of women [15].

Postmenopausal women are at increased risk of osteoporosis because of the association between oestrogen deficiency and accelerated bone loss.  During the first five years of menopause, women can experience bone loss of 2-5% a year, leading to an increased risk of bone fractures, and result discomfort and loss on independence. Oestrogenic and phytoestrogenic replacement has been shown to help guard against the rapid onset of this condition.

Available Treatments/Therapies

Hormone Replacement Therapy (HRT)
Given that many of the negative symptoms associated with menopause are attributed to the hormonal imbalance created by the erratic, fluctuating levels of progesterone and particularly oestrogen, hormone replacement therapy (HRT) has become popular as a treatment for many millions of women around the world. In essence, HRT endeavours to replenish the levels of oestrogen (and, in some preparations, progesterone) which menopause causes to diminish. In doing so, HRT may provide from the experience of unwanted symptoms such as hot flushes, night sweats and vaginal pain.   

However, long-term treatment with oestrogens may be limited due to its potentially negative health effects: it has repeatedly been associated with an increased risk of breast cancer in women,  an increased risk of endometrial adenocarcinoma and endometrial hyperplasia.

Accordingly, current treatment guidelines indicate that HRT should be used only in the short term for moderate-to-severe symptoms, with the lowest effective dose for treatment.  As a result, a number of complementary and alternative therapies for PMS and menopause have found favour among millions of women around the world.

Alternative HRT
Recent focus has centred around the phytoestrogen compounds, which are naturally occurring and structurally resemble endogenous oestrogens. These compounds can bind directly to oestrogen receptors, and can act as selective oestrogen (previously spelt as estrogen) receptor modulators (SERMs), essentially meaning that they may mediate oestrogenic activity in certain parts of the body, but not in others.  Most importantly, phytoestrogens do not appear to mediate the negative reproductive effects experienced with chronic oestrogen therapy, and do not seem to increase the risk of endometrial or breast cancer. 

In light of the health warnings against conventional HRT, the time to switch to an effective, minimum-risk medication for the management of PMS, menopause and general female health could not be better.

PM H-Regulator – An Effective & Safe Alternative

H-Regulator consists of a unique formula which targets the underlying causes of PMS and menopause-related symptoms. Moreover, the concentrated doses of soy isoflavones and chasteberry contained in H-Regulator are clinically proven.

The inclusion of chasteberry in the H-Regulator formula effectively combats many of the unwanted symptoms associated with PMS, menstruation and menopause by reducing their severity. Meanwhile, soy isoflavones target the underlying causes of the undesirable menstrual and menopause-related hormonal symptoms in order to stop them from occurring altogether. H-Regulator is therefore recommended for ongoing use among pre-, peri- and post-menopausal women.

Benefits: Formulated to support women's health:

  • For the management of PMS and menopause, hormonal balance and bone support.
  • Assists in the management of PMS-related distress symptoms. Relief of menstrual cramps and of pre-menstrual breast pain. For the symptomatic relief of dysmenorrhoea and irregular periods.
  • May reduce the frequency and severity of hot flushes and perspiration.  May provide relief from the common female symptoms of bloating, general oedema and mastalgia (breast tenderness).
  • Provides relief from common psychological complaints such as distress, irritability and headache.
  • Provides direct analgesic action for pain relief.
  • Promotes healthy cardiovascular function.
  • Supports the maintenance of healthy bones.
  • Antioxidant. Aids, assists or helps in the maintenance or improvement of general well-being.

The Ingredients in PM H-Regulator & How They Work

Vitex Agnus-Castus Fruit (Chasteberry)
Attracting considerable interest from pharmaceutical companies in recent years, chasteberry, a shrub native to the Mediterranean, Central Asia and America, has been recognised in folk medicine for its beneficial properties since times dating back to Homer’s Iliad (6th Century BC).

Clinical trials have shown treatment with chasteberry to provide relief for women suffering from the symptoms of PMS and menopause-related distress. In several double-blind, randomised, placebo-controlled studies,  chasteberry has mediated significant improvements in irritability, mood alteration, anger and headache in women relative to placebo controls. Studies have also shown chasteberry to provide relief from the common female symptoms of bloating, general oedema and mastalgia (breast tenderness), providing evidence for its beneficial regulatory effect on hormonal levels prior to, during and post menopause.  It is also indicated for Irregularities of the menstrual cycle.

The effects of chasteberry are thought to be mediated via two key pathways. Firstly, the inhibitory effects of chasteberry on prolactin production strongly suggest that it functions as a dopamine D2 receptor agonist.  While controlling prolactin release, the dopaminergic system is also a key player in the regulation of motor function and emotional/behavioural control. Chasteberry’s action as a D2 receptor agonist is reinforced by the latter of these functions, given its beneficial effects on the PMS and menopause-related symptoms of mood, emotion and headache.

Additional studies  have also shown chasteberry to activate μ-opioid receptors. When activated, opioid receptors are considered the most proficient of all receptor types at providing pain relief, with μ-opioid receptor activation in particular associated with the analgesic effects of drugs such as morphine and codeine. The activation of μ-opioid receptors by chasteberry therefore provides compelling evidence for its ability to provide effective pain relief during PMS and menopause.

Soy Isoflavones
The health benefits of soy foods generally have been known to Chinese medicine for thousands of years. Now that soy isoflavones are available in a concentrated extract form, women are able to make the most of the health benefits of these compounds by increasing their intake to levels never before possible. Soy isoflavones are a type of phytoestrogen – a plant-derived family of several subgroups of molecules. These compounds can bind directly to cellular oestrogen receptors, and can act as selective oestrogen receptor modulators (SERMs), essentially meaning that they may exert estrogenic activity in certain parts of the body, but not in others.

The antioxidant properties of isoflavones are well recognised. While this has positive implications in terms of reduced production of dangerous free radicals by the body, which may be beneficial for skin protection and repair, there is also evidence to suggest that this property of isoflavones may in fact support the maintenance of a healthy cardiovascular system.


Figure 1. Oestrogen and isoflavones can bind to the same active site on nuclear oestrogen receptors to cause transcriptional changes in the nucleus, culminating in protein synthesis.


The decrease in oestrogen levels women experience during menopause, is accompanied by a decreased ability to absorb calcium. As a consequence, women tend to undergo rapid bone loss (osteoporosis) during menopause.  Clinical evidence has emerged that chronic supplementation with soy isoflavones can significantly lessen the effects of post and peri-menopausal bone degeneration,  theoretically by increasing gastrointestinal calcium absorption in a manner similar to oestrogen.

In recent years, the health profile of isoflavones has been significantly bolstered by findings that they may help ameliorate the severity and occurrence of menopausal symptoms such as hot flushes, increased perspiration and night sweats.  Yet, perhaps most importantly, isoflavones do not appear to mediate the negative reproductive effects experienced with long-term oestrogen therapy,  and have not been associated with any increase in the risk of endometrial or breast cancer, making them a safer, attractive therapeutic choice for the management of menopause and general female health.

Quality Control

PM H-Regulator is regulated as a therapeutic good in Australia and therefore has to comply with the stringent regulations of the Australian Therapeutic Goods Administration (TGA), one of the strictest health authorities in the world. The production of PM H-Regulator is required to meet Australian Good Manufacturing Process (GMP) requirements before its release into the market. Post-market surveillance requirements further ensure that the product remains under strict control after it leaves the manufacturing facilities, ensuring the highest standard of quality is continually maintained.


Final Words

PM H-Regulator is an effective alternative for the ongoing management of female health from pre-menopause into later life. Chasteberry helps provide relief from menstrual cycle problems, PMS symptoms, and menopausal distress such as irritability, mood alteration, emotion, headache, pain relief, headache, bloating, general oedema and mastalgia. Soy isoflavones are antioxidants, provide bone support, assist with menopausal symptoms such as hot flushes and perspiration as well as promoting healthy cardiovascular function.

All of PM H-Regulator’s ingredients are clinically proven and scientifically formulated, making it a safe and effective alternative for women seeking assistance for problems associated with PMS, menstrual conditions and menopause.
 
REFERENCES

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  2.   Mortola, J. L (1992) Premenstrual syndrome. The Western Journal of Medicine. 156(6): 651.
  3.   Previously spelled as “estrogen.” Some outdated acronyms still exist based on the old-fashioned spelling, such as “S.E.R.M.s” – “Selective Oestrogen Receptor Modulators.”
  4.   Clayton AH (2008) Symptoms related to the menstrual cycle: diagnosis, prevalence, and treatment, Journal of Psychiatric Practice, 14(1):13-21.
  5.   Yonkers KA, O’Brien PM, Eriksson E (2008) Pre-menstrual Syndrome, Lancet, 371(9619):1200-10.
  6.   Women’s Health Program, Monash University. Menstrual cycle problems.
  7.   Waters W and O’Connor, P. J. (1971) Epidemilogy of headache and migraine in women. J. Neurol. Neurosurg. Psychiat., 34: 148-153.
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  9.   Mannix LK. (2008) Menstrual related pain conditions: dysmenorrheal and migraine. J Womens Health (Larchmt). 17(5):879-91.
  10.   Silberstein, S. D. and Merriam, G. R. (1991). Estrogens, progestins, and headache. Neurology, 41:786-93.
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  12.   Cheung, A. M, Chaudhry, R., Kapral, M., Jackevicius, C. and Robinson, G. (2004) Perimenopausal and Postmenopausal Health. BMC Women’s Health. 4(Suppl 1): S23.
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  26.   Anthony, M.S., Clarkson, T.B., Hughes, C.L., Jr., Morgan, T.M. & Burke, G.L. (1996). Soybean isoflavones improve cardiovascular risk factors without affecting the reproductive system of peripubertal rhesus monkeys. The Journal of Nutrition, 126, 43-50; Kapiotis, S., Hermann, M., Held, I., Seelos, C., Ehringer, H. & Gmeiner, B.M. (1997). Genistein, the dietary-derived angiogenesis inhibitor, prevents LDL oxidation and protects endothelial cells from damage by atherogenic LDL. Arteriosclerosis, Thrombosis, and Vascular Biology, 17, 2868-74; Kirk, E.A., Sutherland, P., Wang, S.A., Chait, A. & LeBoeuf, R.C. (1998). Dietary isoflavones reduce plasma cholesterol and atherosclerosis in C57BL/6 mice but not LDL receptor-deficient mice. The Journal of Nutrition 128, 954-9.
  27.   Riggs BL, Khosla S, Melton LJ, III (2002) Sex steroids and the construction and conservation of the adult skeleton. Endocrine Reviews 23(3):279-302; Chapurlat RD, Gamero P, Sornay-Rendu E, Arlot ME, Claustrat B, Delmas PD (2000) Longitudinal study of bone loss in pre- and perimenopausal women: evidence for bone loss in perimenopausal women. Osteoporosis International 11(6):493-8.
  28.   Ma DF, Qin LQ, Wang PY, Katoh R. (2008) Soy isoflavone intake increases bone mineral density in the spine of menopausal women: meta-analysis of randomized controlled trials, Clinical Nutrition 27(1):57-64.
  29.   Nahas EA, Nahas-Neto J, Orsatti FL, Carvalho EP, Oliveira ML, Dias R (2007) Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study, Maturitas 58(3):249-58; Faure ED, Chantre P, Mares P (2002) Effects of a standardized soy extract on hot flushes: a multicenter, double-blind, randomized, placebo-controlled study, Menopause 9(5):329-34; Upmalis DH, Lobo R, Bradley L, Warren M, Cone FL, Lamia CA (2000) Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study, Menopause 7(4):236-42; Khaodhiar L, Ricciotti HA, Li L, Pan W, Schickel M, Zhou J, Blackburn GL (2008) Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women, Menopause 15(1):125-32.
  30.   Finking Beate Hess, H.H.G. (1999). The value of phytestrogens as a possible therapeutic option in postmenopausal women with coronary heart disease. Journal of Obstetrics and Gynaecology, 19, 455-9; Phipps, W.R., Duncan, A.M. & Kurzer, M.S. (2002). Isoflavones and postmenopausal women: a critical review. Treatment Endocrinology, 1, 293-311.

 

 

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