Cool Flare: An Herbal Approach to Cool Hot Flashes Associated with Menopause

By Geoff D’Arcy, Lic. Ac., D.O.M.

I was asked by a group of medical doctors to use the following format, to review the literature of one of my favorite herbal formulas. I would like to share this article with you, regarding what I found in the conventional databases.

Overview

The side effects and dangers associated with Hormone Replacement Therapy (HRT) have led millions of peri-menopausal and menopausal women to search for herbal alternatives. Patients often question their medical doctors about these issues. Two thousand years ago, physicians of Traditional Chinese Medicine (TCM) began looking for botanical answers and documenting their findings. Cool Flare is an herbal formula with a TCM base of (5:1) extracts with organic western 1:1 herbs and is formulated to treat the hot flashes of peri-menopause and menopausal crises. This formula is often used in conjunction with another formula, Meno-Peace for treatment of severe menopausal crises.

The "hot flash" (HF), or vasomotor instability, is experienced by 75% of peri-menopausal and menopausal women in the United States. The experience for some women is minor, yet for others, the HF is an extremely unpleasant sensation that is disruptive to their sleep patterns and daily living. The HF is believed to be triggered by a number of external and internal stimuli including anxiety, stress, high temperatures, caffeine and alcohol. Thinner women tend to experience more severe and frequent HFs than do women with more adipose tissue, probably due to the ability of adipose tissue to transform androstenedione to estrone and estradiol.

Smoking history also tends to be associated with the experience of HFs at an earlier age. The etiology of HFs in the pattern of decreasing estrogen levels is related to the downward resetting of the hypothalamic thermo-regulating mechanism, probably by the action of norepinephrine, which is usually modulated by estrogen. The body attempts to dissipate unwanted body heat via vaso-dilation thereby causing the sensation of the HF.1

The risks and potential side effects of HRT can include: vaginal bleeding (starting or returning), breast tenderness (which often goes away after three months), nausea (which may resolve spontaneously), fluid retention, changes in the shape of the eye (sometimes leading to contact lens intolerance), headache, dizziness, depression, an increased risk for reduced tolerance to sugar and other carbohydrates, and an increased risk for gallbladder disease.1Studies have not confirmed that estrogen causes weight gain, yet, in some women, HRT causes water retention, and thus temporary weight increase.1 Some scientists have pointed out that there is an increased risk of breast or uterine cancer with HRT, especially when used without progesterone.1

These side effects and risks associated with HRT have led millions of peri-menopausal and menopausal women to seek out herbal alternatives. Robert Rister, in his book, Japanese Herbal Medicine, reports that in Japan, the usefulness of herbal medicine is growing rapidly among conventionally trained medical doctors. In 1976 only 42 herbal formulas had been approved by the Japanese FDA, with only 19.2% of Japanese medical doctors utilizing herbal medicine.2,5In 1996 148 formulas had been approved by the Japanese FDA, and it is estimated today that almost 77% of Japanese medical doctors, who have every method of modern medicine available to them, prescribe herbal formulas.2,3This increased use of herbal medicine has been driven by hundreds of scientific studies validating the effectiveness of herbal formulas. Sixty percent of these Japanese doctors consider herbal formulas to be the first choice for some diseases.4Rister reports, "In cases where standard medications deliver predictable results without side effects, Japanese doctors prefer synthetic drugs to Kampo (herbal medicine). These doctors, however, note seven situations for which Kampo (herbal formulas) are especially suitable, and menopause is most definitely one of them.”

Actions of Individual Constituents

Rehmannia Six Formula

Chinese Name: Liu Wei Di Huang;Japanese name: Rokumi-Jio-Gan Ingedients: RehmanniaRehmannia glutinosa, Alisama alisma orientale, Cornus cornus officinalis, Dioscorea dioscorea opposita, Poriaporia cocos, Moutan paeonia suffruticosa

This is a classic women’s formula, dating back to the 12th century in China; it is a combination of six herbs commonly used in Traditional Chinese Medicine (TCM) and Japanese (Kampo). This formula is classified as enriching the yinand nourishing the kidneys. The traditional concept of the kidneysin TCM is that they nourish marrow and the strength of bones. When the kidney yinfails to nourish and contain the liver energies, firespreads upward, resulting in hot flashes, night sweats, heat in the palms and chest, spontaneous sweating, headache, sore hot dry throat. This condition can go on to create whole body dryness, vaginal dryness, etc. The Rehmannia Six formula makes up one third of the Cool Flare formula and modern science is starting to verify some of its ancient anecdotal results. Studied recently in China and Japan for its use in treating menopausal problems,8,9there is some evidence from animal studies that this formula, plus a derivative formula Rehmannia Eight, may have a positive, preventive effect for osteoporosis as well as the hot flashes of menopause.7,10The preventive effects produced by traditional Chinese (Kampo) medicines, Hachimi-jio-gan, (Rehmannia Eight), which has two more ingredients than Rokumi jio gan, (Rehmannia Six), on the progress of bone loss induced by ovariectomy in rats were investigated by studying the bone mineral density (BMD) of tibia in ovariectomized (OVX) rats. The results of this study strongly suggest that the gynecological Kampo medicines are as effective as 17 beta-estradiol in preventing the development of bone loss induced by ovariectomy in rats.7

In another study, after a relatively long-term injection of hydrocortisone into rats, the strength of bone (anti-stress capacity) reduced evidently, while the rigidity (anti-deformity capacity) increased markedly (i.e., bone fragility elevated). At the same time, the content of serum 25(OH) D3 decreased remarkably. After oral administration of Liu Wei Di Huang Wan(RehmanniaSix), the anti-stress capability of bone increased evidently and its anti-deformity capability returned to normal; however, there was no elevation of serum 25(OH) D3 content. The experiments suggests that Liu Wei Di Huang Wan is beneficial to preventing and curing osteoporosis, but no correlation between its mechanism and the metabolism of 25(OH) D3 was demonstrated.10

In another study, Liu Wei Di Huang Wan (Rehmannia Six), not only increased plasma estradiol levels, but also increases the leucocytic estrogen receptors (ER) levels. The number of ER in human peripheral leucocytes in 22 women with climacteric syndrome weremeasured by radioligand method. The results were compared with those of 12 normal child-bearing aged women and showed that the contents of leucocytic ER in climacteric syndrome patients were significantly lower than those of normal child-bearing aged women. The authors used a Chinese prescription--Liu Wei Di Huang Wan (Rehmannia Six), to treat the patients for 2 months. The numbers of leucocytic ER were significantly increased after treatment. The data indicate that decrease of ER levels in cells may be involved in the pathogenesis of climacteric syndrome. Liu Wei Di Huang Wan(Rehmannia Six), not only increases plasma estradiol levels, but also increases the leucocytic ER levels. This may be the basis of the therapeutic effect on the disease.11

Dong Quai Root, Angelica Chinensis

This well known herb increases circulation, protects the heart, and increases the effectiveness of other herbs in the formula.17It has been used for thousands of years by Traditional Chinese Medicine and has long been considered the women’s ginseng.It is rarely used alone and is often used in prescriptions for menstrual and menopausal problems. It may be effective for PMS through its antispasmodic action especially on smooth muscle.16Traditionally used in formulas for hot flashes with peri-menopause, it also has a record in the treatment of cardiovascular disease, including high blood pressure and circulation for men and women.15

Black Cohosh Root, Cimicifuga Racemosa

Considered 80% effective in relieving the symptoms of menopause when taken for four weeks or longer, it increases vaginal lubrication as effectively as estrogen replacement therapy.25It also relieves headaches and muscle pain and stops irregular bleeding.21

Traditional Chinese and Japanese herbal medicines classify this herb as cold, as it relieves the symptoms of heat during menopause. Black cohosh is considered a leading phytoestrogen for menopausal problems by some authors.

18,19,20,21,22,23,24,25 Clinical studies from Germany demonstrate that black cohosh decreases Luteinizing Hormone (LH), which can be responsible for hot flashes and other menopausal and perimenopausal problems.19A review of eight human studies on the effectiveness of Cimicifuga racemosa(black cohosh) for the symptoms of menopause concludes it is a safe and effective alternative to estrogen.18 Menopausal women taking Cimicifugaethanol extract for 8 weeks had lower LH and unchanged FSH. Fractions tested showed both competitive binding at estrogen receptors and reduction of LH secretion.19In another study, sixty post-hysterectomy menopausal women randomized to Cimicifugaor 3 types of estrogen all had a lower Kupperman-Index but no significant differences in serum FSH and LH.20Black cohosh may be debunked as a phytoestrogen at least in animal studies (as has dong quai) its actions may lie in two mechanisms:

1) Compounds bind to receptor sites in the reproductivetract, brain and other organs that otherwise would receive estrogen, therefore reducing overall estrogen activity when estrogen levels are high.

2) These compounds block the formation of LH, which stimulates a surge of estrogen production during the first fourteen days of the menstrual cycle. This stimulates estrogen production when levels are low, thus giving a dual stabilizing action of the body’s estrogen fluctuations and the problems they cause.22Black Cohosh has demonstrated its ability to provide balance and prevent nervousness, hot flashes, depressed moods and vaginal dryness associated with menopause. 3. A recent study suggests that black cohosh actually protects animals from osteoporosis.24Human studies have not yet confirmed this action.

Chaste Tree Berry, Vitex Agnus-Castus

The whole fruit contains several different components thought to be medicinally active.1Vitex,as it is commonly known, does not contain hormones. Its benefits come from its action on the pituitary gland and the production of estrogen and progesterone. Vitexincreases the hormone levels to help balance and regulate the menstrual cycle.2

Cool Flare may be used by patients concerned with maintaining healthy hormone levels during peri-menopause and menopause. This isespecially pertinent for those individuals with a family history or a significant risk profile for HRT.

Side Effects:

When taken according to the recommended dosage and schedule, and for individuals with no other predisposing medical conditions or sensitivities to any of the constituents, the potential for serious side effects is minimal or none.

Potential side effects from constituents:

Rehmannia Six Formula These herbs may exacerbate patients already suffering with indigestion and diarrhea.

Dong Quai, Angelica Chinensis Only a few mild side effects have been reported sensitivity to sunlight for a small percentage of fair skinned people.

Black Cohosh Root, Cimicifuga Racemosa Headache, dizziness, abdominal pain and nausea have been reported, usually with high dosages.

Chaste Tree Berry, Vitex Agnus-Castus Side effects of Vitexare extremely rare and usually consist of minor gastrointestinal upset and a minor skin rash, reported in less than 2% of women.28

Contraindication

As with the use of conventional medications, known hypersensitivity or allergy to any one of the constituents in this product is an absolute contraindication. Case reports are suggestive of interaction between warfarinand dong quai at much higher dosageswhen used as a single herb.14In this formula the dosage is much lower than in those sited.

Pregnancy and nursing: Due to the known effects of some constituents and unknown effects of many other constituents on fetal and neonatal growth and development,this product should be avoided during pregnancy and breast-feeding.

Dosage

Two capsules,three times daily, on an empty stomach with warm water. Take at least two hours after any medication. When results are achieved and held for two weeks, drop to a maintenance dosage of one capsule three times daily, on an empty stomach with warm water.

References

  1. Shaw, C.R.The perimenopausal hot flash: epidemiology, physiology, and treatment.Nurse Pract1997 Mar; 22 (3):55-6, 61-6 Marquette University College of Nursing, Milwaukee, Wisconsin.(From Robert Rister’s footnotes, Japanese Herbal Medicine, p.11. Avery Publishing)

  2. Shirota,F., Cyong,J.C. What is Kampo? The role of Kampo Medicine in Japanese Healthcare Tokyo:Tsumura and Company 1996, pp. 121-124

  3. Shirota,F., Cyong,J.C. What is Kampo? The role of Kampo Medicine in Japanese Healthcare, Tokyo:Tsumura and Company 1996, p. 16

  4. "Kampo Makes Large Inroads in Japanese Medical Care, Survey Indicates" Kampo Today: News of Japanese Herbal Medicine, Vol. 2, No.1 (February1997) p.1

  5. Shirota,F., Cyong,J.C. What is Kampo? The role of KampoMedicine in Japanese Healthcare Tokyo:Tsumura and Company 1996, pp. 121-124

  6. Shirota,F., Cyong,J.C. What is Kampo? The role of Kampo Medicine in Japanese Healthcare Tokyo:Tsumura and Company 1996, pp. 20

  7. Hidaka S., Okamoto Y., Nakajima K., Suekawa M., Liu S..Y Preventive effects of traditional Chinese (Kampo) medicines on experimental osteoporosis induced by ovariectomy in rats Calcif Tissue Int1997 Sep; 61(3): 239-46. Department of Oral Biochemistry, Fukuoka Dental College, 15-1, Tamura 2-Chome, Sawara-Ku, Fukuoka, 814-01, Japan.

  8. Wu X.N., Zheng H.Y., Xu R.Q., Zhou Z.J., Li Y.Y., Wang Y.F. Comparative effectiveness of Chinese H3 (CH3) and liu wei di huang wan (LWDHW) in female climacteric and their mechanism of action. J Tradit Chin Med1987 Dec;7 (4):266-8.

  9. Wu, X.N. Effects of liu wei dihuang wanand some other TCM drugs on bone biomechanics and serum 25 (OH) D3 content in rats. Chung Hsi I Chieh Ho Tsa Chih1986 Jun; 6 (6): 336-8.

  10. Chen Y, Qu C, Zhong H, Xue Y, Zhou C, Li W, Cheng X J Institute of Orthopedics and Traumatology, China Academy of Traditional Chinese Medicine, Beijing. Tradit Chin Med1994 Dec; 14 (4): 298-302.

  11. Zhang J.P., Zhou D.J. Changes in leucocytic estrogen receptor levels in patients with climacteric syndrome and therapeutic effect of liu wei di huang pills.Dept. of Endocrinology, Second Military Medical University, Changhai Hospital. Chung Hsi I Chieh Ho Tsa Chih 1991 Sep; 11 (9):521-3, 515.

  12. Hardy M.L. Herbs of special interest to women. J Am Pharm Assoc (Wash). 2000 Mar-Apr; 40 (2): 234-42; quiz 327-9. Review.

  13. Review of the pharmacological effect, toxicity & dosage of Dong Quai, used by generations of women. Am J Chin Med1987;.15.(3-4):117-25.

  14. Potentiation of warfarin by dong quai. Page RL 2nd, Lawrence JD Department of Pharmacy Practice, School of Pharmacy, University of Colorado Health Sciences Center, Denver 80262, USA.

  15. Foster S, Chongxi Y. Herbal Emissaries. Rochester, VT: Healing Arts Press, 1992,65-72.

  16. Qi-bing M, Jing-yi T, Bo C.Advance in the pharmacological studies of radix Angelica sinensis(Oliv) Diels (Chinese danggui). Chin Med J1991; 104:776-81.

  17. Hirata, J.D., Swiersz, L.M., Zell, B., Small, R., Ettinger, B., "Does dong quai have estrogenic effects in postmenopausalwomen? A double-blind, placebo-controlled trial, " Fertility and Sterility, 68(6), 981-986 (December 1997).

  18. Lieberman S. A review of the effectiveness of Cimicifuga racemosa (black cohosh) for the symptoms of menopause. J Womens Health1998 Jun; 7(5):525-9.

  19. Duker E.M., Kopanski L., Jarry H., Wuttke W. Effects of extracts from Cimicifuga racemosa on gonadotropin release in menopausal women and ovariectomized rats. Planta Med1991 Oct; 57(5):420-4.

  20. Lehmann-Willenbrock E., Riedel H. Clinical and endocrinologic studies of the treatment of ovarian insufficiency manifestations following hysterectomy with intact adnexa. Zentralbl Gynakol1988; 110(10):611-8.

  21. Duker E.M., Kopanski L., Jarry H., WuttkeW. Effects of extracts from Cimifuga racemosa on gonadotropin release in menopausal women and ovariectomized rats. Planta Medica 1992 ; 57:420-24.

  22. Einer-Jensen, N., Zhao,J., Andersen,K.P., Kristoffersen,K.,"Cimicifuga and Melbrosia lacloestrogenic effects in mice and rats" Maturitas25(2), 149-153 (October 1996).

  23. Lehmann-Willenbrock, E., Riedel, H.H., "Clinical and endocrinologic studies of the treatment of ovarian insufficiency manifestations following hysterectomoy with intact adnexa," Zentralblatt fur Gynakologie, 110(10), 611-618 (1988).

  24. Kadota S, Li JX, Litt Y et al. Effects of cimicifugae rhizome on serum calcium and phosphate levels in low calcium dietary rats and on bone mineral density in ovariectomized rats. Phytomed 1996/7; 3:379-85.

  25. Hudson, T., "Naturopathic specific condition review: menopause," Protocol Journal of Botanical Medicine, 1(4), 100 (Spring,1996).

  26. Monograph Agni casti fructus (Chaste tree fruits). Bundesanzeiger May 15, 1985 (no. 90), Dec 2, 1992(no.226)

  27. Sliutz G, Speiser P, et al. Agnus castus extracts inhibit prolactic secretion of rat pituitary cells. Horm Metab Res1993; 25:253-55

Cailin D'Arcy