Menopausal Hot Flashes, Cool Flare Herbal Article

 
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Cool Flare Formula: An Herbal Approach to Cool Hot Flashes Associated with Menopause
By Geoff D’Arcy, Lic. Ac., D.O.M.

Cool Flare Formula: 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) 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 of (5:1) extracts 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.1 Studies 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.2,5 In 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.2,3 This 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.4 Rister 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

Ingedients: Rehmannia Rehmannia glutinosa, Alisama alisma orientale, Cornus cornus officinalis, Dioscorea dioscorea opposita, Poria poria 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 yin and nourishing the kidneys.  The traditional concept of the kidneys in TCM is that they nourish marrow and the strength of bones.  When the kidney yin fails to nourish and contain the liver energies, fire spreads 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,8,9 there 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.7,10 The 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 (Rehmannia Six), 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 were measured 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

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.  

Contraindications: 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 warfarin and dong quai at much higher dosages when used as a single herb.14 In 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 Pract 1997 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 Kampo Medicine 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 Int 1997 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 Med 1987 Dec;7 (4):266-8.

  9. Wu, X.N. Effects of liu wei dihuang wan and some other TCM drugs on bone biomechanics and serum 25 (OH) D3 content in rats. Chung Hsi I Chieh Ho Tsa Chih 1986 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 Med 1994 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 Med 1987;.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 J 1991; 104:776-81.

  17. Hirata, J.D., Swiersz, L.M., Zell, B., Small, R., Ettinger, B., "Does dong quai have estrogenic effects in postmenopausal women?  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 Health 1998 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 Med 1991 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 Gynakol 1988; 110(10):611-8.  

  21. Duker E.M., Kopanski L., Jarry H., Wuttke W. 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"   Maturitas 25(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 Res 1993; 25:253-55

*The statements contained in this article have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease

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