Controversy re Black Cohosh for Hot Flashes

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Hi All,

 

As often happens in bioresearch, different authors / studies come up

with opposite conclusions. This applies also to Cimicifuga racemosa

(Black Cohosh) in menopausal symptoms

 

Study Finds Black Cohosh No Better Than Placebo in Treating Hot

Flashes: see: http://www.mayoclinic.org/news2005-sct/2823.html

 

J Clin Oncol. 2001 May 15;19(10):2739-45. Randomized trial of black

cohosh for the treatment of hot flashes among women with a history of

breast cancer. Jacobson JS, Troxel AB, Evans J, Klaus L, Vahdat L,

Kinne D, Lo KM, Moore A, Rosenman PJ, Kaufman EL, Neugut AI,

Grann VR. Herbert Irving Comprehensive Cancer Center and Joseph L.

Mailman School of Public Health, Columbia University, and Weill-Cornell

Medical College, New York, NY 10032, USA. PURPOSE: Most breast

cancer survivors experience hot flashes; many use complementary or

alternative remedies for these symptoms. We undertook a randomized

clinical trial of black cohosh, a widely used herbal remedy for

menopausal symptoms, among breast cancer patients. PATIENTS AND

METHODS: Patients diagnosed with breast cancer who had completed

their primary treatment were randomly assigned to black cohosh or

placebo, stratified on tamoxifen use. At enrollment, patients completed a

questionnaire about demographic factors and menopausal symptoms.

Before starting to take the pills and at 30 and 60 days, they completed a

4-day hot flash diary. At the final visit, they completed another

menopausal symptom questionnaire. Follicle-stimulating hormone

(FSH) and luteinizing hormone (LH) levels were measured in a subset of

patients at the first and final visits. RESULTS: Of 85 patients (59 on

tamoxifen, 26 not on tamoxifen) enrolled in the study, 42 were assigned

to treatment and 43 were assigned to placebo; 69 completed all three

hot flash diaries. Both treatment and placebo groups reported declines

in number and intensity of hot flashes; the differences between the

groups were not statistically significant. Both groups also reported

improvements in menopausal symptoms that were, for the most part,

not significantly different. Changes in blood levels of FSH and LH also

did not differ in the two groups. CONCLUSION: Black cohosh was not

significantly more efficacious than placebo against most menopausal

symptoms, including number and intensity of hot flashes. Our study

illustrates the feasibility and value of standard clinical trial methodology

in assessing the efficacy and safety of herbal agents. Publication

Types: Clinical Trial Randomized Controlled Trial PMID: 11352967

[PubMed - indexed for MEDLINE]

 

J Reprod Med. 2005 Mar;50(3):155-65. Menopausal vasomotor

symptoms: a review of causes, effects and evidence-based treatment

options. Bachmann GA. Department of Obstetrics and Gynecology,

University of Medicine and Dentistry of New Jersey-Robert Wood

Johnson Medical School, New Brunswick 08901, USA.

bachmaga Vasomotor symptoms are the most common

medical complaint of perimenopausal and postmenopausal women.

Frequent vasomotor symptoms can be disabling, affecting a woman's

social life, psychological health, sense of well-being and ability to work.

Women with hot flushes are more likely to experience disturbed sleep,

depressive symptoms and significant reductions in quality of life as

compared to asymptomatic women. Despite the prevalence and impact

of these symptoms, the pathophysiology of hot flushes is unclear;

however, estrogen withdrawal clearly plays an important role. It is

postulated that declining estrogen concentrations may lead to changes

in brain neurotransmitters and instability in the hypothalamic

thermoregulatory center. The most effective therapy for relieving

vasomotor symptoms and reducing their impact on quality of life is

hormone therapy. Other options for women who decline hormone

therapy include selective serotonin reuptake inhibitors and related

agents. Most herbal therapies that have been evaluated in placebo-

controlled trials have shown no clinically significant benefit. Publication

Types: Review PMID: 15841927 [PubMed - indexed for MEDLINE]

 

Climacteric. 2003 Dec;6(4):278-84. Comment in: Climacteric. 2003

Dec;6(4):265-7. Review of alternative therapies for treatment of

menopausal symptoms. Amato P, Marcus DM. Departments of

Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas

77030, USA. Many women use alternative therapies to treat hot flushes

and other menopausal symptoms. The purpose of this review is to

summarize current information on the efficacy and safety of

phytoestrogens and the herbal medicine black cohosh. A

preponderance of evidence indicates that phytoestrogens are ineffective

in treating hot flushes. Trials of black cohosh, many of which are small,

of limited duration and of poor methodological quality, provide conflicting

results, and at present it is unclear whether black cohosh is more

effective than placebo. Although phytoestrogens and black cohosh

appear to be safe when used for short periods of time, much larger and

longer studies are needed to detect infrequent but potentially serious

adverse events. Women who do not wish to take hormone therapy to

treat menopausal symptoms should be encouraged to consider using

selective serotonin reuptake inhibitors and other conventional

therapeutic options. Publication Types: Review Review, Tutorial PMID:

15006249 [PubMed - indexed for MEDLINE]

 

But see also:

 

Maturitas. 2003 Mar 14;44 Suppl 1:S67-77. The Cimicifuga preparation

BNO 1055 vs. conjugated estrogens in a double-blind placebo-

controlled study: effects on menopause symptoms and bone markers.

Wuttke W, Seidlova-Wuttke D, Gorkow C. Department of Clinical and

Experimental Endocrinology, University of Gottingen, Robert-Koch-

Strasse 40, 37075 Gottingen, Germany. ufkendo-

goettingen.de OBJECTIVES: In the present study, therapeutic effects of

the Cimicifuga racemosa preparation CR BNO 1055

(Klimadynon/Menofem) on climacteric complaints, bone metabolism and

endometrium will be compared with those of conjugated estrogens (CE)

and placebo. The question whether CR BNO 1055 contains substances

with selective estrogen receptor modulator (SERM) activity will be

investigated. METHODS: Sixty-two evaluable postmenopausal women

were included in the double-blind, randomized, multicentre study, and

treated either with CR BNO 1055 (daily dose corresponding to 40 mg

herbal drug), 0.6 mg CE, or matching placebo, for 3 months.

Menopausal symptoms were assessed by the menopause rating scale

(MRS) and a diary. Levels of CrossLaps (marker of bone degradation)

were determined by ELECSYS system and bone-specific alkaline

phosphatase (marker of bone formation) by an enzymatic assay.

Endometrial thickness was measured via transvaginal ultrasound;

vaginal cytology was also studied. The primary efficacy criterion was the

change from baseline to end point in the MRS. Change from baseline

was analyzed for the secondary variables too. RESULTS: CR BNO

1055 proved to be equipotent to CE and superior to placebo in reducing

climacteric complaints. Under both verum preparations, beneficial

effects on bone metabolism have been observed in the serum. CR BNO

1055 had no effect on endometrial thickness, which was significantly

increased by CE. Vaginal superficial cells were increased under CE and

CR BNO 1055 treatment. CONCLUSION: The results concerning

climacteric complaints and on bone metabolism indicate an equipotent

effect of CR BNO 1055 in comparison to 0.6 mg CE per day. It is

proposed that CR BNO 1055 contains substances with SERM activity,

i.e. with desired effects in the brain/hypothalamus, in the bone and in the

vagina, but without exerting uterotrophic effects. Publication Types:

Clinical Trial Multicenter Study Randomized Controlled Trial PMID:

12609561 [PubMed - indexed for MEDLINE]

 

Acta Obstet Gynecol Scand. 2005 Oct;84(10):972-9. Hot flashes

revisited: pharmacological and herbal options for hot flashes

management. What does the evidence tell us? Haimov-Kochman R,

Hochner-Celnikier D. Department of Obstetrics and Gynecology, The

Division of Reproductive Endocrinology and Infertility, Hadassah Hebrew

University Hospital, Mt. Scopus, Jerusalem, Israel.

rkochman BACKGROUND: Hot flashes are the most

frequent symptoms of menopause and the most common reason for

climacteric women seeking medical advice. Estrogen therapy is by far

the most effective therapy. However, fears of side-effect of estrogen

therapy urged many patients to seek alternative modalities for

symptomatic relief. METHODS: The MEDLINE database for the years

1975-2004 was searched for clinical placebo-controlled trials for the

treatment of hot flashes with alternative therapy. Articles reporting the

use of progesterone, alpha adrenergic agonists, anti-depressants, anti-

convulsants, soy products, black cohosh (BC), red clover, dong quai,

ginseng root, evening primrose oil, vitamin E, and wild yam were

included. RESULTS AND CONCLUSIONS: A critical review of the

literature shows that progesterone may have an independent effect on

relieving hot flashes. New nonhormonal agents such as selective

serotonin-uptake-inhibitor anti-depressants and a new anti-convulsant

gabapentin yielded promising results on small well-conducted studies.

Isoflavone's effect on hot flashes is variable and inconsistent, and only

modest and delayed improvement of symptoms could be expected by

BC and vitamin E. There are insufficient data on the other herbal

alternative therapies at this time. Well-designed large studies are

needed to further explore new modalities of treatment. PMID: 16167914

[PubMed - in process]

 

Maturitas. 2005 Aug 16;51(4):397-404. Epub 2004 Dec 10. Cimicifuga

racemosa dried ethanolic extract in menopausal disorders: a double-

blind placebo-controlled clinical trial. Frei-Kleiner S, Schaffner W,

Rahlfs VW, Bodmer Ch, Birkhauser M. Institute of Pharmaceutical

Biology, University of Basel, Switzerland. susanne

OBJECTIVES: To compare the efficacy and safety of the black cohosh

root extract Cr 99 with placebo in women with climacteric complaints.

METHODS: A multicenter, randomized, placebo-controlled, double-

blind, parallel group study was conducted in 122 menopausal women

(intention-to-treat population) with > or =3 hot flashes a day, treated over

12 weeks. Two main efficacy measures - weekly weighted score of hot

flashes and Kupperman Index - and secondary efficacy variables, e.g.

Menopause Rating Scale, were defined. Routine safety laboratory

parameters and adverse events were documented. RESULTS: The

primary efficacy analysis showed no superiority of the tested black

cohosh extract compared to placebo. However, in the subgroup of

patients with a Kupperman Index> or =20 a significant superiority

regarding this index could be demonstrated (P<0.018). A decrease of

47% and 21% was observed in the black cohosh and placebo group,

respectively. The weekly weighted scores of hot flashes (P<0.052) and

the Menopause Rating Scale (P<0.009) showed similar results.

Prevalence and intensity of the adverse events did not differ in the two

treatment groups. CONCLUSIONS: The results indicate a superiority of

the tested Cimicifuga racemosa extract compared to placebo in patients

with menopausal disorders of at least moderate intensity according to a

Kupperman Index > or =20, but not in the intention-to-treat population as

a whole. PMID: 16039414 [PubMed - in process]

 

Cancer Invest. 2004;22(4):515-21. Comment in: Cancer Invest.

2004;22(4):645-7. Pilot evaluation of black cohosh for the treatment of

hot flashes in women. Pockaj BA, Loprinzi CL, Sloan JA, Novotny PJ,

Barton DL, Hagenmaier A, Zhang H, Lambert GH, Reeser KA, Wisbey

JA. Department of Surgery, Mayo Clinic, Scottsdale, Arizona 85259,

USA. pockaj.barbara BACKGROUND: Hot flashes cause

significant morbidity in postmenopausal women, including women with

breast cancer. We undertook a pilot study to estimate the effectiveness

of black cohosh to reduce hot flashes. METHODS: Women who

reported significant hot flashes (> or = 14 per week) were enrolled.

Black cohosh was given in the form of the commercial product

Remifemin. The first week was a no-treatment baseline period, and

therapy was given for the subsequent 4 weeks. Hot flash data were

collected by daily questionnaires during baseline and treatment weeks.

Adverse effects were recorded. RESULTS: Twenty-one women

completed the study. Their mean age was 56 years (range, 38-80).

Thirteen patients had a history of breast cancer. Six patients were taking

tamoxifen or raloxifene. Patients reported an average of 8.3 hot flashes

per day during the baseline week. The reduction in mean daily hot flash

frequency was 50% (95% CI, 34%-65%), while weekly hot flash scores

were reduced 56% (95% CI, 40%-71%) at completion of the study.

Overall, patients reported less trouble with sleeping, less fatigue, and

less abnormal sweating. No patients stopped therapy because of

adverse effects. CONCLUSIONS: Black cohosh appeared to reduce hot

flashes and had a low toxicity. The efficacy found in this trial seems to

be more than would be expected by a placebo effect (20%-30% hot

flash reduction in previous trials). These results suggest that further

evaluation of this black cohosh preparation with a phase III randomized

trial is indicated. Publication Types: Clinical Trial PMID: 15565808

[PubMed - indexed for MEDLINE]

 

Ann Pharmacother. 2004 Sep;38(9):1482-99. Epub 2004 Aug 3.

Nonestrogen treatment modalities for vasomotor symptoms associated

with menopause. Fugate SE, Church CO. Department of Pharmacy,

Clinical and Administrative Sciences, College of Pharmacy, University of

Oklahoma Health Sciences Center, Oklahoma City, OK 73190-5040,

USA. Susan-Fugate OBJECTIVE: To systematically review

the literature regarding the efficacy and safety of nonestrogen

treatments for menopause-associated vasomotor symptoms not due to

cancer or chemotherapy. DATA SOURCES: Pertinent literature and

clinical studies were identified by searching MEDLINE (1966-February

2004) and EMBASE (1959-February 2004) using the key search terms

vasomotor symptoms, hot flashes, and menopause. Bibliographies of

relevant articles were reviewed for additional references. STUDY

SELECTION AND DATA EXTRACTION: English-language articles

reporting efficacy and safety of nonestrogen treatment modalities for

perimenopausal and postmenopausal vasomotor symptoms were

evaluated. All articles identified from the data sources were evaluated,

and all information deemed relevant was included. Emphasis was

placed on randomized, double-blind, placebo-controlled clinical trials, as

these provide the best efficacy and safety data. Studies evaluating

treatment of vasomotor symptoms from other causes, such as cancer or

chemotherapy, were excluded. DATA SYNTHESIS: Prescription

medications reviewed for efficacy and safety in postmenopausal

vasomotor symptoms include clonidine hydrochloride, danazol,

gabapentin, methyldopa, mirtazapine, progestins, propranolol

hydrochloride, selective serotonin-reuptake inhibitors (SSRIs), and

venlafaxine. Nonprescription therapies reviewed include black cohosh,

dong quai, evening primrose oil, physical activity, phytoestrogens, and

red clover. CONCLUSIONS: According to this systematic literature

review, postmenopausal vasomotor treatments that have been shown to

be safe and effective in short-term use include black cohosh, exercise,

gabapentin, medroxyprogesterone acetate, SSRIs (ie, paroxetine

hydrochloride), and soy protein. Initial, small reports are suggestive for

efficacy in menopausal vasomotor symptoms with megestrol acetate

and venlafaxine. Publication Types: Review PMID: 15292498 [PubMed

- indexed for MEDLINE]

 

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