Black Cohosh

Black Cohosh

PEP Topic 
Hot Flashes
Description 

The root of an herb used as a complementary or alternative therapy by some cultures for treatment of various conditions. The plant is a perennial native to eastern North America and has been studied for treatment of symptoms of menopause, including hot flashes. It is also known as bugwort, rattlesnake root, bugbane, and black snakeroot.

Effectiveness Not Established

Research Evidence Summaries

Hernández Muñoz, G., & Pluchino, S. (2003). Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer. Maturitas, 44(Suppl. 1), S59–S65.

doi:10.1016/S0378-5122(02)00349-3
Print

Study Purpose:

The purpose of this study was to examine the effect of Cimicifuga racemosa (CR BNO 1055) on hot flashes caused by tamoxifen adjuvant therapy in young premenopausal breast cancer survivors. This treatment presents an off-label use of CR BNO 1055 (also known as black cohosh).

Intervention Characteristics/Basic Study Process:

Participants took one tablet twice daily with meals for 60 days. Duration of treatment was five years for tamoxifen, and 12 months for CR BNO 1055. Participants were instructed not to initiate new therapies for hot flashes while participating in the study. Forty-six participants were randomly assigned (1-2) to receive tamoxifen 20 mg per day orally (usual-care group;mean age = 47 years); 90 participants received tamoxifen plus CR BNO 1055 corresponding to 20 mg of herbal drug (intervention group; mean age = 46 years.).

Sample Characteristics:

  • The study enrolled 136 breast cancer survivors aged 35–52 years who completed treatment with segmental or total mastectomy, radiation therapy and adjuvant chemotherapy.
  • Inclusion Criteria: Premenopausal status with regular menstruation and normal duration of cycle, and breast cancer diagnosis with estrogen receptor–positive tumor.
  • Exclusion criteria: Refusal to consider a study treatment for relief of symptoms, history of other cancers, and history of serious chronic medical conditions.

Study Design:

This was a two-arm, randomized and open-label trial. The primary endpoint was to assess the effect of CR BNO 1055 on the frequency and intensity of hot flushes.

Measurement Instruments/Methods:

Control visits occurred every two months, when the supply of CR BNO 1055 was replaced and clinical assessments made. Hot flashes were considered severe when five or more heat episodes occurred during the day and were accompanied by sweating, sleep disturbances, feeling of irritation, and anxiety. A few episodes of heat with discrete sweating were classified as moderate hot flushes. Participants completed hot flash diaries at baseline, at every control visit, and at the end of the study at 12 months.

Results:

The hot flash patterns were significantly different between the two groups using Fisher’s exact test (p < 0.01). Among the 46 study participants included into the usual-care group, 73.9% experienced severe hot flushes and 26.1% moderate symptoms. Among the 90 study participants in the intervention group, at the end of the study, 46.7% were free of hot flashes, and 24.4% reported severe symptoms.

Conclusions:

In the intervention group, the administration of CR BNO 1055 in combination with tamoxifen for a 12-month period significantly reduced the vasomotor episodes induced by tamoxifen in breast cancer survivors.

Limitations:

Methodologic problems included an open label trial  and unbalanced arms  (twice as many participants in the Black Cohosh group as in the usual care group).

Jacobson, J.S., Troxel, A.B., Evans, J., Klaus, L., Vahdat, L., Kinne, D., … Grann, V.R. (2001). Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. Journal of Clinical Oncology, 19, 2739–2745. 

Print

Study Purpose:

 To assess the effect of black cohosh on the frequency and intensity of hot flashes in survivors of breast cancer

Intervention Characteristics/Basic Study Process:

The study explored the use of black cohosh for treatment of hot flashes among women with a history of breast cancer. The black cohosh and placebo were supplied by the manufacturer. Each participant received 130 tablets and took one tablet twice daily with meals for 60 days.

Sample Characteristics:

  • Eighty-five participants were enrolled  (59 on tamoxifen, 26 not on tamoxifen); 42 participants were assigned to treatment; 43 were assigned to placebo; 69 completed all three hot flash diaries.
  • Inclusion criteria: Participants had to have completed primary therapy, including chemotherapy and radiation therapy, at least two months before entering the trial.
  • Exclusion criteria: Patients could not be using hormonal replacement therapy for hot flashes, be pregnant, have major psychiatric illness, or have recurrent or metastatic breast cancer.
  • Participants were stratified based on if they used tamoxifen.

Study Design:

The study was a randomized clinical trial: two-arm randomization, double-blind, placebo-controlled.

Measurement Instruments/Methods:

Participants were asked to record in a diary the number of hot flashes and the intensity of each. Participants scored severity as 1 = mild, 2 = moderate, and 3 = severe, for three days before starting to take any study pills, then again on days 27 to 30, and on days 57 to 60. FSH and LH levels were measured in a subset of participants at the first and final visits.

Results:

Sample size was chosen for 90% power to detect a 30% difference between groups in mean numbers of hot flashes, with a SD of 4.0. All analyses were stratified by tamoxifen use. The primary efficacy end point was mean numbers of hot flashes at 57 to 60 days. The safety end points were changes in mean levels of FSH and LH at the start and end of study participation associated with treatment. In hot flash intensity, both groups experienced a decline during the first month of study participation. The differences between groups in intensity at the end of the study were not significant. For the overall hot flash activity score, the differences between the treatment and placebo groups adjusted for tamoxifen were not statistically significant. Changes in FSH and LH levels of also did not differ between the two groups.

Conclusions:

Data provide little evidence of either harm or benefit from using black cohosh to control hot flashes.

Limitations:

A limitation of this study is that participation lasted only two months.

Pockaj, B.A., Gallagher, J.G., Loprinzi, C.L., Stella, P.J., Barton, D.L., Sloan, J.A., … Fauq, A.H. (2006). Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG trial N01CC1. Journal of Clinical Oncology, 24, 2836–2841.

doi:10.1200/JCO.2005.05.4296
Print

Study Purpose:

The purpose of the study was to measure the efficacy of black cohosh (one capsule, Cimicifuga racemosa 20 mg twice daily) for the treatment of hot flashes in women with and without a history of breast cancer.

Intervention Characteristics/Basic Study Process:

Participants received four weeks of therapy with black cohosh or an identical appearing placebo. The black cohosh or placebo was given as one tablet twice per day. After completing the first four weeks, participants were crossed over to the alternative treatment arm.

Sample Characteristics:

  • The study randomized 132 participants. 107 participants (81%) completed the first five weeks of hot flash diaries; 99 participants (75%) completed the entire nine weeks of therapy. The mean age was 56 years.
  • Inclusion criteria:
    • History of breast cancer, a perceived increased risk of breast cancer, or did not want to take estrogen due to the increased risk of breast cancer.
    • Participants experienced bothersome hot flashes (14 or more per week) for at least one month.
    • Concomitant therapy with tamoxifen, raloxifene, or an aromatase inhibitor was allowed as long as patient had been on the therapy for one month.
    • Use of vitamin E and/or soy was allowed if the patient had been on a stable dose for one month or more and planned to continue the same dose during the entire study period.
  • Exclusion criteria:
    • Receiving concomitant chemotherapy, androgens, or estrogens.
    • Any prior use of black cohosh; use of antidepressants within the prior two weeks (or planned use during the next nine weeks); or current or planned use of other agents for treating hot flashes (e.g., clonidine, belladonna alkaloids, dehydroepiandrosterone) 
    • Other oral herbal therapies, therapeutic herbal teas, or tinctures during the study period were not allowed because of potential interactions with black cohosh.

Study Design:

This was a double-blind, randomized, cross-over clinical trial with two four-week periods.

Measurement Instruments/Methods:

Participants completed a prospective, daily hot flash diary during the baseline week and then during the two four-week crossover treatment periods. Hot flash scores were measured by assigning points to each hot flash based on severity (1 for mild to 4 for very severe) and then adding the points for a given time period.

Results:

The primary end point was the average intrapatient hot flash score (which is a construct of average daily hot flash severity and frequency) difference between the baseline week and the last study week of the first treatment period. Hot flash activity was analyzed in a number of ways. The difference between treatment week 4 (study week 5) and baseline  hot flash score (study week 1) was compared between placebo and black cohosh arms by standard two-sided Wilcoxon procedures. Confidence intervals were constructed for median reductions in hot flash frequency and score. Patients receiving black cohosh reported a mean decrease in hot flash score of 20% (comparing the fourth treatment week to the baseline week) compared with a 27% decrease for patients on placebo (p = .53). Mean hot flash frequency was reduced 17% on black cohosh and 26% on placebo (p = .36). Patient treatment preferences were measured after completion of both treatment periods. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Toxicity was minimal across both groups.

Conclusions:

This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

Limitations:

Limitations of the study included using a subset of participants did not have a diagnosis of breast cancer but met the eligibility criteria of a perceived increased risk of breast cancer, or did not want to take estrogen because of the increased risk of breast cancer. The numbers of participants with and without a breast cancer diagnosis were not specified.

Rostock, M., Fischer, J., Mumm, A., Stammwitz, U., Saller, R., & Bartsch, H. H. (2011). Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints - a prospective observational study. Gynecological Endocrinology, 27(10), 844-848.

doi:10.3109/09513590.2010.538097
Print

Study Purpose:

The purpose of this study was to evaluate the dosage, effectiveness, and tolerability of an isopropanolic extract of black cohosh (Cimicifuga racemosa) in patients with breast cancer taking tamoxifen and reporting menopausal symptoms.   

Intervention Characteristics/Basic Study Process:

The study drug, Remifenin, was dosed at 2 tablets by mouth per day (40 mg black cohosh total) for 4 weeks but then participants could self-escalate the dose per patient preference (20, 40, 60, or 80 mg) and continue daily tablets for up to 6 months (mean 134 days). Participants were assessed at baseline and again 3- and 6-months later (90 and 180 days later). A subset of 4 patients also took St. John’s Wort.

Sample Characteristics:

  • 50 participants completed baseline, 47 completed first assessment, 40 secondassessment, and 35 final assessment. All available participants were used in the analyses.
  • AGE:  Mean age of 56 years (range 43-77), no age SD reported.
  • MALES (%)  0%    FEMALES (%)  100%
  • KEY DISEASE CHARACTERISTICS:  All stages of breast cancer, estrogen receptor positive (n=44, 94%), metastases (n=4, 9%)
  • OTHER KEY SAMPLE CHARACTERISTICS:  Mean of 8.6 months post diagnosis, 74% postmenopausal, 100% taking tamoxifen

 

Setting:

  • SITE: Single site   
  • LOCATION: Germany
     

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Transition phase after initial treatment
  • APPLICATIONS: Late effects & survivorship

Study Design:

Prospective, longitudinal, non-randomized study

Measurement Instruments/Methods:

  • Menopause rating scale - self-assessment, profile and intensity of 11 menopausal symptoms, subscores for symptom domains of vegetative-somatic, psychic, and urogenital symptoms
  • Physician documentation of tumor characteristics

Results:

There was a significant reduction in menopause rating scale scores, total scores, and subscales of vegetative-somatic and psychic symptoms at 1, 3, and 6 months of treatment. The overall MRS II score significantly decreased from 17.6 to 13.6 between baseline and last observation (p<0.001).   Two of the three symptom subscales also decreased significantly (vegetative-somatic and psychic both p<0.01).  However, the was no evidence of effectiveness for urogenital symptoms.  Symptoms that were initially most intense such as hot flashes, sweating, and sleep disturbances improved most during the observation period.

Conclusions:

The effectiveness of black cohosh extract for treatment of menopausal symptoms among women taking adjuvant tamoxifen is still unclear.  Daily use over at least 4 weeks may result in reduced hot flashes and sleep disturbances.  The drug was well tolerated in the small sample; however, it is unclear what the ideal dosing is for therapeutic benefit.

Limitations:

Limitations of the study included:

  • No appropriate control group
  • Small, non-randomized study  
  • 30% drop out rate over 6 months 
  • Dosage varied
  • Use of St. John’s Wort known to interfere with CYP450 isoenzymes and could have affected tamoxifen metabolism and the resulting side effects 
  • Did not study possible impact on hormones
     

Nursing Implications:

Black cohosh could be studied in a randomized trial but this study does not provide any efficacy information in relation to placebo. 


Menu