Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG trial N01CC

Barbara A Pockaj, James G. Gallagher, Charles Lawrence Loprinzi, Philip J. Stella, Debra L. Barton, Jeff A Sloan, Beth I. Lavasseur, Radha M. Rao, Tom R. Fitch, Kendrith M. Rowland, Paul J. Novotny, Patrick J. Flynn, Elliott Richelson, Abdul H. Fauq

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Abstract

Purpose: Hot flashes can cause significant morbidity in postmenopausal women undergoing or finished with breast cancer treatment. Black cohosh has been used to treat hot flashes, but definitive clinical data about efficacy have been equivocal. Methods: A double-blind, randomized, cross-over clinical trial with two 4-week periods, was used to study the efficacy of black cohosh (1 capsule, Cimicifuga racemosa 20 mg BID) for the treatment of hot flashes in women. Participants kept a daily hot flash diary during a baseline week and then during two 4-week crossover treatment periods. Hot flash scores were measured by assigning points (1 to 4 for mild to very severe) to each hot flash based on severity and then adding the points for a given time period. Results: Between October 31, 2003, to March 4, 2004, 132 patients were randomly assigned. Toxicity was minimal and not different by treatment group. 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 by ascertaining which treatment period, if any, the patient preferred. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Conclusion: This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

Original languageEnglish (US)
Pages (from-to)2836-2841
Number of pages6
JournalJournal of Clinical Oncology
Volume24
Issue number18
DOIs
StatePublished - Jun 20 2006

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Cimicifuga
Hot Flashes
Cross-Over Studies
Placebos
Therapeutics
Patient Preference
Double-Blind Method
Capsules

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes : NCCTG trial N01CC. / Pockaj, Barbara A; Gallagher, James G.; Loprinzi, Charles Lawrence; Stella, Philip J.; Barton, Debra L.; Sloan, Jeff A; Lavasseur, Beth I.; Rao, Radha M.; Fitch, Tom R.; Rowland, Kendrith M.; Novotny, Paul J.; Flynn, Patrick J.; Richelson, Elliott; Fauq, Abdul H.

In: Journal of Clinical Oncology, Vol. 24, No. 18, 20.06.2006, p. 2836-2841.

Research output: Contribution to journalArticle

Pockaj, BA, Gallagher, JG, Loprinzi, CL, Stella, PJ, Barton, DL, Sloan, JA, Lavasseur, BI, Rao, RM, Fitch, TR, Rowland, KM, Novotny, PJ, Flynn, PJ, Richelson, E & Fauq, AH 2006, 'Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG trial N01CC', Journal of Clinical Oncology, vol. 24, no. 18, pp. 2836-2841. https://doi.org/10.1200/JCO.2005.05.4296
Pockaj, Barbara A ; Gallagher, James G. ; Loprinzi, Charles Lawrence ; Stella, Philip J. ; Barton, Debra L. ; Sloan, Jeff A ; Lavasseur, Beth I. ; Rao, Radha M. ; Fitch, Tom R. ; Rowland, Kendrith M. ; Novotny, Paul J. ; Flynn, Patrick J. ; Richelson, Elliott ; Fauq, Abdul H. / Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes : NCCTG trial N01CC. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 18. pp. 2836-2841.
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abstract = "Purpose: Hot flashes can cause significant morbidity in postmenopausal women undergoing or finished with breast cancer treatment. Black cohosh has been used to treat hot flashes, but definitive clinical data about efficacy have been equivocal. Methods: A double-blind, randomized, cross-over clinical trial with two 4-week periods, was used to study the efficacy of black cohosh (1 capsule, Cimicifuga racemosa 20 mg BID) for the treatment of hot flashes in women. Participants kept a daily hot flash diary during a baseline week and then during two 4-week crossover treatment periods. Hot flash scores were measured by assigning points (1 to 4 for mild to very severe) to each hot flash based on severity and then adding the points for a given time period. Results: Between October 31, 2003, to March 4, 2004, 132 patients were randomly assigned. Toxicity was minimal and not different by treatment group. 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 by ascertaining which treatment period, if any, the patient preferred. Thirty-four percent of patients preferred the black cohosh treatment, 38{\%} preferred the placebo, and 28{\%} did not prefer either treatment. Conclusion: This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.",
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T1 - Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes

T2 - NCCTG trial N01CC

AU - Pockaj, Barbara A

AU - Gallagher, James G.

AU - Loprinzi, Charles Lawrence

AU - Stella, Philip J.

AU - Barton, Debra L.

AU - Sloan, Jeff A

AU - Lavasseur, Beth I.

AU - Rao, Radha M.

AU - Fitch, Tom R.

AU - Rowland, Kendrith M.

AU - Novotny, Paul J.

AU - Flynn, Patrick J.

AU - Richelson, Elliott

AU - Fauq, Abdul H.

PY - 2006/6/20

Y1 - 2006/6/20

N2 - Purpose: Hot flashes can cause significant morbidity in postmenopausal women undergoing or finished with breast cancer treatment. Black cohosh has been used to treat hot flashes, but definitive clinical data about efficacy have been equivocal. Methods: A double-blind, randomized, cross-over clinical trial with two 4-week periods, was used to study the efficacy of black cohosh (1 capsule, Cimicifuga racemosa 20 mg BID) for the treatment of hot flashes in women. Participants kept a daily hot flash diary during a baseline week and then during two 4-week crossover treatment periods. Hot flash scores were measured by assigning points (1 to 4 for mild to very severe) to each hot flash based on severity and then adding the points for a given time period. Results: Between October 31, 2003, to March 4, 2004, 132 patients were randomly assigned. Toxicity was minimal and not different by treatment group. 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 by ascertaining which treatment period, if any, the patient preferred. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Conclusion: This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

AB - Purpose: Hot flashes can cause significant morbidity in postmenopausal women undergoing or finished with breast cancer treatment. Black cohosh has been used to treat hot flashes, but definitive clinical data about efficacy have been equivocal. Methods: A double-blind, randomized, cross-over clinical trial with two 4-week periods, was used to study the efficacy of black cohosh (1 capsule, Cimicifuga racemosa 20 mg BID) for the treatment of hot flashes in women. Participants kept a daily hot flash diary during a baseline week and then during two 4-week crossover treatment periods. Hot flash scores were measured by assigning points (1 to 4 for mild to very severe) to each hot flash based on severity and then adding the points for a given time period. Results: Between October 31, 2003, to March 4, 2004, 132 patients were randomly assigned. Toxicity was minimal and not different by treatment group. 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 by ascertaining which treatment period, if any, the patient preferred. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Conclusion: This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

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