crossover
    2006
    High Quality

    Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1

    Pockaj BA, Gallagher JG, Loprinzi CL, Stella PJ, Barton DL, Sloan JA, et al.

    Published in J Clin Oncol, Vol. 24 (18), pp. 2836-41

    Methodology

    Phase III double-blind, randomised, placebo-controlled crossover trial (NCCTG N01CC1) with two 4-week periods; black cohosh 20 mg twice daily; daily hot flash diaries scored by severity.

    Key Findings

    132 women randomised. Hot flash score fell 20% on black cohosh versus 27% on placebo (P = .53); frequency fell 17% versus 26% (P = .36). 34% preferred black cohosh, 38% placebo and 28% neither. Toxicity was minimal and similar between arms.

    Conclusions

    The trial found no evidence that black cohosh reduced hot flashes more than placebo.

    Limitations

    Short treatment periods (4 weeks each); crossover design assumes no carry-over.

    Supplements Studied

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

    Outcomes Measured

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

    Related Health Concerns

    Study Details

    Year:2006
    Sample Size:132
    Duration:8 weeks
    Quality Score:8/10

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