A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes

North central cancer treatment group N08C7

Sandhya Pruthi, Rui Qin, Shelby A. Terstreip, Heshan Liu, Charles L. Loprinzi, Tushar R C Shah, Kenneth F. Tucker, Shaker R. Dakhil, Martin J. Bury, Robert L. Carolla, Preston D. Steen, Jacqueline Vuky, Debra L. Barton

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

OBJECTIVE: Preliminary data suggest that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment of hot flashes. A phase III, randomized, placebo, controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes. METHODS: Postmenopausal women with or without breast cancer were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks versus a placebo bar. Participants completed daily, prospective, hot flash diaries during the baseline week, and then ate one study bar per day for 6 weeks while recording their daily hot flashes. The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment. RESULTS: A total of 188 women were enrolled in this trial. The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group (P = 0.29). In both groups, slightly more than a third of the women received a 50% reduction in their hot flash score. Only one adverse effect was significantly different between groups, grade 1 pruritus, which was more common in the placebo group (8% vs 1%). Both groups reported abdominal distension, flatulence, diarrhea, and nausea. Adherence and ability to detect treatment assignment did not differ between groups. CONCLUSIONS: The results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes. The bars were fairly well tolerated, with both groups reporting gastrointestinal effects, probably due to the fiber content.

Original languageEnglish (US)
Pages (from-to)48-53
Number of pages6
JournalMenopause
Volume19
Issue number1
DOIs
StatePublished - Jan 2012
Externally publishedYes

Fingerprint

Hot Flashes
Flax
Placebos
Lignans
Neoplasms
Therapeutics
Flatulence
Pruritus
Terminology
Self Report
Nausea
Diarrhea
Randomized Controlled Trials
Breast Neoplasms

Keywords

  • Clinical trial
  • Dietary supplement
  • Flaxseed
  • Hot flashes
  • Menopause

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes : North central cancer treatment group N08C7. / Pruthi, Sandhya; Qin, Rui; Terstreip, Shelby A.; Liu, Heshan; Loprinzi, Charles L.; Shah, Tushar R C; Tucker, Kenneth F.; Dakhil, Shaker R.; Bury, Martin J.; Carolla, Robert L.; Steen, Preston D.; Vuky, Jacqueline; Barton, Debra L.

In: Menopause, Vol. 19, No. 1, 01.2012, p. 48-53.

Research output: Contribution to journalArticle

Pruthi, S, Qin, R, Terstreip, SA, Liu, H, Loprinzi, CL, Shah, TRC, Tucker, KF, Dakhil, SR, Bury, MJ, Carolla, RL, Steen, PD, Vuky, J & Barton, DL 2012, 'A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes: North central cancer treatment group N08C7', Menopause, vol. 19, no. 1, pp. 48-53. https://doi.org/10.1097/gme.0b013e318223b021
Pruthi, Sandhya ; Qin, Rui ; Terstreip, Shelby A. ; Liu, Heshan ; Loprinzi, Charles L. ; Shah, Tushar R C ; Tucker, Kenneth F. ; Dakhil, Shaker R. ; Bury, Martin J. ; Carolla, Robert L. ; Steen, Preston D. ; Vuky, Jacqueline ; Barton, Debra L. / A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes : North central cancer treatment group N08C7. In: Menopause. 2012 ; Vol. 19, No. 1. pp. 48-53.
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abstract = "OBJECTIVE: Preliminary data suggest that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment of hot flashes. A phase III, randomized, placebo, controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes. METHODS: Postmenopausal women with or without breast cancer were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks versus a placebo bar. Participants completed daily, prospective, hot flash diaries during the baseline week, and then ate one study bar per day for 6 weeks while recording their daily hot flashes. The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment. RESULTS: A total of 188 women were enrolled in this trial. The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group (P = 0.29). In both groups, slightly more than a third of the women received a 50{\%} reduction in their hot flash score. Only one adverse effect was significantly different between groups, grade 1 pruritus, which was more common in the placebo group (8{\%} vs 1{\%}). Both groups reported abdominal distension, flatulence, diarrhea, and nausea. Adherence and ability to detect treatment assignment did not differ between groups. CONCLUSIONS: The results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes. The bars were fairly well tolerated, with both groups reporting gastrointestinal effects, probably due to the fiber content.",
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T1 - A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes

T2 - North central cancer treatment group N08C7

AU - Pruthi, Sandhya

AU - Qin, Rui

AU - Terstreip, Shelby A.

AU - Liu, Heshan

AU - Loprinzi, Charles L.

AU - Shah, Tushar R C

AU - Tucker, Kenneth F.

AU - Dakhil, Shaker R.

AU - Bury, Martin J.

AU - Carolla, Robert L.

AU - Steen, Preston D.

AU - Vuky, Jacqueline

AU - Barton, Debra L.

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N2 - OBJECTIVE: Preliminary data suggest that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment of hot flashes. A phase III, randomized, placebo, controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes. METHODS: Postmenopausal women with or without breast cancer were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks versus a placebo bar. Participants completed daily, prospective, hot flash diaries during the baseline week, and then ate one study bar per day for 6 weeks while recording their daily hot flashes. The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment. RESULTS: A total of 188 women were enrolled in this trial. The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group (P = 0.29). In both groups, slightly more than a third of the women received a 50% reduction in their hot flash score. Only one adverse effect was significantly different between groups, grade 1 pruritus, which was more common in the placebo group (8% vs 1%). Both groups reported abdominal distension, flatulence, diarrhea, and nausea. Adherence and ability to detect treatment assignment did not differ between groups. CONCLUSIONS: The results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes. The bars were fairly well tolerated, with both groups reporting gastrointestinal effects, probably due to the fiber content.

AB - OBJECTIVE: Preliminary data suggest that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment of hot flashes. A phase III, randomized, placebo, controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes. METHODS: Postmenopausal women with or without breast cancer were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks versus a placebo bar. Participants completed daily, prospective, hot flash diaries during the baseline week, and then ate one study bar per day for 6 weeks while recording their daily hot flashes. The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment. RESULTS: A total of 188 women were enrolled in this trial. The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group (P = 0.29). In both groups, slightly more than a third of the women received a 50% reduction in their hot flash score. Only one adverse effect was significantly different between groups, grade 1 pruritus, which was more common in the placebo group (8% vs 1%). Both groups reported abdominal distension, flatulence, diarrhea, and nausea. Adherence and ability to detect treatment assignment did not differ between groups. CONCLUSIONS: The results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes. The bars were fairly well tolerated, with both groups reporting gastrointestinal effects, probably due to the fiber content.

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