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Randomized Controlled Trial
. 2018 Mar;27(3):333-340.
doi: 10.1089/jwh.2017.6406. Epub 2017 Dec 13.

A Randomized Controlled Multicenter Trial of an Investigational Liquid Nutritional Formula in Women with Cyclic Breast Pain Associated with Fibrocystic Breast Changes

Robert E Mansel  1 , Tapas Das  2 , Geraldine E Baggs  2 , Michael J Noss  3 , William P Jennings  4 , Jay Cohen  5 , David Portman  6 , Mario Cohen  7 , Anne Coble Voss  2
Affiliations
Randomized Controlled Trial

A Randomized Controlled Multicenter Trial of an Investigational Liquid Nutritional Formula in Women with Cyclic Breast Pain Associated with Fibrocystic Breast Changes

Robert E Mansel et al. J Womens Health (Larchmt). 2018 Mar.

Abstract

Objective: A randomized, multicenter, controlled double-blind trial was performed in women with cyclic breast pain (mastalgia) associated with fibrocystic breast changes (FBCs) to determine whether a nutritional formula reduced breast pain and/or nodularity.

Study design: Women were randomized to receive a specifically designed liquid formulation (n = 93) (1 g gamma-linolenic acid [GLA], 750 μg iodine, and 70 μg selenium) or control formula (n = 95) (without GLA, iodine, and selenium) daily for three cycles. Women recorded breast pain, medications, and menstrual signs daily using interactive voice-response system. Nodularity was determined by physical breast examination.

Results: Breast pain scores decreased similarly in the experimental (-32.2%) and control (-33.1%) groups (p = 0.64). Nodularity was reduced in the experimental, but not the control group (p = 0.03). Among women who continued pain medication, the amount was reduced in the experimental group relative to controls (p = 0.02).

Conclusion: Women with FBC using the formula containing GLA, iodine, and selenium experienced reduced nodularity and in those women who took over-the-counter breast pain medication, a decrease in the quantity of pain medication was observed.

Keywords: fibrocystic breast changes; gamma-linolenic acid; iodine; mastalgia; selenium.

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Conflict of interest statement

R.E.M. is a consultant for Abbott Nutrition and no other competing financial interests exist. T.D. and G.E.B. are scientists employed by Abbott Nutrition. A.C.V. was formerly employed by Abbott Nutrition as a scientist. M.J.N. was a paid investigator for this study and no other competing financial interests exist. W.P.J. was a paid investigator for this study and no other competing financial interests exist. J.C. was a paid investigator for this study and no other competing financial interests exist. D.P. was a paid investigator for this study and no other competing financial interests exist. M.C. was a paid investigator for this study and no other competing financial interests exist. All other authors were paid study investigators and have no other conflicts of interest.

Figures

<b>FIG. 1.</b>
FIG. 1.
Study design.
<b>FIG. 2.</b>
FIG. 2.
Participant flow diagram.
<b>FIG. 3.</b>
FIG. 3.
Total nonprescription pain medication consumed during each cycle for breast pain.
See this image and copyright information in PMC

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