Effects of a Bovine Lactoferrin Formulation from Cow's Milk on Menstrual Distress in Volunteers: A Randomized, Crossover Study.
Dysmenorrhea is a highly prevalent complaint and highly undiagnosed gynecologic condition. Dairy products have a potential in the management of menstrual distress, and bovine lactoferrin can help the subjective dysphoria associated with dysmenorrhea. In the present study, we aimed to investigate the effects of a lactoferrin formulation isolated from cow's milk on menstrual symptoms in volunteers. A double-blind, randomized, placebo-controlled, crossover study of the iron-lactoferrin complex (FeLf) was performed in thirty-five healthy Japanese women. Participants received the 150 mg FeLf (per day) or placebo from day ten of the luteal phase to day four of the follicular phase. The Moos Menstrual Distress Questionnaire (MDQ) was measured for menstrual distress, and heart rate variability was measured as an index of autonomic nerve balance during menses. A visual analog scale for menstrual pain, and a verbal rating scale for quality of life during the first three days of menstruation were measured. The MDQ score for the automatic nervous system subscale was lower and the parasympathetic nervous system activity was greater in FeLf than in placebo for intention-to-treat or per-protocol populations. The other variables were not different between the groups. No treatment-related side effects were observed during the study. The results indicate that FeLf can provide a beneficial effect on the psychological symptoms in women affected by menstrual distress.
Milk Science Research Institute, Megmilk Snow Brand Co., Ltd., Saitama 350-1165, Japan. hiroshi-ueno@beanstalksnow.co.jp.
Hiroshi M
HM
Ueno
Milk Science Research Institute, Megmilk Snow Brand Co., Ltd., Saitama 350-1165, Japan. yr-emilie@meg-snow.com.
Ran Emilie
RE
Yoshise
Soiken Inc., Osaka 560-0082, Japan. sugino@soiken.com.
Tomohiro
T
Sugino
Graduate School of Medicine, Osaka City University, Osaka 545-8585, Japan. kajimoto@med.osaka-cu.ac.jp.
Osami
O
Kajimoto
Milk Science Research Institute, Megmilk Snow Brand Co., Ltd., Saitama 350-1165, Japan. t-kobayashi@meg-snow.com.
Toshiya
T
Kobayashi
D000328:Adult; D000818:Animals; D002417:Cattle; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000523:psychology*; D005260:Female; D006306:Health Surveys; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D007501:Iron / Q000008:administration & dosage* / Q000494:pharmacology; D007564:Japan; D007781:Lactoferrin / Q000008:administration & dosage* / Q000494:pharmacology; D008875:Middle Aged; D008892:Milk / Q000378:metabolism; D010147:Pain Measurement / Q000187:drug effects*; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome
D007501:Iron; D007781:Lactoferrin
complex; distress; iron; lactoferrin; menses