Fenugreek use while Breastfeeding
Fenugreek Levels and Effects while Breastfeeding
Summary of Use during Lactation
Fenugreek (Trigonella foenum-graecum) seeds contain mucilage, trigonelline, 4-hydroxyisoleucine, sotolon, diosgenin, phenolic acids, and protodioscin. Fenugreek has been used in a number of geographical regions worldwide as a galactogogue to increase milk supply, and is included in numerous proprietary mixtures promoted to increase milk supply. Evidence for a galactogogue effect is mostly anecdotal. A limited number of published studies of low to moderate quality have found mixed results for a galactogogue effect for fenugreek. The galactogogue effect of fenugreek may be primarily psychological, Some of these studies used a multi-ingredient combination products in which fenugreek was only one component, so the results might be different from studies in which fenugreek was used alone. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.
Fenugreek is "generally recognized as safe" (GRAS) as a flavoring by the US Food and Drug Administration. Limited scientific data exist on the safety of fenugreek in nursing mothers or infants, although it has a long history of use as a food and medicine in India and China. When used as a medicinal, it is generally well tolerated in adults, but gastrointestinal side effects such as diarrhea and flatulence may occur. Allergic reactions, exacerbation of asthma, and a 14% decrease in serum potassium have been reported. One nursing mother developed toxic epidermal necrolysis thought to be cause by her intake of fenugreek as a galactagogue. Cross-reactions with chickpeas, peanuts, and other legumes are possible. Dosages typically used to increase milk supply are 1 to 6 grams daily; in dosages of about 25 grams or more daily, fenugreek may cause lowering of cholesterol and blood sugar. It can also interact with warfarin to cause bleeding. Caution should be used in giving high dosages to women with diabetes mellitus or those taking warfarin. In a survey of nursing mothers in the United States, 100 had used fenugreek as a galactogogue and 44% reported having experienced an adverse reaction from the supplement. Perhaps its most unusual side effect is the imparting an odor of maple syrup to the urine, sweat, feces, and possibly breastmilk by the sotolon in fenugreek.
Dietary supplements do not require extensive pre-marketing approval from the US Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.
Maternal Levels. Relevant published information was not found as of the revision date.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
A study in mothers of preterm infants less than 31 weeks gestation compared the use of fenugreek (product and dosage not stated) 3 capsules 3 times daily for 21 days to placebo. No adverse effects were noted in the infants given the breastmilk.
Effects on Lactation and Breastmilk
Forty women who complained of an insufficient milk supply at 5 days postpartum were given a combination herbal supplement as 2 capsules of Lactare (Pharma Private Ltd., Madras, India) 3 times daily. Each capsule contained wild asparagus 200 mg, ashwagandha (Withania somnifera) 100 mg, fenugreek 50 mg, licorice 50 mg, and garlic 20 mg. By day 4 of therapy, no infants required supplementary feeding. Infants were weighed before and after each feeding on the fifth day of maternal therapy to determine the amount of milk ingested. On the day of the test weighing, infants' milk intake averaged 388 mL, and the fluid and caloric intake was considered adequate. This study cannot be considered as valid evidence of a galactogogue effect of these herbs because it lacks randomization, blinding, a placebo control, and maternal instruction in breastfeeding technique. Additionally, infants were breastfed only 6 to 8 times daily, which is insufficient to maximize milk supply.
A study of healthy women who delivered a fullterm infant and desired to breastfeed for at least 4 months compared fenugreek, torbangun (Coleus amboinicus) and a product containing placental extract and vitamin B12 (Molocco+B12) for their effects on breastmilk volume. No mention was made of any breastfeeding support provided to the women. Participants were randomly assigned to receive one of the products for 30 days and followed for another 30 days. Capsules containing powdered fenugreek seeds 600 mg (Bullivants Natural Health, Auckland, New Zealand) were given 3 times daily. Infants were weighed before and after each nursing at 2-week intervals during the study to measure 24-hour milk volume. At no time point during the study was milk volume in the fenugreek group (n = 22) statistically different from the reference group (n = 22) who received Molocco+B12, although the torbangun group did have a statistically significant increase. The daily volume of milk actually decreased in the fenugreek group over time, although the change was not statistically significant. The dosage of fenugreek used in this study was lower than that typically recommended by most sources.
A study was performed in 10 postpartum women who delivered preterm infants (24 to 38 weeks gestation) and had been pumping their milk for at least 14 days, but usually 3 to 4 weeks. The women recorded their baseline pumped milk volumes during one week and then took one 610 mg fenugreek capsule (Nature's Way) 3 times daily for a second week during which they recorded milk volumes. Average daily milk volumes increased from 207 mL in week 1 (range 57 to 1057 mL) to 464 mL (range 63 to 1140 mL) in week 2. This study was neither randomized nor blinded and did not have a placebo control group, so the result is questionable. A study in 26 mothers of preterm infants less than 31 weeks gestation compared fenugreek (product and dosage not stated) 3 capsules 3 times daily for 21 days to placebo. Mothers began pumping within 12 hours of delivery and recorded pumping frequency and milk volume. Maternal serum prolactin was also measured weekly during the 21 days. No statistical differences were found in milk volumes or serum prolactin values between the two groups. The study is thus far published only in abstract form, so many study details are missing.
Sixty-six postpartum mothers (22 in each of 3 groups) with no concurrent illnesses were randomly assigned to receive an herbal tea, placebo, or nothing after delivering healthy, fullterm infants. Mothers in the herbal tea group received at least 3 cups daily of 200 mL of Still Tea (Humana-Istanbul, Turkey; containing hibiscus 2.6 grams, fennel extract 200 mg, fennel oil 20 mg, rooibos 200 mg, verbena [vervain] 200 mg, raspberry leaves 200 mg, fenugreek 100 mg, goat's rue 100 mg, and, vitamin C 500 mg per 100 grams, per manufacturer's web site November 2011). A similar-looking apple tea was used as the placebo. All women were followed by the same nurse and pediatrician who were blinded to what treatment the mothers received. Mothers who received the Still Tea produced more breastmilk with an electric breast pump on the third day postpartum than mothers in the other groups. The infants in the Still Tea group had a lower maximum weight loss, and they regained their birth weights sooner than those in the placebo or no treatment arms. No long-term outcome data were collected. Because many of the ingredients in Still Tea are purported galactogogues, no single ingredient can be considered solely responsible for the tea's effects, although the authors attributed the action to fenugreek.
An herbal tea containing fenugreek, hibiscus, fennel, rooibos, vervain, raspberry, goat's rue, and vitamin C (Humana Still-Tee, Humana GmbH, Herford, Germany) or water was randomly given to nursing mothers in a dosage of 3 cups daily beginning on the day of delivery. Several markers of antioxidant capacity were measured in breastmilk on day 1 and again after 7 to 10 days. No difference was found in the markers between mothers who received the tea and the water.
A nonblinded study randomized mother to receive 2 grams of fenugreek as a tea three times a day, 100 grams of palm date flesh three times a day, or nothing beginning on the first day postpartum. The duration of therapy was not stated. Their full-term, healthy infants were weighed on days 3, 7 and 14 of age, and mothers measured the morning (only) milk volume from both breasts on the third day postpartum. The infants of the fenugreek and date flesh groups lost less weight on days 3 and 7 than the control mothers, but there was no difference in weight among the groups on day 14. On day 3, morning milk volumes were greater in the two treated groups than in the untreated group. The lack of blinding and incomplete milk collection call the results into question.
A nonblinded study compared several infant growth parameters after their mothers were randomized to receive either black tea or black tea plus 7.5 grams of fenugreek three times daily. Infants were healthy girls and ranged from 0 to 4 months old (mean about 2 months). At baseline, control mothers were breastfeeding two times more per day than the fenugreek group (11.2 vs 9.2 times/day). At the end of the 4 week study, several parameters were greater in the fenugreek group than in the control group: frequency of feeding infant weight, head circumference, and daily numbers of wet diapers and defecation. No difference was seen in infant height.
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