Lactation
Conditions
Keywords
fenugreek, galactogogue, breastmilk, Trigonella foenum-graecum, Bird's Foot, Greek Clover, Greek Hay, Hu Lu Ba, Trigonella
Brief summary
Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stops. Termed Insufficient Milk Syndrome, this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant. The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply. In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue. This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.
Detailed description
This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.
Interventions
DRUGfenugreek
3 capsules 3 times per day with a full glass of water each dose for 7 days
DRUGPlacebo (Psyllium)
3 capsules 3 times a day with a full glass of water each dose for 7 days
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Mothers 2-12 weeks postpartum * Mothers with term infants 37 weeks gestation or older * Mothers with poor milk supply documented by professional lactation consultants * Mothers whose milk supply is less than 600 cc per 24 hours * Mothers who agree not to breastfeed or provide their milk to their infants during this study
Exclusion criteria
* Mothers with documented mastitis * Mothers with breast engorgement * Mothers with inverted nipples * Maternal BMI greater than 35 * Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production * Mothers who are clinically ill or hospitalized, or taking the following medications: 1. Diuretics 2. Pseudoephedrine 3. Anticholinergics 4. Warfarin or any anticoagulant 5. An estrogen-containing birth control pill * Mothers with Diabetes mellitus * Mothers who have had breast surgery that could alter milk synthesis or production * Mothers diagnosed with Polycystic ovary syndrome * Mothers with tubular breasts or breasts with insufficient glandular tissue * Mothers diagnosed with Asthma or atopic disease * Mothers who are known to be allergic to peanuts or soybeans * Mothers who are pregnant * Mothers whose milk supply per 24 hours exceeds 600 mL * Mothers with Obstetrical evaluation recommending exclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Main Outcome Variable of This Study is the Quantity of Milk Produced. | Day 0 , Day 8 | The single value of this variable was calculated average from day 0 and day 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content. | day 0; day 8 | Milk-fat content was not measured in these samples as we had decided to close the study. Protein content was not measured in these samples as we had decided to close the study. |
Countries
United States
Participant flow
Recruitment details
3 patients were recruited to participate. Recruitment was stopped due to a similar study had already been published and the inability to recruit patients.
Participants by arm
| Arm | Count |
|---|---|
| 2 Group Scheduled to Receive Placebo Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days | 1 |
| 1 Group Scheduled to Receive Fenugreek fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | 2 Group Scheduled to Receive Placebo | 1 Group Scheduled to Receive Fenugreek | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
The Main Outcome Variable of This Study is the Quantity of Milk Produced.
The single value of this variable was calculated average from day 0 and day 8.
Time frame: Day 0 , Day 8
Secondary
Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.
Milk-fat content was not measured in these samples as we had decided to close the study. Protein content was not measured in these samples as we had decided to close the study.
Time frame: day 0; day 8
Population: 0 patient samples