Table 2.

Human Observational Trials of the Use of Herbs During Lactation

Studies and Herb Characteristics	Type of Study	Aim of Study	Outcome of Study
Study by Westfall, 2003 (21)	N = 23, NRCT, qualitative	To discuss the potential value of herbs in breastfeeding women and provide direction for future research	14 of the 23 women used some form of galactagogue and 11 of these women used herb: blessed thistle, 2 users; fennel, 4 users; fenugreek, 4 users; raspberry leaf, 2 users; and stinging nettle, 2 users. Women received herbal advice from midwives, friends, a doula, or a family member.
N: blessed thistle, fennel, fenugreek, raspberry leaf, stinging nettle
L: Cnicus benedictus, Foeniculum vulgare, Trigonella foenum-graecum, Rubus idaeus, Urtica dioica
D: unknown
T: tea from seeds, capsule, oil
Study by Damanik et al, 2006 (22)	N = 75, RCT	To report the effects of consumption of torbangun leaves for 1 month after birth on the quantity and quality of breast milk	Milk intake significantly increased from 361 to 479 mL, an mean 65% increase (P<.05).
N: torbangun vs reference group and fengugreek group
L: Coleus amboinicus, Trigonella foenum-graecum Lour
D: 150-g leaves vs 600-mg capsule
T: leaves vs seeds
Study by Mennella and Beauchamp, 1991 (23)	N = 8, NRCT, before-after	To assess whether odor of human milk is altered because of certain flavors in the mother’s diet that are transmitted to her milk	Infants latched for a longer period (P<.05) and suckled more when the milk (P = .007) smelled like garlic.
N: garlic extract
L: unknown
D: 1.5 g of garlic extract (General Nutrition)
T: capsule
Study by Mennella and Beauchamp, 1993 (24)	N = 30, NRCT, case-crossover	To evaluate the infant’s behavior after maternal garlic ingestion	4 of 10 infants in the placebo group and 4 from garlic group were colicky.
N: garlic extract			Infants whose mother ingested garlic breastfed longer, but no differences in milk volume were observed.
L: unknown
D: 1.5 g of garlic extract (General Nutrition)
T: capsule
Study by Faber and Strenge-Hesse, 1988 (25)	N = 20, NRCT, open label	To determine the amount of the sennoside metabolite rhein in breast milk after repeated doses of senna pods	None of the breastfed infants had any changes in stool consistency.
N: senna and psyllium laxative (Agiolax)			0.007% of the sennoside intake (as rhein) was excreted in breast milk.
L: Senna spp, Plantago ovata			Postdose varied between 0 and 27 ng/ml, with values below 10 ng/mL in 94% in milk samples.
D: 5 g of the standardized senna preparation (=15 mg sennosides A+B) with psyllium
T: granules
Study by Shelton, 1980 (26)	N= 471, RCT	To determine the success of constipation treatment by Senokot and its effect on breastfed infants	Mild abdominal cramps were reported in mothers. No diarrhea or loose stool were observed in the infants. Successful treatment of constipation in the immediate postpartum period was observed in 94% of patients.
N: senna tablets (Senokot)
L: Senna spp
D: 7 mg of sennosides A+B
T: tablets
Study by Klier et al, 2002 (27)	N = 1, NRCT, case report	To examine the effect of St John’s wort on the infant	No adverse effects were reported in the mothers or infants. Hypericin was not excreted to breast milk but hyperforin was detected in fore- and hindmilk in very low concentrations.
N: St John’s wort
L: unknown
D: 300 mg 3 times daily (Jarsin)
T: unknown
Study by Lee et al, 2003 (28)	N = 167, NRCT, cohort	To examine the safety of St John’s wort in breastfeeding mothers and their infants	No maternal adverse events were reported. In groups 2 and 3 there was 1 colicky infant in each group, and in group 1 there were 2 cases of colic, 2 cases of drowsiness, and 1 case of lethargy. No change in milk production.
N: St John’s wort
L: Hypericum perforatum
D: unknown
T: unknown
Study by Klier et al, 2006 (29)	N = 7, NRCT, open label	To evaluate the safety of St John’s wort during breastfeeding	No adverse effects or unusual behavior, such as lethargy, rashes, photosensitivity, and sleep pattern. The hyperforin concentration was analyzed and varied from 2.1 to 5.6 ng/mL in foremilk.
N: St John’s wort
L: Hypericum perforatum
D: 300 mg 3 times daily (Jarsin)
T: tablets
Study by Chien et al, 2006 (30)	N = 72, NRCT, survey and lead analysis	To assess the relationship between consumption of traditional Chinese herbs and lead concentration in breast milk	The concentration of the lead in breast milk was higher in the group consuming traditional Chinese herbs compared with the control group (P<.05).
N: traditional Chinese herbs – Dong quai root, lycium fruit, jujube fruit, shy wuh tang (formula of rehmannia tuber, dong quai root, Sichuan lovage root, and Chinese peony root)
L: Angelica sinensis, Lycium spp. Ziziphus jujube, shy wuh tang (Rehmannia glutinosa, Angelica sinensis, Ligusticum sinense, Paeonia lactiflora)
D: 1 g of herb – analyzed
T: unknown

D=dose; L=Latin name; N=name of product or plant; NRCT=nonrandomized control trial; RCT=randomized control trial; T=type of preparation.