Table 1 Characteristics of included studies.

From: Herbal galactagogues to improve breastmilk production and lactation in mothers of preterm babies: a systematic review of clinical trials

Author

Country

Participant characteristics

Intervention groupa

Control/ comparator groupa

Study duration

Day postpartum intervention initiated

Primary outcomes

Conflicts of interest/funding reported by study authors

Estrella et al. [58]

Philipin es

Mean gestational age of infants (weeks): 33.7 ± 1.9 (intervention) 33.1 ± 2.3 (control)

Mean age of mothers (years): 25.8 ± 5.1 (intervention) 30.9 ± 15.7 (control)

N = 31

One Moringa oleifera leaf capsules containing 250 mg of the leaves—orally twice daily.

Total daily dose = 500 mg

Placebo—identical flour capsules (n = 37)

5 days (galactagogue and placebo given from day 3 to 5 of study)

Day 3

To determine if there is a significant difference in volume of breastmilk on postpartum days 3 to 5 between those given the placebo and the intervention

Not reported

Reeder et al. [53]

USA

Mean gestational age of infants (weeks): 28.0 (intervention), 28.1 (control)

Mean age of mothers (years): 25.8 (intervention)

27.4 (control)

N = 14

3 capsules of 575 mg fenugreek orally 3 times daily. Total daily dose = 5175 mg

Placebo—starch capsules (n = 12)

21 days

Day 5

Increase in breastmilk volume (no units stated)

Increase in prolactin levels in ng/ml

Adverse effects

Not reported

Peila et al. [52]

Italy

Mean gestational age of infants (weeks): 29.0 (both intervention and control)

Mean age of mothers (years): 35.0 (intervention)

33.0 (control)

N = 25

One BIO-C® sachet containing 252 mg micronised silymarin (corresponding to a dose of 420 mg Silybum marianum) orally twice daily.

Total daily dose = 504 mg of silymarin

Placebo—maltodextrin sachet (n = 25)

28 days

Day 10 ± 1

Difference between mean milk production after 26, 27 and 28 days of administration and basal production in g/day

The authors received financial support from Milte Italia S.r.l.—the manufacturer of the herbal product used

Zecca et al. [50]

Italy

Mean gestational age of infants (weeks):

31.5 (intervention) 30.6 (control)

Mean age of mothers (years): 34.0 (intervention and control)

N = 50

Piùlatte® 5 g sachet containing silymarin- phosphatidylserine (400 mg phytosomes containing 130 mg

silymarin and 130 mg phosphatidylserine) with 150 mg galega orally once dailyTotal daily dose = 5 g

Placebo—5 g of lactose (n = 25)

25 days

Day 3

Daily volume of milk produced (ml)

The authors declare no conflict of interest

Demirci et al. [49]

USA

Five women delivered between 36 ± 0 and 36 ± 6 weeks, and 6 delivered between 37 ± 0 and 37 ± 6 weeks

Participants ranged in age from 23 to 35 years

N = 6

Commercially available alcohol-free tincture herbal supplement (Motherlove®: More Milk Plus Alcohol Free containing fenugreek (Trigonella foenum- graecum), blessed thistle (Cnicus benedictus), nettle (Urtica dioica), and fennel (Foeniculum vulgare))

Participants were instructed to add the tincture to a palatable liquid <1 oz and drink it 3–4 times per day. The precise dosage was based on the mother’s weight, as advised by the manufacturer.

Meditation intervention via an Apple iPod Shuffle© (n = 5)

There was a choice of three guided meditations lasting 5–8 min.

Participants were instructed to listen to the meditations at least twice each day.

9 days

Days 9–16

Difference between infant weight pre and post intervention (g)

Difference between volume of expressed milk pre and post intervention (ml)

The authors declare no conflict of interest

Ozalkaya et al. [51]

Turkey

Mean gestational age of infants (weeks): 30.1 (intervention), 29.1 (control 1), 29.2 (control 2)

Mean age of mothers (years): 28.8 (intervention), 29.7 (control 1), 27.7 (control 2)

N = 32

8 g orally twice daily of commercially available tea granules (Hipp Natal®) containing 1.0% nettle (Urtica dioica) and six other herbs (Melissa (Melisa officinalis L.), caraway (Carum carvi L.), anise (Pimpinella anisum), fennel (Foeniculum vulgare), goat’s rue (Galega officinalis), and lemon grass (Cymbopogon citratus)). Total daily dose = 16 g

Control group 1: placebo—8 g fruit tea (containing hibiscus, rosehip fruit powder, lemon, orange and apple aroma, vitamin C) (n = 32)

Control group 2: advice on supportive measures (n = 21)

7 days

Participants included ranged from a minimum of 3 to a maximum of 47 days postpartum, with a mean of 14–16 days between the three study arms

Daily breastmilk volumes in ml/day

Weight gain of preterm infants in g

Serum prolactin levels in ng/ml

The authors declare no conflicts of interest.

Ranade and Mudgalkar [54]

India

Mean gestational age of infants (weeks): 31.2 (intervention), 30.2 (control)

Mean age of mothers (years): 23.2 (intervention), 24.2 (control)

N = 23

2.5 g of Lepidium sativum seeds soaked in warm water for 30 min (n = 23) orally once daily.

No medication (n = 23)

28 days

Not specified

The difference in milk production between the two groups at 28 days (ml)

Adverse drug effects

The authors declare no conflict of interest.

Wesolowska et al. [55]

Poland

Mean gestational age of infants (weeks): 31.8 (intervention), 31.4 (control)

Mean age of mothers (years): 30.9 (intervention), 31.6 (control)

Femaltiker® sachet (80 mg powdered lemon balm leaves (Melissa officinalis L.); 5 g barley malt (Hordeum vulgare Linn) enriched with 70% barley beta-glucan—minimum 300 mg beta-glucans from barley per sachet) (n = 40) orally twice daily. Total daily dose = 2 sachets

Placebo—a blend of sucrose, apple fibre and natural aroma caramel (n = 40)

14 days

Day 2

Total volume of milk expressed by participants from the second to the 14th postnatal day (ml)

Safety of the intervention

Nutropharma LLC sponsored the clinical trial—the manufacturer of Femaltiker®.

Medela Ltd, Poland, rented the lactation equipment to the study authors free of charge

Khalili et al. [56]

Iran

Mean gestational age of infants (weeks): 30.0(intervention), 30.0 (control 1), 29.0 (control 2)

Mean age of mothers (years): 30.7 (intervention), 29.8 (control 1), 32.3 (control 2)

N = 45

3 g Pimpinella anisum seed herbal tea (2 g of dried anise seeds plus 1 g of black tea) orally 3x daily

Total daily dose = 6 g of Pimpinella anisum seeds

Control group 1: placebo—3 g of dried black tea (n = 45)

Control group 2: no treatment (n = 39)

7 days

Day 3

Daily milk volume (cc)

Infant’s weight at day 3 and day 7 (g)

The authors declare no conflict of interest

Izaddoost et al. [57]

Iran

Gestational age of infants (weeks): 29.91 ± 1.26

(intervention), 29.72 ± 1.25

(control group 1), 29.55 ± 1.03 (control group 2)

Mean age of mothers (years): 30.17 ± 5.94 (intervention), 30.43 ± 6.78

(control group 1), 29.66 ± 7.49 (control group 2)

N = 50

10 ml orally of Lactuca sativa (lettuce) syrup divided 3× daily (syrup standardised based on total phenol content, containing at least 10 mg per 10 g of syrup). Total daily dose = 30 ml

Control group 1: Placebo—sugar syrup (n = 50)

Control group 2: No intervention (n = 50)

8 days

Day 3

Primary outcomes:

Time spent pumping milk Frequency of using the pump

Time spent skin-to-skin with the infant (kangaroo care), Type and amount of any serums injected into the infant

The authors declare no conflict of interest

       

Volume of pumped milk at the end of each day Infant weight at day 1 (before the intervention), day 3, day 5, and day 7

Secondary outcomes: Medication side effects

 
  1. aWe have included the number of participants (indicated by n) who completed the study and were therefore not excluded from analysis in this table in the intervention and control groups.