EAL

BF: Dietary Factors, Breast Milk and Infant Outcomes (2008)

Citation:

Damanik R, Wahlqvist M, Wattanapenpaiboon N. Lactagogue Effects of Torbangun, a Bataknese Traditional Cuisine. Asia Pacific Journal of Clinical Nutrition. 2006; 15(2): 267-274.

PubMed ID: 9440304

Study Design:

Randomized controlled trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To investigate the effect of Coleus amboinicus Lour (CA) supplementation during the first month of lactation on the quantity and quality of breast milk production.

Inclusion Criteria:

Pregnant women in Simalungan District of North Sumatra Province in Indonesia
Pregnant women in their last trimester
Age between 20y and 40y
Healthy (with no malnutrition or chronic diseases, not taking medication on regular basis, no medical conditions or complications during previous pregnancies or deliveries)
Do not drink or smoke regularly
Plan to breastfeed newborns exclusively for no fewer than four months
Infant must be full-term (gestation of 37wk to 43wk)
Infant must have birth weight of no less than 2.5kg
Infant must be healthy.

Exclusion Criteria:

None other than those not meeting all inclusion criteria.

Description of Study Protocol:

Recruitment

Potential subjects were recruited by midwife practices in the particular district.

Design

Randomized controlled trial with three parallel arms with 25 subjects each
Treatment given for 30 days, starting on day two after birth
After the 30-day treatment, subjects were followed up for another 30 days.

Blinding used

Not reported.

Intervention

Intervention started on day two after birth and continued for one month. Subjects received one of three treatments:

Coleus amboinicus (CA) group consumed a soup made from 150g of CA leaves per day from Monday through Saturday. Soup was prepared by the same local woman. 150-g sample of this soup contains 16.3g fat, 2.4g protein, 5.3g carbohydrate, 121.5g water, 2.8mg zinc, 6.8mg iron, 393.1g calcium, 124.1g magnesium, and 1,219.2g potassium.
Fenugreek group consumed Fenugreek seeds in capsules (Bullivant Natural Product, Auckland, New Zealand Batch) three times per day. The capsule included 600mg of Trigonella foenum graecum Lour seed powder.
Reference group consumed sugar-coated Moloco+B₁₂ tablets (Kenrose, Jakarta, Indonesia) three times per day. The tablet included 20mcg of vitamin B₁₂ and 15mg of "placental extract".

Statistical Analysis

ANOVA, paired T-test.

Data Collection Summary:

Timing of Measurements

24-hour breast milk volume: every two weeks
Feeding frequency: every two weeks
Total time spent breastfeeding: every two weeks
Milk sample collection: days eight, 33 and 60
Compliance with treatment: timing not reported.

Dependent Variables

24-hour breast milk volume: sum of the differences in weights of infants before and after the feeding within 24 hours, and multiplied by 0.983ml/g to adjust for the density of breast milk; done by trained research assistants using baby electronic weighing scale at subjects' homes
Feeding frequency: measurement not described
Total time spent on breastfeeding: measurement not described
Milk sample collection: 40ml of milk collected between 8 a.m. and 10 a.m. after cleaning both breasts with deionized water
Compliance with treatment: pill count and "structured conversation".

Independent Variables

Randomized treatment assignment.

Description of Actual Data Sample:

Initial N: 75 (25 CA group, 25 Fenugreek group, 25 B₁₂ group)

Attrition N: 67 (23 CA group, 22 Fenugreek group, 22 B₁₂ group)

Anthropometry: No data

Location: Simalungun District, North Sumatra Province, Indonesia.

Summary of Results:

**24-hour Breast Milk Volume**
	B₁₂ group (n=22)	CA group (n=23)	Fenugreek group (n=22)
Day 14	453.8±192.6	361.1±201.1	466.9±253
Day 28	385.1±201.9	478.7±157	400.3±215.1
Day 42	387.4±188.3	439.8±196.7	456.6±247.1
Day 56	385.5±170.5	478.3±265	358.5±135.2

% Change in 24-hour Breast Milk Volume, Compared with Day 14

	B₁₂ group (n=22)	CA group (n=23)	Fenugreek group (n=22)
Day 28	+9.7%	+65.2% (P<0.05)	+20.3%
Day 42	-1.2%	+53.5%	+19.6%
Day 56	-4.2%	+68.4%	+5%

There were no significant differences among the three groups in milk volume.
The only significant within-group change in milk volume was the CA group between day 14 and day 28.
Effect of Fenugreek on breast milk quality was not examined because it "seems to have no effect on breast milk quantity".
On day 8, nutritional content of breast milk was not different between B₁₂ and CA groups. On day 33, breast milk of the CA group, compared with B₁₂ group, had less protein, more ash and less water.
Mineral contents of breast milk did not differ between B₁₂ and CA groups, except that CA group milk had less magnesium.

Author Conclusion:

CA can increase milk production without decreasing nutritional quality. Such effect is valid during CA supplementation as well as a month after end of supplementation.

Funding Source:

University/Hospital:

Faculty of Human Ecology IPB University (Bogor-Indonesia), Monash Asia Institute (Australia)

Reviewer Comments:

Reference group is not a true placebo group. CA treatment was in a form of soup. Reference treatment was a pill. Additionally, the reference treatment contained B₁₂ and another substance called Moloco.

No report on reasons for drop out for those who did not complete the study.

No report on feeding frequency, total time spent on breastfeeding or compliance, although these variables were measured (per methods section).

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		No
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	No
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		No
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	???
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	N/A
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	???
	10.2.	Was the study free from apparent conflict of interest?	???