Dr Purandare

for the use only of a registered merJical practitioner or a hospital or a laboratory

for the use only of a registered merJical practitioner or a hospital or a laboratory

STUDY OF THE COMPOSITION OF BREAST MILK AND THE EFFECT OF LEPTADEN ON THE QUALITY OF BREAST MILK

BY

Dr. B. N. PURANDARE, MD, FRCOG,FRCSE,FCPS,FICS,FAMS.,

Dr. MANDAKINI C. PURANDARE, MD, DGO, DFP.,

Dr. N.M. PURANDARE, MD (PATH),

Post-Graduate Institute (for Study and Research) in Gynaecology,  Obst. & Family Planning (PIGOFP), Nawrosjee Wadia Maternity Hospital, Bombay.

 

Paper presented at: XV International Congress of Paediatrics 23-29 Oct. 1977, New Delhi.

 

 

 

The composition of breast milk has been known to vary from individual to individual and from one country to another.

 

In this connection it is interesting to note that quality wise, United States has the poorest quality of breast milk. The composition is slightly better in Scandinavia followed by other places in this order - Britain, Japan, India and South East Asia.

This accounts for the rapid adoption of artificial feeds in America and Scandinavia.

 

The present study was conducted by the authors at N. Wadia Maternity Hospital, Bombay, India, during the year 1975-76, under the auspices of its Post Graduate Institute for Study and Research in Gynecology and Obstetrics and Family Planning. The aim of the study was:

1. to qualitatively analyze breast milk obtained from a representative section of normal lactating mothers in Bombay, the majority of whom belonged to the lower socio­economic status. and

2. to study the effect of an Indian herbal drug LEPTADEN on the quality of breast milk.

 

Earlier work done on LEPTADEN has shown its (1) lactogenic, (2) galactokinetic (3) galactopoietic properties in human as well as animal lactation. However, no work had been done on the effect of LEPTADEN on the quality and constituents of breast milk. This study was conducted as a double blind trial. The cases admitted included a cross section of lower socio-economic group settled in Bombay City, a city which has more than 8 million population.

 

Selection of cases

 

Only healthy primi-gravida with normal deliveries were considered for this study. They had normal birth weight. Those cases who did not fully cooperate were dropped from the study.

 

Eight cases of abnormal deliveries were also included as they had no lactation problems. Of these, there were 5 cases of forceps delivery, 2 breach extractions and 1 case of induced labour.

 

Three breast milk samples were obtained from each mother. Samples I and II were collected in the hospital itself as the primigravidae usually stayed in the ward for 6 days. Sample III was collected during the first post-natal visit on the 17th day. The mothers were informed about this project in order to get their cooperation in attending the post-natal O.P D. on the 17th day.

 

The study consisted of 100 cases, of whom 50 cases were given placebos and 50 were given LEPTADEN. The capsules containing the drug and the capsules containing the placebo were identical in size, shape and colour. The true identity of the capsules was revealed only after the whole study was over and the data of 100 cases computed. Then the X capsules were found of contain LEPTADEN while Y capsules contained placebo. The analysis of the data was statistically evaluated.

 

 

Table 1

Age group distribution

 

Age group

Y Group

(Control

Group)

X Group

(LEPTADEN

Group)

Total

%

16-20 Years

28

25

53

53%

21-25 Years

17

22

39

39%

26-30 Years

4

3

7

7%

31 Years

1

-

1

1%

Total

50

50

100

100%

 

The majority of cases ranged between 16-25 years (92%). There was one case of 31 years which was the highest age in this series.

 

Method of Breast feeding

 

Colostrum was not expressed out during pregnancy or in the post-natal period. The new born baby was put to the breast about 4-6 hours after delivery and was fed colostrum 3 hourly during the day time. After the initiation of lactation the baby was breast fed with an interval of 3 to 4 hours between 2 feeds.

 

Maternal diet consisted of her usual diet with no special additions or instructions.

The mothers were investigated routinely for blood and urine at the time of admission. In this study haemoglobin ranged between 64 to 90% with a mean of 77% in both groups. Only cases with normal findings in the blood and urine were included in the study.

 

 

Leptaden: an Indian herbal drug

 

Patel (1947) first drew the attention of the medical profession to the potentialities of this drug in the management of habitual abortion, infertility and allied conditions.Trivedi (1956) first studied its effect as a galactagogue. Since then the following studies have been published on LEPTADEN 

1. LEPTADEN in human lactation: Trivedi (1956); Malati Gokhale (1965); Maiati Deshpande and Manju Ashar (1962); Kusum Gupta (1966); Habla Akhtar and Sitaratna (1972); 
2. LEPTADEN in animal lactation: Moulvi (1963); Vaishnav and Buch (1965); Anjaria and Gupta (1967); Kaikini, Hukeri and Pargaonkar (1968); Kaikini, Pargonkar and Kadu (1969); Murthy (1969); Prasad (1970); Azmi (1970); Kulkarni (1970); Chauhan, Nair, Mittal and Rangan (1971); Nisal, Sapre and Khare (1975); Harkawat and Singhvi (1977); Mujumdar (1977); Agarwal, Deshmankar, Verma and Saxena (1960); Ahmad et al (1974);

Composition of Leptaden

 

Each capsule of LEPTADEN contained (equi­valent to one commercially available tablet):

Jeevanti (Leptadenia Reticulata) :        150 mg.

Kamboji (Breynia Patens) :                150 mg.

 

Pharmacology

 

In the Ayurvedic Pharmacopoeia, Jivanti and Kamboji are considered as `garbhashaya shodhan', `garbha sthapan' and `shothaghna' which mean: properties to help nidation of the zygote, to promote normal environmental factors for reproduction and to activate neurQglandular system. And `stanya' that is, galactagogue properties are also attributed to these drugs.

 

Sharma (1976) using sensitive radio­immunoassay methods studied the possible mechanism of action of LEPTADEN. These studies indicated that LEPTADEN has an inhibitory effect on the ability of the guinea piguterine tissue to biosynthesize Prostaglandin F2alpha.

 

Dosage:

 

The dose given in this study was 2 capsules thrice daily for 16 days. First dose was given after sample 1 of initial milk was taken, within a few hours of the initiation of lactation.

 

Breast Milk sample for analysis

 

From the mothers selected for the study, only one sample of breast milk was taken by hand expression. It was not a pooled collection of 24 hours. It was not possible to do so for practical difficulties for all concerned-the administration, mothers, laboratory and social workers, who cooperated in this study.

 

However, as far as possiable, the timings and conditions, such as cooperation of mother, the infant, interval of breast feed, method of hand expression etc. were uniformly followed for each case. This procedure was as per general guidelines suggest by ICMR (Indian Council of Medical Research) for research workers on human lactation in India (ICMR Report, 1963).

 

Method of expression:

 

Milk was expressed by hand after proper guidance and help. Milk was expressed from both breasts in quantities sufficient for analysis.

 

Quantity of Milk expressed:

 

10 to 15 cc. were collected in a bowl and later transferred to a test tube.

 

Sample 1(Initial milk): was taken within a few hours of initiation of lactation but not exceeding twelve hours and before X and Y Capsules were given.

 

Then they were given 2 capsules three times a day for 16 days.

 

Sample // (Transitional milk): The breast milk was taken on the 6th day after delivery.

 

Sample lll (Mature milk): This sample was collected on the 17th post-natal day.

 

 

 

Results

Analysis of breast-milk samples Techniques used and methods adopted

 

The breast milk samples were analysed and the contents in grams percent were determined

for the following constituents by the methods mentioned below.

(1) Proteins were estimated by Esbasch Tube method.

(2) Lactose was estimated by Folin-wu method using standard concentrations of lactose for comparison.

(3) Fat was estimated after eliminating the protein from the breast milk and then analyzing this protein-free sample.

(4) Calcium estimations were done by the Titration Method

(5) Phosphorous was estimated by the Gomorri Method.

(6) Ash was estimated by the usual laboratory methods.

 

Water estimation was by the ordinary laboratory method of evaporation. It was also verified by the deduction of total weight of solids namely non-fat, fat and ash components.

 

Statistical evaluation

 

The mean percentage of change from sample I to III was adopted for both the groups. To evaluate statistically the effect of LEPTADEN on the quality of breast milk students' 't' test was used.

Data from sample I containing initial milk. sample II transitional milk and sample III mature milk were analyzed to study the variations from sample I to sample I II and also to evaluate the effect of LEPTADEN on the quality of breast milk.

The composition of breast milk in the present study compares favorably with the values given by other authors except in so far as its fat content is concerned. However, studies by ICMR (Indian Council of Medical Research) and others have shown that the fat content of human breast milk in developing and under - developed countries can be as low as seen in the present study. Fat values as low as 1 % and as high as 9% have been reported in samples of human, cow and goat milk.

 

Statistical study of mean-change

 

The overall benefit seen in the LEPTADEN group is 11.8%. In some constituents it is quite high e.g. protein content increased by 19.6%, fat content increased by 26.2% and calcium by 26.6%. The mean percentage of change of the milk constituents in the LEPTADEN group was 11.8%. This is significant from the point of view of proper growth and development in relation to infant nutrition.

 

Table 2

Gradual dilution of milk from initial milk to mature

milk as seen by the specific gravity changes.

 

                                       Sample1      Sample 2             Sample 3

Control                            1.0322         1.0319                 1.0307

Drug series                      1.0363         1.0343                 1.0319

 

 

From the above table it is obvious that milk gradually gets diluted in both the groups. This dilution however is found to be more in the control group than in the LEPTADEN group when the water content is considered. In the LEPTADEN group therefore, it is found that the thickness and thereby the quality of milk is better than in the control group.

Table 3

Water content in Gm %

 

                                       Sample1      Sample 2             Sample 3

Control                            85.82           88.22                   89.13

Drug series                      85.21           86.71                   86.86

 

 

Table 4

Composition of normal breast-milk (Mature milk)

Constituent

g1100 ml

S.D. t

Protiens

1.5

0.59 g

Lactose

7.3

1.24 g

Fat

1.8

0.81 g

Calcium

0.03 (25.5 mg)

5.43 mg

Phosphorous

0.01 (8.6 mg)

3.76 mg

Ash

0.23 (233 mg)

75.00 mg

Water (Rest)

89.13

 

Total

100.00

 

 

 

Table 5

 

 

 

 

 

Composition of breast-milk given by other authors

Consti       Belavady

tuent         and Gopalan

 

Karmarkar

 

eial

Rao &

Ramanathan

nathan

Elsdon

Kleiner

& Orien

Watt &

Mernll

Hawk

Proteins

 

 

 

 

 

(g%)                 1.06

1.12

1,2

1,4

1.1

1.2

Lactose

 

 

 

 

 

(g%)                  7.51

7.08

6.9

7.6

9.5

6 9

Fat

 

 

 

 

 

(g°i°)                  3.42

4.47

4.1

4.0

4.0

4.6

Calcium

 

 

 

 

 

(mg%)              31,2

-

-

-

33

30

Phosphorous

 

 

 

 

 

(mg%)                   -

-

-

-

14

13

Ash

 

 

 

 

 

(g%)                 -

-

-

0.2

-

0.21

(Restwater)

 

 

 

 

 

 

 

 

 

Table 6

Effect of Leptaden on quality of breast-milk.

Qualitative analysis of breast-milk in both groups. Statistically evaluated by Students ‘t’ test.

 

Constituent

Protein g%

Control

Group

Leptaden

Group

P value

Mean

1.5

2.6

 

S. D. ±

0.59

0.42

 

S. E.

0.08

0.06

< 0.001

Lactose g%

 

 

 

Mean

7.3

7.7

 

S.D. t

1.24

1.26

 

S. E.

0.18

0.18

N. S.

Fat g%

 

 

 

Mean

1.8

2.5

 

S.D. t

0.81

0.76

 

S.E.

0.12

0.11

< 0.001

Calcium mg%

 

 

 

Mean

25.50

28.20

 

S. D. t

5.43

5.30

 

S. E.

0.77

0.75

< 0.02

Phosphorous

 

 

 

mg%

 

 

 

Mean

8.6

8,6

 

S. D. t

3.76

3.21

 

S.E.

0.53

0.45

N.S.

Ash mg%

 

 

 

Mean

233

262

 

S. D. t

75

49

 

S. E.

10.61

6.93

< 0.05

 

 

 

 

 

 

 

Table 7

 

 

Mean percentage of change of the constituents of breast milk of the ;

control (Normal) Group and the LEPTADEN Group from Sample I  to Sample Ill.

 

 

 

 

 

 

Initial

Tr.

Mature

Mean

% of

Beneficial

 

 

Milk

Milk

Milk

Change

mean

action of

 

 

t

II

III

from

change

Leptaden

 

 

 

 

 

I to lll

 

if any%

Proteins

 

 

 

 

 

 

 

(g/100 ml)

 

 

 

 

 

 

 

Normal:

Mean

4.5

2.4

1.5

-3.0

-66.6%

 

 

S.D. ±

2.58

0.8

0.59

 

 

 

LEPTADEN:

Mean

4,9

3.6

2.6

-2.3

-47.00%

19.6%

 

S.D. ±

2.63

0.86

0.42

 

 

 

Lactose

 

 

 

 

 

 

 

(g/100 MI)

 

 

 

 

 

 

 

Normal:

Mean

6.4

6.9

7.3

+0.9

+14.1%

 

 

S.D. ±

1.10

0.94

1.24

 

 

 

LEPTADEN:

Mean

6.7

6.9

7.7

+1.0

+15.0%

0.9%

 

S.D. ±

1.12

0.84

1.26

 

 

 

Fat

 

 

 

 

 

 

 

(g/100 ml)

 

 

 

 

 

 

 

Normal:

Mean

3.0

2.2

1.8

-1.2

-40.0%

 

 

S.D. t

1.19

0.61

0.81

 

 

 

LEPTADEN:

Mean

2.9

2.5

2.5

-0.4

-13.8%

26.2%

 

S.D. ±

1.06

0.86

0.78

 

 

 

Calcium

 

 

 

 

 

 

 

(mg/100 ml)

 

 

 

 

 

 

 

Normal:

Mean

25.15

25.45

25.50

+0.35

+1.3

5

 

 

S.D. ±

5.69

5.92

5.43

 

 

 

LEPTADEN:

Mean

22.15

26.17

28.20

+6.05

+27.3%

26%

 

S.D. ±

5.51

5.50

5.30

 

 

 

Phosphorus

 

 

 

 

 

 

 

(mg/100 ml)

 

 

 

 

 

 

 

Normal:

Mean

6.5

7.8

8.6

+2.1

+32.3%

 

 

S.D. ±

4.25

3.64

3.76

 

 

 

LEPTADEN:

Mean

6.4

9.4

8.6

+2.2

+34.4%

2.1%

 

S.D. ±

3.88

3.28

3.21

 

 

 

Ash

 

 

 

 

 

 

 

(mg/100 ml)

 

 

 

 

 

 

 

Normal:

Mean

235

248

233

-2.0

-0.9%

 

 

S.D. ±

70

50

75

 

 

 

LEPTADEN:

Mean

260

248

262

+2.0

+0.8%

1.7%

 

S.D. ±

61

50

49

 

 

 

TOTAL:

 

 

 

 

 

 

 

g%

 

 

 

 

 

 

 

Normal:

Mean

14.167

-

10.868

-3.3

-23.3%

 

LEPTADEN:

Mean

14.788

-

13.099

-1.7

-11.5%

11.8%

 

 

 

Overall effect of Leptaden on the quality of breast milk

 

After delivery, with 15 days of treatment with LEPTADEN, the quality of Mature Milk improved overall by 11.8%. The improvement was statistically significant in the content of protein, fat, calcium and ash (minerals) constituents and this was without affecting the quantity or regularity of  lactation in any way.

 

 

The advantages of LEPTADEN treatment can thus be summarized as follows:

 

1. Protein: Increase (19.6%) is helpful for better infant growth and is prophylaxis against protein deficiency and Kwashiorkor.

2. Fat: Increase (26.2%) helps weight gain and maintenance and is of special importance in under weight infants and premature babies in whom the weight gain is earlier than expected.

3. Calicum: Increase (26.0%) helps better bone growth and is prophylaxis against hypocalcemia and rickets.

4. Ash: Slight increase (1.7%) in ash content is just enough to improve the quality of breast milk without overloading kidneys.

5. Water: Dilution (2.27 g%) is less in the Leptaden Group. LEPTADEN therefore maintains the thickness (quality) of milk.

 

 

Toxic or side effects

 

No toxic or adverse side effects were observed or reported in any of the 50 LEPTADEN treated cases either in the mother or in the infant. However, 2 cases of infants in the LEPTADEN group and 3 cases of infants in the Control group developed transient diarrhoea. This was controlled with 48 hours with ordinary binding mixtures.

 

Observations


Since LEPTADEN has shown significant beneficial effect on the quality of breast milk, it can be started within the first 3 days of delivery. It can be continued as 1 tablet twice or thrice a day for as long as the mother wants to breast-feed. As mentioned earlier, it is worthwhile to avail of its utility in prevention of infant diseases such as marasmus, kwashiorkar and rickets, particularly in the Third World countries. And thereby provide the benefits of the mother's milk to the new born from the point of view of the immunological protection against B.Coli and other organisms entering in the intestinal tract soon after birth. By ensuring the natural production of increasing quantities of mother's milk with the proper and timely use of this drug, the need for the use of outside milk is reduced.

Aknowledgements


We are thankful to Registrars Dr. Jamshed R. Bhavnagari M.D., D.G.O. and Dr. Aspi Navroz Raimalwala M.D., D.G.O.; Sunil Chitale, Laboratory Technician; Dr. R.V.S. Rao for statistical work; social workers, our colleagues and staff members.

 

And above all we are grateful to the mothers and their families who willings cooperated in this project.