for the use only of a registered medical practitioner or a hospital or a laboratory.

A CONTROLLED TRIAL ON LEPTADEN IN WEIGHT GAIN OF INFANTS AND AS A GALACTAGOGUE IN LACTATION CASES

Dr. N.R. BHANDARI, M.D. (Paed.), M.A.M.S., F.I.A.P.,

Professor & Head of Paediatric Dept. Dr. S.L. SONI, M.B.B.S., D.C.H., Post-Graduate in Paediatrics Gandhi Medical College, Bhopal, (M.P.)

THE INDIAN PRACTITIONER Vol. XXXII No. 4 Pages 229 to 240 April 1979

INTRODUCTION

BREAST MILK is an ideal natural food for the child and superior to all artificial feeds and breast-feeding exerts a salutary influence on child-mother relationship.

It is claimed that Leptaden the herbal drug, which consists of Leptadenia reticulata (Jeevanti) and Breynia patens (Kamboji), when given to post-natal cases of lactation, results in increased milk secretion, with initiation, then discharge of secreted milk through nipple and then in maintenance of breast milk, though the exact mechanism of their actions are not known.

The usefulness of Leptaden in lactation cases was first reported by Trivedi.' In 1962, 'Malati Deshpande et al.' studied the effects of Leptaden on selected lactation cases. They re­ported that this drug stimulated lactation with no side-effects to the mother or the child. Kusum Gupta et a1.⁴ reported that Leptaden could be recommended routinely in normal failure of lac­tation as they found good response in such cases. Jyoti Kothari & Meena Kothari₃ showed that routine administration of Leptaden was ef­fective in decreasing the number of cases of lactational failure.

Habla Akhtar & Sitaratna ² found that Lepta­den established lactation within 8 to 24 hours of administration, and 75% of cases showed good response and 21 % of cases showed satisfac­tory response.

MATERIAL & METHODS

242 cases taken from the post-natal Clinic, Children's O.P.D. & Children's ward were in­cluded in this study, out of which 210 cases formed the Trial or the Leptaden Group and 32 cases formed the Control Group. No mother or infant with acute or any other illness was taken up for study. Mothers were taken from different socio-economic groups and included, primiparas and multiparas. All the children were under the age of nine months: The cases were taken at randon during the period July 1977 to Sept. 1978.

In the Trial Group, Leptaden was given for four weeks. Observations were made before starting Leptaden to mothers, and then once a week for four weeks, as' to the condition of the breast and details of Milk flow. Infants were weighed before starting the Study and then once a week regularly for four weeks. Similar observations were recorded in. the mothers of the control Group and their children. Control group did not receive any drug during the course of this study.

OBSERVATIONS

PARITY:

Out of 242 cases taken for Study, 94 cases (38.8%)  were primipara and 148 cases (61.2%) were multipara. The details are given in Table I.

TABLE-I

Para	leptaden Group	Control Group	Total	%
Primipara:	82	12	94	38.8%
Multipara :	128	20	148	61.2%
Total:	210	32	242	100.0%

 

SOCIO-ECONOMIC STATUS

Out of 242 cases taken for study, 144 cases (59.5%) belonged to Poor class, 95 cases (38.3%) belonged to Middle class and 3 cases (1.2%) belonged to Upper class. The details are given in Table II.

TABLE-II

Socio-Economic Status

Status	Leptaden Group	Control Group	Total	%
Poor Class:	125	19	144	59.5%
Middle Class:	82	13	95	39.3%
Upper Class:	3	-	3	12%
Total:	210	32	242	100.0%

 

INFANTS IN DIFFERENT AGE GROUPS

Out of 242 cases taken for study, 138 infants (57.0%) were in the age group of 0-2 months; 48 infants (19.8%) were in the age group of 2-4 months; 30 infants (12.4%) were in the age group of 4-6 months; 26 infants (10.8%) were in the age group of 6-9 months. The details are given in Table III.

TABLE-III

Number of cases in different Age Groups

Age Group	Leptaden Group	Control Group	Total	%
0-2 mnths:	122	16	138	57.0%
2-4 months:	40	8	48	19.8%
4-6 months:	26	4	30	12.4%
6-9 months:	22	4	26	10.8%
Total:	210	32	242	100.0%

DOSAGE OF LEPTADEN

210 Mothers, were given Leptaden 2 tabs. three times a day for 15 days, followed by 2 tabs, two times a day for the next 15 days. 32 cases of Control Group did not receive any drug. The condition of lactation in both Lepta­den and Control Groups was recorded once a week for four weeks. Infants of both the groups were weighed once a week for four weeks.

CLASSIFICATION OF IMPROVEMENT

Improvement was classified into the follow­ing four categories.

GOOD: Breast engorged and painful; nipple normal; lactation good; good improvement in the amount of weight gain of the infant.

FAIR: Breast not engorged or painful; nipple normal; lactation satisfactory; moderate im­provement in the amount of weight gain of the infant.

POOR:^- Clinically improvement in lactation poor; poor improvement of weight gain of the in­fant.

NIL: No improvement in lactation. No up­ward gradient in the increase in weight gain of the infant.

RESULTS:                                                           

Weight gain of infants in the Leptaden      

The mean increase in weight of the infant per day, during the trial of four weeks, in the Lepta­den Group was 31.04 Gms. The largest amount of increase was observed in the youngest age group of 0-2 months with 33.54 Gms. The de­tails are given in Table IV.

                                                            TABLE-IV

Weight gain of infants in Leptaden Group according to Age Groups (in Gms.)

Age Group	No. of cases	1 st Wk.	2nd Wk.	3rd Wk.	4th Wk.	Mean/ Week	Mean/ day
0-2 months:	122	213.59	241.23	252.80	231.50	234.78	33.54
2-4 months:	40	212.30	209.19	220.00	220.00	215.37	30.77
4-6 months:	26	203.71	209.62	209.62	209.62	208.14	29.71
6-9 months:	22	216.50	209.00	209.00	209.00	210.88	30.12
Total Cases:	210
Mean:		211.53	211.26	226.86	217.53	217.53	31.04

RESULTS:

Weight gain of infants in the Control Group

The mean increase in weight of the infant per day, during the trial period of 4 weeks, in the Control Group was 18.48 Gms. As in the Lepta­den Group, the largest amount of increase was observed in the youngest age Group of 0-2 months with 20.36 Gms. The details are given Table V.

TABLE-V
Weight gain of infants in Control Group according to Age Groups (in Gms.)
Age Group	No. of cases	1st Wk.	2nd Wk.	3rd Wk.	4th Wk.	Mean/ Week	Mean/ day
0-2 months:	16	159	140	140	140.8	142.5	20.36
2-4 months;-	8	140	140	140	140	140	20.00
4-6 months:	4	125	125	125	125	125	17.86
6-9 months:	4	110	110	110	110	110	15.71
Total Cases:	32'
Mean:		131.3	128.8	128.8	128.8	129.4	18.48

 

COMPARISION OF DAILY WEIGHT GAIN IN THE LEPTADEN AND CONTROL GROUPS:

Leptaden Group when compared to the Con­trol Group showed the largest increase in weight in the age group of 6-9 months when compared to the other age groups with an in­crease of 14.41 Gms. The next in order was the group of 0-2 months with an increase of 13.18 Gms: While the weight increase was the high­est in the age group of 0-2 months of both the groups, when we come to the difference in the increase of infant weights between Leptaden & Control Groups, the largest difference was seen in the age group of 6-9 months. This indi­cates the beneficial action of Leptaden very clearly. The details are given in Table VI.

TABLE VI Daily weight gain in Control & Leptaden Groups (in Gms.)

Age Group	Mean Weight gain in control group	Mean Weight gain in leptaden group	Increase in Leptaden group
0-2 months:	20.36	33.54	13.18
2-4 months:	20.00	30.77	10.77
4-6 months:	17.86	29.71	11.88
6-9 months:	15.71	30.12	14.41
Mean:	18.48	31.04	12.56

 

RESULTS ACCORDING TO PARITY

In the Leptaden group, combining primipara and multipara, the result was Good in 33.33%, Fair in 58.10%, Poor in 7.14% and Nil 1.43%. Primipara showed better response (95.12%) than multipara (89.07%).

Padma Rao' reported good re­sponse in multipara, where as in this series primipara showed a slightly better response. Over all satisfactory response (Good + Fair) was 91.43% in the Leptaden Group. In the Con­trol Group, combining primipara and multipara, the result was Poor in 75.0% and Nil in 25.0%. The details are given in Table VII.

TABLE-VII Results in Leptaden and Control Groups according to Parity

Response	LEPTADEN GROUP Primipara        %          Multipara       %        Total       %						Control (Pri. + Mul) No cases     %
GOOD	33	40.24%	37	28.91 %	70	33.3%
FAIR	45	54.88%	77	60.16%	122	58.1%
POOR	4	4.88%	11	8.59%	15	7.14%	24	75.0°/°
Nil			3	2.34%	3	1.43%	8	25.0%
Total	82	100%	128	100%	210	100%	32	100%

 

RESULTS ACCORDING TO SOCIO­ECONOMIC STATUS

In the Leptaden Group, combining all the Socio-economic groups, result was Good in 33.33%, Fair in 58.10% Poor in 7.14% and Nil in 1.43%. Good result was slightly better in Mid­dle class (41.46%) than the other cases. How­ ever on the whole, satisfactory response (Good + Fair) was better in Poor class (92.80%) than in the Middle Class (90.24%). In the Control Group, combining all the socio­economic classes, the result was poor in 75.0% and Nil 25.0%. The details are given in Table VIII.

TABLE-VIII    Results in Leptaden and Control Groups according to Socio-Economic Status

Response	LEPTADEN GROUP								CONTROL GR.
	Poor class	%	Middleclass	%	Upperclass	%	Total	%	No. of cases (All classes)	CONTROL GR.%
GOOD:	35	28.00	34	41.46%		33.33	70	33.33
FAIR:	81	64.80	40	48.78%	1	33.33	122	58.10%
POOR:	8	6.40	6	7.32	1	33.33	15	1.14	24	75.0
NIL:	1	0.80%	2	2.44			3	1.43	8	25.0
Total:	125	100.00°I°	82	100.00%	3	100.00°/°	210	100.00°/°	32	100.00

 

STATISTICAL STUDY

Weight gain of infants: Paired `t' Test:

For the purpose of statistical study, weekly observations of weight gain made for four weeks in all the age groups (0-9 months) of the Leptaden Group of Table IV, are compared with similar observations of the Control Group of Table V, as all the conditions of study are iden­tical in both the groups except as to the treat­ment that each group received. For statistical analysis, the test applied is Paired `t' Test of Dif­ferences namely X₁-X₂= Y

The value as per this test in this study is 22.90 and is much more in value than of the Paried Test Table of Differences for signifi­cance at 0.001. Hence it is concluded that the results of the weight gain in infants is highly sig­nificant at P<0,001 in the Leptaden when compared to the Control Group. The details are given in Table IX.

TABLE-IX Statistical study: Weight gain in infants: Paired `t' Test

Periods (Stages)	1 st Week	2nd Week	3rd Week	4th Week
0-2 months;	54,59	101.23	112.80	91.50
2-4 months:	12.30	69.19	80.00	80.00
4-6 months;	78.71	84.52	84.62	83.14
6-9 months;	106.50	99.00	99.00	99.00

T₁₅=22.90   P< 0.001

STATISTICAL STUDY: WEIGHT GAIN IN INFANTS: CHI SQUARE TEST:

In the Leptaden Group, as per Table IV, the best results were obtained in weight gain in 122 infants of the age group of 0-2 months with 33.54 Gms. increase in weight per day and the rest of 88 cases are taken as No Improvement for the purpose of this test. In the Control Group, as per Table V, all the 32 cases are taken as No Improvement as the highest mean increase in weight per day was only 20.36 Gms. The total number of cases that showed the best results from both the groups, was 122. Simi­larly, the total number of cases that did not show any results from both the groups was 120. On the hypothesis that Leptaden has no effect on the lactation of mothers and consequently no appreciable amount of increase in the weight gain of the infant, CHI square test is used. Since the calculated value of this trial is higher than the Table value of 2x2 contingency Tables is the hypothesis is rejected and it is concluded that Leptaden is effective as the re­sult is significant at P < 0,001. This also con­firms the results by Paired `t' Test as to weight gain in infants. The concerned Table X is given below.

TABLE-X

Statistical Study: Weight gain

Group	Good	Fair + Poor + Nil	Total
leptaden Group Control Group	122 -	88 32	210 32
Total:	122	120	242

 

STATISTICAL STUDY: LACTATION IN MOTHER AS TO PARITY & SOCIO­ECONOMIC STATUS

As per Table VII & VIII Leptaden Group showed Good results in 70 cases and Fair + Poor + Nil results in 140 cases. In the Con­trol Group, all.the 32 cases showed Poor + Nil results. Combining both the Groups (242 cases), Good results were seen in 172 cases. This was put to CHI square test to see whether the assumption that Leptaden has no action as a Galactagogue is correct or this assumption is to be rejected. Using 2 x 2 contingency tables, it is found that the result is significant at P < 0.001, and so it is concluded that Leptaden is effective in increasing lactation in mothers. The details are given in Table XI.

TABLE-XI     Statistical Study: Parity & Socio-economic Status

Group Good	Good	Fair + Poor + Nil	Total
leptaden Group; Control Group:	70	140 32	210 32
Total: 10	70	112	242

DISCUSSION

The process of lactation consists of secre­tion of breast milk, discharge and continued maintenance. Galactogenisis is governed by hypothalamus and it may also be influenced by psychological factors. Hypothalamus controls pituitary and indirectly controls the secretary hormone prolactin which initiates lactation. Galactopoisis depends upon many factors in­cluding good sucking capacity of the baby and also good nutrition of the mother. Flow of breast milk may be affected by a variety of factors, many of which are not known.

This study has shown that infants of the mothers treated with l.eptaden showed a daily increase in weight of 31,04 Gms., while those in the Control Group showed only 18.48 Gms.The increase was better in all the age groups. This shows that breast milk of the Leptaden treated mothers had better quality and quantity of breast milk, as reflected on the increase of the weight gain of the infants, than the breast milk of the control group.

Statistical studies have confirmed that the effect of Leptaden is significant at P < 0.001.

The difference in weight gain between the Leptaden and Control groups was the highest 'in the age group of 6-9 months with 14.41 Gms. showing that response was comparatively bet­ter in the later part of lactation and will help in prolongation of lactation period and delaying the weaning time.

In our series response was slightly better in primipara when compared to multipara. Poor and middle classes showed better response than the upper class.

While in our study 91.43% of cases showed satisfactory response, Habla Akhtar & Si°ta Ratna reported satisfactory response in 75% of cases. Padma Rao et al. reported satisfac­tory response in 86.67%.

SUMMARY & CONCLUSION

Clinical trial with Leptaden was done in 210 lactation cases and 32 cases were taken as Control. The trial period was of four weeks with weekly observations of results. Mothers were evaluated clinically as to their lactation. Chil­dren were weighed once a week for four weeks.

Clinically the response to Leptaden was found to be 91.43%, as satisfactory improve­ment. In the control group, there was no satis­factory improvement and the improvement was either poor or nil.

The clinical improvement in lactation had di­rect bearing on the quality and quantity of breast milk and if had reflected on the weight gain of the infant. The mean increase per day of weight gain was 31.04 Gms. in the Leptaden Group and it was only 18.48 Gms. in the Control group, that is, Leptaden group showed 12.56 Gms. more increase in weight per day than the Control Group-Response was slightly better in the primipara (95.12%) than in the multipara (89.07%).

Statistical study of the results showed that the effect of Leptaden in lactation cases and the weight gain of the infants whose mothers were treated with Leptaden were statistically signific­ant at P < 0.001. This study has shown the good effect of Leptaden in lactation cases both clinically and statistically.

This controlled trial with Leptaden in Post­natal cases of lactation showed that there was appreciable increase in secretion of breast milk. The results are also statistically signific­ant. Leptaden therapy can be recommended to post-natal lactation cases to increase the quan­tity and quality of breast milk which will help in the increase of weight gain in the breast-fed in­fants. This is of vital importance in developing countries like India.

No side effects were observed in both the mother and child.

ACKNOWLEDGEMENT

We express our thanks to the Dean, Gandhi Medical College, Bhopal for permission to carry out this study and to publish the same. Our thanks to the Superintendent, Hamidia Hospi­tal, Bhopal, for the cooperation given.

We are thankful to Alarsin Pharmaceutical, Bombay, for the supply of Leptaden tablets.

REFERENCES

1. Deshpande, Malati Manju Ashar : Mystery of Lactation (A clinical study on an Indian Drug). The Antiseptic, November, Vol. 56. (1962)
2. Habla Akhtar & Sitaratna  : LEPTADEN a          clinical trial     as a Galactagogue. The Antiseptic, Vol. 69. (May). (1972)

3. Kothari, Jyothi, Meena           : Breast   Feed ing and  `Leptaden'.    48th All India Med. Con­ference, Ahmedabad, Dec. 1972.

4. Kusum Gupta & Naval Kishore : Lactation: A clinical trial with `Leptaden' a Herbal Drug. The Antiseptic, Vol. 63, (October). (1966)

5. Padma Rao, A. & H.I. Devi :          Effect         of Leptaden on Lactation - a controlled clinical study. The Antiseptic, 74: 377-90. (1977)

6. Purandare, B. N. and Manda C. Purandare Study of the Composition of Breast MILK and effect of Leptaden on the Quality of Breast Milk - XV International Congress of Paediatrics, New Delhi, Oct. 23 to 29,1977.

7. Trivedi, B.S. : Can Lactation be Stimulated ? The Ind. Pract., Vol. 9 (Feb.). (1956)

for information on ALARSIN products please write to : ALARSIN, Alarsin House, A/32, Road No. 3, M.I.D.C., Andheri (E), Bombay-400 093.