for the use only of Registered Medical Practitioner, a hospital or a
laboratory
LEPTADEN ALARSIN
(A Herbal Drug useful in LACTATION & PREGNANCY
(Review of 20 Clinical Trials by 40
Senior Gynecologists)
by
Dr. A. PADMA RAO, M.D. D.G.O.
Professor & Director of Post-graduate Studies, Department of Obstetrics & Gynaecology,
Leptaden is a herbal Ayurvedic
drug which has proved to be of value in improving lactation and also preventing
abortion and premature labour. In this presentation
the important publications on the above effects of Leptaden are reviewed:
Botany, Chemistry and Pharmacology of Leptaden Composition of Leptaden:
Each tablet of Leptaden consists of two herbs:
a) Leptadenia Reticulata . 150 mg.
b) Breynia
Patens . 150 mg.
Leptadenia Reticulata
This
plant belongs to the family of Asclapiadiaceae and is
known by Vernacular names Jeevanthy (Sanskrit), Dori (Hindi), Kalasa and Mukkutummudu (Telugu) and Palaikkodi
(Tamil). It is a branched twining creeper; leaves are thick, heart shaped
smooth on the upper surface and hairy on the undersurface. This plant is found
in the sub Himalayan tracts of
The stem and roots of the plant yield a waxy material
composed of aliphatic esters. Stigmasterol is the
major component and Alpha sitosterol in small
quantities.
It is
rich in flavinoids - rutin,
quercetin - 3 - glucoside.
Fresh follicles on plucking or cutting yield a thick
yellow latex which coagulates in a few minutes. The logumes
are 2" to 3" long and are used as a vegetable in
Pharmacological actions of Leptadenia Reticulata:
Intravenous
administration of the extract in dogs produced a sudden fall of blood pressure
which recovered within 20 minutes and secondary fall in blood pressure which
lasted for about 2 to 6 hours. The pattern of blood pressure is not modified by
vagotomy or by atropinisation.
Pressure-effects of adrenaline and non adrenaline are not altered by the
extract. Therefore it appears that the extract of Leptadenia
reticulata acts directly on the muscle wall of the
vessels.
The extract also causes increase in the rate and depth of
respiration followed by diminution in depth.
Toxicities:
No lethal effect was noted on intravenous administration
of aqueous extract in doses up to 4 ml/kg. Intraperitoneal
injection did not induce any immediate or delayed alteration in the activity of
the animals, showing that the drug is devoid of any sedative action.
General Properties:
“The plant is used as a
stimulant, tonic and restorative. It prolongs life, acts as a binding agent in
intestines, improves eye sight, increases lactation and acts as an antipyretic.
It is a mild diuretic, expectorant and cardiac tonic" (Extract from Dravya guna vigyana).
The powdered root is generally used.
Breynia Patens:
This
plant belongs to the family of Euphorbiaceae, the
vernacular names being kalamahamad (Hindi), Peruniuri (Malayalam), Bahupraya,
Bahupushpa and Devadasa, Kamboji (Sanskrit), Nallapurugudu
(Telegu).
The plant grows as
a shrub with spreading branches and grows in Tropical Himalayas,
Pharmacological Action:
"The
bark of Breynia Patents is used as a general tonic.
The juice of the stem is used for conjunctivitis: It is an astringent to the
bowels and also useful in inflammation. Its action as a 'general
tonic' is made use of in promoting lactation" (extract).
Review
Leptaden in Lactation:
There have
been several studies both clinical and experimental on the effect of Leptaden
on Lactation.
The effects of Leptaden on Lactation are several. It
initiates failed galactogenesis, it improves the
quantity and also the quality of milk; it _prolongs the period of lactation and
thus postpones the time for weaning and lastly Leptaden administered during the
prenatal period ensures successful lactation in women with history of failure
of lactation.
Leptaden in Galactogenesis
and Galactopoiesis
Nine clinical studies during the
years from 1962 to 1982 were done. (Table 1) of which four were controlled
studies and one was a double blind study. In all the studies galactogenesis was attained in 87% to 100% of cases; galactopoiesis in nearly 100% in straight studies and in controlled
studies it was twice as much as in control cases. In two studies the mean
weight gain of new borns in `Leptaden-treated' cases
was found to be double that of control cases.
In Nawal Kishore's study Leptaden was administered during the third trimester of pregnancy in women with history of poor or failed lactation. In 75% of cases lactation was established and in nearly 30% the lactation was good.
Table 1
Leptaden: Lactogenesis,
Galactopoiesis, Galactokinesis
|
Author and Year of study |
Type of study |
Results |
RemRemarks |
|
Deshpande (1962) |
50 Indoor post-natal cases (random) |
Leptaden stimulates lactation in 6-10 hours. (100%) |
Leptaden 2 tabs. tds
for 2-3 days. Then 2 tabs bd for 4 weeks. Lactogenesis and galactokinesis
observed in all cases. |
|
Gokhale {1965} |
25 Multipara
with history of lactational failure/ Deft ciency presenting the
same complaints now. |
Leptaden showed gala Ctopoietic & Galacto kinetic properties in all the cases.
(100%) |
2 tabs tds after deficient/ absence of
lactation was observed (3rd or 4th day.) |
|
Naval Kishorc & Gupta (1966) |
50 antenatal cases of Deficient Lactation: Postnatal cases: 50 cases of Deficient lactation: 15 cases with No lactation: 50 normal cases: |
28% Good 43t% Partial 24% Nil 83% Good 33% Good 40% Partial 27% Nil 6% Good |
1 tab tda from 32 weeks. After delivery, 2
tabs tds till lactation was established or failed. 2 tabs four times a day for 7 days or till lactation is established and
maintained. |
|
Sitaratna & Habla Akthar (1972) |
History of Deficient 24 cases: History of No lactation: 6 cases |
75% Good 21% Satisfactory 4% Nil. 100% Good |
2 tabs tds for I Week; 2 bd
for 2 months. |
|
Kothari & Kothari (1972) |
Leptaden Group:
50 cases: Control (No
drug given) 50 cases: |
86% Good Lactation 60% Good Lactation |
Consecutive cases. 2 tabs. tds for 3-6 weeks. Consecutive cases |
|
Padma Rao & H.1. Devi (1977) |
Post-natal 150 cases - Leptaden: Post-natal Control (No
drug) |
Good 80% Poor 13.33% Excess 6.6% Good 64% Excess 0 |
2 tabs for 7 days No drugs given |
|
Bhandari (1977) |
Weight Gain of infants
0-9 months Leptaden Group of
mothers 210 children Control - mothers No drug: |
217 gms
weight gain/week 129 gms
weight gain/ week |
Mothers given 2 tabs tds 15 days; 2 tabs bd for 15 days. No drug. Observed results of 4 weeks. Statistically significant P 0.001 by Paired `t'
test. 57% of children were aged 0-2 months. |
|
Kasturi Lal et al (1980) |
50 post-natal cases
received Leptaden. 38 cases Deficient
Lactation: 12 cases: No Lactation: 50 post-natal cases Control:(Placebo) 38 cases Deficient
Lactation 12 cases of No Lactation: |
100% improvement. 83.3% Lactation initiated & esta blished, 16.7% Failure Only 7.9% cases improved. 92.1% Failure of Lactation 16.7% initiation of Lactation 83.3% No initiation. |
2 tabs tds:
1 week 2 tabs bd: 2
weeks placebo: 2 tabs tds 1 week. 2 tabs bd 2 weeks. |
|
Patel, Patel & Parikh (1981, 1982) |
Double-blind trial. Dailv Secretionof Breast Milk for 7 davs.(Assessed
by weighing the child before & after every feed) (12 hour period) 30 cases: Leptaden Group: 30 cases Control (Placebo) Before-therapy results compared |
Good 36.7%(121_180 g) Satisfactorv 50% (61-120 g) Poor 13.3%(21-60 g) Good 6.7% Satisfactory 20% Poor 73.3% Leptaden/ Placebo given for l week
Milk secretion of |
Leptaden in Capsules: 2 caps. tds for 7 days. Placebo in Capsules; 2 capsules tds |
Table 2
shows the result of Leptaden in rats. The weight increase was nearly 5 gms more per week than in the
control group.
There are several studies on several varieties of animals,
varying from rats to elephants.
Leptaden was found to improve milk yield in cows (Murthy 1965, Vaishnav 1965, Chauhan 1971); in
goats, sheep and cows and buffaloes (Anjaria 1967);
in elephant (Nambiar 1980). Lactation was established
and continued for eight months in Leptaden treated Jersey Heifer that had an
abortion (Nambiar 1981).
Table ll
Animal Experiments:
Rats' Litters - increase in weight with Leptaden
|
Author & |
Type of |
Mean weight
increase in Grams |
|||
|
year of |
Study & |
|
|
|
|
|
study |
No. |
Birth |
First |
Second |
Third |
|
|
|
weight |
Week |
Week |
Week |
|
Kasturi Lal |
112 litters each in |
|
|
||
|
'et al |
Leptaden & Control Group |
|
|
||
|
(1980) |
Leptaden Group: |
7.45 |
17.22 |
23.66 |
27.44 |
|
|
|
± 0.79 |
+0.79 |
_+ 0.69 |
+0.66 |
|
|
Control Group: |
7.49 |
12.67 |
16.91 |
20.72 |
|
|
|
+ 0.23 |
+0.44 |
+ 0.51 |
+0.42 |
|
|
p Value |
|
0.001 |
0.001 |
0.001 |
Leptaden Improves
the quality of Milk
Table 3 summarizes the result of two studies which estimated the protein,
lactose and fat contents of breast milk in Leptaden treated cases and in
controls. Purandare's study showed distinct increase
in protein content of milk. Lal et al (1980) reported
that Leptaden Group increased quantity of Fat and protein when compared to
control (Placebo Group).
|
Author &
Year of Studv |
Milk Contents |
Leptaden
Placebo Group
Group |
Remarks |
|
|
Purandare et al |
Specific |
1.0319 |
1.0307 |
Double-blind Statistical |
|
(1977) |
Gravitv |
|
|
Studv. |
|
|
Proteins |
2.6 |
1.5 |
Values for Mature Milk |
|
|
gms % |
|
|
|
|
|
Lactose |
7.7 |
7.3 |
Leptaden Group= 50 cases |
|
|
gms % |
|
|
Placebo Group = 50 cases |
|
|
Fat |
2.5 |
1.8 |
Leptaden increases protein, |
|
|
gms % |
|
|
fat and mineral Contents |
|
|
|
|
|
of milk. |
|
|
Minerals |
262 |
233 |
|
|
|
Mg. % |
|
|
|
|
Kasturilal |
Protein |
|
|
|
|
et al (1980) |
gms % |
2.69 |
2.60 |
Controlled Studv |
|
|
Fat |
|
|
|
|
|
gins % |
4.40 |
4.20 |
Value after 5-7 davs |
|
|
|
|
|
of Leptaden Therapv. |
|
|
|
|
|
Control: Placebo given. |
|
|
Carbohvdrate |
|
|
|
|
|
gins % |
5.90 |
5.63 |
Improvement of Qualitv |
|
|
|
|
|
of milk in Leptaden Group |
|
|
|
|
|
seen. |
Leptaden in
Prevention of Abortion & Premature Labour
Table 4 summarises
the result of seven clinical studies an the effect of
Leptaden in cases of threatened abortion and in cases of recurrent abortion and
in threatened premature labour. Successful pregnancy
outcome varies from 60 to 84 percent. In three studies bed rest and
progesterone injections were also given. No congenital anamolies
were noted in any of the 218 full term babies born to `Leptaden treated'
group.
|
Author & |
Type of
Study |
Results |
Remarks |
|
Year |
|
|
|
|
Kamala Achari & Renu Sinha (1966) |
Habitual
Abortion = 22 cases. H/O I Abortion 8
cases 2 Abortions
6 cases 3 or more, 8
cases Threatened
Abortions = 40 cases. Gestation:
6-22 weeks |
FTND 13
cases: 59.1% Aborted 7
40,9% Premature
100.0% Labour 2 FTND 24
cases: 60% Aborted 16
cases :40% |
l. Leptaden
2 tabs tds
through out pregnancy. 2.
Progesterone Depot LM.
once A week till
22nd week. |
|
Kamala Achari (1975) |
60 cases of
Threatened Abortion
(18-28 weeks of
gestation) IS cases of
previous bad Obst. History |
FTND (53): 88% Aborted (5): 12% FTLB -
(12):80% Premature Delivery
(1):6.7% Still Birth (I):6.7%a Aborted
(1):6.7% |
Leptaden 2
tabs: tds for 10 days till
bleeding controlled. Then 2 tabs. bd Throughout pregnancy. Serum Histami nase was found diminished
before treatment. It improved
with Leptaden.
Those that did not
show increase did
not progress to FTN D. |
|
Philips (1977) |
96 cases of Threatened
Abortion. |
FTLB 81
cases: 84.3% Pre-term Delivery 5 cases:
5.2% (37-39 wks) Premature Labour (28-36
wks~1: 1.1% Aborted |
2 tabs tds or four times a day throughout pregnancy. 7 pre-eclampsia & I case
of eclampsia: All had
FTLB. |
|
Philips (1980, 1983) |
Controlled Study Progesterone + Leptaden = 62 cases. Leptaden only = 48 cases. |
FTLB Prog. + Leptaden =
79% FTLB
Leptaden only = 72.9% |
Leptaden,
alone Results are satisfactorily Significant (72.9% of
FTLB) |
|
viii |
Other Uses of
Leptaden
Naik (1957) tried this drug in dysfunctional
uterine bleeding and found good results.
Ishwar (1981) found that Leptaden
improved the growth and maturity of white Leghorn Pullets. It also improved the
blood levels of inorganic calcium, phosphorus and cholesterol in the pullets.
The growth of internal organs in Broiler chicks was better with Leptaden.
Summary:
Leptaden seems to be useful in a
variety of disorders of which its action on initiation and maintenance of
lactation is the most widely tried and firmly established. The role of Leptaden
in prevention of abortion and premature labour
appears to be impressive as well. The exact mechanism of its action on the
uterus is not clear. Sharma (1976) found in Leptaden treated guinea pigs, the
level of Prostaglandin F2 alpha was lower than in the control and postulated
that Leptaden prevents the biosynthesis of prostaglandins and thus prevents
abortion and premature labour. The dose of Leptaden
is the same for both promotion of lactation and for prevention of abortion.
This herbal drug deserves to be studied more to unravel
its precise pharmacological actions.
Acknowledgement:
I am grateful to Prof. M. N. Guruswamy, Professor &
Director of Pharmacology,
I thank Manthan,
Research Division of Alarsin,