for the
use only of a registered medical practitioner or a hospital or a laboratory.
NONHORMONAL AYURVEDIC DRUGS IN
THE TREATMENT OF PRIMARY INFERTILITY
Dr. Mrs. BAKULA P. SHAH, B.Sc., L.M., D.G.O. (Dublin), F.R.C.O.G. (Lond)
and
Dr. PRAMOD H. SHAH, F.R.C.S. (Lond), F.R.C.S.
(Edin), Shah Surgical & Maternity Hospital, AMRAVATI 444 601, Maharashtra.
INTRODUCTION
Hormonal factor is one among many
factors that are responsible for infertility in males and females. There are
other factors like surgical and gynaecological factors, immunological factors,
psychological factors etc. Then we have the perplexing problem of infertile
couple where both the partners are found to be normal after necessary
investigations, and it is estimated that about 15% of infertile couples belong
to this group. As such nonhormonal drugs have a place in the management of
human infertility.
In
this study the efficacy of nonhormonai Ayurvedic drugs, Aloes Compound and
Leptaden in the management of Primary Sterility is evaluated. Fortege was used
on all husbands to improve the quality and quantity of semen and for better sex
performance.
ALOES COMPOUND
It consists of Aloes Indica, Myrrh
(Balsamodendron myrrha), Manjistha (Rubia cordifolia), Harmal (Pegunnum
Harmala), Jiwanti (Leptadenia reticulata), Kasis Bhasma (Ferri Sulphas), and
Kamboji (Breynia patens). Aloes and Myrrh with Iron have been in clinical use
for menstrual disorders since centuries all over the world, and were B.P drugs
before the advent of hormones.
Aloes
Compound stimulates Physiological and timely ovulat:lon, ensures
proper quality and quantity of cervical mucus to facilitate better forward
movement of sperms. It regulates menstruation.
Review of literature on Aloes Compound has shown
that many authors have reported favourable conception rates when used in
infertility.
MALE INFERTILITY
It is
estimated that male factor in human infertility is as common as female factor.
Hormonal treatment for male infertility has been unsatisfactory while
increasing the hazards.
AIMS AND OBJECTS OF THIS STUDY
The object of this study was to see
whether Ayurvedic drugs are useful in the treatment of infertility by
increasing Fertility Index. Aloes Compound was given to increase the Fertility
Index in women till conception. Then Leptaden was given to help sustenance of
pregnancy till full term. Fortege was given to males to correct probable sperm
defects, to improve the quality and quantity of samen, and for proper insemination
by better sc- x performance.
LEPTADEN
Leptaden acts as prophylaxis against Threatened
Abortion, Habitual Abortion and Premature delivery. Sharma (1976) has shown by
sensitive radio-immuno-assay studies that Laptaden inhibits biosynthesis of PG
F 26, by the uterine tissues and thus acts as prophylaxis against abortion,
since any increase in PG F2a causes abortion. Leptaden improves environmental
factors for proper implantation of fertilised ovum. It helps in sustenance of
pregnancy to full term. There are reports that it has helped even in cases of
4-10 previous Habitual Abortions. Leptaden ensures FTLB and a child that
thrives.
FORTEGE
Fortege improves spermatogenesis and
sperm count and increases sperm mobility. It decreases morphological sperm
defects, corrects Functional Impotence and Premature ejaculations. Improves
sex performance: erection, penetration and proper insemination. Relieves
`Fatigue' and `Stress' as these adversely affect spermatogenesis. Fortege tones
up neuroglandular and genito-urinary systems gradually and activates
metabolism.
MATERIAL & METHODS
This
trial was conducted on patients that attended our Hospital during 1975-80. 200
cases of Primary Sterility were included in this trial, but as 45 patients
could not be followed up properly, the final analysis was on 155 cases only.
Cases with organic defects like tubal obstruction were excluded from this
study. Semen analysis was made in the husband without exception.
Cases
of azoospermia, and those having sperm count of less than 30 mlnlcc. were
excluded from the study. If any spouse had any systemic disease like
tuberculosis, diabetes etc. such couples were, also excluded. Endometrial
biopsy could be done only in 26 cases. Testicular biopsy could not be done for
want of facilities. No hormonal tests could be done: Four cases of
Stein-Leventhal Syndrome were included in this study separately.
AGE GROUPS
Cases of Primary Sterility were in
the Age Groups of 18-38 years. Majority of them, 134 cases forming 86.5% were
aged between 2130 years.
DURATION OF MARRIED LIFE
Duration of married life in
these cases ranged between 3-15 years.
UTERUS, CERVIX, OVARIES
Uterus
was retroverted in 12 cases and retroverted and mobile in 6 cases. 15 cases
were corrected by Hedge pessary and in 3 cases ventrisuspension was done.
Cervix was adherent in 3 cases,
Separation was done by a blunt operation. Pin-point cervix was present in 10
cases and D & C was done in all these cases.
There
were 4 cases of Stein-Leventhal Syndrome. Laparotomy was done and wedge resection
made in all these cases. Histopathological examination confirmed
Stein-Leventhal Syndrome.
ENDOMETRIAL BIOPSY
Endometriai biopsy (premenstrual) was done in 2s
cases. 8 cases showed secretory phase and 18 cases showed proliferative phase.
SEMEN EXAMINATION
Semen examination was done in the husband in every
case. Those cases of azoospermia and those with sperm count of less than 30
min./dc. were not included in this study.
RUBAL POTENCY TEST
The potency of Fallopian tubes was determined by
insufflation or hysterosalpingography. Cases of tubal obstruction were not included
in this study.
MENSTRUAL PATTERN
26 cases
(16.8%) had normal menstrual pattern and 129 cases (83.2%) had menstrual irregularities.
DOSAGE ADOPTED
For the Husband: Fortage was given 2 tabs bd or tds
till wife conceived.
ALOES COMPOUND
In cases with Regular Menstruation: 2 tabs bd from
the 1st to 14th day of each menstrual cycle. (Then Leptaden as mentioned
below).
In cases with
irregular Menstruation: 2 tabs tds from 1 st to 14th day of each menstrual
cycle. Once the periods were regular, then the dosage was given as in Regular
Menstruation.
In cases with Scanty Menstruation: 2 tabs tds
continuously, even during menstruation, for 4 menstrual cycles. Once periods
were normal, then the dosage was given as in Regular Menstruation.
LEPTADEN
Leptaden 2 tabs bd was given during the second half
of each menstrual cycle in all cases to impove environmental factors for proper
implantation of fertilised ovum.
Once the period was missed, Aloes Compound was
stopped and Leptaden alone 2 tabs. bd was continued.
throughout pregnancy as prophylaxis against abortion or premature delivery and
to ensure FTLB and the child that thrives.
RESULTS: CONCEPTION RATE AND DURATION OF THERPAY .
Conception
rate in women with normal menstrual pattern was 84.6% and in women
with menstrual
irregularities the conception rate was 80.6%.
Overall
conception rate in 155 cases of Primary Infertility was 81.3%.
TABLE I CONCEPTION RATE:
PRIMARY INFERTILITY
|
Menstrual Pattern |
Conceived |
% |
Not con ceived |
% |
Total |
% |
|
Normal |
22 |
84.6% |
4 ' |
15.4% |
26 |
100.0% |
|
Irregular Scanty |
104 |
80.6% |
25 |
19.4% |
129 |
100.0% |
|
Total |
126 |
81.3% |
29 |
18.7% |
155 |
100.0% |
Sixty nine cases (54.7%) conceived between 3-6
months of Aloes Compound treatment; 29 cases (23.0%) conceived between 79
months of treatment; 22 cases (17.5%) conceived between 10-12 months of
treatment; and 6 cases (4.8%) conceived between 13-15 months of treatment.
(Table II)
TABLE II RESULTS: CONCEPTION & DURATION OF TREATMENT
|
Duration of treatment |
Conceived |
% |
|
3-6
months |
69 |
54.7% |
|
7-9
months |
29 |
23.0% |
|
10-12 months |
22 |
17.5% |
|
13-15 months |
6 |
4.8% |
|
Total |
126 |
100.0% |
STEIN-LEVENTHAL SYNDROME
4
cases of Stein-Leventhal Syndrome were taken up for study separately to see if
Aloes Compound is beneficial in the management of this condition. All these
cases were first surgically treated by laparotomy and bilateral wedge
resection of ovaries. Histopathology confirmed the diagnosis. Then they were
put on Aloes Compound treatment. Three of them conceived within six months of treatment.
During pregnancy, they were given Leptaden. One case delivered naturally and
two cases were delivered by Caesarean. the fourth case was lost to follow-up.
TOXIC OR SIDE EFFECTS
No
toxic or side effect were observed with the use of these Ayurvedic drugs: Aloes
Compound, Leptaden & Fortege.
THE FINAL OUTCOME OF PREGNANCY
112 cases (88.9%) had live birth (Full Term +4
preterm),13 women aborted in 12 weeks or (10.3%); there was one Still 'Birth
(Table III).
TABLE 111 FINAL OUTCOME OF PREGNANCY
|
Outcome of pregnancy |
No. |
% |
|
Live Birth: |
|
|
|
(Full term + 4 preterm) |
112 |
88.9%, |
|
Abortion |
|
|
|
(12 weeks or less) |
13 |
10.3% |
|
Still Birth |
1 |
0.8% |
|
Total |
126 |
100.0% |
SUMMARY
155
cases of Primary Sterility were treated with dosage scheme of Aloes Compound
and Leptaden. Husbands were given Fortege for proper insemination by better sex
performance.
Overall
conception rate was 81.3% (126 cases out of 155). Majority of them (69 cases
54.7%) conceived between 3-6 months of treatment-88.9% of them had Live Birth
(112 cases out of 126).
Stein-Leventhal Syndrome;
4 cases were under study. All the four cases were operated by wedge resection,
and then put on Aloes Compound. Three of them conceived within 6 months of
treatment and one case was lost to follow-up. All the three delivered live
birth.
ACKNOWLEDGEMENT
Our thanks to Alarsin Pharmaceuticals, Bombay, for their cooperation.
REFERENCES
ALOES COMPOUND
1. Mrs.
Balsara, Roshan R.: Sterility associated with irregular and, scanty menstruation
(use of Aloes Compound as an adjuvant). The Indian Pract.19:1,123-125, Jan. 1966.
2. Miss Bhatia, Geeta: Primary Dysmenorrhota in the
unmarried treated with Aloes Compound: Current Med. Pract.15:4, 715-17, April,
1971.
3. Deshpande P. J.: Use of Aloes
in Irregular and Scanty Menstruation. The Antiseptic, 59: 12, Amarnath .S.
& Dahthankar S.G. (1979): For-1045-52, .Dec.,1962.
4. Mrs. Gupta,Kusum : Aloes Compound (A Herbal Drug) in
Functional Sterility, XVI All India Obst. & Gyrtec. Congress, New Delhi,
10-12 March, 1972.
5. Jhaveri C.L., Mrs. Ila S.
Mody, Mrs. Munim J. K, and Miss Dass : Clinical Evaluation in Infertility
associated with irregular menstrual cycles treated with an indigenous
preparation. XVI All India Obst. & Gynec. Congress, New Delhi, 10-12,
March, 1972.
6.
Mukherjee, Krishna; Pande M. and Mukherjee, Meena : A trial of Aloes Compound
(an indigenous drug) in cases of Sterility associated with menstrual Irregularity.
XVI All India Obst. & Gynec. Congress, New Delhi, 10-12 March, 1972.
7. Rajasekharan N., Vijaya R.,
Celia Dorothy White' & Uma Rani S. :Trial with the indigenous drug Aloes
Compound in Infertility. The Antiseptic, 72: 9, 451-57, Sept. 1972.
8. Ramani Sivaraman, Sujaya
Kumari, Usha Kannan and Dhathri : Aloes Compound In Sterility. The Antiseptic
73: 7, 33640, July 1976.
9. SharmaS.C., Chadha H. andBurjorjee M.M. :The effect of Aloes Indica on the
Fertility of Female Rabbits. XVI All India Obst. & Gynec. Congress, New
Delhi, 10-12, March, 1972.
LEPTADEN
1 PatelN. V. : A suggestion to Gynaecologists. The Antiseptic, 44:6, 377380, June 1947.
2.
Mrs. Philips, Florance S. Clinical trial with Leptaden for.recurrent and
threatened abortions & Premature Labour. Current Med. Pract. 21(7) 317-320, Labour. 1977.
3.Poobalaravol Agnes, Mrs. Philips, Florence S.
Outcome of Pregnancy in threatened abortions treated with Progesterone and
Leptaden. Second Congress of Indian Society of Perinatology, Reproductive
biology and Planned Parenthood, Jammu,27-29 Sept.80.
4. Mrs. Savitri C. and Venkata Rao N.
Role of Leptaden during Pregnancy. XIX All India Obst. & Gynec. Congress,
Cuttack, 2729, December 1977 and Bombay Hosp. J. 23:4, 28-32, Oct. 1981.
5. Sharma B.C.: A possible Mechanism
of Leptaden Action by inhibiting prostaglandin F2a Synthesis, Indian J: of
Med. Research, 64:4, 597-600, April, 1976.
FORTEGE
1. Bhalerao, Mohan N., Mrs.
Bhalerao Savitha: Fortege in Male Infertility-A Controlled Trial All India
Obst. & Gynec. Congress Bangalore, 29-31, Dec. 1979, Current Med. Pract. XXIV
(3), 95-99. March '80.
2. Gupta L.N., Saluja J.S.:
Role of Fortege in Oligospermia. Current Med. Pract.19:6, 272-273, June 1975.
3. Joshi S.K.: Syndrome of Dhat in the
male (Use otanAyurvedicCompound) Mah. Med. J.12: 9, Dec. 1965.
4. Kamlesh Kumar : Management of some male
sexual disorders with Fortege. The Antiseptic, 76:3,145-49, March 1979.
5. Shelat R.K., Majumdar,
Muktiben, Bhandaria, Bhartiben C. & Basu K.N. : Use.fulness of Fortege in Oligospermia
and low Mobility of sperms (A Controlled Trial). I Asian Congress of Fertility
& Sterility, Bombay 19-23, Feb. 1977.
for
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