DR. Shah

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

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.


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