chapter1.2

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 nonhormonal 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 ovulation, 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 semen, and for proper insemination by better sex 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 Leptaden inhibits biosynthesis of PG F2α by the uterine tissues and thus acts as prophylaxis against abortion, since any increase in PG F2α 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 mil./ml. 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 21-30 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 Hodge 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

Endometrial biopsy (premenstrual) was done in 26 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 mil./ml. were not included in this study.

TUBAL 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:

Fortege 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 1st 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 improve 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 THERAPY

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%.

84.6% Normal menstrual pattern
80.6% Menstrual irregularities
81.3% Overall reported conception rate

TABLE I — CONCEPTION RATE: PRIMARY INFERTILITY

Menstrual Pattern Conceived % Not Conceived % 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 7-9 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 — 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 less (10.3%); there was one Still Birth.

TABLE III — 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 Dysmenorrhoea 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, 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, 336-40, July 1976.
9. Sharma S.C., Chadha H. and Burjorjee 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. Patel N. V.: A suggestion to Gynaecologists. The Antiseptic, 44:6, 377-380, 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, 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. 1980.
4. Mrs. Savitri C. and Venkata Rao N. Role of Leptaden during Pregnancy. XIX All India Obst. & Gynec. Congress, Cuttack, 27-29 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 Medical 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 of an Ayurvedic Compound). 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.: Usefulness of Fortege in Oligospermia and low Mobility of sperms (A Controlled Trial). I Asian Congress of Fertility & Sterility, Bombay 19-23, Feb. 1977.
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.

Important:
This section reproduces information from a historical study published on the Alarsin website. The study describes its own methodology, treatment protocol and reported outcomes from patients treated during 1975–1980. The information should be read in the context of that study and is not, by itself, a current clinical recommendation or evidence of treatment effectiveness.

The original page states: “for the use only of a registered medical practitioner or a hospital or a laboratory.”