Trial with the Indigenous Drug Aloes Compound in Infertility*

The problem of infertility is as old as is the World. Numerous descriptions in the Puranas about King Dasaratha and Dilip performing Yagnas for the sake of begetting children are well known to all Indians. Equally well known is the fact that their Queens conceived after taking the Prasaadam form the lord’s temple. Though the actual cause of sterility in the puranic characters and the mode of action of the Prasaadams are not known, the sterility was invariably belived to be due to some curse.

Even in this modern era of tremendous scientific advances, we have not fully understood the subtle biochemical phenomena leading to the successful fertilization and implantation of ovum. There are group of couples in whom there is no obvious cause for the barren marriage detectable by the gynecologist, but with reassurance and reasonable waiting, nothing fruitful has been gained.

Again there are others, who in the opinion of the specialist, have very remote chances of conceiving but who, surprisingly enough, promptly conceive at times even without treatment, though such cases are not very frequent.

Surgery plays a very limited role in the management of the problem of infertility. Epidydimo-vasostomy for a vas obstruction and tuboplasty operation for tubal block are rarely performed because of the poor success rate.

Medical treatment is of equally limited significance until recently, due to lack of availability of suitable and effective drugs. Testoterone for treating all types of male infertility and Oestrogen and progesterone for nearly all kinds of female infertility were the only available drugs.

Ofcourse recently Clomid and Gonadotropin have come into vogue but these drugs are not yet freely and easily available in India for routine use.

At this juncture, any product claimed to be useful for curing infertility should therefore, be quite welcome both to the patient and to the gynaecologist.

Aloes Compound (Alarsin) is an indigenous drug which is found to show fertility-promoting properties in several research trials. It is claimed that this Compound regulates menstrual irregularities and improves fertility in women with unexplained barrenness. Trials conducted in various hospitals in India have shown encouraging results. Hence, it was thought worth-while undertaking a trial with the Aloes Compound in our infertility clinic also.

PHARMACOLOGY OF THE DRUG

Each tablet of Aloes Compound contains:-

Aloes

Is an appetizer and laxative and by stimulation of the pelvic circulation, causes congestion of the uterus and acts as an emmenagogue.

Myrrh

Potentiates the action of aloes.

Manjishta

Has anti-inflammatory properties and acts as an uterine sedative.

Hurmal

Is an antispasmodic sedative and emmenagogue, useful in amenorrhoea and dysmenorrhoea. Manjishta and Hurmal are supposed to soothen the anxiety states of these sterile women.

In India, before the introduction of hormones, aloes has been used with myrrh and/or iron for menstrual disorders.

MATERIAL AND METHODS:-

This study was starte in June 1971. The cases were selected from the Gynaec-out-patient department of the Government Women and Children Hospital, Madras.

Both primary and secondary sterility cases were included in the trial. The female partners were subjected to the routine investigations for sterility.

Endometrium for study was obtained by doing an endometrial biopsy on the 1st day of the period as an outpatient. If there was associated dysmenorrhoea, dilation and curettage were done.

Women with tubal block, azoospermic husbands and women whose husbands were not willing for seminal analysis were not given this drug.

Women who were otherwise normal, those with irregular cycles and oligo-ovulation and anovulation formed the bulk of the material in this study.

The recommended dosage of the Compound is 2 tablets thrice daily and at the beginning we were giving this dose. As some of the patients complained of griping abdominal pain, we reduced the dose to 4 tablets per day.

The medication was stopped during periods to be restarted after the cessation of flow and also when the periods were delayed and pregnancy was suspected.

RESULTS:-

During the one year period from June 1971 to May 1972, 208 patients attended the infertility clinic.

Of these, the first 133 cases form the trial group (Group-1) while the latter 75 cases form the control group (Group-II).

The trial patients were put on Aloes Compound while the control group received placebo tablets.

Aetiological factors

For assessing the aetiological factors of infertility, the total number of cases were considered. 35% were due to anovulation and in 20% there was tubal block. 12% of the husbands were azoospermic, while 6% had oligospermia (Sperm count of 19 million or less).

Data about the trial group are given in Table I.

Trial group

Of the 133 cases in Group-1, 77 or 58.5% dropped out even before the investigations could be completed and 56 or 41.5% attended the clinic to get the tablets after the tests had been completed.

In this group, 77.5% had primary sterility and 22.5% secondary sterility.

Age distribution

18% of the patients were under 20 years; 13.5% over 30 years and 68.5% belonged to the 21 to 30 age group.

Menstrual rhythm

77.5% had regular menstrual cycles and in 22.5% they were irregular.

Duration of marital life

13.5% had been married for 3 years or less, 19.5% over 10 years, while 67% had been married for 4 to 10 years.

Tubal patency

19% had blocked tubes while in 81% they were patent.

Endometrial histology

65.5% showed a secretory pattern while in 34.5% it was proliferative. In one patient, no endometrium could be obtained.

Seminal analysis of the male partner: 83.2% were normal; 7.2% azoospermic and 9.6% oligospermic.

Duration of medication

The duration of drug-administration ranged from 10 days to one year. 25.6% took the tablets only for one month or less; 34.5% from 1 to 3 months; 25.6% from 3 months to 6 months and only 14.5% continued to take it beyond 6 months.

Side-effects

Some patients complained of griping abdominal pain with 6 tablets per day but no side-effects were noted when the dosage was reduced to 4 tablets.

A few complained of loose motions. Patients whose menstrual flow was already moderate or on the profuse side tended to have a still increased flow which was bound to be troublesome.

Apart from these, there were no major side-effects.

Pregnancy rate

Out of the 56 patients, who took Aloes Compound, 11 conceived, giving a gross pregnancy rate of 19.6%; of these 56, 19 had taken the drug for less than a month and one conceived.

After excluding these, the corrected pregnancy rate was 10 out of 37 or 27%.

Analysis of the clinical data of the 11 women who conceived is given in Table II.

One conceived within one month of taking the tablets; 6 within 3 months; 3 in 6 months and one after 8 months.

Marital status

Four had been married for 3 years, 5 between 3 and 9 years and the remaining 2 had been married for 11 and 12 years respectively.

Type of endometrium and pregnancy

Two patients with a proliferative endometrium conceived while the others had a secretory pattern.

Menstrual rhythm and pregnancy rate

Of the 56 patients, 39 had regular and 17 irregular cycles. The pregnancy rate in patients with regular cycles was 20.5% and irregular cycles 17.6%.

Control group

There were 75 patients in the control group. Only 25, i.e., 33% came regularly for taking tablets and 67% dropped out before investigations could be completed.

Of the 25 who came regularly 3 or 12% conceived. The comparative data between the trial and control groups are given in Table I.

TABLE-I

TABLE-II

Analysis of the clinical data of the 11 women who conceived.

DISCUSSION:-

Kusum Gupta has tried out Aloes Compound in the sterility clinic of S.N. Hospital, Agra on 250 patients and reported a fertility rate of 46% in 100 normally menstruating women and 39% in 150 with disturbed menstrual function.

Jhaveri reported a pregnancy rate of 52% in the trial series as against 20% in the control. The pregnancy in primary sterility and secondary sterility in the trial series was 54% and 46% respectively as compared to 16% and 24% in the control series.

Roshan R. Bulsara found that 30 out of 45 primary sterility and 1 out of 5 secondary sterility cases conceived when treated with Aloes Compound, thyroid and Lugol’s iodine solution giving an incidence of 66% and 20% respectively.

Our pregnancy rate of 27% is low as compared with these studies. The reason may be that our patients were very irregular in taking the tablets.

In the present trial, even though there was no conscious selection of patients for each group, there is a slight difference in the quality of the patients as will be seen from Table-I, i.e., 20.8% azoospermia in Group-II as against 7.2% in Group-I, 33.3% irregular cycles in Group-II as against 22.5% in Group-I; 45% proliferative pattern in Group-II as against 34.5% in Group-I.

But this was purely coincidental. All the same, the pregnancy rate of 27% with Aloes Compound and 12% without it goes to show that this drug has had some favourable influence in sterility cases.

Again 2 anovulators conceived. With the lack of availability of other ovulation stimulators, it is worthwhile trying this drug in such cases.

Kusum Gupta claims an improvement of menstrual function in 44 to 66% of cases. But in our trial, the menstrual rhythm was not appreciably altered with the dose used. Probably higher dosage might have been more helpful.

ACKNOWLEDGEMENT:-

Our grateful thanks are due to Manthan (Research Division of Alarsin Pharmaceuticals, Bombay-1) in particular to Mr. K.M.S. Chetty for providing adequate supplies of the drug used in this clinical trial.

REFERENCES:

1. L. Jhaveri; Ila Mody; J.K. Munim and P.G. Das — Paper read at the XVIth All India Obstetrics & Gynaecological Congress, New Delhi., 1972.
2. Kusum Gupta — Paper read at the XVIth All India Obstetrics & Gynaecological Congress, New Delhi., 1972.
3. Roshan R. Bulsara — Indian Practitioner 19 (1): 123-125., 1966.