Dr. Jhaveri

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

 

CLINICAL EVALUATION OF INFERTILITY ASSOCIATED WITH IRREGULAR MENSTRUAL CYCLES TREATED WITH AN INDIGENOUS PREPARATION

by

Dr. C. L. JHAVERI, M.D., F.A.C.S., F.C.P.S.
Dr. (MRS.) ILA S. MODY, M.D., F.R.C.S.-, D.R.C.O.G., D.G.O. Dr.(MRS.) J. K. MUNIM, M.D., D.G.O.
Dr. (MISS) P. G. DAS, M.B.B.S.
Sterility Clinic, Department of Obstetrics & Gynaecology, Dr. Balabhai Nanavaty Hospital, Bombay-56

Reprinted from "Proceedings of the XVlth All India Obstetrics and Gynaecological Congress", pp. 138-142 New Delhi, 1972.

 

INTRODUCTION

One of the most vexing problems in Gynecology today is the management of a Sterile couple, in whom organic and physical defects have been excluded. Increasing ad­vances in understanding of menstrual and en­docrine physiology, new drug formulations, better diagnostic methods etc. have brought encouraging results in an ovulation, tubal bloc­kage, polycystic ovaries, cervical incompetence etc. However when all these obvious physical factors are excluded we are still left with 10­15% of couples who are apparently normal and fail to conceive. These are the couples with the low "Fertility Index". Whatever treat­ment holds promise for these couples, there­fore, is worth following up.
Tab, Aloes Compound (Alarsin) has been successfully used in Scanty and Irregular menstruation and it was worthwhile to initiate trials of this drug on these couples with the low "Fertility Index".


Pharmacology of the Drug History of Aloes

Use of Aloes in medicine dates back to the fourth century B.C. It is a genus of about 160 species of Xerophytic plants indigenous to East and South Africa. In course of time sev­eral species have been introduced in different parts of the world and is used all over Europe,
West Indies and Asia including India, Japan and China.

Its main varieties are: A Chinensis, A. Fefrox - best South African Aloes, A. Perryl which yields socaioin, 'barbaloin, A. Vera from which official aloes is obtained; A. Vulgaris, a species which grows in West Indies, dark coloured in­spissated juice of which is cathartic and stimulating; A Cabaldina is a coarse variety used in Veterinaiy practise; A. Capensis is a South African species. Indian aloes is obtained from A. Vulgaris. The active constituent of aloes is a mixture of glycosides called `aloin' which varies in different varieties. The principal constituent of `aloin' is barabaloin.2°'°

PHARMACOLOGICAL ACTIONS

Aloes is obtained from the sap of leaves cut from the aloes plants. It consists of the follow­ing fractions:

(1) a crystalline glycoside aloin (2) aloes­emodin (3) Resin and (4) Volatile oils etc.

(i) G.I. tract - The glycosides in aloes after being hydrolysed by bile, irritate the colon, and stimulate peristalsis, taking 10-12 hours to cause purgation. It also increases the vascu­-larity of the rectum and other pelvic organs.

(ii) Uterus-aloin stimulates uterine muscle and by increasing pelvic vascularity causes congestion of the uterus. It can therefore act as an abortifacient when given to - pregnant women in large doses. It is thus used in Amenorroea, delayed menstruation etc. espe­cially in young girls.

Pharmacology text books, therefore, cau­tion against the use of aloes in piles, menor­rhagia, pregnancy and lactation etc.

Surprisingly aloes has been successfully used in Primary Dysmenorrhoea inspite of its action stimulating Uterine musculature.


USUAL DOSAGE -

B. P. dose of Aloes is 2 to 5 grs or 0.12 to 0.3 grm.


PRESENT STUDY

For the purpose of this trial 50 patients were selected at random from our sterility clinic in the Department of Obstetrics and Gynaecol­ogy. The selection was done after the routine tests for the detection of the organic causes of sterility were proved to be negative. On the same criteria 50 other cases were studied as controls with no treatment.

MATERIALS AND METHODS

Cases of both Primary and Secondary Sterility were selected for the trial. The relative incidence of the two types was:


TABLE I

                                 Series                               Control
                     No.      Incidence     No.               

Primary         35      70%             25                50%
Secondary     15      30%             25                50%


Menstrual cycles of these patients were also carefully noted as Aloes Compound was re­ported as having a beneficial action on menstrual irregularity. The menstrual cycles in the 50 patients studied were as follows:

 

TABLE II

 

Series

Control

Normal

6

10

Amenorrhoea

3

5

Oligomenorrhoea

24

18

Irregular periods

17

17

 

50

50

Approximately 50% of the cases in the series had associated dysmenorrhoea.

 

In the pretreatment workout of the patients, the routine investigations of sterility viz. Hus­band's semen examination, Endometrial Biopsy, Tubul Insufflation and post coital tests were done.

     In 2 cases which showed evidence of hypothyroidism, Thyroid function tests viz. B.M.R. and Blood cholesterol estimates were done. (However, Radio active Iodine uptake study, could not be done.) In one case which looked like Sheehan's Syndrome, X-ray of Sella Turcica and hormonal excretion studies including Urinary Gonadotropin studies and urinary estriol estimate were carried out.

These cases were then administered Aloes Compound 2 tablets thrice daily for 5 days prior to the expected date of the menstrual period. This was continued for varying periods

    of time.

TABLE III

Duration of

treatment

No. of

patients

Range of

dosage

0 - 1 month :

2

15 - 40 tabs.

1- 3 months:

18

30 -120 tabs.

3 - 6 months:

20

60 - 240 tabs.

6 -12 months:

10

195 - 420 tabs.

 

50

 


TABLE IV

                                                              Strength In grm.

                               Dosage Range        Per tab. strength

Daily dose                 1-2 tabs. t.d.s         .21 grm.to .42 grm
                     

Per patient                30-420 tabs.          6.3 grm. to 88.2 grm.

Per cycle                   15-40 tabs.           3.15 grm. to 8.4 grm.

Minimum No. of                    1                3.15 grm. to 8.4 grm.
cycle

Maximum No. of                   13               40.75grm. to 108.2 grm.

cycles


RESULTS

(1) Improvements in menstrual cycle:

 

 

No.

Mean duration of

treatment(in patient cycles)

Improved

Yes

No

Amenorrhoea

3

10

1

2

 

 

 

 

 

Oligomenor­rhoea

24

7.23

21

3

Irregular

 

 

 

 

periods

17

6.02

10

7


(2) Successful i.e. conception achieved in:

 

 

Series

No.


Conceived

%

Mean duration of treatment (in patient cycles)

No.

Control

Conceived

Primary

35

19

(54%)

7.02

25

4(16%)

Secondary

15

7

(46%)

6.85

25

6(24%)

 

50

26

(52%)

 

 

10(20%)


SIDE EFFECTS AND TOXICITY

No worthwhile. evidence of any toxic reac­tion was detected. None of the patients com­plained of any significant incidence of side ef­fects.

DRUG USED, ACTIONS AND USES OF INGREDIENTS


The drug used in this trial was tablet Aloes Compound (Alarsin) which consists of the fol­lowing ingredients; each tablet containing:

Aloes (Aloes indica)                     60 m.g.
Bol (Bal, Myrrh)                          60 m.g.         

Loha Bhasma (Iron Bhasma)          30 m.g.
Manjistha (Rubia cordifolia)           32 m.g.
Hurmal (Paganum hurmala)           30 m.g.
Jeevanti                                    30 m.g.

Kamboji                                     30 m.g.

Aloes (Aloes indica): emmenagogue, liver Corrective, digestive and milk laxative. By stimulation of the pelvic circulation it causes congestion of uterus and acts as an em- - menagogue. Used in delayed or irregular menstruation occuring at the interval of two or three months. Aloes gives better results in combination with Myrrh.

Bol (Bal, myrrh): emmenagogue, haematinic, appetizer-excreted by the mucous membrane of the genito-urinary tract which it stimulates, disinfects and regulates. Used in amenorrhoea due to anaemia with Iron bhasma, in painful and scanty menstruation.

Loha Bhasma (iron bhasma): preparation of established value for anaemia and debility, without the usual side effects of iron therapy like constipation and blackening of teeth. Used along with Myrrh in irregular menstruation due to anaemia.

Manjistha (Rubia cordifolia): Cooling seda­tive, anti-imffammatory, ecbof ic, astringent. It acts on uterine muscle through the nervous system. Stimulating effect on uterus, enables easy menstrual flow. Used in scanty menstrua­tion, amenorrhoea after delivery, endometritis.

Hurmal (Peganum hurmala): antispas­modic, emmenagogue, sedative. Used in amenorrhoea; dysmenorrhoea.2°'°


OVERALL EFFECT ESTIMATED

The overall action of Tab, Aloes Compound is not only simply additive of the various ingre­dients but also vastly improved synergestic ef­fect is observed. This is mainly as shown by (1) Uterine hyperaemia, (2) Toning up of pelvic musculature, (3) Relief of constipation and (4) a secondary beneficial effect on anaemia.


DISCUSSION

By convention a couple was considered In­fertile only when they fail to achieve pregnancy after at least 2 to 3 years of unprotected inter­course.' With increasing knowledge of the re­productive processes and the later age at which couples marry these days, it would be proper to have a limit of one year after which the couple should be advised to proceed with investigations of sterility.

About 85% of women conceive within the first year of marriage (without using any means of contraception)3. While 10-15% of women fail to conceive in the first 3 years and then come under medical attention for infertility.

The major organic causes of infertility are of course too well known to bear repetition here. Treatment of existing organic defects is suc­cessful, in as much as successful in achieving conception, in 20-25% in various studies. One of the largest series studied (Warner, M.P.)12 of 1553 couples over 25 years, 727 concep­tions occurred i.e. 60%, of these 84% of the conceptions resulted 'in live babies. These fi­gures may however be slightly misleading as it was observed that at least 20% of patients at­tending an infertility clinic conceive without any treatment at all.

As we are here concerned not with the couples having organic defects, we may con­sider major contributory factors as a low fertility Index or an ovulation.

It is well known that `a barren marriage may result from the union of two persons of lowered fertility, each of whom may prove fertile when remarried to a partner of high fertility"5. A sterile union is therefore a result of minor de­fects in both partners. It is here that Aloes Compound may be quite successful in either increasing the fertility index or in ameliorating the minor defects.

Nonovulatory cycles are usually seen in around 10% of all endometrial biopsies but only about half of these will be found to have re­peated nonovulatory cycles.9. Recent treatment with clomiphene citrate (350 to 500 mg. per cycle for 3-4 months) is effective in causing succes­

ful pregnancy in 25-28% only.6 Treatment with Human Menopausal Gonadotrophin (HMG) followed by Human Chorionic Gonadotrophin (HCG) is effective in causing ovulation in about 75% or more cases with conception rates rang­ing from 20-25°/a'. However, cost is prohibitive for all at present but for the very rich and nonavailability is a great factor, Treatment with HMG-HCG can lead to Polycystic ovaries in 2% of cases and multiple births in 40%.4. In this group aloes may be worth administering as a much cheaper and safer alternative.

ACKNOWLEDGEMENT

We are thankful to Dr. S. C. Sheth, Superin­tendent of Dr. Balabhai Nanavati Hospital, Bombay for allowing us to carry out this trial. Our thanks are also due to Mr. P. G. Shukla of Mls. Alarsin Pharmaceuticals, Bombay-1 for a liberal supply of tablets to conduct this study.


REFERENCES

1. Bowes, K: Modern Trends in Obst. & Gynec. Butterwath, London, 1950.

2. Chopra, R. N.: Indigenous Drugs of India, 2nd Edition, 1958.

3. Diddle, A. W., Jack, R. W. and Pearse, R. L.: Am. J. Obst. & Gynec. 54, 57, 1947.

4. Gemsell, Carl: Proc. Vth World Congress of Gynec. & 4bst., Sydney, Butterworth's, 240,1967.

5. Menstrual Disorders and Sterility, S. Lean Israel,~Hoeber 1967.

6. Kistner, R.: Obst. & Gynec. Surgery, 20: 873,i965.

7. Lunenfeld, B., J., Int. Fed. of Obst. & Gynec.,1963.

8. Marcus and Marcus: In Advances in Obst. & Gynec. Vol. I, Williams & Walies, Balti­more, 1967.

9. M. Moore-White and V. B. Green Armit­age: The Management of Impaired Fertil­ity. Oxford University Press, 1962.

10. Nadkarni, K. M.: Indian Materia Medica, 3rd Edition, 1946.

11. Shahani, S. M.: Ind. J. Gynec., XXI: 2,123, 1971.

12. Warner, M. P.: New York State M.J., 62: 2663,1962.

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