TRIAL WITH THE INDIGENOUS DRUG ALOES COMPOUND IN INFERTILITY*
BY
Dr. N. Rajasekharan, M.D., D.G.O.,
Director – Supdt., Institute of Obst. and Gynec. – Govt. Hospital for Women and Children, Madras-600 008 : Professor of Obst. and Gynec. Madras Medical College, Madras-600 003.
Dr. R. Vijaya, M.D., D.G.O.,
Asst. Prof. of Obst. and Gynec. Madras Medical College, Madras-600 003.
Research Asst., Institute of Obst. and Gynec. and Govt. Hospital for Women and Children, Madras-600 008.
Dr. Celia Dorothy White, M.B.B.S., D.G.O.,
Asst. Surgeon (Sub-Fertility), Institute of Obst. and Gynec. and Govt. Hospital for Women and Children, Madras-600 008 ; Post-graduate in M.D.,
AND
Dr. Uma Rani, M.B.B.S., D.G.O.,
Asst. Surgeon (Sub-Fertility) Institute of Obst. and Gynec. and Govt. Hospital for Women and Children, Madras-600 008.
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.
PHARMACOLO.GY OF THE DRUG
Each tablet of Aloes Compound contains:
Aloes (Aloes indica): 60 mg. Bol (Myrrh): 60 mg. Kasis Bhasma (Iron Bhasma); 30 mg. Manjishta (Rubia cordifolia): 30 mg. and Hurmal (Peganum hurma/a): 30 mg.
Aloes: Is an appetizer and laxative and by stimulation of the pelvic circulation, causes congestion of the uterus and acts as an em menagogue.
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 dysrTienorrhoea. 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-pa tient 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. Tbe 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 infertil ity clinic. Of these, the first 133 cases form the trial group (Group-1) while the latter 75 cases form the control group (Group-I/). 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 inves tigations could be completed and 56 or 41.5% attended the clinic to get the tablets after the tests had been completed . Inthis 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 ir regular.
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 1O 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 1O 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 dos age 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 Aoes Compound , 11 conceived, giv ing 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 1O 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 remain ing 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 pat tern.
Menstrual rhythm and pregnancy rate: Of the 56 patients,39 had regular and 17 irregu lar 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 reg ularly 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
|
Total Cases |
Age group | Primar
|
c:-
c · C CI> U5 Cl) |
Periods | Tubes | Endometrium | Husband | Duration of infertility | |
| 20 &·1 21·30 1 30 &
under above |
lrre-r I Regu-
gular lar |
Bloc· 1 Pat- ked ent | Secre- 1 Prolife- tory rative | normal I azoos- 1 Oligos·
perm1a perrrna |
3 4-10 over 10
years years years |
||||
| 133
Drop out Taking Regularly |
18% 68.5% 13.5%
: 77 58-5% – – :56 41-5% – – Follow up – 1 year |
77.5% 22.5%
– – – – – – |
22.5% 77.5%
– – – – – – |
19% 81%
– –
– – Not done in 39 cases |
65.5% 34.5%
– –
– – No Endometnum in 1 case |
83.2% 7.2% 9.6%
– – –
– – – Not done in 50 cases Necrospermia – 3.6% |
13.5% 67% 19.5%
– – – – – – – – – |
||
| Control cases
Drop out Coming regularly |
: 75 30% 65 5% 5.5% : 50 67% – – : 25 33% – – Follow up- 6 months |
86.6% 13.4% – – – – – – |
33.3% 66.7% – – – – – – – |
21.3% 78.7% – –
– –
Not done in 28 cases |
55% 45% – – – – Not done in 27 cases. No Endometrium in 2 cases. Tuberculosis Endometrium in 1 case |
70.7% 20.9% 8.5% – – – – – – Not done in 27 cases
– – – |
11-3% 75% 7.7% – – – – – – – – –
– – – |
||
TABLE-II
|
SI. No. |
Name and Married for |
Age in yrs. |
Primary Sterility |
Relative sterility |
Menstrual Cycle |
Duration of Husbands Se- Tubal Endometrium the tablets minal analysis function (in months) (Sperm count) |
|||
|
Relative |
in millions | ||||||||
| 1. | Smt N. – 4 yrs. | 19 | sterility Regular Patent Secretory 3 38 | ||||||
| Delivered on 6-8-1972 – live female baby | |||||||||
| 2. | Smt R. – 7 yrs. | 20 | Primary | Regular | Patent | ||||
| sterility | Patient delivered a live female baby | Secretory | 2 | 58 | |||||
| 3. | Smt R. – 3 yrs. | 22 | Primary | ||||||
| sterility | Regular | Patent | Secretory | 6 | 52 | ||||
| 4. | Smt J. – 11 yrs. | 32 | Relative | ||||||
| Sterility | Regular | Patent | Secretory | 2 | 48 | ||||
| 5. Smt S.B. – 3 yrs. 20 Primary 2 years back – Vas-recanlisat ion done Hysterosalpingography – Patent | |||||||||
| sterility | Irregular | Patent | Proliferative | 2 | 62 | ||||
| 6. | Smt S.- 3 yrs. | 19 | Primary | ||||||
| sterility | Irregular | Patent | Proliferative | 3 | 62 | ||||
| 7. | Stm. V.- 6 yrs. | 29 | Primary | ||||||
| sterility | Regular | Patent | Poor secretory | 6 | 40 | ||||
| 8. | Smt B. -8 yrs. | 25 | Primary | Aborted during the 2nd month | |||||
| sterility | Regular | Patent | Secretory | 38 | |||||
| 9. | Smt G.- 3 yrs. | 23 | Primary | Delivered | |||||
| sterility | Regular | Patent | Poor Secretory | 8 | 68 | ||||
| 10. | Smt M. -11 yrs. | 30 | Primary | 3 months – missed abortion | |||||
| sterility | Regular | Patent | Secretory | 2 | 40 | ||||
| 11. | Smt S.-12 yrs. | 21 | Relative | ||||||
| sterility Irregular | Patent | Poor secretory | 4 | 58 | |||||
| CONTROL GROUP | |||||||||
| 1. | Smt.R.B. – 3 yrs. | 23 | Primary | ||||||
| sterility | Regular | Patent | Not done | No tablets | 45 | ||||
| 2 | Smt L – 2 yrs. | 24 | Primary | ||||||
|
3. |
Smt L – 4 yrs. |
20 |
sterility Primary | Regular | Patent | Proliferative | 65
conceived |
||
| sterility | Regular | Patent | Not done | No tablets | before seminal | ||||
| analysis | |||||||||
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% re spectively 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 dif ference in the quality of the patients as will be seen from Table-I, i.e., 20.8% azoospermia in Group-I/ as against 7.2% in Group-I, 33.3% ir regular cycles in Group-I as against 22.5% in Group-/; 45% proliferative pattern in Group-I/ 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 (Re search 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:
- L. Jhaveri; Ila Mody; J.K. Munim and P.G. Das — Paper read at the XVlth All india Obstetrics & Gynaecological Congress, New Delhi., 1972.
- Kusum Gupta – Paper read at the XVlth All India Obstetrics & Gynaecological Con gress, New Delhi.,1972.
- Roshan R. Bulsara – Indian Practitioner 19 (1): 123-125.,1966.