chapter3.10
AYAPON IN DYSFUNCTIONAL UTERINE BLEEDING
Functional Uterine Bleeding affects 10 to 15% of all the gynaecological patients and may be related to a single or multiple etiological factors. Normal menstruation is a complex process which involves functional interrelation between the higher cerebral centres of the brain and hypothalamus, pituitary, ovaries and endometrium.
Dysfunctional Uterine Bleeding is referred to bleeding from the uterine endometrium unrelated to gross anatomical lesions of the uterus. This problem is predominant during adolescence and at menopause.
Successful management of Dysfunctional Uterine Bleeding is dependent on many factors, such as the age of the patient, parity, type of bleeding, etc. Since the choice of therapy is guided by various factors, the main aim in management is to control the prolonged and profuse bleeding pervaginum.
Ayapon, a herbal preparation which is said to be useful in Dysfunctional Uterine Bleeding was selected for this study.
PHARMACOLOGY
“Ayapon” (Alarsin) contains Ayapan (Eupatarium ayapana), Ashoka (Saraca indica), Godanti (Gypsum) and Nagkesar (Mesua ferrea).
Ayapan: The dried leaves of Ayapan contains ayapin (6:7 methylene dioxycoumarin), ayapanin (? -methylene coumarin) and an essential volatile oil. Both ayapin and ayapanin possess haemostatic property when applied locally or when taken internally.
Ashoka: The bark of the Ashoka tree possesses strongly astringent and uterine sedative properties. It is said to act on the muscular fibres of the uterus and exert a stimulating effect on the endometrium and the ovarian tissue. It has been recommended in uterine affections, especially menorrhagia due to fibroids or other causes.
Godanti: (Gypsum) is hydrated calcium sulphate. It has been recommended for the treatment of menorrhagia in Ayurvedic literature.
Nagkesar: (Mesuaferra) is astringent and haemostatic. It controls acute bleeding and is indicated in uterine bleeding.
The combination of Ashoka and Nagkesar act synergistically to give a pronounced haemostatic effect in arresting Functional Uterine Bleeding.
MATERIALS AND METHODS
This study was conducted in 140 cases of Dysfunctional Uterine Bleeding. Of these 70 formed the Ayapon treated Group and the other 70 formed the Control Group (Untreated Group). 10 patients from each group were in the adolescent age group. 8 patients of the Ayapon Group and 9 patients of the control group were unmarried. The rest 123 patients were in the childbearing age group.
In all the 140 patients a detailed history was taken, including the history of menstruation, personal history and marital status. History of previous treatment, if any, was also elicited. A complete general, systemic and gynaecological examination was conducted. Complete haemogram was done in every case.
Dilatation and Curettage was done in all the married cases (123) and in one unmarried patient. In the Ayapon Group of 70 patients, treatment with Ayapon was given continuously for three Course when given, lasted for a further three month.
The control group was not given Ayapon. The patients of the Ayapon Group had haematinics, in addition, when those of the control group received only haematinics.
All the 140 patients were asked to report every month. The patients were followed up for 6 to 9 months. This study was carried out for a period extending to two years, from April 1973 to March 1975.
AGE INCIDENCE
Table 1 shows the age incidence of the patients of the present series. 51 patients of the Ayapon group and 55 patients of the Control Group, a total of 106 patients (75.7%) were between 21 to 35 years age. The youngest patient was aged 16 years.
| Age Group | Ayapon Group No. |
Ayapon Group % |
Control Group No. |
Control Group % |
Total No. |
Total % |
|---|---|---|---|---|---|---|
| Below 20 yrs. | 10 | 14.3% | 10 | 14.3% | 20 | 14.3% |
| 21 – 25 yrs. | 15 | 21.4% | 14 | 20.0% | 29 | 20.7% |
| 26 – 30 yrs. | 24 | 34.3% | 21 | 30.0% | 45 | 31.1% |
| 31 – 35 yrs. | 12 | 17.1% | 20 | 28.6% | 32 | 22.9% |
| 36 – 40 yrs. | 9 | 12.9% | 5 | 7.1% | 14 | 10.0% |
| Total | 70 | 100.0% | 70 | 100.0% | 140 | 100.0% |
PARITY
Table II shows the Parity. 8 patients (11.4%) in the Ayapon Group and 9 patients (12.9%) in the Control Group were unmarried (Total of 17 patients) (12.1%). A total of 32 patients (for both Groups) (22.9%) were Nulliparous, 70 patients (50.0%) had a parity of 1 to 5.
| Parity | Ayapon Group No. |
Ayapon Group % |
Control Group No. |
Control Group % |
Total No. |
Total % |
|---|---|---|---|---|---|---|
| Unmarried | 8 | 11.4% | 9 | 12.9% | 17 | 12.1% |
| Nulliparous | 17 | 24.3% | 15 | 21.4% | 32 | 22.9% |
| Para 1 – 3 | 18 | 25.8% | 20 | 28.5% | 38 | 27.1% |
| Para 4 – 5 | 15 | 21.4% | 17 | 24.3% | 32 | 22.9% |
| Para 6 & above | 12 | 17.1% | 9 | 12.9% | 21 | 15.0% |
| Total | 70 | 100.0% | 70 | 100.0% | 140 | 100.0% |
ENDOMETRIAL PATTERN
All the married women and one unmarried patient of the Ayapon Group, a total of 124 patient had Dilatation and Curettage. In the one unmarried patient above referred, the uncontrollable bleeding pervaginum, in spite of styptics, necessitated Dilatation and Curettage to rule out any pathological condition.
Secretory pattern of endometrium was found in 15 women (23.8%) of the Ayapon Group and in 18 women (29.5%) of the control group. On the whole 33 patients (26.6%) had a secretory pattern of the endometrium. 48 of the Ayapon Group and 43 of the Control Group, a total of 91 patients (73.4%) showed the non-secretory type of endometrium.
(D & C Not Done in 7 unmarried patients of the Ayapon Group and in 9 unmarried patients of the control group)
| Endometrium | Ayapon Group No. |
Ayapon Group % |
Control Group No. |
Control Group % |
Total No. |
Total % |
|---|---|---|---|---|---|---|
| Proliferative Endometrium | 23 | 36.5% | 28 | 45.9% | 51 | 41.1% |
| Secretory Endometrium | 15 | 23.8% | 18 | 29.5% | 33 | 26.6% |
| Cystoglandular Hyperplastic Endometrium | 14 | 22.2% | 5 | 8.2% | 19 | 15.3% |
| Hyperplastic Endometrium | 11 | 17.5% | 10 | 16.4% | 21 | 17.0% |
| Total | 63 | 100.0% | 61 | 100.0% | 124 |
DOSAGE
Cases of the Dysfunctional Uterine Bleeding of the Ayapon Group were started with 2 tablets of Ayapon three times a day, till the bleeding was controlled. This took about 6 to 9 days.
Thereafter, these patients were given Ayapon 2 tabs. two times a day after food, for three months continuously. This formed the 1st Course of treatment. Where necessary, the 2nd Course of three months was given.
The control group did not receive any Ayapon, but were continued with oral haematinics. Each patient was followed up for 6 to 9 months.
RESPONSE TO TREATMENT CORRELATED WITH ENDOMETRIAL HISTOLOGY
Ayapon Group: Since Endometrial pattern was known only in 63 women of the group, the results could be correlated in these patients only.
The response obtained in Cystoglandular Hyperplasia and Hyperplastic Endometrium was not as good as those obtained in the normal endometrium (Proliferative and secretory types) (Table V).
50.8% had Excellent Response, 31.8% had Good response, 7.9% had Fair Response, and 9.5% had Poor Response. Overall, 82.6% had satisfactory and encouraging response.
RESULTS
The response to treatment with Ayapon is classified as Excellent, Good, Fair and Poor, according to the immediate effect, recurrence, general well being of the patient, the duration of treatment etc. The results are compared with the Controls (Table IV).
These are illustrated in chart 1. 36 patients (51.6%) required only one Course of treatment and these were classified as Excellent. The majority of patients with Excellent response were in the age group of 21 to 30 years (Total of 39 patients).
20 patients (28.6%) are classified as Good response as they responded well with one month therapy with Ayapon. In the Control Group, who were all under constant observation and follow up, the response was Excellent only in 16 patients (22.8%).
| Group | Excellent | Good | Total Satisfactory | Fair | Poor | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | No. | % | |
| Ayapon | 36 | 51.6% | 20 | 28.6% | 56 | 80.2% | 8 | 11.4% | 6 | 8.4% |
| Control | 16 | 22.8% | 19 | 27.3% | 35 | 50.1% | 24 | 34.2% | 11 | 15.7% |
RESPONSE TO TREATMENT CORRELATED WITH ENDOMETRIAL HISTOLOGY
Ayapon Group: Since Endometrial pattern was known only in 63 women of the group, the results could be correlated in these patients only.
The response obtained in Cystoglandular Hyperplasia and Hyperplastic Endometrium was not as good as those obtained in the normal endometrium (Proliferative and secretory types) (Table V).
50.8% had Excellent Response, 31.8% had Good response, 7.9% had Fair Response, and 9.5% had Poor Response. Overall, 82.6% had satisfactory and encouraging response.
| Endometrium | Total No. |
Excellent | Good | Fair | Poor | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | ||
| Proliferative | 23 | 12 | 52.2% | 10 | 43.5% | 1 | 4.3% | – | – |
| Secretory | 15 | 10 | 66.7% | 2 | 13.3% | 2 | 13.3% | 1 | 6.7% |
| Cystoglandular Hyperplasia | 14 | 7 | 50.0% | 4 | 28.6% | 2 | 14.3% | 1 | 7.1% |
| Hyperplastic Endometrium | 11 | 3 | 27.2% | 4 | 36.4% | – | – | 4 | 36.4% |
| Total | 63 | 32 | 50.8% | 20 | 31.8% | 5 | 7.9% | 6 | 9.5% |
The patients aged 31 to 37 years had a repeat curettage one month after stopping Ayapon. These patients showed poor response in spite of 6 months therapy with the drug. The endometrial pattern was the same as before, Cystoglandular and Hyperplastic.
ENDOMETRIAL PATTERN AND OBSERVATIONS
The Control Group: In the Control Group 23.0% had Excellent Response, 26.2% had Good Response, 34.4% had Fair Response and 16.4% had Poor Response.
Over-all 49.2% had a satisfactory and encouraging response, while in the Ayapon group, the overall satisfactory response was 82.6%.
This indicated that Ayapon has a beneficial effect on the endometrial pattern in Dysfunctional Uterine Bleeding when compared to the Controls.
| Endometrium | Total No. |
Excellent | Good | Fair | Poor | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | ||
| Proliferative | 28 | 4 | 14.3% | 10 | 35.7% | 11 | 39.3% | 3 | 10.7% |
| Secretory | 18 | 7 | 38.9% | 4 | 22.2% | 5 | 27.8% | 2 | 11.1% |
| Cystoglandular Hyperplasia | 5 | 1 | 20.0% | – | – | 2 | 40.0% | 2 | 40.0% |
| Hyperplastic Endometrium | 11 | 2 | 20.0% | 2 | 20.0% | 3 | 30.0% | 3 | 30.0% |
| Total | 61 | 14 | 23.0% | 16 | 26.2% | 21 | 34.4% | 10 | 16.4% |
Chart 2 shows the Response to Endometrial Pattern in the Ayapon treated group and the untreated group who were kept as control.
The response is encouraging in the normal pattern (Proliferative and secretory) when compared to Cystoglandular & Hyperplastic patterns. However, even in these 2 conditions, the response in Ayapon Group is better than in the untreated cases.
SIDE EFFECTS
Two patients of the Ayapon Group complained of palpitation and they felt better after reassurance. Both of them were obese patients.
DISCUSSION
The variety of drugs in the form of styptics, hormones-varying from oestrogens, progestogens to androgens, and vitamins, used by various gynaecologists have varying claims.
Even among the hormones, the dose of the drug is different with different doctors, and it may change during each menstrual cycle. The patients desire a dramatic and remarkable improvement and they do not have any patience, which makes them visit different doctors.
Proper history and choice of treatment are very essential. Hormones cannot be used for a long time, especially among the young girls and in women of the premenopausal age group. There may be side effects such as intense nausea, headache and profuse withdrawal bleeding.
Ayapon is safe for prolonged use and cheap as compared to the hormones. Side effects are negligible and there is no fear of withdrawal bleeding.
Saxena had observed Excellent Response in 8% and overall encouraging results in 58% among 50 patients. In our study, 36 patients (51.6%) showed Excellent Response and overall encouraging results in 56 patients (80.2%).
Shah and Visaria obtained Excellent Response in 65% and Good in 16%, and overall response of 81% almost as in our series. Shelat and Shah have tried this drug for bleeding after myomectomy and found encouraging results.
CONCLUSION
- The present trial shows the response to Ayapon in 70 patients with Dysfunctional Uterine Bleeding. 70 patients were under observation and follow-up as Control, where no treatment was given.
- 124 patients of these 140 patients had dilatation and curettage.
- Encouraging results were observed in 2% with Ayapon.
- Best results were observed in the proliferative and secretory endometrial patterns, and in the age groups of 21 to 30.
- Ayapon showed negligible side
- This drug is safe and
ACKNOWLEDGEMENT
I am thankful to Dr A. Sitaratna, Superintendent, Govt. Kasturba Gandhi Hospital for Women and Children, Madras, for permitting me to publish this paper.
I thank the Research Division of Alarsin Pharmaceuticals, Bombay-1, and in particular Mr. Thirugnanamurthy, for the adequate supply of Ayapon and the relevant literature.
REFERENCES
- Javeri: Indian Practitioner, 18 (11): 783-786, Nov. 1965.
- Mukerjee, Gouri, and Mukerjee, Krishna, The Indian Practitioner, XXVII (9): 405-408, Sept. 1974.
- Rohatgi, P.: The Antiseptic, 63 (11): 874-878, 1966.
- Saxena, C.: Current Medical Practice, 17 (5): 223-228, May 1973.
- Shah, M. and Visaria, S.: Paper read at the conference of the Bombay Obst. & Gynec. Society, 16-17, Dec. 1972, Bombay.
- Shelat, K. and Shah, U. N.: The Indian Practitioner, 19 (10): 697-702, Oct. 1966.
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