for the use only of a registered medical practitioner or a hospital or a laboratory.
Safe, Simple Approach
to DYSFUNCTIONAL UTERINE BLEEDING
USE OF AYAPON IN FUNCTIONAL UTERINE BLEEDING
By
Dr S. C. SAXENA, M.S.,
Reader in Obstetrics and Gynaecology, Medical College, Jabalpur, M.P.
Current Medical Practice, Page 223 to 228 Vol. 17 – No. 5 May 1973
Irregular vaginal bleeding is a common complaint in women of child-bearing age attending the gynaecological out-patients department of every hospital. It is doubtful whether the word ‘functional’ should be used to describe any clin ical condition, but it has a useful currency in medicine as a definition of a group of complaints in which no detectable pathology, or therefore, physical signs can be found by ordinary clinical examination. Strictly, the terms functional’ should apply only to such conditions as are caused by a disturbance of normal function, whether nervous or endocrine before structural changes have begun. The limits of normal functions are so wide that perfect health may exist within these limits. They are blurred and easily passed one way or the other as a result of minor or temporary influences of daily life. The functions of normal menstruation, for example, differs so much in different people that each individual may be normal though her period lasts two days or a week. So long her health is unimpaired, inconvenient though her type of menstruation personally may be, we must say that her function is normal. A woman may complain of a week’s or even more of menstruation, perhaps with inconveniently heavy loss, but for her it is inherent in her endocrine pattern and nothing we do will change it any more than we can alter the colour of her iris. But a prolonged and definite alteration of function beyond the wide limits of a particular individual’s normal, will sooner or later, cause a detectable pathology and so organic disease. Menstruation is the end result of a chain of coordinated glandular activities of unknown complexity and affords a remarkable example of the interplay of hormonal influences which can de range before organic changes occur.
The fundamental principles of treatment of such type of bleeding are : (1) In youthful pa tients it is usually safe and wise to procrasti nate, whereas in women past the age of 40 years, treatment should be prompt and radical, and (2) Intrue functional disturbances the treat ment aims at controlling symptoms, the cure being nearly always spontaneous .
As the disease is self-limiting , treatment should be aimed at tiding over the crisis. The present.study deals with the treatment of functional uterine bleeding with Ayapon (Alarsin).
MATERIALS’ AND METHODS
50 female patients of child-bearing age were selected for the present trial. Before instituting the treatment a thorough general and systemic examination was performed. Patients suffering from organic disorders like neoplasms of female genital tract or tuberculosis were excluded from the present trial.
Pharmacology of Ayapon :
The.drug used was tablets of Ayapon . Each tablet contains:-
Ayapan (Eupatorium ayapana) 130 mg
Ashoka (Saraca indica) 130 mg
Godanti (Gypsum) 32 mg
Nagkeshar (Mesua ferrea) 32 mg
Ayapan (Eupatorium ayapana) : It is prepared from dried leaves of Eupatorium ayapana, which contains ayapin (6:7 methylene dioxycoumarin) and ayapanin (7- methylene coumarin) and an essential volatile oil. Both ayapin and ayapanin are non-toxic and possess haemostatic property when applied locally or taken internally. Ayapan has been used effectively to check internal haemorrhage. The haemostatic properties of E.ayapana have been studied in dogs (quoted by Jahagirdar 1970).
Ashoka (Saraca indica) : Is the bark of the tree possessing strongly astringent and uterine sedative properties. It acts on the muscle fibres of the uterus and exerts a stimulating effect on the endometrium and ovarian tissue and has been used In uterine affections especially menorrhagia due to uterine fibroids and other causes and postpartum haemorrhages.
Godanti (Gypsum) : Is dehydrated calcium sulphate. It has been recommended in Ayurvedic literature for the treatment of menorrhagia. It is astringent,antacid and is cooling. It provides calcium in assimilable form and is therefore haemostatic.
Nagkeshar (Mesua ferrea) : It is astringent. haemostatic, and stomachic. It decreases acute bleeding and is therefore useful during bleeding episodes and thus decreases the amount of bleeding.
DOSAGE :
28 patients had regular menstrual cycles with menorrhagia.They were given 2 tablets of Ayapon three times a day, starting 7 days before the onset of bleeding.
13 patients had polymenorrhagia, and 9 had menometrorrhagia. They were given 1 tablet of Ayapon three times a day for 30 days.
In both the groups. the treatment was continued for three months. Along with Ayapon they were given hematinics for anaemia.
At the first visit a detailed history including the menstrual history, personal and marital his tory was taken. A thorough general,systemiic and gynaecological examination was conducted.
The patients were asked to come for follow up every month. At each visit a detailed history regarding the amount and duration of bleeding was noted. They were enquired regarding any side effects of the drug. Patients were followed up for a period of six months. If the patient did not respond to three month therapy, the treatment was continued for a period of six months. Patients who responded to the treatment were also followed up for a period of six months
OBSERVATIONS
Age Incidence: Table I show the age incidence of the patients of the present series. A maximum number of patients belonged to the age group 21-35 years. The youngest patient was aged 18 years and the oldest was aged 40 years.
TABLE-1
Age incidence
| Age group | No. of cases | % |
| 15-20 years | 7 | 14 |
| 21-25 years | 10 | 20 |
| 26-30 years | 11 | 22 |
| 31-35 years | 14 | 28 |
| 36-40 years | 8 | 16 |
| 50 |
Parity : Table 2 shows the parity distribution of the patients of the present series.
TABLE-2
Parity distribution
| Parity | No. of cases | % |
| Para O | 10 | 20 |
| 1 | 10 | 20 |
| 2 | 4 | 8 |
| 3 | 10 | 20 |
| 4 | 10 | 20 |
| 5 | 2 | 4 |
| Unmarried | 4 | 8 |
| 50 |
Menstrual History: Table 3 shows the type of menstruation with which these patients presented at the hospital.
TABLE-3
Menstr·ual history
| Type of menstrual disorders | No. of cases | % |
| Menorrhagia (with normal cycles) | 28 | 56 |
| Polymenorrhagia | 13 | 26 |
| Meno-metrorrhagia | 9 | 18 |
| 50 |
Duration of Complaints: Table 4 shows the duration of complaints in these patients.
TABLE-4
| Duration | No. of cases | % |
| 1-6 months | 19 | 38 |
| 7-12 months | 10 | 20 |
| 13-24 months | 7 | 14 |
| More than 2 years | 14 | 18 |
| 50 |
Pelvic Examination Findings: Table 5 shows the pelvic examination findings in these patients.
TABLE-5
Pelvic examination findings
| Physical findings | No. of cases | % |
| Bulky uterus | 13 | 26 |
| Retroverted uterus | 20 | 40 |
| Palpable ovaries | 4 | 8 |
| Normal | 50 |
PREVIOUS TREATMENT :
40 patients gave history of some previous treatment. 4 patients were previously treated with lnj. testosterone (Aquaviron 25 mg alt. day i.m.x. 4 each month). 4 patients were treated earlier with lnj. Ranodine (probably for pelvic in flammation) : 4 patients gave history of previ ous treatment with oral progestogens (Primolut-N). 28 patients gave history of previ ous dilatation and curettage. In one case 1t was performed 4 times, in 2 cases three times, in 3 cases two times, and in 22 patients once. Table 6 shows the previous treatment received by these patients.
TABLE-6
Type of previous treatment
| Previous treatment | No. of cases | % |
| lnj. Testosterone | 4 | 8 |
| Oral Progestogens | 4 | 8 |
| lnj. Ranodine | 4 | 8 |
| Dilatation and currettage | 28 | 56 |
| None | 10 | 20 |
| 50 |
The histology findings of endometrium in 28 patients who had the previous curettage shown in Table 7.
TABLE-7
Endometrial biopsy findings
| Type of endometrium | No. of cases | % |
| Non-secretary endometrium | 16 | 57 |
| Secretory endometrium | 6 | 21 |
| Hyperplastic endometrium | 3 | 11 |
| Metropathia haemorrhagic | 3 | 11 |
| 28 |
RESULTS
Table 8 gives the results of the treatment. In 4 patients the result was excellent. All of them re responded after one course only. In 25 patients the result was good, all of them responded to the treatment after getting a three month course. 11 patients responded after asix month therapy. Inthem the amount of bleeding had reduced. Hence the result was considered as fair, while 1o patients did not respond even to a six month therapy.
Thus 40 patients out of 50 cases responded favourably to the treatment and had relief of their symptoms.
TABLE-8
Results
| Result | No. of cases | % |
| Excellent | 4 | 8 |
| Good | 25 | 50 |
| Fair | 11 | 22 |
| No relief | 10 | 20 |
| 50 |
Table 9 shows the result according to the type of menstrual disorder.
It is seen that the patients who responded best with treatment were those who were suf firing from menorrhagia. Out of these 28 cases, 4 responded very well to treatment (requiring one course only) while in 17 cases the amount of bleeding reduced after three-month therapy. 4 patients showed response after six months, while 3 did not respond at all.
TABLE-9
Result according to the type of menstrual disorder 0
| Result | ||||||
| Type of menstrual disorder | No. of cases | Excellent | Good | Fair | No | % |
| Menorrhagia | 28 | 4 | 17 | 4 | 3 | 89.3% |
| Polymenorrhagia | 13 | – | 8 | 2 | 3 | 76.9% |
| Menometrorrhagia | 9 | – | 5 | 4 | 55.5% | |
RESPONSE TO TREATMENT CORRE LATED WITH ENDOMETRIAL HISTOLOGY :
The pattern of endometrium was known in 28 patients who had endometrial curettage ear lier. They were suffering from menorrhagia. They were given 2 tablets of Ayapon three times a day, 7 days prior to the onset of menstruation. The response of treatment in them is shown in Table 10. The curettage was not repeated after the completion of therapy, hence the endometrial histologic response to treatment is not known.
TABLE-10
Result according to the type of endometrium {in 28 cases)
| Result | ||||||
| Type of endometrium | No. of cases. |
Excellent |
Good |
Fair |
No cure |
% |
| Non-secretory Endo. | 16 | – | 15 | 1 | – | 100% |
| Secretory Endo. | 6 | 4 | 2 | – | – | 100% |
| Hyperplastic Endo. | 3 | – | 3 | – | 100% | |
| Metropathia Haemorr. | 3 | – | – | 3 | 0% | |
Relation of dosage to response to treatment: 28 patients suffering from menorrhagia were given 2 tablets three times a day starting 7 days prior to the onset of menstruation. 13 patients with polymenorrhagia and 9 cases with menometrorrhagia were given one tablet three times a day for thirty days. In both the groups the treatment was given for three courses. Table 11 and 12 show the relation of dosage to the treatment response.
TABLE-11
Relation of dosage to response to treatment
| Dosage | No. of cases | % | ||||
| Excellent | Good | Fair | No cure | |||
| 2 t.d.s. x 7 days | 28 | 4 | 17 | 4 | 3 | 89.3% |
| 1 t.d.s. x 30 days | 22 | 8 | 7 | 7 | 68.1% |
TABLE-12
Duration of treatment
|
Type of menstrual disorder |
No. of cases | Duration of treatment |
No relief after 6 mth. |
||
| 1 mth. | 3 mth. | 6 mth. | |||
|
Menorrhagia |
28 | 4 | 17 | 4 | 3 |
| Polymenorhagia | 13 | – | 8 | 2 |
3 |
| Menometrorrhagia | 9 | – | – | 5 |
4 |
Side effects : Only one patient complained of excessive heat and ‘ghabrahat’. Otherwise no other side-effects were noted in other cases
DISCUSSION
The multiplicity of methods of treatment employed for functional uterine haemorrhage is evidence of the difficulties and disappointments.
Styptics, drugs, various combinations and timings of hormones including ovarian hormones, androgens, gonadotrophins, lactogen, thyroid extract, pitressin, vitamins, an anti-menorrhagia factor of liver, radiotherapy and operations have all been tried with varying claims of success by different workers.
A patient who consulted a dozen different gynaecologists would probably be given the same number of different hormones in different combinations and af differentiates in the menstrual cycle. And the result of each of the treatments might well be substantially the same.
Some hormonal and other treatments which have been advocated, are based upon a tenu ous “Physiology”, and have been assessed on vague reports by the patients who are naturally incapable of exactitude unless the results have been unmistakable. In functional haemorrhage, there is no sharp measurement by which the effects of the treatment can be estimated, and al ways there is a strong subject factor in the ob server which gives him a bias in favour of suc cess.
In those where the active treatment is necessary, the lead will be given by general examination, curettage, and the emotional type of the woman. Antecedent events particularly aseptic abortion or labour must also be considered.
The main mode of action of Ayapon is its haemostatic properties, presence of assimilable calcium and its effects on uterine musculature causing coordinated uterine contractions, thereby limiting the amount of haemorrhage. As the drug is nonhormonal, the problem of hor monal disturbance by the drug does not arise. For similiar reasons, the timing of the drug dur ing a menstrual cycle is also not a problem. In the present study two regimens were used. In one the drug was given in higher dose in pre menstrual phase, while in the other it was given continuously for a month. The latter regimen was more suitable for patients having irregular acyclical bleeding and for patients with shortcycles and heavy bleeding (Polymenorrhagia), where there was difficulty in calculating the length of the cycle.
The drug was also used by various workers for the treatment of menorrhagia after the childbirth or abortion (Jhaveri, 1965; Shelat and Shah 1966; Jahagirdar 1970; Shah and Visaria, 1972), for menorrhagia or irregular bleeding due to l.U.C.D, (Jhaveri 1965; Shelat Shah 1966), and bleeding after myomectomy (Shelat and Shah 1966). All these authors gave en couraging results with the drug for various indications.
CONCLUSIONS AND SUMMARY
- Present paper deals with the use of Ayapon for the treatment of functional uterine bleed ing in 50 cases.28 patients had menorrhagia, 13 had iJOlymenorrhagia, and 9 had.metrorrhagia.
- Menorrhagia cases were given 2 tablets three times a day in premenstrual phase for 7 days, while the other two groups were given 1 tablet three times a day for 30 In all the three groups the treatment was continued for three to six months.
- Best results were obtained in menorrhagia
- 4 patients had cure after one-month treatment, 25 showed cure after three-month treatment, and 11 after six month 1O cases did not respond to the treatment at all.
- Only one patient complained of ‘Ghabrahat’ and feeling of heat, otherwise, no other side effects were observed with the use of the drug.
- The drug owes its effect to its haemostatic properties and uterine sedative action.
- The drug is nonhormonal, cheap, very effective and without side-effects.
- The cure-rate in the present series is 80% .
ACKNOWLEDGEMENT
I am thankful to Prof. K. Gupta, Head of De partment of Obstetric and Gynaecology and Dr.
P. Mishra, Dean, Medical College, Jabalapur (M.P.), for their kind permission to present this series. I am also thankful to Shri Yuvraj Singh of M/s. Alarsin for his co-operation in the conduct of this trial.
REFERENCES:
- Jahagirdar , R. : Paper read at XVI Conference of International College of Surgeons , Hyderabad, 2-4 October 1970.
- Jhaveri, : The Indian Practitioner, November 1965.
- Kodkany, K. :The Indian Parctitioner, December 1968.
- Mehta, M. : Paper read before the Scientific session of 40th All India Medical Conference, AT Kakinada (A.P). December 1963.
- Mitra, : Mediscope, Madras, May 1968.
- Phadnis, H. : The Antiseptic , October 1964.
- Rohatigi, : The Antiseptic , November 1966.
- Shah, M. and Visaria, S. : Paper before 2nd Conference of the Bombay Obstetric and Gynaecological Society, 16-17 December 1972.
- Shelat, K. and Shah, U. N. : The Indian Practitioner, October 1966.