FUNCTIONAL UTERINE BLEEDING
TREATMENT WITH AN INDIGENOUS DRUG: “AYAPON”

INTRODUCTION

The term functional uterine bleeding includes all the cases in which bleeding occurs from the uterus in the absence of any discoverable uterine disease. Some authors prefer to call it “Dysfunctional haemorrhage.”

Such cases are frequently seen in gynecological practice. The pathogenesis of the condition is not yet fully understood, but it is believed to be due to disturbance of the normal pituitary ovario-uterine relationship which controls the normal menstrual cycle.

Presenting features in these cases may be menorrhagia, polymenorrhoea, or prolonged bleeding at irregular intervals.

The treatment of functional uterine bleeding is frequently a difficult problem, and quite often the usual medical, surgical or hormone therapy affords no relief.

From ancient times, certain indigenous herbal preparations have been used in India for treating uterine diseases. The present trial was undertaken to study the efficacy of “Ayapon” (Alarsin), a combination of some Ayurvedic drugs, in the treatment of established cases of functional uterine bleeding.

AYAPON TABLET

Each tablet of “Ayapon” contains:

1. Ayapan (Eupatorium ayapana) — 130 mg
2. Nagkeshar (Mesua ferrea) — 32 mg
3. Ashoka (Saraca indica) — 130 mg
4. Godanti (Gypsum) — 32 mg

PHARMACOLOGY

1. Ayapan: Is prepared from the dried leaves of Eupatorium ayapana and contains ayapin (6:7 methylene dioxycoumarin), ayapanin (7-methylene coumarin) and an essential volatile oil. Both ayapin and ayapanin possess hemostatic property when applied locally or taken internally. Ayapan has been used to check internal haemorrhage, haematuria, haemoptysis, etc. It has also been used as a bitter tonic, expectorant, diaphoretic and antiperiodic and as an antidote to snake-bites.
2. Nagkeshar: (Mesua ferrea) — It is an astringent and stomachic and contains two bitter principles; it has been used in the treatment of gastritis and other conditions.
3. Ashoka: (Saraca indica) is the bark of the tree of that name possessing strongly astringent and uterine sedative properties. It acts on the muscular fibers of the uterus and exerts a stimulating effect on the endometrium and the ovarian tissue and has been used in uterine affections, specially menorrhagia, also hemorrhoids and haemorrhagic dysentery.
4. Godanti: (Gypsum) is hydrated calcium. It is antacid and astringent and has been recommended in Ayurvedic literature for use in the treatment of menorrhagia.

All the 4 drugs have been advocated for the treatment of menorrhagia in Ayurvedic literature and are generally used in combination, to secure better synergistic action.

SELECTION OF CASES

One hundred and ten patients between 20 and 48 years of age, with functional uterine bleeding were selected for this study.

They were either attending the Out-patient Departments of Upper India Sugar Exchange Maternity Hospital and Dufferin Hospital or were admitted in these hospitals.

A thorough preliminary examination excluded local pathological conditions. Cases with profuse bleeding and in a serious condition were not included in the study.

“Ayapon” (Alarsin) was given to the patients, in a dosage of 2 tablets three times a day for 2 to 3 months. In some cases the drug was continued for about 5 months.

The 110 patients, with functional uterine bleeding (F.U.B.) fell into 7 different groups (see Table I).

RESULTS

The main criteria of improvement were:

1. Reduction in quantity of bleeding;
2. Reduction in duration of bleeding; and
3. Change in the irregularity of the period towards normal.

Depending upon the degree of relief obtained the results were placed in groups as under:

Excellent — showing complete relief of symptoms and reversal to regular periods;
Good;
Slightly improved; and
No improvement.

I. MENORRHAGIA

Improvement was observed in 49 or 84.5% of cases. Reduction in the quantity and duration of bleeding was observed within 8 to 10 days of therapy.

In 16 cases the periods were irregular; and in 12 of them which showed improvement, the periods had become regular after 2 or 3 months of therapy.

In most cases the treatment was continued for about 3 months, while in a few cases the drug was continued for 2 more months.

Twenty patients in this group were followed up for 8 to 10 months after stopping the drug. Recurrence of bleeding occurred in 4 after 6 to 9 months.

They, however, responded to a second course of Ayapon which was again continued for 2 or 3 months.

Fourteen patients in this series presented with profuse bleeding. The bout of bleeding was controlled by hormone therapy in these patients who were then put on Ayapon therapy to regulate the cycle.

All of them reported regular cycles and moderate bleeding after 2 to 3 months of treatment.

II. FUNCTIONAL UTERINE BLEEDING AFTER DILATATION AND CURETTING

Improvement was observed in 13 or 81.25% of the 16 cases and the bleeding stopped in all after 2 or 3 weeks of therapy.

Subsequent periods had become normal in 6 patients while profuse bleeding occurred in eight during subsequent cycles which became moderate after 2 or 3 months of therapy.

III. FUNCTIONAL UTERINE BLEEDING OF PUBERTY

Improvement was observed in 5 or 83.3% of the 6 cases; and treatment had to be continued for 4 to 5 months.

In 3 of them the cycles were also irregular and became regular after 3 or 4 months of therapy.

IV. FUNCTIONAL UTERINE BLEEDING AFTER DELIVERY

Fourteen patients had continuous irregular bleeding for 3 to 6 months after delivery.

Methylergometrine tablets, Calcium injections, Styptochrome, Clauden were all of no avail.

Reduction in quantity was observed in 13 of the 14 patients after 2 or 3 weeks of Ayapon therapy; the cycles had also become regular and moderate after 2 or 3 months of therapy.

V. FUNCTIONAL UTERINE BLEEDING OF MENOPAUSE

Improvement was observed in 3 of the 4.

Hormonal therapy showed initial improvement in 2 of the 4 patients but later on there was recurrence in spite of treatment.

Ayapon therapy brought about an improvement within 4 to 6 weeks, and the treatment was continued for 4 months.

In one patient bleeding recurred one month after stopping the drug, but was controlled after 4 weeks of Ayapon therapy.

VI. FUNCTIONAL UTERINE BLEEDING AFTER CAESAREAN SECTION

Eight patients had irregular or continuous but not profuse bleeding after caesarean section for 1 to 3 months.

Ayapon therapy effected improvement in 7 or 87.5%.

Bleeding stopped within 2 to 4 weeks of therapy.

In 3 of them bleeding stopped completely resulting in lactational amenorrhoea; and the periods became regular and moderate after treatment.

VII. METROPATHIA HAEMORRHAGICA

Four patients with metropathia haemorrhagica showed cystic hyperplasia on histopathological examination of their endometrium.

Curettage and hormonal therapy had failed to evoke any satisfactory response.

Continuous Ayapon therapy for four months effected a reduction in the bleeding in only one patient in whom bleeding recurred after six months.

Ayapon was started again and relief was obtained after two months.

DISCUSSION

In the absence of a precise knowledge of the aetiology of functional uterine bleeding, treatment has to be empirical and it is not satisfactory in most cases.

The results of Ayapon therapy in 110 patients with functional uterine bleeding are very encouraging as it produced satisfactory response in 81.8% of the patients, which included cases of menorrhagia, functional uterine bleeding after dilatation and curettage, of puberty, menopause, after caesarean section and a few cases of metropathia haemorrhagica.

Phadnis (1964) from Poona reported very encouraging results with Ayapon in some resistant cases of functional uterine bleeding.

Pandya (1963) found a combination of Ashoka and Nagkeshar useful in the treatment of menorrhagia; Mehta (1964) also reported good results with Ayapon therapy in menorrhagia and metrorrhagia.

Javeri (1965) from Baroda found it to be effective in 89.8% of cases of functional uterine bleeding.

Ayapon therapy showed encouraging results in 81.8% of the patients in our series, and proved helpful in some cases in avoiding surgical or other drastic drug treatment.

The drug was not used on patients who had profuse bleeding and the general condition therefore, was serious.

In a few cases where the initial bout of hemorrhage was controlled by hormone therapy in cases of menorrhagia, subsequent Ayapon therapy helped in regulating the menstrual cycle.

Relapse was seen in 4 or 20% of 20 patients with menorrhagia who were followed up for 8 to 10 months, but all of them responded to a second course of the same therapy.

No toxic symptoms were observed even when the drug was continued for 4 to 5 months.

SUMMARY

Ayapon (Alarsin) was tried in the treatment of 110 patients with functional uterine bleeding, and found effective in 81.8% of them.

They included cases of menorrhagia, functional uterine bleeding after dilatation and curetting, of puberty, menopause, after delivery and caesarean section and metropathia haemorrhagica.

Of 4 cases of metropathia haemorrhagica treated with the drug, improvement was observed in only one case and this patient had a relapse after six months.

No toxic effects were observed even when the drug was continued for 5 months.

ACKNOWLEDGEMENT

I am thankful to M/s. Alarsin Pharmaceuticals, Bombay, for the supply of Ayapon tablets, used in this clinical study.

REFERENCES

1. K. L. (1896) — The Indigenous Drugs of India, 2nd Ed., Thacker Spink and Co., Calcutta.
2. Ghosh (1957) — Pharmacology, Materia Medica and Therapeutics, 20th Edition. Hilton & Co., Calcutta.
3. V. (1965) — Ind. Practitioner, 18: 783.
4. Mehta, M. (1964) — Paper read at the Session of 40th All India Conference at Kakinada.
5. Nadkarni, M. (1954) — Indian Materia Medica, revised and enlarged by Nadkarni, A. K., 3rd Edition.
6. S. C. (1963) — Current Medical Practice, 7: 543.
7. Phadnis, H. N. (1964) — The Antiseptic, 61.
8. The Antiseptic, November 1966: 63: 11, 874-78.