(The Antiseptic (1988): (85), 4, 190.)

SEPTILIN — A Study of its efficacy in
Patents with Chronic Suppurative Otitis Media

S.R. Agrawal, M.D., D.L.O.,
Officiating Head,

and
A.K. Saxena, M.B.,B.S., D.L.O.,
Post-graduate Student,
E.N.T. Department, G.R. Medical College, Gwalior, (M.P.).

 

INTRODUCTION

Septilin is a drug which is chemically distinct from other available antibiotics.

Each tablet of Septilin contains:

Balsamodendron mukul

0.612 g.

Maharasnadi quath

65 mg.

Exts.

Phyllanthus emblica

16 mg.

Tinospora cordiforia

49 mg.

Rubia cordifolia

32 mg.

Moringa pterygosperma

16 mg.

Pristimera indica

6 mg.

Shankh bhasma

32 mg.

It is claimed that Septilin is very effective in chronic infections especially of the upper respiratory tract and ear.

The present study with Septilin was done in patients with chronic suppurative otitis media. The culture and sensitivity (to commonly used chemotherapeutic agents) of causative organisms was done in one group of patients.

MATERIAL AND METHODS

Patients with suppurative otitis media were selected from the Out-Patient Department and E.N.T. Ward of J.A. Group of Hospitals attached to G.R. Medical College, Gwalior. A total of 150 patients of different age groups suffering from chronic suppurative otitis media were selected. In all cases, a complete E.N.T. examination was done.

Group A consisted of 75 patients whose ear swabs were taken and culture and sensitivity test were done in cases. Other investigations done were: total and differential W.B.C. count, urine examination, X-ray of both mastoids, X-ray of paranasal sinuses, surgical interventions such as antrum puncture and lavage.

Group B comprised of 75 patients who were taken up for treatment without the usual investigation.

Tonsillectomy was done in some cases. The cases were categorised as mild or severe grade infections. The dose of Septilin employed depended on the severity of the infection, response to the drug during the first two weeks and on the age of the patients. The dosage schedule is given in Table I.

 

Table I : Dosage schedule of Septilin in the present study

Route

Adult

Children

 

Mild

Severe

Mild

Severe

Oral

1 t.i.d.

2 t.i.d.

1 t.i.d.

1 t.i.d. to 2 t.i.d.

In severe cases in adults dose of 2 t.i.d. was continued for 3-4 weeks. In mild cases dose of 1 t.i.d. was continued for 3-4 weeks.

The response to Septilin was evaluated as excellent, good, poor and no response. Clinical improvement was judged on the basis of the degree of discharge, whether it was reduced, stopped or became thin and then reduced.

RESULTS

Before starting Septilin therapy, culture and sensitivity of ear swab were done in 75 patients. The organisms cultured and their sensitivity to various chemotherapeutic agents has been shown in Table II.

Table II : Resistance of organisms to different chemotherapeutic agents

Organism

Chomotherapeutic agents

 

P.

Str.

Tet.

Ery

Kan.

Amp.

Chl.

Su.

Staphylococcus (Coagulase negative) ...

R

R

R

R

R

R

R

R

Staphylococcus (Coagulase positive) ...

R

R

R

R

R

R

R

R

Mixed growth ...

R

R

R

R

R

R

R

R

E. Coli ...

R

R

R

R

R

R

R

R

Legend: P = Pencillin, Tet = Tetracycline, Kan = Kanamycin, Chl. = Chloramphenicol, R = Resistant,

Str. = Streptomycin, Ery. = Erythromycin, Amp. = Ampicilin, Su. = Sulfa.

The clinical response to therapy in both the groups of patients (Group A— where culture and sensitivity of ear swab was done and Group B — where therapy was started without such investigation) has been shown in Tables III and IV.

Table III : Group A
Culture and sensitivity done — All cases were resistant to all commonly-used therapeutic agents

No. of cases

Excellent

Good

Poor

No response

75

42

17

10

6

Percentage

56%

22.66%

13.33%

8%

Table IV : Group B
Therapy was started without doing the culture and sensitivity

No. of cases

Excellent

Good

Poor

No response

75

39

16

11

9

Percentage

52%

21.33%

14.66%

12%

The average duration of therapy was 4 weeks and the average duration of follow-up was 6 weeks.

DISCUSSION

The present study shows that Septilin therapy was effective in cases of chronic suppurative otitis media, observations being made on the basis of response to therapy.

Out of the 75 patients of Group A (cases resistant to all antibiotics):—

1.

56% cases showed excellent results. The response was achieved within 1-3 weeks and there was no discharge for the total duration of follow-up (6 weeks on an average).

2.

22.66% patients showed good response—response was achieved within 3-5 weeks and there was no discharge for the total duration of follow-up.

3.

13.33% cases showed poor response—discharge was reduced but had not stopped altogether.

4.

8% patients did not show any respose to therapy.

 

Out of 75% patients of Group B—where culture and sensitivity was not done, the results were as follows :

53% excellent, 21.33% good response, 14.66% poor response, 12% no response. No drug reaction or any sign of toxicity was noticed.

Vishwakarma, S.K, also observed in his trial that Septilin is equally effective in acute and chronic infections of ear, nose and throat with minimal recurrence. The marked anti-inflammatory and anti-exudative property of Balsamodendron mukul has been demonstrated by Gujral, M.L. (1962) in experimental rate. This is in accord with the result of the present trial.

SUMMARY

Septilin therapy was found to be effective in cases of chronic suppurative otitis media with minimal recurrence (only 2 in Group A and 5 in Group B) particularly in resistant cases. As far as recurrence is concerned, this was overcome when therapy was continued again for about 4-5 weeks without any sign of toxicity, sensitivity of hypersensitivity.

The cause of recurrence was probably due to the discontinuation of the drug by the patients. Secondly it may be due to the fact that patients did not follow the instructions of aural hygiene properly.

ACKNOWLEDGEMENT

The authors are thankful to Dr. J.N. Monga, M.D., Professor and Head of the Department of Pathology, G.R. Medical College, Gwalior, for the necessary guidance and facilities. We are also thankful to Dr. S. Vashishtha, M.S., Superintendent and Joint Director, J.A. Group of Hospitals, Gwalior for permitting us to conduct the trial.

REFERENCES

1.

Barber, M. And Waterworth, P.M. (1964)— Brit. Med. J., 2: 603.

2.

Cooper, R.A.F. and Merchant, N.R., (1958)—Ind. J. Otolaryngology, 4: 14.

3.

Duncan, I.B.R. and Jeans, B., (1965) — Canad. Med. Assoc. J. 93: 685.

4.

Weinstein, L. (1965) — in the Pharmacological basis of therapeutics, Ed L.S. Goodman & Gilman, The MacMillan Company, New York, p.1260.

5.

Gujral, M.L. et al. (1962)— Ind. J. Med. Sci., 10: 847.

6.

Vishwakarma, S.K., (1979)—Septilin in Ear, Nose and Throat Infection, Probe, 2: 85.