P. Ramanjaneyulu, M.S., D.L.O., F.I.C.S., F.I.M.S.A.,
Civil Surgeon, E.N.T. Specialist,
Gandhi Medical College, Hyderabad and Gandhi Hospital, Secunderabad.

Septilin (Himalaya), an indigenous drug, is chemically distinct from all other antibiotics.

Each tablet of Septilin contains :—

Chronic otorrhoea is a common condition in the out-patient department of E.N.T. constituting nearly one-third of the cases. Many a time otorrhoea persists in several cases in spite of the administration of several antibiotics which are not only costly but quite often ototoxic. In view of this, the present trial of Septilin in chronic otorrhoea was taken up, as Septilin is an indigenous drug which is economical and has no known ototoxicity.

This study was conducted from December 1981 to November 1982 for a period of one year and in Gandhi Hospital, Secunderabad attached to the Gandhi Medical College, Hyderabad. The total number of cases was 204, comprising either sex and of all ages. As a routine, a thorough general and E.N.T. check-up was done and aural swabs were taken for culture and sensitivity of organisms to various chemotherapeutic agents including Septilin, before starting this trial with Septilin.

The usual course of treatment consisted of Septilin two tablets, three times a day for adults and one tablet three times a day for children for 10 days. The response was assessed by the absence of ear discharge and the ear becoming dry. Wherever, necessary the course was repeated till the ear became dry.

In order to have a controlled study to judge the response to therapy, treatment with a placebo tablet of same size, shape and colour was administered. In addition to the oral administration of cleaning the ear, followed by administration of "spirit boric drops" and sometimes chloramtration of tablets, the local treatment consisted of phenicol ear drops. The various organisms that were found on culture from the aural discharmococcus, Pseudomonas, Klebsiella, E. Coli and Proteus organisms. The culture was sterile in a good number of cases (49). The response to Septilin with one course of treatment was 59%, whereas with a repeat course of Septilin it was 90%. The average duration of therapy was 20 days.

Septilin is found to be helpful in the majority of cases with administration of 2 courses of therapy i.e., 2 tabs. 3 times a day, for 20 days. This therapy is in addition to the commonly-used spirit boric acid ear-drops in out-patients and chloramphenicol ear-drops for those who could not attend the out-patient department.

Septilin therapy was found effective in patients who have developed resistance to various antibiotics. Moreover, in some cases not only the clinical response but also the antibiotic sensitivity with Septilin show a zone of inhibition in culture media (Staphylococci-3, Streptococci-Nil, Pseudomonas-3, Pneumococci-Nil, Klebseilla-3, E. Coli-3, Proteus-1).

There was no response to placebo treatment in any case. (The same cases, when treated with Septilin tablets were responsive to therapy). There was no response to this therapy even after giving for 40 days in 7 cases. The response in vitro was rather disappointing whereas in vivo the action was probably enhanced by the enzymatic factors of the human body.

It has been found that most of the otorrhoea cases are associated with central perforation, thereby indicating the disease is tubotympanic by nature (mucosal infections). Septilin is found ineffectual in cases where the perforation is either in the marginal or in the attic region, associated with cholestaetoma, wherever there is involvement of the bone. Septilin may also be used as an adjuvant to surgery, first to achieve the dry ear and later for myringoplasty (2 cases). Mastoidectomy was done in 2 cases and adenotonsillectomy in one case, where therapy with Septilin had failed to yield satisfactory results.

Most of the cases were followed up nearly for a month and recurrence of discharge was not observed in nearly 90% of cases. There were no hypersensitive or allergic reactions, impairement of liver or kidney functions and ototoxic effects during therapy. The marked anti-inflammatory and anti-exudative property of Balsamodendron Mukul (demonstrated in experiments on rats by Granuloma pouch method) probably holds good even in human beings. It has also been demonstrated (Behl and Pradhan, 1978) that it is the superior phagocytic co-efficient obtaining with Septilin which renders it a more potent antibacterial than other chemotherapeutic agents.

Septilin therapy is effective in 90% cases of chronic otorrhoea of tubo-tympanic origin. The recommended treatment consists of two tablets, three times daily for 20 days in adults and one tablet three times daily for 20 days in children, in addition to local treatment of the ear, consisting of aural toilet and administration of antiseptic/antibiotic ear drops.

The complete absence of response to placebo proved beyond doubt that Septilin acts in vivo much better than in vitro, although some organisms are susceptible to Septilin in vitro. It is safe and sure to ensure a dry ear for a considerable time, without any hazard of development of any resistance to this drug.

Gujra, M.L., et al., Ind. J. Physio. Pharma (1960): 4, 267.