Brit. J. vener. Dis. (1975) 51, 123 Br J Vener Dis: first published as 10.1136/sti.51.2.123 on 1 April 1975. Downloaded from

Miconazole nitrate compared with chlordantoin in the treatment of vaginal candidiasis

DELIA F. MORRIS AND DENIS L. SUGRUE From the Special Treatment Centre, Shelton, Stoke-on- Trent

This paper reports the results of a double-blind study Results of miconazole nitrate compared with chlordantoin for Some characteristics of the patients are given in the treatment of vaginal candidiasis. Table I: these include factors such as pregnancy and the recent taking of antibiotics and oral contraceptives which might have helped to predispose the patient Material and methods to vaginal candidiasis. No patient had glycosuria. All female patients who attended the Special Treatment Centre for sexually-transmitted diseases at Stoke-on- TABLE I Relevant personal and medical details Trent for the first time between January and mid- ofpatients and defaulters December, 1973, were questioned and examined accord- Treatment Miconazole Chlordantoin Defaulters ing to a defined protocol. Those with evidence of vaginal candidiasis were included in this trial. Total patients 42 41 16 Vaginal, cervical, and urethral swabs were collected Mean age (yrs) 26 24 25 tests a was Marital status Single 26 28 12 copyright. for laboratory and urine specimen examined. Married 16 13 4 The swabs were examined by direct microscopy of wet Previous history of films and Gram-stained smears; for culture they were Candida infection 16 14 4 transported in Stuart's transport medium with added Pregnancy 0 0 1 Diabetes mellitus 0 0 0 charcoal and examined by standard microbiological Oral contraceptives 22 21 7 techniques. Vaginal candidiasis was diagnosed if blasto- Tetracycline recently 4 1 1 spores or mycelia were seen in direct films of vaginal Other antibiotics recently 15 9 3 Concomitant treatment* 9 9 3 secretion or if Candida albicans was cultured. After http://sti.bmj.com/ treatment patients were considered to be cured if their *This included penicillin, metronidazole, nalidixic acid, topical symptoms were absent and Candida could not be demon- podophyllin, and idoxuridine strated in direct films or by culture over a mean period of The response to treatment in patients with culture- 6 5 weeks (range 2 to 14 weeks). summarized in Tables II to IV. Of 569 new patients, 99 showed evidence of vaginal proven candidiasis is candidiasis; twelve of the 99 had no symptoms. Each Cure was more common in women treated with was treated with a cream containing an antifungal agent, miconazole nitrate than in those with chlordantoin.

the identity of which was unknown to the investigators After a single course of treatment twenty of 33 on September 26, 2021 by guest. Protected until all the clinical data had been collected. The creams women using miconazole and fifteen of 36 women and their containers appeared identical but they con- using chlordantoin, became culture-negative, a tained either 2 per cent. miconazole nitrate or 1 per cent. difference which was not statistically significant chlordantoin. (Table II). Each patient was given a tube of antifungal cream sufficient for ten nightly treatments, each of 5 gm. A TABLE II Response after one course of treatment plastic applicator for intravaginal use was supplied. The in patients with C. albicans isolated before treatment patients were asked to record how many applications of cream were necessary before they experienced relief of Response after one course of treatment Treatment Total symptoms; they were re-examined 4 to 6 days after completing the course and then 2 weeks and 4 weeks Miconazole Chlordantoin later. When Candida persisted, a second 10-day course Success 20 15 35 of the same cream (as identified by its code number) was Failure 13 21 34 given and the patient re-examined as before. Sixteen patients defaulted so that the results here apply Total 33 36 69 only to the 83 women who completed their course of x2= 1-771 treatment and who had subsequent tests of cure. Two courses of cream were required by Received for publication July 3, 1974 nine of the 29 women successfully treated with Address for reprints: D. L. Sugrue, Special Treatment Centre, Wellesley Street. Shelton, Stoke-on-Trent, ST1 4NF miconazole and by six of the 21 successfully treated 124 British Journal of Venereal Diseases Br J Vener Dis: first published as 10.1136/sti.51.2.123 on 1 April 1975. Downloaded from with chlordantoin (Table III). Thus, after one or daily application of 2 per cent. miconazole nitrate two courses of treatment, only four of 33 women for 2 weeks. Breen (1961) cured only 69 per cent. failed to be cured by miconazole compared with of his patients with twice-daily applications of fifteen of 36 women who were still culture-positive chlordantoin for 2 weeks, but 95 per cent. were cured after two courses of chlordantoin. This difference if this regimen was maintained for 6 weeks. In the is statistically significant (P < 0 02). trial reported by the General Practitioner Research Group (1974), 41 of fifty women were found to be TABLE III Response after one or two courses of culture-negative after a single daily application of treatment in patients with C. albicans isolated before 2 per cent. miconazole nitrate for 10 days, when treatment re-examined on the fourteenth day; this figure Treatment dropped to 38 when they were re-examined on the 28th day. These observations indicate that a 10-day Response Miconazole Chlordantoin Total course of miconazole nitrate is probably too short and Success 29 21 50 that better results can be obtained if treatment is Failure 4 15 19 continued for at least 2 weeks. Total 33 36 69 Miconazole nitrate used according to this regimen X2 = 6-12 P<002 has a useful place in the treatment of this often dis- tressing condition. Fourteen patients initially had positive direct smears but negative cultures. They are included in Summary Table IV together with those who initially had In a double-blind study of the treatment of vaginal positive cultures. The cure-rate then becomes higher candidiasis, miconazole nitrate gave a cure-rate of for both fungicides. However, direct microscopical 88 per cent. (29 out of 33) compared with 58 per cent. appearances can be misleading, as when only blasto- (21 out of 36) using chlordantoin. Although approxi- spores are seen these could be commensal yeasts and mately two-thirds of the patients who responded did not necessarily C. albicans. All fourteen patients so to a 10-day course of treatment, the different copyright. responded satisfactorily to treatment, a proportion rates of cure with these preparations at this stage were which would be unlikely if the yeasts had been not statistically significant. However, when a second predominantly C. albicans. course of treatment was given to those women who iv still had proven candidiasis, the overall cure-rate TABLE Response among all patients including with miconazole was significantly greater than that those initially positive by smear only with chlordantoin. Treatment We should like to thank Dr. H. C. Masheter and Mrs. A. http://sti.bmj.com/ Response Miconazole Chlordantoin Total Hewitt of Janssen Pharmaceutical Ltd. for their co- operation in this study. Success 38 26 64 Failure 4 15 19 References Total 42 41 83 BREEN, J. L. (1961) Obstet. and Gynec., 17, 112 X2 = 7-14 P