Treatment of Non-gonococcal Urethritis with Sigmamycin: A CONTROLLED METHOD OF INVESTIGATION

Abstract

Many different drugs have been tried for treating non-gonococcal urethritis (NGU) with varying degrees of success; this report describes an attempt to evaluate the effect of Sigmamycin at two different dosage levels.Sigmamycin is a 2 :1 combination of the antibiotics tetracycline hydrochloride and oleandomycin phosphate, and the claim has been made that this combination exhibits a synergistic action, so that the two drugs together are more potent than the sum of the individual components. To test this claim two separate trial series of patients were treated, using a small dose for a minimum time in the first, and a large dose for a slightly longer period in the second. In each series controls were used and the drug or a placebo was administered by the double-blind method to a total of 200 white male patients with non-gonococcal urethritis. Neither patients nor medical staff knew who received antibiotic or placebo, and the key to the coding used was retained by the suppliers of the drug until the completion of each half of the trial.A certain amount of selection of patients was used, those giving a history of gonorrhoea or NGU within a year, those who had recently had treatment, and those who were unlikely to attend for follow up being excluded from the trial.* Received for publication May 25, 1959. MethodThe patients were first seen in the ordinary clinic, the history was taken, a full examination was carried out and the preliminary diagnosis of non-gonococcal urethritis was confirmed by examination of an urethral smear. Cultures were set up to exclude gonorrhoea and to reveal any bacteria present in the discharge. In addition, a fresh wet preparation and culture were examined routinely for Trichomonas vaginalis. Finally, the result of the two-glass test was carefully recorded and blood was taken for serological tests for syphilis. Patients were seen again the following morning whenever possible, for an early morning test (E.M.S.) before urinating. This included urethral scraping of the terminal urethra and fossa navicularis, and a further search for T. vaginalis in a wet preparation and by culture. The two-glass test was then carried out and recorded. Anyone who on first attending had held his urine overnight or for 8 hours or more was excused attending for an E.M.S. the next morning.Contact slips were issued, and each patient was exhorted to send along his recent sex contacts. Finally, each patient was handed a bottle containing the capsules, taken at random from the cupboard and bearing only a label with a number on it and instructions how to take the drug. Alcohol and sexual intercourse were banned during the period of attendance at the clinic.In order to standardize the follow-up tests, the first hundred patients were asked to attend in the early morning before urinating. In this way a two-glass test could be carried out as a standard procedure on the first urine specimen of the day, and a truer indication could be obtained of the response to treatment. As far as possible, 223 copyright.

Treatment of Non-Gonococcal Urethritis with Demethylchlortetracycline ("Ledermycin")

“…Discussion It has been shown that early "cure" of NGU after a placebo or with no treatment at all can be expected in 20-25 per cent. of cases (Doyle and others, 1957;Willcox, 1957;Leach, 1959;Csonka, 1959) and, as it is generally accepted that administration of the broad-spectrum antibiotics is followed by an early response in over 70 per cent. of patients (Harkness, 1953;Mayne, 1957;Willcox, 1957;Morton and Read, 1957), it was possible to dispense with untreated controls in this series.…”

“…It has been shown by several investigators that the tetracycline group comprise the most effective antibiotic therapy in non-gonococcal urethritis (NGU), although no drug or combination of drugs so far tried has been entirely successful in this condition (Harkness, 1953;Doyle, Gill, and Laird, 1957;Willcox, 1957;Leach, 1959;Csonka, 1959; and many others).…”

Lincomycin, non-gonococcal urethritis, and mycoplasmata.

“…The clinical effect of lincomycin in NGU one week after the start of treatment appeared to be no better than that of a placebo (Leach, 1959;Csonka, 1959); however, in a few patients improvement was prompt and in these lincomycin may have had an effect.…”