An evaluation of a modified nystatin vaginal tablet in a multi-centre study

Summary

A multi-centre, double-blind controlled study in eleven hospitals was carried out to assess the efficacy, tolerance and patients' acceptance of a new ‘Mycostatin’ effer-vescent vaginal tablet (E.V.T.). One hundred and ninety-one patients received the effervescent tablet and 96 patients the currently-available ‘Mycostatin’ pessary. Both formulations, containing 100,000 units of nystatin per pessary or tablet, were initially prescribed as one tablet or pessary nocte for 14 days. The patients selected had signs and symptoms of candidal vaginitis confirmed by either a positive wet smear or culture for Candida albicans.

The new effervescent formulation disintegrated and dispersed completely, resulting in a more uniform distribution of the active material throughout the vaginal walls (p =0.002). After 14 days treatment 87% of the patients were clinically and mycologically clear of candidal vaginitis. A further 7 days therapy with one E.V.T. twice daily resulted in a complete cure in all but 5 patients (2.6% of the total).

The incidence of leakage was no higher in the group receiving the E.V.T. Both formulations were equally well tolerated, any symptoms of intolerance being transient in nature. The new formulation was found to be an acceptable treatment in 97% of patients.

Key Words::

• Candidiasis
• vaginitis
• nystatin
• pessaries