The Open Women's Health Journal

2012, 6 : 19-23
Published online 2012 February 13. DOI: 10.2174/1874291201206010019
Publisher ID: TOWHJ-6-19

Diagnosis of Vulvovaginal Candidiasis and Effectiveness of Combined Topical Treatment with Nystatin: Results of a Non-Interventional Study in 973 Patients

G. Dressen , W. Kusche , C. Neumeister and U. Schwantes
Department of Medical Science/Clinical Research, Dr. R. Pfleger GmbH, D-96045 Bamberg, Germany.

ABSTRACT

Introduction & Objectives: This non-interventional study was performed in 231 gynaecological surgeries in order to assess current routine diagnostic practice as well as present effectiveness and tolerability of a combined topical treatment with nystatin in patients with uncomplicated vulvovaginal candidiasis (VVC).

Methods: Naive or insufficiently treated VVC patients received a combined topical antimycotic treatment§. Diagnostic procedures were documented. Cardinal disease symptoms and dosage regimens were recorded before and after therapy. Investigators and patients rated treatment effectiveness and tolerance. Adverse events and withdrawals were documented.

Results: All 1,011case reports were included in the safety analysis; thereof 973 cases in the efficacy analysis. Based on diagnoses conform to guidelines 74.7% of the patients had a primary infection while 24.9% were experiencing a relapse. After a treatment period of 6 days (median), individual symptoms had ceased in up to 81.9%. Complete healing was achieved in 63.1% (vulva) and 65.4% (vagina). Investigators rated therapy outcome as “healing/significant improvement” in 90.0% (vulva) and 88.2% (vagina), and tolerance “as very good/good” in 97.4%.

Conclusions: Routine diagnosis of VVC predominantly corresponds to relevant guidelines. Combined intra- and perivaginal therapy of VVC with nystatin is an effective, safe and cost-conscious treatment option. Nystatin has not lost its effectiveness over the years. §Nystatin cream and vaginal tablets (Biofanal® 100.000 IU combination package), Dr. R. Pfleger GmbH, D-96045 Bamberg, Germany