The efficacy of vaginal tablets (Gynoflor) containing 50 mg of a lyophilisate of viable, H2O2-producing Lactobacillus acidophilus (at least 10(7) colony forming units/tablet) and 0.03 mg estriol (CAS 50-27-1) for the treatment of bacterial vaginosis (BV) was tested in a multicentric, randomised, placebo-controlled clinical trial with parallel-group design.
A positive clinical diagnosis of BV required at least 2 of the following 4 clinical criteria to be positive;
greyish-white, homogeneous leukorrhea;
vaginal pH > 4.5;
KOH test for volatile amines;
presence of clue cells.
Microscopic diagnosis of BV, on the other hand, was obtained if examination of the Gram-stained vaginal smear showed less than 6 lactobacilli per field of view (1,000 x magnification). This corresponds to another definition of BV as "lactobacilli deficiency syndrome".
The cure rate (defined as < or = 1 of the 4 clinical criteria positive) two weeks after the start of therapy was 77% in the verum group and 25% in the placebo group. Four weeks after the start of therapy, the cure rate was 88% in the verum group and 22% in the placebo group.
The trial showed that after 6 days of treatment with the test preparation, the lactobacilli were capable of recolonising the vagina.
Parent D et al., Therapy of bacterial vaginosis using exogenously-applied Lactobacilli acidophili and a low dose of estriol: a placebo-controlled multicentric clinical trial. Arzneimittelforschung, 1996 Jan, 46:1, 68-73.
Investigated the effect of hormone replacement therapy (H.R.T.) for patients with stress incontinence.
We investigated 25 postmenopausal women, age 54-73 years, with a leakage volume is less than 15 g/day.
Five of the 24 patients (20.8%) were improved significantly both clinically and urodynamically. Six patients (25.0%) improved clinically, and two patients (8.3%) improved urodynamically, the remaining 11 patients (45.8%) showed no change.
Side effects occurred in eight cases. In one patient, it was necessary to stop administration due to severe irregular genital bleeding and leukorrhea, and in one patient the dosage was reduced due to swelling of breasts. The side effects of swelling of breasts and genital bleeding were relatively mild in the remaining six patients and they could continue H.R.T. administration.
Suzuki Y et al., [A study of the clinical effect of hormone replacement therapy for patients with stress incontinence]. Nippon Hinyokika Gakkai Zasshi, 1997 Mar, 88:3, 427-33.
A comparison was made of two brands of pH test paper and electronic instrumentation for measuring the pH of vaginal secretions.
When the pH of vaginal secretions was greater than 4.5 (abnormal), there was no significant difference between the methods, showing that pH test paper is reliable for pH determination of vaginal secretions.
Thomason JL et al., Is pH test paper as accurate as the electronic measurement of the pH of vaginal secretions? Am J Obstet Gynecol, 1990 May, 162:5, 1213-4.
A practice guideline as a preformatted chart is presented.
It is designed to be simple in concept and design, easy to use, parsimonious of data, easily scanned for quality assurance, and to provide clinical and cost-effectiveness prompts. An abbreviated "pocket practice guideline" is also provided.
A patient aftercare instruction sheet is appended.
This format is clearly appropriate only for simple, not complex, clinical encounters.
Dailey RH: Vaginal discharge in the adult: a practice guideline. J Emerg Med, 1996 Mar-Apr, 14:2, 227-32.
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