antimicrobial drugs, mixed vaginal infections, pentamycin, polyene antifungal antibiotic, trichomoniasis, vaginal candidiasis
J Balmer. Treatment of Vaginal Infections with Intravaginal Pentamycin in Clinical Practice. The Internet Journal of Gynecology and Obstetrics. 2008 Volume 11 Number 1.
Vaginitis is one of the most frequent conditions for which women seek medical care  and the most common gynecologic diagnosis in the primary care setting . Vaginal discharge and symptoms are usually related to one of the following conditions: vaginal candidiasis, trichomoniasis and bacterial vaginosis . In these conditions, the vaginal flora has been altered by introduction of a pathogen or by changes in the local environment that allow pathogens or normal saprophytes to proliferate . Candidal infection is most frequently provoked by
Most forms of vaginal infections usually respond to pathogen-specific treatments  but, in absence of a single drug that can treat the most frequent infections, treatment efficacy largely depends on the ability of health care providers to make the correct diagnosis with appropriate laboratory tests . Moreover, many women with vaginal complaints self-treat incorrectly with over-the-counter drugs without consulting health care providers for a confirmatory diagnosis . The inappropriate or indiscriminate use of antimicrobials for these disorders weaken the natural defenses against infections and favor the emergence of strains of microorganisms resistant to treatment or the development of mixed infections . As a result, forms of difficult-to-treat vaginal infections and recurrences of vaginal candidiasis or trichomoniasis are frequently observed . The availability of a drug effective in more than one form of infectious vaginitis would reduce the need for a confirmatory diagnosis and the risk of treatment failure.
Pentamycin is a polyene macrolide antibiotic , naturally produced by
Materials and Methods
This study was conducted on 159 women, aged 17 to 65 years, who attended the gynaecology clinic for symptoms of vaginitis (including itching, burning, dyspareunia, leucorrhoea and xanthorrhea) and had a diagnosis of candidiasis, trichomoniasis or mixed infectious vaginitis on the basis of the history, complete gynecological examination, wet mount microscopy and microbiology testing (Gram staining and cultures). The causative agents were
In patients with mixed infections, various combinations of
Patients were treated with intravaginal pentamycin at the recommended doses of either 6 mg daily (one tablet in the morning and in the evening) for 5 days (N = 104) or 3 mg daily (one tablet in the morning) for up to 10 days (N = 55) (Table 2). As per common practice, pentamycin was used alone in 65.4% of the cases and in combination with other therapies (mainly metronidazole or topical azole antifungal agents, or clindamycin) in the other cases, depending on the results of microbiology testing (Table 2).
The treatment success rate was evaluated by determining the proportion of patients who experienced resolution of symptoms at the end of the treatment period and the proportion of women in whom post-treatment microbiology testing showed eradication of the causative agents. Treatment tolerability was assessed by monitoring adverse events. Treatment acceptance was examined by asking the patients to rate their level of satisfaction as “good”, “insufficient” or “null”. The data were analyzed separately in each subgroup of patients, according to the type of infection and to the treatment dose and duration, with the use of descriptive statistics.
Treatment success rate by infection type
Resolution of symptoms was experienced by 100% (8/8) of patients with vaginal trichomoniasis, 92.7% (76/82) of patients with vaginal candidiasis and 85.5% (59/69) of patients with mixed infections (Figure 1).
Treatment success was confirmed by eradication of the causative agents in 100% (8/8) of patients with vaginal trichomoniasis, 87.8% (72/82) of patients with vaginal candidiasis and 84.0% (58/69) of patients with mixed infections (Figure 2).
Treatment acceptance rate by infection type
Treatment acceptance was rated as “good” by 100% (8/8) of patients with vaginal trichomoniasis, 84.1% (69/82) of patients with vaginal candidiasis and 78.3% (54/69) of patients with mixed infections (Figure 3).
Treatment success rate and acceptance rate by dose and treatment duration
When the effectiveness of treatment was evaluated on the basis of the dose of intravaginal pentamycin administered and duration of treatment, the overall treatment success rate was slightly higher with the dose of 6 mg daily for 5 days than with the dose of 3 mg daily for up to 10 days (Figure 4). Resolution of symptoms was experienced by 88.7% of patients who received the 6-mg dose regimen and by 85.4% of patients who received the lower dose for up to 10 days (Figure 4). Treatment success was confirmed on microbiology testing in 85.5% of cases treated with 6 mg daily of pentamycin for 5 days and 76.4% of cases treated with 3 mg daily for up to 10 days (Figure 4). Acceptance of treatment was rated as “good” by 83.4% of patients who used the higher dose of pentamycin for 5 days and by 76.3% of patients who received the 3-mg dose for up to 10 days (Figure 4).
Treatment with intravaginal pentamycin, singly or in combination with other therapies, was tolerated well, irrespective of the dose and treatment duration. There was no report of local adverse events, such as irritation or burning, attributable to the use of this drug.
Most forms of vulvovaginal infections can be successfully treated by using one or more pathogen-specific antimicrobials, according to international guidelines and recommendation . Oral metronidazole and the nitroimidazole derivative tinidazole are the primary drugs used for bacterial vaginosis and trichomoniasis, while topical azole antifungal agents are the first-line treatment for candidal vaginitis . Mixed infections need treatment with a combination of drugs, which usually includes metronidazole and a topical azole antifungal medication . However, many physicians find it difficult to diagnose accurately and manage effectively these disorders in clinical practice . Before vaginitis is treated, the cause must be ascertained by using appropriate laboratory tests . This is often not done, and treatment failure results . Moreover, some strains of
This study included data from a relatively large number of patients, who had a complete evaluation of their disease and microbiology testing before and after treatment. Fifty percent of patients with trichomoniasis and over 60% of patients with candidiasis (63.4%) and mixed infections (69.6%) were treated with vaginal pentamycin alone. The vast majority of patients experienced resolution of symptoms by the end of the treatment period, irrespective of the infection type. Treatment success was confirmed by eradication of the causative agents in 100% of patients with vaginal trichomoniasis and in 87.8% of patients with vaginal candidiasis. These results support and extend, on a larger population of affected women, previous observations on the effectiveness of vaginal pentamycin for the treatment of vulvovaginal infections caused by
This study also included patients suffering from vaginal infections caused by mixed microorganisms, which are considered difficult-to-treat forms of vaginal infections . Indeed, about one-third of these patients had not experienced any benefit from previous treatments with other antimicrobials. Treatment with vaginal pentamycin alone or in combination with other pathogen-specific drugs induced complete resolution of symptoms and eradication of the causative agents in 84% of patients. Most of the observed treatment success was due to intravaginal pentamycin because this product was used alone by about two-third of patients.
Treatment with intravaginal pentamycin, singly or in combination with other therapies, was well-tolerated by patients, irrespective of the dose and treatment duration. The favorable tolerability profile of this drug is confirmed by the absence of reports of adverse events in the population of over 40,000 patients who have been treated with pentamycin in clinical practice since the first registration in Switzerland.
In addition to efficacy and tolerability, this study also examined patients’ satisfaction with the use of intravaginal pentamycin. Treatment acceptance was rated as “good” by 100% of patients with vaginal trichomoniasis, 84.1% of patients with vaginal candidiasis and 78.3% of patients with mixed infections. These findings correlated with the treatment success rate reported for each type of vaginal infection and also confirmed the good tolerability of the drug.
When the effectiveness of treatment and its acceptance were evaluated on the basis of the dose of intravaginal pentamycin administered and duration of treatment, the overall treatment success rate was slightly higher with the dose of 6 mg daily for 5 days than with the dose of 3 mg daily for up to 10 days. Acceptance of treatment was rated as “good” by 83.4% of patients who used the higher dose of pentamycin for 5 days and by 76.3% of patients who received the 3-mg dose for up to 10 days. These results may reflect a better compliance with treatment when the drug was administered for a short period of time. However, the use of a high dose of pentamycin from the beginning of the treatment period may also increase the chance of complete eradication of the causative germs. In this context, it is worth noting that a 10-mg dosage strength of vaginal pentamycin (FemiFect®, Lumavita AG, Basel, Switzerland) is being developed for registration in the European Union and in the United states of America. This product may be effectively used once daily for shorter periods of time than the 3-mg dosage strength, thereby increasing patients’ acceptance and compliance with treatment.
In conclusion, the results of this study suggest that intravaginal pentamycin, either alone or in combination with other therapies, may be effective for the treatment of vaginal candidiasis, trichomoniasis and mixed infections. The drug seems to exhibit a favorable tolerability profile and is well-accepted by patients. Controlled clinical trials and comparative studies in various forms of vaginal infections are warranted to substantiate the promising findings of this study.