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Infectious Diseases in Obstetrics and... 2020A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind,... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women.
METHODS
The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications.
RESULTS
Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples.
CONCLUSION
The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.
Topics: Administration, Oral; Adult; Antifungal Agents; Area Under Curve; Benzydamine; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Delivery Systems; Econazole; Female; Healthy Volunteers; Humans; Middle Aged; Vagina; Young Adult
PubMed: 32410819
DOI: 10.1155/2020/7201840 -
Deutsches Arzteblatt International Feb 2020In Germany, 17-23% of the population suffers from chronic itching of the skin; in 5-10% of cases, the female genitalia are affected, specifically, the vulva. Vulvar... (Review)
Review
BACKGROUND
In Germany, 17-23% of the population suffers from chronic itching of the skin; in 5-10% of cases, the female genitalia are affected, specifically, the vulva. Vulvar pruritus is thus a common symptom that often markedly impairs the affected women's quality of life.
METHODS
This review is based on pertinent publications that were retrieved by a selective search in MEDLINE/PubMed for articles on the pathogenesis, diagnosis, and treatment of vul- var pruritus. The search terms were (in German and English) "vulvärer Juckreiz," "pruritus vulvae," and "genital itch," alone and in combination with "Behandlung," "Therapie," or "treat- ment."
RESULTS
The most common cause of vulvar pruritus is vulvo- vaginal candidiasis followed by chronic dermatoses, such as lichen sclerosus and vulvar eczema. Especially in refractory cases, an invasive or preinvasive lesion such as squamous epithelial dysplasia (VIN, vulvar intraepithelial neoplasia) should be borne in mind in the differential diagnosis. Rarer causes include infection, atrophy, and vulvodynia. The essen- tial elements of treatment are topical/oral antimycotic drugs and high-potency glucocorticoids, along with consistently ap- plied, basic moisturizing care and the avoidance of potential triggering factors.
CONCLUSION
As vulvar pruritus has multiple causes, standard- ization of its diagnostic evaluation and treatment would be l efficacy and to meet the diverse needs of women who suffer from this condition.
Topics: Female; Germany; Humans; Pruritus Vulvae
PubMed: 32181734
DOI: 10.3238/arztebl.2020.0126 -
Beneficial Microbes Dec 2019Disruption of vaginal microbiota equilibrium promotes infectious clinical syndromes with annoying symptoms, such as vaginal discharge, odour, irritation, pruritus, and...
Disruption of vaginal microbiota equilibrium promotes infectious clinical syndromes with annoying symptoms, such as vaginal discharge, odour, irritation, pruritus, and vulvar burning. Although identifying and eradicating the pathogen involved has been the standard of care, regional microbiota restoration with probiotics has been gaining ground in recent years. This study aimed to assess the effectiveness of topical treatment for patients exhibiting vaginal discomfort symptoms. A clinical trial was conducted on the use of a topical regimen among reproductive-age women (n=70) with vaginal discomfort symptoms. We assessed their symptoms using a questionnaire, measured vaginal pH, and performed vaginal swabs for microscopy and cultivation. Over the next 4 days, patients received vaginal douches and suppositories with appropriate antibiotic treatment being added on the fourth day based on vaginal swab results. Patients returned 16 days later to fill out in the questionnaire again. The Wilcoxon signed-ranked test was then used to assess differences in symptomatology and pH between appointments. A reduction in vaginal pH was reported between the first and second visit (<0.001). The probiotic regimen exerted a beneficial effect in all vaginal manifestations: vulvovaginal itching, burning sensation, vaginal irritation, and vaginal discharge (<0.001 for all symptoms). Additionally, three out of the four symptoms were alleviated to a greater extent during the first four days of exclusive probiotic use than during the second phase (=0.007, =0.004, and =0.033). Our sample provided significant results regarding the benefits of for vaginal discomfort. We postulate that the greatest symptom improvement was achieved within the first 4 days of exclusive probiotic use, before the addition of antibiotics. This study agrees with the increasing literature on the contribution of probiotics toward vaginitis treatment.
Topics: Administration, Intravaginal; Adolescent; Adult; Anti-Infective Agents; Bacillus coagulans; Female; Humans; Hydrogen-Ion Concentration; Middle Aged; Probiotics; Treatment Outcome; Vagina; Vulvovaginitis; Young Adult
PubMed: 31965832
DOI: 10.3920/BM2019.0048 -
Urologiia (Moscow, Russia : 1999) Dec 2019The symptoms of genitourinary syndrome of menopause are considered as typical for late menopausal period. However, these symptoms are increasingly diagnosed in... (Review)
Review
The symptoms of genitourinary syndrome of menopause are considered as typical for late menopausal period. However, these symptoms are increasingly diagnosed in perimenopausal and early menopausal period. Women seldom seek medical care, since autonomic menopausal symptoms are usually more bothersome. In many cases, doctors are not sure in necessity of any hormonal replacement. Moreover, a confusion still exists between systemic hormone replacement therapy (HRT) and local estrogen preparations. Besides moisturizers and local intravaginal estrogens, novel treatment modalities have emerged that extend therapeutic armamentarium.
Topics: Atrophy; Consensus; Female; Humans; Lubricants; Menopause; Sexual Dysfunction, Physiological; United Kingdom; Vagina; Vaginal Diseases; Vulva
PubMed: 31808652
DOI: No ID Found -
Current Infectious Disease Reports Oct 2019To present a comprehensive systematic approach for diagnosing correctly the cause(s) of bothersome genital symptoms. (Review)
Review
PURPOSE OF REVIEW
To present a comprehensive systematic approach for diagnosing correctly the cause(s) of bothersome genital symptoms.
RECENT FINDINGS
We searched the PUBMED for practical clinical guidelines, written by a multidisciplinary team of healthcare providers directed for diagnosing bothersome genital symptoms. This search was performed by a professional information specialist using the keywords "vulvovaginal," "vulvar," "multidisciplinary diagnosis," "interdisciplinary consultation," and "vulvology." We found numerous publications defining the criteria for diagnosing specific disorders, but only a few publications presented a multidisciplinary clinical algorithm for diagnosing bothersome vulvovaginal symptoms. The authors, from three different specialities, gathered together (online), in aim to present a comprehensive systematic approach for accurate diagnosing of bothersome vulvovaginal symptoms. Six principles for accurately diagnosing a woman with bothersome genital symptoms were endorsed: (1) locate the discomfort (vulva, clitoris, vestibule, vagina, cervix, pelvis); (2) consider more than one entity; (3) evaluate each symptom separately (it is common to have more than one entity necessitating treatment for each); (4) use pH and wet mount microscopy; (5) obtain a follow-up visit in 2-4 weeks; (6) perform a biopsy for dermatological conditions that are resistant to treatment.
PubMed: 31595345
DOI: 10.1007/s11908-019-0693-6 -
Journal of Lower Genital Tract Disease Oct 2019Group A streptococcus (GAS) vulvitis is rare, mainly reported in association with vaginitis. We examined the clinical features of GAS vulvitis in adults, the presence of...
OBJECTIVES
Group A streptococcus (GAS) vulvitis is rare, mainly reported in association with vaginitis. We examined the clinical features of GAS vulvitis in adults, the presence of other infected sites, and its association with dermatological conditions.
MATERIALS AND METHODS
We retrospectively analyzed the medical files and photographs of adult patients with bacteriologically confirmed GAS vulvitis seen at 3 private clinics. Coexisting infected sites, associated dermatological conditions, and bacteriological results for the husbands of 3 patients were examined.
RESULTS
Nineteen patients (mean age = 52.2 [range = 23-83] years) with vulvar GAS infections were identified. The vulvar symptoms consisted of pain (11 cases), pruritus (9), burning (4), and discharge (10). The predominant physical feature was bilateral erythema, mainly located on the labia minora and the inner aspect of the labia majora. This erythema was associated with oozing (3), edema (6), or fissures (6). Seventeen patients had an associated vaginal infection, which was asymptomatic in 7 cases; anal infections were present in 9 cases. The following 10 patients had associated dermatological conditions: psoriasis (6), lichen sclerosus (2), Paget disease (1), or vitiligo (1). Two (one each from the throat and penis) of the 3 bacteriological specimens taken from the 3 husbands were GAS positive.
CONCLUSIONS
In most adult women, GAS vulvitis is associated with a vaginal infection that may be asymptomatic. A bilateral, oozing, and edematous or fissured erythema involving the vulvar or anovulvar area is suggestive of GAS vulvitis. The association with psoriasis and the benefits of screening household members and sexual partners deserves further attention.
Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Middle Aged; Psoriasis; Retrospective Studies; Streptococcal Infections; Streptococcus pyogenes; Vulvitis; Young Adult
PubMed: 31592977
DOI: 10.1097/LGT.0000000000000492 -
Anaesthesia Sep 2019Patient-centred care and factors associated with patient satisfaction with anaesthesia have been widely studied. However, the most important considerations in the... (Observational Study)
Observational Study
Patient-centred care and factors associated with patient satisfaction with anaesthesia have been widely studied. However, the most important considerations in the setting of obstetric anaesthesia are uncertain. Identification of, and addressing, factors that contribute to patient dissatisfaction may improve quality of care. We sought to identify factors associated with < 100% satisfaction with obstetric anaesthesia care. At total of 4297 women treated by anaesthetists provided satisfaction data 24 h after vaginal and 48 h after caesarean delivery. As 78% of women were 100% satisfied, we studied factors associated with the dichotomous variable, 100% satisfied vs. < 100% satisfied. We evaluated patient characteristics and peripartum factors using multivariable sequential logistic regression. The following factors were strongly associated with maternal dissatisfaction after vaginal delivery: pain intensity during the first stage of labour; pain intensity during the second stage of labour; postpartum pain intensity; delay > 15 min in providing epidural analgesia and postpartum headache (all p < 0.0001). Pruritus (p = 0.005) also contributed to dissatisfaction after vaginal delivery, whereas non-Hispanic ethnicity was negatively associated with dissatisfaction (p = 0.01). After caesarean delivery, the intensity of postpartum pain (p < 0.0001), headache (p = 0.001) and pruritus (p = 0.001) were linked to dissatisfaction. Hispanic ethnicity also had a negative relationship with dissatisfaction after caesarean delivery (p = 0.005). Thus, inadequate or delayed analgesia and treatment-related side-effects are associated with maternal dissatisfaction with obstetric anaesthesia care. Development of protocols to facilitate identification of ineffective analgesia and provide an appropriate balance between efficacy and side-effects, are important goals to optimise maternal satisfaction.
Topics: Adult; Anesthesia, Obstetrical; Delivery, Obstetric; Female; Humans; Labor Pain; Labor, Obstetric; Patient Satisfaction; Pregnancy; Retrospective Studies
PubMed: 31264207
DOI: 10.1111/anae.14756 -
Lasers in Medical Science Dec 2019Vulvovaginal candidiasis (VVC) is a frequent infection of the female genitourinary tract. It is considered the second most common genital infection in women, after...
Vulvovaginal candidiasis (VVC) is a frequent infection of the female genitourinary tract. It is considered the second most common genital infection in women, after bacterial vaginosis. VVC is treated with oral or topical azole derivatives. However, these agents may lead to adverse reactions and their chronic use might lead to resistance to antifungal agents. Given that the ultraviolet A/blue light-emitting diode (LED) is an electromagnetic radiation source with antimicrobial properties, it is hypothesized that this resource may be a non-drug alternative to the treatment of vulvovaginitis. A technical/experimental safety test was conducted to characterize the light source spectrum and temperature generation of the device, followed by a pilot study in a 52-year-old patient with a clinical diagnosis of VVC confirmed by culture and examination of fresh vaginal samples, owing to the presence of lumpy vaginal discharge and a complaint of pruritus. The vulva and vagina were exposed to 401 ± 5 nm ultraviolet A/blue LED irradiation in a single session, divided into two applications. A reassessment was performed 21 days after the treatment. The light-emitting device had a visible spectrum, in the violet and blue ranges, and a maximum temperature increase of 7 °C. During the reassessment, the culture was found to be negative for fungus, and the signs and symptoms of the patient had disappeared. A light-emitting device with a spectrum in the range of 401 ± 5 nm could potentially be an alternative treatment modality for women with VVC, as it led to the resolution of clinical and microbiological problems in our patient.
Topics: Candidiasis, Vulvovaginal; Female; Humans; Middle Aged; Pilot Projects; Temperature; Ultraviolet Therapy
PubMed: 30945022
DOI: 10.1007/s10103-019-02782-9