RESUMEN
AIM: This study aims to incorporate alginate microparticles containing berberine and fluconazole into two different types of pharmaceutical formulations, to subsequently evaluate the antifungal activity against Candida albicans. METHODS AND RESULTS: Alginate microparticles containing BBR (berberine) and FLU (fluconazole) were produced by the spray-drying technique, characterized and incorporated in two pharmaceutical formulations, a vaginal cream and artificial saliva. Broth microdilution, checkerboard, time-kill curve, and scanning electron microscopy were carried out to determine the antifungal effects of BBR and FLU against C. albicans. The minimum inhibitory concentration (MIC) and minimum fungicidal concentration (MFC) values of free BBR were 125 µg ml-1. Synergism between BBR and FLU was demonstrated by a fractional inhibitory concentration index (FICI) = 0.0762. The time-kill curve for the combination BBR + FLU showed a more pronounced decrease in fungal growth in comparison to free drugs, and an antibiofilm effect of BBR occurred in the formation and preformed biofilm. CONCLUSION: Alginate microparticles containing BBR and FLU were obtained and incorporated in a vaginal cream and artificial saliva. Both formulations showed good stability, antifungal effects, and organoleptic characteristics, which suggest that BBR-FLU microparticles in formulations have potential as antifungal therapy.
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Berberina , Candidiasis , Humanos , Femenino , Fluconazol/farmacología , Antifúngicos/farmacología , Antifúngicos/uso terapéutico , Berberina/farmacología , Saliva Artificial/farmacología , Saliva Artificial/uso terapéutico , Cremas, Espumas y Geles Vaginales/farmacología , Cremas, Espumas y Geles Vaginales/uso terapéutico , Candidiasis/microbiología , Candida albicans , Pruebas de Sensibilidad Microbiana , Alginatos/farmacología , Sinergismo Farmacológico , Farmacorresistencia FúngicaRESUMEN
BACKGROUND: Vulvovaginal candidiasis is a common gynecologic infection, and recurring cases are yet incurable. This trial was based on Persian medicine to compare how effective marshmallow aqueous extract 4% plus clotrimazole 1% (CLOT-M) is compared to clotrimazole 1% vaginal creams on VVC. METHODS: This study randomly assigned 100 women with VVC into two groups. The target group (n = 50) was treated with CLOT-M while controls (n = 50) with clotrimazole vaginal creams for seven consecutive nights. Different VVC symptoms and signs, and yeast culture from vaginal discharge were evaluated as the outcome measures before the intervention and 7 and 30 days after. RESULTS: The efficacy of CLOT-M vaginal cream was assessed during the 1st and 2nd follow-ups, indicating a significant decrease in mean itching (P = 0.001 for both comparisons) and dyspareunia score (P = 0.001 and P = 0.04, respectively) as compared to treatment with clotrimazole vaginal cream. Moreover, after 7 days of the intervention, patients in the CLOT-M group experienced significant improvement in mean dysuria score compared to those in the control group (P = 0.001). Neither cream caused any significant adverse events. CONCLUSION: It seems that CLOT-M vaginal cream had a significant effect on the VVC symptoms improvement, without any significant side effects. However, larger sample-sized trials are needed for more evidence-based judgment.
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Althaea , Candidiasis Vulvovaginal , Femenino , Humanos , Candidiasis Vulvovaginal/tratamiento farmacológico , Clotrimazol/uso terapéutico , Antifúngicos/uso terapéutico , Cremas, Espumas y Geles Vaginales/uso terapéuticoRESUMEN
BACKGROUND AND OBJECTIVE: Vaginal atrophy is a condition where the vaginal epithelium gets thinner and includes symptoms, such as vaginal dryness, abnormal vaginal discharge, vaginal bleeding, dyspareunia, and sexual problems. Hormone therapy is associated with some problems and some women prefer herbal medicine to reduce vaginal atrophy. Considering the phytoestrogenic compounds present in the nettle, this study aimed to investigate the effect of the nettle vaginal cream on subjective symptoms of vaginal atrophy in postmenopausal women. MATERIALS AND METHODS: This triple-blind randomized placebo-controlled clinical trial study was conducted on 84 eligible postmenopausal women aged 45-60 years, who referred to comprehensive health service centers in Aliabad Katul in 2021-2022. Women eligible for the study received 5% nettle vaginal cream and placebo for 8 weeks. Subjective symptoms of vaginal atrophy were assessed before, four and eight weeks after the intervention. Data collection tools included a checklist for research unit selection, individual and midwifery characteristics questionnaire, vaginal assessment scale (VAS), vaginal pH, laboratory results of the vaginal maturation value (VMV). Data analysis was performed using SPSS software (version 21) and independent t-test, Mann-Whitney, chi-square, Two-way analysis of variance and analysis of covariance. P value less than 0.05 was considered significant. RESULTS: Subjective symptoms of vaginal atrophy decreased significantly after the intervention compared to before the intervention in both the nettle and placebo groups (p < 0.001), but in the comparison between groups four weeks and eight weeks after the intervention, the subjective symptoms of vaginal atrophy in nettle group decreased significantly (p < 0.001). In the nettle group, the scores of vaginal burning, vaginal dryness, vaginal itching and dyspareunia significantly improved after the intervention compared to before the intervention (p < 0.001). Also, in the nettle group compared to the placebo group, after the intervention, vaginal burning and vaginal dryness score (p < 0.001) and vaginal itching score (0.004) improved significantly. CONCLUSION: Based on the results of the present study, Nettle vaginal cream reduced subjective symptoms of vaginal atrophy, including vaginal burning, vaginal dryness, vaginal itching, and dyspareunia in postmenopausal women, so it is a cost-effective, available and do not have the side effects product that can be useful for menopausal women.
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Dispareunia , Enfermedades Vaginales , Femenino , Humanos , Cremas, Espumas y Geles Vaginales/uso terapéutico , Posmenopausia , Dispareunia/tratamiento farmacológico , Administración Intravaginal , Enfermedades Vaginales/tratamiento farmacológico , Enfermedades Vaginales/patología , Vagina , Atrofia/tratamiento farmacológico , Atrofia/patología , Prurito/tratamiento farmacológico , Prurito/patología , Resultado del TratamientoRESUMEN
BACKGROUND: Female sexual dysfunction (FSD) is a common complaint among postmenopausal women, which is largely because of the genitourinary syndrome in these women (GSM). AIM: Considering the phytoestrogenic effects of chamomile, the present study was primarily aimed to investigate the effect of chamomile vaginal gel on the sexual function of postmenopausal women. The side effects of these drugs were evaluated as a secondary outcome of the study. METHODS: This randomized double-blind clinical trial and placebo-controlled study was conducted on postmenopausal women with sexual dysfunction (FSFI ≤26.55). To this aim, 96 postmenopausal women were randomly assigned into three groups (n = 32 each) including women receiving (i) chamomile vaginal gel 5%, (ii) conjugated estrogen vaginal cream, and (iii) placebo vaginal gel, for 12 weeks (ie, every night in the first 2 weeks, and 2 nights per week in the next 10 weeks, each night 1 g was used). The sexual function was measured using female sexual function index (FSFI) before and after the intervention. Data analysis was performed by chi-square, one-way ANOVA, descriptive statistics, analysis of covariance (ANCOVA), and paired t test using SPSS software version 22. P < .05 was considered statistically significant. OUTCOMES: The main study outcome measure was evaluate the effects of vaginal administration of chamomile gel in comparison with conjugated estrogen cream and placebo gel on postmenopausal FSD using the FSFI. RESULTS: The findings showed that chamomile vaginal gel in compared to placebo vaginal gel caused a significant improvement in all six sexual function domains and the total FSFI score (effect size = +2.9 [95% CI, +2.1 to +3.6], P < .001). Also, there was no significant difference between the chamomile vaginal gel and conjugated estrogen vaginal cream groups in terms of the total score and all sub-domains of sexual function with the exception of orgasm (effect size = +0.13 [95% CI, -0.36 to +0.63], P = .02) and sexual satisfaction (effect size = 0 [95% CI, -0.49 to +0.49], P = .04). Two women in the chamomile group and one in the placebo group experienced a burning sensation (P = .345). CLINICAL IMPLICATIONS: This treatment can be considered as a treatment option for postmenopausal women with sexual dysfunction who have contraindications to the use of hormone therapy. STRENGTHS & LIMITATIONS: This study is the first study to investigate the effectiveness of chamomile vaginal gel on sexual function in postmenopausal women. However, in this study, treatment duration was 12 weeks and no follow up was performed beyond this time CONCLUSION: Based on the results of this study, the use of vaginal chamomile gel improved sexual function in postmenopausal women. Bosak Z, Iravani M, Moghimipour E, et al. Effect of Chamomile Vaginal Gel on the Sexual Function in Postmenopausal Women: A Double-Blind Randomized Controlled Trial. J Sex Med 2022;19:983-994.
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Disfunciones Sexuales Fisiológicas , Cremas, Espumas y Geles Vaginales , Manzanilla , Método Doble Ciego , Estrógenos Conjugados (USP)/farmacología , Estrógenos Conjugados (USP)/uso terapéutico , Femenino , Humanos , Extractos Vegetales/farmacología , Extractos Vegetales/uso terapéutico , Posmenopausia , Disfunciones Sexuales Fisiológicas/tratamiento farmacológico , Cremas, Espumas y Geles Vaginales/farmacología , Cremas, Espumas y Geles Vaginales/uso terapéuticoRESUMEN
OBJECTIVE: The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18ß-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks. STUDY DESIGN: Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days. MAIN OUTCOME MEASURE: The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function. RESULTS: Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001). CONCLUSIONS: The present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance. This trial is registered prospectively with the Clinical Trials Registry - India, number CTRI/2019/05/01911.
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Dispareunia/tratamiento farmacológico , Vagina/patología , Cremas, Espumas y Geles Vaginales/uso terapéutico , Enfermedades Vaginales/tratamiento farmacológico , Vulva/patología , Enfermedades de la Vulva/tratamiento farmacológico , Anciano , Atrofia , Método Doble Ciego , Dispareunia/patología , Femenino , Glucógeno/uso terapéutico , Ácido Glicirretínico/uso terapéutico , Hippophae , Humanos , Ácido Hialurónico/uso terapéutico , Persona de Mediana Edad , Aceites de Plantas/uso terapéutico , Preparaciones de Plantas/uso terapéutico , Posmenopausia , Resultado del Tratamiento , Enfermedades Vaginales/patología , Enfermedades de la Vulva/patologíaRESUMEN
Candidal vaginitis has a relatively high prevalence, and its resistance to treatment is on the rise. Considering the complications of chemical drugs, the use of herbal medicines has now been favored due to the lack of changes in the normal vaginal flora. The aim of this study was to compare the effectiveness of Satureja khuzestanica and clotrimazole vaginal creams for the treatment of candidal vulvovaginitis. A randomized clinical trial was conducted on 84 reproductive-aged women in the city of Ahvaz, Iran. Individuals were randomly divided into two treatment groups: 1% Satureja khuzestanica vaginal creams (n=42) and 1% clotrimazole vaginal cream (n=42) who used a one-full applicator daily for one week. About 4-7 days after the end of treatment, a clinical examination and laboratory re-tests were performed to determine the level of treatment. The data were analyzed using the Mann-Whitney U, t-test and Chi-square tests, with SPSS version 22. After the treatment, no significant difference was observed between the two groups in terms of vaginal discharge (p = 0.32), vaginal itching (p = 0.26), dysuria (p = 0.99) and dyspareunia (p = 0.60). Moreover, the results of culture (p = 0.62) and smear (p = 0.58) were not statistically significant in the two groups. Also, there was no significant difference between the two groups in terms of complete recovery after the treatment (p = 0.35). Satureja khuzestanica seems to have the same effect as clotrimazole in improving the symptoms of vaginal candidiasis, the negative results of culture and smear, as well as complete treatment.
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Candidiasis Vulvovaginal/tratamiento farmacológico , Clotrimazol/uso terapéutico , Satureja/química , Cremas, Espumas y Geles Vaginales/uso terapéutico , Adulto , Antifúngicos/uso terapéutico , Candidiasis Vulvovaginal/diagnóstico , Femenino , Humanos , Irán , Resultado del TratamientoRESUMEN
OBJECTIVE: To compare the effects of a 12-week course of 5%Pueraria mirifica gel and placebo gel on the prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms in postmenopausal women. STUDY DESIGN: In a randomized, double-blinded, placebo-controlled study (TCTR20160517002), 60 postmenopausal women were randomly assigned to a 12-week course of eitherP. mirifica gel or identical placebo gel. MAIN OUTCOME MEASURE: Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment. RESULTS: After 12 weeks of treatment, the proportion of participants with an abnormal Nugent score in the P. mirifica and the placebo groups were 6.7 % (2/30) and 23.3 % (7/30), respectively (pâ¯=⯠0.006). The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (pâ¯<⯠0.05). There were no significant decreases in the prevalence of symptoms between the two groups after treatment (pâ¯>â¯0.05). CONCLUSION: A 12-week course of treatment with 5 % P. mirifica vaginal gel in postmenopausal women with GSM has been proved to be effective in reducing indicators of bacterial vaginosis compared with placebo gel. Nevertheless, the effect on alleviating genital symptoms was not demonstrated.
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Infecciones Bacterianas/tratamiento farmacológico , Enfermedades Urogenitales Femeninas/tratamiento farmacológico , Micosis/tratamiento farmacológico , Extractos Vegetales/uso terapéutico , Pueraria , Método Doble Ciego , Femenino , Humanos , Concentración de Iones de Hidrógeno , Persona de Mediana Edad , Fitoterapia , Posmenopausia , Síndrome , Vagina/química , Vagina/efectos de los fármacos , Cremas, Espumas y Geles Vaginales/uso terapéuticoRESUMEN
OBJECTIVE: The aim of this overview was to evaluate the effectiveness of phytoestrogens on vaginal health and dyspareunia in peri- and post-menopausal women. MATERIAL AND METHODS: Three databases including MEDLINE, Scopus and the Cochrane Central Register of Controlled Trials were from inception to August 2017. RESULT: Two systematic reviews and 11 RCTs were included in the overview. According to the findings, isoflavones increased the maturation value and attenuated the vaginal atrophy in the post-menopausal women. Topical isoflavones had beneficial effects on the vaginal atrophy. Similar efficacy was found in Pueraria mirifica and conjugated estrogen cream on dryness ( p = 0.277), soreness ( p = 0.124) and irritation ( p = 0.469), as well as discharge ( p = 0.225) and dyspareunia ( p = 0.089). However, the conjugated estrogen cream was more effective compared to Pueraria mirifica ( p > 0.005) regarding maturation index improvement. Comparison of fennel 5% vaginal cream and placebo gel showed significant difference in superficial cells ( p < 0.01), parabasal cells ( p < 0.01) and intermediate cells ( p < 0.01), whereas no difference was found between the oral fennel and placebo in terms of superficial, parabasal and intermediate cells as well as Maturation value. Administration of 80 mg red clover oil had a significant effect on superficial ( p < 0.005), intermediate ( p < 0.005) and parabasal and vaginal dryness ( p < 0.005) compared to the placebo. Flaxseed had also a trivial effect on maturation value. Genistein had a more prominent effect on the genital score. The severity of dyspareunia decreased by 27%. CONCLUSION: Phytoestrogens have various effects based on administration route and type on the vaginal atrophy.
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Dispareunia/tratamiento farmacológico , Foeniculum , Isoflavonas/uso terapéutico , Fitoestrógenos/uso terapéutico , Pueraria , Vagina/patología , Atrofia/tratamiento farmacológico , Femenino , Lino , Geles , Humanos , Isoflavonas/administración & dosificación , Perimenopausia , Fitoestrógenos/administración & dosificación , Preparaciones de Plantas/uso terapéutico , Posmenopausia , Trifolium , Cremas, Espumas y Geles Vaginales/uso terapéuticoRESUMEN
Objective: The aim of this study was to assess the effect of fennel on sexual function in postmenopausal women. It was a randomized controlled trial in 60 postmenopausal women with sexual dysfunction who were randomly assigned to two groups receiving either fennel vaginal cream (n=30) or placebo (n=30). Vaginal atrophy in the women was assessed using symptoms such as pallor, dryness, dyspareunia, itching and burning. The pH of the vagina and cytology of the vaginal mucosa were also measured at baseline and 8 weeks after the intervention. All participants were requested to fill out the Female Sexual Function Index (FSFI) at baseline and after 8 weeks. The intervention group was requested to use fennel vaginal cream (5 grams) every night, while the control group used placebo each night for 8 weeks. The data were analyzed using the independent t-test and Chi-square, Mann-Whitney and Wilcoxon tests. All areas of sexual function including arousal, lubrication, orgasm, sexual satisfaction and pain improved in both fennel and placebo groups after 8 weeks; however, the differences in the fennel group were more evident (p<0.05). The total FSFI score was significantly higher in the fennel group compared to the control group (8.2 ±9.4 and 8.03±10.36 before the intervention and changing to 33.79±0.7 and 18.99±1.09 after the intervention in the fennel and placebo groups, respectively; p<0.001). Discussion: According to our results, fennel vaginal cream is an effective means of improving sexual activity in postmenopausal women. The use of this product in women who have sexual dysfunction and contraindications for hormone therapy is recommended.
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Foeniculum/química , Extractos Vegetales/uso terapéutico , Posmenopausia/efectos de los fármacos , Disfunciones Sexuales Fisiológicas/tratamiento farmacológico , Cremas, Espumas y Geles Vaginales/uso terapéutico , Demografía , Método Doble Ciego , Femenino , Humanos , Persona de Mediana Edad , Placebos , Extractos Vegetales/farmacología , Cremas, Espumas y Geles Vaginales/farmacologíaRESUMEN
Vaginal dryness and associated symptoms may occur in women of any age and are a frequent burden after menopause. The North American Menopause Society recommends long-acting non-hormonal vaginal creams as first-line therapy. A new type of such creams was developed (Remifemin® FeuchtCreme in Austria and Germany). This hormone-free cream contains hamamelis virginiana distillate and well-established vaginal cream ingredients. We explored its physical function and tolerability in an open interventional clinical trial. 20 postmenopausal women (54 to 76 years, median 60) treated their vaginal dryness using this cream once daily for 7 days and reported about their symptoms before, 4 to 8 h after first and 14 to 22 h after last application. A physician assessed tolerability and local physical function. All patients completed the study. Local physical function significantly improved from dryness at baseline (mean 4.0 ± SD 1.8) to a normal moisture level, on average (6.3 ± 2.1 after first, 6.7 ± 2.1 after last application, p = 0.0001). Subjective assessment of a feeling vaginal dryness showed a significant improvement at both times (p = 0.0001). Onset and duration of feeling moisturized were reported to be 0 to 2 min and 11.3 ± 6.9 h after application. All women reported vaginal dryness at baseline. 55 and 80% of patients reported no dryness after first application and at the end of the investigation. The cream was seen at the application site for up to 21 h. Tolerability assessments did not reveal any relevant change over time. There were four adverse events in 4 patients, all not serious and of mild intensity: urinary urgency (2), diarrhoea (1) and mild spotting after first application (1). The latter was caused by the dry surface of the applicator and was avoided by moisturizing the surface of the applicator at subsequent applications. In conclusion, these study results indicate a well-tolerated and long-acting function of this new vaginal moisturizing cream. Further clinical research in more patients will follow.
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Extractos Vegetales/uso terapéutico , Cremas, Espumas y Geles Vaginales/uso terapéutico , Enfermedades Vaginales/tratamiento farmacológico , Cimicifuga , Climaterio/efectos de los fármacos , Femenino , Humanos , Persona de Mediana Edad , Fitoterapia , Extractos Vegetales/farmacología , Resultado del Tratamiento , Vagina/efectos de los fármacos , Vagina/patologíaRESUMEN
OBJECTIVE: To assess whether the orally administered combination of hyaluronic acid (HA), chondroitin sulfate (CS), curcumin and quercetin could be effective in preventing recurrent cystitis in postmenopausal women and whether its efficacy was conditioned by the concurrent use of local estrogen therapy. STUDY DESIGN: This was a prospective evaluation of 145 postmenopausal women consecutively recruited from the database of three different investigators. All women should have mild-to-moderate urogenital atrophy and a history of recurrent urinary tract infections (≥2 episodes within 6 months or ≥3 episodes within 12 months documented by positive urine cultures) during the last year. Patients were assigned to three different therapeutic regimens: the first group was treated only with vaginal estrogens, the second group only with HA, CS, curcumin and quercetin per os, and the third group was treated with HA, CS, curcumin and quercetin associated with local estrogens. We evaluated the number of patients with <2 infective episodes in the 6-month follow-up and <3 episodes in the 12-month follow-up (main aim definition) and the reduction of related symptoms through a Visual Analog Scale (VAS) and the Pelvic Pain and Urgency/Frequency (PUF) patient symptom scale. Student's t-test and chi-squared test were used for data analysis as appropriate. RESULTS: At 6-month follow up, the main aim rate was 8%, 11.1% and 25% in the three groups, respectively (p<0.05 compared to baseline only in group 3). Although the reduction in the number of recurrent episodes became significant in all groups at 1 year follow-up, the main aim rate was almost double in women receiving both local estrogens and oral therapy (group 3) compared to those receiving single treatments. The improvement of related symptoms was significant in all groups at 12-month follow-up. CONCLUSIONS: In postmenopausal women, the combination of HA, CS, curcumin and quercetin per os was effective in preventing recurrent urinary tract infections, especially if administered with vaginal estrogen therapy.
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Envejecimiento , Sulfatos de Condroitina/uso terapéutico , Curcumina/uso terapéutico , Suplementos Dietéticos , Ácido Hialurónico/uso terapéutico , Quercetina/uso terapéutico , Infecciones Urinarias/prevención & control , Antiinfecciosos Urinarios/efectos adversos , Antiinfecciosos Urinarios/uso terapéutico , Antioxidantes/efectos adversos , Antioxidantes/uso terapéutico , Vaginitis Atrófica/complicaciones , Vaginitis Atrófica/tratamiento farmacológico , Vaginitis Atrófica/fisiopatología , Sulfatos de Condroitina/efectos adversos , Terapia Combinada/efectos adversos , Curcumina/efectos adversos , Suplementos Dietéticos/efectos adversos , Resistencia a la Enfermedad/efectos de los fármacos , Estriol/efectos adversos , Estriol/uso terapéutico , Terapia de Reemplazo de Estrógeno/efectos adversos , Estrógenos/efectos adversos , Estrógenos/uso terapéutico , Femenino , Humanos , Ácido Hialurónico/efectos adversos , Persona de Mediana Edad , Posmenopausia , Quercetina/efectos adversos , Prevención Secundaria , Índice de Severidad de la Enfermedad , Infecciones Urinarias/complicaciones , Infecciones Urinarias/microbiología , Infecciones Urinarias/orina , Cremas, Espumas y Geles Vaginales/efectos adversos , Cremas, Espumas y Geles Vaginales/uso terapéuticoRESUMEN
OBJECTIVE: To prove the efficacy, tolerability and safety of Monurelle Biogel(®) (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women of reproductive age suffering from vaginal dryness. DESIGN: Randomized clinical trial (RCT) (Z7213M01). SETTING: Five University Gynaecological Units. PATIENTS: Ninety-five subjects were allocated at random to receive either ZP-025 (n=48) for about 23 intermenstrual days (1 or 2 times/daily intra-vaginally) or no treatment (lubricants on demand were allowed). MAIN OUTCOME MEASURES: Change of Verbal Rating Scale (VRS) total and single score for vaginal symptoms, Vaginal Health Index (VHI) score, Female Sexual Function index (FSFI) and Female Sexual Distress Scale-revised (FSDS-R) scores. RESULTS: A total number of 85 subjects was evaluable for primary analyses. Symptoms (VRS) of vaginal discomfort improved significantly already after 11 days, as compared to the control arm (p<0.0001). The mean VHI score was also significantly higher in ZP-025 group (p<0.001) at the end of the study. The analysis of covariance with the baseline value as covariate carried out on the FSFI Total Score showed a statistically significant difference in favour of the ZP-025 arm (p<0.032). A shift from presence to absence of sexual distress (≤11 points) was more prominent in the ZP-025 arm [10 subjects (40%) in the ZP-025 arm (p<0.0001) and 6 subjects (21.4%) in the control arm (p=0.01)]. Women reported a compliance rate of 100% for one ZP-025 application/day. Local tolerability of ZP-025 was excellent or good in 82.9% of the subjects. CONCLUSIONS: The present multicentre RCT supports the use of Monurelle Biogel(®) in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident.
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Libido/efectos de los fármacos , Cremas, Espumas y Geles Vaginales/uso terapéutico , Enfermedades Vaginales/tratamiento farmacológico , Administración Intravaginal , Adulto , Calostro , Femenino , Humanos , Persona de Mediana Edad , Conducta Sexual/efectos de los fármacos , Resultado del Tratamiento , Cremas, Espumas y Geles Vaginales/farmacología , Adulto JovenRESUMEN
BACKGROUND: Problems affecting the vaginal tract in diabetic women are very often neglected. The efficacy and safety of three gynecological treatments in diabetic women have been assessed. MATERIALS AND METHODS: A single-blind randomized progressive trial on 48 diabetic women affected by vaginal dryness, dyspareunia, and recurrent Candida infections was carried out. The ICIQ Vaginal Symptoms (ICIQ-VS) questionnaire was administered. RESULTS: The analysis of the parameters of ICIQ-VS questionnaire among the three groups showed significant difference only for "dragging pain" (p = 0.0 19) and "soreness" (p = 0.028). In all groups and for all parameters of the questionnaire, improvement of symptoms was observed. In particular, in Group 1 for all symptoms a highly significant difference was observed, to support the already known benefits of the products and of the proposed combination. Significant improvement was also observed in Group 2. CONCLUSIONS: The proposed treatment with DermoXEN® Ultracalming Special for diabetics and DermoXEN® Vitexyl vaginal gel exert effective moisturizing and soothing action. Indeed, the aforementioned products have been proven effective for the main gynecological problems of diabetic women.
Asunto(s)
Candidiasis Vulvovaginal/prevención & control , Complicaciones de la Diabetes/prevención & control , Diabetes Mellitus , Dispareunia/prevención & control , Glicerol/uso terapéutico , Ácido Hialurónico/uso terapéutico , Ácido Láctico/uso terapéutico , Ácido Pantoténico/análogos & derivados , Viscosuplementos/uso terapéutico , ortoaminobenzoatos/uso terapéutico , Administración Intravaginal , Adulto , Candidiasis Vulvovaginal/tratamiento farmacológico , Complicaciones de la Diabetes/tratamiento farmacológico , Combinación de Medicamentos , Dispareunia/tratamiento farmacológico , Femenino , Humanos , Lípidos/uso terapéutico , Persona de Mediana Edad , Ácido Pantoténico/uso terapéutico , Recurrencia , Método Simple Ciego , Cremas, Espumas y Geles Vaginales/uso terapéutico , Vulvovaginitis/tratamiento farmacológico , Vulvovaginitis/prevención & controlRESUMEN
OBJECTIVE: Vaginal atrophy is one of the main concerns of postmenopausal women. The aim of the present study was to investigate the effect of fennel vaginal cream on vaginal atrophy in postmenopausal women in Ahvaz, Iran. MATERIALS AND METHODS: This double-blind randomized controlled trial was conducted on 60 postmenopausal women (45-65 years of age) in Ahvaz, Iran. The study participants were randomly divided into one of two groups, receiving either a placebo (n=30) or fennel 5% vaginal cream (n=30) administered as one application per day (5g/day) for 8 weeks. MAIN OUTCOME: The vaginal pH and maturation vaginal index (MVI) were measured at baseline and 8 weeks after the intervention, while the vaginal atrophy symptoms was measured at baseline and at 2, 4, and 8 weeks after the intervention. The data were analyzed using the independent t-test, chi-square test, paired sample t-test, and the generalized estimating equation. RESULTS: The number of superficial cells increased significantly in the fennel group after 8 weeks compared to the control group (76.1±15.3 vs. 11.8±8, p<0.001). The number of intermediate and parabasal cells decreased significantly in the fennel group compared to the control group (p<0.001). The vaginal pH decreased significantly at the 8-week follow-up in the fennel group compared to the control group (100% vs. 7.4%, p<0.001). All women in the fennel group had an MVI of 65-100 at the 8-week follow-up, whereas almost half (40.7%) of the women in the control group had an MVI of 50-64 (p<0.001). CONCLUSION: According to results of this study, fennel is an effective means to manage the symptoms of vaginal atrophy in postmenopausal women and is devoid of side effects. Larger studies are necessary to confirm the positive impact of fennel for vaginal conditions occurring among postmenopausal women.
Asunto(s)
Foeniculum , Fitoterapia , Vagina/efectos de los fármacos , Vagina/patología , Cremas, Espumas y Geles Vaginales/uso terapéutico , Atrofia/tratamiento farmacológico , Atrofia/patología , Método Doble Ciego , Femenino , Humanos , Concentración de Iones de Hidrógeno , Persona de Mediana Edad , Preparaciones de Plantas/uso terapéutico , Posmenopausia , Vagina/químicaRESUMEN
BACKGROUND: Vulvovaginal candidiasis is known as one of the most common fungal infection among women of reproductive age and considered as an important public health problem. In recent years, due to resistance to common antifungal medication, the use of traditional medicine of anti-fungal and herbal treatment increased. Therefore the objective of this study was to determine the effects of vaginal cream, mixture of yogurt and honey and comparing it with clotrimazole vaginal cream on symptoms of Vulvovaginal candidiasis in patients. METHODS: In this randomized, triple blind clinical trial of 70 non-pregnant women infected with Candidal vulvovaginitis were placed in two groups of Vaginal cream mixed of yogurt and honey recipients (N=35) and clotrimazole vaginal cream (N=35). Both groups were treated for 7 days. At the beginning of study, Clinical and laboratory signs and symptoms were registered 7 and 14 days after treatment by questionnaire, observation form and secretions culture results. Data by chi-square test, t test, McNemar tests were analyzed by SPSS version 21. Significance level of 0.05 was considered. RESULTS: The result of present study reveals the significant differences in symptom improvement of ' yogurt and honey, than clotrimazole group (P<0.05) and also Positive results of the first cultures (one week after treatment) in "yogurt and honey" and clotrimazole (20% versus 8.6%) and second time cultivation (14 days after treatment) (17/1% versus 8.6%) were similar and there was no significant differences between the two groups. (P>0.05) CONCLUSION: This study indicated that he therapeutic effects of vaginal cream, yogurt and honey is not only similar with clotrimazole vaginal cream but more effective in relieving some symptoms of vaginal candidiasis. Therefore, the use of this product can be suggested as an herbal remedy for candida infection treatment.
Asunto(s)
Antifúngicos/uso terapéutico , Candidiasis Vulvovaginal/tratamiento farmacológico , Clotrimazol/uso terapéutico , Miel , Cremas, Espumas y Geles Vaginales/uso terapéutico , Yogur , Adulto , Femenino , Humanos , Resultado del TratamientoRESUMEN
Vaginal infections are extremely prevalent, particularly among women of reproductive age. Although they do not result in high mortality rates, these infections are associated with high levels of anxiety and reduction of quality of life. In most cases, topical treatment of vaginal infections has been shown to be at least as effective as oral treatment, resulting in higher local drug concentrations, with fewer drug interactions and adverse effects. Furthermore, the emergence of microbial resistance to chemotherapeutics and the difficulties in managing infection recurrences sustain the need for more effective local treatments. However, conventional dosage forms have been associated with low retention in the vagina and discomfort. Formulation strategies such as the development of bioadhesive, thermogelling systems and microtechnological or nanotechnological approaches have been proposed to improve delivery of traditional drugs, and other treatment modalities such as new drugs, plant extracts, and probiotics are being studied. This article reviews the recent strategies studied to improve the treatment and prevention of the commonest vaginal infections-namely, vaginal bacteriosis, aerobic vaginitis, vulvovaginal candidosis, and trichomoniasis-through the intravaginal route.
Asunto(s)
Antibacterianos/administración & dosificación , Sistemas de Liberación de Medicamentos/métodos , Tecnología Farmacéutica/métodos , Cremas, Espumas y Geles Vaginales/administración & dosificación , Vaginitis/tratamiento farmacológico , Administración Intravaginal , Antibacterianos/farmacocinética , Antibacterianos/uso terapéutico , Candidiasis Vulvovaginal/tratamiento farmacológico , Femenino , Humanos , Aceites Volátiles/uso terapéutico , Probióticos/uso terapéutico , Vaginitis por Trichomonas/tratamiento farmacológico , Vagina/fisiología , Absorción Vaginal , Cremas, Espumas y Geles Vaginales/farmacocinética , Cremas, Espumas y Geles Vaginales/uso terapéutico , Vaginosis Bacteriana/tratamiento farmacológicoRESUMEN
Sexually transmitted infections like HIV, HPV, and HSV-2, as well as unplanned pregnancy, take a huge toll on women worldwide. Woman-initiated multipurpose prevention technologies that contain antiviral/antibacterial drugs (microbicides) and a contraceptive to simultaneously target sexually transmitted infections and unplanned pregnancy are being developed to reduce these burdens. This review will consider products that are applied topically to the vagina. Rectally administered topical microbicides in development for receptive anal intercourse are outside the scope of this review. Microbicide and microbicide/contraceptive candidates must be rigorously evaluated in preclinical models of safety and efficacy to ensure that only candidates with favorable risk benefit ratios are advanced into human clinical trials. This review describes the comprehensive set of in vitro, ex vivo, and in vivo models used to evaluate the preclinical safety and antiviral efficacy of microbicide and microbicide/contraceptive candidates.
Asunto(s)
Antivirales/uso terapéutico , Anticonceptivos Femeninos/uso terapéutico , Evaluación Preclínica de Medicamentos/métodos , Modelos Biológicos , Embarazo no Planeado , Enfermedades Virales de Transmisión Sexual/prevención & control , Administración Intravaginal , Animales , Antivirales/administración & dosificación , Antivirales/efectos adversos , Antivirales/farmacocinética , Anticonceptivos Femeninos/administración & dosificación , Anticonceptivos Femeninos/efectos adversos , Anticonceptivos Femeninos/farmacocinética , Evaluación Preclínica de Medicamentos/normas , Femenino , Infecciones por VIH/prevención & control , Haplorrinos , Herpes Genital/prevención & control , Humanos , Ratones , Infecciones por Papillomavirus/prevención & control , Embarazo , Vagina/fisiología , Absorción Vaginal , Cremas, Espumas y Geles Vaginales/farmacocinética , Cremas, Espumas y Geles Vaginales/uso terapéuticoRESUMEN
Curcumin and curcumin containing polyherbal preparations have demonstrated anti-microbial and anti- viral properties in pre-clinical studies. Till date no therapeutic intervention has been proved to be effective and safe in clearing established cervical human papillomavirus (HPV) infection. The present study evaluated the efficacy of Basant polyherbal vaginal cream (containing extracts of curcumin, reetha, amla and aloe vera) and of curcumin vaginal capsules to eliminate HPV infection from cervix. Women were screened by Pap smear and HPV DNA test by PCR. HPV positive women without high grade cervical neoplasias (N=287) were randomized to four intervention arms to be treated with vaginal Basant cream, vaginal placebo cream, curcumin vaginal capsules and placebo vaginal capsules respectively. All subjects were instructed to use one application of the assigned formulation daily for 30 consecutive days except during menstruation and recalled within seven days of the last application for repeat HPV test, cytology and colposcopy. HPV clearance rate in Basant arm (87.7%) was significantly higher than the combined placebo arms (73.3%). Curcumin caused higher rate of clearance (81.3%) than placebo though the difference was not statistically significant. Vaginal irritation and itching, mostly mild to moderate, was significantly higher after Basant application. No serious adverse events were noted.
Asunto(s)
Curcumina/uso terapéutico , Papillomaviridae/efectos de los fármacos , Infecciones por Papillomavirus/tratamiento farmacológico , Extractos Vegetales/uso terapéutico , Cremas, Espumas y Geles Vaginales/uso terapéutico , Adulto , Cuello del Útero/efectos de los fármacos , Cuello del Útero/virología , Femenino , Humanos , Prueba de Papanicolaou/métodos , Infecciones por Papillomavirus/virología , Plantas Medicinales , Frotis Vaginal/métodosRESUMEN
OBJECTIVE: The authors' intent was to determine the clinical efficacy of comprehensive pelvic floor rehabilitation among women with symptoms of pelvic floor dysfunction (PFD). METHODS: We performed a retrospective analysis of women referred to an academic female pelvic medicine and reconstructive surgery practice for PFD. Data were gathered from the records of 778 women referred for pelvic floor therapy for urinary, bowel, pelvic pain, and sexual symptoms over the course of 4 years. RESULTS: Patients who completed at least 5 therapy sessions reported a mean symptom improvement of 80% in each of the 3 main categories analyzed, namely, urinary incontinence, defecatory dysfunction, and pelvic pain. CONCLUSIONS: Comprehensive, nonoperative management of PFD including pelvic floor muscle training, biofeedback, electrogalvanic stimulation, constipation management, behavioral modification, incontinence devices, and pharmacotherapy including vaginal estrogen is effective in the treatment of women with PFD.