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A 64-year-old woman had severe vulvovaginitis develop while she was receiving intravaginal nystatin therapy for Candida glabrata infection. Mucocutaneous adverse effects have rarely been reported with nystatin despite long years of use. This complication should be included in the differential diagnosis of clinical failure of intravaginal nystatin therapy.
Bacterial vaginosis is common among patients seen by gynecologists. Several types of therapy have been proposed. The purpose of this prospective, randomized, double-blind clinical trial was to examine the efficacy of clindamycin vaginal cream for the treatment of bacterial vaginosis. Sixty patients with symptoms of bacterial vaginosis were randomized into the study, and 46 completed the protocol. Twenty-three patients received 2% clindamycin vaginal cream (5 g applied intravaginally at bedtime for 7 days), with placebo oral tablets twice daily for 7 days. The other 23 patients received oral metronidazole tablets (500 mg twice a day for 7 days) and placebo vaginal cream (5 g intravaginally for 7 days). The cure rates for the two regimens were comparable. Twenty-two (97%) of the patients treated with clindamycin vaginal cream had improvement or cure at the first follow-up visit versus 19 (83%) of those taking metronidazole. There was no statistically significant difference between the two results. Side effects for both regimens were comparable. We conclude that 2% clindamycin vaginal cream offers similar efficacy and safety to standard oral metronidazole therapy for bacterial vaginosis.
OBJECTIVE: To support the practitioner in the diagnosis of vaginal atrophy and in the management of the related symptoms. OPTIONS: The modalities of evaluation range from basic pelvic examination, examination of the vulva, and laboratory tests. OUTCOMES: A comprehensive approach to the detection of vaginal atrophy and a discussion of available therapeutic and nontherapeutic options. EVIDENCE: Published opinions of experts, supplemented by evidence from clinical trials, where appropriate. VALUES: The quality of the evidence is rated using the criteria described by the Canadian Task Force on the Periodic Health Examination. BENEFITS, HARMS, AND COSTS: Diagnosis of vaginal atrophy is often a challenge because women are unwilling to report symptoms, which have the potential to significantly decrease their quality of life. Increased clinical suspicion is the first step in the diagnosis of vaginal atrophy, which will prompt the initiation of safe therapies with proven efficacy. RECOMMENDATIONS: 1. Health-care providers should routinely assess postmenopausal women for the symptoms and signs of vaginal atrophy, a common condition that exerts significant negative effects on quality of life. (III-C) 2. Regular sexual activity should be encouraged to maintain vaginal health. (II-2B)3. Women experiencing recurrent urinary tract infections should be instructed that consumption of pure cranberry-lingonberry juice, rather than cranberry drink, will decrease their risk of urinary tract infections. (I-A) 4. Vaginal moisturizers applied on a regular basis have an efficacy equivalent to local hormone replacement for the treatment of local urogenital symptoms such as vaginal itching, irritation, and dyspareunia, and should be offered to women wishing to avoid use of hormone replacement therapy. (I-A) 5. Women experiencing vaginal atrophy can be offered any of the following effective vaginal estrogen replacement therapies: conjugated equine estrogen cream (I-A), a sustained-release intravaginal estradiol ring (I-A), or a low-dose estradiol tablet (I-A). 6. Although systemic absorption of estrogen can occur with local preparations, there is insufficient data to recommend annual endometrial surveillance in asymptomatic women using local estrogens. (III-C) 7. For menopausal women experiencing recurrent urinary tract infections and who have no contraindication to local hormone replacement, vaginal estrogen therapy should be offered. (I-A).
The objective of this prospective, randomised study was to compare the efficacy, safety and tolerability of vaginal micronised progesterone with oral dydrogesterone as luteal phase support after in-vitro fertilisation (IVF). A total of 430 women underwent IVF/intracytoplasmic sperm injection (ICSI) treatment. Long protocol gonadotropin releasing hormone analogue down-regulation was followed by gonadotropin stimulation. Human chorionic gonadotropin was given when two or more follicles reached > or = 17 mm. After 36 h, oocytes were retrieved and IVF was performed. Embryo transfer was done at the 4-8 cell embryo stage. Luteal support was initiated from the day of embryo transfer and continued for up to 14 days. Patients were randomised to luteal supplementation with either intravaginal micronised progesterone 200 mg three times daily (n=351) or oral dydrogesterone 10 mg twice daily (n=79). In cases of a positive pregnancy test, luteal support was continued for 12 weeks. Both dydrogesterone and micronised progesterone were associated with similar rates of successful pregnancies. Vaginal discharge or irritation were reported by 10.5% of patients given micronised progesterone. Significantly (p<0.05), more patients given dydrogesterone than micronised progesterone were satisfied with the tolerability of their treatment. There were no differences between the treatments with regard to liver function tests.
OBJECTIVE: To determine the efficacy of oral nifedipine as prophylaxis against uterine tachysystole associated with misoprostol induction of labor. METHODS: A total of 116 patients undergoing induction with term, singleton pregnancies were enrolled. All patients received 50 microg misoprostol intravaginally every 4 h. Patients were randomly assigned also to receive nifedipine 10 mg orally every 4 h, or no prophylaxis. The primary outcome variable was the incidence of 12 or more contractions in any 20-min interval. RESULTS: Data on 106 patients were available for analysis. There were 55 subjects in the misoprostol-nifedipine group and 51 controls. Nifedipine did not diminish the incidence of tachysystole when added to misoprostol (42% vs. 45% without nifedipine; p = 0.7). CONCLUSION: Prophylactic oral nifedipine was not shown to decrease the uterine tachysystole associated with vaginal misoprostol induction at a 50-microg dose.
OBJECTIVE: To compare oral misoprostol (100 microgram) to vaginal misoprostol (25 microgram) for cervical ripening and labor induction. METHODS: Two hundred thirty-six women with medical or obstetric indications for labor induction and undilated, uneffaced cervices were assigned randomly to receive 100 microgram of oral or 25 microgram of vaginal misoprostol every 4 hours for 24 hours. Intravenous oxytocin was then given using a standardized protocol. We anticipated that 31% of women treated orally and 50% of women treated vaginally would deliver vaginally within 24 hours of starting labor induction. RESULTS: Among 234 subjects, 121 received oral and 113 received vaginal misoprostol. The mean (+/- standard deviation [SD]) interval from start of induction to delivery was 1240 +/- 845 minutes for orally treated women and 1381 +/- 802 minutes for vaginally treated women (P =.06, log-transformed data). More orally treated women delivered vaginally in 24 hours than vaginally treated women (74 versus 54, P =.14, relative risk [RR] 1.14, 95% confidence interval [CI] 0.92, 1.40). One hundred six women (87.6%) who received oral misoprostol delivered vaginally, compared with 88 women (77.9%) who received vaginal misoprostol (P =.07). Oxytocin was given to 60 (49. 6%) orally treated and 59 (52.2%) vaginally treated subjects (P =. 69). More women in the oral group had tachysystole, nine compared with two (P =.06), hypertonus, and hyperstimulation. Frequencies of intrapartum complications and birth outcomes were similar between groups. CONCLUSION: Oral misoprostol 100 microgram and vaginal misoprostol 25 microgram were similarly effective for cervical ripening and labor induction. Oral administration was associated with trends toward higher likelihood of vaginal delivery and more uterine tachysystole.
In a double-blind trial comprising 66 patients we assessed the effect of metronidazole-nystatin vagitories on the prevention of bacterial vaginosis (BV) in women using IUD as a contraceptive method after an initial oral single dose of 2.0 g metronidazole and 7 days of intravaginal metronidazole-nystatin or placebo treatment. The prophylactic treatment consisted of metronidazole-nystatin or placebo vagitories applied at bedtime for 3 days after menstruation over 6 consecutive menstrual periods. The patients were randomized in two study groups: a treatment group of 32 patients (group A) and a placebo group of 34 patients (group B). The overall objective cure rate after the initial treatment was 97% in group A and 91% in group B. After 6 months of follow-up, the overall cumulative objective cure rate in group A was 100%, and 76% in group B. The single-dose oral treatment was well tolerated and no notable side effects were recorded.
OBJECTIVE: To review literature examining exogenous Lactobacillus therapy for vulvovaginal candidiasis and to discuss recommendations for clinical practice and future research. DATA SOURCES: Computerized searches on MEDLINE and CINAHL November 2000, September 2001, and March 2002, with search terms including Lactobacillus, acidophilus, Candida, and yeast infections. STUDY SELECTION: Relevant English-language articles from the past 10 years. Unique or seminal studies included where pertinent. DATA EXTRACTION AND SYNTHESIS: Data organized under the following headings: endogenous Lactobacillus, exogenous Lactobacillus, Candida, studies of intravaginal Lactobacillus therapy for vulvovaginal candidiasis, studies of oral Lactobacillus therapy for vulvovaginal candidiasis. CONCLUSIONS: Vaginally administered or orally ingested Lactobacillus is able to colonize the vaginal ecosystem. Controlled intervention studies regarding the effect of such colonization on vulvovaginal candidiasis are promising but few. These studies had small numbers of participants, were inconsistent in the form of Lactobacillus used, and reported conflicting results. Further randomized controlled trials involving large numbers of women are imperative. In the meantime, health care providers should discuss potential benefits with affected patients while clarifying the current lack of conclusive evidence. Without further research into currently available sources and brands of Lactobacillus and without governmental regulation of supplements and their contents, however, it is difficult to make recommendations regarding appropriate product choice.
The purpose of this study was to compare the efficacy of a recommended protocol of oral melengestrol acetate (MGA) to intravaginal medroxyprogesterone acetate (MPA), with or without equine chorionic gonadotropin (eCG), for out-of-season breeding of sheep on Prince Edward Island. One hundred and twenty ewes were assigned to 1 of 4 groups in a factorial design and were treated with either an intravaginal MPA sponge or oral MGA. Ewes received either an intramuscular injection of eCG or a saline placebo at cessation of progestogen treatment. The reproductive performance was best for the MPA-eCG group, followed by the MGA-eCG, MGA-saline, and MPA-saline. Pregnancy rates of 66.7%, 43.3%, 31.0%, and 16.7%, respectively, and ratios of lambs born to ewes exposed to the ram of 1.17, 0.63, 0.52, and 0.23, respectively, were recorded for these groups. We concluded that, under the conditions of this study, the use of oral MGA resulted in fewer lambs than did the use of MPA sponges with eCG. Nonetheless, the use of MGA may be attractive to producers because it is less expensive and more convenient than the use of sponges.
OBJECTIVES: To compare efficacy, acceptability and patient preference of a single oral dose of fluconazole with a single intravaginal dose of 500 mg clotrimazole (medication groups) in women with vaginal candidosis visiting gynaecologists or general practitioners (study groups). DESIGN: A comparative, randomized multicenter study. EVENTS: Baseline visit and treatment, short-term follow-up after 1 week and long-term follow-up after 4 weeks. At each visit, symptoms were graded and cultures were obtained. RESULTS: Symptomatic and mycological efficacy did not differ statistical significant in the medication groups or study groups. A complicated history regarding vaginal candidosis was more often found among gynaecologists, yielding poorer results of treatment. Patients preferred oral treatment over intra-vaginal treatment. CONCLUSIONS: No differences were found in the clinical and mycological efficacy of both drugs. Clinical results were related to parameters originating from the patients history, resulting in less favourable results in the study group of gynaecologists.
One hundred and twenty nine nulliparous requesting first trimester induced abortion between 7 and 12 weeks of amenorrhea (SA) were included in the study to evaluate the effectiveness and the side effects of misoprostol in the cervical ripening before aspiration. Three randomized groups of 43 patients received misoprostol 12 hours before induced abortion: group A received 200 mug inserted vaginally; group B received 400 mu g inserted vaginally and group C received 400 mu g orally. Cervical dilatation after treatment and maximal dilatation realized with Hegar dilatator were significantly higher in group B. The rate of partial abortion is significantly higher in group B. Tolerance is good in the three groups. No significant difference between the three groups related digestive disorders, pelvic pain and hyperthermia were noted. On the other hand the rate of metrorrhagia and hemorrhages more important than menstruation is higher in group B. Misoprostol 400 mu g inserted vaginally 12 hours before induced abortion in nulliparous women seem to be an effective, safe, practical and cheap method for cervical ripening before aspiration.
AIMS: to compare the benefits and harms of misoprostol to induce labour in the second and third trimester of pregnancy with cervagem. METHODS: MEDLINE was searched using the terms abortion, induced; abortifacient agents; pregnancy, second trimester; pregnancy, third trimester; misoprostol; cervagem; and gemeprost to identify randomised controlled trials in which misoprostol was compared with cervagem, for induction of labour to terminate pregnancy in the second or third trimester. Outcomes included vaginal birth not achieved within 24h; induction to delivery interval; analgesia requirements; blood loss; blood transfusion; surgical evacuation of the uterus; maternal death or serious maternal morbidity; side effects. RESULTS: Six randomised trials were included. Five compared vaginal misoprostol with cervagem [el Refaey H, Hinshaw K, Templeton A. The abortifacient effect of misoprostol in the second trimester: a randomized comparison with gemeprost in patients pre-treated with mifepristone (RU486). Hum Reprod 1993;8(10):1744-6; Ho PC, Chan YF, Lau W. Misoprostol is as effective as gemeprost in termination of second trimester pregnancy when combined with mifepristone: a randomised comparative trial. Contraception 1996;53(5):281-3; Nuutila M, Toivonen J, Ylikorkala O, Halmesmaki E. A comparison between two doses of intravaginal misoprostol and gemeprost for induction of second trimester abortion. Obstetr Gynecol 1997;90(6):896-900; Wong KS, Ngai CS, Wong AY, Tang LC, Ho PC. Vaginal misoprostol compared with vaginal gemeprost in termination of pregnancy: a randomized controlled trial. Contraception 1998;58(4):207-10; Dickinson JE, Godfrey M, Evans SF. Efficacy of intravaginal misoprostol in second trimester termination of pregnancy: a randomized controlled trial. J Mater Fetal Med 1999;7(3):115-9], and one oral misoprostol with gemeprost [Bartley J, Baird DT. A randomised study of misoprostol and gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy. Br J Obstetr Gynaecol 2002;109(11):1290-4]. Vaginal misoprostol compared with cervagem was associated with reduced narcotic analgesia (3 studies, 169 women, RR 0.64 95% CI 0.49-0.84), and surgical evacuation of the uterus (5 studies, 319 women, RR 0.71 95% CI 0.53-0.95). No other statistically significant differences were observed for other outcomes with reported data. In the single trial comparing oral misoprostol with gemeprost, reported outcomes were similar. CONCLUSIONS: Vaginal misoprostol for the termination of second and third trimester of pregnancy appears as effective as cervagem, but information about maternal safety is limited.
Meloxicam, a selective cyclooxygenase-2 inhibitor, was administered orally or intravaginally, to sperm-positive female rabbits to assess its effect on ovulation. A single oral dose (20 mg/kg), administered 5 h postcoitus resulted in 100% contraceptive rate. On the other hand, for females receiving meloxicam suppositories (14.9 mg/kg), 5 h postcoitus, the contraceptive rate was 62.5% compared to placebo. The decrease in the contraceptive effect of meloxicam suppository may be due to the rejection of the dose by some females. Corpora lutea, maternal plasma progesterone, ovary fresh weight and maternal body weight gain were not affected by meloxicam treatment compared to placebo. Histopathologically, the surface of the ovary of meloxicam-treated females appears irregular and dilated due to the presence of different-sized cysts. Some of the cystic follicles were retained ova. Further, immunohistochemical stains for estrogen and progesterone receptors showed positive staining in granulosa cells and the wall of the unruptured follicle. It is concluded that contraceptive effect of meloxicam in female rabbits resulted in a failure of follicular rupturing.
Candida vaginitis develops in approximately one-fourth of women in their childbearing years. Conventional management consists of antifungal creams or tablets/suppositories administered intravaginally. Many patients have stated preferences for oral therapy. A randomized, double-blind placebo trial compared the efficacy of a single oral 200 mg dose of fluconazole with the application of terconazole 80 mg vaginal suppository daily for 3 days. Twenty-two patients (fluconazole = 12, terconazole = 10) were evaluated during a four-month period and favorable clinical responses were observed at both early and late evaluations. Mycologic cure was attained by 75% of the fluconazole group and 50% of the terconazole group at the early evaluation. At the late evaluation, mycologic cure was 75% and 100% respectively. The mean time to onset of symptom relief was 2.4 (1.7) days for the fluconazole group and 1.8 (1.8) days for the terconazole group. The mean time to complete relief of symptoms was 6.08 (2.84) and 6.6 (2.95) days respectively. A statistically significant difference did not exist for any of these measures. Seventy-three percent of the patients preferred oral therapy.
OBJECTIVE: To compare effectiveness of misoprostol and ethacridine lactate with or without oxytocin in second-trimester medical abortions. SUBJECTS AND METHODS: A randomized prospective study. A total of 388 women with genetic indications for termination of pregnancy at 13-24 weeks of gestation were recruited. Group I (n=85) were treated with extra-amniotic ethacridine lactate, 10 ml instilled per gestational week, to a maximum of 200 ml. Group II (n=93) were treated with misoprostol administered intravaginally (200 microg), followed by 100 microg of oral misoprostol 4 hourly for 24 h. Group III (n=102) were treated with a combination of ethacrine lactate and oxytocin. An initial dose of 6 mU/min oxytocin was given, followed by additional 6 mU/min doses every 20 min. Group IV (n=96) were treated with a combination of misoprostol and oxytocin administered in a similar way as in group III. The main outcome measures were time to induce abortion, side effects, and failure/success rates. RESULTS: The mean time to induce abortion was 14.2+/-3.6, 13.2+/-3.4, 10.8+/-2.6, and 9.9+/-2.4 h in groups I, II, III, and IV, respectively (p<0.001). Addition of oxytocin to ethacridine lactate did not decrease the risk of prolongation of induction beyond 24 h but use of oxytocin with misoprostol did reduce the risk of induction beyond 24 h (OR: 0.46, 95%CI: 0.21-1, p<0.05). The occurrence of minor side effects was similar in all groups. CONCLUSION: Addition of oxytocin to ethacridine lactate or misoprostol significantly decreases the length of time to induce abortion without supplementary side effects.
Two trials were conducted to determine whether 7-d progestogen treatment beginning on d 17 of the estrous cycle altered 1) ovarian follicular development, 2) serum concentration of estradiol-17 beta (E2) and progesterone (P4), and 3) patterns of release of luteinizing hormone (LH). In both trials, Angus, Angus x Holstein, or Holstein cows 2 to 6 yr of age were randomly assigned to receive either melengestrol acetate (MGA, .5 mg.animal-1.d-1; n = 23), a progesterone-releaseing intravaginal device (PRID, n = 26) or to serve as untreated Controls (n = 14). Ultrasonography and blood sampling were performed daily throughout the experiment beginning on d 3 (Trial 1) or d 9 (Trial 2) of the estrous cycle. In Trial 2, blood samples were collected every 15-min for 6 h on d 17 (all cows) and d 20 and 23 (MGA and PRID cows) for determination of LH. Estrous cycle length was 3 to 5 d greater (P < .05) for MGA- and PRID-treated cows characterized by two (MGA-2 and PRID-2) or three (MGA-3 and PRID-3) dominant follicles than for control cows exhibiting two (Control-2) or three (Control-3) dominant follicles. A greater proportion (P < .05) of MGA- than of PRID-treated cows ovulated the follicle that was dominant at the beginning of treatment on d 17 (10 of 23 vs 1 of 26). Serum P4 concentrations declined 3 d earlier in Control-2 and MGA-2 cows than in Control-3, MGA-3 or PRID-3 cows.(ABSTRACT TRUNCATED AT 250 WORDS)
A new simian-human immunodeficiency virus (SHIV) stock (SHIV 89.6-PD), derived from plasma of a rhesus macaque used for in vivo serial passage of virulence-attenuated SHIV 89.6, produces systemic infection after intravenous, intravaginal, or intrarectal inoculation of rhesus macaques. Infection with this virus results in high levels of viral antigen in plasma, a precipitous decline in CD4+ T-cell counts, and a disease syndrome that is characteristic of AIDS. Rapid progression to disease was associated with failure to seroconvert to viral antigens, whereas longer survival was associated with production of antiviral antibodies. In intravenously inoculated animals, peak antigenemia occurred at 7 days postinjection (PI) and severe CD4+ depletion occurred at 14 days PI. In mucosally infected animals, peak antigenemia occurred at 14 days PI and severe CD4+ depletion was not evident until 21 days PI. The 1-week delay in both viral antigenemia and CD4+ T-cell decline in mucosally infected animals is consistent with the hypothesis that, following vaginal inoculation, virus dissemination proceeds in a stepwise manner from the mucosal surface to the draining lymph nodes and subsequently to the bloodstream. This animal model can be used to test the ability of HIV-1 envelope-based vaccines to prevent infection or disease after challenge by the three major routes of HIV transmission.
Two topical formats containing clotrimazole [500 mg single dose vaginal tablet (VT) or 10% single dose vaginal cream (VC) for intravaginal use] combined with additional clotrimazole cream for topical application to the vulval area (Canesten 1 Combi, Bayer AG, Leverkusen, Germany) were compared with oral fluconazole 150 mg single dose treatment of vulvovaginal mycosis (VVM) in a single-blind clinical study. The objective of the study was to demonstrate the equivalent efficacy of the clotrimazole combination therapies (VT + 1% cream and VC + 2% cream), and fluconazole 150 mg oral capsule (Diflucan 1, Pfizer Gmbh, Karlsruhe, Germany) in terms of overall response defined as clinical cure and mycological resolution. Overall, combination therapies containing either clotrimazole 500 mg VTs or clotrimazole 10% VC were as effective as a single dose fluconazole 150 mg oral tablet in treating VVM with rates for overall response being 66%, 61% and 60%, respectively, after 14 days. There were no significant differences in the time to onset of symptom relief in the clotrimazole 500 mg tablet group and clotrimazole 10% VC compared with fluconazole 150 mg oral capsules. Only 50% of 88 patients across treatment groups with mycological recurrence also experienced return of symptoms over the entire 8 week follow-up period. All treatments administered were safe and well-tolerated and the number of patients experiencing adverse events was low.