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Biomedical subjects

J L Thomason

Publications and source records attributed to J L Thomason.

At least 19 recordsLinked to original sources

Comparison of clindamycin phosphate vaginal cream with triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

BACKGROUND: Triple sulfonamide vaginal cream has been used to treat bacterial vaginosis for many years. There are few studies in which triple sulfonamide cream has been compared with newer regimens. GOAL: To compare the efficacy and safety of clindamycin phosphate vaginal cream with that of triple sulfonamide vaginal cream in the treatment of bacterial vaginosis. STUDY DESIGN: In this double-blind, randomized multicenter study, nonpregnant women 16 years of age or older with symptomatic bacterial vaginosis were assigned to receive either 2% clindamycin phosphate vaginal cream or triple sulfonamide vaginal cream for 7 days. Follow-up visits were conducted 5 to 10 days and 25 to 39 days after completion of treatment. RESULTS: Clinical cure or improvement at 25 to 39 days was noted in 55 (69.6%) of 79 assessable participants who received clindamycin vaginal cream and in 33 (41.8%) of 79 women who received triple sulfonamide vaginal cream (P < 0.0001). Most of the difference between the treatment groups was noted in women with a history of bacterial vaginosis. Among women without a history of bacterial vaginosis, clindamycin and triple sulfonamide creams had similar efficacy. Evaluation of Gram-stained vaginal smears correlated with clinical outcome. Most patients in both treatment groups reported an improvement in symptoms. No significant difference was observed between the treatment groups in the incidence of adverse events. CONCLUSION: Clindamycin 2% vaginal cream is more effective than triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

Administration, Intravaginal↗

Concerns regarding the Centers for Disease Control's published guidelines for pelvic inflammatory disease.

The International-Infectious Disease Society for Obstetrics and Gynecology-USA (I-IDSOG-USA) has concerns about the most recently published Centers for Disease Control and Prevention (CDC) guidelines for pelvic inflammatory disease (PID). I-IDSOG-USA advocates the following changes when the guidelines are revised. We recommend the use of the term "upper genital tract infection" (UGTI), followed by the designation of the etiologic agent, instead of the currently employed term, "pelvic inflammatory disease," or PID. In diagnoses, there should be greater emphasis on signs and symptoms related to subclinical or occult UGTI. Therapeutic recommendation for the treatment of UGTI should be documented for various stages of this diverse disease entity. There should be greater emphasis on hospitalization for infected nulligravida teenagers. This permits monitoring of antibiotic treatment and provides a site for medical educational efforts to teach this medically underserved segment of our society how to protect their future fertility, their health, and their lives.

Acute Disease↗

Single oral dose fluconazole compared with conventional clotrimazole topical therapy of Candida vaginitis. Fluconazole Vaginitis Study Group.

OBJECTIVES: Candida vaginitis is currently treated with a wide range of intravaginal preparations usually prescribed over several days. Fluconazole with its marked activity against Candida species and favorable pharmacokinetics offered a safe, effective, and convenient alternative to topical therapy in a single-dose regimen. STUDY DESIGN: We conducted a multicenter, randomized, prospective, single-blinded study of 429 patients with acute Candida vaginitis, comparing the efficacy and safety of a single oral 150 mg dose of fluconazole with 7-day clotrimazole 100 mg vaginal treatment. Posttherapy evaluations and mycologic eradication rates were conducted. RESULTS: No statistically significant differences were seen between fluconazole and clotrimazole in the clinical, mycologic, or therapeutic responses. At the 14-day evaluation clinical cure or improvement was seen in 94% of fluconazole-treated patients and 97% of clotrimazole-treated patients. Mycologic and therapeutic cures were seen in 77% and 76% of the fluconazole and 72% of the clotrimazole groups, respectively. At the 35-day evaluation 75% of both groups remained clinically cured, and 56% of the fluconazole and 52% of the clotrimazole group were considered therapeutic cures. In both treatment groups patients with a history of recurrent vaginitis (33/84) compared with those without a history of recurrent vaginitis (177/266) were significantly less likely to respond clinically and mycologically (p < 0.001). Twenty-seven percent of the fluconazole-treated patients and 17% of the clotrimazole-treated patients reported mild side effects only. CONCLUSION: Fluconazole administered as a single 150 mg oral dose proved to be as safe and effective as 7 days of intravaginal clotrimazole therapy for Candida vaginitis. Therapy of vaginitis should be individualized, taking into consideration severity of disease, history of recurrent vaginitis, and patient preference.

Acute Disease↗

Bacterial vaginosis: efficacy and safety of intravaginal metronidazole treatment.

OBJECTIVE: We evaluated the effectiveness and safety of intravaginal metronidazole in the treatment of bacterial vaginosis. Demographic data, Gram stain score, and individual clinical diagnostic criteria for bacterial vaginosis were evaluated for association with therapeutic outcome. METHODS: According to accepted diagnostic criteria and blinded Gram stain scoring for quality control, a multicenter, prospective, double-blinded trial of patients randomized to either 0.75% metronidazole gel 5 gm twice daily for 5 days or placebo was undertaken. Therapeutic response after completion of treatment was evaluated by examination at 4 to 16 days and again at 28 to 32 days for patients initially cured. RESULTS: After metronidazole treatment, 38 (78%) of 49 patients were cured initially, compared with 11 (27%) of 41 placebo recipients (p < 0.001). One month after treatment 31 (91%) of 34 in the group initially cured by metronidazole remained cured. Side effects were uncommon and mild. Significant intercenter differences were noted for vaginal discharge assessment but not for other diagnostic criteria. Among patients cured initially with metronidazole, mean Gram stain score was 0.58 among those in whom cure was maintained versus 2.33 for those in whom recurrent bacterial vaginosis developed 1 month after treatment (p = 0.03). Curative metronidazole treatment was found initially in 4 (100%) of 4 patients with sperm present on gram stain compared with 34 (76%) of 45 with sperm absent (p = 0.56) and in 6 (100%) of 6 and 25 (89%) of 28, respectively, at the final visit (p = 1.0). CONCLUSIONS: Intravaginal metronidazole is effective, safe, well-tolerated, durable therapy for bacterial vaginosis. Characterization of vaginal discharge appears to be the most variable among the diagnostic criteria for bacterial vaginosis. Gram stain score may be able to identify patients cured early after therapy who are at risk for later recurrence. Exposure to semen does not appear to affect efficacy of intravaginal metronidazole.

Administration, Intravaginal↗

Is trichomoniasis often associated with bacterial vaginosis in pregnant adolescents?

The same criteria for identifying bacterial vaginosis are often present in women with trichomoniasis. These criteria include elevated vaginal pH, vaginal odor, homogeneous discharge, increased anaerobic bacteriologic vaginal flora, and elevated levels of bacterial enzymes. Clinically mixed vaginal infections occur, and because the treatment for these two conditions can be different, it is important to distinguish between them. Trichomoniasis can interfere with a Gram stain diagnosis or the proline aminopeptidase test for bacterial vaginosis. Clue cells are not generally found in women with Trichomonas vaginalis, but when present, they strongly indicate the concomitant presence of bacterial vaginosis.

Adolescent↗

Simplified gram stain interpretive method for diagnosis of bacterial vaginosis.

OBJECTIVE: Two methods which only consider bacterial morphotypes and require counting various types of bacteria, for interpreting Gram stains of vaginal secretions for the purpose of diagnosing bacterial vaginosis were previously described. A new interpretative method, which combines clue cells with bacterial morphotypes as diagnostic markers, is offered. STUDY DESIGN: One hundred twenty patients were tested with the new interpretative method and clinical criteria of bacterial vaginosis as the reference standard. RESULTS: The new method was found comparable to older methods when all were compared with clinical diagnostic methods. The sensitivity of the clue cell method was 86.1% and the specificity was 92.8%. The predictive value of a positive test was 83.7% for a population with a prevalence of bacterial vaginosis of 30%. The negative predictive value was 94.0%. CONCLUSION: If clue cells are present and the nonlactobacilli morphotypes exceed lactobacilli morphotypes, bacterial vaginosis can be diagnosed without the need for exact bacterial counts.

Adolescent↗

Bacterial vaginosis: current review with indications for asymptomatic therapy.

Bacterial vaginosis is a definable clinical entity whose exact origin is unknown. A shift in normal vaginal flora from aerobic, predominantly but not exclusively lactobacilli, to a predominantly anaerobic flora characterizes the condition. More than one half of all women with bacterial vaginosis have no symptoms. The condition is not entirely benign. The potentially pathogenic bacteria present in the vagina in large numbers place these women at risk for postoperative morbidity and adverse obstetric outcome. Sexual transmission has not been proved, but therapeutic cures sometimes require that patient and partner be treated simultaneously. Recommended therapy is with metronidazole or clindamycin and must be given for 7 days for maximal effectiveness. Recurrence of disease can be a problem.

Antifungal Agents↗

Statistical evaluation of diagnostic criteria for bacterial vaginosis.

Bacterial vaginosis is the most common cause of vaginitis in women of reproductive age. In an attempt to clarify diagnosis of this condition, various parameters of signs and symptoms and groups of parameters were compared with classical diagnostic criteria in 310 patients. There was no significant difference in positive diagnosis rates between the Amsel et al. criteria and those of Thomason et al. (p = 0.25). The single most reliable indicator of bacterial vaginosis was the presence of clue cells on wet mount examination of vaginal secretions (sensitivity 98.2%, specificity 94.3%, positive predictive value 89.9%, negative predictive value 99.0%). The best two combinations of parameters for rapid accurate clinical diagnosis were clue cells and odor on alkalinization (sensitivity 99.5%) positive predictive value 98.8%, negative predictive value 92.1%). Gram stain criteria (bacterial morphologic types) were less accurate predictors of the disease (sensitivity 97.0%, specificity 66.2%, positive value 57.2%, negative predictive value 97.9%). Even when the bacterial morphologic type criteria were combined with presence of clue cells, predictive accuracy did not exceed that of clue cells on wet mount examination alone (sensitivity 93.9%, specificity 84.7%, positive predictive value 74.2%, negative predictive value 96.8%). Homogeneous discharge was found to be of little diagnostic value.

Bacterial Infections↗

Bacterial vaginosis: diagnostic and pathogenetic findings during topical clindamycin therapy.

We examined subjective and objective correlates among 67 women with symptomatic bacterial vaginosis before and after treatment with intravaginal clindamycin or placebo. We found no preponderance of any sexual practices among these patients. Nine patients (13.4%) had had hysterectomy. Whereas odor and discharge were the most common symptoms, 30 patients (44.8%) also complained of vulvovaginal irritation. Symptoms correlated poorly with objective therapeutic outcome. On examination the diagnosis would have been missed in seven patients (10.4%) if the clinician relied on presence of an abnormal vaginal discharge to suggest bacterial vaginosis. Vaginal pH greater than 4.5 was found immediately after curative therapy in 59.6% of patients. Mobiluncus spp. morphotypes were 99.0% specific and 52.1% sensitive and proline aminopeptidase activity in vaginal fluid was 84.4% sensitive and 70.2% specific for diagnosis. Our Gram stain criteria yielded no false-negative results, 6.1% false-positive, and frequent indeterminate results after therapy. We found little evidence for sexual transmission of bacterial vaginosis. Recurrence after effective therapy was not predicted by vaginal pH elevation, positive or indeterminate Gram stain result, or positive proline aminopeptidase test.

Administration, Intravaginal↗

Growth of Trichomonas vaginalis in commercial culture media.

There are only two commercially available, ready-to-use culture media which are approved by the Food and Drug Administration for clinical diagnosis of vaginal trichomoniasis: Kupferberg's STS and Diamond's medium (modified). Diamond's medium (Klaas modification), recommended by the Centers for Disease Control for the isolation of Trichomonas vaginalis, was compared in vitro to Kupferberg's (STS) medium. Growth studies using six fresh clinical isolates, all from different patients, showed that while generation time was about 6 h in both STS and Diamond's, the period of exponential growth was longer in Diamond's. More important, in STS there was a 4-h lag period during which the population significantly decreased prior to exponential growth. This did not occur in Diamond's medium. Three hundred organisms inoculated into Diamond's reached a population of over 10(5) organisms in 72 h. In STS, the same inoculum could multiply to only 6 x 10(3) organisms. The fact that there is a lag phase in STS which is not seen in Diamond's could explain why low numbers of T. vaginalis do not multiply in STS but do multiply and can be detected in Diamond's. We conclude that because Diamond's medium (modified) allows more prolific growth over a shorter period of time, it is more suitable than Kupferberg's (STS) for detecting T. vaginalis in patients with vaginitis.

Animals↗

Bacterial vaginosis: treatment with topical intravaginal clindamycin phosphate.

We tested topical intravaginal clindamycin phosphate at concentrations of 0.1, 1.0, and 2.0% in the treatment of 62 women with symptomatic bacterial vaginosis in a prospective, randomized, double-blind, placebo-controlled trial, and offered open-label treatment with 1.0% clindamycin to patients with persistent disease after blinded treatment. Blinded intravaginal clindamycin phosphate treatment cured bacterial vaginosis in 93.5% (43 of 46) of patients 4-7 days after therapy, compared with 25.0% (four of 16) of patients receiving placebo (P less than .001). One month later, 89.7% (35 of 39) of those who initially responded to clindamycin treatment showed persistent cure. There were no significant side effects.

Administration, Intravaginal↗

Terconazole for the treatment of vulvovaginal candidiasis.

A double-blind, randomized trial was conducted to evaluate the efficacy and safety of terconazole for vulvovaginal candidiasis. Treatment consisted of daily intravaginal application of one of the following regimens: 80-mg terconazole suppositories for 3 days, miconazole nitrate suppositories for 7 days or placebo suppositories for 7 days. The terconazole and miconazole nitrate groups had significantly higher therapeutic cure rates than did the placebo group. Evaluation of vaginal secretions with microscopic examination showed no evidence of leukocyte proliferation. Proline aminopeptidase activity, present in patients who have bacterial vaginosis, could not be detected in the vaginal secretions from patients with yeast vulvovaginitis.

Administration, Intravaginal↗