A double-blind treatment study of bacterial vaginosis with normal vaginal lactobacilli after an open treatment with vaginal clindamycin ovules

The expected 4-week cure rate after conventional treatment of bacterial vaginosis are only 65-70%. In an attempt to improve the cure rate by adding probiotic lactobacilli we performed a double-blind placebo-controlled study of adjuvant lactobacilli treatment after an open treatment with vaginal clindamycin ovules. Women with bacterial vaginosis as defined by Amsel's criteria were treated with clindamycin ovules. Vaginal smears were collected and analysed according to Nugent's criteria. During the following menstruation period the women used, as an adjuvant treatment, either lactobacilli-prepared tampons or placebo tampons. The lactobacilli tampons were loaded with a mixture of freeze-dried L. fermentum, L. casei var. rhamnosus and L. gasseri. The cure rate was recorded after the second menstruation period. There was no improvement in the cure rate after treatment with lactobacilli-containing tampons compared to placebo tampons; the cure rates as defined by Amsel's criteria were 56% and 62%, respectively, and 55% and 63%, as defined by Nugent's criteria. This is the first study to report cure rates for women with 'intermediate' wet smear ratings according to Nugent's classification and this group had an overall cure rate of 44%. The cure rate of treatment of bacterial vaginosis was not improved by using lactobacilli-prepared tampons for one menstruation.     

A clinical,prospective, randomized,double-blind trial comparing skin whitening complex with hydroquinone vs. placebo in the treatment of melasma

Objectives To compare, in a double‐blind, randomized, prospective study, the clinical improvement of hyperpigmentation in 30 patients with melasma using hydroquinone or skin whitening complex topically on one side of the face vs. a placebo cream on the other. The study was performed during the period November 2000 to March 2001 at the Federal University of São Paulo, Escola Paulista de Medicina. Methods Thirty patients received three tubes of cream and were divided into two groups: group 1, one tube containing hydroquinone 4% cream and one tube containing placebo to be applied to opposite sides of the face at night, and standardized sunscreen [sun protection factor (SPF) 25] for daily use; group 2, one tube containing skin whitening complex 5% cream and one tube containing placebo to be applied to opposite sides of the face at night, and standardized sunscreen (SPF 25). All of the tubes had the same appearance and the creams had the same characteristics. The only person who knew what was being used by each patient on each side of the face was the pharmacist. A professional photographer took photographs before and after treatment, which lasted for 3 months. Clinical evaluation was performed by two independent observers and by the patients themselves. Statistical evaluation was by the chi‐squared and kappa methods. Results Twenty‐five patients completed the study, with an overall improvement of 72% in comparison with placebo. Group 1 (hydroquinone and placebo) presented an improvement of 76.9% with 25% side‐effects, and group 2 (skin whitening complex and placebo) presented an improvement of 66.7% with 0% side‐effects. Conclusions Both depigmentation agents were useful in the treatment of melasma. The hydroquinone group presented more collateral effects than the skin whitening complex group. Considering that the patients showed Fitzpatrick skin types IV to VI and the study was conducted in the summer, skin whitening complex seems to be an excellent choice for the treatment of melasma.     

A randomized, double-blind, placebo-controlled clinical trial of itraconazole in the treatment of cutaneous leishmaniasis

BACKGROUND: Several modalities have been used for the treatment of cutaneous leishmaniasis (CL) with various results. In vitro and in vivo studies have shown inhibitory effects of azole drugs on Leishmania parasites. OBJECTIVES: To evaluate the efficacy and tolerability of oral itraconazole in the treatment of CL caused by L. major. METHODS: A total of 200 patients with parasitologically confirmed CL with a duration of less than 45 days from a well known L. major endemic area were included in a randomized, double-blind, placebo-controlled clinical trial. The patients received either itraconazole 200 mg daily (100 patients) or placebo (100 patients) for 8 weeks. The primary outcome measures were clinical cure (complete re-epithelization of all lesions) and parasitological cure at the end of the treatment. RESULTS: Eighty-three patients in the itraconazole and 75 patients in the placebo group completed the treatment course. After 8 weeks of treatment, clinical cure was observed in 59% and 53% and parasitological cure was observed in 83% and 76% of patients in the itraconazole and placebo groups, respectively, which were not significantly different. There was no difference in the rate of adverse events. CONCLUSIONS: An 8-week course of oral itraconazole was not more effective than placebo in the treatment of CL.     

Efficacy of povidone-iodine vaginal suppositories in the treatment of bacterial vaginosis

A prospective, randomized clinical trial was performed to study the efficacy of povidone iodine (Betadine) suppositories for the treatment of bacterial vaginosis (BV) in comparison to capsules containing lactobacilli (D?derlein Med). Seventy patients with BV included in the study were randomly assigned to be either treated with povidone iodine suppositories or lactobacilli. Patients were treated once a day for 5 days. Initial examinations took place on the first day of the study with follow-up examinations on days 8 and 15. The examinations included clinical parameters, patient evaluation, secretion screens, and quantitative and qualitative microbiological tests of vaginal flora. Both treatment groups showed improvement of clinical parameters, condition of secretions and subjective state of health. At day 15 there was a trend towards a better efficacy of the treatment with povidone iodine but this was not significant. However, patients with acute BV treated with povidone iodine had significantly better scores after 15 days. Both treatments were well tolerated. The microbiological examinations showed an increase of the mean number of lactobacilli in the vagina on day 8 after initiation of treatment with lactobacilli, but a decrease on day 15. Contrary to that the lactobacilli counts from patients treated with povidone iodine suppositories decreased after the first week but increased in the second one. Potentially pathogenic germs, e.g. Gardnerella, Bacteroides and Enterobacteria were reduced in a higher extent and with a longer lasting effect after treatment with povidone iodine suppositories than with capsules containing lactobacilli. The results of this study show that native lactobacilli rapidly re-colonize after the antiseptic treatment with povidone iodine. Therefore, there is no need to use lactobacilli in addition.     

A randomized, double-blind, placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis

OBJECTIVE: To evaluate pentoxifylline for the treatment of recurrent aphthous stomatitis. DESIGN: A 60-day, randomized, double-blind, placebo-controlled trial with a 60-day no treatment follow-up. SETTING: An oral medicine specialist referral center in Manchester. PARTICIPANTS: Forty-nine volunteers who passed the initial assessment for recurrent aphthous stomatitis entered a pretrial phase in which their eligibility for the trial phase of the study was assessed. Sixteen subjects were deemed ineligible, and 7 failed to attend or withdrew. The remaining 26 subjects were randomized to placebo or treatment. Six subjects withdrew because of adverse effects, and 1 was unavailable for follow-up. INTERVENTION: Pentoxifylline (also called oxpentifylline), 400 mg 3 times daily, or matching placebo. MAIN OUTCOME MEASURE: A reduction in the median pain score, ulcer size, number of ulcers, or total number of ulcer episodes. RESULTS: Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline. Patients taking placebo reported no improvement in these variables. Patients taking pentoxifylline also reported more ulcer-free days than those taking placebo. However, the differences were small and, with the exception of median ulcer size (P = .05), did not reach statistical significance. Adverse effects were common with pentoxifylline, but not significantly different from those experienced by patients taking placebo. CONCLUSIONS: Although pentoxifylline may have some benefit in the treatment of recurrent aphthous stomatitis, the benefit is limited. It may have a role in the treatment of patients unresponsive to other treatments, but cannot yet be recommended as a first-line treatment.     

盐酸左氧氟沙星凝胶治疗细菌感染性皮肤病的多中心临床研究

目的:评价盐酸左氧氟沙星凝胶治疗细菌感染性皮肤病的疗效和安全性.方法:本试验为随机、双盲、多中心临床研究.入选患者分别接受盐酸左氧氟沙星凝胶或氧氟沙星凝胶治疗,每日2次,共7天.在治疗时及治疗后第4天和治疗后评价临床和细菌学疗效.结果:共入选受试者222例,脱落5例,剔除2例,治疗后第4天和治疗后各项症状/体征指标记分及总记分均有明显下降.试验组和对照组组间比较差异无统计学意义.用药4天和7天后,试验组基愈率分别为0.93%和50.93%,有效率分别为35.19%、88.89%;对照组基愈率分别为0.93%和40.93%,有效率分别为25.23%和88.79%.病原体的清除率分别为85.19%和78.48%.研究中两组均无严重不良反应发生,试验组不良反应发生率为2.70%(3/111),对照组不良反应发生率为4.50%(5/111).结论:盐酸左氧氟沙星凝胶治疗细菌感染性皮肤病疗效确切、安全性好.     

A double-blind, randomized, comparative trial of itraconazole versus terbinafine for 2 weeks in tinea capitis

In this randomized, double-blind study, the efficacy and safety of oral itraconazole ( n  = 28) and terbinafine ( n  = 27), each given for 2 weeks, was compared in patients with tinea capitis. Trichophyton violaceum was the major pathogen in both groups (82.1% and 88.9%, respectively). The final evaluation at week 12 showed a cure rate of 85.7% and 77.8%, respectively ( P  > 0.05). Adverse events noted were mild and did not warrant discontinuation of therapy.     

Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial.

OBJECTIVE--To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN--Randomised clinical trial. SETTING--30 general practices in the Netherlands. PATIENTS--125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES--Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS--Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS--Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication.     

依巴斯汀抗组胺活性的随机、双盲、安慰剂对照研究

目的:研究单次口服依巴斯汀10mg的药效动力学特点。方法:60名健康受试者随机、双盲口服依巴斯汀10mg或安慰剂1片,于服药前和服药后2、4、24h,对全部受试者行组胺皮肤点刺滴定试验。在揭盲后,对依巴斯汀组的受试者于服药后48h再做一次组胺皮肤点刺滴定试验。以剂量-反应曲线下面积(AUDRC)和痒觉积分为参数,评价依巴斯汀的抗组胺活性。结果:服药前两组数据无统计学差异。依巴斯汀组的风团和红晕AUDRC于服药后2h即明显低于安慰剂组,而痒觉积分于服药后4h才明显低于安慰剂组(P<0.01)。服用依巴斯汀后24h,AUDRC和痒觉积分均降至最低;48h上述两者均有所升高,但仍明显低于服药前(P<0.01)。结论:依巴斯汀的抗组胺作用起效较慢,作用较强,持续时间较长。     

A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men

BACKGROUND: Topical minoxidil solution 2% stimulates new hair growth and helps stop the loss of hair in individuals with androgenetic alopecia (AGA). Results can be variable, and historical experience suggests that higher concentrations of topical minoxidil may enhance efficacy. OBJECTIVE: The purpose of this 48-week, double-blind, placebo-controlled, randomized, multicenter trial was to compare 5% topical minoxidil with 2% topical minoxidil and placebo in the treatment of men with AGA. METHODS: A total of 393 men (18-49 years old) with AGA applied 5% topical minoxidil solution (n = 157), 2% topical minoxidil solution (n = 158), or placebo (vehicle for 5% solution; n = 78) twice daily. Efficacy was evaluated by scalp target area hair counts and patient and investigator assessments of change in scalp coverage and benefit of treatment. RESULTS: After 48 weeks of therapy, 5% topical minoxidil was significantly superior to 2% topical minoxidil and placebo in terms of change from baseline in nonvellus hair count, patient rating of scalp coverage and treatment benefit, and investigator rating of scalp coverage. Hair count data indicate that response to treatment occurred earlier with 5% compared with 2% topical minoxidil. Additionally, data from a patient questionnaire on quality of life, global benefit, hair growth, and hair styling demonstrated that 5% topical minoxidil helped improve patients' psychosocial perceptions of hair loss. An increased occurrence of pruritus and local irritation was observed with 5% topical minoxidil compared with 2% topical minoxidil. CONCLUSION: In men with AGA, 5% topical minoxidil was clearly superior to 2% topical minoxidil and placebo in increasing hair regrowth, and the magnitude of its effect was marked (45% more hair regrowth than 2% topical minoxidil at week 48). Men who used 5% topical minoxidil also had an earlier response to treatment than those who used 2% topical minoxidil. Psychosocial perceptions of hair loss in men with AGA were also improved. Topical minoxidil (5% and 2%) was well tolerated by the men in this trial without evidence of systemic effects.     

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.     

盐酸奥洛他定治疗慢性自发性荨麻疹多中心、随机、双盲、平行对照临床研究

目的 评价盐酸奥洛他定治疗慢性自发性荨麻疹的疗效和安全性。 方法 多中心、随机、双盲、平行对照临床研究。试验组口服盐酸奥洛他定5 mg每日2次,对照组口服盐酸左西替利嗪及其模拟片5 mg每日2次。两组均连续服药28 d。以疗效指数作为主要指标,总体疗效评价及总有效率作为次要指标。 结果 3个研究中心共入选病例144例,可进行疗效分析病例为137例,其中试验组和对照组分别为70例、67例。ITT分析试验组治疗后第7天、第14天、第28天的总有效率分别为64.29%（45/70）、82.86%（58/70）、87.14%（61/70）,对照组为56.72%（38/67）、74.63%（50/67）、77.61%（52/67）,两组比较差异均无统计学意义（均P > 0.05）。治疗4周,试验组的疗效指数（82.67% ± 22.70％）高于对照组（70.51% ± 32.07％）（P ＜ 0.05）。试验组和对照组的不良反应发生率分别为33.80%（24/71）、27.94%（19/68）（P > 0.05）,主要有嗜睡、口干、疲倦等。 结论 盐酸奥洛他定治疗慢性自发性荨麻疹安全有效。     

A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

Background Hidradenitis suppurativa (HS) has an impact on patients’ quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. Objectives To test the efficacy of adalimumab in HS. Methods This was a prospective, randomized, double‐blinded, placebo‐controlled, two‐centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1 : 2 (placebo/active). Actively treated patients received adalimumab 80 mg subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo‐treated patients received identical‐looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer‐randomized containers. Participants, care givers and those assessing the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring. Recruitment was terminated early due to expiry date of trial medication. Results Twenty‐one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after 6 weeks and an almost significant reduction was seen after 12 weeks of active treatment (?10·7 vs. 7·5, P = 0·024 and ?11·3 vs. 5·8, P = 0·07) when compared with the placebo group. Conclusions A significant reduction in HS severity was gained after 6 weeks. No long‐term curative effect was uniformly seen.     

The effect of treatment for vaginal yeast infection on the prevalence of bacterial vaginosis in early pregnancy

Both bacterial vaginosis and candidiasis are commonly seen in pregnancy, with marked differences in pregnancy outcome. The aim of this study was to assess the effect of antifungal treatment on the prevalence of bacterial vaginosis in early pregnancy. This prospective randomized study included 126 women in early pregnancy with heavy vaginal yeast colonization and 88 healthy controls. Vaginal flora was evaluated on initial visit and on two check-ups for the presence of bacterial vaginosis. Half of the heavily colonized patients received an antimycotic agent (clotrimazole). The prevalence of vaginosis was compared among the three groups. Xi (2)-test and Fisher's exact test were used for statistical analysis. Three of 72 (4.2%) yeast-free controls, two of 79 (2.5%) yeast infected but not treated patients, and nine of 63 (14.3%) infected and treated patients presented with bacterial vaginosis 4 weeks after the initial visit. There was a statistically significant increase in the prevalence of bacterial vaginosis (p<0.03) in yeast infected and treated patients as compared to colonized and untreated patients. Treatment of candidiasis in early pregnancy may contribute to an increased rate of bacterial vaginosis.