Prevalence of periodontal disease in dogs and owners' level of awareness - a prospective clinical trial

Periodontal disease (PD) is widely known among veterinarians for its high prevalence and serious consequences to the dogs. The objective of this study was to assess the occurrence of PD in dogs that live in the micro-region of Viçosa, treated at the Veterinary Hospital of the Federal University of Viçosa (HVT - Hospital Veterinário da Universidade Federal de Viçosa), as well as to assess how aware of this disease dog owners are. In order to do so, all dogs treated at the HVT from March 10th, 2009 to November 30th, 2009, on alternate days, had their oral cavities examined. Medical history data, such as age, type of food, main complaint and owner consent, halitosis, presence of dental calculus, inflammation and gingival recession and tooth loss, were collected. A prevalence of 88.67% was found for PD in dogs referred to the HVT, and 2.67% were referred due to this disease. Of all the owners who participated in the study, 43.83% knew about periodontal disease and of these 17.46% made use of some type of prevention or treatment. Therefore, periodontal disease is highly prevalent and the owners are not aware of the disease. Thus, a dog owner clarification program on periodontal disease is needed in the area where HVT-UFV operates.

Vocal warm-up and breathing training for teachers: randomized clinical trial

OBJECTIVE To compare the effectiveness of two speech therapy interventions, vocal warm-up and breathing training, focusing on teachers’ voice quality.METHODS A single-blind, randomized, parallel clinical trial was conducted. The research included 31 20 to 60-year old teachers from a public school in Salvador, BA, Northeasatern Brazil, with minimum workloads of 20 hours a week, who have or have not reported having vocal alterations. The exclusion criteria were the following: being a smoker, excessive alcohol consumption, receiving additional speech therapy assistance while taking part in the study, being affected by upper respiratory tract infections, professional use of the voice in another activity, neurological disorders, and history of cardiopulmonary pathologies. The subjects were distributed through simple randomization in groups vocal warm-up (n = 14) and breathing training (n = 17). The teachers’ voice quality was subjectively evaluated through the Voice Handicap Index (Índice de Desvantagem Vocal, in the Brazilian version) and computerized voice analysis (average fundamental frequency, jitter, shimmer, noise, and glottal-to-noise excitation ratio) by speech therapists.RESULTS Before the interventions, the groups were similar regarding sociodemographic characteristics, teaching activities, and vocal quality. The variations before and after the intervention in self-assessment and acoustic voice indicators have not significantly differed between the groups. In the comparison between groups before and after the six-week interventions, significant reductions in the Voice Handicap Index of subjects in both groups were observed, as wells as reduced average fundamental frequencies in the vocal warm-up group and increased shimmer in the breathing training group. Subjects from the vocal warm-up group reported speaking more easily and having their voices more improved in a general way as compared to the breathing training group.CONCLUSIONS Both interventions were similar regarding their effects on the teachers’ voice quality. However, each contribution has individually contributed to improve the teachers’ voice quality, especially the vocal warm-up.TRIAL RECORD NCT02102399, “Vocal Warm-up and Respiratory Muscle Training in Teachers”.

Effects of acupressure on progress of labor and cesarean section rate: randomized clinical trial

OBJECTIVE To analyze the effects of acupressure at the SP6 point on labor duration and cesarean section rates in parturients served in a public maternity hospital.METHODS This controlled, randomized, double-blind, pragmatic clinical trial involved 156 participants with gestational age ≥ 37 weeks, cervical dilation ≥ 4 cm, and ≥ 2 contractions in 10 min. The women were randomly divided into an acupressure, placebo, or control group at a university hospital in an inland city in the state of Sao Paulo, Brazil, in 2013. Acupressure was applied to the SP6 point during contractions for 20 min.RESULTS The average labor duration was significantly different between the SP6 acupressure group [221.5 min (SD = 162.4)] versus placebo [397.9 min (SD = 265.6)] and versus control [381.9 min (SD = 358.3)] (p = 0.0047); however, the groups were similar regarding the cesarean section rates (p = 0.2526) and Apgar scores in the first minute (p = 0.9542) and the fifth minute (p = 0.7218) of life of the neonate.CONCLUSIONS The SP6 acupressure point proved to be a complementary measure to induce labor and may shorten the labor duration without causing adverse effects to the mother or the newborn. However, it did not affect the cesarean section rate.

Safety and efficacy of fenproporex for obesity treatment: a systematic review

ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.

Assessment of oltipraz in schistosomiasis mansoni clinical trial

Seventy three children (6-15 years) and 75 adults (18-47 years) with active schistosomiasis mansoni were treated with oltipraz. All cases had at least 100 eggs per gram of feces as determined by the Kato-Katz technique. Children and adults were divided in two groups receiving respectively 25 or 30 mg/kg, as a single oral dose. Clinical examination, laboratories tests (haemogram, urinalysis, hepatic and kidney functions tests, glycemia, cholesterol, triglicerides, lipoprotein — HLD and LDL) and ECG were performed before, 3 or 7 days and 1 month after treatment. Parasitological control with 3 daily coprological examinations, was done on the 1st, 3rd j 6th month after drug administration. Giddiness, somnolence, headache, nausea, vomiting and abdominal distress were the most frequent side effects. Pain in the finger tips that need further investigations also occurred. No significant alteration in complementary tests were observed, whereas eosinophilia 1 month after treatment was detected, probably indicating worm death. The cure rate in children was 81.8% and 74.2% with 25 and 30 mg/kg respectively, and in adults 75.0% and 81.2% of the patients. No statistical significant difference was observed between cure rate and side effects at different dosages employed, neither between adults nor children. In all groups the percentage of egg reduction in feces in the non cured patients was higher than 96.0%. Further investigation with this new compound is necessary to accomplish the real value of oltipraz in the schistosomiasis chemotherapy.

Survey on the clinical trial results achieved in Brazil comparing praziquantel and oxamniquine in the treatment of mansoni schistosomiasis

A random, double-blind, parallel group clinical trial program was carried out to compare praziquantel, a recently developed anti-helmintic drug, and oxamniquine, an already established agent for treating mansoni schistosomiasis. Both drugs were administered orally as a single dose, on the average, praziquantel 55 mg/kg and oxamniquine 16 mg/kg BWT. The diagnosis and the parasitological follow-up lasting for a minimum of six months, were based on stool examinations according to Kato/Katz technique. A patient was considered cured if all results were negative and if he had performed at least three post-treatment controls, each one comprising three stool examinations. The finding of a single S. mansoni egg in any stool examination indicated, a therapeutical failure. A total of 267, cases were treated with praziquantel and 272 with oxamniquine. The two groups were homogeneous in regard to patients, age, clinical form of the disease, risk of reinfection and worm burden, relevant factors in the therapeutical response. The incidence and severity of untoward, effects were similar in both groups but abdominal distress and diarrhoea were more frequently reported under praziquantel and dizzines under oxamniquine (p < 0.05). In the former group a marked urticariform reaction was observed whereas in the latter one patient presented convulsion. The laboratory work-up. failed to disclose any significant alteration although the AST, ALT and y-GT mean values revealed a tendence to increase on the 7th day after oxamniquine intake. The overall parasitological cure rates were 75.5% (139/ 184) with praziquantel and 69.8% (134/192) with oxamniquine (p > 0.05). Amongst the noncured aptients a reduction of 88.6% and 74.6% in the mean number of eggs/g of feces Was seen following the treatment with praziquantel and oxamniquine, respectively (p < 0.05). In conclusion, in spite of their different chemical, pharmacological and toxicological profiles as well as mechanisms-of-action, inclusively praziquantel already had proved to be 100% active against S. mansoni strains resistant to oxamniquine, both drugs showed comparable tolerance and therapeutical efficacy.

Treatment of patients with Schistosomiasis mansoni: a double blind clinical trial comparing praziquantel with oxamniquine

A double-blind clinical trial involving 120 patients with chronic schistosomiasis was carried out to compare the tolerability and efficacy of praziquantel and oxamniquine. The patients were randomly allocated into two groups. One was treated with praziquantel, 55 mg/kg of body weight CBWT), and the other one with oxamniquine, 15mg/kg bwt, administered in a single oral dose. The diagnosis and the parasitological follow-up was based on stool examinations by quantitative Kato-Katz method and on rectal biopsies. Side-effects — mainly dizziness, sleepness, abdominal distress, headache, nausea and diarrhea — were observed in 87% of the cases. Their incidence, intensity and duration were similar for both drugs but abdominal pain was significantly more frequent after praziquantel intake and severe dizziness was more commonly reported after oxamniquine. A significant increase of alanine-aminotransferase and y-glutamyltransferase was found with the latter drug and of total bilirubin with the former one. A total of 48 patients treated with praziquantel and 46 with oxamniquine completed with negative findings the required three post-treatment parasitological controls — three slides of each stool sample on the first, third and sixth month. The achieved cure rates were 79.2% and 84.8%, respectively, a difference without statistical significance. The non-cured cases showed a mean reduction in the number of eggs per gram of feces of 93.5% after praziquantel and of 84.1% after oxamniquine. This diference also was not significant. Five patients retreated with praziquantel were cured but only one out of three treated a second time with oxamniquine. These findings show that both drugs — despite their different chemical structures, pharmacological properties and mechanisms-of-action — induce similar side-effects as well as a comparable therapeutical efficacy, in agreement with the results reported from analogous investigations.

A randomized clinical trial with high dose of chloroquine for treatment of Plasmodium falciparum malaria in Brazil

This clinical trial compared parasitological efficacy, levels of in vivo resistance and side effects of oral chloroquine 25 mg/Kg and 50 mg/Kg in 3 days treatment in Plasmodium falciparum malaria with an extended followed-up of 30 days. The study enroled 58 patients in the 25 mg/Kg group and 66 in the 50 mg/Kg group. All eligible subjects were over 14 years of age and came from Amazon Basin and Central Brazil during the period of August 1989 to April 1991. The cure rate in the 50 mg/Kg group was 89.4% on day 7 and 71.2% on day 14 compared to 44.8% and 24.1% in the 25 mg/Kg group. 74.1% of the patients in the 25 mg/Kg group and 48.4% of the patients in the 50 mg/Kg group had detectable parasitaemia at the day 30. However, there was a decrease of the geometric mean parasite density in both groups specially in the 50 mg/Kg group. There was 24.1% of RIII and 13.8% of RH in the 25 mg/Kg group. Side effects were found to be minimum in both groups. The present data support that there was a high level resistance to chloroquine in both groups, and the high dose regimen only delayed the development of resistance and its administration should not be recommended as first choice in malaria P. falciparum therapy in Brazil.

FACTORS ASSOCIATED TO ADHERENCE TO DIFFERENT TREATMENT SCHEMES WITH MEGLUMINE ANTIMONIATE IN A CLINICAL TRIAL FOR CUTANEOUS LEISHMANIASIS

The favorable outcome of the treatment of a disease is influenced by the adherence to therapy. Our objective was to assess factors associated with adherence to treatment of patients included in a clinical trial of equivalence between the standard and alternative treatment schemes with meglumine antimoniate (MA) in the treatment of cutaneous leishmaniasis (CL), in the state of Rio de Janeiro. Between 2008 and 2011, 57 patients with CL were interviewed using a questionnaire to collect socioeconomic data. The following methods were used for adherence monitoring: counting of vial surplus, monitoring card, Morisky test and modified Morisky test (without the question regarding the schedule); we observed 82.1% (vial return), 86.0% (monitoring card), 66.7% (Morisky test) and 86.0% (modified Morisky test) adherence. There was a strong correlation between the method of vial counting and the monitoring card and modified Morisky test. A significant association was observed between greater adherence to treatment and low dose of MA, as well as with a lower number of people sleeping in the same room. We recommend the use of the modified Morisky test to assess adherence to treatment of CL with MA, because it is a simple method and with a good performance, when compared to other methods.

The indeterminate form of human chronic Chagas' disease: a clinical epidemological review

Data on the epidemiology and the natural history of the indeterminate form of human chronic Chagas' disease (IFCCD) are discussed, revealing its great importance in endemic areas of Brazil. The work shows that IFCCD presents a gradual and very slow course, causing a benign picture in the studied patients. Evolution patterns, prognostic and anatomopathological features are also discussed. For practical purposes, the classical concept of IFCCD proved to be simple, operational and consistent, It is defined by the absence of symptoms and clinical findings in chronic infected patients with positive serology and/or parasitological examinations for Trypanosoma cruzi coupled with normal electrocardiographic and radiological exams (heart, oesophagus and colon X-Rays). If a patient is submitted to more rigorous and sophisticated tests, these can reveal some alterations, generally small ones and unable to interfere with the prognosis of the infection. It is suggested that research lines specially related to the evolution ary factors and immunological involvement during this phase be adopted.

The effect of Lactobacillus casei and Bifidobacterium breve on antibiotic-associated diarrhea treatment: randomized double-blind clinical trial

INTRODUCTION: Antibiotic-associated diarrhea (AAD) is an important side effect of this specific class of drugs. The objective of this study was to investigate the effect of the use of probiotics in the treatment of AAD. METHODS: A group of hospitalized patients, who contracted diarrhea during or after 7 days of suspension of antimicrobial medication, was blindly randomized to receive a standardized diet associated with the use of the probiotics (Lactobacillus casei and Bifidobacterium breve) or its corresponding placebo, three times a day. RESULTS: Seventy patients were studied. For the experimental (n=35) and control (n=35) groups, respectively, the average time of treatment was 5.06±2.18 and 5.49±3.17 days (p=0.95), and the average duration of diarrhea, among those who were healed, was 4.87±2.13 and 4.52±2.55 days (p=0.36). Four (11.4%) patients who received probiotics and ten (28.6%) who received the placebo were not cured (p=0.13), and relapse rates were similar between both groups. Seven patients from each group, in addition to diarrhea, presented cases of bloating and/or abdominal cramps and/or vomiting (p=1.00). CONCLUSIONS: In this light, it is concluded that L. casei associated with B. breve, in the administered dosage and frequency, has no effect on the antibiotic-associated diarrhea. Similar studies need to be conducted with higher doses of these or other probiotics.

Antimicrobial use, incidence, etiology and resistance patterns in bacteria causing ventilator-associated pneumonia in a clinical-surgical intensive care unit

INTRODUCTION : Antimicrobial resistance is an increasing threat in hospitalized patients, and inappropriate empirical antimicrobial therapy is known to adversely affect outcomes in ventilator-associated pneumonia (VAP). The aim of this study was to evaluate antimicrobial usage, incidence, etiology, and antimicrobial resistance trends for prominent nosocomial pathogens causing ventilator-associated pneumonia in a clinical-surgical intensive care unit (ICU). METHODS : Gram-negative bacilli and Staphylococcus aureus causing VAP, as well as their antimicrobial resistance patterns and data on consumption (defined daily dose [DDD] per 1,000 patient days) of glycopeptides, extended-spectrum cephalosporins, and carbapenems in the unit were evaluated in two different periods (A and B). RESULTS: Antimicrobial use was high, mainly of broad-spectrum cephalosporins, with a significant increase in the consumption of glycopeptides (p < 0.0001) and carbapenems (p < 0.007) in period B. For Acinetobacter baumannii and members of the Enterobacteriaceae family, 5.27- and 3.06-fold increases in VAPs, respectively, were noted, and a significant increase in resistance rates was found for imipenem-resistant A. baumannii (p = 0.003) and third-generation cephalosporins-resistant Enterobacteriaceae (p = 0.01) isolates in this same period. CONCLUSIONS: Our results suggest that there is a link between antibiotics usage at institutional levels and resistant bacteria. The use of carbapenems was related to the high rate of resistance in A. baumannii and therefore a high consumption of imipenem/meropenem could play a major role in selective pressure exerted by antibiotics in A. baumannii strains.

Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil

Introduction Parenteral antimony-based compounds are still the standard of care for cutaneous leishmaniasis (CL) treatment in many countries, despite their high toxicity. Previous studies showed that oral azithromycin could be an option for CL treatment. The aim of this study was to evaluate efficacy and safety of oral azithromycin (AZ) for CL treatment compared with injectable meglumine antimoniate (MA). Methods This was a randomized, open-label, 2-arm, non-inferiority clinical trial. Treatment-naïve patients with localized CL were treated with MA (15mg/kg/day up to 1,215mg) or AZ (500mg/day) during 20 consecutive days. The primary efficacy end point was a CL cure 90 days after treatment completion. The analysis was performed with intention-to-treat (ITT) and per protocol (PP) analyses. After an anticipated interim analysis, the study was interrupted due to the high failure rate in the azithromycin group. Results Twenty-four volunteers were included in each group. The MA group had a higher cure rate than the AZ group with the ITT and PP analyses, which were 54.2% versus 20.8% [relative risk (RR) 1.97; 95% confidence intervals (95%CI) 1.13-3.42] and 72.2% versus 23.8% (RR 3.03; 95%CI 1.34-6.87), respectively. No unexpected adverse events were observed. Conclusions Azithromycin is ineffective for CL treatment and does not seem to have a role in the therapeutic arsenal for CL.

A clinical trial for uniform multidrug therapy for leprosy patients in Brazil: rationale and design

Leprosy will continue to be a public health problem for several decades. The World Health Organization (WHO) recommends that, for treatment purposes, leprosy cases be classified as either paucibacillary or multibacillary (MB). A uniform leprosy treatment regimen would simplify treatment and halve the treatment duration for MB patients. The clinical trial for uniform multidrug therapy (U-MDT) for leprosy patients (LPs) in Brazil is a randomised, open-label clinical trial to evaluate if the effectiveness of U-MDT for leprosy equals the regular regimen, to determine the acceptability of the U-MDT regimen and to identify the prognostic factors. This paper details the clinical trial methodology and patient enrolment data. The study enrolled 858 patients at two centres and 78.4% of participants were classified as MB according to the WHO criteria. The main difficulty in evaluating a new leprosy treatment regimen is that no reliable data are available for the current treatment regimen. Relapse, reaction and impaired nerve function rates have never been systematically determined, although reaction and impaired nerve function are the two major causes of nerve damage that lead to impairments and disabilities in LPs. Our study was designed to overcome the need for reliable data about the current treatment and to compare its efficacy with that of a uniform regimen.

Brazilian clinical trial of uniform multidrug therapy for leprosy patients: the correlation between clinical disease types and adverse effects

This study sought to verify the correlation between leprosy types and the adverse effects of treatment drugs. This quantitative, prospective, nested study was developed at the Dona Libânia Dermatology Centre in Fortaleza, Brazil. Data were collected from November 2007-November 2008. During this period, 818 leprosy patients were diagnosed and began treatment. Forty patients with tuberculoid leprosy (TT) were selected. Twenty patients followed a standard therapy of dapsone and rifampicin and 20 were administered dapsone, rifampicin and clofazimine (U-MDT). Twenty patients with borderline lepromatous (BL) and lepromatous leprosy (LL) were also selected and treated with U-MDT. All of the subjects received six doses. With the exception of haemolytic anaemia, there was a low incidence of adverse effects in all the groups. We did not observe any differences in the incidence of haemolytic anaemia or other side effects across groups of patients with TT, BL or LL treated with U-MDT.