Long-term efficacy of a rural community-based integrated intervention for prevention and management of chronic obstructive pulmonary disease: a cluster randomized controlled trial in China's rural areas

This study aimed to assess the efficacy of a rural community-based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China. This 18-year cluster-randomized controlled trial encompassing 15 villages included 1008 patients (454 men and 40 women in the intervention group [mean age, 54 ± 10 years]; 482 men and 32 women in the control group [mean age, 53 ± 10 years]) with confirmed COPD or at risk for COPD. Villages were randomly assigned to the intervention or the control group, and study participants residing within the villages received treatment accordingly. Intervention group patients took part in a program that included systematic health education, smoking cessation counseling, and education on management of COPD. Control group patients received usual care. The groups were compared after 18 years regarding the incidence of COPD, decline in lung function, and mortality of COPD. COPD incidence was lower in the intervention group than in the control group (10% vs 16%, <0.05). A decline in lung function was also significantly delayed in the intervention group compared to the control group of COPD and high-risk patients. The intervention group showed significant improvement in smoking cessation compared with the control group, and smokers in the intervention group had lower smoking indices than in the control group (350 vs 450, <0.05). The intervention group also had a significantly lower cumulative COPD-related death rate than the control group (37% vs 47%, <0.05). A rural community-based integrated intervention is effective in reducing the incidence of COPD among those at risk, delaying a decline in lung function in COPD patients and those at risk, and reducing mortality of COPD.

Effects of intracutaneous injections of sterile water in patients with acute low back pain: a randomized, controlled, clinical trial

Intracutaneous sterile water injection (ISWI) is used for relief of low back pain during labor, acute attacks of urolithiasis, chronic neck and shoulder pain following whiplash injuries, and chronic myofascial pain syndrome. We conducted a randomized, double-blinded, placebo-controlled trial to evaluate the effect of ISWI for relief of acute low back pain (aLBP). A total of 68 patients (41 females and 27 males) between 18 and 55 years old experiencing aLBP with moderate to severe pain (scores ≥5 on an 11-point visual analogue scale [VAS]) were recruited and randomly assigned to receive either ISWIs (n=34) or intracutaneous isotonic saline injections (placebo treatment; n=34). The primary outcome was improvement in pain intensity using the VAS at 10, 45, and 90 min and 1 day after treatment. The secondary outcome was functional improvement, which was assessed using the Patient-Specific Functional Scale (PSFS) 1 day after treatment. The mean VAS score was significantly lower in the ISWI group than in the control group at 10, 45, and 90 min, and 1 day after injection (P<0.05, t-test). The mean increment in PSFS score of the ISWI group was 2.9±2.2 1 day after treatment, while that in the control group was 0.9±2.2. Our study showed that ISWI was effective for relieving pain and improving function in aLBP patients at short-term follow-up. ISWI might be an alternative treatment for aLBP patients, especially in areas where medications are not available, as well as in specific patients (e.g., those who are pregnant or have asthma), who are unable to receive medications or other forms of analgesia because of side effects.

Effectiveness of motivational interviewing at improving oral health: a systematic review

OBJECTIVE : To analyze the effectiveness of motivational interviewing (MI) at improving oral health behaviors (oral hygiene habits, sugar consumption, dental services utilization or use of fluoride) and dental clinical outcomes (dental plaque, dental caries and periodontal status). METHODS : A systematic search of PubMed, LILACS, SciELO, PsyINFO, Cochrane and Google Scholar bibliographic databases was conducted looking for intervention studies that investigated MI as the main approach to improving the oral health outcomes investigated. RESULTS : Of the 78 articles found, ten met the inclusion criteria, all based on randomized controlled trials. Most studies (n = 8) assessed multiple outcomes. Five interventions assessed the impact of MI on oral health behaviors and nine on clinical outcomes (three on dental caries, six on dental plaque, four on gingivitis and three on periodontal pockets). Better quality of evidence was provided by studies that investigated dental caries, which also had the largest population samples. The evidence of the effect of MI on improving oral health outcomes is conflicting. Four studies reported positive effects of MI on oral health outcomes whereas another four showed null effect. In two interventions, the actual difference between groups was not reported or able to be recalculated. CONCLUSIONS : We found inconclusive effectiveness for most oral health outcomes. We need more and better designed and reported interventions to fully assess the impact of MI on oral health and understand the appropriate dosage for the counseling interventions.

Non-adherence to telemedicine interventions for drug users: systematic review

OBJECTIVE To estimate rates of non-adherence to telemedicine strategies aimed at treating drug addiction. METHODS A systematic review was conducted of randomized controlled trials investigating different telemedicine treatment methods for drug addiction. The following databases were consulted between May 18, 2012 and June 21, 2012: PubMed, PsycINFO, SciELO, Wiley (The Cochrane Library), Embase, Clinical trials and Google Scholar. The Grading of Recommendations Assessment, Development and Evaluation was used to evaluate the quality of the studies. The criteria evaluated were: appropriate sequence of data generation, allocation concealment, blinding, description of losses and exclusions and analysis by intention to treat. There were 274 studies selected, of which 20 were analyzed. RESULTS Non-adherence rates varied between 15.0% and 70.0%. The interventions evaluated were of at least three months duration and, although they all used telemedicine as support, treatment methods differed. Regarding the quality of the studies, the values also varied from very poor to high quality. High quality studies showed better adherence rates, as did those using more than one technique of intervention and a limited treatment time. Mono-user studies showed better adherence rates than poly-user studies. CONCLUSIONS Rates of non-adherence to treatment involving telemedicine on the part of users of psycho-active substances differed considerably, depending on the country, the intervention method, follow-up time and substances used. Using more than one technique of intervention, short duration of treatment and the type of substance used by patients appear to facilitate adherence.

Systematic reviews on leptospirosis

OBJECTIVES: To find the existing clinical evidence on interventions for leptospirosis. The objective is to evaluate the effectiveness and safety of any intervention on leptospirosis through systematic reviews of randomized controlled trials (RCTs). DATA SOURCE: The sources of studies used (where there were no limitations concerning language, date, or other restrictions) were: EMBASE, LILACS, MEDLINE, the Cochrane Controlled Clinical Trials Database, and the Cochrane Hepato-Biliary Group Randomized Trials register. SELECTION OF STUDIES: Type of Study: All systematic reviews of randomized controlled trials. Participants: patients with clinical and/or laboratorial diagnosis of leptospirosis, and subjects potencially exposed to leptospirosis as defined by the authors Interventions: any intervention for leptospirosis (as antibiotics or vaccines for prevention or treatment). DATA COLLECTION: The assessment will be independently made by the reviewers and cross-checked. The external validity was assessed by analysis of: studies, interventions, and outcomes. DATA SYNTHESIS: Located 163 studies using the search strategy described above, at the electronic databases above. Only 2 hits were selected, which are protocols of systematic reviews of Cochrane Collaboration, and not full reviews. One of the protocols evaluates antibiotics for treatment, and the other evaluates antibiotics for prevention of leptospirosis. CONCLUSIONS: There were not complete systematic reviews on interventions for leptospirosis. Any interventions for leptospirosis, such as prevention and treatment remains unclear for guidelines and practice.

Risks and benefits of hormone replacement therapy in older men

The use of testosterone in older men, known as male hormonal replacement therapy or androgen replacement therapy, has become of increasing interest to both the medical and lay communities over the past decade. Even though the knowledge of the potential benefits and risks of male Androgen Replacement Therapy has increased dramatically, there is still much that needs to be determined. Although there are a number of potential benefits of male Androgen Replacement Therapy and data concerning clinical effects of such replacement have accumulated, as yet there have not been any large multicenter randomized controlled trials of this therapy. It is the purpose of this article to review what is currently known about the possible risks and benefits of male Androgen Replacement Therapy by discussing the clinical trials to date.

Tai Chi Chuan for Cardiac Rehabilitation in Patients with Coronary Arterial Disease

Background:Several studies have shown that Tai Chi Chuan can improve cardiac function in patients with heart disease.Objective:To conduct a systematic review of the literature to assess the effects of Tai Chi Chuan on cardiac rehabilitation for patients with coronary artery disease.Methods:We performed a search for studies published in English, Portuguese and Spanish in the following databases: MEDLINE, EMBASE, LILACS and Cochrane Register of Controlled Trials. Data were extracted in a standardized manner by three independent investigators, who were responsible for assessing the methodological quality of the manuscripts.Results:The initial search found 201 studies that, after review of titles and abstracts, resulted in a selection of 12 manuscripts. They were fully analyzed and of these, nine were excluded. As a final result, three randomized controlled trials remained. The studies analyzed in this systematic review included patients with a confirmed diagnosis of coronary artery disease, all were clinically stable and able to exercise. The three experiments had a control group that practiced structured exercise training or received counseling for exercise. Follow-up ranged from 2 to 12 months.Conclusion:Preliminary evidence suggests that Tai Chi Chuan can be an unconventional form of cardiac rehabilitation, being an adjunctive therapy in the treatment of patients with stable coronary artery disease. However, the methodological quality of the included articles and the small sample sizes clearly indicate that new randomized controlled trials are needed in this regard.

Effects of Yoga in Patients with Chronic Heart Failure: A Meta-Analysis

The use of yoga as an effective cardiac rehabilitation in patients with chronic heart failure (CHF) remains controversial. We performed a meta-analysis to examine the effects of yoga on exercise capacity and health-related quality of life (HRQOL) in patients with CHF. Methods: We searched MEDLINE, Cochrane Central Register of Controlled Trials, Excerpta Medica database, LILACS, Physiotherapy Evidence Database, The Scientific Electronic Library Online, and Cumulative Index to Nursing and Allied Health (from the earliest date available to December 2013) for randomized controlled trials (RCTs) examining the effects of yoga versus exercise and/or of yoga versus control on exercise capacity (peakVO2) and quality-of-life (HRQOL) in CHF. Two reviewers selected studies independently. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were calculated, and heterogeneity was assessed using the I2 test. Two studies met the selection criteria (total: 30 yoga and 29 control patients). The results suggested that yoga compared with control had a positive impact on peak VO2 and HRQOL. Peak VO2, WMD (3.87 95% CI: 1.95 to 5.80), and global HRQOL standardized mean differences (-12.46 95% CI: -22.49 to -2.43) improved in the yoga group compared to the control group. Yoga enhances peak VO2 and HRQOL in patients with CHF and could be considered for inclusion in cardiac rehabilitation programs. Larger RCTs are required to further investigate the effects of yoga in patients with CHF.

When are we going to celebrate the centenary of the discovery of efficient treatment for congenital toxoplasmosis?

In 2008, we have celebrated the centenary of the discovery of Toxoplasma gondii.Although this ubiquitous protozoan can generate devastating damage in foetuses and newborns, its treatment is the only field in which we have made little progress, despite a huge body of research, and has not yet been validated. Pregnant women who seroconvert are generally given spiramycine in order to reduce the risk of vertical transmission. However, to date, we have no evidence of the efficacy of this treatment because no randomized controlled trials have as yet been conducted. When foetal contamination is demonstrated, pyrimethamine, in association with sulfadoxine or sulfadiazine, is normally prescribed, but the effectiveness of this treatment remains to be shown. With regard to postnatal treatment, opinions vary considerably in terms of drugs, regimens and length of therapy. Similarly, we do not have clear evidence to support routine antibiotic treatment of acute ocular toxoplasmosis. We must be aware that pregnant women and newborns are currently being given empirically potentially toxic drugs that have no proven benefit. We must make progress in this field through well-designed collaborative studies and by drawing the attention of policy makers to this disastrous and unsustainable situation.