Conventional Standard Treatment Research Articles

Non-Invasive Ventilation Decreases the Blood Level of Paco2, but Increases the Levels of Pao2 and Sao2 in Albanian Patients with Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure

BACKGROUND: The aim of this study was to compare the partial pressure of carbon dioxide (PaCO 2 ), the partial pressure of oxygen (PaO 2 ) in the blood, and the arterial oxygen saturation (SaO 2 ) between patients with chronic obstructive pulmonary disease (COPD) and acute respiratory failure undergoing non-invasive ventilation (NIV) and their counterparts under conventional therapy. METHODS: This study was conducted at the University Hospital of Lung Diseases “Shefqet Ndroqi” in Tirana during 2011-2014 including 250 patients diagnosed with COPD and acute respiratory failure. Patients were divided into two groups: 125 patients were administered NIV, whereas 125 patients underwent the standard (conventional) treatment procedure. Mann-Whitney U-test was used to compare the mean values of PaCO 2 , PaO 2 and SaO 2 between the two groups of patients both upon hospital admission and hospital discharge. RESULTS: Upon hospital discharge, mean value of PaCO 2 was significantly lower in patients who were administered NIV compared with those who underwent the standard/conventional therapy (46.4±1.9 vs. 58.6±2.3, respectively; P 2 and SaO 2 were both higher among patients administered NIV than in their counterparts undergoing the conventional therapy (for PaO 2 : 69.7±5.8 vs. 53.7±6.4, respectively, P 2 : 92.1±2.8 vs. 81.6±3.2, respectively, P CONCLUSION: Our findings indicate that NIV is effective in the management of COPD and acute respiratory failure in Albanian hospitalized patients. Health professionals and decision-makers should be aware of the importance and benefits of NIV as an effective tool for the management of patients with COPD and acute respiratory failure. Keywords: Albania, arterial oxygen saturation (SaO 2 ), carbon dioxide (PaCO 2 ), chronic obstructive pulmonary disease, non-invasive ventilation, partial pressure of oxygen (PaO 2 ), respiratory failure. Normal 0 21 false false false RO X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:Table Normal; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin-top:0cm; mso-para-margin-right:0cm; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:Calibri,sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Times New Roman; mso-bidi-theme-font:minor-bidi; mso-fareast-language:EN-US;}

A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction.

The notion that oral intestinal sorbent AST-120 slows renal disease progression has not been evaluated thoroughly. In this study, we investigated the long-term effect of AST-120 on renal disease progression (doubling of serum creatinine, eGFR decrease >50%, or initiation of RRT) in patients with advanced CKD. We prospectively recruited 579 patients (CKD stage 3 or 4) from 11 medical centers in Korea from March 4, 2009 to August 31, 2010 and randomized them into an AST-120 arm and a control arm. Patients in the AST-120 arm were given 6 g AST-120 in three divided doses per day, and those in the control arm received only standard conventional treatment (open-label design) for 36 months or until the occurrence of primary outcomes. Levels of serum and urine indoxyl sulfate and β2-microglobulin decreased throughout the study period in both treatment arms; however, there was not a significant difference in change in uremic toxins in the AST-120 and control arms. The two arms were not different in the occurrence of composite primary outcomes (100 events in 272 individuals in the AST-120 arm and 100 events in 266 individuals in the control arm; hazard ratio, 1.12; 95% confidence interval, 0.85 to 1.48; log-rank P=0.45). The decline in eGFR and change in proteinuria were similar in the two treatment arms over time (Prandomization-time=0.64 and Prandomization-time=0.16, respectively). There was no difference in mortality (nine deaths in the AST-120 arm and 11 deaths in the control arm; log-rank P=0.73) or unplanned hospitalizations (102 in the AST-120 arm and 109 in the control arm; log-rank P=0.76) in the two treatment arms. There was no significant difference of the health-related quality of life score between the two arms. Long-term use of AST-120 added to standard treatment did not change renal disease progression, proteinuria, mortality, and health-related quality of life in patients with advanced renal dysfunction.

Long-term postoperative azithromycin in patients with chronic rhinosinusitis: A randomized clinical trial.

Chronic rhinosinusitis (CRS) is recognized as a common disease that imposes a big burden on the health system worldwide. There is ongoing evidence of the anti-inflammatory effect of long-term macrolide in the management of patients with CRS. The aim of this randomized clinical trial was to evaluate the efficacy of long-term consumption of low-dose azithromycin after functional endoscopic sinus surgery. Sixty-six patients who fulfilled the inclusion criteria were randomly divided into intervention and control groups. The subjects received the standard conventional treatment (fluticasone nasal spray plus normal saline solution irrigation) or the conventional treatment plus 250 mg of azithromycin on a daily basis for 3 months. Evaluation was made based on the 22-item Sino-Nasal Outcome Test (SNOT-22) immediately before surgery and 3 months after surgery. The intervention group showed a statistically significant improvement in SNOT-22 scores after the treatment and a higher percentage change after 3 months of therapy compared with the control group. A significant correlation was found between the percentage change of SNOT-22 scores and smoking in the placebo group. Lund-Mackay scores, patient age, and the duration of symptoms had no significant correlation with the percentage change. Treatment with long-term low-dose azithromycin in combination with the conventional therapy could statistically reduce the recurrence rate of CRS symptoms after functional endoscopic sinus surgery, but there was not sufficient evidence to support clinical significance of azithromycin at the investigated dose. Further larger scale trials, along with a longer follow-up period, is needed to evaluate the effectiveness of the therapy.

4 Immune response evaluation to curative conventional therapy – The IRECT trial

Introduction Cancer-testis antigens (CTA) are specifically expressed in different cancer types, but not in healthy normal tissue with the exception of testis. This tumor-restricted presence makes them an ideal target for specific cancer immunotherapy. In head and neck squamous cell carcinoma (HNSCC), CTA of the MAGE-A family and NY-ESO-1 have been identified as independent prognostic markers for poor survival. The addition of immunotherapeutic strategies targeting CTA may specifically improve the survival of this group of patients with an increased risk of death. To date little is known about the dynamics of CTA-specific immune responses during conventional treatment. Material and methods The IRECT trial is a non-interventional, prospective clinical trial. Stage III/IV HNSCC patients who are treated with curative intent by surgery followed by (chemo-)radiation as indicated or by primary chemoradiation are monitored over the course of standard-of-care treatment for HNSCC. Tumor tissue is being collected at the time of diagnosis. Serum, plasma and peripheral blood mononuclear cells (PBMC) are collected at defined time points before and during treatment and at every follow-up after treatment for the first 12 months. Results Patient recruitment started 09/2013 at the University Medical Center Ulm. To date 13 patients have been included into the trial. The primary sites were oropharynx (6/13), larynx (2/13), hypopharynx (1/13) and oral cavity (4/13). Five patients had stage III, 7 stage IVa and 1 patient stage IVb disease. Eleven patients were treated by primary surgery and 2 patients received primary chemoradiation. Detailed immune monitoring data are not yet available. Conclusion The results from this trial will help to understand how state of the art treatment could be complemented by cancer-testis antigen specific vaccines and immune-modulating drugs. The dynamics of host/tumor immune interaction during the conventional standard treatment will be analyzed to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule. First results may be available at the time of presentation.

Single session robotic radiosurgery for a patient with low risk prostate cancer

Here, we describe the first patient treated by single session robotic radiosurgery for low risk prostate cancer. The initial PSA of this 70-year-old patient was 5.05 ng/dl and transrectal biopsy confirmed a Gleason score 3+3=6 tumor. The patient refused a standard surgical and conventional radiation treatment. The combined choline PET/CT before treatment did not show any additional tumor locations and MRI excluded prostate capsule infiltration. Robotic radiosurgery was offered upon the patient's request as an individual treatment attempt. After ultrasound-guided transrectal fiducial implantation, a highly conformal treatment plan was generated and the patient was treated in April 2008 with 19 Gy to the 70% isodose in a single session. The treatment was tolerated very well with the minor dysuretic symptoms during the first two weeks after the procedure. The PSA continuously dropped in the following years and measured 0.07 ng/dl in July 2014. During this period, no significant clinical symptoms were detected, and the patient experienced no rectal or urinary toxicity. This is the first published patient treated with single session prostate radiosurgery, and we believe a prospective trial is warranted to investigate further the options of this attractive treatment concept for low-grade prostate cancer patients.

Decitabine Is More Cost Effective Than Standard Conventional Induction Therapy In Elderly Acute Myeloid Leukemia Patients

▪ IntroductionDecitabine (Dec) is not approved in the United States (US) for acute myeloid leukemia (AML) because it did not improve overall survival compared with standard conventional induction treatment. We asked what would be the cost effectiveness of Dec versus conventional induction therapy in AML patients (pts) older than 60 years of age. MethodsThe standard conventional induction including cytarabine, and daunorubicin, (AD) (N Engl J Med. 2009 361:1235-48) was compared with Dec (Haematologica. 2012 97:393-401) using a semi-Markov model compiling survival and cost data. Survival probabilities were retrieved from the literature. Data accounted for re-induction therapy with IDA-FLAG (idarubicin, fludarabine, cytarabine and granulocyte colony-stimulating factor) and consolidation therapy with high-dose cytarabine (HiDAC) but not for stem cell transplantation. The assumption-based model considered a maximum of 4 cycles of HiDAC and continuing Dec until loss of benefit. Drug costs were derived from the 2012 US market. Hospital costs accrued were evaluated in a diagnosis-related group (DRG) system. Drug dosage was estimated based on a body surface area of 1.85 m2. The quality of life (QoL) was assumed as 1 for healthy individuals; 0 for death; 0.524 for active disease; 0.91 for AML in remission on AD; 0.71 and 0.524 for AML being actively treated with Dec or AD, and 0.81 for AML in remission treated with Dec or HIDAC. QoL data were based on the literature except for pts on consolidation therapy. The latter was the mean of QoL of AML in remission and AML actively being treated. ResultsAssuming 1,000 pts for each treatment arm in a semi-Markov model over 1 year time horizon, the quality-adjusted life year (QALY) for AD vs. Dec was 0.1754 and 0.5982. The percentage survival for AD and Dec was 45.2% and 50.5%. Their costs were $127,867 and $55,777. The incremental cost-effectiveness ratio (ICER) was -$72,090/0.4228 = -$170,506/year. By sensitivity analysis, Dec was superior to AD to all parameters (Table 1). ConclusionDec is a more cost-effective therapy for pts older than 60 years of age than conventional induction therapy. Given the economic pressures in the US Health System, one should consider approving Dec for newly diagnosed AML pts older than 60 years of age. Disclosures:No relevant conflicts of interest to declare.

CLINICAL ASSESSMENT OF THE EFFECT OF LOW LEVEL LASER TREATMENT OF ORAL MUCOSA DECUBITUS ULCERS

Decubitus ulcers in the oral mucosa tend to be very painful causing discomforting sensation in patients in speaking and eating. Low energy lasers can provide an alternative method for the treatment of these ulcers. The aim of the present paper was to assess clinically the healing effect of low level laser irradiation on oral mucosa decubitus ulcers. Material and methods: A total of 90 patients with decubitus ulcers were treated in the present study; they were randomly assigned to three groups: group I included 30 patients treated with low level laser (LLL) irradiation (wavelength of irradiation 658 nm); group II - 30 patients treated with laser irradiation of 904 nm; and group III (controls) - 30 patients who received a standard conventional treatment with “granofurin” and “solcoseryl”. The treatment sessions in all three groups were administered once daily. The patients in groups I and II were irradiated with focused irradiation at an angle from a distance using a conically shaped light probe 3 mm in diameter. The irradiated area was 0.5 cm 2 . The light was focused on the oral mucosa ulcer and the surrounding inflamed mucosa at a distance of 0.5 to 1 cm. Diode lasers were used in the study. The dosage of irradiation was 1.2 J/cm 2 . Results and discussion: The treatment effect was evaluated by changes in the studied parameters: pain intensity, erythema, and epithelialization. They were assessed at baseline, and at days 1, 3 and 5. Conclusions: LLLT administered with the proposed methodology manages pain rapidly and accelerates the process of epithelialization of decubitus ulcers in the soft tissues of the mouth.

Spezialisierte Behandlungsangebote für erstmals schizophren Erkrankte: Konzepte und Ergebnisse

Multifaceted evidence suggests that patients in the early phase of a psychotic disorder need a specific treatment strategy meeting their specific needs and problems in this "critical" phase of the disorder. The present review summarises this evidence and presents early treatment approaches according to already internationally established different models, while in Germany comparable concepts are only in a pilot stage. Previous evaluation studies showed a superior efficacy of such early treatment approaches compared to conventional standard treatment in terms of both clinical outcome and in relation to the total costs of treatment. Questions remain, however, especially with regard to the specificity and durability of such effects, and with regard to the effective treatment components. Before similar programmes can be broadly established in Germany, a consensus on their indispensable characteristics and appropriate quality indicators should be achieved.

Comparative Effectiveness of Homoeopathic vs. Conventional Therapy in Usual Care of Atopic Eczema in Children: Long-Term Medical and Economic Outcomes

BackgroundOne in five children visiting a homeopathic physician suffers from atopic eczema.ObjectivesWe aimed to examine the long-term effectiveness, safety and costs of homoeopathic vs. conventional treatment in usual medical care of children with atopic eczema.MethodsIn this prospective multi-centre comparative observational non-randomized rater-blinded study, 135 children (48 homoeopathy, 87 conventional) with mild to moderate atopic eczema were included by their respective physicians. Depending on the specialisation of the physician, the primary treatment was either standard conventional treatment or individualized homeopathy as delivered in routine medical care. The main outcome was the SCORAD (SCORing Atopic Dermatitis) at 36 months by a blinded rater. Further outcomes included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months after baseline. A multilevel ANCOVA was used, with physician as random effect and the following fixed effects: age, gender, baseline value, severity score, social class and parents’ expectation.ResultsThe adjusted mean SCORAD showed no significant differences between the groups at 36 months (13.7 95% CI [7.9–19.5] vs. 14.9 [10.4–19.4], p = 0.741). The SCORAD response rates at 36 months were similar in both groups (33% response: homoeopathic 63.9% vs. conventional 64.5%, p = 0.94; 50% response: 52.0% vs. 52.3%, p = 0.974). Total costs were higher in the homoeopathic versus the conventional group (months 31–36 200.54 Euro [132.33–268.76] vs. 68.86 Euro [9.13–128.58], p = 0.005).ConclusionsTaking patient preferences into account, while being unable to rule out residual confounding, in this long-term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs.

Photodynamic therapy in the management of lesions of the head and neck

Photodynamic therapy (PDT) is a promising and effective treatment for lesions of the head and neck. It uses illumination with light of a specific wavelength, which activates a photosensitising drug in the presence of oxygen. It can be used in combination with other treatments or on its own, and results in the cellular destruction of the lesion through a free-radical process. Photosensitisers can be applied topically or given systemically depending on the lesion being treated. Results indicate that PDT is an effective adjunct to standard conventional treatments. We review its use.

NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: A randomized controlled trial for pharmacogenetics-based therapy

ObjectiveThis study is a pharmacogenetic clinical trial designed to clarify whether the N-acetyltransferase 2 gene (NAT2) genotype-guided dosing of isoniazid improves the tolerability and efficacy of the 6-month four-drug standard regimen for newly diagnosed pulmonary tuberculosis.MethodsIn a multicenter, parallel, randomized, and controlled trial with a PROBE design, patients were assigned to either conventional standard treatment (STD-treatment: approx. 5 mg/kg of isoniazid for all) or NAT2 genotype-guided treatment (PGx-treatment: approx. 7.5 mg/kg for patients homozygous for NAT2*4: rapid acetylators; 5 mg/kg, patients heterozygous for NAT2*4: intermediate acetylators; 2.5 mg/kg, patients without NAT2*4: slow acetylators). The primary outcome included incidences of 1) isoniazid-related liver injury (INH-DILI) during the first 8 weeks of therapy, and 2) early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the8th week.ResultsOne hundred and seventy-two Japanese patients (slow acetylators, 9.3 %; rapid acetylators, 53.5 %) were enrolled in this trial. In the intention-to-treat (ITT) analysis, INH-DILI occurred in 78 % of the slow acetylators in the STD-treatment, while none of the slow acetylators in the PGx-treatment experienced either INH-DILI or early treatment failure. Among the rapid acetylators, early treatment failure was observed with a significantly lower incidence rate in the PGx-treatment than in the STD-treatment (15.0 % vs. 38 %). Thus, the NAT2 genotype-guided regimen resulted in much lower incidences of unfavorable events, INH-DILI or early treatment failure, than the conventional standard regimen.ConclusionOur results clearly indicate a great potential of the NAT2 genotype-guided dosing stratification of isoniazid in chemotherapy for tuberculosis.

Efficacy of Yun Zhi (Coriolus versicolor) on Survival in Cancer Patients: Systematic Review and Meta-Analysis

Patients with cancer frequently use herbs along with the conventional medical treatment, hoping to enhance recovery. Mushrooms have an established history of use in traditional oriental therapies. In Asian cultures, mushrooms are combined with herbal mixtures to treat cancer. This systematic review and meta-analysis draw from randomized, placebo-controlled, double-blind trials to assess the efficacy of Yun Zhi (YZ) for survival in cancer patients. Systematic review and meta-analysis technique were used to aggregate and analyze the efficacy of Yun Zhi on survival in cancer patients from 13 clinical trials using computerized database and manual search. The findings show that Yun Zhi results in a significant survival advantage compared with standard conventional anti-cancer treatment alone. Of patient randomized to Yun Zhi, there was a 9% absolute reduction in 5-year mortality, resulting in one additional patient alive for every 11 patients treated. In patients with breast cancer, gastric cancer, or colorectal cancer treated with chemotherapy, the effects of the combination of Yun Zhi preparation on the overall 5-year survival rate was more evident, but not in esophageal cancer and nasophayngeal carcinoma. However, subgroup analysis could not conclude which type of anti-cancer treatment may maximize the benefit from Yun Zhi. This meta-analysis has provided strong evidence that Yun Zhi would have survival benefit in cancer patients, particularly in carcinoma of breast, gastric and colorectal. Nevertheless, the findings highlight the need for further evidence from prospective studies of outcome to guide future potential modifications of treatment regimes. Recent patents on the use of mushrooms for the treatment of cancer are also summarized in this review.

Acute and Late Toxicity in High-risk Prostate Cancer Treated with Androgen Suppression and Hypofractionated Intensity Modulated Radiotherapy

Acute and Late Toxicity in High-risk Prostate Cancer Treated with Androgen Suppression and Hypofractionated Intensity Modulated Radiotherapy

Complementary and Alternative Medicine for Pain: An Evidence-based Review

Pain is one of the most prevalent conditions for which patients seek medical attention. Additionally, the number of patients who utilize complementary and alternative medicine as a treatment of pain either in lieu of, or concurrent with, standard conventional treatments continues to grow. While research into the mechanisms, side effect profiles, and efficacies of these alternative therapies has increased in recent years, much more remains unknown and untested. Herein, we review the literature on complementary and alternative medicine for pain, with particular emphasis on evidence-based assessments pertinent to the most common alternative therapies, including acupuncture, herbal therapy, massage therapy, hypnosis, tai chi, and biofeedback.

Late Toxicity in High-risk Prostate Cancer Treated with Androgen Suppression and Hypofractionated Intensity Modulated Radiotherapy

Late Toxicity in High-risk Prostate Cancer Treated with Androgen Suppression and Hypofractionated Intensity Modulated Radiotherapy

Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial

BackgroundFunctional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventional treatments. Alternative therapies, such as herbal formulas, are widely used to treat FD. However, there are inadequate evidences regarding the safety and efficacy of these formulas. Moreover, the mechanisms by which herbal formulas act in the gastrointestinal tract are controversial. In traditional Korean medicine, Banha-sasim-tang has long been one of the most frequently prescribed herbal formulas for treating dyspepsia. The current study is designed to evaluate the efficacy and safety of Banha-sasim-tang for FD patients and to examine whether there will be a significant correlation between cutaneous electrogastrography recordings and dyspeptic symptoms in FD patients, and between changes in gastric myoelectrical activity and improvement in dyspeptic symptoms during Banha-sasim-tang administration.MethodsThis randomized, double-blind, placebo-controlled trial will be performed at two centers and will include a Banha-sasim-tang group and placebo group. Each group will consist of 50 FD patients. Six weeks of administration of Banha-sasim-tang or placebo will be conducted. During the subsequent 2 months, follow-up observations of primary and secondary outcomes will be performed. The primary outcomes are differences as measured on the gastrointestinal symptom scale, and the secondary outcomes are differences as measured on the visual analogue scale for dyspepsia and on the questionnaire for FD-related quality of life. All outcomes will be measured at baseline, at 2, 4, and 6 weeks of treatment, and at the 1 and 2 month follow-up. Cutaneous electrogastrography will be performed and assessed at baseline and at 6 weeks.DiscussionThis trial will provide evidence of the safety and efficacy of Banha-sasim-tang for the treatment for FD. Furthermore, based on the assessment of the relationship between cutaneous electrogastrography recordings and dyspeptic symptoms in this trial, the possibility of clinical applications of cutaneous electrogastrography in the treatment of FD will be elucidated.Trial RegistrationCurrent Controlled Trials (ISRCTN 51910678); Clinical Trials.gov Identifier: NCT00987805

Atrial Fibrillation in the Failing Heart – A Clinical Review

Not only are atrial fibrillation (AF) and heart failure (HF) the most commonly encountered disease conditions in clinical practice, they are also associated with an increased risk of both morbidity and mortality. Both diseases are affiliated with maladaptive neurohormonal changes and remodelling of the heart. Treatment of AF has focused on prevention of thromboembolism, rate control and rhythm maintenance. Rhythm maintenance with anti-arrhythmic drugs has been relatively ineffective in maintaining patients in sinus rhythm, with the addition of increased adverse side effects. Rhythm control of AF via catheter radiofrequency ablation is a viable treatment option, with several studies showing improvement in ejection fraction, quality of life and the six-minute-walk test. Future multicentre randomised controlled trials are pending, the first being Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation (CASTLE-AF), to determine whether catheter ablation of AF is superior to conventional therapy for patients suffering from AF and HF.

Catheter Ablation versus Standard Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation (CASTLE‐AF) ‐ Study Design

Electrical isolation of the pulmonary veins by catheter ablation is an emerging treatment modality for the treatment of atrial fibrillation (AF) and is increasingly used in patients with heart failure. The catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation trial (CASTLE-AF) is a randomized evaluation of ablative treatment of atrial fibrillation in patients with left ventricular dysfunction. The primary endpoint is the composite of all-cause mortality or worsening of heart failure requiring unplanned hospitalization using a time to first event analysis. Secondary endpoints are all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of heart failure requiring unplanned hospitalization, unplanned hospitalization due to cardiovascular reason, all-cause hospitalization, quality of life, number of therapies (shock and antitachycardia pacing) delivered by the implantable cardioverter-defibrillator (ICD), time to first ICD therapy, number of device-detected ventricular tachycardia and ventricular fibrillation episodes, AF burden, AF free interval, left ventricular function, exercise tolerance, and percentage of right ventricular pacing. CASTLE-AF will randomize 420 patients for a minimum of 3 years at 48 sites in the United States, Europe, Australia, and South America.

Foreword

This subanalysis of the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial aimed to address the association between atrial fibrillation (AF) recurrence, AF burden, and hard clinical outcomes in heart failure (HF) patients with AF.The CASTLE-AF trial demonstrated the benefit of CA compared to pharmacological treatment in decreasing mortality and CV hospitalizations in patients with AF and HFrEF. However, the impact of AF recurrence and AF burden after ablation on long-term treatment benefit remains unknown.The CASTLE-AF protocol randomized 363 patients with coexisting HF and AF in a multicenter prospective controlled fashion to catheter ablation (n = 179) versus pharmacological therapy (n = 184). Two hundred eighty patients were included in this subanalysis (as-treated), 128 of them underwent ablation and 152 received pharmacological treatment. All patients had implanted dual chamber or biventricular implantable defibrillators with activated home monitoring capabilities. The individual AF burden was calculated as the percentage of the atrial arrhythmia time per day.AF burden at baseline was not predictive of the primary endpoint (p = 0.473) or all-cause mortality (p = 0.446). AF recurrence (defined as any episode >30 s) did not show any relationship with the primary endpoints of mortality and occurrence of HF, irrespective of the treatment arm. An AF burden below 50% after 6 months of catheter ablation, was associated with a significant decrease in primary composite outcome (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.15 to 0.71; p = 0.014) and all-cause mortality (HR: 0.23; 95% CI: 0.07 to 0.71; p = 0.031). The risk of the primary endpoint or mortality was directly related to a low (<50%) or high (≥50%) AF burden at 6 months post-ablation.AF burden at 6 months was predictive of hard clinical outcomes in HF patients with AF. The first recurrent atrial tachyarrhythmia episode >30 s after ablation was not associated with improvement in mortality and hospitalization for HF. (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF [CASTLE-AF]; NCT00643188)

The use of homeopathic combination remedy for dengue fever symptoms: a pilot RCT in Honduras

A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.