Evidence Of Improvement In Symptoms Research Articles

Effects of a high-prebiotic diet versus probiotic supplements versus synbiotics on adult mental health: The "Gut Feelings" randomised controlled trial.

Preliminary evidence supports the use of dietary interventions and gut microbiota-targeted interventions such as probiotic or prebiotic supplementation for improving mental health. We report on the first randomised controlled trial (RCT) to examine the effects of a high-prebiotic dietary intervention and probiotic supplements on mental health. "Gut Feelings" was an 8-week, 2 × 2 factorial RCT of 119 adults with moderate psychological distress and low prebiotic food intake. Treatment arms: (1) probiotic supplement and diet-as-usual (probiotic group); (2) high-prebiotic diet and placebo supplement (prebiotic diet group); (3) probiotic supplement and high-prebiotic diet (synbiotic group); and (4) placebo supplement and diet-as-usual (placebo group). The primary outcome was assessment of total mood disturbance (TMD; Profile of Mood States Short Form) from baseline to 8 weeks. Secondary outcomes included anxiety, depression, stress, sleep, and wellbeing measures. A modified intention-to-treat analysis using linear mixed effects models revealed that the prebiotic diet reduced TMD relative to placebo at 8 weeks [Cohen's d = -0.60, 95% confidence interval (CI) = -1.18, -0.03; p = 0.039]. There was no evidence of symptom improvement from the probiotic (d = -0.19, 95% CI = -0.75, 0.38; p = 0.51) or synbiotic treatments (d = -0.03, 95% CI = -0.59, 0.53; p = 0.92). Improved anxiety, stress, and sleep were noted in response to the prebiotic diet while the probiotic tentatively improved wellbeing, relative to placebo. No benefit was found in response to the synbiotic intervention. All treatments were well tolerated with few adverse events. A high-prebiotic dietary intervention may improve mood, anxiety, stress, and sleep in adults with moderate psychological distress and low prebiotic intake. A synbiotic combination of high-prebiotic diet and probiotic supplement does not appear to have a beneficial effect on mental health outcomes, though further evidence is required. Results are limited by the relatively small sample size. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372753, identifier ACTRN12617000795392.

Use of aripiprazole in an obsessive compulsive disorder case with associated motor tics

IntroductionObsessive compulsive disorder (OCD) is a pathology represented by thoughts, images, impulses or feelings that generate great anxiety and discomfort, as well as the development of compulsive acts and rituals that cause great dysfunction.The comorbidity of different psychiatric disorders with OCD is known, such as impulse control disorder and tic disorder.ObjectivesThe objective of this study is to describe the clinical characteristics, comorbidities and the treatment used in a patient with an OCD diagnosis and motor tics.MethodsDescription of a clinical case of motor tics associated with OCD in an adult patient.ResultsA 29-year-old man begins mental health follow-up for presenting, as a result of a choking episode, obsessive thoughts with significant emotional and behavioral repercussions, to the point of restricting his diet and losing several kilos of weight. He also manifested checks and rituals in order to avoid possible choking.Treatment with sertraline and clonazepam was started, without evidence of improvement in symptoms. Months later, bucolingual and guttural tics, difficult to control by the patient and which caused bite lesions in the mouth and tongue, were added to the described clinic. Oral aripiprazole was associated to the treatment and then prolonged- release intramuscular administration was used, achieving improvement in obsessive symptoms and motor tics.ConclusionsThe usefulness of adjuvant treatment with atypical antipsychotics has been demonstrated in adults with OCD who present an insufficient response to an SSRI. Injectable prolonged-release antipsychotics can help improve long-term prognosis by ensuring adherence.DisclosureNo significant relationships.

Effects of a mind-body program on symptoms of depression and perceived stress among adults with neurofibromatosis type 2 who are deaf: A live-video randomized controlled trial

IntroductionNeurofibromatosis type 2 (NF2) is a rare, progressive and incurable genetic disorder associated with progressive hearing loss and eventual deafness. As a group, patients with NF report high levels of stress and depressive symptoms. However, no studies have explored improvement in these symptoms after psychosocial interventions. We have previously shown that a mind-body program tailored to adults with NF2 who are deaf (the Relaxation Response and Resiliency Program for Deaf NF2, d3RP-NF2) improves quality of life and resiliency over and above a Health Enhancement program when both are delivered via live-video and assisted by Communication Access Realtime Translation (CART). Here we tested the effects of the programs on depression and perceived stress. MethodsForty-five patients with NF2 and significant hearing loss were randomized to the d3RP-NF2 or Health-Enhancement program and completed measures of depression (PHQ-9) and perceived stress (PSS-10) at baseline, post-intervention, and six-month follow-up. ResultsPatients randomized to the d3RP-NF2 program, but not to the control condition, experienced significant decreases on both measures from baseline to post-test, which were maintained at follow-up (within group tests). However, improvements following the d3RP-NF2 program was not significantly higher than those observed in the control group (between group tests). ConclusionResults provide the first evidence of improvement in symptoms of depression and perceived stress among deaf patients living with NF2 who participate in a virtual mind-body program.

Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis

APT-1011, a fluticasone propionate orally disintegrating tablet formulation, is under investigation for the treatment of eosinophilic oesophagitis (EoE). To evaluate the safety and tolerability of APT-1011 administered to patients with EoE and to assess the effect on clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia. A randomised, double-blind, placebo-controlled, multicentre, phase 1b/2a study was conducted at seven medical centres in the US to evaluate the safety and tolerability of APT-1011 over 8 weeks in adults and adolescents with EoE. Participants were randomised to placebo (n=8), 1.5mg APT-1011 BID (n=8) or 3.0mg APT-1011 QD (n=8). Safety and tolerability were assessed as the primary outcome; histologic and endoscopic measures were assessed as exploratory outcomes. There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE. In one participant randomised to 1.5mg APT-1011 BID, a reduction in cortisol was observed, but without evidence of adrenal insufficiency. Compared with placebo, treatment with APT-1011 resulted in greater reductions in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom-based EoE activity index from baseline to end of treatment (Week 8). APT-1011 was safe and well tolerated in adolescents and adults with EoE. Exploratory efficacy outcomes demonstrated improvement in histologic and endoscopic findings as well evidence of symptom improvement. The results of this study support the continued development of APT-1011 for the treatment of EoE (NCT-01386112).

A Pilot Study of Sirolimus in Subjects with Cowden Syndrome or Other Syndromes Characterized by Germline Mutations in PTEN

Lessons Learned.This is the first human interventional study in patients with Cowden syndrome that is driven by inactivation of germline PTEN gene.Single‐agent sirolimus, a mTOR inhibitor, suppressed mTOR signaling in surrogate human tissues without significant toxicity.Background.Cowden syndrome is characterized by inactivating germline PTEN mutations, which can lead to activation of the PI3K‐Akt‐mTOR pathway.Methods.Adult subjects with germline PTEN mutation who met international diagnostic criteria for Cowden syndrome and who had Eastern Cooperative Oncology Group (ECOG) performance status 0–2 and adequate organ function were enrolled. Subjects were treated with a 56‐day course of daily oral sirolimus. In addition to symptom assessment and physical examination, dermatologic, endoscopic, neurologic (cerebellar), and radiographic assessments were conducted. Inhibition of the mTOR pathway in benign skin and gastrointestinal (GI) lesion was assessed by immunohistochemistry.Results.A total of 18 patients and 16 families were enrolled. PTEN mutations were located at exons 1–8. Regression of skin and GI lesions was observed by dermoscopy or endoscopy. Neurological evaluation showed improvement in cerebellar function score at 1 month. Immunohistochemistry (IHC) analysis in skin and GI benign lesions showed a decrease in the ratio of phosphorylated (p)S6 to total S6 in response to sirolimus. Ratios of pS6K to total S6 at days 14 and 56 were significantly lower than at baseline (p = .0026, p = .00391, respectively). A 56‐day course of sirolimus was well tolerated.Conclusion.A 56‐day course of sirolimus was well tolerated in subjects with Cowden syndrome and was associated with some evidence of improvement in symptoms, skin and GI lesions, cerebellar function, and decreased mTOR signaling.

Eisenmenger syndrome: current perspectives

Eisenmenger syndrome: current perspectives Heba Nashat,1–3 Aleksander Kempny,1–3 Colm McCabe,1 Laura C Price,1–3 Carl Harries,1 Rafael Alonso-Gonzalez,1–3 Michael A Gatzoulis,1–3 Stephen J Wort,1–3 Konstantinos Dimopoulos1–3 1Adult Congenital Heart Centre and National Centre for Pulmonary Hypertension, Royal Brompton Hospital, 2National Heart and Lung Institute (NHLI), Imperial College, 3National Institute for Health Research (NIHR) Cardiovascular Biomedical Research Unit, Royal Brompton Hospital and National Heart and Lung Institute, Imperial College, London, UK Abstract: Eisenmenger syndrome (ES) is the most severe form of pulmonary arterial hypertension (PAH) related to congenital heart disease (CHD). It results from a cardiac defect allowing significant systemic-to-pulmonary (left-to-right) shunting, which triggers the development of pulmonary vascular disease (PVD) if the defect is not repaired in a timely fashion. Once severe PVD has developed, the defect cannot be repaired. With advances in pediatric cardiology and surgery, the prevalence of ES is steadily falling in developed countries; nonetheless, there will always be patients who are unsuitable for repair at the time of diagnosis, or emigrating from countries with less advanced healthcare, who will develop ES. ES is a multisystem disorder causing chronic hypoxemia and reduced cardiac output resulting in significant morbidity and mortality. While lung (plus defect repair) or combined heart and lung transplantation is thought be the definitive treatment for ES, transplant organs are a limited resource and long-term results are still suboptimal. PAH pharmacotherapy was, until quite recently, largely directed at symptomatic relief and had no impact on morbidity and mortality. Targeted PAH therapies have recently been proven to be beneficial in various forms of PAH in terms of functional status, progression of disease, and prognosis. Data on the effect of PAH therapies in the ES cohort remain limited, but available studies demonstrate evidence of improvement in symptoms, exercise capacity, and some evidence of survival benefit. ES patients should be followed in specialized centers, by means of an interdisciplinary approach by clinicians experienced in PAH and CHD. However, local physicians working in cardiology, respiratory medicine, primary care, and emergency services are likely to encounter ES patients and need to be aware of the main issues and pitfalls in their care. The authors present an overview of the management of ES, focusing on the most common issues and complications. Keywords: Eisenmenger syndrome, pulmonary arterial hypertension, congenital heart disease, cyanosis, pulmonary arterial hypertension therapies, hyperviscosity, thrombosis, bleeding, pregnancy, Down syndrome

Efeito do Lactobacillus reuteri na cólica infantil: revisão baseada na evidência

Objective: To review the evidence for the effectiveness of probiotic supplementation with Lactobacillus reuteri in reducing symptoms of infantile colic. Data sources: National Guideline Clearinghouse, Guideline Finder, Canadian Medical Association, The Cochrane Database, DARE, Bandolier and MEDLINE/PubMed. Methods: A review of clinical guidelines, meta-analyses, systematic reviews, and randomized controlled clinical trials, published between August 2005 and August 2015, in both the Portuguese and English languages was conducted. The following MeSH terms were used: ‘Lactobacillus reuteri’ and ‘Colic’. For the attribution of levels of evidence and the strength of recommendations, the Strength of Recommendation Taxonomy scale was used. Results: Fifty-nine papers were found and eight fulfilled the inclusion criteria. These included two systematic reviews and six randomized controlled clinical trials. Five of the included studies and both systematic reviews found statistically significant improvements in symptoms of colic with probiotic supplementation. One study did not demonstrate the effectiveness of Lactobacillus reuteri in infantile colic. Conclusion: There is evidence for improvement of symptoms of infantile colic with Lactobacillus reuteri supplementation, compared to placebo (Strength of Recommendation A). More good quality studies are necessary to validate these findings and to aid in the formulation of clinical guidelines.

Plasmapheresis in Treatment of Severe Hypertriglyceridemia Induced Acute Pancreatitis

Hypertriglyceridemia induced pancreatitis (HTGP) is the third most common causes of acute pancreatitis (AP) after alcohol and gallstones. The commonly used treatment for HTGP is either intravenous (IV) insulin or heparin along with fenofibrates. A 34 year old obese Hispanic female with past medical history of hyperlipidemia (HPL) presented to the emergency room with a chief complaint of 3 days history of progressively worsening severe epigastric pain radiating to her lower back, associated with nausea and vomiting. She had no prior similar episodes. Her personal, family, medication and social history was unremarkable except occasional alcohol drinking of the standard one to two drinks every month, but prior to this ER visit she reported drinking more than 3 standard drinks per day for the past 2 days. Relevant laboratory tests revealed mild hyponatremia of 130 mEq/L, lipase of 1039 U/L, with a normal calcium, blood glucose (BG) and liver function tests, but the serum was abnormally milky white in appearance. The lipid panel revealed triglycerides (TG) > 3000 mg/dl. An abdominal ultrasound showed non-obstructive cholelithiasis with a common bile duct size of 7 mm. She was managed conservatively with AP treatment guidelines, but due to severe hypertriglyceridemia (SHTG) and symptoms she underwent one session of plasmapheresis with albumin replacement. The TG subsequently trended down to 349 mg/dl and she was advanced on a low fat diet and Fenofibrate. Follow-up TG after 1 month was 80 mg/dl. HTGP is clinically evident when levels are > 1000mg/dl and is classified as SHTG and very severe HTG for levels > 2000 mg/dl. The goal of the treatment is lowering the TG levels to < 250 mg/dl and identifying the underlying cause. Patients with HTGP have higher chances of recurrent AP than pancreatitis from other causes. There is evidence of improvement in symptoms as well as lowering TG levels with IV insulin in patients with HTGP and marked hyperglycemia, but in patients with normal BG levels treatment of HTGP is not very well defined. Our patient was treated with plasmapheresis leading to a significant improvement in her TG levels, clinical and laboratory parameters in a relatively short time leading to a shorter hospital stay. Currently there are no guidelines for the use of plasmapheresis in treatment of HTGP. Plasmapheresis seems to be an effective method for the treatment of HTGP and an important area of future research, especially in patients with severe AP and normal BG levels.

Development and Implementation of an Ambulatory Integrated Care Pathway for Major Depressive Disorder and Alcohol Dependence.

Integrated care pathways (ICPs) provide an approach for delivering evidence-based treatment in a hospital setting. This column describes the development and pilot implementation in a clinical setting of an ICP for patients with concurrent major depressive disorder and alcohol dependence at the Centre for Addiction and Mental Health (CAMH), an academic tertiary care hospital, in Toronto, Canada. The ICP methodology includes evidence reviews, knowledge translation, process reengineering, and change management. Pilot results indicate high patient satisfaction, evidence of symptom improvement, and excellent retention.

Quality of life in symptomatic cervical myelopathy after open-door laminoplasty

&lt;sec&gt;&lt;title&gt;OBJECTIVE:&lt;/title&gt;&lt;p&gt; To analyze the results obtained by open-door laminoplasty using the Newbridge&lt;sup&gt;(r)&lt;/sup&gt;/Blackstone plate, in cases of myelopathy associated with cervical lordosis.&lt;/p&gt;&lt;/sec&gt;&lt;sec&gt;&lt;title&gt;METHODS:&lt;/title&gt;&lt;p&gt; From December 2010 to October 2012, eight patients between the ages of 49 and 68 underwent open-door laminoplasty with the use of the Newbridge&lt;sup&gt;(r)&lt;/sup&gt; fixation system for maintenance and stabilization of the cervical laminoplasty. Minimum follow-up was four months. For the evaluation of quality of life the questionnaire SF-36 was applied at the following times: preoperative, one month and three months after surgery associated with the subjective assessment of the patient regarding satisfaction with the procedure and with the Nurick neurological scale applied prior to surgery and three months later.&lt;/p&gt;&lt;/sec&gt;&lt;sec&gt;&lt;title&gt;RESULTS:&lt;/title&gt;&lt;p&gt; According to the SF-36, there was significant improvement in the domains functional ability, general health perceptions and emotional aspects over time; regarding physical limitations and social aspects there was no improvement in the first postoperative month, only in the third month. There were no statistically significant changes observed during the period covered by this study related to pain, vitality and mental health. According to Nurick scale, there was evidence of improvement in symptoms of cervical myelopathy. Based on the subjective evaluation of the patients, surprisingly, all patients were satisfied with the surgical procedure and the results.&lt;/p&gt;&lt;/sec&gt;&lt;sec&gt;&lt;title&gt;CONCLUSION:&lt;/title&gt;&lt;p&gt; The open-door laminoplasty technique with rigid fixation to maintain the opening is useful in improving the symptoms of cervical myelopathy associated with lordosis, leading to improved quality of life and with a high degree of patient satisfaction and fewer complications.&lt;/p&gt;&lt;/sec&gt;

Pharmacological treatment of children with gastro-oesophageal reflux.

Pharmacological treatment of children with gastro-oesophageal reflux.

“Stay in the Game”: Collecting Data on Symptom Improvement in Naturalistic Settings in Order to Increase Reimbursement Rates

An industrious approach to increasing reimbursement rates from third-party payers is reviewed. Balancing fidelity to treatment with real-world demands at a local hospital is discussed, as well as ways we were able to increase reimbursement within our own department. Data in naturalistic settings, though not always able to adhere to randomized controlled trials, offers evidence of improvement in symptoms. This reaction paper encourages other clinical programs to "stay in the game" of data collection while balancing treatment fidelity.

Treatment of Diverticular Disease of the Colon and Prevention of Acute Diverticulitis: A Systematic Review

Diverticular disease of the colon is a common disorder, characterized by recurrent symptoms and complications such as diverticulitis, requiring hospital admissions and surgery. This study aimed to systematically review the evidence for medical therapy of diverticular disease in reducing symptoms and preventing acute diverticulitis. MEDLINE and Embase databases (1966 to February 2010). The studies selected were prospective clinical trials on uncomplicated diverticular disease of the colon. Four investigators independently reviewed articles, extracted data, and assessed study quality according to standardized criteria. The main outcomes measured were improvement in symptoms, complete remission of symptoms, and prevention of acute diverticulitis. We identified 31 studies, including 6 placebo-controlled trials. The methodological quality of these studies was suboptimal. Only 10 trials provided a detailed description of the patient history, 8 assessed symptoms by the use of a validated questionnaire, and 14 appropriately defined inclusion and exclusion criteria. Only one long-term double-blind placebo-controlled study was identified. This reported a significant improvement in symptoms and greater prevalence of symptom-free patients at 1 year with fiber plus rifaximin in comparison with fiber alone. The efficacy of treatment in preventing acute diverticulitis was evaluated in 11 randomized trials. Four trials compared rifaximin plus fiber vs fiber alone and failed to show a significant difference between treatments. However, cumulative data from these trials revealed a significant benefit following rifaximin and fiber (1-year rate of acute diverticulitis: 11/970 (1.1%) vs 20/690 (2.9%); P = .012), but with a number needed to treat of 57, to prevent an attack of acute diverticulitis. : Heterogeneity of the study design, patients' characteristics, regimens and combination of studied treatment, and outcome reporting precluded the pooling of results and limited interpretation. The treatment for diverticular disease relies mainly on data from uncontrolled studies. Treatment showed some evidence of improvement in symptoms, but its role in the prevention of acute diverticulitis remains to be defined.

Treatment of heart failure with preserved systolic function: a review of the evidence

The importance of heart failure with preserved systolic function (HF-PSF) has been increasingly recognised during the last decade. However, until recently there were no large, randomised, controlled clinical outcome trials in patients with this condition. Indeed, the best evidence of symptom improvement came from two very small studies with the rate-limiting calcium-channel blocker verapamil, in a total of fewer than 50 patients. The largest outcome trial was an ancillary study (with about 900 patients) of the Digitalis Investigators Group (DIG) trial, in which digoxin was reported to have a proportionately similar effect on morbidity to that seen in patients with reduced systolic function. Recently, the CHARM-Preserved study randomised over 3000 patients to placebo or candesartan. There was a trend to a reduction in cardiovascular death or hospitalisation for heart failure with candesartan (333 vs. 366 patients, unadjusted p = 0.118; co-variate adjusted p = 0.051), and clear reductions in the proportion of patients admitted (by 15% from 270 to 230 patients, p = 0.017) and the total number of hospital admissions for worsening heart failure (by 29% from 566 to 402 admissions, p = 0.014). Overall the results of the CHARM Programme showed that candesartan exerted a favourable effect across a broad spectrum of patients with heart failure, irrespective of left-ventricular function, co-morbidity, symptomatic class or concomitant treatment.

Is there a role for systemic corticosteroids in the management of stable chronic obstructive pulmonary disease?

COPD, encompassing both chronic bronchitis and emphysema, usually results from exposure to tobacco smoke. Smoking causes infiltration of the airways with leukocytes, an imbalance between proteases and their naturally occurring inhibitors and local cytokine secretion in the lung, which leads to airway inflammation and alveolar destruction. Corticosteroids have a range of anti-inflammatory actions, particularly inhibition of cytokine secretion, which suggests that they may be effective in COPD. However, data from the highest quality studies available do not show any evidence of significant improvement in symptoms of patients with COPD treated with systemic corticosteroids.A meta-analysis found that about 10% of patients with stable COPD showed an improvement in lung function following treatment with short-term systemic corticosteroids compared with placebo. Exercise capacity in patients with COPD was evaluated in four studies, only one of which found a significant improvement with oral corticosteroids compared with placebo. Long-term systemic corticosteroid treatment in patients with stable COPD has not been found to alter the rate of decline in FEV(1). Although systemic corticosteroids are associated with a range of adverse effects, the data do not allow precise quantification of their contribution to morbidity. However, studies show an increased risk of osteoporosis in COPD. Recent studies have also found an association between oral corticosteroid administration and mortality in patients with stable COPD, but it is not clear if this is a cause and effect relationship. Current data do not support long-term administration of systemic corticosteroids to all patients with stable COPD. Results of studies suggest that short-term oral corticosteroid administration may identify a sub-population of patients with COPD who may benefit through a reduction in the decline in FEV(1) and better control of symptoms by long-term administration of inhaled corticosteroids; these findings need to be tested by further research.