Significant Improvement In Symptom Scores Research Articles

Real-World Study of Ragweed Sublingual Immunotherapy in Hungary.

Ragweed (Ambrosia elatior) has become invasive in Europe, causing significant respiratory issues. Subcutaneous allergen immunotherapy (SCIT) has long been used to manage pollen allergies, but sublingual immunotherapy (SLIT) has gained interest. This study aimed to evaluate the clinical benefits of ragweed SLIT under real-world in a cohort of Hungarian patients allergic to ragweed pollen. We retrospectively reviewed the clinical records of 57 patients during the 2015 and 2016 ragweed pollen seasons. Patients were divided into two groups: Group 1 (n = 29), who had not received immunotherapy, and Group 2 (n = 28), who had previously undergone immunotherapy with another sublingual preparation. All patients were treated with Oraltek® ragweed for 4-6 months, initiating 2-4 months before the pollen season and rest of the period was 2 months of the 2016 pollen season. Symptom score (SS), medication score (MS), and combined symptom and medication score (CSMS) were evaluated intra- and intergroup. Pollen counts were consistent between 2015 and 2016. All patients showed significant improvement in SS, MS, and CSMS, with a large effect size (>0.8). Group 2 had significantly lower SS and CSMS in 2015 because of prior immunotherapy. By 2016, both groups exhibited marked improvements, with Group 1 showing a 75% improvement in CSMS. No local or systemic reactions were recorded, indicating a high safety profile. Ragweed SLIT significantly improved symptoms and reduced use of medication in patients allergic to ragweed pollen. The treatment was effective even in patients with previous immunotherapy, with a high benefit-risk ratio demonstrated by the absence of adverse reactions. These findings support the use of Oraltek SLIT for managing ragweed pollen allergy.

DOMPERIDONE VS METOCLOPRAMIDE: COMPARATIVE EVALUATION OF EFFICACY IN TREATING DIABETIC GASTROPARESIS

Diabetic gastroparesis, a common complication of diabetes mellitus, presents a challenging clinical scenario characterised by delayed gastric emptying and symptoms such as nausea, vomiting, abdominal pain, and bloating. Objectives: The primary aim of the study is to compare domperidone vs metoclopramide to evaluate their efficacy in treating diabetic gastroparesis. Methods: This comparative study was conducted in DHQ Hospital Nowshera Khyber Pakhtunkhwa—from June 2022 to June 2023. Data was collected from 190 patients from both genders. Patients meeting the inclusion criteria are randomised into Group A (Domperidone) and Group B (Metoclopramide). The severity of gastroparesis symptoms is assessed using validated symptom-scoring tools before treatment initiation and at regular intervals throughout the study. Results: Data was collected from 190 patients suffering from DM. The mean age of the patients in group A was 52.4 ± 8.2 years and in group B, 53.1 ± 7.5 years. There were 105 female and 185 male patients. The mean duration of DM is 12.3 ± 4.1 years and 11.8 ± 3.8 years in groups A and B, respectively. Group A (Domperidone) and Group B (Metoclopramide) demonstrated significant improvement in symptom scores from baseline to the final assessment. Group A exhibited a substantial reduction in symptom score from 18.2 ± 4.5 at baseline to 8.7 ± 3.2 at the end of the study (p < 0.001), while Group B showed a decrease from 17.9 ± 4.3 to 9.5 ± 3.8 (p < 0.001). Moreover, both groups experienced notable reductions in gastric emptying time. Conclusion: It is concluded that both domperidone and metoclopramide are effective in managing diabetic gastroparesis, with nuances in their safety profiles.

Efficacy and safety of ebastine 10 mg and phenylephrine 10 mg fixed-dose combination in Indian patients with allergic rhinitis: A phase 4 multicentre study

There is a lack of comprehensive studies examining the efficacy and safety of the fixed-dose combination (FDC) of ebastine 10 mg and phenylephrine 10 mg in allergic rhinitis (AR), especially in Indian settings. So, this study aimed to fill the existing research gap by evaluating the efficacy and safety of the FDC ebastine 10 mg and phenylephrine 10 mg in Indian patients with moderate/severe persistent AR.An open-label, non-randomized, single-group, multicentric, phase 4 clinical study included adult patients visiting the outpatient departments of 4 sites across India. All the selected subjects received the FDC once daily in the evening for 5 days. Safety and efficacy of the FDC were evaluated by comparing the Individual Symptoms Score (ISS), Total symptom Score (TSS), and analysing adverse event profiles reported by patients, assessed by the investigator, from baseline to 6 days. The study also assessed the impact of this condition on patients' quality of life using the rhino-conjunctivitis quality of life scale (RQLS). The study included 145 participants with a mean age of 37.17 ± 12.65 years and male-to-female ratio of 1:1.26. Comparison of baseline symptoms with day 6 revealed statistically significant and clinically meaningful improvements in Individual Symptoms Score (ISS). The mean difference in Total Symptom Score (TSS) from baseline to day 6 also showed a substantial improvement of 3.52 ± 1.54 (95% CI: 3.27-3.78; P <0.001). Rhino-conjunctivitis quality of life scale (RQLS) also demonstrated statistically significant improvement from day 1 to day 6 (t = 24.44, P <0.001). Adverse events were effectively managed with the use of readily available over-the-counter medications like antipyretics, analgesics, and/or antacid.The study validated the efficacy and safety of the FDC ebastine 10 mg and phenylephrine 10 mg, in managing AR with good safety profile. The findings underscore the importance of this combination as a viable therapeutic option, with significant improvements in symptom scores and quality of life observed within a short duration.

A three-arm randomised controlled trial of a telehealth intervention targeting improvement in addictive eating for Australian adults (the TRACE program)

There is a substantial research base for addictive eating with development of interventions. The current 3-arm RCT aimed to investigate the efficacy of the TRACE (Targeted Research for Addictive and Compulsive Eating) program to decrease addictive eating symptoms and improve mental health. Participants (18-85 yrs) endorsing ≥3 addictive eating symptoms were randomly allocated to 1) active intervention, 2) passive intervention, or 3) control group. Primary outcome was change in addictive eating symptoms 3-months post-baseline measured by the Yale Food Addiction Scale. Depression, anxiety and stress were also assessed. A total of 175 individuals were randomised. Using Linear Mixed Models, from baseline to 3-months, there was significant improvement in symptom scores in all groups with mean decrease of 4.7 (95% CI: −5.8, −3.6; p < 0.001), 3.8 (95% CI: −5.2, −2.4; p < 0.001) and 1.5 (95% CI: −2.6, −0.4; p = 0.01) respectively. Compared with the control group, participants in the active intervention were five times more likely to achieve a clinically significant change in symptom scores. There was a significant reduction in depression scores in the active and passive intervention groups, but not control group [-2.9 (95% CI: −4.5, −1.3); −2.3 (95% CI: −4.3, −0.3); 0.5 (95% CI: −1.1, 2.1), respectively]; a significant reduction in stress scores within the active group, but not passive intervention or control groups [-1.3 (95% CI: −2.2, −0.5); −1.0 (95% CI: −2.1, 0.1); 0.4 (95% CI: −0.5, 1.2), respectively]; and the reduction in anxiety scores over time was similar for all groups. A dietitian-led telehealth intervention for addictive eating in adults was more effective than a passive or control condition in reducing addictive eating scores from baseline to 6 months. Trial registration: Australia New Zealand Clinical Trial Registry ACTRN12621001079831.

Randomized controlled trial comparing the effectiveness of tamsulosin, tamsulosin with tolterodine and double J stent position in controlling stent related symptoms after ureteroscopic lithotripsy

Background: Objective of the study was to determine the effect of stent position and medications in preventing stent-related symptoms. Methods: This was a prospective study conducted at Meenakshi Mission Hospital and Research Centre Madurai, Tamil Nadu, India. 150 patients who underwent ureteroscopic lithotripsy with indwelling stent were distributed into three groups. On demand analgesics were given to group 1 (n=50), Tamsulosin 0.4 mg daily for group 2 (n=50) and tamsulosin 0.4 mg and tolterodine 4 mg daily for group 3 (n=50). The patients were also subclassified into appropriate or inappropriate group according to stent position. All patients completed various domains of Ureteral stent symptom questionnaire (USSQ) on 1st and 7th postoperative days. Appropriate tests statistics were performed using EPI-Info statistical software package. Results: In control group, patients with appropriate stent position had significantly lower symptom scores than those with inappropriate stent position (p value~0.0001) in all domains of USSQ except global quality of life score (p value=0.08). Addition of tamsulosin 0.4 mg (group 2) had superadded beneficial effect in appropriate position group, but not in patients with inappropriately positioned stents. Patients taking both tamsulosin 0.4 mg and tolterodine 4 mg (group 3) had no significant improvement in symptom scores in appropriate position group (all domains of USSQ) and inappropriate position group (most domains). Conclusions: Appropriate stent position is the most important independent factor than medications in preventing stent related symptoms; tamsulosin has superadded benefit in patients with correctly positioned stents.

A pragmatic feasibility trial of the Primary Care Intervention for PTSD: A health service delivery model to reduce health disparities for low-income and BIPOC youth

ObjectiveThis study is a non-randomized pragmatic trial to assess the feasibility and acceptability of the Primary Care Intervention for Posttraumatic stress disorder (PCIP) (Srivastava et al., 2021), an Integrated Behavioral Health Care treatment for PTSD in adolescents. MethodFollowing routine clinic procedures, youth who were suspected of having trauma-related mental health symptoms were referred by their primary care providers to integrated care social workers for evaluation. The integrated care social workers referred the first 23 youth whom they suspected of having PTSD to the research study. Twenty youth consented to the study and 19 completed the pre-assessment (17 female; mean age = 19.32, SD = 2.11; range 14–22 years). More than 40% identified as Black and a third as Hispanic/Latinx. PCIP mechanisms and clinical outcomes were assessed pre- and post-treatment, and at one-month follow-up. Participants and therapists completed post-treatment qualitative interviews to assess feasibility and acceptability, and treatment sessions were audio recorded to assess fidelity. ResultsFindings suggest high acceptability, satisfaction, and feasibility of the PCIP delivered in “real-life” safety net pediatric primary care. Integrated care social workers had high treatment fidelity. Despite the small sample size, there was significant improvement in symptom scores of anxiety (g = 0.68, p = 0.02) and substance use (g = 0.36, p = 0.04) from pre to post, and depression symptoms (g = 0.38, p = 0.04) from pre to follow-up. Qualitative data from patients who completed exit interviews and integrated social workers indicated high satisfaction with the treatment, with some participants reporting that the integrated intervention was more acceptable and less stigmatizing than seeking mental health care outside of primary care. ConclusionsThe PCIP may improve treatment engagement and access for vulnerable youth. Promising findings of high acceptability, feasibility, and initial clinical effectiveness suggest that PCIP warrants larger-scale study as part of routine care in pediatric integrated care.

The effect of hyperbaric oxygen therapy on bladder symptoms of female patients with overactive bladder

Overactive bladder (OAB) is a disease with symptoms such as feelings of urgency, nocturia, and frequent urination which is usually accompanied by urinary incontinence. We aimed to assess the effect of hyperbaric oxygen (HBO2) therapy on the symptoms of female patients with overactive bladder (OAB). This study is a prospective observational cohort study. The patients were analyzed into two groups. The patients who received HBO2 therapy were in Group 1, and the patients who received mirabegron treatment were in Group 2. The symptom scores and quality of life scores of the patients before and after treatment were recorded and compared. Significant improvement in symptom scores were seen in both groups after treatment compared to baseline. The study included 31 patients in Group 1 and 44 patients in Group 2. The mean changes in the ICIQ-SF, OAB-V8, and IIQ-7 scores in the third month of treatment in Group 1 were 4.12 ± 3.51, −10.70 ± 6.92, and −4.51 ± 2.68, respectively. The corresponding mean score changes in Group 2 were −4.31 ± 3.16, −11.22 ± 5.93, and −3.68 ± 2.67, respectively. The mean changes in all three scores were not significantly different between Groups 1 and 2 (p = 0.81, 0.73, and 0.19, respectively). We observed that HBO2 treatment improved quality of life by reducing the symptom score in patients with OAB. Moreover, this effect continued in the third month after the treatment. Considering the efficacy and side effect profiles of the available treatments, HBO2 therapy may be a new treatment alternative in OAB.

Efficacy of Endoscopic Radiofrequency Ablation for Treatment of Reflux Hypersensitivity: A Study Based on Rome IV Criteria.

Objective Effective therapies for reflux hypersensitivity are lacking. Endoscopic radiofrequency ablation may reduce the sensitivity of the distal esophagus through direct interference with nociceptors or vagal afferent fibers and thus may be useful in reflux hypersensitivity. The aim of this study is to assess the effectiveness and possible mechanisms of endoscopic radiofrequency ablation in reflux hypersensitivity patients. Methods Patients with reflux hypersensitivity who fulfilled the Rome IV criteria and who wished to receive further treatment were recruited. Endoscopic radiofrequency ablation was delivered to the gastroesophageal junction. Data were collected by questionnaire using a 6-point Likert scale. The primary outcome measure was effect on symptoms including heartburn, regurgitation, and chest pain. The secondary outcomes were degree of satisfaction, medication use, acid exposure time (AET), low esophageal sphincter (LES) pressure, and total reflux episodes. We also assessed positive cell density of transient receptor potential vanilloid type 1 receptor (TRPV1) and calcitonin gene-related peptide (CGRP), both of which are biomarkers of afferent fibers, in biopsies obtained from esophageal mucosa 0.5 cm-1 cm above the Z line. These scales will be administered at baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up. Results A total of 22 reflux hypersensitivity patients were enrolled (14 males, median age 50.0 years). A significant improvement in symptom scores (heartburn, regurgitation, and chest pain) was noted at 3 months, 6 months, and 12 months (P < 0.001). Satisfaction with life increased to 72.7% (16/22), 72.7% (16/22), and 68.2% (15/22) at 3, 6, and 12 mo, respectively, compared with baseline (P < 0.001). Nineteen patients reduced their medication use after treatment. Of these, 22.7% (5/22), 31.8% (7/22), and 40.9% (9/22) subjects stopped medication use at 3 mo, 6 mo, and 12 mo, respectively. No statistical differences were noted in AET, LES pressure, or total reflux episodes from preoperation to 12 mo postoperation. After treatment, the positive cell density of both TRPV1 and CGRP decreased significantly; however, only TRPV1 had a positive correlation with heartburn (r = 0.51, P = 0.03) and chest pain (r = 0.77, P < 0.01). Conclusion Endoscopic radiofrequency ablation was an effective and safe therapeutic option in reflux hypersensitivity patients. Further studies with large sample size are required to validate the role of radiofrequency in reflux hypersensitivity.

178 RANDOMIZED CONTROLLED TRIAL COMPARING ANGLE OF HIS ACCENTUATION WITH TOUPET FUNDOPLICATION IN PATIENTS UNDERGOING LAPAROSCOPIC HELLERS MYOTOMY: INTERIM RESULTS

Abstract Laparoscopic Heller’s Cardiomyotomy (LHCM) is the surgical treatment of choice for achalasia. Addition of an antireflux procedure is recommended to reduce the postoperative reflux. However, there is no consensus regarding the ideal antireflux procedure. In an earlier study we have shown that Angle of His accentuation (AOH) is similar to Dor fundoplication. In this study we present the interim results of an RCT comparing AOH with Toupet fundoplication as an adjunct to LHCM. Methods Patients of Achalasia cardia presenting after October 2017 were randomised to receive either AOH or Toupet following Heller cardiomyotomy based on computer generated random sequence. Primary outcome was incidence of post-operative symptomatic reflux and esophagitis on endoscopy. Secondary outcome was relief of dysphagia and Achalasia specific health related Quality of life assessment (ASHRQoL). Symptom scores for dysphagia, regurgitation and heartburn as well as ASHRQoL were noted pre operatively and at 3 monthly intervals. Objective evaluation was done using timed barium swallow, Upper GI endoscopy and oesophageal manometry. Data was recorded on excel spreadsheet and analysis done using SPSS v5. Results A total of 52 patients (25 Toupet, 27 AOH) were included in the analysis. All patients were successfully operated laparoscopically with no conversions, intraoperative perforations or perioperative mortality. The mean operative duration was 128 min in the AOH group and 146 min in the Toupet group (p &amp;lt; 0.05). There was significant improvement in symptom scores as well as objective parameters in both groups with no difference between the 2 groups at a mean follow-up of 6 months (5-9 months; Table 1). 3 patients in AOH group (11%) and 4(16%) patients had new onset reflux with esophagitis in 2 patients in each group. Conclusion AOH is technically easier and can be performed in a shorter time. The symptom relief is similar in both groups with similar incidence of heartburn and esophagitis in the short term. A longer follow up is recommended in a larger number of patients.

Psychedelic-Assisted Psychotherapy for Post-Traumatic Stress Disorder, Anxiety Disorders, Mood Disorders, or Substance Use Disorders

&#x0D; Two systematic reviews, 3 randomized controlled trials, and 2 single-arm safety trials were identified that evaluated several combinations of psychedelic-assisted psychotherapy. Psilocybin was the psychedelic most tested. Other psychedelics identified in the systematic reviews and primary studies were 3,4-methylenedioxymethamphetamine (or MDMA), lysergic acid diethylamide (or LSD), ayahuasca (also named N,N-dimethyltryptamine [or DMT]), ibogaine, ketamine, and nitrous oxide.&#x0D; Manualized therapy (not defined) and non-directive support (not defined) were the psychotherapies most studied in the relevant primary studies in the 2 systematic reviews. Other psychotherapies identified included integrative psychotherapy, cognitive behavioural therapy (CBT), CBT and motivational enhancement therapy, psychosocial interventions, non-directive support, group talk therapy, and guided support.&#x0D; Clinical effectiveness lasting weeks to months was observed in 1 systematic review that reviewed primary studies examining various combinations of psychedelics and psychotherapy in patients with various mental health conditions. Significant improvement in symptom scores related to mental illnesses and no serious and long-term adverse events were reported in the other systematic review.&#x0D; Various combinations of psychedelics and psychotherapies were evaluated in 3 randomized controlled trials (RCTs) and 2 safety studies. Ketamine-assisted psychotherapies were associated with improvements in the symptoms related to substance use disorder in 2 RCTs. Psilocybin-assisted psychotherapy was reported to be efficacious in treating MDD in 1 RCT. No serious adverse effects were reported in the RCTs or in 2 safety trials using MDMA-assisted psychotherapy.&#x0D; There were several limitations to the included studies, including small sample sizes (less than 20 in the majority of primary studies), relatively short follow-ups (1 week to 3 years; less than or equal to 1 year in 27 out of 31 relevant publications), differences in psychotherapy classification between systematic reviews, considerable heterogeneity between studies, and unclear generalizability and availability of the interventions in Canadian contexts. Therefore, findings should be interpreted with caution. No relevant guidelines were identified.&#x0D;

Impact of metformin therapy on health-related quality of life outcomes in tuberculosis patients with diabetes mellitus in India: A prospective study.

To assess the impact of metformin use on health-related quality of life (HRQoL) in tuberculosis (TB) patients who are presented with type 2 diabetes mellitus (T2DM). In this community-based prospective study, TB patients attending Hakeem Abdul Hameed Centenary Hospital, New Delhi (India) and had comorbidity of T2DM between April 2018 and July 2019 were enrolled. Patients were divided into metformin users and metformin non-users on the basis of the presence of metformin in their routine as antidiabetic drug(s). HRQoL was determined using a validated TB-specific tool (Dhingra and Rajpal-12 scale ie, DR-12) consists of symptom and socio-psychological and exercise adaptation domains. The HRQoL scores were compared at pretreatment (1st visit), end of intensive phase (2nd visit) and end of treatment (3rd visit) between the two groups. A total of 120 patients were enrolled, of which 24 were excluded as they did not respond at follow-up visits. Among the metformin users (n=48) the mean age of patients was 47.56years and 62.50% was males. Among the metformin non-users (n=48), the mean age of patients was 49.02years and 54.10% was males. The baseline characteristics were similar in both groups except for the substance used history (P=.025), literacy level (P=.048) and BMI (P=.028). Metformin users demonstrated significant improvement in symptom scores (2nd visit: P<.001; 3rd visit: P=.001) and socio-psychological and exercise adaptation scores (2nd visit: P<.0001; 3rd visit: P<.0001) as compared with metformin non-users at 2nd visit and 3rd visit. Overall, scores were also found to be significantly improved in metformin users (2nd visit: P<.001; 3rd visit: P=.001). Metformin therapy exerted favourable effects on HRQoL in patients with TB and T2DM and can be recommended as an adjuvant antitubercular drug in TB patients with co-morbidity of T2DM, unless contraindicated.

Anorectal biofeedback: an effective therapy, but can we shorten the course to improve access to treatment?

Background:Instrumented anorectal biofeedback (BF) improves symptoms and quality of life in patients with faecal incontinence and defecation disorder-associated chronic constipation. However, demand for BF greatly outweighs availability, so refinement of the BF protocol, in terms of the time and resources required, is of importance. Our aim was to evaluate the outcomes of an abbreviated BF protocol in patients with defecation disorder-associated chronic constipation and/or faecal incontinence compared to standard BF.Methods:Data were collected from consecutive patients (n = 31; age 54 ± 15; 29 females; 61% functional constipation) undergoing an intentionally abbreviated BF protocol, and compared in a 1:2 ratio with 62 age, gender and functional anorectal disorder-matched control patients undergoing a standard BF. Outcomes included change in symptoms, physiology, patient satisfaction and quality of life.Results:On intention to treat, patients in both protocols showed significant improvement in symptom scores and the magnitude did not differ between groups. Impact on quality of life, satisfaction and control over bowel movements improved in both protocols, but satisfaction improved to a greater extent in the standard BF protocol (p = 0.009). Physiological parameters were unchanged after BF apart from improvement in rectal sensation in the standard BF group compared to abbreviated BF (p ⩽ 0.002).Conclusions:Abbreviated anorectal BF offered to patients travelling from far away was not different to a standard BF in providing substantial, at least short term, improvements in symptoms of constipation and faecal incontinence, quality of life and feeling of control over bowel movements. Refinement of the standard BF protocol according to individual patient phenotypes and desired outcomes warrants further study in order to maximize efficacy and improve access for patients.

Gastrointestinal Electrical Stimulation Benefits Patients With Gastroparesis Symptoms and Co Existent Inflammatory Bowel Disease

Introduction: Inflammatory Bowel Disease (IBD) involves chronic inflammation of the gastrointestinal (GI) tract characterized by TNF-a release. Gastrointestinal Electrical Stimulator (GES), used to treat upper GI motility symptoms (UGI sx), has been shown to exert an anti-inflammatory effect via TNF-a suppression. We hypothesize that patients with Crohn's Disease (CD) and UGI sx may respond to GES via its immune modulating effect. Methods: We examined 284 patients with gastroparesis (Gp) sx who underwent GES placement. Patients with Gp sx were evaluated by a standardized upper and lower GI PRO (Dig Dis Sci 2016;61(1):176-180). Scores were obtained at baseline (B), after temporary GES placement (T), and post-permanent GES placement (P) > one year (range 12-15 months). The 11 Crohn's disease (CD) patients were analyzed for improvement in their CD activity using the Harvey Bradshaw Index (HBI). For data analysis, a 3 point decrease in the HBI was stated to be a clinical response to GES and an HBI of Analysis of data was done using an unadjusted repeated measures analysis. Results are reported as mean ± SD, and by percent improvement in symptoms. A statistically significant outcome was defined as p≤0.05.2827_A Figure 1. PRO for Gp with Crohn's2827_B Figure 2. PRO for Gp without IBD2827_C Figure 3. Harvey Bradshaw Index seen in CD patients at baseline and after permanent GES placementResults: Our cohort prevalence of CD was found to be 4%, with the following demographics: 2 M & 9 F, mean age 49.8 yrs. Within the CD +Gp subgroup (Table1), statistically significant improvements in symptom scores occurred after both temporary and permanent GES placement for all UGI sx. Overall, effects were notable for long term improvement in all UGI sx with no change seen in lower GI sx, after GES placement. The PRO for UGI sx decreased by 50-75% after temporary GES and 15-50% after permanent GES placement. Within the CD subgroup, when comparing HBI at baseline to HBI after permanent pacemaker placement, 64% patients showed a clinical response by a 3 point reduction in their HBI, and one patient achieved clinical remission with an HBI of <5, as is shown in Table 3. Conclusion: A 4% incidence of CD was seen in our Gp cohort. Gp patients with CD responded well to GES for UGI sx. We also found a strong effect on HBI, suggesting that the neuromodulatory effect of GES seen in Gp can also improve CD sx. The interaction of gastroparesis and CD should be further evaluated as a potential reason for UGI sx in CD patients, while the beneficial effects that electrical stimulation imparted upon CD sx also warrant additional investigation.

Implementing a structured exercise program for persistent concussion symptoms: a pilot study on the effects on salivary brain-derived neurotrophic factor, cognition, static balance, and symptom scores

ABSTRACTPrimary objective: Persistent concussion symptoms (PCS) affect 10–30% of individuals after sports-related concussion. This study evaluated the effect of exercise-based rehabilitation on symptom scores, brain-derived neurotrophic factor (BDNF), cognitive functions and static balance in a sample of participants with PCS.Research design: One group pre-test post-test pilot study.Methods and procedure: Nine participants with PCS received a structured exercise-based rehabilitation program. Changes in symptom scores, BDNF, cognitive functions and measures of static balance were used to evaluate the utility of the exercise program.Main outcome and results: The results of this pilot study indicate a significant improvement in symptom scores following treatment, as well as some associated benefits in regards to cognitive function and static balance. BDNF levels in the participants with PCS within this study are notably lower than in a previous study on healthy controls.Conclusions: The preliminary evidence reported in the current pilot study is clinically relevant as our findings suggest exercise-based treatments may improve PCS outcomes in a more favourable manner than rest-based treatment.

Therapeutic efficacy of low-dose (25 mg) mirabegron therapy for patients with mild to moderate overactive bladder symptoms due to central nervous system diseases.

The incidence of overactive bladder (OAB) increases with age, especially in patients with central nervous system (CNS) disorders such as cerebrovascular accident (CVA) and Parkinson's disease (PD). Mirabegron is a novel medication for the treatment of OAB. The present study investigated the therapeutic effect of mirabegron on OAB patients with CNS diseases. Patients with CVA, PD, dementia, and OAB symptoms were consecutively enrolled in the study group, and mirabegron 25 mg q.d. was prescribed. Clinical effects, evaluated using the Overactive Bladder Symptom Score (OABSS), Urinary Sensation Scale (USS), International Prostate Symptom Score (IPSS), and Patient Perception of Bladder Condition (PPBC), as well as urodynamic parameters and adverse events were assessed at baseline and 4 and 12 weeks after treatment. In all, 44 patients (mean [± SD] age 77.7 ± 9.49 years) with OAB due to CVA (n = 27), PD (n = 6), and dementia (n = 11) were included in the present prospective study. Mirabegron resulted in significant improvements in symptom scores on the OABSS (P = .02), USS (P = .009), total IPSS (P = .002), Storage and Voiding domains of the IPSS (P = .001 and .017, respectively), and PPBC (P = .001). No significant changes were noted in post-void residual, maximum flow rate, and voided volume after treatment. Only 5 patients dropped out due to poor therapeutic efficacy and shifted to antimuscarinics. Three patients complained of adverse effects, including dizziness and dysuria. No patient complained of urine retention or constipation. Mirabegron 25 mg once daily effectively decreased urgency symptoms in elderly OAB patients with CNS lesions after the 12-week treatment period. The adverse events were mild and only noted in a few cases.

The effect of onabotulinumtoxinA according to site of injection in patients with overactive bladder: a systematic review and meta-analysis.

This study assessed the efficacy and safety of onabotulinumtoxinA according to injection site for treatment of overactive bladder. A systematic literature review located randomized controlled trials of onabotulinumtoxinA treatment for neurogenic detrusor overactive bladder and idiopathic overactive bladder in adults. We searched MEDLINE, EMBASE, and the Cochrane Controlled Trials Register using the Ovid platform. Meta-analysis was based on Cochrane Review Methods. Eight studies (419 participants) were included. Trigone-including injection demonstrated a significant improvement in symptom score (SMD=-0.53, 95% CI -1.04 to -0.02, P=0.04, I 2=78%), higher complete dryness rates (OR=2.19 patients, 95% CI 1.32-3.63, P=0.002, I 2=41%), and lower frequency of incontinence episodes (WMD=-0.85 per day, 95% CI -1.55 to -0.16, P=0.02, I 2=87%) in patients. Comparing trigone-including injection to trigone-sparing injection, lower detrusor pressure (WMD=-2.55cm H2O, 95% CI -4.16 to -0.95, P=0.002, I 2=0%) and higher volume at first desire to void (WMD=17.54ml, 95% CI 1.00-34.07, P=0.04, I 2=0%) were observed with trigone-including injection. Between intradetrusor and suburothelial injection sites, there were no differences in efficacy or safety regarding the incidence of vesicoureteral reflux, hematuria, general weakness, bladder discomfort, large post-void residual, and urinary tract infection. Trigone-including onabotulinumtoxinA injection has superior efficacy to trigone-sparing injection without increased complications. The depth of injection does not influence the efficacy or safety of onabotulinumtoxinA.

Efficacy of serotonin receptor agonists in the treatment of functional dyspepsia: a meta-analysis

IntroductionFunctional dyspepsia (FD) is typically treated with serotonin receptor (5-HT) agonists such as cisapride, mosapride, tegaserod and tandospirone citrate. However, there are conflicting efficacy data, possibly due to significant heterogeneity between studies. In this meta-analysis, we analyzed the efficacy and safety data from studies evaluating the efficacy of serotonin receptor agonists in patients with FD.Material and methodsRelevant studies were selected from the Medline, Cochrane, EMBASE, and Google Scholar databases. The meta-analysis included 10 RCTs which evaluated the efficacy of serotonin receptor agonists in patients with FD (final total of 892 patients in the serotonin receptor agonist group, and 640 participants in the placebo group). The primary outcomes were the response rates and abdominal symptoms score. The Cochrane Collaboration’s tool was used to assess risk. Sensitivity analysis was carried out using the leave-one-out approach.ResultsPatients treated with serotonin receptor agonists had a significantly higher response rate compared to placebo-treated patients (pooled OR = 2.99; 95% CI: 1.15–7.77; p = 0.025). Patients treated with serotonin receptor agonists had a significant improvement in symptom scores compared to the placebo group (pooled standardized mean difference = –0.43; 95% CI: –0.83 to –0.04; p = 0.031). Sensitivity analysis indicated that the pooled estimates for abdominal symptom score might be affected by the Yeoh et al. (1997) study.ConclusionsSerotonin receptor agonists had a significantly higher efficacy compared to placebo in the treatment of FD.

Long term outcomes from catheter ablation of very longstanding persistent atrial fibrillation

IntroductionSuccess rates for catheter ablation of longstanding persistent atrial fibrillation (AF) are significantly poorer than for recently persistent or paroxysmal forms. We report on single centre long term outcomes from ablation of very longstanding (> 2years) persistent AF. Material and methodsA retrospective analysis of outcomes for patients undergoing catheter ablation for symptomatic very longstanding persistent AF between 2008 and 2013 was performed. ResultsTwenty-nine patients were followed for a mean of 61±15months following the index ablation procedure. The mean duration of persistent AF prior was 64±51months (range 24–200), mean age 61±6years and mean CHA2DS2-VASc score 1.1±1.2. Antral pulmonary vein electrical isolation only was performed in 14 (48%) with the remainder having additional lines and/or CFAE ablation also. At last follow-up 24 (83%) were in sinus rhythm but only 9 (31%) remained free of detectable arrhythmia, 25 (86%) were taking antiarrhythmic therapy and 18 (62%) required intermittent DC cardioversions. The mean time to first AF recurrence was 14±14months (range 2–48). Redo ablation was required in 13 (45%) at a mean follow-up time of 15±12months. The mean EHRA score improved from 3.5±0.5 to 1.4±0.4 (p<0.0001). ConclusionsThe vast majority (83%) of very longstanding persistent AF patients maintained sinus rhythm at a mean follow-up time of 5years following catheter ablation, associated with a significant improvement in symptom scores. Adjunctive therapies including antiarrhythmics, DC cardioversions and redo ablation were required in most patients.

Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study.

BackgroundIngestion of AndoSanTM, based on the mushroom Agaricus blazei Murill, has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn’s disease (CD). In this randomized single-blinded placebo-controlled study we examined whether intake of AndoSanTM also resulted in clinical effects.Methods and Findings50 patients with symptomatic CD were randomized for oral daily consumption of AndoSanTM or placebo for a 21-day experimental period, in this per-protocol study. Patients reported validated scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSanTM group (n = 25) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.52 (4.64–6.40), 4.48 (3.69–5.27) and 4.08 (3.22–4.94) (p<0,001). We found significant improvements in symptom score for both genders in the AndoSanTM group, and no significant changes in the placebo (n = 25) group. There were however no significant differences between the groups (p = 0.106), although a marginal effect in symptom score for men (p = 0.054). There were comparable improvements in physical, mental and total fatigue for both groups. HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the AndoSanTM group and for vitality and social functioning in the placebo group. No crucial changes in general blood samples and fecal calprotectin were detected.ConclusionsThe results from this single-blinded randomized clinical trial shows significant improvement on symptoms, for both genders, in the AndoSanTM group, but no significant differences between the study groups. The results on fatigue, HRQoL, fecal calprotectin and blood samples were quite similar compared with placebo. The patients did not report any harms or unintended effects of AndoSanTM. CD patients with mild to moderate symptoms may have beneficiary effects of AndoSanTM as a safe supplement in addition to conventional medication.Trial RegistrationClinicalTrials.gov NCT01496053

Evaluation of symptoms & spirometry in children treated for asthma.

Background & objectives:Spirometry plays an important role in the assessment and long term monitoring of patients with asthma. Difficulty in performing spirometry in children has resulted in a paucity of Indian studies using spirometry regularly for research in the paediatric population. This study was undertaken to assess the clinical improvement and changes in spirometric measurements with treatment in children with newly diagnosed asthma and to compare the changes in the symptom score and spirometric measurements.Methods:This prospective study included 32 children between 6 to 12 yr of age (enrolled over a period of one year with follow up of six months) who were newly diagnosed as cases of asthma on the basis of symptoms and medical history. Baseline symptom score and spirometric measurements were determined at the first visit. The children were treated and followed up at six weeks, three and six months of initiating treatment. Symptom score and spirometric measurements were repeated at every visit.Results:Significant improvement in symptom score was evident at six weeks of therapy (P<0.05) while the lung function parameters FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) showed significant improvement at three months of therapy. Peak expiratory flow rate (PEFR) was found to improve at six months. There was a positive linear correlation between the changes in symptom score and FEV1, FVC and PEFR with treatment.Interpretation & conclusions:Symptomatic improvement became apparent before the improvement in spirometric parameters in children with asthma (after treatment initiation).