Improvement In Overall Symptoms Research Articles

A diet low in fermentable oligo-, di-, monosaccharides and polyols improves abdominal and overall symptoms in persons with all subtypes of irritable bowel syndrome.

A diet low in fermentable oligo-, di-, monosaccharides and polyols (LFD) improves symptoms in patients with irritable bowel syndrome (IBS). Previous studies have focused on patients with IBS and diarrhea (IBS-D). It is unclear whether LFD is effective for IBS with constipation (IBS-C) or IBS with mixed bowel habits (IBS-M). This open-label, real-world study evaluates the relative effectiveness of the LFD among IBS subtypes. This study analyzes data from a service that provides low-FODMAP meals to individuals with IBS. Participants met with a registered dietitian and completed the IBS symptom severity survey (IBS-SSS) before and after undergoing a 2-4-week period of FODMAP restriction. The primary endpoint was the proportion of participants with ≥50-point decrease in IBS-SSS between the three IBS subtypes. After FODMAP restriction, 90% of participants with IBS-D, 75% with IBS-C, and 84% with IBS-M met the primary endpoint (p = 0.045). Similar improvement was seen for a 100-point decrease, but the difference between IBS subtypes was not significant (p = 0.46). After FODMAP restriction, all groups had statistically significant improvement in total IBS-SSS as well as individual symptom categories. Improvement in IBS-SSS subcategories was similar among the groups except for the categories of bloating severity (IBS-M had greatest improvement) and bowel movement satisfaction (IBS-C had less improvement). Though the proportion of responders was highest for IBS-D and lowest for IBS-C, the LFD led to robust improvement in overall symptoms in all IBS subtypes. Key individual symptoms also showed significant improvements in all IBS subtypes.

Use of Artificial Intelligence in the Prediction of Chiari Malformation Type 1 Recurrence After Posterior Fossa Decompressive Surgery.

Purpose The purpose of this study was to train a deep learning-based method for the prediction of postoperative recurrence of symptoms in Chiari malformation type 1 (CM1) patients undergoing surgery. Studies suggest that certain radiological and clinical features do exist in patients with treatment failure, though these are inconsistent and poorly defined. Methodology This study was a retrospective cohort study of patients who underwent primary surgical intervention for CM1 from January 2010 to May 2020. Only patients who completed pre- and postoperative 12-item short form(SF-12) surveys were included and these were used to classify the recurrence or persistence of symptoms. Forty patients had an improvement in overall symptoms while 17 had recurrence or persistence. After magnetic resonance imaging (MRI) data augmentation, a ResNet50, pre-trained on the ImageNet dataset, was used for feature extraction, and then clustering-constrained attention multiple instance learning (CLAM), a weakly supervised multi-instance learning framework, was trained for prediction of recurrence. Five-fold cross-validation was used for the development of MRI only, clinical features only, and a combined machine learning model. Results This study included 57 patients who underwent CM1 decompression. The recurrence rate was 30%. The combined model incorporating MRI, pre-operative SF-12 physical component scale (PCS), and extent of cerebellar ectopia performed best with an area under the curve (AUC) of 0.71 and an F1 score of 0.74. Conclusion This is the first study to our knowledge to explore the prediction of postoperative recurrence of symptoms in CM1 patients using machine learning methods and represents the first steptowarddeveloping a clinically useful prognostication machine learning model. Further studies utilizing a similar deep learning approach with a larger sample size are needed to improve the performance.

Ultra-High-Risk that do not transition to psychosis. What happens?

IntroductionSpeaking prospectively we use the concept of “at risk mental state” (ARMS) to describe the state in which a person has a heightened risk of developing a psychotic disorder. Young people who are experiencing ARMS can be more precisely defined as being at ultra-high-risk of psychosis using a specific set of criteria known as the UHR criteria.ObjectivesTo clarify the concept of ultra-high-risk individuals and to characterize the clinical and functional characteristics and general psychopathology of those individuals that do not transition to psychosis during the follow-up period.MethodsResearch on UpToDate using the terms “Ultra-High-Risk”; “psychosis”, “transition”.ResultsRecent literature has suggested that less than 30% of those who meet established criteria for being at Clinical-High-Risk of psychosis (CHR-P) go on to develop a psychotic illness. It is therefore of crucial importance and relevance to assess and clarify what happens to high-risk individuals who do not transition to psychosis, who make up the vast majority.One of the most recent studies (NAPLS-2) that encompassed 764 of CHR-P individuals who were followed for 2 years, concluded that 278 did not transition to psychosis during the follow-up period. Three clinical outcomes were recorded: 1 group had experienced a psychopathological remission (39.57%); the other kept symptomatic but not currently meeting criteria for a prodromal risk syndrome (33.45%); the third group had a prodromal progression (26.98%). The study concluded among others that although the remission group had improved social functioning at 2 years compared with the other groups, they were still functioning below the healthy control group.Another meta-analysis that included a total of 2756 CHR-P individuals with a mean duration of follow-up of 30.7 months evaluated several clinical outcomes in CHR-P that didn’t transitioned to psychosis and between CHR-P non-transitioning versus those transitioning to psychosis. It concluded that CHR-P that do not transition to psychosis have an overall improvement of symptoms (APS, negative, depressive) and functioning at follow-up compared to baseline.ConclusionsThe occurrence of a first psychotic episode is often devastating for the patient and their family, especially given its usual onset in adolescence and early adulthood. This is a critical period in the individual’s development as a person, and disorders at this stage can threaten the potential for a productive and inclusive adult life. Studies have suggested that less than 30% of individuals classified as UHR actually develop a psychotic disorder.However, little is known about the individuals belonging to this group who do not transition to psychosis. We therefore consider it is relevant to clarify the clinical and functional outcomes of this group of individuals.Disclosure of InterestNone Declared

Obese patients with CEAP (clinical, etiology, anatomy, pathophysiology) C2 and C3 disease show enhanced symptom improvement after endovenous thermal ablation

ObjectiveEndovenous thermal ablation (EVTA) is a prevalent treatment option for patients with severe venous disease. However, the decision to intervene for patients with less severe disease (CEAP [clinical, etiology, anatomy, pathophysiology] C2 and C3) is less clear and becomes further complicated for patients with obesity, a pathology known to increase venous disease symptom severity. Therefore, the objective of this study was to use the Society for Vascular Surgery Vascular Quality Initiative database to evaluate outcomes after EVTA in obese patients with CEAP C2 and C3 venous insufficiency. MethodsUsing the Society for Vascular Surgery Vascular Quality Initiative database, we retrospectively analyzed the initial procedure of all patients with a CEAP clinical class of C2 or C3 who underwent EVTA from January 2015 to December 2021. Patients were grouped by obesity, defined as a body mass index of ≥30 kg/m2. The primary outcome was the change in venous clinical severity score (VCSS) from the procedure to the patient's initial follow-up. The secondary outcomes included the change in patient-reported outcomes at follow-up via the HASTI (heaviness, achiness, swelling, throbbing, itching) score, incidence of follow-up complications, and recanalization of treated veins. The change in the VCSS and HASTI score were analyzed using Student t tests, and complications and recanalization were assessed using the Fisher exact test. Significant outcomes were confirmed by multiple variable logistic regression. The remaining significant variables were then analyzed, with obesity categorized using the World Health Organization classification system to analyze how increasing obesity levels affect outcomes. ResultsThere were 8146 limbs that met the inclusion criteria, of which 5183 (63.6%) were classified as nonobese and 2963 (36.4%) as obese. Obesity showed no impact on improvement in the VCSS (−3.29 vs −3.35; P = .408). Obesity was found to be associated with a larger improvement in overall symptoms, as evidence by a greater improvement in the HASTI score (−7.24 vs −6.62; P < .001). Obese limbs showed a higher incidence of superficial phlebitis (1.5% vs 0.7%; P = .001), but no difference was found in recanalization or any other complication. ConclusionsThese data suggest that obese patients with CEAP clinical class C2 or C3 experience greater improvement in their perceived symptoms after EVTA with little difference in clinical improvement and complications compared with nonobese patients. Although obesity has been associated with increased severity of venous disease symptoms, obese patients are able to derive significant relief after treatment during the short term and may experience greater relief of symptoms than nonobese patients when treated at more mild disease presentations.

A Comprehensive Ayurvedic Management of Amavata

Amavata is an Ama pradoshaja vikara, caused by Agnimandya, which leads to accumulation of Ama in Shleshmasthana and Prakopa of Vata dosha, resulting in pain, stiffness and swelling of joints, which closely resembles the chronic inflammatory autoimmune disorder called Rheumatoid arthritis. Prevalence of rheumatoid arthritis is approximately 0.8% worldwide and 0.5-0.75% in India. Materials and Methods: A 44 years female presented with pain in multiple joints associated with swelling and stiffness since 2 years was diagnosed as Amavata. The patient was treated with Kottamachukkadi lepa, Dashamoola kashaya and Dhanyamla Kayaseka, Vaitarana basti followed by Guduchyadi kashaya basti along with Rasayana and oral medications. Results: There was a significant improvement in overall symptoms. Conclusion: Contemporary medicine offers DMARDS and steroid medications for very long time as it is Auto immune condition. Whereas on other hand Panchakarma therapies can target on root cause of the Vyadhi and provide more promising results.

Gallstone Ileus; the Radiographic Findings in an Elderly Patient: A Case Report

Since the beginning of the COVID-19 pandemic in December 2019, Ivermectin has been proposed as an alternative for prophylaxis and treatment of COVID-19 infection despite the lack of evidence and clinical trials recommending its use. In this study, we report the case of a 52-year old Filipino male with newly diagnosed diabetes mellitus who developed a subacute history of fever, cough and generalized weakness, causing him to self-medicate with supratherapeutic doses of Ivermectin and thereafter subsequently developed decrease in sensorium, restlessness and complex visual hallucinations. Significant laboratory examinations showed hyperglycemia, mild hyponatremia, positive SARS-CoV2 reverse transcriptase polymerase chain reaction test and bilateral pneumonia on chest radiograph. He was subsequently started on antibiotics, high flow nasal cannula and given two doses of activated charcoal. During the first 24 hours of hospital admission, there was significant improvement in the patient’s sensorium with resolution of restlessness and visual hallucinations. During the rest of the hospitalization, his respiratory symptoms had improved and he was subsequently discharged. Clinical outcome in our patient after administration of activated charcoal and completion of antibiotics showed an overall improvement in symptoms and without any neurologic sequelae.

Identifying the Toxidrome of Ivermectin Toxicity

Since the beginning of the COVID-19 pandemic in December 2019, Ivermectin has been proposed as an alternative for prophylaxis and treatment of COVID-19 infection despite the lack of evidence and clinical trials recommending its use. In this study, we report the case of a 52-year old Filipino male with newly diagnosed diabetes mellitus who developed a subacute history of fever, cough and generalized weakness, causing him to self-medicate with supratherapeutic doses of Ivermectin and thereafter subsequently developed decrease in sensorium, restlessness and complex visual hallucinations. Significant laboratory examinations showed hyperglycemia, mild hyponatremia, positive SARS-CoV2 reverse transcriptase polymerase chain reaction test and bilateral pneumonia on chest radiograph. He was subsequently started on antibiotics, high flow nasal cannula and given two doses of activated charcoal. During the first 24 hours of hospital admission, there was significant improvement in the patient’s sensorium with resolution of restlessness and visual hallucinations. During the rest of the hospitalization, his respiratory symptoms had improved and he was subsequently discharged. Clinical outcome in our patient after administration of activated charcoal and completion of antibiotics showed an overall improvement in symptoms and without any neurologic sequelae.

Unmasking the truth Progressive multifocal leukoencephalopathy immune reconstitution inflammatory syndrome PML IRIS in a 36 year old male with HIV

Progressive Multifocal Leukoencephalopathy – Immune Reconstitution Inflammatory Syndrome (PMLIRIS) is the subacute onset of neurological deficits that appeared or was exacerbated after initiation antiretroviral therapy (ART) for treatment of PML. It is due to severe neuroinflammation with re-establishment of immuncompetence. Approximately 25% of patients with HIV and PML develop IRIS. Clinical trials on the treatment of PML-IRIS is lacking with only limited evidence supporting the use of investigative therapies such as corticosteroids and Maraviroc. We report a case of a 36-year old Filipino male, known hypertensive and diagnosed with HIV, who presented with memory problems. He was eventually treated as a case of PML-IRIS on the 3rd week after initiation of ART. He was treated with a course of intravenous Dexamethasone, oral Mefloquine and intravenous immunoglobulin, and ART was continued. Clinical outcome in our patient shows an overall improvement of symptoms and no deterioration of neurologic deficits.

Unmasking the Truth: Progressive Multifocal Leukoencephalopathy–Immune Reconstitution Inflammatory Syndrome (PML-IRIS) in a 36-year Old Male with HIV, A Case Report

Progressive Multifocal Leukoencephalopathy Immune Reconstitution Inflammatory Syndrome (PMLIRIS) is the subacute onset of neurological deficits that appeared or was exacerbated after initiation antiretroviral therapy (ART) for treatment of PML. It is due to severe neuroinflammation with reestablishment of immunocompetence. Approximately 25% of patients with HIV and PML develop IRIS. Clinical trials on the treatment of PML-IRIS is lacking with only limited evidence supporting the use of investigative therapies such as corticosteroids and Maraviroc. We report a case of a 36-year old Filipino male, known hypertensive and diagnosed with HIV, who presented with memory problems. He was eventually treated as a case of PML-IRIS on the 3rd week after initiation of ART. He was treated with a course of intravenous Dexamethasone, oral Mefloquine and intravenous immunoglobulin, and ART was continued. Clinical outcome in our patient shows an overall improvement of symptoms and no deterioration of neurologic deficits.

(021) Sexual Function in Patients with Major Depressive Disorder before and after Treatment with Selective Serotonin Reuptake Inhibitor (SSRI)

Abstract Introduction Major Depressive Disorder (MDD) is closely associated with sexual dysfunction, which may worsen during treatment with SSRIs due to side-effects of pharmacological treatment. This can potentially aggravate the depressed state or result in non-compliance with the treatment. Currently, little is known about the interplay between effects of SSRI treatment, patient characteristics and sexual function. Objective To examine the association between sexual function and the severity of MDD in drug-naïve patients compared to healthy controls and how treatment with SSRIs affects sexual function over time in individuals with MDD. Interaction with gender and treatment response was examined. Methods In 92 patients with MDD, we measured MDD severity with Hamilton Depression Rating Scale (HDRS) and level of sexual function with the Changes in Sexual Function Questionnaire (CSFQ) at baseline and 4, 8, and 12 weeks after initiating treatment with escitalopram. Baseline sexual function was compared to sexual function of 73 healthy controls. Results Patients had worse sexual function at baseline than healthy controls, which was not associated with severity of MDD. Patients’ sexual function improved significantly during treatment. Improvement in sexual function was coupled with amelioration of symptoms of depression, but treatment response groups did not predict change in sexual function. Gender had no effect on sexual dysfunction symptoms during treatment. Conclusions Sexual dysfunction was strongly associated with MDD and improved in parallel with improvement in overall symptoms of depression across a standard 12-week SSRI antidepressant treatment. Disclosure Yes, this is sponsored by industry/sponsor: The Lundbeck Foundation alliance BrainDrugs, Sahakian: Lundbeck Foundation Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: FREYA, Novo Nordic

S125 Oral and Esophageal Manifestations in a Patient With Severe Ulcerative Colitis

Case: Ulcerative colitis (UC) is a chronic inflammatory disorder of the colon with a growing prevalence. Traditionally, UC is thought to affect the rectum and colon exclusively, and spare the remainder of the gastrointestinal (GI) tract. The course of illness can range from mild colitis to full blown toxic megacolon requiring complete colonic resection. While various treatment options are available, total colectomy is viewed as potentially curative since it has been shown to result in complete cessation of symptoms. We report an unusual case of UC in a patient who presented with oral and esophageal ulcers that resolved completely following total colectomy. A 26-year-old male with no significant past medical history presented with a 1-week history of severe oral ulceration, odynophagia and fevers along with a 4-month history of intermittent bloody diarrhea. Infectious workup was negative. CT scan of the abdomen and pelvis showed evidence of pancolitis concerning for inflammatory bowel disease (IBD). An upper endoscopy (UE) showed multiple clear base, non-bleeding esophageal ulcers and a colonoscopy revealed severe ulceration spanning the entire colon. Patient’s hospital course was complicated by development of toxic megacolon requiring urgent total colectomy with end ileostomy. Following surgery patient reported significant improvement in overall symptoms. Biopsies from the colon revealed evidence of mucosal inflammation with crypt abscesses and absence of granulomas. Biopsies from the esophagus revealed acute esophagitis with no evidence of viral or fungal infection. Patient was discharged with 4 weeks of pantoprazole therapy and inhaled budesonide however no treatment for IBD was started. A follow up magnetic resonance enterography was obtained which showed no evidence of small bowel inflammation. Postoperatively patient continued to have improvement in symptoms with adequate weight gain. His budesonide and pantoprazole therapy was discontinued. An UE was repeated 5 months later which showed normal esophageal mucosa and no evidence of ulceration. Biopsies from the esophagus showed normal mucosa with no signs of inflammation. An ileoscopy was performed which was unremarkable and biopsies showed no evidence of small intestinal inflammation. Patient continues to do well off therapy with plans of undergoing a proctocolectomy with ileal pouch-anal anastomosis. There have been approximately 20 case reports that describe upper gastrointestinal (GI) involvement in patients with UC. These patients tend to be young and have evidence of severe UC. Clean base esophageal ulcers were observed in majority of these cases. Significant advances have been made in the treatment of UC however total proctocolectomy with ileo-anal anastomosis remains as a last resort therapy which can alleviate all symptoms including extraintestinal manifestations in up to 58% of UC patients. We therefore describe a rare case of UC that presented with primarily upper GI manifestations and emphasize the notion that UC may not be restricted to the colon only and that a total colectomy can serve as a treatment option for resolution of these symptoms.

Endoscopic Intrapyloric Botulinum Toxin Injection with Pyloric Balloon Dilation for Symptoms of Delayed Gastric Emptying after Distal Esophagectomy for Esophageal Cancer: A 10-Year Experience.

Patients with esophageal cancer undergoing esophagectomy have an improved survival over time, however adverse events associated with the use of a gastric conduit are increasingly being reported. Delayed gastric emptying (DGE) is an esophagectomy-related complication which can decreased quality of life by causing debilitating gastrointestinal symptoms and malnutrition. The aim of our study was to evaluate the effect of endoscopic intrapyloric botulinum (BT) injection in combination with pyloric balloon dilation in patients with DGE following distal esophagectomy at our tertiary cancer center. Patients with a prior history of distal esophagectomy who had also undergone endoscopic BT injection with pyloric balloon dilation by a single endoscopist between 2007 and 2017 were included in the study. One hundred units of BT were injected endoscopically into the pylorus in four quadrants using an injection needle. Following BT injection, a standard through-the-scope balloon was passed to the pylorus and inflated to a maximum diameter of 12−20 mm. For patients who underwent repeat procedures, the symptomatic outcomes were assessed and documented by the endoscopist; for the other patients, the electronic medical records were reviewed. A total of 21 patients undergoing 44 endoscopic intrapyloric botox injections combined with balloon dilatations were identified. The patients underwent the procedures at a median of 22 months (range, 1−108 months) after esophagectomy. The procedures were performed only once in 43% of the patients; 43% patients underwent the procedure twice, while 14% had it multiple times (>2). Overall, intrapyloric BT injection coupled with balloon dilation was a safe procedure, without any major immediate or delayed (1 month) procedure-related adverse events. Eighteen patients (85%) reported a significant overall improvement in symptoms from the initial presentation. One patient (5%) showed no improvement, whereas in two (10%) patients responses were not available. In our particular cohort of patients, the interventions of endoscopic intrapyloric BT injection with pyloric balloon dilation proved to be very beneficial, leading to significant symptomatic improvement. The balloon dilation after BT injection might have resulted in better diffusion of the BT into the pyloric sphincter complex, possibly increasing its therapeutic effects. Further prospective studies are needed to validate these results.

Sickle Cell Disease (SCD) Burden on Patients Treated With Hydroxyurea (HU): Results from the Real-World Assessment Survey for SCD in Saudi (ROARS)

The prevalence of SCD in the Kingdom of Saudi Arabia (KSA) is one of the highest in the world with up to 2.6% of the population affected. The Real-World Assessment Survey for Sickle Cell Disease in Saudi (ROARS) was conducted to evaluate the impact of SCD on the quality of life (QoL) of this population. Here, we present data on the QoL burden experienced by patients with SCD in KSA treated with hydroxyurea (HU). Between September and December 2021, patients in KSA with SCD (age: 5-65 years) were surveyed (caregivers were surveyed for patients 5-14 years) using structured, bilingual ROARS questionnaires (English/Arabic) through personal quantitative web-assisted telephone interviews. The survey includes the Patient-Reported Outcomes Measurement Information System (PROMIS) global health domain, a validated tool for assessing QoL among SCD patients and caregivers. The survey evaluated topics such as the impact of SCD on QoL, symptoms, impact of SCD on productivity at work/school, and treatment goals. A total of 1011 responses to the survey were collected; of these, 32.3% (n=327) of patients were currently being treated with HU (47% of adult and 17% of pediatric patients surveyed) and are the focus of this analysis. Amongst these patients, the median age (range) was 25 (5-83) years. Patients were responsible for reporting their SCD genotype: 58% of respondents were diagnosed with HbSS (n=189), 26% with HbSC (n=86), 2% with HbSβ0 thalassemia (n=8), and 5% with HbSβ+ thalassemia (n=15). Overall, 35% (adults, n=84; pediatric n=25) of patients in the eastern province were treated with HU, 27% (adult, n=71; pediatric, n=17) in the western province, 24% (adult, n=55; pediatric, n=24) in the southern province, and 14% (adult, n=29; pediatric, n=22) in the central province. Among HU-treated patients, 64% reported never ceasing/stopping treatment, 21% rarely ceased/stopped treatment and 15% of patients cease/stop treatment sometimes, often, or all the time. The most common reason for patients ceasing/stopping treatment was forgetting to take their medication (79%). Of patients who cease/stop treatment sometimes, often, or all the time (n=48), 17% of these stated that their medication was not available while 4% could not afford their medication. The mean (SD) number of VOCs reported by HU-treated patients in the 12 months prior to survey completion was 4.6 (4.09), while 32% (n=104) of these patients reported experiencing ≥5 VOCs in the same period. The most common SCD symptoms (other than VOCs) experienced by HU-treated patients were bone ache (reported by 92% of respondents), fatigue/tiredness (85%), headache (79%), anxiety (61%), joint stiffness (56%) and numbness/tingling (51%). Most HU-treated patients reported poor/fair or good health for all QoL metrics assessed (Figure 1). Almost half of patients (49%) reported that their SCD was impactful/extremely impactful on their emotional wellbeing. Of those treated with HU, 71% of patients reported that HU is effective in treating their SCD symptoms. However, 84% of patients report a desire for alternatives to their current pain management medication while 72% report concerns about the long-term side effects of HU. The most important treatment goals for these patients were improvement in quality of life (82%), improvement in overall symptoms (79%), and reduction in the number of severe pain crises and increase in the number of days free from severe pain crises (79%). A total of 48% of HU-treated patients were bothered by limitations in performing everyday activities; 48% and 55% of patients also reported that their SCD has prevented them from progressing in their career or education, respectively. Patients treated with HU reported missing a mean (SD) of 6.9 (10.4) hours of work in the 7 days prior to survey completion because of their SCD. Access to HU treatment continues to be a challenge, with approximately 70% of patients surveyed not receiving HU. Despite the observed clinical benefit in symptom control, patients receiving HU continue to experience disease burden including substantial impact on QoL and productivity at work/school (as evident from the treatment goals identified by patients). These data highlight the necessity of optimizing HU accessibility and treatment strategies to improve patient outcomes. These data also illustrate the need for novel therapeutic options and management strategies for patients with SCD to target patient-reported treatment goals. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Natural history of spontaneous intracranial hypotension: a clinical and imaging study

BackgroundAlthough spontaneous intracranial hypotension (SIH) is well studied, there are few studies of the clinical and imaging history of SIH without interventional treatments. For example, what is the natural history...

S514 Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Controlled, Double-Blind Pilot Study

Introduction: Functional dyspepsia (FD) is a common functional GI disorder, characterized by symptoms of abdominal pain, nausea, and/or early satiety. Virtual reality (VR) is a promising intervention which has been shown to alleviate pain in various clinical settings. There are currently no studies assessing VR for the treatment of FD. The aim of this study was to investigate the effectiveness and safety of VR for the treatment of FD. Methods: This is a prospective, single-center, randomized, controlled, double-blinded study of adult patients with FD (Rome IV criteria). Enrolled patients were randomized 2:1 (experimental to control). Experimental patients were given a VR headset with software consisting of immersive audiovisual programs. Control patients were given an identical headset with 2-D nature videos. Patients were asked to use their headset at least daily and completed Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) and Nepean Dyspepsia Index (NDI) questionnaires at their initial visit, after 1 week of use, and at the conclusion of the 2-week study. Paired sample t-tests were used to compare questionnaire scores. Results: Thirty-seven patients were enrolled in the study (27 experimental, 10 controls); demographic data are shown in Table (Table). Patients used the VR headset an average of 1.3 times/day for a mean of 23.2 minutes/day. Total PAGI-SYM scores significantly decreased for all patients [2.51 (baseline) to 0.62 (week 2); p=0.000]. Notably, patients in the experimental group had greater improvement in mean total PAGI-SYM scores [2.51 baseline) to 1.83 (week 2); mean difference -0.68; p=0.000], compared to the control group [2.50 (baseline) to 2.04 (week 2); mean difference -0.46; p=0.046]. Further, quality of life (QoL) significantly improved for all patients, as the total NDI QoL score increased from 40.97 (baseline) to 57.14 (week 2), p=0.000, though experimental patients saw greater improvement in QoL, compared to control patients (Figure). Seventeen patients (45.9%; 11 experimental, 6 controls) reported non-serious adverse effects (AE), with headache and dizziness being the most common; 1 experimental patient withdrew due to AEs (migraines). Conclusion: In the first randomized, controlled, double-blind study to assess VR for the treatment of FD, VR was shown to be safe and result in statistically significant overall improvement in symptoms and QoL in FD patients. We propose VR as a novel treatment for FD worthy of further investigation.Figure 1.: Total PAGI-SYM and NDI Quality of Life Scores Table 1. - Study Population Demographic Data Mean Age 45 years (± 14) Mean BMI 24.56 (± 6.79) SexFemaleMale 30 (81.1%)7 FD subtypeEPSPDSMixed EPS/PDS 12 (32.4%)20 (54.1%)5 (13.5%) Anxiety 17 (45.9%) Depression 9 (24.3%) PTSD 2 (5.4%) Fibromyalgia 4 (10.8%) Prior H. pylori infection 5 (13.5%) MedicationsPPIAntidepressantsGabapentinOpioidsNSAIDs 16 (43.2%)11 (29.7%)4 (10.8%)2 (5.4%)0 Alcohol Use 7 (18.9%) Marijuana Use 4 (10.8%)

Unexplained regression in Down syndrome: Management of 51 patients in an international patient database.

Research to guide clinicians in the management of the devastating regression which can affect adolescents and young adults with Down syndrome is limited. A multi-site, international, longitudinal cohort of individuals with a clinical diagnosis of Unexplained Regression in Down syndrome (URDS) was collated through seven Down syndrome clinics. Tiered medical evaluation, a 28-item core symptom list, and interim management are described naturalistically. Improvement-defined by the percentage of baseline function on a Parent-reported Functional Score, overall improvement in symptoms on a Clinician-administered Functional Assessment, or report of management type being associated with improvement-was analyzed. Improvement rates using ECT, IVIG, and others were compared. Across seven clinics, 51 patients with URDS had regression at age 17.6 years, on average, and showed an average 14.1 out of 28 symptoms. Longitudinal improvement in function was achieved in many patients and the medical management, types of treatment, and their impact on function are described. Management with intravenous immunoglobulin (IVIG) was significantly associated with higher rate of improvement in symptoms at the next visit (p=0.001). Our longitudinal data demonstrates that URDS is treatable, with various forms of clinical management and has a variable course. The data suggests that IVIG may be an effective treatment in some individuals. Our description of the management approaches used in this cohort lays the groundwork for future research, such as development of standardized objective outcome measure and creation of a clinical practice guideline for URDS.

Mitochondrial modulators for obsessive–compulsive and related disorders: a systematic review and meta-analysis

It remains unclear whether mitochondrial modulators (MMs) are beneficial in the treatment of obsessive–compulsive and related disorders. Thus, in an attempt to answer this clinical question, we performed a systematic review and a random-effects meta-analysis of double-blind, randomized, placebo-controlled trials. The primary outcome was change in overall symptoms as measured using standardized rating scales. Other outcomes were response to treatment; improvement in anxiety-related scales scores, depression-related scale scores, Clinical Global Impression Severity Scale (CGI-S) scores, and Sheehan Disability Scale (SDS) scores; all-cause discontinuation; and individual adverse events. We calculated the standardized mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals. We reviewed 17 studies (n = 629, 72.62% female; duration = 2–20 weeks; mean age = 30.47 years) of MMs: eicosapentaenoic acid (K = 1), folic acid (K = 1), lithium (K = 1), N-acetylcysteine (K = 10), inositol (K = 3), and silymarin (K = 1). MMs outperformed placebo in overall improvement in symptoms (p < 0.01) and in improving anxiety-related scale scores (p = 0.05). Subgroup analysis of individual MMs revealed that although overall symptoms were better improved by N-acetylcysteine (p < 0.01) and lithium (p = 0.04), no MMs outperformed placebo in terms of improving anxiety-related scale scores. Neither pooled nor individual MMs outperformed placebo in improving response to treatment, depression-related scale scores, CGI-S scores, SDS scores, or all-cause discontinuation. N-acetylcysteine was no more associated with a higher incidence of individual adverse events including gastrointestinal symptoms, than placebo. In conclusion, N-acetylcysteine was beneficial in the treatment of obsessive–compulsive and related disorders. However, further study with larger samples is necessary to confirm this finding.

A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of DA-9701 (Motilitone) in Patients With Constipation-type Irritable Bowel Syndrome and Functional Dyspepsia Overlap: A Pilot Study.

Background/AimsTo assess the effects and safety of DA-9701 (Motilitone) in patients with constipation-type irritable bowel syndrome (IBS-C) which frequently accompany functional dyspepsia (FD).MethodsFD and IBS-C were diagnosed based on the Rome III criteria. Randomized subjects were administered 30 mg of DA-9701 or placebo 3 times a day for 4 weeks. The study endpoints were evaluated the percentage of responders in the overall symptom evaluation of IBS-C and FD.ResultsThirty IBS-C patients and 30 placebos were prospectively enrolled. The proportion of responders with improvement in overall symptoms of IBS-C was 53.33% in the DA-9701 group and 40.00% in the placebo group (P = 0.301). Compared to the placebo group, the decrease of abdominal pain score in the DA-9701 group was significantly higher at week 3 in the DA-9701 group (0.96 ± 0.77 vs 0.55 ± 0.79, P = 0.042) but no significance at week 4. There was no significant difference in total IBS quality of life score at week 4 between the 2 groups (P = 0.897). Among patients with IBS-C accompanied by FD, the proportion of responders in the DA-9701 group was 50.00% (15/30), which was higher than 31.03% (9/29) of the placebo group (P = 0.138).ConclusionsDA-9701 showed trend of treatment efficacy in patients with IBS-C and FD overlap including overall improvement, and safety, compared to placebo but without significance probably due to small numbers. It is suggested the need for a large-scale clinical trial to confirm this preliminary effect of DA-9701.

Identification of factors associated with the efficacy of atomoxetine in adult attention-deficit/hyperactivity disorder.

AimAtomoxetine (ATX) is a non‐central stimulant and a standard treatment for adult attention‐deficit/hyperactivity disorder (ADHD). The long‐term efficacy of Atomoxetine is about 40% at 6 months. The variability in efficacy between individuals is thought to be related to patient‐specific factors, but no detailed research has been conducted. In this retrospective cohort study, we aimed to identify the factors associated with Atomoxetine efficacy.MethodsA total of 147 patients with attention‐deficit/hyperactivity disorder aged ≥18 years who were using Atomoxetine for the first time were included in this study. The outcome was treatment success (treatment maintained for at least 6 months and improvement in symptoms). Symptom assessment was based on the overall improvement in symptoms judged by an expert physician.ResultsOf the patient sample, 103 (70.1%) achieved the outcome. Logistic regression analysis identified “the maximum dose of ATX” and “gambling habit” as factors associated with efficacy ( P < 0.05). In the process of Atomoxetine titration, the larger the maximum dose, the higher the efficacy was shown to be. Gambling habits may be indicative of impulsivity, which is among the core symptoms of attention‐deficit/hyperactivity disorder. Thus, a gambling habit may be considered a surrogate marker for impulsivity.ConclusionsKnowledge of these factors will help healthcare professionals to predict the likely efficacy of Atomoxetine in a given patient before subscribing it, facilitating individualized pharmacotherapy for adult attention‐deficit/hyperactivity disorder.

Medical hypnotherapy; even in a tertiary care setting a promising treatment

Background: Medical hypnotherapy has shown to be an effective treatment in specified conditions such as abdominal pain or headache. Since 2016 the Beatrix children’s hospital, a tertiary care center, offers medical hypnotherapy for a high variety of complex symptom disorders in pediatric patients.Methods: This retrospective COHORT study analyzed the characteristics of pediatric patients treated with medical hypnotherapy in a tertiary care center as well as the effectiveness of the treatment.Results: 214 patients with complex chronic symptoms were treated with medical hypnotherapy. 48% Percent of all patients referred had more than one symptom and 59% of them had had their symptoms for over a year. An overall improvement of symptoms was achieved in 76% of all patients.Conclusions: Medical hypnotherapy seems an effective treatment for patients with multiple chronic and complex symptoms even in a tertiary clinical setting.