Weeks Of Therapy Research Articles

Telehealth Social Rhythm Therapy to Reduce Mood Symptoms and Suicide Risk Among Adolescents and Young Adults With Bipolar Disorder.

Social rhythm irregularities are associated with increased bipolar disorder symptoms and suicide risk. This study was the first to examine the feasibility and acceptability of a 12-week social rhythm therapy (SRT) delivered predominantly via telehealth (three in-person sessions, nine via video teleconferencing) to adolescents and young adults with bipolar disorder. The primary aim was to determine the feasibility and acceptability of SRT delivered predominantly via telehealth. Secondary aims were to explore the intervention's impacts on social rhythm regularity, mood symptoms, and suicide propensity. Thirteen adolescents and young adults with bipolar disorder received a modified SRT called Brain Emotion circuitry-targeted Self-Monitoring And Regulation Therapy for Daily Rhythms (BE-SMART-DR) administered mostly remotely, adjunctive to treatment as usual. Retention rates, client satisfaction, therapeutic alliance, and pre- to postintervention changes in social rhythm regularity, mood symptoms, and suicide propensity were assessed. BE-SMART-DR was associated with high retention rates (77%), high mean±SD scores on the Client Satisfaction Questionnaire (29.4±2.7), and high participant global scores on the Working Alliance Inventory (231.3±8.1), indicative of strong therapeutic alliance. Secondary outcome measures on social rhythm irregularities, mood symptoms, and suicide propensity decreased from pre- to posttherapy. Increased social rhythm regularity was associated with reduced suicide propensity after analyses were controlled for reductions in mood symptoms. These preliminary results indicate that SRT delivered largely by telemedicine is feasible and acceptable. The intervention appeared to reduce mood symptoms, and suicide propensity independent of mood symptoms, among adolescents and young adults with bipolar disorder.

Assessment of the responsiveness of four scales in geriatric patients with chronic neck pain.

The purpose of this study was to evaluate the responsiveness of Copenhagen Neck Functional Disability Scale (CNFDS), Neck Disability Index (NDI), Neck Bournemouth Questionnaire (NBQ), Neck Pain and Disability Scale (NPDS) in geriatric patients with non-specific chronic neck pain. A total of 52 geriatric patients with non-specific chronic neck pain were included in the present study. All participants were included in a physical therapy and rehabilitation program for five sessions per week that lasted 3 weeks. All participants were evaluated before and after the treatment. Pain and disability were assessed with the Visual Analog Scale-pain (VAS-pain), VAS-disability, muscle spasm, CNFDS, NDI, NBQ, NPDS scales. Additionally, patient satisfaction scores were questioned both before and after the treatment. Following the 3-week physical therapy and rehabilitation program, significant improvements were detected in the VAS-pain, VAS-disability, muscle spasm, CNFDS, NDI, NBQ, and NPDS scores (p < 0.05). Responsiveness values were found to be as follows: CNFDS [effect size (ES) = 0.78; standardized response mean (SRM) = 0.90], NDI (ES = 0.66; SRM = 1.18), NBQ (ES = 0.82; SRM = 0.97) and NPDS (ES = 0.87; SRM = 0.98). Our study demonstrated that CNFDS, NDI, NBQ, and NPDS are responsive scales in determining treatment-related changes in geriatric patients with non-specific neck pain. These results also suggest that all of these four scales can be used in the assessment of treatment induced changes in geriatric patients with chronic neck pain.

Early reduction of serum RANTES can predict HBsAg clearance in patients with chronic hepatitis B treated with nucleos(t)ide analogues combined with peginterferon alpha

Objective: To observe the dynamic changes of serum RANTES during the treatment with nucleos(t)ide analogues combined with pegylated interferon alpha (peginterferon-α), and further analyze the predictive effect of RANTES on HBsAg clearance in patients with chronic hepatitis B. Methods: 98 cases of chronic hepatitis B with quantitative HBsAg < 3 000 IU/ml and HBV DNA < 20 IU/ml after≥1 year NAs treatment were enrolled. Among them, 26 cases continued to receive NAs monotherapy, 72 cases received NAs combined with pegylated interferon alpha therapy. The changes in RANTES during treatment were observed. The receiver operating characteristic curve was used to analyze the early changes of RANTES to predict the HBsAg clearance during 48 weeks. Results: During 48 weeks, 15 cases (20.83%) had achieved HBsAg clearance in combination group, while no patient had achieved HBsAg clearance in NAs group. The overall serum RANTES level had decreased from baseline in NAs and combination group. At week 48, in the combination group, the serum RANTES level was decreased more significantly in patients with HBsAg clearance than patients without. Further analysis showed that, in combination group, HBsAg clearance rate of patients with serum RANTES decreased at week 12 and 24 was higher than patients with elevated (29.17% vs. 4.17%, P = 0.014; 28.00% vs. 4.55%, P = 0.052), and quantitative HBsAg reduction was larger significantly [(1.49 ± 1.26) log(10)IU/ml vs. (0.73 ± 0.81) log(10)IU/ml, P = 0.017; (1.54 ± 1.27) log(10)IU/ml vs. (0.57 ± 0.56) log(10)IU/ml, P = 0.004]. Receiver operating characteristic curve analysis showed that the baseline quantitative HBsAg and the reduction in quantitative HBsAg and serum RANTES during the early period were predictors of HBsAg clearance after 48-week combination therapy. Furthermore, the combination of baseline quantitative HBsAg and 12 - or 24-week reduction of serum RANTES were better predictors of HBsAg clearance than that of baseline quantitative HBsAg combined with HBsAg decrease at week 12 or 24. The area under the receiver operating characteristic curve of the former was 0.925 and 0.939, while that of the latter was 0.909 and 0.929, respectively. Conclusion: Early reduction of serum RANTES at week 12 and 24 can predict HBsAg loss in CHB patients receiving addition of peginterferon-α to ongoing NAs Therapy, so serum RANTES could be one of the key immunological markers for predicting HBsAg clearance.

English

Tuberculosis (TB) is the leading cause of mortality among infectious diseases with estimated 1.5 million deaths from TB in 2018 -19 and presented as a public health concern. In 1897, the Frenchman Antonin Poncet first described Poncet's disease (PD) as a rare syndrome, where polyarthritis in an acute stage of TB, resolved without joint damage. Similar reports on patients of tuberculosis and joint pain led authors to improve the definition, and in 1978, PD was described as a para infective arthritis by Bloxham and Addy. Regardless of its doubtful existence, cases have been continued to be reported over the years. Poncet's disease is a form of reactive arthritis which is characterized by articular affection in patients diagnosed with TB where there is immune reaction to the tuberculous protein but there is no direct invasion by the micro-organism.1,2 PD is to be differentiated from tuberculous arthritis where there is monoarticular and direct tubercular involvement of the joint. Before more obvious features develop, the sole manifestation of the disease is joint involvement. Crippling pain is experienced during polyarthritis which limits the mobility and activities of patients. Polyarthritis can also occur in common causes such as rheumatological diseases as a symptom and thus can be easily misdiagnosed. Polyarthropathy, that is multiple large and small joints involvement in the body, is the one of the rarest presentations in both active pulmonary and extrapulmonary tuberculosis. This polyarticular impairment observed in patients with active TB, a form of reactive arthritis is known as Poncet’s disease. Since there is no direct bacillary invasion of the joints, it is an aseptic form of arthritis. It is not to be confused with tuberculous arthritis, which is usually monoarticular and where there is direct tuberculin infection. Poncet's disease remains a diagnosis of exclusion. Since case reports are very rare even in countries where tuberculosis is common thus no accepted diagnostic criteria is set for Poncet's disease. This diagnostic possibility becomes increasingly important as the use of corticosteroids, immune suppressants or biologicals can risk further dissemination of the disease. We describe the case of a 50-year-old woman, who presented with active tuberculosis where polyarthralgia was the first and only symptom for four months. Polyarthritis patients were being treated with both non-steroidal anti-inflammatory drugs and antitubercular therapy and to the surprise patients with antitubercular treatment had complete resolution of symptoms after 6-week therapy whereas non-steroidal anti-inflammatory drugs (NSAIDS) offer no benefit. The total duration of therapy was 6 months.

Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial.

The aim of the study was to evaluate the overall biohumoral and metabolic effects of a 12-week add-on therapy consisting of a new nutraceutical formulation (BHC) based on berberine, hesperidin, and chromium picolinate in type 2 diabetes mellitus (T2D) patients with suboptimal glycemic compensation receiving metformin. After 12 weeks, participants in the group receiving metformin plus BHC, compared to the group receiving metformin only, saw a significant improvement in their glucose profile, in terms of both glycated hemoglobin (HbA1c) and fasting blood glucose (FBG). Their FBG dropped from 145 ± 20 mg/dL to 128 ± 23 mg/dL (p < 0.01), a decrease of 11.7% compared with the baseline. This decrease differed significantly from the situation in the control arm (p < 0.05). HbA1c decreased by 7.5% from the baseline, from 53.5 ± 4.3 mmol/mol to 49.5 ± 5.1 mmol/mol (p < 0.01), in the group given BHC, while no difference was seen in the control group. Advanced glycation end products (AGEs) and malondialdehyde (MDA) were found to be significantly reduced (p < 0.01) only in the BHC group, from 9.34 ± 7.61 μg/mL to 6.75 ± 6.13 μg/mL, and from 1.7 ± 0.15 μmol/L to 1.4 ± 0.25 μmol/L, respectively. In patients with T2D taking metformin with suboptimal glycemic compensation, adding BHC for 3 months significantly improved glucose control in terms of FBG and HbA1c, and had a positive effect on the lipid peroxidation profile, as indicated by a decrease in AGEs and MDA.

Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes.

OBJECTIVEAdvances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets.RESEARCH DESIGN AND METHODSThis single-arm, multicenter, prospective study enrolled 112 children (age 6–13.9 years) and 129 adults (age 14–70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70–180 mg/dL (“time in range”).RESULTSA total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.CONCLUSIONSThis tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia.

Toxoplasma gondii multifocal central nervous system infiltration in an apparently immunocompetent cat in Italy

A young cat with progressive ambulatory deficits with multifocal neurolocalization underwent spinal cord and brain magnetic resonance imaging (MRI). After serological testing through indirect immunofluorescence (IFI; IgG titer=640, IgM titer=160; cut-off titer for both=80) for Toxoplasma gondii and unsuccessful 3-week therapy with clindamycin, his condition worsened. MRI revealed multiple lesions in the cervical and thoracolumbar spinal cord and brain and cerebellum meninges. Subsequent serology revealed low seroconversion (IFI; IgG titer=1280, negative IgM titer; cut-off titer for both=80), suggesting chronic infection. Cerebrospinal fluid was negative for T. gondii on PCR. Postmortem histology of the brain and spinal cord confirmed protozoan infiltration. Immunohistochemistry was negative for feline infectious peritonitis but strongly positive for T. gondii. Other infectious agents were not identified. In an apparently immunocompetent young cat with multiple central nervous system inflammatory lesions, without other viral infections, even with low seroconversion, T. gondii differential diagnosis could not be definitively excluded antemortem without biopsy.

Effect of whole-body vibration therapy on lower extremity function in subacute stroke patients.

This study aimed to investigate the effect of whole-body vibration therapy on lower extremity function in subacute stroke patients. Subacute stroke patients who were able to undergo gait training were randomly divided into a vibration therapy group and a control group. All patients attended 20-min training sessions twice daily, 5 times a week for 2 weeks. Each session included 45 squats. The vibration group trained on a vibration platform and the control group trained on the ground. The degree of maximal isokinetic voluntary contraction torque was evaluated, and manual muscle tests of hip and knee flexion and extension were performed. The Berg Balance Scale, 10-m walk test, Timed Up and Go Test, and Functional Ambulation Category were used. A total of 38 patients, 20 in the vibration group and 18 in the control group, were included in the analysis. After the 2-week therapy, the vibration group showed significant improvements in lower extremity strength, balance, and gait performance. The vibration group showed significantly better performance on the Berg Balance Scale, 10-m walk test, and Functional Ambulation Category than the control group. There were no significant differences in maximal isokinetic voluntary contraction torque or manual muscle tests between the groups. Our results suggest that additional training with whole-body vibration may effectively improve the balance and gait performance of subacute stroke patients. Further studies on large populations are required to determine the therapy’s clinical efficacy.

Application of ultrasound elastography for monitoring the effects of TβR1 shRNA therapy on hepatic fibrosis in a rat model.

BackgroundTo investigate the application of ultrasound elastography in monitoring the effects of the transforming growth factor (TGF)-β1 signaling pathway-targeted combination therapy for hepatic fibrosis.Methods1. Short hairpin RNA (shRNA) constructs targeted towards TβR1 were designed, synthesized, and packaged using an adeno-associated virus (AAV), and the effective target shRNA was selected based on transfection results. 2. Fifty rats were randomly allocated (n = 10 per group) to the (A) control group, (B) model group, (C) 0-week therapy group, (D) 4-week therapy group, and (E) combination therapy group. At weeks 2, 4, 6, 8, 10, and 12, acoustic radiation force impulse (ARFI) elastography was used to measure the liver stiffness, inner diameter of the portal vein diameter, and blood velocity; radio frequency ultrasound imaging was used to measure the abdominal aortic elasticity parameter and pulse wave velocity (PWV) of the rats. 3. At week 12, portal vein puncture was performed to measure the portal venous pressure, and rat liver specimens were obtained for the pathological measurement of the degree of hepatic fibrosis.Results1. An shRNA interference sequence targeted towards TβR1 was successfully designed, screened, and packaged using an AAV, and small-animal imaging results indicated expression of the specific shRNA in the liver. 2. At week 12, the ultrasound elastography results were significantly different between the experimental groups and the control group (p < 0.01); among the experimental groups, differences were significant between the therapy groups and the model group (p < 0.01). For groups C and E, the therapeutic effects on hepatic fibrosis in rats were significant, with the pathological results indicating a significant reduction in the degree of hepatic fibrosis (p < 0.01). The therapeutic effectiveness of group D was less than that of group C (p < 0.05). Significant differences existed between the portal venous pressure of the experimental groups and of the control group (p < 0.01). For the abdominal aortic elasticity parameter measured by radio frequency ultrasound imaging, differences existed between the values obtained from the experimental groups and from that of the control group (p < 0.05), while statistically significant differences were not found among the various experimental groups. 3. Continuous ultrasound examination results indicated that the elasticity value of group A was significantly different from those of the other groups after 2 weeks of model establishment (p < 0.01); after 6 weeks, the elasticity values of groups C and E were significantly different compared with those of groups B and D (p < 0.01). For the abdominal aortic elasticity parameter and pulse wave velocity (PWV), there were no significant differences among the various groups (p > 0.05).ConclusionCCl4-induced hepatic fibrosis can be treated through shRNA silencing of TβR1. Ultrasound ARFI elastography is superior to external force-assisted elastography as it can reflect the degree of fibrosis in moderate to severe hepatic fibrosis and the variations in the degree of fibrosis after treatment. Portal venous pressure was positively correlated with the degree of fibrosis; with early combination therapy, both the degree of fibrosis and portal venous pressure could be effectively reduced.

Yoga therapy to reduce fatigue in cancer: effects of reminder e-mails and long-term efficacy

ObjectiveTo examine the efficacy of reminder e-mails to continue yoga therapy on practice frequency and fatigue in cancer patients and long-term effects of yoga on fatigue, depression, and quality of life.MethodologyOne hundred two cancer patients who completed an 8-week yoga therapy were randomly allocated to two groups: reminder (N = 51) vs. no-reminder group (N = 51). After completing yoga therapy, the reminder group received weekly e-mails for 24 weeks, which reminded them of practicing yoga, whereas the no-reminder group did not. Primary outcomes were fatigue and practice frequency, and long-term outcomes were fatigue, depression, and quality of life. Data were assessed using questionnaires after yoga therapy (T1) and 6 months after completing yoga therapy (T2).ResultA significantly stronger reduction of general (p = 0.038, d = 0.42) and emotional fatigue (p = 0.004, d = 0.59) and a higher increase of practice frequency (p = 0.015, d = 0.52) between T1 and T2 were found for the reminder group compared to the no-reminder group. In the mediation model, practice frequency as a mediator partially explained the changes in emotional fatigue (indirect effect B = − 0.10). Long-term effects of yoga therapy regarding fatigue, depression, and quality of life were found (F > 7.46, p < 0.001, d > 0.54).ConclusionWeekly reminder e-mails after yoga therapy can positively affect general and emotional fatigue and help cancer patients with fatigue establish a regular yoga practice at home. However, higher practice frequency did not lead to higher physical or cognitive fatigue improvement, suggesting other factors that mediate efficacy on physical or cognitive fatigue, such as mindfulness or side effects of therapy.

Occupational therapy addressing the ability to perform activities of daily living among persons living with chronic conditions: a randomised controlled pilot study of ABLE 2.0

BackgroundThe ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated.MethodsThe study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful).ResultsDue to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3–100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects.ConclusionsProceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed.Trial registrationThe study was registered at ClinicalTrials.gov (Identifier: NCT04295837) on December 5th, 2019. Retrospectively registered.

Twenty-four-hour and office blood pressure measurement in a comprehensive assessment of the effectiveness of 12-week therapy with a triple fixed-dose combination of amlodipine/indapamide/perindopril in hypertensive patients in actual clinical practice

Aim. To study the efficacy and safety of the triple fixed-dose combination (FDC) of amlodipine/indapamide/perindopril on blood pressure (BP) profile in patients with grade I-II hypertension (HTN) in actual clinical practice.Material and methods. Data from 54 patients with paired 24-hour ambulatory BP monitoring (ABPM) data were included in the TRICOLOR subanalysis (ClinicalTrials. gov study ID — NCT03722524). The mean 24-hour, daytime, and nighttime BP were calculated at baseline and after 12-week follow-up. We determined the proportion of patients with nocturnal HTN (≥120/70 mm Hg) and nocturnal hypotension (&lt;100/60 and &lt;90/50 mm Hg) initially and after 12 weeks of triple FDC therapy. Patients with nocturnal BP decrease included dippers (D; 10-20%), reduced dippers (RD; 0-10%) and extreme dippers (ED; &gt;20%), as well as those without nocturnal BP decrease (&gt;0%, non-dipper (ND)). The smoothness index (SI) was analyzed as the ratio of the mean hourly SBP fall to its mean standard deviation in paired ABPM. To assess the BP phenotypes, two methods were used with reference values of &lt;130/80 and &lt;140/90 mm Hg for ABPM and office BP, respectively. Controlled hypertension (CHT), uncontrolled hypertension (UHT), white coat hypertension (WHT) and masked ineffectiveness of antihypertensive therapy were distinguished.Results. Among 1247 participants of the TRICOLOR study, 54 patients with valid paired ABPM were selected (men, 46%; mean age, 57,7 [12,1] years; mean office BP, 150,4 [16,6]/93,3 [10,7] mm Hg; HTN duration, 8,3 [7,5] years). Initially, the mean 24-hour, daytime and nighttime BP was 141,1 [15,4]/85,9 [9,9], 144,2 [15,5]/88,8 [10,5] and 132,6 [18,0]/78,1 [9,9] mm Hg, respectively. After 12-week follow-up, the mean 24-hour, daytime and nighttime BP was 123,1 [10,5]/75,6 [8,5], 125,7 [10,9]/77,9 [8,7] and 115,4 [10,2]/68,6 [8,8] mm Hg, respectively (p&lt;0,001). After 12-week follow-up, the proportion of patients with nocturnal hypertension decreased from 64,8% to 25,0% (2,6 times) (p&lt;0,001). The proportion of NDs and EDs decreased from 16,7% and 7,4% to 5,8% and 0%, respectively (p=0,048); the proportion of patients with RD and D patterns increased from 42,6% and 33,3 to 57,7% and 36,5%, respectively (p=0,048). With triple FDC therapy, the SI during the day was higher than 0,73 in half of the cases. According to the two methods, the proportion of patients with UHT decreased from 81,6% to 4,4%, WHT from 12,2% to 0%. The prevalence of CHT increased from 4,1% to 57,8%, while masked ineffectiveness of antihypertensive therapy — from 2,0% to 37,8%.Conclusion. Twelve-week FDC therapy of amlodipine/indapamide/perindopril led to a significant fall in the mean 24-hour, daytime and nighttime BP values. Comprehensive analysis of two techniques (24-hour and office BP measurement) identified patients requiring further triple FGC titration.

Correction of eating behavior in patients with erosive reflux esophagitis

AIM: To compare the efficacy of 1-month inhibitors of H+,K+-ATPase therapy and eating behavior correction over 6 months with initial 1-month and 5-month maintenance inhibitors of H+,K+-ATPase therapy in overweight and obese patients with erosive esophagitis.&#x0D; MATERIALS AND METHODS: The randomized clinical study included 29 patients 54.8 13.5 years with erosive esophagitis. 13 (45%) patients were overweight, 16 (55%) obese, 26 (90%) had abdominal obesity. The patients were randomized into 2 groups: control group 15 patients received 20 mg of omeprazole twice a day during 4 weeks and 20 mg of omeprazole once a day during 5 months; intervention group 14 patients participated in the eating behavior correction program and received 20 mg of omeprazole once a day for 4 weeks initially. Clinical symptoms, the endoscopic and histological data , anxiety, depression and quality of life, motor disorders were under investigation.&#x0D; RESULTS: At the end of the 4-week therapy, the control group had a lower frequency of heartburn (1.8 0.08 vs 2.4 0.6 points), intensity of heartburn (1.13 0.51 vs 1.78 0.89 points), healing of erosive esophagitis was more common (13 (86%) vs 5 (35%) patients), more % weakly acidic (2.5 1.6 vs 0.8 0.4) and % weakly alkaline time (0.44 0.3 vs 0.15 0.2) in the esophagus, more alkaline gastroesophageal refluxes (9.1 9.8 vs 2.8 3.9). By the end of the sixth month, the control group had higher frequency (3.46 0,5 vs 2.28 0.7 points) and the intensity of regurgitation (1.6 0.5 vs 1.07 0.26 points), more % weakly acidic (2.32 1.86 vs 0.89 0.57) and % weakly alkaline time (0.54 0.72 vs 0.22 0.28), lower quality of life according to GH scale and RE scale SF-36 questionnaire.&#x0D; CONCLUSIONS: The superiority of an eating behavior correction strategy over inhibitors of H+,K+-ATPase therapy was demonstrated in this study. Weight loss leads to fewer symptoms of gastroesophageal reflux disease and improved gastroesophageal motility.

The Therapeutic Effects of Whole-Body Vibration in Patients With Fibromyalgia. A Randomized Controlled Trial.

Fibromyalgia is a chronic pain disease with few effective therapeutic options. We evaluated the efficacy of a 12-weeks therapy program that involves the use of whole body vibration in patients with fibromyalgia. The experimental group (N = 20 patients) participated in a neuromuscular training with a rotational whole body vibration platform for 12 weeks. The control group (N = 20 patients) received no physiotherapy treatment. The following variables were assessed before, after and 3 months after the therapy program: Fibromyalgia impact questionnaire, pain intensity, quality of life, sensitivity measurements (pressure pain thresholds, vibration thresholds), motor function tasks (Berg scale, 6-min walk test, isometric back muscle strength), and static and dynamic balance. We found improvements in the indexes of functional disability, static equilibrium and vibration sensitivity and a reduction of pain sensitivity. Our results showed that the intervention group improved almost all parameters immediately after the therapy program, in contrast to the control group that showed no changes. These improvements were not maintained in the follow-up. The whole body vibration therapy can be an effective therapy in patients with fibromyalgia and it can improve symptomatology and quality of life in these patients.

Effects of Sphinx Pose (Salamba Bhujangasana) Yoga on chronic low back pain

Background: Chronic Low back pain (LBP) is among the most prevalent conditions distressing the adult population worldwide. The use of complementary and alternative medicinal (CAM) therapies for the management of LBP have rapidly gained popularity, where Yoga is being widely used as mind-body CAM therapy for relieving back pain. The aim is to assess the effectiveness of Sphinx Yoga Pose (Salamba Bhujangasana), in managing CLBP and to measure the variations in the disability index, quality of life, and stress scores.&#x0D; Methodology: A randomized controlled clinical trial will be conducted including the Nurses and midwives. Numerical Pain Rating (NPR) Scale, Roland Morris Disability Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ) will be used for initial screening. Subjects meeting inclusion criteria will be randomly assigned to either of the study group i.e. Group A (Experimental) and Group B (Control). The Group A subjects will be assigned with Sphinx Yoga therapy for 12 weeks while group B subjects will be assigned to usual care. Pre and post samples will be collected for Substance P (SP), Beta Endorphins (β-Endorphin), and Cortisol. Moreover, Oswestry Low Back Pain Disability index, World Health Organization Quality of Life (WHOQOL) and Sadaf Stress Scale (SSS), will be used at baseline and after 12 weeks follow-up (post-intervention).&#x0D; Discussion: Offering a 12-week Yoga therapy to the subjects with CLBP might give an insight into its application and efficacy. To be precise, the findings of this research will support the wider implementation of Sphinx Yoga as a lifestyle intervention.&#x0D; Trial registration: The trial was registered with ClinicalTrials.gov (NCT04721639).

P546 The safety and efficacy of the new-generation budesonide-MMX in the aspect of the cytochrome P-450 enzyme genotype

Abstract Background Unlike previous forms of budesonide absorbing from the ileal and ascending colon region, the new-generation budesonide-MMX contains a formula, that allows absorption throughout the whole colon. Budesonide is degraded in the liver by cytochrome P450 3A enzyme, but so far, there is no study examining the relationship between the budesonide’s effect and the enzyme activity. CYP3A5 is absent in 90% of the European/caucasian population due to a functional loss mutation (CYP3A5*3), whereas patients with the wild-type CYP3A5*1 allele may be expected to have increased metabolism. The most common genetic polymorphisms in CYP3A4 (CYP3A4*1B and CYP3A4*22) result in increased and decreased expression, respectively. Methods We enrolled 33 patients with UC in this prospective study until January of 2021. Patients received 9 mg oral budesonide-MMX once daily until 8 weeks. Laboratory parameters (cholesterol, triglyceride, CRP) and serum hormone levels (parathormone, dehydroepiandrosterone and cortisol) were monitored before and after the 8-week therapy to follow metabolic and hormonal changes. During these visits, body composition analysis was also performed with InBody 770 machine to observe the adverse effects of budesonide-MMX in respect of body fat mass, body mass index, protein content of the body and bone mineral content. We examined the CYP450 3A (CYP3A5 and CYP3A4) enzyme genotype of the patients, to see, whether the different alleles of this drug-degrading enzyme affect the efficacy and safety. Results 33 patients had received the 2-month therapy. By the end of follow-up, based on partial Mayo score, 26 (78.8%) patients experienced remission and 6 patients (18.2%) were primary non-responders. Mean pMayo score decreased from 4.18 to 1.63 (p&amp;lt;0.001). No significant changes were observable regarding body composition. Serum cholesterol level showed significant increase (p&amp;lt;0.001), while triglyceride and CRP did not show significant changes. Serum cortisol levels were decreased (p&amp;lt;0.001), while PTH and DHEA showed no significant decrease. Only two patients experienced side effects: one of them hypertonia, headache and acnes, while the other mild diarrhoea. 3 patients have CYP3A5*1/*3 genotype, and 16 have CYP3A5*3/*3. There was no significant difference between the two groups, regarding safety and efficacy. Only 1 patient have CYP3A4*1B genotype, while the rest have CYP3A4*1, hence, no statistics could be performed. Conclusion In our study, budesonide-MMX proved to be safe and effective in the therapy of UC, however, cholesterol was elevated in the serum. Based on our cohort, different genotypes of CYP3A don’t have an impact on the effect of the drug, however, CYP3A allele variants are rare, therefore, further examinations should be performed.

Comparing the efficacy of two different temperature stimulation in warm acupuncture on acute low back pain: A randomized controlled trial

BackgroundWarm acupuncture, a combination of the mechanical stimulation of acupuncture and thermal stimulation of moxibustion, is commonly used in treating acute low back pain (LBP). This trial aimed to compare the efficacy of stronger (above 43°C) and weaker (above 40°C) heat stimulation in warm acupuncture on the function and pain in patients with acute LBP due to lumbosacral disc degeneration (LDD). MethodsOne hundred and fifty-nine adults were randomly assigned to receive warm acupuncture treatment with silver needle (SvN) or with stainless steel needle (SSN) (1:1). Both groups received a 3-week therapy with 3 sessions per week. The primary outcome was the modified Oswestry Disability Index at week 4. The secondary outcomes included average pain, three physical sign tests and adverse events. Participants were followed up at week 16 and week 28 after randomization. ResultsThe LBP related disability and pain intensity significantly relieved more in the SvN warm acupuncture group than in the SSN group, in both the short and long term (p<0.001). The between-groups difference in physical signs showed statistical significance only in the short term (p = 0.024), but not in long term (p = 0.081; p = 0.069). ConclusionCompared with warm acupuncture with stainless-steel needle at above 40°C, warm acupuncture with silver needle at above 43°C relieved more disability and pain in patients with acute LBP due to LDD. Study registrationChinese Clinical Trial Registry, ChiCTR1800019051.

Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection

Shortened duration therapy for acute and recent HCV infection has been shown to be highly effective inseveral small non-randomised studies with direct-acting antiviral regimens; however, large randomised studies are lacking. REACT was an NIH-funded multicentre international, open-label, randomised, phase IV non-inferiority trial examining the efficacy of short course (6-week) vs. standard course (12-week) therapy with sofosbuvir-velpatasvir for recent HCV infection (estimated duration of infection ≤12 months). Randomisation occurred at week 6. The primary endpoint was sustained virological response 12 weeks after treatment end (SVR12) in the intention-to treat (ITT) population. A total of 250 participants were due to be enrolled, but on advice of the data safety and monitoring board the study was halted early. The primary analysis population consisted of 188 randomised participants at termination of study enrolment; short arm (n= 93), standard arm (n= 95). Ninety-seven percent were male and 69% HIV positive. ITT SVR12 was 76/93, 81.7% (95% CI 72.4-89.0) in the short arm and 86/95, 90.5% (95% CI 82.7-95.6) in the standard arm. The difference between the arms was -8.8 (95% CI -18.6 to 1.0). In modified ITT analysis, wherein non-virological reasons for failure were excluded (death, reinfection, loss to follow-up), SVR12 was 76/85, 89.4% (95% CI 80.8-95.0) in the short arm and 86/88, 97.7% in the standard arm (95% CI 92.0-99.7; difference -8.3%, p= 0.025). In this randomised study in recent HCV infection, a 6-week course of sofosbuvir-velpatasvir did not meet the criteria for non-inferiority to standard 12-week therapy. In this randomised trial, 188 people with recently acquired hepatitis C infection were randomly assigned to treatment using either a short 6-week course (93 people) or standard 12-week course (95 people) of the hepatitis C treatment sofosbuvir/velpatasvir. There were 9 cases of relapse after treatment with the short course and 2 following the standard course. A shortened course of 6-week therapy for hepatitis C infection appeared to be less effective than a standard 12-week course in people with recently acquired hepatitis C infection. CLINICALTRIALS. NCT02625909.

Effectiveness of Acceptance and Commitment Therapy (ACT) in Professional Dementia Caregivers Burnout

ABSTRACT Objectives: To implement and assess the efficacy of a 6-week Acceptance and Commitment Therapy intervention to reduce anxiety and burnout in healthcare professionals working with dementia, and to increase their psychological flexibility and life satisfaction. Methods: A total of 105 workers from the XXXXX Hospital were randomly assigned to an intervention group (Acceptance and Commitment Therapy) or a wait list control group. Psychological Flexibility (AAQ-II), Life Satisfaction (SWLS), Anxiety (STAI-T), and Burnout (MBI) were measured before and after the intervention. Follow-up data were collected 3 months and 12 months post-intervention. Split-plot analyses were performed following intention to treat approach. Results: No significant differences were found in baseline outcome measures. No time effects were found in wait list control group in any variable. In the intervention group, pre-post comparison showed a significant decrease in levels of MBI emotional exhaustion (p = .001) and anxiety (p < .001), and an increase in life satisfaction levels (p < .001) and MBI personal accomplishment (p < .001). These results were maintained at the 3- and 12-month follow-up periods. No significant intervention effects were observed in pre-post flexibility scores; however, data suggest slight progressive increase in flexibility at follow-up. Conclusions: Acceptance and Commitment Therapy showed positive effects in healthcare professionals working with dementia by reducing anxiety and burnout. Clinical implications: The implementation of Acceptance and Commitment Therapy could help to increase the psychological well-being of healthcare professionals working with dementia.

430 Outcome of Sleep-Wake Pattern in Obstructive Sleep Apnea Patients after Positive Airway Pressure Therapy using Actigraphy

Abstract Introduction The initial phase of continuous positive airway pressure (CPAP) therapy in patients with obstructive sleep apnea (OSA) may affect sleep parameters and PAP compliance. Actigraphy is a validated method using accelerometer to objectively measure sleep parameters in patients with a range of sleep disorders, including OSA, particularly to follow-up after treatment. We compare sleep parameters from actigraphy, sleep log, sleep diary, Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), heart rate and blood pressure in OSA patients before and after CPAP therapy for 1 week. Methods This pilot study have been prospectively performed at Central Chest Institute of Thailand (CCIT) since June to November 2020. Adult OSA patients, diagnosed by ICSD-3 criteria and achieved optimal or good CPAP pressure titration from split-night polysomnography (PSG), were informed and consent to wear actigraphy before and after CPAP therapy each for 1 week. Clinical and sleep parameters were recorded and analyzed using Wilcoxon matched-pair signed-rank and Mann Whitney U test. P-value &amp;lt; 0.05 was considered to have statistical significance. Results All 11 OSA patients participated in this study. Most patients were male (63.6%), hypertension (54.5%) and dyslipidemia (45.4%). Means of age, body mass index (BMI), ESS, PSQI, apnea hypopnea index (AHI), nadir SpO2, and CPAP usage were 45.5 ± 15.9 years, 29.1 ± 5.2 kg/m2, 10.8 ± 3.9, 7.7 ± 2.9, 65.2 ± 37.7 events/h, 82.3 ± 10.8 % and 9.5 ± 3.1 cmH2O, respectively. Comparing before and after 1-week CPAP therapy, an average number of wake bouts ((NWB), 48.4 vs 38 events, p=0.010), ESS (11 vs 9, p=0.035) and PSQI (8 vs 4, p=0.005) were significantly decrease. Additionally, when comparing between poor and good CPAP compliance group, NWB (55.1 vs 36.3 events, p=0.036) and the difference of wake after sleep onset (WASO, 10.5 vs -0.11 min, p=0.035) were significantly decrease. Conclusion OSA patients treated with CPAP for 1-week experienced marked improvement in sleepiness, sleep quality and nighttime awakening. Support (if any):