Post-treatment Week Research Articles

A randomised sham-controlled study evaluating rTMS analgesic efficacy for postherpetic neuralgia.

Postherpetic neuralgia (PHN) is a refractory neuropathic pain condition in which new treatment options are being developed. Repetitive transcranial magnetic stimulation (rTMS) may have the potential to reduce pain sensations in patients with postherpetic neuralgia. This study investigated the efficacy on postherpetic neuralgia by stimulating two potential targets, the motor cortex (M1) and the dorsolateral prefrontal cortex (DLPFC). This is a double-blind, randomised, sham-controlled study. Potential participants were recruited from Hangzhou First People's Hospital. Patients were randomly assigned to either the M1, DLPFC or Sham group. Patients received ten daily sessions of 10-Hz rTMS in 2 consecutive weeks. The primary outcome measure was visual analogue scale (VAS) assessed at baseline, first week of treatment (week 1), post-treatment (week 2), 1-week (week 4), 1-month (week 6) and 3-month (week 14) follow-up. Of sixty patients enrolled, 51 received treatment and completed all outcome assessments. M1 stimulation resulted in a larger analgesia during and after treatment compared to the Sham (week 2 - week 14, p < 0.005), as well as to the DLPFC stimulation (week 1 - week 14, p < 0.05). In addition to pain, sleep disturbance was significantly improved and relieved by targeting either the M1 or the DLPFC (M1: week 4 - week 14, p < 0.01; DLPFC: week 4 - week 14, p < 0.01). Moreover, pain sensations following M1 stimulation uniquely predicted improvement in sleep quality. M1 rTMS is superior to DLPFC stimulation in treating PHN with excellent pain response and long-term analgesia. Meanwhile, M1 and DLPFC stimulation were equally effective in improving sleep quality in PHN. https://www.chictr.org.cn/, identifier ChiCTR2100051963.

Preliminary Evaluation of Translated and Culturally Adapted Internet-Delivered Cognitive Therapy for Social Anxiety Disorder: Multicenter, Single-Arm Trial in Japan.

Internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD), which is a therapist-guided modular web-based treatment, has shown strong efficacy and acceptability in English-language randomized controlled trials in the United Kingdom and Hong Kong. However, it is not yet known whether iCT-SAD can retain its efficacy following linguistic translation and cultural adaptation of treatment contents and implementation in other countries such as Japan. This study aimed to examine the preliminary efficacy and acceptability of the translated and culturally adapted iCT-SAD in Japanese clinical settings. This multicenter, single-arm trial recruited 15 participants with social anxiety disorder. At the time of recruitment, participants were receiving usual psychiatric care but had not shown improvement in their social anxiety and required additional treatment. iCT-SAD was provided in combination with usual psychiatric care for 14 weeks (treatment phase) and for a subsequent 3-month follow-up phase that included up to 3 booster sessions. The primary outcome measure was the self-report version of the Liebowitz Social Anxiety Scale. The secondary outcome measures examined social anxiety-related psychological processes, taijin kyofusho (the fear of offending others), depression, generalized anxiety, and general functioning. The assessment points for the outcome measures were baseline (week 0), midtreatment (week 8), posttreatment (week 15; primary assessment point), and follow-up (week 26). Acceptability was measured using the dropout rate from the treatment, the level of engagement with the program (the rate of module completion), and participants' feedback about their experience with the iCT-SAD. Evaluation of the outcome measures data showed that iCT-SAD led to significant improvements in social anxiety symptoms during the treatment phase (P<.001; Cohen d=3.66), and these improvements were maintained during the follow-up phase. Similar results were observed for the secondary outcome measures. At the end of the treatment phase, 80% (12/15) of participants demonstrated reliable improvement, and 60% (9/15) of participants demonstrated remission from social anxiety. Moreover, 7% (1/15) of participants dropped out during treatment, and 7% (1/15) of participants declined to undergo the follow-up phase after completing the treatment. No serious adverse events occurred. On average, participants completed 94% of the modules released to them. Participant feedback was positive and highlighted areas of strength in treatment, and it included further suggestions to improve suitability for Japanese settings. Translated and culturally adapted iCT-SAD demonstrated promising initial efficacy and acceptability for Japanese clients with social anxiety disorder. A randomized controlled trial is required to examine this more robustly.

Evidence for feasibility of implementing online brief cognitive‐behavioral therapy for eating disorder pathology in the workplace

CBT-T is a brief (10-week) cognitive-behavioral therapy for non-underweight eating disorders. This report describes the findings from a single center, single group, feasibility trial of online CBT-T in the workplace as an alternative to health service settings. This trial was approved by the Biomedical and Scientific Research Ethics committee, University of Warwick, UK (reference 125/20-21) and was registered with ISRCTN (reference number: ISRCTN45943700). Recruitment was based on self-reported eating and weight concerns rather than diagnosis, potentially enabling access to treatment for employees who have not previously sought help and for those with sub-threshold eating disorder symptoms. Assessments took place at baseline, mid-treatment (week 4), post-treatment (week 10), and follow-up (1 and 3 months post-treatment). Participant experiences following treatment were assessed using quantitative and qualitative approaches. For the primary outcomes, pre-determined benchmarks of high feasibility and acceptability were met, based on recruiting >40 participants (N = 47), low attrition (38%), and a high attendance rate (98%) over the course of the therapy. Participant experiences revealed low previous help-seeking for eating disorder concerns (21%). Qualitative findings indicated a wide range of positive impacts of the therapy and the workplace as the therapeutic setting. Analysis of secondary outcomes for participants with clinical and sub-threshold eating disorder symptoms showed strong effect sizes for eating pathology, anxiety and depression, and moderate effect sizes for work outcomes. These pilot findings provide a strong rationale for a fully powered randomized controlled trial to determine the effectiveness of CBT-T in the workplace. This study demonstrates the feasibility of implementing an eating disorders intervention (online CBT-T) in the workplace as an alternative to traditional healthcare settings. Recruitment was based on self-reported eating and weight concerns rather than diagnosis, potentially enabling access to treatment for employees who had not previously sought help. The data also provide insights into recruitment, acceptability, effectiveness, and future viability of CBT-T in the workplace.

Development and Assessment of an Information Technology Intervention to Improve the Clarity of Radiologist Follow-up Recommendations

It is challenging to ensure timely performance of radiologist-recommended additional imaging when radiologist recommendation language is incomplete or ambiguous. To evaluate whether voluntary use of an information technology tool with forced structured entry of recommendation attributes was associated with improved completeness of recommendations for additional imaging over time. This cohort study of imaging report data was performed at an academic quaternary care center in Boston, Massachusetts, and included consecutive adults with radiology examinations performed from September 12 to 13, 2019 (taxonomy validation), October 14 to 17, 2019 (before intervention), April 5 to 7, 2021 (1 week after intervention), and April 4 to 7, 2022 (1 year after intervention), with reports containing recommendations for additional imaging. A radiologist scored the 3 groups (preintervention group, 1-week postintervention group, and 1-year postintervention group) of 336 consecutive radiology reports (n = 1008) with recommendations for additional imaging. Final implementation on March 27, 2021, of a voluntary closed-loop communication tool embedded in radiologist clinical workflow that required structured entry of recommendation attributes. The a priori primary outcome was completeness of recommendations for additional imaging, defined in a taxonomy created by a multidisciplinary expert panel. To validate the taxonomy, 2 radiologists independently reviewed and scored language attributes as present or absent in 247 consecutive radiology reports containing recommendations for additional imaging. Agreement was assessed with Cohen κ. Recommendation completeness over time was compared with with 1-sided Fisher exact tests and significance set at P < .05. Radiology-related information for consecutive radiology reports from the 4 time periods was collected from the radiology department data warehouse, which does not include data on patient demographic characteristics or other nonimaging patient medical information. The panel defined 5 recommendation language attributes: complete (contains imaging modality, time frame, and rationale), ambiguous (equivocal, vague language), conditional (qualifying language), multiplicity (multiple options), and alternate (language favoring a different examination to that ordered). Two radiologists had more than 90% agreement (κ > 0.8) for these attributes. Completeness with use of the tool increased more than 3-fold, from 14% (46 of 336) before the intervention to 46% (153 of 336) (P < .001) 1 year after intervention; completeness in the corresponding free-text report language increased from 14% (46 of 336) before the intervention to 25% (85 of 336) (P < .001) 1 year after the intervention. This study suggests that supplementing free-text dictation with voluntary use of a structured entry tool was associated with improved completeness of radiologist recommendations for additional imaging as assessed by an internally validated taxonomy. Future research is needed to assess the association with timely performance of clinically necessary recommendations and diagnostic errors. The taxonomy can be used to evaluate and build interventions to modify radiologist reporting behaviors.

Therapeutic outcomes of mycophenolate mofetil and glucocorticoid in thyroid-associated ophthalmopathy patients.

To analyze the efficacy of mycophenolate mofetil (MMF) and glucocorticoid administration in patients with thyroid-associated ophthalmopathy (TAO). Sixty patients with moderate to severe TAO treated in Jingzhou Central Hospital from January 2022 to June 2022 were selected and enrtolled in this study. The subjects were divided into experimental group (n=30) and control group (n=30) based on the random number table method. Glucocorticoid pulse therapy was provided in the control group, while MMF was given in the experimental group on the basis of Control group. Clinical activity score (CAS), quality of life (QOL), visual acuity, eyelid fissure width, intraocular pressure, and degree of exophthalmos were observed at the time of admission and at the 12th week and 24th post-treatment weeks. We compared the immune function (TRAb, IL-6, and CD4+/CD8+) of the two groups pre-treatment and 24 weeks post-treatment, and evaluated the clinical therapeutic effect. The clinical effective rates at 12 and 24 weeks in the experimental group were higher (73.3% and 83.3%) than those in the control group (46.7% and 60.0%) (P <0.05). After 12 weeks of treatment, patients' CAS scores, and bilateral lid fissure width decreased and right eye visual acuity increased in the control group compared with those before treatment (P < 0.05); further, after 24 weeks of treatment, patients' QOL scores and bilateral visual acuity increased and CAS scores, bilateral lid fissure width and proptosis decreased compared with those before treatment, and patients' QOL scores, CAS scores and bilateral proptosis improved more than those at 12 weeks of treatment (P <0.05). Additionally, greater improvements were observed in the patients' QOL and CAS scores, and proptosis after 24-week treatment than after 12-week treatment (P<0.05). In the experimental group, the QOL score and binocular visual acuity increased, whereas the CAS score, intraocular pressure, lid width, and proptosis decreased after 12 weeks of treatment as compared to the values of these parameters in the pre-treatment period (P < 0.05); after 24 weeks of treatment, greater improvements were established in the ocular-related indexes improved compared to the pre-treatment period and after 12 weeks of treatment (P < 0.05). After 12 weeks of treatment, the patients in the experimental group had more considerable improvements in the right visual acuity, right intraocular pressure, and left lid fissure width than the control group (P < 0.05); at 24 weeks of treatment, patients in the experimental group had greater improvements in the QOL score, bilateral visual acuity, intraocular pressure, bilateral lid fissure width, and bilateral proptosis than the control group (P < 0.05). No significant differences were found in the values of TRAb, IL-6, and CD4+/CD8+ between the two groups before treatment (P>0.05); the values of TRAb, IL-6, and CD4+/CD8+ in the experimental group was significantly lower than those before treatment and in the control group after 24weeks of treatment. (P>0.05). No statistically significant difference was observed in the incidence of liver damage and menstrual disorders between the two groups during the 24 weeks of treatment (P>0.05). The combination of oral MMF and glucocorticoid shock therapy is an effective drug for the treatment of patients with moderately active TAO.

Effect of three commonly used aquaculture chemicals against enteropathogenic Escherichia coli and Salmonella spp.

Enteric bacteria such as Escherichia coli and Salmonella spp. are significant fish pathogens and related to thousands of cases of food-borne diseases every year in human. Since aquatic environments are reservoirs of these pathogens, they may contaminate the food fish and result in outbreaks. Therefore, it is crucial to reduce or eliminate these pathogens from aquaculture facilities. We tested effectiveness of three commonly used aquaculture chemicals, viz., lime, hydrogen peroxide and zeolite on bacterial load, Escherichia coli and Salmonella spp. under laboratory and earthen pond conditions where they were applied at a dose recommended for freshwater aquaculture. Results of the bacteriological study showed that lime had a significant role in reducing bacterial abundance from an initial value of 1.5 × 103 to 1.9 × 103 cfu/ml and 3.9 × 103 to 6.3 × 103 to a final value of 1.2 × 103 to 1.5 × 103 cfu/ml and 1.9 × 103 to 6.3 × 103 cfu/ml within 24 h under aquaria and pond condition, respectively. A complete inactivation of E. coli was observed in lime treated aquaria and ponds 24 h post-treatment, whereas Salmonella spp. remained unaffected in pond water but inactivated under aquarium condition after same period. However, neither hydrogen peroxide nor zeolite treatment reduced total bacterial count as well as E. coli and Salmonella even after 1-week post-treatment. It is, therefore, recommended that the water treatment chemicals should be applied in aquaculture ponds at appropriate dose, and farmers need to adopt biosecurity measures to ensure food safety.

Effects of mental contrasting on sleep and associations with stress: A randomized controlled trial.

Mental contrasting with implementation intentions (MCII) has been successfully applied to improve health-related behaviors (e.g. exercise). We explored its effectiveness to improve sleep outcomes beyond effects of sleep hygiene (SH) information, and investigated associations with stress. Eighty university employees (mean age: 29.6, SD = 4.5) were randomized to either a MCII + SH or a SH-only condition. During a baseline-week and a post-intervention week, sleep duration (Fitbit Alta and self-report), sleep quality, and stress were assessed daily and saliva was collected to assess the cortisol awakening response (CAR). In total, self-reported sleep quality and duration increased, but there was no meaningful condition*week interaction for sleep parameters or CAR. Higher average stress was associated with shorter sleep duration and lower sleep quality. Within-person, days with higher stress were followed by nights with lower sleep quality. Despite overall improvements, effects of MCII were not confirmed. MCII might be less effective to improve behaviors which are less controllable.

Impact of Health Education on Hypertension Knowledge, Motivation and Preventive Practices towards Hypertension Control among Pre-Hypertensive Traders in Lagos State, Nigeria

Undiagnosed cases of hypertension remain prevalent in developing countries. Insufficient and lack of knowledge of hypertension and its risk factors limit its proper management and healthy self-care practices. Therefore, this study assessed effect of health-education intervention on hypertension related knowledge, motivation and preventive practices among traders in Lagos State. Quasi-experimental design was employed with seventy participants forming experimental and control group each in major markets of Alimosho and Ajeromi-Ifelodun local government areas of Lagos State, Nigeria. Multistage sampling technique was used. Interviewer administered questionnaire was developed. Weight (kg) and height (m) were measured by bathroom weighing scale and sphygmomanometer respectively. Participants’ body mass index (kg/m2) was calculated. Data were collected at baseline, immediate post intervention and sixth week of follow-up; analyzed by SPSS version 21.0 with level of significance placed at p&lt; 0.05. Frequency, percentage, means and standard deviation were used to describe findings while independent t-test was used for inferential statistics. Treatment effect were judged on t-distribution and Cohen’s d effect size. Participants’ mean age in experimental and control groups was 44.91±8.82 years and 44.37±8.80 years respectively. More than a quarter (40.0%) in experimental group and 34.3% in control group had tertiary education. Overweight is 22.9% and 20.0%, while obesity is 41.4% and 57.1% in experimental and control groups respectively. Knowledge, motivation and preventive practices significantly increased after intervention among experimental group more than control group (p&lt; 0.05). Information-Motivation Behavioral (IMB) model promotes hypertension knowledge, motivation and preventive practices.

Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study.

Glecaprevir/pibrentasvir (G/P) has demonstrated high rates (>95%) of sustained virologic response at posttreatment Week 12 (SVR12) in treatment-naïve (TN) patients with hepatitis C virus (HCV) infection and compensated cirrhosis (CC). Here, in a key real-world subset of TN Italian patients with CC, we evaluated the effectiveness and safety of 8-week G/P treatment, including subgroups of interest such as those with genotype 3 (GT3) infection, elderly patients, and those with more advanced liver disease. Subanalysis of Italian patients enrolled in the CREST study. The full analysis set (FAS) included all patients enrolled in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 results. Primary and secondary endpoints included SVR12 and safety, respectively. Of 42 patients included in the FAS, 1 discontinued for unknown reasons, and 2 had missing SVR12 data, leaving 39 patients included in the MAS. At treatment initiation, 74% of patients had ≥1 comorbidity, and 62% were receiving concomitant medications, including some that may potentially interact with G/P. SVR12 was achieved in 100% of patients in the MAS, and in 95% in the FAS. In subgroups of interest, the proportion of patients achieving SVR12 in the MAS (and FAS) was: 100% (94%) for patients ≥65 years, 100% (86%) for GT3, and 100% (100%) for patients with platelet count <150 × 109/L and FibroScan® >20 kPa. Overall, 2 (5%) patients had an adverse event and neither were serious. Results from this real-world Italian cohort demonstrated the safety and effectiveness of 8-week G/P, with SVR12 rate >95%, even in elderly patients. These findings further support real-world evidence of the use of short-course G/P treatment in all patients with CC, including those with GT3, and those with advanced liver disease.

Short-term effects of intravitreal anti-vascular endothelial growth factor agents on body weight and multiple systems after treatment for retinopathy of prematurity.

This study's goal was to assess the short-term effect on body weight and multiple systems following intravitreal injections of ranibizumab and aflibercept for retinopathy of prematurity (ROP). We retrospectively assessed infants with ROP who received intravitreal anti-vascular endothelial growth factor agents (VEGF) treatment at our hospital. They were classified into 2 groups based on the drugs administered: the intravitreal ranibizumab (IVR) group and the intravitreal aflibercept (IVA) group. The body weight (BW) gains for the pre-treatment week, the 1st week after treatment, and the 2nd week after treatment were compared for each group. Additionally, other parameters such as blood pressure, heart rate, oxygen concentration, volume of milk and output of urine at four time points were also measured. We used repeated measurement analysis of variance analyzed these data. In total, 95 preterm infants were recruited, including 51 cases in the IVR group and 44 cases in the IVA group. The BW gain for the 1st week after treatment was significantly lower than the pre-treatment week in each group (P < 0.05), while there was no decrease in weekly BW gain in the 2nd week after treatment compared with that pre-treatment week. Based on the comparison between groups, the BW gain in the IVR group was significantly higher than in the IVA group in the second post-treatment week. Repeated measurement analysis of variance showed that there were no significant differences in blood pressure, heart rate, oxygen concentration, volume of milk and output of urine in both groups over time. IVR and IVA could have a short-term inhibitive effect on body weight gain in infants after treatment for ROP, whereas there is no significant impact on other systems.

Effectiveness of cognitive rehabilitation on mild cognitive impairment using teleneuropsychology.

To measure the effects of cognitive telerehabilitation on cognition, neuropsychiatric symptoms, and memory strategies in a cohort of patients with mild cognitive impairment. A sample of 60 patients with mild cognitive impairment according to Petersen's criteria was randomly divided into two groups: 30 treatment cases and 30 controls (waiting list group). Subjects were matched by age, sex, and Montreal Cognitive Assessment. The treatment group received ten cognitive telerehabilitation sessions of 45 minutes duration once a week. Pre-treatment (week 0) and post-treatment (week 10) measures were assessed for both groups. Different linear mixed models were estimated to test treatment effect (cognitive telerehabilitation vs. controls) on each outcome of interest over time (pre/post-intervention). A significant group (control/treatment) x time (pre/post) interaction revealed that the treatment group at week 10 had better scores in cognitive variables: memory (RAVLT learning trials p=0.030; RAVLT delayed recall p=0.029), phonological fluency (p=0.001), activities of daily living (FAQ p=0.001), satisfaction with memory performance (MMQ satisfaction p=0.004) and use of memory strategies (MMQ strategy p=0.000), as well as, and a significant reduction of affective symptomatology: depression (GDS p=0.000), neuropsychiatric symptoms (NPI-Q p=0.045), forgetfulness (EDO-10 p=0.000), and stress (DAS stress p=0.000). Our study suggests that CTR is an effective intervention.

Synbiotic-IgY Therapy Modulates the Mucosal Microbiome and Inflammatory Indices in Dogs with Chronic Inflammatory Enteropathy: A Randomized, Double-Blind, Placebo-Controlled Study

Chronic inflammatory enteropathy (CE) is a common cause of persistent gastrointestinal signs and intestinal inflammation in dogs. Since evidence links dysbiosis to mucosal inflammation, probiotics, prebiotics, or their combination (synbiotics) may reduce intestinal inflammation and ameliorate dysbiosis in affected dogs. This study's aim was to investigate the effects of the synbiotic-IgY supplement on clinical signs, inflammatory indices, and mucosal microbiota in dogs with CE. Dogs with CE were enrolled in a randomized prospective trial. Twenty-four client-owned dogs were fed a hydrolyzed diet and administered supplement or placebo (diet) for 6 weeks. Dogs were evaluated at diagnosis and 2- and 6-week post-treatment. Outcome measures included clinical activity, endoscopic and histologic scores, inflammatory markers (fecal calprotectin, C-reactive protein), and composition of the mucosal microbiota via FISH. Eleven supplement- and nine placebo-treated dogs completed the trial. After 6 weeks of therapy, clinical activity and endoscopic scores decreased in both groups. Compared to placebo-treated dogs, dogs administered supplement showed decreased calprotectin at 2-week post-treatment, decreased CRP at 2- and 6-week post-treatment increased mucosal Clostridia and Bacteroides and decreased Enterobacteriaceae in colonic biopsies at trial completion. Results suggest a beneficial effect of diet and supplements on host responses and mucosal microbiota in dogs with CE.

1242. Hepatitis C Treatment as a Complement to Syringe Service Programs: Pilot Progress and Pathways Forward

Abstract Background Hepatitis C (HCV) poses a significant chronic infectious disease threat in the United States, and people who inject drugs (PWID) are at elevated HCV risk. We assessed implementation of a program that provided low-barrier services for high-risk PWID, coupling harm reduction with clinical care, including HCV treatment. Methods In 2018, the University of Illinois at Chicago established a program to deliver comprehensive care to PWID in an underserved Chicago neighborhood, including syringe services (SS) and HCV treatment. We performed chart reviews of SS clients who sought HCV care from 09/2018-01/2021. We assessed patient demographics; the proportions prescribed and initiated on HCV treatment; and the proportions with undetectable HCV RNA at treatment week 4, end of treatment, and 12-weeks post-treatment. Results Among 67 patients, 45 (67%) were male, median age was 45 years (IQR 35-57), 22 (33%) were Black, and 11 (16%) were Hispanic. 66 (99%) reported current or former drug use and 62 (93%) injection drug use, and 3 (4%) sex work. 36 (54%) were undomiciled or lived in unstable housing, 22 (33%) were unemployed, 19 (28%) had been incarcerated within the past year, and 30 (45%) had a history of psychiatric illness. Median pre-treatment HCV RNA was 701,626 IU/L (IQR 39,944-1,979,898). 40 (60%) were prescribed HCV treatment and 31 (46%) initiated treatment (Figure). Of these, 21/31 (68%) completed HCV RNA testing at treatment week 4, of whom 18/21 (86%) had an undetectable viral load; 16/31 (52%) completed end of treatment testing, of whom 16/16 (100%) had an undetectable viral load; and 15/31 (48%) completed 12-week post-treatment testing, of whom 13/15 (87%) had an undetectable viral load. Of the 2 patients who did not achieve sustained viral suppression following treatment, 1 missed four weeks of treatment due to incarceration and 1 reported full adherence to treatment. Numbers and percentages of patients at each step in the treatment cascade Conclusion This comprehensive program offering SS and HCV care successfully reached PWID in an underserved area before and during the pandemic. Losses along the HCV treatment cascade were high: Only 60% were prescribed treatment and less than one-third of those prescribed treatment achieved sustained viral suppression. Among those who remained in care, over 80% achieved sustained viral suppression. Disclosures All Authors: No reported disclosures.

Effects of sodium bicarbonate bath on the quality of sleep: An assessor-blinded, randomized, controlled, pilot clinical trial

BackgroundSleep is fundamental to a healthy life, and sleep disorders are an important health issue in healthcare. Whole-body warm water bathing is a non-pharmacological, safe (non-invasive), and widely used method for comforting. Here, we explored the feasibility and preliminary effectiveness of sodium bicarbonate bath (SBB) on sleep quality. MethodsHealthy adults without sleep disturbances were randomly assigned to shower baths (SHB), tap-water baths (TWB, placebo tablets), or SBB. All participants took a bath (shower, tap-water, or SBB) once a day for 10 min, after dinner, for 7 days. Sleepscan-derived sleep parameters, including total sleep time (TST), symptom questionnaires, and salivary α-amylase concentration were evaluated as outcome measures. ResultsForty participants were enrolled (14, 13, and 13 in SHB, TWB, and SBB groups, respectively) and 38 participants completed the trial (13, 12, and 13, respectively). The recruitment, adherence, and completion rates were 90.9% (40/44), 95.0% (38/40), and 95.0% (38/40), respectively. The SBB group showed a significant increase (12.35 [mean]±10.07 [standard deviation] min) in the mean TST at 1-week post-intervention (p = 0.0041) than the SHB (−1.81 ± 14.58 min; p = 0.0231) and TWB (4.54 ± 10.97 min; p = 0.0377) groups. The TST scores at 1-week post-intervention, sleep onset latency, wake after sleep onset, and sleep efficiency were significantly different between the groups. Sleep satisfaction by questionnaire was significantly improved with intervention in the SBB group than that in the SHB and TWB groups. Salivary α-amylase levels significantly improved in the SBB and TWB groups than in the SHB group, with the change being greater in the SBB group. ConclusionsSBB for 7 days had positive effects that improved sleep quality of adults. Further studies are needed to examine the efficacy and safety of SBB for prolonged usage in people diagnosed with insomnia, using objective sleep measurements, and to investigate potential sleep-enhancing mechanisms of action.

THERAPEUTIC EFFECT OF COCKTAIL VS PROLOTHERAPY INJECTION IN CHRONIC PLANTAR FASCIITIS, A PROSPECTIVE CONTROLLED RANDOMIZED CLINICAL STUDY

Introduction:- Plantar fasciitis is the most common cause of heel pain. It is a self-limiting condition. If causative factors are not addressed properly, it becomes chronic plantar fasciitis. Objectives:- The study aimed to evaluate the efficacy of 15 % hypertonic dextrose (treatment group) in the treatment of chronic plantar fasciitis through comparison with a cocktail group (control group). Design:- In this prospective controlled, randomized clinical study at N.S.C.B. Medical College Jabalpur, from 1 January 2020 to 31 September 2021. The statistical test used in this study isthe chi-square test and independent students t-test.A totalof 41 patients were taken intothe study. Patients were divided into two groups, In the Prolotherapy group (treating group) (n=18), a single shot of 15% Hypertonic dextrose injection was administered (1.2 ml of 50 % hypertonic dextrose, 1.8 ml distilled water and 1 ml of 2% lignocaine mixture)and the cocktail group (control group) (n=23) single shot of cocktail was given (1ml 40mg local methylprednisolone mixed with 1 ml distilled water and with 1 ml 2% lignocaine). During a 24-week follow-up period, pain intensity was measured using the visual analoguescale and American orthopaedics foot and ankle score, the measurements were undertaken before treatment and post-treatment weeks 4 and 12 and 24. Result:- In this study, both treatments were significantly effective in plantar fasciitis treatment for up to the 12th week. However the cocktail group (control group) was found to have a significantly better result at both the 4th week (AOFAS 93.17±3.33, VAS 1.65±.49 vs AOFAS 71.94±5.46, VAS 4.54±.71) and 12th week (AOFAS 90.43±2.86, VAS 1.91±.29 vs AOFAS 76.78±4.12, VAS 3.94±.64), but significantly better even up to 24th weeks (AOFAS 86.39±4.20, VAS 2.35±.71vs AOFAS 67.22±4.19, VAS 5.00±.34), (p-value &lt;.001) in term of pain intensity and disability as compared to prolotherapy group (treating group). Conclusion:- This study showed a favourable outcome towards the cocktail injectionin terms of VAS and AOFAS score as compared to prolotherapy injection.

A gamification-based intervention to encourage active travel

Abstract Purpose ‘Beat the Street’ is a community-wide intervention which aims to increase active travel by turning an area into a 6-week game. Residents earn points and prizes by walking and cycling and tapping a smartcard on RFID readers called ‘Beat Boxes’ placed on lampposts at half-mile intervals. To-date, over 1 million people have taken part in the intervention, however, the impact of the program on adult active travel is yet to be explored. Methods In Autumn 2019, Beat the Street was delivered throughout the London Borough of Hounslow. Prior, and immediately following the intervention, residents were invited to complete a self-report questionnaire (Sport England Active Lives Survey-SF) to assess changes in physical activity. Time-stamp data generated through Beat Box activity provided an objective measure of intervention engagement and a traffic survey camera was used to measure the number of cars travelling along 1 target road between 1-week pre- and 1-week post-intervention. Results 28,219 people took part in the six-week game. Between pre- and post-intervention there was 7% decrease in adults reporting less than 30mins of activity per week and a 13% rise in adults reporting 150+ mins (n = 346, p &amp;lt; 0.01). Beat box data ascertained that 25% of total taps at all Beat Boxes were made between 08:00-08:59am and a further 28% were made between 3:00-3:59pm, typical travel to school/work periods. Further, traffic camera data showed that between the week before and week following Beat the Street, 1199 and 705 fewer cars and 130 and 36 fewer vans were observed travelling along Cambridge Road between 07:00-09:30am and 2:00-4:30pm, respectively. Conclusions These data sources, in combination, suggest gamification may be an encouraging approach to increasing levels of active travel at a community-wide level. Key messages • Gamification based intervention increases physical activity. • Gamification encourages active travel to school and work.

A randomized controlled trial of a peer-facilitated self-management program for people with recent-onset psychosis

Early patient-centered interventions can improve mental health and prevent psychotic relapse in people with recent-onset psychosis (ROP). However, limited effective peer-facilitated early interventions are found worldwide. We aimed to test the effects of a four-month peer-facilitated self-management intervention (PFSMI) for Chinese patients with ROP compared with a psychoeducation group (PEG) and treatment-as-usual (TAU) group. A randomized controlled trial was conducted at six Integrated Community Centers for Mental Wellness in Hong Kong. The primary outcome was level of recovery. Secondary outcomes were improvement of problem-solving ability, insight into illness/treatment, and functioning, and reducing psychotic symptoms and re-hospitalization rates. Overall, 180 ROP patients were randomly selected, and after collecting baseline data, randomly assigned to the PFSMI, PEG or TAU (60 per group). Their outcomes were measured at 1-week and 6-month post-intervention. One hundred and sixty-one patients (89.4 %) completed their interventions, with an overall attrition rate of 7.8 % (n = 14). Based on intention-to-treat principle, results of generalized estimating equation test indicated that the PFSMI group reported significantly greater improvements in levels of recovery, functioning and insight into illness/treatment and reductions in psychotic symptoms and duration of re-hospitalizations (p = 0.0007–0.02, with moderate to large effect sizes) than the TAU group at 1-week post-intervention, and both the TAU and PEG at 6-month post-intervention. Significantly fewer PFSMI participants were hospitalized than the TAU and PEG over 6-month follow-up (p = 0.003). The findings support that PFSMI can produce medium-term positive effects on the mental health and functioning of patients with ROP.

HCV direct acting antiviral treatment leads to highly durable rates of ALT and AST lower than 30/19 criteria and improved APRI and FIB-4 scores.

Direct acting antiviral treatment (DAA) has been the standard of care for hepatitis C virus (HCV) infection, but its long-term benefits in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) improvement and hepatic fibrosis assessed by aspartate aminotransferase-to-platelet ratio index (APRI) and Fibrosis-4 index (FIB-4) scores remain unknown. The purpose of the present study was to assess DAA's long-term benefits, including frequencies of posttreatment week 96 ALT/AST < 30 (males)/19 (females) (<30/19), improvement of APRI and FIB-4 scores, and the associated factors. This was a single-center, retrospective study on 157 patients with HCV with DAA-mediated sustained virological response (SVR) 12. At posttreatment week (post-Rx wk) 96, 75.4% had ALT < 30/19; 62.7%, AST < 30/19; and 60.1%, both ALT/AST < 30/19. ALT/AST < 30/19 at post-Rx wk 96 was associated with ALT/AST < 30/19 at post-Rx wk 12 (p=0.026), independently of Child-Turcotte-Pugh < 6 (p=0.862), platelets ≤ 120 × 109 /L (p=0.343). Improvement rates of APRI < 0.5 and FIB-4 < 1.45 from baseline to post-Rx wk 96 were from 30.9% to 80.5%, and from 23% to 37.8%, respectively. Both APRI and FIB-4 improvement was associated with both ALT/AST < 30 (males)/19 (females) at post-Rx wk 12 (p=0.012 and 0.011, respectively). Conclusion: The present study showed that DAA-mediated SVR12 in patients with HCV resulted in (1) high and durable rates of ALT (75.4%), AST (62.7%), and both ALT/AST (60.1%) < 30/19, and (2) high rates of APRI < 0.5 (80.5%) and FIB-4 < 1.45 (37.8%) at post-Rx wk 96, demonstrated clinical value of ALT/AST < 30/19 and excellent long-term outcomes of DAA-mediated SVR12 in these patients.

The Efficacy of Lactocare® Synbiotic on the Clinical Symptoms in Patients with Psoriasis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Background Attention to the administration of probiotics for the treatment of psoriasis has recently increased. Aim In the present study, improvements in dermatology life quality index (DLQI), psoriasis area severity index (PASI), and visual analogue scale (VAS) scores in the psoriasis patients receiving Lactocare® probiotic were compared to psoriasis patients receiving placebo. Methods A total of 52 psoriasis patients were included in this study and randomly divided into treatment and placebo (control) groups. The control group received topical hydrocortisone associated with placebo; in the treatment group, Lactocare® was administrated orally associated with hydrocortisone. The mean of VAS, DLQI, and PSAI scores was recorded and evaluated pretreatment and post-treatment in both groups for 3 months. The mean of the scores in the control groups was compared to the treatment group. Intragroup analysis was preformed with a comparison of the mean of these scores at baseline 4-, 8-, and 12-weeks post-treatment. Results In the treatment group, a significant decrease was seen in PASI, VAS, and DLQI scores compared to the control group on week 12 post-treatment. Conclusion Oral administration of Lactocare® probiotic (two times daily) associated with administration of topical hydrocortisone resulted in the improvement of PASI, DLQI, and VAS scores in the patients with psoriasis after 12 weeks of treatment. PASI reduction occurred in all patients who received probiotics.

S544 Rifaximin Improves Both Fecal Urgency and Stool Consistency in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Composite Endpoint Analysis of Two Randomized, Phase 3 Trials

Introduction: For patients with IBS-D, in addition to loose stool consistency, fecal urgency is a common, bothersome symptom. The aim was to evaluate rifaximin for simultaneously improving symptoms of fecal urgency in addition to loose/watery stool consistency as a unique composite bowel symptom endpoint. Methods: A post hoc analysis was conducted with data from 2 identically designed, phase 3, randomized, double-blind trials. Adults with IBS-D, with screening daily mean stool consistency score of ≥3.5 (range, 1 “very hard”; 5 “watery”), took rifaximin 550 mg TID or placebo for 2 weeks, followed by a 4-week treatment-free phase to assess response. Fecal urgency was based on patient response to the daily question, “Have you felt or experienced a sense of urgency today?” Composite bowel symptom responders were defined as patients who simultaneously achieved a ≥30% decrease from baseline in the percentage of days with fecal urgency and had a mean weekly stool consistency score of < 4 for ≥2 of the first 4 post-treatment weeks. Data were analyzed using last observation carried forward; P values were calculated using the Cochran-Mantel-Haenszel method, adjusting for analysis center. Results: A total of 1258 adults (rifaximin [n=624], placebo [n=634]) were included (mean ± SD age, 45.9 ± 14.5 years; 72.3% female). Similar values at baseline were observed for rifaximin and placebo groups for the percentage of days with fecal urgency (82%), mean daily stool consistency score (3.9), and mean ± SD number of daily bowel movements (3.0 ± 1.5). A significantly greater percentage of patients treated with rifaximin were bowel symptom composite responders vs placebo for ≥2 of the first 4 weeks post-treatment (47.9% vs 39.3%, respectively; P=0.002). A higher percentage of responders with rifaximin was observed vs placebo when analyzed by week (Figure). A significantly higher percentage of patients who were bowel symptom composite responders during ≥2 of the first 4 weeks post-treatment maintained response during ≥3 of the additional 6 weeks of treatment-free follow up (Week 12) in rifaximin vs placebo groups (44.7% vs 36.1%; P=0.002). For the individual components of response, a significantly greater percentage of patients in rifaximin group were fecal urgency responders vs placebo (52.9% vs 43.1%; P< 0.001) or stool consistency responders (82.7% vs 77.8%; P=0.03). Conclusion: A 2-week course of rifaximin significantly and simultaneously improved fecal urgency and stool consistency vs placebo in adults with IBS-D.Figure 1.: Percentage of patients with ≥30% decrease from baseline in percentage of days with fecal urgency and mean weekly stool consistency score of < 4, by week *P< 0.05 vs placebo.