Changes In Symptom Scores Research Articles

Efficacy of overactive neurogenic bladder treatment: A systematic review of randomized controlled trials.

Overactive bladder (OAB) symptoms of frequency, urgency and urge incontinence are frequently associated with known neurological diseases like multiple sclerosis (MS), spinal cord injury (SCI), Parkinson's disease (PD), stroke. The aim of our study was to review the efficacy of pharmacological and non-pharmacological treatments for neurogenic overactive bladder. We searched two electronic databases (PubMed and EMBASE) for randomized controlled trials focusing on pharmacological and non-pharmacological medical treatments for overactive bladder symptoms associated with neurological diseases published up to 30 April 2022. A total of 157 articles were retrieved; 94 were selected by title and abstract screening; after removal of 17 duplicates, 77 records were evaluated by full-text examination. Sixty-two studies were finally selected. The articles selected for review focused on the following interventions: anticholinergics (n = 9), mirabegron (n = 5), comparison of different drugs (n = 3), cannabinoids (n = 2), intravesical instillations (n = 3), botulinum toxin (n = 16), transcutaneous tibial nerve stimulation (TTNS) (n = 6), acupuncture (n = 2), transcutaneous electrical nerve stimulation TENS (n = 4), pelvic floor muscle training (PFMT) (n = 10), others (n = 2). Anticholinergics were more effective than placebo in decreasing the number of daily voids in patients with PD (mean difference [MD]- 1.16, 95 % CI - 1.80 to - 0.52, 2 trials, 86 patients, p < 0.004), but no significant difference from baseline was found for incontinence episodes and nocturia. Mirabegron was more effective than placebo in increasing the cystometric capacity in patients with MS (mean difference [MD] 89.89 mL, 95 % CI 29.76 to 150.01, 2 trials, 98 patients, p < 0.003) but no significant difference was observed for symptom scores and bladder diary parameters. TTNS was more effective than its sham-control in decreasing the number of nocturia episodes (MD -1.40, 95 % CI -2.39 to -0.42, 2 trials, 53 patients, p < 0.005) but no significant changes of OAB symptom scores were reported. PFMT was more effective than conservative advice in decreasing the ICIQ symptom score (MD, -1.12, 95 % CI -2.13 to -0.11, 2 trials, 91 patients, p = 0.03), although the number of incontinence episodes was not significantly different between groups. The results of the meta-analysis demonstrate a moderate efficacy of all considered treatments without proving the superiority of one therapy over the others. Combination treatment using different pharmacological and non-pharmacological therapies could achieve the best clinical efficacy due to the favorable combination of the different mechanisms of action. This could be associated with fewer side effects due to drug dosage reduction. These data are only provisional and should be considered with caution, due to the few studies included in metaanalysis and to the small number of patients.

The efficacy and safety of Yupingfeng Powder with variation in the treatment of allergic rhinitis: Study protocol for a randomized, double-blind, placebo-controlled trial.

Background: Allergic rhinitis (AR) is an upper airways chronic inflammatory disease mediated by IgE, which affects 10%-20% of the population. The mainstay for allergic rhinitis nowadays include steroids and antihistamines, but their effects are less than ideal. Many patients therefore seek Chinese medicine for treatment and Yupingfeng Powder is one of the most common formulae prescribed. In this study, we aim to investigate the efficacy and safety of Yupingfeng Powder with variation for the treatment of allergic rhinitis. Study design: This is a double-blind, randomized, placebo-controlled trial. A 2-week screening period will be implemented, and then eligible subjects with allergic rhinitis will receive interventions of either "Yupingfeng Powder with variation" granules or placebo granules for 8weeks, followed by post treatment visits at weeks 12 and 16. The change in the Total Nasal Symptom Score (TNSS) will be used as the primary outcome. Discussion: This trail will evaluate the efficacy and safety of Yupingfeng Powder in treating allergic rhinitis. The study may provide the solid evidence of Yupingfeng Powder with variation can produce better clinical efficacy than the placebo granules. Trial registration: ClinicalTrials.gov, identifier NCT04976023.

Effects of a Pedometer-Based Walking Home Program Plus Resistance Training on Inflammatory Cytokines and Depression in Thai Older People with Sarcopenia: A Three-Arm Randomized Controlled Trial

ABSTRACT Objective To examine the effects of daily walking steps plus resistive exercise on chronic inflammatory markers and depressive symptoms in older adults with sarcopenia. Methods Ninety men and women aged over 60 years were enrolled and divided into 60 and 30 adults with and without sarcopenia, respectively. Older individuals were screened for sarcopenia using the Asian Working Group for Sarcopenia in 2019. A simple random sample was conducted to divide the older adults with sarcopenia into two groups: control and intervention. Thirty older adults with sarcopenia were assigned to perform 12 weeks of step walking (>7500 steps) daily for 5 days/week plus resistance exercise with an elastic band twice/week; the control groups (i.e., no sarcopenia and sarcopenia) performed routine daily life Changes in depression and expression of the pro-inflammatory cytokines tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6) were measured before and after the 12-week intervention program. Two-way mixed ANOVA models were computed for group and interaction effects for each variable. Results Changes in depressive symptom scores (Δ2.86 ± 0.92) and TNF-α levels (Δ22.16 ± 2.30) were observed in the intervention group after the 12-week program. In addition, an interaction effect between the intervention (Δ4.04 ± 3.10) and control groups (Δ8.10 ± 4.88) was found for the symptoms of depression. Conclusion Older people with sarcopenia who accumulated >7,500 steps/day, 5 days/week plus resistive elastic band twice /week show improvements in inflammation and depressive symptoms. Clinical implications: Encourage physical activity had a positive effect on reducing inflammation and depression among older people with sarcopenia.

Mental health symptom changes in pregnant individuals across the COVID-19 pandemic: a prospective longitudinal study

BackgroundInitial studies found that mental health symptoms increased in pregnant and postpartum individuals during the COVID-19 pandemic. Less research has focused on if these putative increases persist over time and what factors influence these changes. We examined the longitudinal change in mental health symptoms in pregnant and postpartum individuals and investigated moderation by maternal emotion dysregulation and the incidence of coronavirus.MethodsPregnant and postpartum individuals at the University of Utah were invited to join the COVID-19 and Perinatal Experiences (COPE) Study. Beginning on April 23, 2020 participants were sent a survey comprised of demographics, medical and social history, pregnancy information and self-assessments (Time 1). Participants were contacted 90 days later and invited to participate in a follow-up questionnaire (Time 2). Daily coronavirus case counts were accessed from the state of Utah and a 7-day moving average calculated. Within-subject change in mental health symptom scores, as measured by the Brief Symptom Inventory, was calculated. Linear mixed effects regression modeling adjusted for history of substance abuse and mental health disorders.Results270 individuals responded between April 23rd, 2020 and July 15th, 2021. Mental health symptom scores improved by 1.36 points (0.7-2.0 p < 0.001). The decrease in mental health symptoms was not moderated by the prevalence of COVID-19 cases (p = 0.19) but was moderated by emotion dysregulation (p = 0.001) as defined by the Difficulties in Emotion Regulation Scale short form. Participants with higher emotion dysregulation also had higher mental health symptom scores.ConclusionMental health symptoms improved over the course of the pandemic in the same pregnant or postpartum participant. Our findings do not negate the importance of mental health care during the pandemic. Rather, we believe this identifies some aspect of resiliency and adaptability. Examining emotion dysregulation, or asking about a history of mental health, may be helpful in identifying persons at higher risk of heightened responses to stressors.

Effects of stress on neural processing of combat-related stimuli in deployed soldiers: an fMRI study

Severe trauma exposure may lead to symptoms of both posttraumatic stress disorder and depression. Neuroanatomical theories suggest that both disorders may share imbalances in fronto-limbic circuits. Longitudinal studies are necessary to better understand the impact of a stressful life situation on potential long-term fronto-limbic imbalances. Here we investigated soldiers neural processing of combat-related stimuli versus negative affective stimuli before and after the deployment in different war zones. In the final analysis we included 104 deployed soldiers (combat group) and 36 soldiers that were not deployed (control group). Behaviorally, we found a significant group by time interaction regarding depression symptom scores with an increase in the combat group. Depressive symptoms were subclinical. On the neural level, neither the whole brain analysis nor the region of interest (ROI) analyses including frontal and limbic ROIs revealed any significant results in the group by time interaction. However, extracted ROI values of the group by time interaction of amygdala and hippocampus were positively associated with the change in depression symptom scores in the combat group, but not in the control group. These results highlight the role of depression in individuals that experience stressful life situations. Future studies may need to investigate the role of depressive symptoms after trauma exposure with different tasks that may be particularly sensitive to changes due to depressive symptoms.

Efficacy and Safety of Add-on Parsaclisib to Ruxolitinib Therapy in Myelofibrosis Patients With Suboptimal Response to Ruxolitinib: Final Results From a Phase 2 Study

Background: Ruxolitinib (RUX) is a potent JAK1/JAK2 inhibitor and is effective in patients (pts) with myelofibrosis (MF). However, suboptimal or declining responses to RUX occur in a subset of pts, possibly due to persistent PI3K pathway activation with chronic JAK inhibitor therapy. Parsaclisib is a potent and highly selective next-generation PI3Kδ inhibitor. We conducted a phase 2 study (NCT02718300) evaluating add-on parsaclisib to stable doses of RUX, for pts with MF who experienced a suboptimal response to RUX (Yacoub A. HemaSphere 2021;5 Suppl 2:512). Here we report efficacy and safety results from the completed study. Methods: Eligible pts had primary or post-essential thrombocythemia/post-polycythemia vera MF with suboptimal response (palpable spleen >10 cm below left subcostal margin [LSM], or palpable splenomegaly 5-10 cm below LSM and presence of 1 symptom score ≥5 or 2 symptom scores ≥3 each using the Screening Symptom Form) after ≥6 months of RUX (5-25 mg twice daily; RUX stable dose, ≥8 wks). Pts remained on their stable RUX dose and were randomized to receive add-on parsaclisib 10 mg or 20 mg once daily (QD) for 8 wks and the same dose once weekly (QW) thereafter (QD/QW group), or parsaclisib 5 mg or 20 mg QD for 8 wks and 5 mg QD thereafter (all QD group) (Figure). Primary efficacy endpoint was change in spleen volume (SV) from baseline to wk 12 by MRI/CT scan. Key secondary endpoints included change in SV to wk 24, change in total symptom score (MFSAF-TSS, MPN-SAF-TSS), and safety. Results: Overall, 32 pts received parsaclisib QD/QW and 42 pts received parsaclisib all QD. Baseline median age was 68.0 (range 41.0-89.0) years and 47.3% of pts were male. The study has been completed. Median treatment duration was 336.5 days; median average daily dose was 5.0 mg/day for parsaclisib and 29.8 mg/day for RUX. Among all pts, 16 (21.6%) were rolled over to continue therapy in an open-label parsaclisib study after ending treatment in the present study. Other common reasons for pts discontinuing treatment were adverse events (13 [17.6%]) and progressive disease (10 [13.5%]); remainder discontinued for physician decision, pt decision, or "Other." Baseline median SV (cm3) was 2414.5 in QD/QW (n=29) and 1877.5 in QD (n=37); median MFSAF-TSS was 10.8 (n=28) and 16.3 (n=32) and median MPN-SAF-TSS was 25.5 (n=28) and 30.0 (n=37), respectively. Median percentage change in SV at wk 12 was −1.6 (n=28) in QD/QW and −15.4 (n=37) in QD, and at wk 24 was −2.5 (n=20) and −19.3 (n=29), respectively. Median percentage change in MFSAF-TSS at wk 12 was −14.0 (n=21) in QD/QW and −32.8 (n=24) in QD, and at wk 24 was −10.0 (n=16) and −44.4 (n=18), respectively. Median percentage change in MPN-SAF-TSS at wk 12 was −19.2 (n=20) in QD/QW and −39.8 (n=30) in QD, and at wk 24 was −43.3 (n=15) and −60.8 (n=26), respectively. Responder analysis for these 3 efficacy variables is shown in the Table. Nonhematologic treatment-emergent adverse events (TEAEs) were primarily grade 1/2. Grade 3/4 nonhematologic TEAEs occurring in >1 pt overall were pneumonia (n=5; 3 QD/QW, 2 QD), fatigue, hypoxia (each n=2; each 1 QD/QW, 1 QD), dyspnea (n=2, all QD), fall, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, hypocalcemia (each n=2; all QD/QW). New-onset grade 3 thrombocytopenia was observed in 6/32 pts (18.8%) in QD/QW and 11/42 pts (26.2%) in QD; grade 4 thrombocytopenia was observed in 6/32 pts (18.8%) in QD/QW and 3/42 pts (7.1%) in QD. TEAEs of special interest included grade ≥3 ALT and AST (each n=2; all QD/QW), grade ≥2 diarrhea (n=4) and rash (n=1) (all QD/QW), and any-grade herpes simplex (n= 4; 1 QD/QW, 3 QD) and VZV infection (n= 3; 1 QD/QW, 2, QD). No colitis was reported. TEAEs led to parsaclisib interruption in 16/32 pts in QD/QW and 22/42 pts in QD, and RUX interruption in 5/32 and 8/42 pts, respectively. TEAEs led to parsaclisib discontinuation in 5/32 pts in QD/QW and 4/42 pts in QD, and RUX discontinuation in 2/32 and 2/42 pts, respectively. Conclusion: Final results from the phase 2 study demonstrate improvement in symptoms and SV with add-on parsaclisib in patients with MF having a suboptimal response to ruxolitinib. All daily dosing regimens were more efficacious than daily/weekly dosing. Combination therapy was associated with limited grade 3/4 AEs and TEAE-related discontinuations. Phase 3 studies using 5 mg QD parsaclisib together with ruxolitinib in naive MF patients and ruxolitinib-experienced patients are in progress. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial

BackgroundThe improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Women’s Health Initiative cancer survivorship clinic in Ireland.MethodsThe trial comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility (1) women with early-stage hormone receptor-positive breast or gynecologic cancer (cervix or endometrial), within 12 months of completion of primary curative therapy, and (2) access to the Internet.The complex intervention comprises a nurse-led clinic targeting symptom management through a trigger alert system, utilizing electronic patient-reported outcome (ePRO) assessments at baseline, and 2, 4, 6, 8, 10, and 12 months. It also includes input from a dietitian monitoring diet and nutritional status.The control group will receive their usual care pathway standard of care and attend the cancer survivorship clinic and complete ePRO assessments at the start and end of the study.The primary endpoint (feasibility) includes the proportion of enrolled participants who complete baseline and follow-up ePRO surveys and partake in health professional consultations after ePRO data triggers. Secondary endpoints include changes in cancer-related symptom scores assessed by ePROs, health-related Quality of Life Questionnaire (QLQ) scores, Appraisal Self-Care Agency-R scores, and adjuvant endocrine therapy medication adherence. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis.Ethical approval was granted in December 2020, with accrual commencing in March 2021.DiscussionThis protocol describes the implementation of a parallel arm randomized controlled trial (RCT) which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects the treatment-related effects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care.Trial registrationClinicalTrials.gov, NCT05035173. Retrospectively registered on September 5, 2021

Effect of C-type natriuretic peptide and amiodarone in Chinese patients with arrhythmia

Purpose: To compare the effect of C-type natriuretic peptide and amiodarone in Chinese patients with arrhythmia. &#x0D; Method: Chinese men and women aged 18 to 65 years with premature ventricular complexes (PVCs), were administered C-type natriuretic peptide (CNP) - test group or amiodarone (study group) in ratio of 1:1 for 96 h. Patients in CNP group received infusion of synthetic human CNP (10 pmol/kg/min) for an initial 2 h, and then for 30 min every day until discharge. Patients in amiodarone group received initial dose of 1000 mg over the first 24 h. Change in PVCs from baseline was the primary efficacy endpoint. Secondary efficacy endpoint includes: change in PVCs-related symptom scores from baseline, change in ejection fraction of left ventricle (LV), end‑diastolic diameter of LV, and cardiac events as composite outcome (CCE). The effect of both treatments on hemodynamic and electrocardiography parameters, and safety were evaluated. Data from 200 patients were analyzed. &#x0D; Results: The CNP showed significantly greater decrease in the number of PVCs when compared to amiodarone (p &lt; 0.005). Moreover, CNP was superior in alleviating PVCs- related symptoms when compared to amiodarone (p &lt; 0.005). A similar trend of favorable effect of CNP was observed for other endpoints. &#x0D; Conclusion: The C-type natriuretic peptide offers significantly greater benefits of suppressing PVCs and related symptoms, and demonstrates significantly greater improvement of cardiac function and clinical outcome. Thus, CNP can be considered for further investigation as a suitable alternative in the management of ventricular arrhythmia with PVC among Chinese patients.

Predictors of outcome after a time-limited psychosocial intervention for adolescent depression.

Research on the predictors of outcome for early, community-based, and time-limited interventions targeted for clinical depression in adolescents is still scarce. We examined the role of demographic, psychosocial, and clinical variables as predictors of outcome in a trial conducted in Finnish school health and welfare services to identify factors associating to symptom reduction and remission after a brief depression treatment. A total of 55 12-16-year-olds with mild to moderate depression received six sessions of either interpersonal counseling for adolescents (IPC-A) or brief psychosocial support (BPS). Both interventions resulted in clinical improvement at end of treatment and 3- and 6-month follow-ups. Main outcome measures were self-rated BDI-21 and clinician-rated Adolescent Depression Rating Scale (ADRSc). Latent change score (LCS) models were used to identify predictors of change in depressive symptom scores and clinical remission at end of treatment and 3- and 6-month follow-ups over the combined brief intervention group. Symptom improvement was predicted by younger age and having a close relationship with parents. Both symptom improvement and clinical remission were predicted by male gender, not having comorbid anxiety disorder, and not having sleep difficulties. Our results add to knowledge on factors associating with good treatment outcome after a brief community intervention for adolescent depression. Brief depression interventions may be useful and feasible especially for treatment of mild and moderate depression among younger adolescents and boys, on the other hand clinicians may need to cautiously examine sleep problems and anxiety comorbidity as markers of the need for longer treatment.

A Case Report of Suspected Allergic Rhinitis in a Patient with LBP Hospitalized at a Korean Medicine Hospital and Treated with Korean Medicine

Objective: The purpose of this study is to report the efficacy of using Korean medical treatment for suspected allergic rhinitis.Methods: We used Korean medical treatments (herbal medicines and acupuncture) to treat a hospitalized patient with suspected allergic rhinitis. To evaluate the treatment, we used Total Nasal Symptom Scores to measure sneezing, rhinorrhea, itching, and obstruction. The degree of rhinitis was also evaluated using the Visual Analogue Scale, and the patient’s generic health status was measured using the European Quality of Life 5 Dimensions Scale.Results: Visual Analogue Scale and European Quality of Life 5 Dimensions Scale scores improved after treatment. The change in Total Nasal Symptom Scores showed that the patient’s suspected allergic rhinitis symptoms were relieved.Conclusions: The results of this study suggest that Korean medicine therapies may be effective for treating suspected allergic rhinitis.

Centering Group Treatment for Women With Interstitial Cystitis/Bladder Pain Syndrome: A Prospective, Parallel-Group Cohort Study.

Women with interstitial cystitis/bladder pain syndrome (ICBPS) face isolation and treatment challenges. Group medical visits using Centering models have successfully treated other conditions but have not been explored in ICBPS. This study aimed to describe ICBPS pain and symptom control comparing standard treatment alone versus standard treatment augmented with Centering visits. This prospective cohort study recruited women with ICBPS receiving standard care (control) or standard care augmented with group Centering. We administered validated questionnaires at baseline and monthly for 12 months. The primary outcome was change in the pain numerical rating scale, with Patient-Reported Outcomes Measurement Information System Pain Interference Scale and Bladder Pain/Interstitial Cystitis Symptom Score change as secondary measures. We enrolled 45 women (20 Centering, 25 controls). Centering had significantly better numerical rating scale pain scores at 1 month (mean difference [diff], -3.45) and 2 months (mean diff, -3.58), better Patient-Reported Outcomes Measurement Information System Pain Interference Scale scores at 1 month (mean diff, -10.62) and 2 months (mean diff, -9.63), and better Bladder Pain/Interstitial Cystitis Symptom Score scores at 2 months (mean diff, -13.19), and 3 months (mean diff, -12.3) compared with controls. In modeling, treatment group (Centering or control) and educational levels were both associated with all the outcomes of interest. Beyond 6 months, there were too few participants for meaningful analyses. Women with ICBPS participating in a Centering group have, in the short term, less pain, pain interference, and ICBPS-specific symptoms than patients with usual care alone. Larger studies with more follow-up are needed to determine if this treatment effect extends over time.

The effects of multi-directional, high intensity exercise on the vestibular/ocular motor screening (VOMS) assessment in recreational athletes

ObjectiveIdentify the effects of multi-directional, high intensity exercise on VOMS symptom scores in male and female recreational, college-aged athletes. DesignCross-sectional study. SettingAthletic Therapy facility. ParticipantsA convenience sample of 29 (15 females, 14 males; 21.48 ± 1.40 years old) healthy recreational athletes. Main outcome measuresVOMS symptom scores pre, immediately post-, and 10 min post a multidirectional, high intensity intermittent exercise protocol (HIIP). Friedman tests and Wilcoxon Signed Rank tests identified significant differences at the time points. A Mann-Whitney U Test investigated the effect of sex. ResultsThe majority of component and overall VOMS symptom scores increased post-HIIP (p < 0.001–0.007, effect sizes 0.39–0.50) and 10 min post-HIIP (p = 0.003–0.015, effect sizes 0.32–0.39). Near point convergence distance increased immediately post-HIIP (p < 0.001, effect size 0.52). Females had higher smooth pursuits (z = −2.340, p = 0.019, r = 0.31), vertical vestibular ocular reflex (z = −2.81, p = 0.04, r = 0.39) visual motion sensitivity (z = −2.312, p = 0.021 r = 0.30) and overall VOMS symptom scores (z = −2.84, p = 0.04, r = 0.27) 10 min post-HIIP. ConclusionsMultidirectional, high intensity exercise can induce concussive-like changes in VOMS symptom scores in healthy, recreational athletes, particularly in females. These results may assist in SRC assessment and management of athletes involved in multidirectional, high intensity sports.

Randomized, Double-Blind Placebo-Controlled Trial to Assess the Effect of Probiotics on Irritable Bowel Syndrome in Veterans With Gulf War Illness.

Many veterans who served in Operation Desert Storm (August 1990 to March 1991) experienced a complex of symptoms of unknown etiology called Gulf War illness (GWI), which significantly impacts the health and quality of life (QOL) and may have contributed to irritable bowel syndrome (IBS). We performed a prospective, double-blind placebocontrolled study to determine the efficacy of the multistrain De Simone Formulation probiotic containing 8 strains of bacteria on symptoms of IBS and GWI. Veterans of Operation Desert Storm who had IBS and ≥ 2 nonintestinal symptoms of GWI were included. The primary study endpoint was change in bowel symptom score. The secondary endpoints were mean change in symptoms, QOL, and extra-intestinal and posttraumatic stress disorder (PTSD) symptoms. A total of 101 Gulf War veterans with IBS and GWI were screened at the Veteran Affairs Medical Center in Salt Lake City, Utah. The study was completed by 53 veterans; 47 (89%) were male with a mean (SD) age of 55 (8) years. The probiotic did not improve IBS symptoms or other extra-intestinal symptoms common to IBS and GWI. Our study did not demonstrate statistically significant improvement in IBS symptoms or QOL after treatment with the probiotic. We also did not find any improvement in symptoms of GWI or PTSD.

Phytomedicine ELOM-080 in Acute Viral Rhinosinusitis: A Randomized, Placebo-Controlled, Blinded Clinical Trial.

ELOM-080 is a phytomedicine approved for the treatment of acute and chronic inflammatory diseases of the respiratory tract, sinusitis, and bronchitis in particular. This prospective, randomized, placebo-controlled, double-blind clinical trial was conducted to assess efficacy and safety of ELOM-080 in the treatment of acute viral rhinosinusitis (AVRS). Patients with AVRS received oral treatment (4 × 1 capsule per day) with either ELOM-080 or matching placebo. Primary endpoints were the change in major symptom score (MSS) after 7 and 14 days of treatment assessed by the investigator (MSSINV ). Secondary endpoints were changes in MSS assessed by the patients (MSSPAT ), olfactory function (12-item Sniffin' Sticks), 20-Item Sino-Nasal Outcome Test (SNOT-20 GAV; German adapted version), influence of treatment on viral load, and safety. Four hundred and sixty-three patients were randomized. At day 4, subjective burden of disease (MSS) was significantly ameliorated compared to placebo (p=0.012). During the first treatment week MSS scores improved about 1 day earlier, and 3 days earlier in the second week. Effect with ELOM-080 on mean MSSINV was statistically significantly superior to placebo at visit 3 (p=0.016) and visit 4 (p=0.014). In chemosensory testing identification scores improved comparably in both treatments. The improvement of the SNOT-20 GAV was more pronounced in ELOM-080 patients. Treatment with ELOM-080 indicated a potential for decreasing viral load. Both treatments were well tolerated. ELOM-080 improves the burden of AVRS significantly in comparison to placebo, remission of symptoms occurred 3 days earlier. The results confirm the efficacy and safety of ELOM-080 for treatment of AVRS. 1 Laryngoscope, 133:1576-1583, 2023.

Meta-Analysis of Different Acupuncture Points in the Treatment of Ankylosing Spondylitis with Supervised Moxibustion.

Objective To investigate the clinical efficacy of different acupuncture points in the treatment of ankylosing spondylitis with supervised moxibustion. Methods Retrospective analysis of 61 AS patients (diagnosed as ankylosing spondylitis of kidney-yang deficiency type by Chinese medicine) admitted to our hospital from January 2020 to February 2021, randomly divided into 30 cases in the experimental group (Du moxibustion + basic western medicine treatment) and 31 cases in the control group (basic western medicine treatment alone). The changes in quantitative scores of the main symptoms and major signs (thoracic mobility, occipital-wall distance, finger-ground distance, and laboratory index (ESR)) were analyzed before and after treatment. Results Of the 30 cases in the experimental group, 2 were clinically cured, 3 were apparently effective, 21 were effective, and 4 were ineffective, with an overall effective rate of 86.7%; of the 31 cases in the control group, 1 was clinically cured, 1 was apparently effective, 1 was effective. 24 were effective, and 5 were ineffective, with an overall effective rate of 83.9%. Comparing the efficacy by t-test, P < 0.05, indicating that the effect of Du moxibustion + Western medicine treatment was better. Conclusion The treatment of ankylosing spondylitis with kidney-yang deficiency by moxibustion + western medicine can improve the efficacy, alleviate the inflammatory response and improve the patient's symptoms and signs, and immune indexes.

Are Detailed, Patient-level Social Determinant of Health Factors Associated With Physical Function and Mental Health at Presentation Among New Patients With Orthopaedic Conditions?

Are Detailed, Patient-level Social Determinant of Health Factors Associated With Physical Function and Mental Health at Presentation Among New Patients With Orthopaedic Conditions?

Effect of treatment with Fufang Huangqi decoction on dose reductions and discontinuation of pyridostigmine bromide tablets, prednisone, and tacrolimus in patients with type I or II myasthenia gravis.

To investigate the clinical efficacy of Fufang Huangqi decoction in combination with pyridostigmine bromide tablets, prednisone, and tacrolimus in the treatment of type I and II myasthenia gravis (MG) through changes in the clinical symptom scores of 100 patients with type I and II MG. This study also aimed to examine dose reductions and dis-continuation of these 3 Western medicines after administration of Fufang Huangqi decoction. The clinical data on 100 patients with type I or II MG who were treated in the outpatient department of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, China, between June 2017 and June 2020 were collected. The patients were divided into 4 groups based on whether they had taken pyridostigmine bromide tablets, prednisone, and/or tacrolimus at the time of their hospital visit: the Fufang Huangqi decoction group (group A), the pyridostigmine bromide tablets + Fufang Huangqi decoction group (group B), the pyridostigmine bromide tablets + prednisone + Fufang Huangqi decoction group (group C), and the pyridostigmine bromide tablets + tacrolimus + Fufang Huangqi decoction group (group D). The average treatment time was (15.6 ± 11.5) months (range: 0.5-55 months). Changes in the clinical symptom scores of the 4 groups of patients after medication administration and dose reductions and discontinuation of the 3 Western medicines were analyzed. An overall effectiveness rate of 86.00% was achieved in the 100 patients after treatment for (15.6 ± 11.5) months (range 0.5-55 months). The effectiveness rates were 85.71% in group A, 88.24% in group B, 76.92% in group C, and 80.00% in group D. The dosage of pyridostigmine bromide was reduced for 69.12% of the patients in group B for the first time after (4.2 ± 4.1) months, and 45.59% of the patients in group B discontinued pyridostigmine bromide after (8.8 ± 6.1) months. The dosage of pyridostigmine bromide was reduced for 46.15% of the patients in group C for the first time after (5.3 ± 3.4) months, and 23.08% of the patients in group C discontinued pyridostigmine bromide after (19.8 ± 11.0) months; 76.92% reduced hormone dosage after (2.8 ± 1.9) months, and 23.08% discontinued hormone treatment after (6.7 ± 2.9) months. The dosage of pyridostigmine bromide was reduced for 1 patient in group D after 1 month; this patient discontinued pyridostigmine bromide after 3 months and reduced tacrolimus dosage after 5 months. One patient in group D discontinued pyridostigmine bromide and tacrolimus on his own initiative at 0.5 months and took Fufang Huangqi decoction for 2 months without discontinuing Western medicine. Fufang Huangqi decoction is effective for the treatment of type I and II MG and improves the associated clinical symptoms. Moreover, this agent is conducive to dose reductions and discontinuation of basic Western medicines, thereby reducing the side effects experienced by patients.

Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: An assessor-blinded, randomized, controlled pilot study.

Benign prostatic hyperplasia (BPH) is a disease that affects the quality of life by causing lower urinary tract symptoms (LUTS) in men. Electroacupuncture (EA) and moxibustion therapy have been suggested as an adjunct therapy for improving LUTS in patients with BPH, but clinical studies evaluating the effectiveness of EA and its cotreatment with electronic moxibustion (EM) in patients who have been prescribed alpha blockers have yet to be reported. Therefore, this study aimed to evaluate the effectiveness and safety of EA and EM. Twenty-eight patients diagnosed with BPH were randomized to treatment group (TG, n = 14) or control group (CG, n = 14). The TG continued to use the previously prescribed alpha blocker and received the cotreatment of EA and EM 3 times a week for 6 weeks. The CG continued to use the previously prescribed alpha blocker alone for 6 weeks. The primary outcome was the mean change in the international prostate symptom score (IPSS) from baseline to week 6. The secondary outcomes were IPSS at week 3 and 12, clinical relevance, IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume. The IPSS decreased at all time points with a statistically significant difference between the 2 groups (3W: P = .0313; 6W: P = .0010; 12W: P = .0304). Based on the minimal clinically important difference (MCID, 3 points), there were significant differences between the TG and the CG at week 3, 6, and 12 (3W: P = .0461; 6W: P = .0123; 12W: P = .0216). Significant group × week interaction effects were found for the IPSS score (P = .0018), as determined from analyses using repeated measures analysis of variance. There were no significant differences between the 2 groups in IPSS life satisfaction, EuroQol-Five dimensions, average urinary flow rate, maximum urinary flow rate, and prostate volume. EA and its cotreatment with EM might have a beneficial effect as an adjunct therapy in improving LUTS in patients with BPH. Large-scale randomized controlled trials are warranted to confirm the effectiveness and safety of EA and its cotreatment with EM.

Dapagliflozin for heart failure according to body mass index: the DELIVER trial.

Obesity is common and associated with unique phenotypic features in heart failure with preserved ejection fraction (HFpEF). Therefore, understanding the efficacy and safety of new therapies in HFpEF patients with obesity is important. The effects of dapagliflozin were examined according to body mass index (BMI) among patients in the Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure trial. Body mass index was analysed by World Health Organization (WHO) categories and as a continuous variable using restricted cubic splines. Body mass index ranged from 15.2 to 50 kg/m2 with a mean value of 29.8 (standard deviation ± 6.1) kg/m2. The proportions, by WHO category, were: normal weight 1343 (21.5%); overweight 2073 (33.1%); Class I obesity 1574 (25.2%); Class II obesity 798 (12.8%); and Class III obesity 415 (6.6%). Compared with placebo, dapagliflozin reduced the risk of the primary outcome to a similar extent across these categories: hazard ratio (95% confidence interval): 0.89 (0.69-1.15), 0.87 (0.70-1.08), 0.74 (0.58-0.93), 0.78 (0.57-1.08), and 0.72 (0.47-1.08), respectively (P-interaction = 0.82). The placebo-corrected change in Kansas City Cardiomyopathy Questionnaire total symptom score with dapagliflozin at 8 months was: 0.9 (-1.1, 2.8), 2.5 (0.8, 4.1), 1.9 (-0.1, 3.8), 2.7 (-0.5, 5.8), and 8.6 (4.0, 13.2) points, respectively (P-interaction = 0.03). The placebo-corrected change in weight at 12 months was: -0.88 (-1.28, -0.47), -0.65 (-1.04, -0.26), -1.42 (-1.89, -0.94), -1.17 (-1.94, -0.40), and -2.50 (-4.4, -0.64) kg (P-interaction = 0.002). Obesity is common in patients with HFpEF and is associated with higher rates of heart failure hospitalization and worse health status. Treatment with dapagliflozin improves cardiovascular outcomes across the spectrum of BMI, leads to greater symptom improvement in patients with obesity, compared with those without, and has the additional benefit of causing modest weight loss.

Efficacy and Safety of Transurethral Enucleation with Bipolar Energy for Treatment of Benign Prostatic Hyperplasia: Does Prostate Volume Matter?

We evaluated the association of prostate volume (PV) with the efficacy and safety of transurethral enucleation with bipolar energy (TUEB) for treatment of benign prostatic hyperplasia (BPH). We retrospectively evaluated data from 180 patients with symptomatic BPH who underwent TUEB between 2008 and 2015. Efficacy was assessed by perioperative changes in international prostate symptom score (IPSS), Quality of Life Score (QOLS), maximum flow rate on uroflowmetry (Qmax), and serum prostate-specific antigen level (PSA), which were recorded at 3 months postoperatively. Safety was assessed by perioperative incidence of adverse events (AEs). AEs were recorded up to 2 years after surgery. Patients were divided into two groups based on PV as the standard group (SG; PV < 80 mL) and large group (LG; PV ≥ 80 mL). A total of 132 (73%) patients were grouped as the SG, and 48 (27%) were grouped as the LG. No significant differences between the groups were observed in the preoperative variables age, IPSS, and QOLS. However, the LG had a significantly larger PV and higher serum PSA levels. Analysis of surgical outcomes revealed that postoperative changes in IPSS, QOLS, Qmax, serum PSA, serum sodium, and hemoglobin levels did not differ significantly between groups. However, LG had a significantly longer operative time and heavier specimen weight. The rates of early complications, including hyponatremia and blood transfusion, and late complications after surgery did not differ between the groups. The present findings suggest that TUEB is safe and effective for treatment of BPH, regardless of PV.