Reduction In Symptom Score Research Articles

The effect of bariatric surgery on the improvement of lower urinary tract symptoms in morbidly obese male patients.

Lower urinary tract symptoms (LUTS) are strongly linked with obesity. Whether bariatric surgery can effectively alleviate LUTS in morbidly obese men is unknown. The objective of the present study was to evaluate the effectiveness of bariatric surgery in reducing the prevalence and severity of male LUTS in obese patients. This was a prospective observational study on consecutive morbidly obese men undergoing bariatric surgery. The International Prostate Symptom Score (IPSS) was used to assess for LUTS before and at 1-3 years after surgery. The 3-year changes in IPSS, the changes in LUTS severity, and the factors associated with LUTS improvement were evaluated. This study recruited 143 morbidly obese men (mean age 43.0 ± 10.4 years) undergoing sleeve gastrectomy (n = 89) and Roux-en-Y gastric bypass (n = 54). The rates of follow-up after surgery were 94.4% (n = 119/126) at 1 year, 90.6% (n = 96/106) at 2 years, and 81.2% (n = 69/85) at 3 years. After surgery, there was significant body mass index reduction from 39.1 ± 5.2 kg/m2 preoperatively to 30.1 ± 4.8 kg/m2 at 1 year and 31.5 ± 4.9 kg/m2 at 3 years (P < 0.001). There was significant reduction in IPSS total symptom score, quality of life score, frequency score, and nocturia score (P < 0.05). The prevalence of moderate to severe LUTS reduced from 35.0% (29.4% moderate; 5.6% severe) preoperatively to 21.8% (19.3% moderate; 2.5% severe) at 1 year and 30.4% (24.6% moderate; 5.8% severe) at 3 years (P < 0.001). LUTS improvement was significantly associated with body fat percentage reduction (P = 0.012) and was not associated with weight loss or improvement of metabolic parameters. Bariatric surgery was an effective and durable intervention for alleviating the prevalence and severity of LUTS in morbidly obese men for up to 3 years.

Investigating the Efficacy of Equine Assisted Therapy for Military Veterans With Posttraumatic Stress Symptomology

A unique approach in trauma-focused psychotherapy is the evolving field of Equine Assisted Therapy (EAT), a nontraditional, experiential methodology centered on the therapeutic benefits intrinsic in equines. While there is a plethora of anecdotal and qualitative studies showing effectiveness, evidence-based studies are limited, and those that exist have design and implementation flaws such as small sample size, no control group, lack of counselor-administered curriculum and/or assessments, leaving large empirical gaps. To address these gaps, a quasi-experimental nonrandomized control group design was implemented for this study. Fifty veterans participated with 25 assigned to each, intervention and control groups. Veterans in the intervention group completed 3-hour weekly EAT sessions for 10 weeks and those in the control group continued with treatment as usual. Standardized psychometric assessments were PTSD Checklist—Military Version (PCL-M) and Functional Assessment of Chronic Illness Therapy—Spiritual Well-Being Scale (FACIT-Sp). The ANCOVA revealed no significant difference in mean changes for PCL-M, F(1, 43) = 3.255, p = .078, partial η² = .070, which suggests a medium-small effect size, as well as for the FACIT-Sp, F(1, 43) = .368, p = .547, partial η² = .008, which suggests a small effect size. However, paired samples <em>t</em>-test showed significant reduction in PTSD symptom scores for intervention group when compared to control group. While no conclusion regarding efficacy can be made, the results may be a useful lens to further examine the potential benefits of incorporating a multidimensional, biopsychosocial-spiritual model which could leverage significant outcomes of holistic health for veterans with PTSD symptomology.

Harnessing Mental Imagery and Enhancing Memory Specificity: Developing a Brief Early Intervention for Depressive Symptoms in Adolescence

BackgroundTreatment innovation for depressive symptoms in adolescence is urgently needed. Adult research suggests interventions targeting underlying cognitive mechanisms, such as dysfunctional mental imagery and overgeneral memory, are promising. Here, we describe and evaluate in a case series a brief imagery-based intervention for depressive symptoms that targets these cognitive mechanisms.MethodsNine participants completed the four-session intervention, whose principle components were imagery rescripting and memory specificity training. Questionnaires and experimental tasks (assessing symptomatology and cognitive mechanisms) were administered at three time points: pre-intervention, post-intervention and 3-month follow-up.ResultsThe intervention was feasible to deliver and acceptable to participants. There was a large reduction in depression symptom scores from pre to post intervention (d = 1.32; 67% showed reliable improvement, RI) and this was maintained at follow-up (d = 1.46; RI = 75%). There were also reductions in anxiety (post: d = 1.15, RI = 44%; follow-up: d = 1.67, RI = 63%), increases in self-esteem (post: d = − 0.70, RI = 44%; follow-up: d = − 1.20, RI = 50%) and noteworthy changes in memory specificity (post: d = − 1.80, RI = 67%; follow-up: d = − 0.94, RI = 63%).ConclusionsThis is the first study to use imagery rescripting and memory specificity training in adolescence. Initial evidence is provided that the intervention is acceptable and may have clinical utility. Future randomised controlled trials are needed to further assess the intervention.

Efficacy of Topical Cyclosporine 0.05% the Treatment of Vernal Keratoconjunctivitis

Vernal Keratoconjunctivitis is a chronic bilateral seasonally exacerbated allergy affecting the conjunctiva and cornea of children. As technology has advanced, newer medications have been developed for the control of the disease. To assess the effectiveness of an immunomodulator, cyclosporine, in the treatment of vernal keratoconjunctivitis. Fifty patients of moderate, severe to very severe vernal keratoconjunctivitis were selected for the study. They were given cyclosporine 0.05% eye drops in loading dose followed by gradual tapering. Symptoms and signs were recorded at presentation, after two weeks, after four weeks, after two months and after three months. Vernal keratoconjunctivitis, being a chronic disease showed marked improvement with immunomodulator therapy. There was significant improvement in the symptom and sign score initially, at the first follow up itself with symptom score reduction from median of mean of 2.4 to 0.6 (p=0.00) and a similar sign score reduction from 1.75 to 0.625 (p=0.00). There was gradually more improvement as therapy continued and the beneficial effects were maintained till the end point of the study at three months where median of mean symptom score was 0.4 (p=0.00) and similar sign score of 0.375 (p= 0.000). Topical cyclosporine proved to be an effective and safe treatment strategy to treat cases of moderate, severe and very severe vernal keratoconjunctivitis.

Safety and efficacy of the combination of sonidegib and ruxolitinib in myelofibrosis: a phase 1b/2 dose-finding study

AbstractThe sonidegib and ruxolitinib combination was assessed in an open-label study in JAK inhibitor-naive patients with myelofibrosis (MF). The primary objective of phase 1b was to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and phase 2 was to assess spleen volume reduction at weeks 24 and 48. Fifty patients were enrolled. In the dose-escalation phase (n = 23), doses for sonidegib once daily/ruxolitinib twice daily were 400/10 mg (level 1, n = 8), 400/15 mg (level 2, n = 10), and 400/20 mg (level 3, n = 5). Two patients had dose-limiting toxicity at level 2: increased blood creatine phosphokinase (grades 3 and 4, n = 1 each). MTD/RP2D was determined as sonidegib 400 mg daily + ruxolitinib 20 mg twice daily. In phase 1b expansion and phase 2 stage 1 (n = 27), by weeks 24 and 48, ≥35% reduction in spleen volume was observed in 44.4% and 29.6% patients, respectively. By weeks 24 and 48, 42.0% and 26.0% patients had ≥50% reduction in Myelofibrosis Symptom Assessment Form total symptom score, respectively. Most common treatment-related adverse events (grade 3/4) were increased blood creatine phosphokinase (18%), anemia (14%), and thrombocytopenia (12%). Four deaths were reported due to multiple organ dysfunction syndrome (on-treatment; no relationship with study treatment), acute myeloid leukemia, MF progression, and aspiration pneumonia. Although well tolerated, this combination will not be further developed in MF patients due to modest overall benefit compared with historical ruxolitinib monotherapy. This trial was registered at www.clinicaltrials.gov as #NCT01787552.

Anti-Heartburn Effects of Sugar Cane Flour: A Double-Blind, Randomized, Placebo-Controlled Study.

Gastroesophageal reflux disease (GERD) affects approximately 20% of Australians. Patients suffer a burning sensation known as heartburn due to the movement of acidic stomach content into the esophagus. There is anecdotal evidence of the effectiveness of prebiotic sugarcane flour in controlling symptoms of GERD. This pilot study aimed to investigate the effectiveness of a prebiotic sugarcane flour in alleviating symptoms in medically-diagnosed GERD patients. This pilot study was a single center, double-blinded, placebo-controlled randomized trial conducted on 43 eligible participants. The intervention group (n = 22) were randomized to receive 3 g of sugarcane flour per day, and the control group (n = 21) received 3 g of cellulose placebo per day. Symptoms of gastroesophageal reflux disease were assessed before and after three weeks treatment using the validated Gastroesophageal Reflux Disease-Health Related Quality of Life questionnaire (GERD-HRQL). After three weeks there were significant differences in symptoms for heartburn, regurgitation, and total symptoms scores (p < 0.05) between the sugarcane flour and placebo. Mean GERD-HRQL scores increased in the placebo group for regurgitation (mean increase 1.7; 95% CI 0.23 to 3.2; p = 0.015) and total symptom scores (2.9; 95% CI 0.26 to 5.7; p = 0.033). In contrast, there were significant reductions in heartburn (mean decrease −2.2; 95% CI −4.2 to −0.14; p = 0.037) and total symptom scores (−3.7; 95% CI −7.2 to −0.11; p = 0.044) in the intervention group. This pilot study has shown significant positive effects of sugarcane flour in the reduction of GERD symptoms, and a larger randomized controlled trial is warranted.

174-LB: Association between Metformin Treatment and Improved Symptoms of Post-Traumatic Stress Disorder

U.S. veterans have a high prevalence of post-traumatic stress disorder (PTSD), for which no effective psychotropic medications are indicated. Nearly 25% of veterans have diabetes, for which metformin is a first line treatment. Although metformin is associated with improved neurodegenerative outcomes, there is no evidence on the association between metformin and PTSD-related symptom relief. This study aimed to examine whether metformin was associated with a clinically meaningful reduction in PTSD symptoms (≥20 points reduction PTSD checklist for DSM-5 {PCL-5}) score)) among veterans with PTSD using data from Veterans Health Administration. The metformin cohort was defined as first metformin use after a recorded PTSD diagnosis with a PCL-5 score ≥33 (i.e., clinical cut-score). The control cohort (never used metformin) was selected by propensity score 1:1 matching on the likelihood of initiating metformin with the covariates of age, gender, race, durations of PTSD, diabetes, and depression, and baseline CCI, PCL-5, and PHQ-9 scores. Multivariable Cox proportional regression was used to assess the association between metformin exposure and improvement in the PCL-5 scores. A total of 7950 veterans (mean age: 51.9 ± 13.6 years, male: 85%, white: 61.4%, African American: 28.8%) with confirmed PTSD were comparable on the baseline demographics and medical conditions between metformin and control PSM-matched cohorts with a median follow-up 1.2 years in both cohorts. The baseline PCL-5 score was 56.2±11.6 and 56.5±11.7 in metformin and control cohort, respectively. The metformin-treated cohort was more likely to have a clinically meaningful reduction in PTSD symptoms (adjusted hazard ratio (aHR): 1.31, 95%CI: 1.16-1.48), compared the control cohort. Furthermore, patients on metformin ≥2 years were 22% more likely to reduce PTSD symptoms (aHR: 1.22, 95%CI: 1.04-1.43), compared with metformin exposure &amp;lt;2 years. Metformin exposure may be beneficial to PTSD symptoms among veterans. Disclosure S. Liu: None. A.M. Raines: None. Y. Yoshida: None. W. Tang: None. J.I. Constans: None. V. Fonseca: Consultant; Self; Abbott, Asahi Kasei Corporation, AstraZeneca, Bayer Inc., Novo Nordisk Inc., Sanofi. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Stock/Shareholder; Self; Amgen, Bravo4health. L. Shi: None.

Effectiveness and safety of betahistine in treatment naive acute peripheral vertigo patients

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; The objective of the study was to assess the effectiveness and safety of oral betahistine in treatment naïve patients with acute peripheral vertigo, administered over 21 days.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; Treatment naïve patients with confirmed peripheral vertigo, based on clinical diagnosis, were enrolled in this open-label, single-arm, interventional study. Patients received 48 mg betahistine (16 mg, TDS) for 21 days, and were followed up on day 1, 3, 7 and 21. Safety and effectiveness were assessed based on clinical response (scale for vestibular vertigo severity level and clinical response evaluation (SVVSLCRE)); frequency and severity of peripheral vertigo (videonystagmography (VNG)); dizziness handicap inventory (DHI). &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; Overall, 53 (70.67%) out of 75 enrolled patients completed 21 days of treatment and were included in the study. No significant improvement in SVVSLCRE score was noted from baseline to day 1 (p=0.0572), but significant reduction was seen from day 3 onwards and continued till day 21 (p&amp;lt;0.0001). Level wise severity analysis showed that patients with ‘moderate to severe’ category at baseline reported ‘mild’ severity on day 7. A significant reduction in mean change of DHI scale was observed from baseline to day 3, day 7 and day 21 (p&amp;lt;0.0001). No major therapy related serious adverse events were reported. Headache (4.0%) and nausea (2.6%) were the commonly reported adverse events, which were mild in nature.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Findings suggest that 48 mg betahistine (16 mg, TID) therapy is effective in treatment naive patients with acute peripheral vertigo. Reduction in vertigo symptoms score was significant from day 3 to day 21. Betahistine was found to be safe and easily tolerated in these patients.&lt;/p&gt;

Impact of Renal Supportive Care on Symptom Burden in Dialysis Patients: A Prospective Observational Cohort Study

ContextSymptom burden is a strong predictor of reduced health-related quality of life and survival in patients with end-stage kidney disease. Renal supportive care (RSC) is a comprehensive approach shown to benefit symptoms in nondialysis conservatively managed patients, although its role in dialysis patients has not been reported. ObjectivesThis study aimed to investigate the impacts of RSC intervention on symptoms in dialysis patients. MethodsDialysis patients who were referred to an RSC clinic for symptom control between April 2010 and December 2017 were followed prospectively. Symptoms were scored using the Integrated Palliative care Outcomes Scale-Renal Inventory. Change in symptoms was analyzed at three visits and at final RSC visit within the study period. Correlation and linear regression were used to assess for effect modifiers. ResultsA total of 127 dialysis patients attended the RSC clinic for symptom management. Median age was 74 years, 62% males, median dialysis vintage was 2.2 years, and median-modified Charlson Comorbidity Index was 7. Mean combined physical and emotional symptom score at baseline was 17.5 (SD 9.6), the most overwhelming/severe symptoms being difficulty sleeping (35%), pain (31%), lack of energy (31%), poor mobility (24%), and itch (22%). Eighty patients had follow-up to at least three RSC visits (median 3.1 months). There was significant improvement in combined physical and emotional symptom score during three clinic visits (18.1 vs. 14.2; mean change −3.8; 95% CI −5.7 to −1.9; P < 0.001), with greatest improvement in symptom scores for the five most severe symptoms (each P < 0.001). Follow-up of these 80 patients to final RSC visit (median 13.0 months) showed sustained reduction in mean combined physical and emotional symptom score (18.1 vs. 14.4; mean change −3.7; 95% CI −5.6 to −1.7; P < 0.001). These changes occurred without change in dialysis delivery. ConclusionRSC intervention that focuses on symptom control and patient-centered care is associated with improved total and individual symptom burden in dialysis patients. This supports a role for RSC as a management adjunct in these patients.

Does CPAP treat depressive symptoms in individuals with OSA? An analysis of two 12-week randomized sham CPAP-controlled trials

BackgroundDepression is common in patients with obstructive sleep apnea (OSA). Whether treating OSA with continuous positive airway pressure (CPAP) improves depressive symptoms remains inconclusive. We examined the impact of CPAP on depressive symptoms in OSA patients compared to sham CPAP. MethodsA sub-analysis of two previous randomized sham-controlled trials was conducted. 126 male OSA patients (age = 51 ± 11 years; BMI = 32.0 ± 5.1 kg/m2; apnea hypopnea index = 42.4 ± 22.6 events/hour) were randomised either to therapeutic CPAP (n = 65) or sham CPAP (n = 61). Depressive symptoms were measured using the Depression, Anxiety and Stress Scale (DASS). The main outcome was the change in the DASS depression score (DASSD) after three months between the therapeutic and sham CPAP arms. ResultsThe change in DASSD at three months did not differ between therapeutic and sham CPAP (mean difference: 0.5, 95% CI -3.6 to 4.6, p = 0.80). There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9). In a secondary analysis of patients with baseline depression, adherent therapeutic CPAP use was associated with a greater reduction in DASSD scores compared to non-adherers (−10.0, 95% CI -18.3 to −1.8, p = 0.019). Conclusions: Overall, three months of CPAP did not significantly improve depression scores in OSA patients. Adherent use of therapeutic CPAP in patients with baseline depressive symptoms was associated with a reduction in symptom score. Future trials involving OSA patients with higher depressive symptoms will enable us to understand the complex interaction between OSA and depression.

Safety, efficacy and pharmacokinetics of repeat subcutaneous dosing of avexitide (exendin 9-39) for treatment of post-bariatric hypoglycaemia.

To evaluate the safety, efficacy and pharmacokinetics of repeat dosing of two formulations of subcutaneous (SC) avexitide (exendin 9-39) in patients with post-bariatric hypoglycaemia (PBH). In this phase 2, multiple-ascending-dose study conducted at Stanford University, 19 women with PBH underwent a baseline oral glucose tolerance test (OGTT), with metabolic and symptomatic assessments. Fourteen were then sequentially assigned to receive one of four ascending-dose levels of twice-daily lyophilized (Lyo) avexitide by SC injection for 3 days. On the basis of safety, efficacy and tolerability, five additional participants then received a novel liquid formulation (Liq) of avexitide by SC injection at a fixed dose of 30 mg twice daily for 3 days. All 19 participants underwent a repeat OGTT on day 3 of dosing to quantify metabolic, symptomatic and pharmacokinetic responses. Treatment with Lyo avexitide reduced the magnitude of symptomatic hyperinsulinaemic hypoglycaemia at all dose levels, with dose-dependent improvements in glucose nadir, insulin peak and symptom score; doses ≥20 mg twice daily did not require glycaemic rescue (administered at glucose <2.8 mmol/L). Participants receiving Liq avexitide 30 mg twice daily did not require any glycaemic rescue, and on average achieved a 47% increase in glucose nadir, a 67% reduction in peak insulin, and a 47% reduction in overall symptom score. Equivalent doses of Liq versus Lyo avexitide yielded higher and more sustained plasma concentrations. Both formulations were well tolerated. In patients with PBH, twice-daily administration of SC avexitide effectively raised the glucose nadir and prevented severe hypoglycaemia requiring rescue intervention. Avexitide may represent a viable therapy for PBH.

Efficacy and Safety of Clidinium/Chlordiazepoxide as an Add-on Therapy in Functional Dyspepsia: A Randomized, Controlled, Trial.

The treatment of refractory functional dyspepsia (FD) is a challenge. Clidinium/chlordiazepoxide is a combination of antispasmodic and anxiolytic drugs that has been used as an adjunct treatment for FD in clinical practice with limited supporting evidence of efficacy. The aim of the study is to assess the efficacy and safety of clidinium/chlordiazepoxide as an adjunct treatment to a proton pump inhibitor (PPI) in refractory dyspepsia. We performed a study of patients who met the Rome IV criteria for FD who failed to respond to PPIs. Patients were randomly assigned to groups that received clidinium/chlordiazepoxide or placebo as an add-on treatment to PPI for 4 weeks. The primary outcome was the rate of responders, which was defined as a > 50% reduction in dyspepsia symptom score after 4 weeks of treatment. The secondary outcomes were an improvement in the quality of life and the safety profile. Between March 2017 and February 2018, 78 patients were enrolled. The rates of responders in the clidinium/chlordiazepoxide group and placebo groups were 41.03 % and 5.13% at week 4 (P < 0.001). The clidinium/chlordiazepoxide group also showed significant improvement in overall quality of life over placebo. However, the clidinium/chlordiazepoxide group had more frequent drowsiness than the placebo group (30.27% vs 6.52%, P = 0.034). There were no major adverse events in either group. Clidinium/chlordiazepoxide significantly improved dyspeptic symptoms and quality of life. This combination may be used as an add-on therapy in FD patients without major adverse events.

Effects of interoceptive training on decision making, anxiety, and somatic symptoms

BackgroundInteroception is the perception of afferent information that arises from any point within the body. Individual differences in interoception have been associated with affective processing and decision-making processing. The somatic marker hypothesis summarizes the potential effects of interoception on decision-making processes. According to this theory, individuals with interoceptive dysfunction exhibit disadvantageous decision making. Recently, enhancement of interoceptive accuracy, an element of interoception assessed by objective decision-making tasks, has been demonstrated using biofeedback. Garfinkle et al. developed an interoceptive training task, modified from the heartbeat perception task, which enhanced interoceptive accuracy and reduced anxiety symptoms. The purpose of this study was to determine the effects of interoceptive training on decision-making processes. Based on improvements in interoceptive accuracy, we hypothesized that decision-making scores would change in a manner indicative of increased rationality.MethodsThis longitudinal interventional study was performed with interoceptive training. Before and after the intervention, interoceptive accuracy and rationality of decision-making processes were assessed using a heartbeat perception task and rational decision-making tasks, respectively. Fourteen healthy volunteers (nine women; mean age, 21.9 ± 4.5 years) participated. The analysis included data from 12 participants. To detect individual differences in the effects of interoceptive accuracy on rationality of decision making, correlation analysis was conducted on change ratios of the indices of interoceptive accuracy and rationality of decision making.ResultsInteroceptive training resulted in significant enhancement of interoceptive accuracy scores and significant reductions in somatic symptom and state anxiety scores. In contrast, interoceptive training did not cause significant changes in decision-making indices. There was a significant positive correlation between change ratios of indices of interoceptive accuracy and rationality of decision making.ConclusionsThe results suggested a causal relation between interoception and rationality of decision making. These findings will enhance the understanding of mechanisms underlying alterations of decision-making related to psychotherapy by focusing on interoception.Trial registrationTrial registration number: UMIN000037548.

Randomised clinical trial: transabdominal interferential electrical stimulation vs sham stimulation in women with functional constipation.

Managing chronic constipation is challenging as patients frequently remain dissatisfied with laxative treatments. Novel studies using transabdominal electrical interferential therapy in children have shown benefit but there are inadequate adult studies. To examine the effects of transabdominal interferential stimulation on bowel symptoms and quality of life in women with refractory constipation. In a single-blind, randomised, sham-controlled pilot study, women aged ≥18years with refractory constipation were randomised to receive interferential stimulation (with crossing of electric currents) or a novel sham stimulation (with no crossing of currents) for 1hour a day for 6weeks. Primary outcome was the number of patients with ≥3 spontaneous bowel movements/week. Secondary endpoints included change in PAC-SYM (Patient Assessment of Constipation-SYMptoms), PAC-QOL (Patient Assessment of Constipation-Quality of Life) and an overall symptom severity score (measured at baseline, mid time point of stimulation, end of treatment and 3months after cessation of treatment). Interferential therapy (n=17) met the primary outcome in 9(53%) compared with 2(12%) with sham therapy (n=16) (P=0.02). Interferential therapy resulted in reductions in PAC-SYM (P=0.03) and overall symptom scores (P=0.05). Laxative use more than halved in 66% with interferential therapy compared with 14% with sham therapy (P=0.01). Significant improvements in symptom outcomes were maintained at 3months. There were no treatment-related adverse effects. Transabdominal interferential electrical stimulation is effective in reducing constipation in adult women. Three months after therapy, response is maintained and quality of life improved. Not allowing currents to cross intra-abdominally was an effective placebo. (Australianclinicaltrials.gov.au ACTRN12614000736640).

The Systematic Medical Appraisal Referral and Treatment Mental Health Project: Quasi-Experimental Study to Evaluate a Technology-Enabled Mental Health Services Delivery Model Implemented in Rural India.

BackgroundAlthough around 10% of Indians experience depression, anxiety, or alcohol use disorders, very few receive adequate mental health care, especially in rural communities. Stigma and limited availability of mental health services contribute to this treatment gap. The Systematic Medical Appraisal Referral and Treatment Mental Health project aimed to address this gap.ObjectiveThis study aimed to evaluate the effectiveness of an intervention in increasing the use of mental health services and reducing depression and anxiety scores among individuals at high risk of common mental disorders.MethodsA before-after study was conducted from 2014 to 2019 in 12 villages in Andhra Pradesh, India. The intervention comprised a community antistigma campaign, with the training of lay village health workers and primary care doctors to identify and manage individuals with stress, depression, and suicide risk using an electronic clinical decision support system.ResultsIn total, 900 of 22,046 (4.08%) adults screened by health workers had increased stress, depression, or suicide risk and were referred to a primary care doctor. At follow-up, 731 out of 900 (81.2%) reported visiting the doctor for their mental health symptoms, compared with 3.3% (30/900) at baseline (odds ratio 133.3, 95% CI 89.0 to 199.7; P<.001). Mean depression and anxiety scores were significantly lower postintervention compared with baseline from 13.4 to 3.1 (P<.001) and from 12.9 to 1.9 (P<.001), respectively.ConclusionsThe intervention was associated with a marked increase in service uptake and clinically important reductions in depression and anxiety symptom scores. This will be further evaluated in a large-scale cluster randomized controlled trial.

Gaps in the Management of Depression Symptoms Following Cancer Diagnosis: A Population-Based Analysis of Prospective Patient-Reported Outcomes.

One of the most common psychological morbidities of cancer is depression. Routine depression symptoms screening (DSS) is recommended, but its ability to lead to psychosocial interventions in clinical practice is limited. We examined the use of and factors associated with psychosocial interventions for positive DSS following cancer diagnosis. We conducted a population-based cohort study of patients with diagnoses from 2010 to 2017 who reported ≥1 patient-reported Edmonton Symptom Assessment System (ESAS) score. Positive DSS was defined as ESAS ≥2 out of 10 for the depression item within 6 months of diagnosis. Outcomes were psychosocial interventions around the time of positive DSS: palliative care assessment, psychiatry/psychology assessment, social work referral, and antidepressant therapy (in patients ≥65 years of age with universal drug coverage). We examined reduction in depression symptom score (≥1 point) following intervention. Modified Poisson regression examined factors associated with interventions. Of 142,270 patients, 65,424 (46.0%) reported positive DSS at a median of 66 days (interquartile range: 34-105) after diagnosis. Of those with depression symptoms, 17.1% received palliative assessment, 1.7% psychiatry/psychology assessment, 8.4% social work referral, and 4.3% antidepressant therapy. Depression symptom score decreased in 67.2% who received palliative assessment, 63.7% with psychiatry/psychology assessment, 67.3% with social work referral, and 71.4% with antidepressant therapy. On multivariable analysis, patients with older age, rural residence, lowest income quintile, and genitourinary or oropharyngeal cancer were more likely to not receive intervention other than palliative care. The proportion of patients reporting positive DSS after cancer diagnosis receiving psychosocial intervention is low. We identified patients vulnerable to not receiving interventions, who may benefit from additional support. These data represent a call to action to modify practice and optimize the usefulness of systematic symptom screening. Patient-reported depression symptoms screening should be followed by targeted interventions to improve symptoms and patient-centered management.

Enhanced Efficacy of Dust Mite Sublingual Immunotherapy in Low-Response Allergic Rhinitis Patients after Dose Increment at 6 Months: A Prospective Study

Background: Several studies have suggested that sublingual immunotherapy (SLIT) involves a dose-response relationship and inadequate dosage might not achieve a favorable clinical effect. Objective: The aim of this prospective study was to investigate the efficacy and safety of increasing SLIT dosage at 6 months in patients with house dust mite-induced allergic rhinitis (AR) who had low response to treatment. Methods: A total of 157 AR participants aged 4–60 years were enrolled and received SLIT with Dermatophagoides farinae drops. After 6 months of SLIT, patients were interviewed and then classified into a high-response (HR) group and a low-response (LR) group based on the combined symptom and medication score (CSMS) reduction rate. Patients with a CSMS reduction rate over 50% were defined as HR and continued the original dose, while patients with a CSMS reduction rate ranging from 20 to 50% were defined as LR and received an increased dose (percentage of dosage increment, 33.33% for patients aged <14 years and 50% for patients aged ≥14 years). Patients with a CSMS reduction rate below 20% were considered nonresponse (NR) and recommended to withdraw from SLIT. CSMS, visual analog scale (VAS), and adverse events were assessed at 0.5, 1, 2, and 3 years during the 3-year treatment. Results: A total of 54 and 56 patients completed the treatment in the HR and LR groups, respectively. The CSMS and VAS of both groups decreased significantly at 6 months (p < 0.05). Significant differences between the two groups were found in CSMS and VAS at 6 months and 1 year (p < 0.05), but not in later follow-ups (p > 0.05). The improvement of adults in the LR group was significantly lower than that of children at 6 months (p < 0.05), but there was no difference in later follow-ups (p > 0.05). There was no difference in CSMS or VAS in patients with monosensitization and polysensitization in the same treatment group at 1 year and in subsequent visits (p> 0.05). Overall, 47 patients withdrew from this study due to NR (n = 22) and other reasons (n = 25). Conclusions: Six months might be a critical time point for efficacy assessment and dosage adjustment for AR patients after SLIT. In patients with low response, dosage enhancement within a certain range may enhance the effectiveness of SLIT.

Effects of a topical ointment on responses to treatments used for common genital diseases and on quality of life

Abstract This study assessed the impacts of an ointment on treatment efficacy, side effects and global tolerance of most common genital diseases. This observational study enrolled symptomatic patients with LS and psoriasis under maintenance therapy (topical steroids); patients with condyloma acuminata treated with liquid nitrogen and/or imiquimod; patients suffering from vulvodynia under multidisciplinary treatment. The tested ointment was added to the usual treatment. Subjective and objective clinical scores, tolerance and Dermatology Life Quality Index (DLQI) were evaluated. One hundred patients completed the study: 26 LS, 6 psoriasis, 52 CA and 16 vulvodynia. There were significant reductions in global symptom and clinical scores for LS (−80.61% and −59.20%, respectively, mean follow-up 66 days) and psoriasis (−82.88% and −82.80%, respectively, mean follow-up of 51 days). The DLQI decreased by 40.17% for LS and 76.92% for psoriasis. The use of ointment resulted in low post-treatment scores for CA (Symptom score: 1.92/maximum 50, clinical score: 2.46/24 maximum, mean follow-up of 17 days). Tolerance was good for all except two patients (one CA, one vulvodynia). Our results indicated the daily applications of an ointment improved treatments for lichen sclerosus, psoriasis (symptoms, clinical signs and quality of life) and for condyloma acuminata (reduced healing time) and was well tolerated during vulvodynia.

Putative Antidepressant Effect of Chamomile (Matricaria chamomilla L.) Oral Extract in Subjects with Comorbid Generalized Anxiety Disorder and Depression.

Objectives: This exploratory analysis examined the putative antidepressant effect of Matricaria chamomilla L. (chamomile) extract in subjects with generalized anxiety disorder (GAD) with or without comorbid depression. It was hypothesized that chamomile extract would demonstrate similar anxiolytic activity in both subgroups, but superior antidepressant activity in GAD subjects with comorbid depression. Design: As part of a randomized double-blind placebo-controlled trial of chamomile extract for relapse prevention of GAD, 179 subjects received initial therapy with open-label chamomile extract 1500 mg daily for 8 weeks. Linear mixed-effect models were used to identify clinically meaningful changes in anxiety and depression symptoms between diagnostic subgroups. Settings/Location: The study took place at the University of Pennsylvania in Philadelphia, PA. Subjects: Subjects were ≥18 years old with a primary DSM IV-TR diagnosis of GAD. They were subcategorized into two diagnostic groups: GAD without comorbid depression (n = 100) and GAD with comorbid depression (n = 79). Interventions: Open-label chamomile extract 1500 mg was given daily for 8 weeks. Outcome measures: Generalized anxiety disorder (GAD-7), Hamilton rating scale for anxiety, Beck anxiety inventory, Hamilton rating scale for depression (HRSD), the six-item core HRSD (items 1, 2, 3, 7, 8, and 13), and the Beck depression inventory (BDI). Results: The authors observed similar anxiolytic effects over time in both diagnostic subgroups. However, there was a greater reduction in HRSD core symptom scores (p < 0.023), and a trend level reduction in HRSD total scores (p = 0.14) and in BPI total scores (p = 0.060) in subjects with comorbid depression. Conclusions: M. chamomilla L. may produce clinically meaningful antidepressant effects in addition to its anxiolytic activity in subjects with GAD and comorbid depression. Future controlled trials in subjects with primary major depressive disorder are needed to validate this preliminary observation.

The Efficacy and Safety of Fluticasone/Salmeterol Compared to Fluticasone in Children Younger Than Four Years of Age

The combination of inhaled corticosteroid (ICS) and long-acting β-2 agonist (LABA) is widely used as maintenance therapy for children with asthma. However, use in young children has not been well studied. This study investigates the efficacy and safety of combination therapy with fluticasone propionate 50 µg and salmeterol xinafoate 25 µg in children up to 4 years of age.Study participants were children aged 6 months to 4 years with asthma diagnosed according to the Japanese Pediatric Guideline for the Treatment and Management of Asthma 2012 and in whom ICS and LABA was considered necessary by their physician.This 27-week double-blind, randomized controlled trial was conducted from May 2014 to October 2016 in 70 Japanese pediatric centers. The study consisted of 4 time intervals: (1) a 2-week run-in period, during which all children received inhaled fluticasone propionate twice daily; (2) an 8-week randomized treatment period, during which fluticasone only or fluticasone and salmeterol was administered twice daily; (3) a 16-week open-label period, during which all children received fluticasone and salmeterol twice daily; and (4) a 1-week follow-up period, during which children received care that the investigator felt was appropriate. Children <2 years received 1 inhalation per dose, whereas children 2 years or older received 1 to 2 inhalations per dose, according to the investigator’s judgment. The number of inhalations remained consistent during the run-in and treatment phases but could be adjusted during the open-label phase, if appropriate. As needed, salbutamol 100 µg was allowed as a rescue inhaler. Study endpoints and compliance were assessed via twice-daily recordings in a patient diary by the parent or legal guardian.A total of 300 patients were randomized 1:1 to the double-blind period, of whom 148 completed treatment with ICS and LABA, and 142 completed treatment with ICS only. The study was completed by 268 patients. In both treatment groups, boys predominated, and the majority (≥90%) of patients had moderate or severe persistent asthma. Both groups showed reduction in total asthma symptom scores; however, the primary end point of mean change in total asthma symptom scores from baseline to the last 7 days of the treatment period was not significantly different between the 2 groups (−3.97 for ICS and LABA versus −3.01 for ICS only, P = .21). Secondary outcome analysis showed fewer exacerbations in the ICS and LABA group (3% vs 5% in the ICS group) and statistically greater mean change from baseline in Japanese Pediatric Asthma Control scores in the ICS and LABA group (0.4 points vs −0.3 points for ICS only, P = .04). Little change from baseline in daily rescue medication use or percentage of rescue-free days was seen, with no statistically significant differences between the groups. Incidence of adverse effects was virtually identical between the ICS and LABA (74%) and ICS only (73%) groups and was not associated with age or number of inhalations. No new safety concerns were identified during the open-label period. Decreased plasma cortisol was reported in 6 children during the open-label and follow-up periods, although most values normalized on recheck. No serious adverse effects were considered by the investigators to be drug related.Combination therapy with ICS and LABA showed similar safety profiles to ICS alone in children with asthma up to 4 years of age. Although combination therapy improved total asthma symptom scores, it did not show superior efficacy to ICS alone.Asthma management in young children is challenging because of inability to perform pulmonary function tests and the intermittent nature of symptoms, with many children being clinically well in between exacerbations. Importantly, this study provides new evidence regarding the safety of ICS and LABA use in young children. Regarding efficacy, statistically significant differences were seen for some secondary outcomes, which may suggest better symptom control with ICS and LABA, although it is unclear if these differences warrant the use of ICA and LABA over ICS only in this age group. Further studies are needed to make this determination and support the findings in this study.