Predictors Of Clinical Improvement Research Articles

Baseline Left Ventricle Longitudinal Strain as a Predictor for Clinical Improvement Following Coronary Sinus Reducer Implantation

Coronary sinus narrowing device (reducer) implantation has emerged as an effective treatment to improve the quality of life and functional capacity in patients suffering from disabling refractory angina. Left ventricle global longitudinal strain (LV-GLS) is a useful tool for early diagnosis of subclinical cardiac injury and an independent predictor for coronary artery disease. We aimed to investigate whether LV-GLS could help predict clinical improvement after coronary sinus reducer implantation. LV-GLS assessments were performed at baseline and 6months after reducer implantation in consecutive patients treated for refractory angina. Patients were divided into 2 groups based on reduced (<17% absolute value) or preserved baseline LV-GLS. Clinical improvement was defined as an increase of ≥25m in the 6-minute walk test (6MWT) at follow-up. Overall, 41 patients were included, 31 in the reduced LV-GLS group and 10 in the preserved LV-GLS group. The mean age was 68±8years, with only 2 female patients (5%). Baseline characteristics did not differ significantly between the 2 groups. Univariable analysis revealed that LV-GLS was the only significant predictor for 6MWT improvement. Baseline preserved LV-GLS reduced the likelihood of 6MWT improvement by 82% (odds ratio 0.18 [0.04 to 0.83], p=0.029). A significant increase in 6MWT (307±97m to 343±92m, p=0.017) was observed in the reduced LV-GLS group, compared with a decrease in the preserved LV-GLS group (378±86m to 361±123m, p=0.651). In conclusion, reduced LV-GLS may serve as a marker for potential clinical improvement in patients with refractory angina treated with reducer. Larger clinical trials are needed to establish its role.

Clinical Phenotyping and Multimodal Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome From the Middle East and North Africa: Determining Treatment Outcomes and Predictors of Clinical Improvement

To evaluate the effectiveness of UPOINT based multimodal treatment on patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), and determine factors that could be associated with clinical improvement. A retrospective study was conducted in Doha, Qatar including patients with CP/CPPS from the Middle East and North Africa. The UPOINT phenotyping system was used to classify patients and guide their multimodal therapy. NIH-CPSI scores were computed initially and after 3 months of treatment, and predictors of clinical improvement were assessed. The total NIH-CPSI improved significantly with a mean reduction of 8.21 after 3 months of treatment (P < .001). 66.2% of patients had a clinical improvement demonstrated as a total NIH-CPSI score reduction by at least 6 points after 3 months of treatment. No significant association was found between clinical improvement, and extent of pain (ORa=1.198, 95% CI 0.392-3.662, P=.751), initial total NIH-CPSI (ORa=0.983, 95% CI 0.886-1.089, P=.738), number of positive UPOINT domains (ORa=0.871, 95% CI 0.451-1.681, P=.681), and number of prescribed therapies (ORa=1.118, 95% CI 0.699-1.789, P=.641). UPOINT phenotyping and directed therapy is associated with an important improvement in the CP/CPPS. Therapeutic response does not appear to related to age or ethnicity. Clinical improvement is also not predicted by initial extent and severity of the disease, whether relating to NIH-CPSI or the number of positive UPOINT phenotypes, neither to the number of therapies involved in the multimodal treatment strategy.

Therapeutic plasma exchange in MS refractory relapses: Long-term outcome

IntroductionTherapeutic plasma exchange (TPE) is considered a treatment option for steroid-refractory multiple sclerosis (MS) relapses. Our objective was to assess long-term clinical response to TPE in MS steroid-refractory exacerbations. MethodsRetrospective study of relapsing remitting MS (RRMS) patients presenting intravenous methylprednisolone (IVMPS)-refractory relapses, who underwent TPE. Response to TPE was assessed at 1, 3, 6, 12 and 24-months post-treatment, and compared to a second group of RRMS patients with similar demographic and clinical characteristics presenting, IVMPS-refractory relapses but not treated with TPE. Multivariate regression analysis was used to assess potential predictors of significant clinical response. ResultsBetween 2011 to 2020, a total of 23 RRMS patients were treated with TPE. Twenty-one patients not receiving the treatment served as controls. No differences in demographic or clinical characteristics, or predictors of clinical improvement after TPE were detected between groups. Seventy-eight percent of patients treated with TPE presented clinical improvement at 24 months. TPE-treated patients presented lower EDSS scores at 6 and at 24 months. Younger age, presence of gadolinium-enhancing lesions and TPE treatment were associated with better clinical outcomes. No life-threatening side effects were reported. ConclusionsTPE is a safe and well tolerated procedure that decreases long-term disability in RRMS patients with IVMPS-refractory relapses.

Reduction in movement-evoked pain and fatigue during initial Transcutaneous Electrical Nerve Stimulation treatment predicts responders in women with fibromyalgia

Transcutaneous Electrical Nerve Stimulation (TENS) is a safe, economical non-pharmacological adjunctive intervention. Using data from the Fibromyalgia Activity Study with TENS (FAST) we performed a responder analysis to identify predictors of reduced pain and fatigue after 1-month of daily TENS use in women with FM. Women with FM were randomly assigned to active-TENS (2-125Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1-month. After the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1-month. Responders to TENS were defined as those achieving a 30% reduction in movement-evoked pain and/or 20% reduction in movement-evoked fatigue., The predictor model was developed using data from the randomized phase of the active-TENS group (n=103) and validated using data from the placebo-TENS and no-TENS groups after active-TENS for 1 month (n=155). Participant characteristics, and changes in pain, fatigue, and function were assessed as potential predictors using a logistic regression model. Number needed to treat (NNT), and number needed to harm (NNH) calculations were made comparing the active-TENS group to the placebo-TENS and no-TENS groups using an intention-to-treat analysis. Predictors of clinical improvement in pain at 1-month follow-up were initial decrease in pain during the first TENS use and widespread pain index (AUC=0.80; 95%CI: 0.73,0.87). Predictors of clinical improvement in fatigue at 1-month follow-up were marital status, sleep impairment and initial decrease in fatigue during the first TENS use (AUC=0.67; 95%CI: 0.58,0.75). NNT for pain and fatigue ranged between 3.3-5.3. NNH ranged from 20-100 for minor TENS-related adverse events. The current study shows that 1 in 3 women with FM will experience a clinically significant reduction in pain, while 1 in 5 will experience a clinically significant reduction in fatigue with minimal harms. How a person responds to the first TENS treatment predicts response to daily use over of a 1-month period. Trial Number: NCT01888640, Funded by NIH UM1 AR06338, NIH UM1 AR063381-S1, T32 NS045549-12, and K99AR071517.

Predictors of clinical improvement in heart failure patients with iron deficiency treated with ferric carboxymaltose

Introduction and objectivesIntravenous iron is recommended to correct iron deficiency in heart failure (HF) patients, although not all patients had the same response. We evaluated the impact of ferric carboxymaltose (FCM) in analytical and clinical improvement and analyzed the response according to different parameters. MethodsWe included HF patients who received FCM in the daily hospital to correct iron deficiency. We recorded clinical and analytical parameters at baseline and 3 months follow-up. ResultsWe included 236 patients (age 73.5±10.7 years) with left ventricular ejection fraction 44.5±15.3%. There were no adverse effects during the infusion. All ferric analytical parameters significantly increased at 3 months. 25.1% of patients improved functional class, and New York Heart Association (NYHA) III patients were more likely to improve. Mean corpuscular volume predicted NYHA improvement (OR, 0.97; 95%CI, 0.93–1.00; P=.05). Body mass index (OR, 0.86; 95%CI, 0.78–0.95; P=.002) and ferritin (OR, 1.00; 95%CI, 1.00–1.01; P=.042) were also predictors of N-terminal pro-B-type natriuretic peptide reduction of at least 30% from basal levels. 61.3% received lower doses of FCM than the theoretical ones, and those with the correct dose were more likely to improve NYHA and reduce natriuretic peptides. ConclusionsFCM was useful to correct iron deficiency in clinical practice, independently to anemia, without relevant adverse effects. Clinical improvement was especially relevant in more symptomatic patients and those with absolute deficiency. Mean corpuscular volume, body mass index, ferritin, and dose of FCM were predictors of clinical improvement.

Reduction in movement-evoked pain and fatigue during initial 30-minute transcutaneous electrical nerve stimulation treatment predicts transcutaneous electrical nerve stimulation responders in women with fibromyalgia.

We previously showed that 1 month of transcutaneous electrical nerve stimulation (TENS) reduces movement-evoked pain and fatigue in women with fibromyalgia (FM). Using data from this study (Fibromyalgia Activity Study with TENS [FAST]), we performed a responder analysis to identify predictors of clinical improvement in pain and fatigue with TENS, validated these models using receiver operator characteristic, and determined number needed to treat and number needed to harm. Participants were randomly assigned to active-TENS (2-125 Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1 month. At the end of the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1 month. The predictor model was developed using data from the randomized phase for the active-TENS group (n = 103) and validated using data from placebo-TENS and no-TENS groups after active-TENS for 1 month (n = 155). Participant characteristics, initial response to TENS for pain and fatigue, sleep, psychological factors, and function were screened for association with changes in pain or fatigue using a logistic regression model. Predictors of clinical improvement in pain were initial response to pain and widespread pain index (area under the curve was 0.80; 95% confidence interval: 0.73-0.87). Predictors of clinical improvement in fatigue were marital status, sleep impairment, and initial response to TENS (area under the curve was 0.67; 95% confidence interval: 0.58-0.75). Number needed to treat for pain and fatigue ranged between 3.3 and 5.3. Number needed to harm ranged from 20 to 100 for minor TENS-related adverse events. The response to an initial 30-minute TENS treatment predicts who responds to longer-term TENS use in women with FM, making this a clinically useful procedure. Number needed to treat and number needed to harm suggest that TENS is effective and safe for managing pain and fatigue in FM.

Exploring characteristics of COPD patients with clinical improvement after integrated disease management or usual care: post-hoc analysis of the RECODE study

BackgroundThe cluster randomized controlled trial on (cost-)effectiveness of integrated chronic obstructive pulmonary disease (COPD) management in primary care (RECODE) showed that integrated disease management (IDM) in primary care had no effect on quality of life (QOL) in COPD patients compared with usual care (guideline-supported non-programmatic care). It is possible that only a subset of COPD patients in primary care benefit from IDM. We therefore examined which patients benefit from IDM, and whether patient characteristics predict clinical improvement over time.MethodPost-hoc analyses of the RECODE trial among 1086 COPD patients. Logistic regression analyses were performed with baseline characteristics as predictors to examine determinants of improvement in QOL, defined as a minimal decline in Clinical COPD Questionnaire (CCQ) of 0.4 points after 12 and 24 months of IDM. We also performed moderation analyses to examine whether predictors of clinical improvement differed between IDM and usual care.ResultsRegardless of treatment type, more severe dyspnea (MRC) was the most important predictor of clinically improved QOL at 12 and 24 months, suggesting that these patients have most room for improvement. Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months).ConclusionsMore severe dyspnea is a key predictor of improved QOL in COPD patients over time. More research is needed to replicate patient characteristics associated with clinical improvement with IDM, such that IDM programs can be offered to patients that benefit the most, and can potentially be adjusted to meet the needs of other patient groups as well.Trial registrationNetherlands Trial Register, NTR2268. Registered 31 March 2010.

Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study

BackgroundTocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy. MethodsWe performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28-day follow-up. Results65 patients were included. Among them, 32 were treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups. ConclusionsAt day 28, clinical improvement and mortality were not statistically different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials.

P2686Endothelial reaction mediates enhanced external counterpulsation effects in post-MI cardiac rehabilitation

Abstract Introduction The mechanisms mediating benefits of enhanced external counterpulsation (EECP) are disputable since the origin of the method. One of the possible explanations presumes increased diastolic flow leads to changes of endothelial function and plays a crucial role in alleviating the symptoms of angina and heart failure; the exact mechanisms of action are still under investigation, though the endothelial hypothesis possesses strong evidence. Purpose To reveal the impact of repeated EECP on endothelial function of patients undergoing cardiac rehabilitation program after myocardial infarction (MI) and to identify possible clinical implications of these changes. Methods The randomized sham-controlled study included 46 patients with coronary artery disease who suffered from ST-elevation MI (STEMI) 4–8 weeks prior to enrollment in 2017–2018. All patients had undergone primary PCI due to STEMI in 2–24 hours after the event. Echo parameters, exercise tolerance and the levels of ADMA and nitric oxide (NO) metabolites (total content, nitrite and nitrate) in plasma were determined at the enrollment stage and at three month follow-up. Patients were randomized and given 35 h of active counterpulsation (main group, n=24) or inactive counterpulsation (control group, n=22) over a six-week period after enrollment. Results The analysis showed no significant difference between groups at baseline: mean ejection fraction was 46% in the main group and 45% in the control group, no difference in exercise tolerance. The mean characteristics of endothelial function at baseline were similar in both main and control groups: total NO metabolites (17.3±2.14 μmol/L vs. 19.6±3.31, p=0. 42), nitrite level (0.76±0.17 μmol/L vs. 0.75±0.21, p=0. 36), ADMA level (0.78±0.15 μmol/L vs. 0.81±0.20, p=0. 22). At three month follow up 41,7% of patients of the main group showed improvement of one class of NYHA classification compared to 22,7% in the control group (U=122.3, p=0.012), agreed with improved exercise tolerance: average +2.8 MET in main group in opposite to only +0.8 MET in the controls (U=104, p=0.007). Control group demonstrated no significant dynamics of NO metabolites concentration comparing to baseline values, while in the main group there was a significant decrease of ADMA – 0.57±0.11 μmol/L (Z=r=−2.46, p=0.013) and increase of nitrite level – 1,12±0. 18 μmol/L (Z=r=−2.57, p=0.011), with no changes in total NO metabolites content. The further analysis demonstrated strong correlation between exercise capacity gain and ADMA decrease (R=r=−0.52, p=0.008) or nitrite elevation (R=0.48, p=0.012), with ADMA/nitrite ratio being the strongest predictor of clinical improvement (R=0.68, p=0.002). Conclusion Active EECP improves exercise capacity and heart failre symptoms in patients undergoing post-MI rehabilitation, with those effects being associated with endothelial function enhancement.

Translation, Cross-cultural Adaptation to Brazilian Portuguese, and Analysis of Measurement Properties of the Consultation and Relational Empathy Measure

ObjectiveThe purpose of this study was to translate, cross-culturally adapt to Brazilian Portuguese, and analyze the measurement properties of the Consultation and Relational Empathy (CARE) Measure and investigate whether empathy can be a predictor of clinical improvement. MethodsThis psychometric study was divided into 2 stages: the cross-cultural adaptation process included 30 patients, and the evaluation of the measurement properties included 106 patients with chronic musculoskeletal pain. After the third therapy session with the same physical therapist, the following questionnaires were applied to assess internal consistency, construct validity, and ceiling and floor effects: Pain Numerical Rating Scale, Brazilian Portuguese version of the CARE Measure (CARE-Br), MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care, and Global Perceived Effect Scale. To assess reliability and measurement error, the CARE-Br was answered 48 hours later. For prediction analysis of the CARE-Br in relation to clinical improvement, the participants answered the Pain Numerical Rating Scale and Global Perceived Effect Scale 2 months after baseline. ResultsThe internal consistency was adequate (Cronbach’s ɑ = 0.88), reliability was substantial (intraclass correlation coefficient = 0.77), measurement error was good (standard error of the measurement = 5.16%), and a moderate correlation was found with the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (r = 0.50). A ceiling effect was also found (39.6% of participants). Empathy was not considered a predictor of clinical improvement. ConclusionThe Brazilian Portuguese version of the CARE Measure is reliable, adequate, and applicable in clinical settings and research in Brazil. However, it is not capable of predicting clinical improvement in patients with chronic musculoskeletal pain.

10:40 AM Abstract No. 2 ■ ABSTRACT OF THE YEAR Predictors of clinical improvement after venous stenting: subanalysis from the VIRTUS study

10:40 AM Abstract No. 2 ■ ABSTRACT OF THE YEAR Predictors of clinical improvement after venous stenting: subanalysis from the VIRTUS study

A Review of the Effects of Transcranial Direct Current Stimulation for the Treatment of Hallucinations in Patients With Schizophrenia.

Some 25% to 30% of patients with schizophrenia report auditory verbal hallucinations (AVHs) that fail to respond adequately to antipsychotic treatments. In such cases, transcranial direct current stimulation (tDCS) has been proposed as a therapeutic option. Here, we aim to provide an exhaustive review of the literature examining the clinical effects of tDCS on AVH in patients with schizophrenia. A systematic search in the PubMed and Web of Science databases yielded 14 results, 7 randomized controlled trials (RCTs) and 7 open-label studies. Among them, 4 RCTs and 7 open-label studies reported a significant reduction of AVH after repeated sessions of tDCS, whereas 3 RCTs did not show any advantage of active tDCS over sham tDCS. Altogether, current studies showed an overall decrease of approximately 26% of AVH after active tDCS and 11% after sham tDCS. One suitable approach to decreasing AVH was to deliver twice-daily sessions of tDCS over 5 consecutive days (10 sessions at 20 minutes each, 2 mA) with the anode over the left dorsolateral prefrontal cortex and the cathode over the left temporoparietal junction. Demographic and clinical parameters such as young age, nonsmoking status, and higher frequencies of AVH occurrence seemed to be predictors of clinical improvement. Further RCTs, with larger sample sizes, are needed to confirm the usefulness of tDCS for AVH.

Long-Term Hemodynamic Improvement after Transcatheter Mitral Valve Repair

Correction of mitral regurgitation (MR) alters the load on the left ventricle. There are few data on the long-term hemodynamic adaptations of the cardiovascular system after transcatheter mitral valve repair (TMVR). The aim of this study was to determine a comprehensive hemodynamic status using noninvasive pressure-volume analysis. Pressure-volume parameters were calculated from echocardiography with simultaneous arm-cuff blood pressure measurements at baseline before TMVR and 12months after TMVR. Eighty-eight consecutive patients undergoing edge-to-edge mitral clip implantation because of grade 3+or 4+, symptomatic (79.5% in New York Heart Association functional class≥III) MR were prospectively enrolled. The mean left ventricular (LV) ejection fraction was 42±14%. Sixty-seven percent of the patients had secondary MR. Twelve months after TMVR, 17.7% of patients had died, and 19.0% were rehospitalized because of decompensated heart failure. MR grade was ≤2+in 90% of surviving patients, and 77% were in New York Heart Association functional class≤II. LV end-diastolic volume index decreased from 87±38 to 77±40mL/m2 (P<.0001), end-systolic volume index changed from 54±34 to 50±36mL/m2 (P=.018), hence total stroke volume index was reduced (from 34±11 to 28±7ml/m2, P<.0001). Ejection fraction and global longitudinal peak systolic strain remained unchanged. Increased forward ejection fraction (30±14% vs 41±20%, P<.0001), cardiac index (from 1.7±0.4 to 1.9±0.5mL/min/m2, P=.003), and peak power index (214±114 vs 280±149mm Hg/sec, P=.0001) as well as similar end-systolic elastance at reduced LV volumes indicated improved LV performance. Cardiac efficiency, measured as cardiac index relative to myocardial energy, was improved (0.012±0.008 vs 0.019±0.010mm Hg-1, P=.002). Logistic regression analysis revealed baseline values of total ejection fraction and diastolic pulmonary pressure gradient as predictors of clinical improvement (odds ratios, 1.076 [P=.009] and 0.812 [P=.015], respectively) after TMVR. One year after TMVR, patients showed reverse remodeling and improved LV performance that was associated with improved symptom status. This hemodynamic improvement supports TMVR as long-term effective therapy for patients with symptomatic MR.

FRI-389 - Predictors of clinical improvement among HCV patients with advanced liver disease treated with DAA: a single center experience

FRI-389 - Predictors of clinical improvement among HCV patients with advanced liver disease treated with DAA: a single center experience

Abstract WP298: Clinical Outcomes and Prognostic Factors in Patients With Spinal Dural Arteriovenous Fistulas:a Prospective Cohort Study

Background: The short-term outcomes and prognostic factors of patients with spinal dural arteriovenous fistulas (SDAVFs) have not been defined in large cohorts. Objective: To define the short-term clinical outcomes and prognostic factors in patients with SDAVFs. Methods: A prospective cohort of 112 patients with SDAVFs were included consecutively in this study. The patients were serially evaluated with the modified Aminoff and Logue’s Scale (mALS) on 1 day before operation and at 3 months, 6 months, 12 months after treatment. Univariate and multivariate analyses were performed to identify demographic, clinical, and procedural factors related to favorable outcome. Results: A total of 94 patients (mean age of 53.5 years, 78 were men) met criteria and included in final analyses. Duration of symptom ranged from 0.5-66 months (average time period of 12.7 months). The location of SDAVFs was as follows: 31.6% above T7 level, 48.4% between T7 to T12 level (including T7 and T12), and 20.0% below T12 level. A total of 81 patients (86.2%) underwent neurosurgical treatment, 10 patients (10.6%) underwent endovascular treatment, and 3 patients (3.2%) underwent neurosurgical treatment after unsuccessful embolization. A total of 78 patients demonstrated an improvement in mALS score of 1 points or greater at 12 months. Pre-operative mALS score was associated with clinical improvement after adjusting for age, gender, duration of symptom, location of fistula and treatment modality used unconditional logistic regression analysis (P&lt;.05). Conclusion: Approximately four fifths of the patients experienced clinical improvement at 12 months and pre-operative mALS was the strongest predictor of clinical improvement in cohort.

Predictive response factors of repetitive transcranial magnetic stimulation in treatment-resistant depression

IntroductionRepetitive transcranial magnetic stimulation (rTMS) is a neurostimulation technique used in many indications, especially in psychiatry in the treatment of mood disorders. Although its efficacy in this treatment has been demonstrated, the study of predictive response factors currently remains a major challenge.MethodWe conducted a retrospective study from the cohort of treatment-resistant depressed patients that received rTMS treatment in Esquirol Hospital in Limoges in order to identify response predictors at three months. Of the 416 patients treated between January 2007 and November 2015, 107 subjects have been included. The clinical characteristics of responders and nonresponders at three months after treatment, but also at the end of treatment and after one month were compared. Predictors of clinical improvement objectified by the Hamilton Depression Rating Scale (HDRS) were identified using a logistic regression model.ResultsIn our cohort, the response rates were 52% at the end of treatment, 61% at 1 month and 57% at 3 months. Psychiatric family history and the recurrence of thymic episodes were found to be negative predictors of response to rTMS treatment. Similarly, high subscore of depression core symptoms in HDRS could also predict a poorer response.ConclusionOur data from a naturalistic cohort tended to prove that a number of clinical features should be taken into account in determining the profile of the treatment-resistant depressed patients that could respond to rTMS treatment.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Outcome benefit of abdominal paracentesis drainage for severe acute pancreatitis patients with serum triglyceride elevation by decreasing serum lipid metabolites.

BackgroundOur previous reports demonstrated that abdominal paracentesis drainage (APD) exerts a beneficial effect on severe acute pancreatitis (SAP) patients. However, the underlying mechanisms for this effectiveness are not well understood.MethodsA retrospective cohort of 132 consecutive non-hypertriglyceridemia (HTG)-induced SAP patients with triglyceride (TG) elevation and pancreatitis-associated ascitic fluid (PAAF) was recruited from May 2010 to May 2015 and included in this study. The patients were divided into two groups: the APD group (n = 68) and the non-APD group (n = 64). The monitored parameters mainly included mortality, hospital stay, the incidence of further intervention, levels of serum lipid metabolites and inflammatory factors, parameters related to organ failure and infections, and severity scores.ResultsThe demographic data and severity scores were comparable between the two groups. Compared with the non-APD group, the primary outcomes (including mortality, hospital stay and the incidence of percutaneous catheter drainage) in the APD group were improved. The serum levels of lipid metabolites were significantly lower in the APD group after 2 weeks of treatment than in the non-APD group. Logistic regression analysis indicated that the decreased extent of free fatty acid (FFA)(odds ratio, 1.435; P = 0.015) was a predictor of clinical improvement after 2 weeks of treatment.ConclusionTreatment with APD benefits non-HTG-induced SAP patients with serum TG elevation by decreasing serum levels of FFA.

Cyproheptadine Use in Children With Functional Gastrointestinal Disorders.

The objective of this study was to evaluate clinical improvement and safety with use of cyproheptadine in functional gastrointestinal disorders (FGIDs) in children. Retrospectively evaluating the efficacy and safety of the use for indications including Rome III-defined FGIDs: functional abdominal pain, functional dyspepsia, irritable bowel syndrome (IBS), abdominal migraine, cyclic vomiting syndrome. Response categories were as follows: no improvement group/partial improvement group; requiring intervention, or complete improvement group (CIG); warranting discontinuation; ongoing use; or parental unwillingness to stop medication. Among 307 patients, 151 included; 58% girls, ages 1 to 18 years (median 9); 110 (72.8%) reported complete symptom improvement; 41 (27.2%) reported no or partial improvement. Mean initial and final doses in the CIG were 4.85 mg/day (0.14 mg · kg · day) and 5.34 mg/day (0.14 mg · kg · day), respectively. A total of 102/151 (68%) reported no adverse effects. Adverse effects shown were as sleepiness in 19/151 (13%) and weight gain in 15/151 (10%). Cyproheptadine was effective in improving symptoms of functional abdominal pain, functional dyspepsia, in a relatively larger number of patients. Patients in smaller numbers had significant improvement 13/18 (72%) abdominal migraine, 10/10 (100%) IBS, and 6/8 (75%) cyclic vomiting syndrome. This is the first time report of improvement in IBS. Other pharmacodynamics had been as follows: the lower the body weight, the higher are the odds of no to partial improvement; patients in no improvement group/partial improvement group experience more adverse effects as compared to the CIG; the single best predictor of clinical improvement was body mass index. A 1 unit increase in body mass index with cyproheptadine use increased the odds of clinical improvement by 1.5-fold (P = 0.01). Cyproheptadine effectively improves symptoms of Rome III-defined FGIDs and has a good safety profile when used for these indications.

Antidepressant treatment history and drug-placebo separation in a placebo-controlled trial in major depressive disorder.

A history of antidepressant treatment may predispose subjects toward placebo nonresponse in randomized controlled trials (RCTs) in major depressive disorder (MDD). The objective of this study is to examine self-reported prior antidepressant treatment and response in relationship to clinical outcome in an 8-week randomized trial of reuptake inhibitor antidepressant medication (MED) versus placebo (PBO) administered along with limited supportive care. Chi-square and MMRM analyses examined MED vs. PBO outcomes in antidepressant-naïve vs. antidepressant-experienced subjects. Linear regression models examined treatment history along with covariates as predictors of clinical improvement. Among completers (n = 56), there was no significant difference in response rate between MED (53.3 %) and PBO (42.3 %) (χ (2) = 0.33, p = 0.28, 1-tailed). The antidepressant-experienced subgroup (n = 37), however, showed a significantly greater response rate to MED (52.4 %) than PBO (25.0 %) (χ (2) = 2.82, p = 0.047, 1-tailed). The full intent-to-treat (ITT) sample (n = 69) did not show a significant difference between MED and PBO group improvement over time, but in the treatment-experienced subgroup (n = 46), MED showed significantly greater improvement than PBO (coefficient = .39, SE = .23, p = .045, 1-tailed). A history of prior antidepressant treatment predicted poorer overall response independent of pretreatment symptom severity, number or length of previous episodes, subject expectations, or family history of MDD. Treatment history appears to constitute a factor that is distinct from other commonly studied illness characteristics or expectancy measures, and that impacts overall response as well as drug-placebo separation in RCTs.

Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain.

BackgroundLow back pain (LBP) is a major health issue due to its high prevalence rate and socioeconomic cost. While spinal manipulation (SM) is recommended for LBP treatment by recently published clinical guidelines, the underlying therapeutic mechanisms remain unclear. Spinal stiffness is routinely examined and used in clinical decisions for SM delivery. It has also been explored as a predictor for clinical improvement. Flexion-relaxation phenomenon has been demonstrated to distinguish between LBP and healthy populations. The primary objective of the current study is to collect preliminary estimates of variability and effect size for the associations of these two physiological measures with patient-centered outcomes in chronic LBP patients. Additionally biomechanical characteristics of SM delivery are collected with the intention to explore the potential dose–response relationship between SM and LBP improvement.Methods/DesignThis is a prospective, observational study applying side-lying, high velocity, low amplitude SM as treatment for patients with LBP over a course of 6 weeks. Approximately 80 participants will be enrolled if they present with chronic LBP of 1, 2 or 3 in Quebec Task Force Classification for spinal disorders, a Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6, and persistent LBP ≥ 2 with a maximum ≥ 4 using numerical rating scale. Patient-centered outcomes include LBP using visual analog scale, RMDQ, and PROMIS-29. Lumbar spine stiffness is assessed using palpation, a hand-held instrumented device, and an automated device. Flexion-relaxation is assessed using surface electromyography at the third level of the lumbar spine. Biomechanical characteristics of SM are assessed using a self-reported, itemized description system, as well as advanced kinetic measures that will be applied to estimate forces and moments at the lumbar segment level targeted by SM.DiscussionBeside alterations in material properties of the passive components of the spine, increased neuromuscular activity may also contribute to a stiffened spine. Examining changes in both spinal stiffness and flexion-relaxation along the course of the treatment provides an opportunity to understand if the therapeutic effect of SM is associated with its action on active and/or passive components of the spine.Trial registrationNCT01670292 on clinicaltrials.gov.