Mean Improvement In Quality Of Life Research Articles

S525 The Low FODMAP Diet Improves Abdominal and Overall Symptoms in Patients With All Subtypes of Irritable Bowel Syndrome

Introduction: There is substantial evidence that a diet low in fermenTable oligo-, di-, monosaccharides, and polyols (FODMAPs) improves symptoms in patients with Irritable Bowel Syndrome and diarrhea (IBS-D). Though the low-FODMAP diet is increasingly used in patients with IBS and constipation (IBS-C) or mixed bowel habits (IBS-M), there is little data to support this practice. We aim to compare the real-world effectiveness of a low-FODMAP diet in patients with IBS-D, IBS-C, and IBS-M. Methods: Utilizing a commercially available meal procurement service which prepares and delivers meals certified low in FODMAP content (Modify Health, Atlanta, GA), patients with suspected IBS met with a registered dietitian and completed the IBS symptom severity scale (IBS-SSS) questionnaire before starting the low-FODMAP diet and after the restriction phase of the diet plan. A decrease in IBS-SSS score of >100 was defined as a responder. Results: 403 IBS patients filled out baseline and post-elimination IBS-SSS surveys. 26% of patients were referred by a GI specialist; the rest were self-referrals. 193 (48%) patients had severe IBS (IBS-SSS > 300) prior to the intervention. IBS-D patients had a 71% improvement in pain, 56% improvement in bloating, and 55% improvement in bowel movement satisfaction. 77% of IBS-D patients had improvement in total IBS-SSS >100. IBS-C patients had a 69% improvement in pain, 49% improvement in bloating, and 42% improvement in bowel movement satisfaction. 67% of IBS-C patients had improvements in IBS-SSS >100. IBS-M patients had 85% improvement in pain, 55% improvement in bloating, and 53% improvement in bowel movement satisfaction. 72% of IBS-M patients had improvement in total IBS-SSS >100. Those who used the commercial meals for "all" of the restriction phase had a mean IBS-SSS improvement of 174, and mean quality of life (QOL) improvement of 40%, while those who used the commercial meals for "some" of the elimination phase had mean IBS-SSS improvement of 153, and mean QOL improvement of 33% (p=0.059 and 0.03, respectively). (Table) Conclusion: This data supports the effectiveness of a low-FODMAP diet for all IBS subtypes, including IBS-C and IBS-M. Patients who obtained prepared low-FODMAP meals during the entire restriction phase experienced greater benefits than those who only obtained meals for a portion of the restriction phase. Table 1. - Improvement in IBS-SSS Categories by IBS-Subtype IBS Subtype Total Number of Patients IBS-SSS (Mean % Improvement) Pain (Mean % Improvement) Bloating (Mean % Improvement) BM Satisfaction (Mean % Improvement) % Improvement in IBS-SSS >100 IBS-D 87 59 (p< 0.001) 72 56 56 77 IBS-C 73 50 (p< 0.001) 70 49 42 67 IBS-M 91 56 (p< 0.001) 73 55 53 73

Health-Related Quality of Life After Laparoscopic Cholecystectomy.

BackgroundThis study aimed to determine the mean improvement in the quality of life (QoL) after laparoscopic cholecystectomy (LC) in patients with symptomatic cholelithiasis.MethodologyAfter obtaining approval from the hospital’s ethical committee, the Gastrointestinal Quality of Life Index (GIQLI) proforma was filled on admission (T0) and at week six (T1) postoperatively. All data were collected, and GIQLI scores were calculated for individual patients.ResultsIn our study, among the 70 patients undergoing LC, 20% (n = 14) were aged 18-30 years and 80% (n = 56) were aged 31-60 years, with the mean ± standard deviation calculated as 41.56 ± 10.13 years. Overall, 44.29% (n = 31) of patients were men and 55.71% (n = 39) were women. GIQLI scores were 94.64 ± 2.24 for pre-treatment and 106.09 ± 2.40 for post-treatment, with a mean change of 11.44 ± 3.29, and a p-value of 0.001, showing a significant difference.ConclusionsThe mean improvement in QoL after LC in patients with symptomatic cholelithiasis is significantly higher when compared with pretreatment.

Determinants of improved quality of life among older adults with multimorbidity receiving integrated outpatient services: A hospital-based retrospective cohort study

BackgroundOlder adults with multiple complex care needs tend to receive fragmented care that may jeopardize their quality of life (QoL) and health outcomes. This study evaluated the determinants of improved QoL among integrated outpatient service recipients with multimorbidity. MethodsWe conducted a retrospective cohort study of integrated geriatric outpatient services (IGOS) at a tertiary medical center in Taiwan. Data from 2018 to 2019 were retrieved. All patients underwent comprehensive geriatric assessment, which included demographic information, serial functional assessments, and assessment for QoL. QoL was reassessed through a telephone survey 6 months after the patients’ first visit to IGOS. Factors associated with the interval changes in QoL were identified using multivariate logistic regression. ResultsData from 995 patients receiving IGOS (mean age: 82.21 ± 7.96 years, 54.5% males) were analyzed. An overall mean improvement in QoL was noted (EQ-5D index: +0.055±0.26, p <0.001) while 747 recipients reported maintained or improved QoL. The results of the multivariate logistic regression showed that poorer nutritional status (OR = 1.56, 95% CI: 1.07–2.28), depressive symptoms (OR = 1.99, 95% CI: 1.38–2.86), and frailty (OR = 1.66, 95% CI: 1.10–2.52) were independent risk factors for poorer QoL after adjustment for baseline QoL. ConclusionsIntegrated outpatient services improved the quality of life of older adults with multimorbidity. Those with poorer nutritional status, depressive symptoms and frailty were less likely to show improvement in their QoL.

Abstract No. 40 Does the use of a hybrid 4D angio-CT system significantly impact procedure time for prostate artery embolization?

To evaluate whether the use of a hybrid angio-CT (4DCT) imaging impacts procedure time during prostate artery embolization (PAE) This is an institutional review board approved, single-center, retrospective study. Medical charts of 10 consecutive patients who underwent technically successful bilateral PAE in a hybrid angio-CT suite between September 2017 and February 2020 were reviewed. Every patient had intraprocedural selective CT angiography (CTA) of each prostatic artery (PA), resulting in 2 CTA/patient. Procedure time (PT) was measured from the start of the procedural conscious sedation until the patient left the angiography suit. Timestamps of the CTA and DSA/fluoroscopy (DSAFCs) were extracted from the imaging DICOM data. The time required to obtain an intraprocedural CTA of a PA (CTT) was defined as the time elapsed between the last DSAFC before and the first DSAFC after the CTA acquisition. CTT also included “on-the-go” evaluation of the images by the operators. Short-term clinical success was evaluated by comparing International Prostate Symptom Score (IPSS) and Quality of Life (QOL) scores before treatment and at 6-week follow-up. Mean PT was 147.9 minutes (range 94-225 mins). Mean CTT was 17.1 minutes per procedure (range 7.9-34.3 mins; n = 10) including 2 CTAs/procedure for every patient. CTT was 12.3 ± 5.4% of PT. Three of the 20 PA angiograms revealed intra-prostatic collateral flow, confirmed with CTA, which were treated with preventative coiling. No serious adverse event was reported. In 2 of 10 patients, minor side effects (rectal discomfort, fever, and flank pain) occurred. Clinical improvement was significant, with mean IPSS reduction from 21.1 ± 6.06 to 7.2 ± 4.38 (P< .001; n = 8) and mean QOL improvement from 3.6 ± 1.14 to 1.6 ± 0.52 (P = .004; n = 5). Intraprocedural CTA of bilateral PAs is valuable for confirming PA origin as well as the presence of intra- and extra-prostatic collaterals in order to optimize treatment success and avoid non-target embolization. Acquisition of intraprocedural CTA of bilateral PAs consumed only 12% (17 min) of total procedure time.

Whole brain radiotherapy with partial hair-sparing technique-a feasibility study

Introduction: Whole brain radiotherapy (WBRT) is a common palliative treatment for brain metastases from solid tumours. Traditionally, it is given with opposed lateral fields causing total alopecia as hair-bearing scalp skin receives the full dose. Volumetric modulated arc therapy (VMAT) can deliver WBRT with a simultaneous integrated boost (SIB) to larger metastases whilst minimising dose to critical structures such as the hippocampus. This feasibility study aimed to test the hypothesis that a reduced dose to the scalp using a VMAT hair-sparing WBRT protocol would spare scalp hair and reduce alopecia at four weeks post treatment without compromising disease control at three months. Methods: The Hair Spare study (01.07 WBRTMel sub-study SS01.13) was an investigator-initiated, prospective feasibility study. A VMAT hair-sparing WBRT protocol was developed to limit the dose to the scalp to 16 Gray (Gy) in 15 fractions. The primary objective was the rate of alopecia at 4 weeks post RT as measured by CTCAE v4 and clinician and patient perception. Quality of life (QoL) was assessed at baseline, one month and three months post treatment with validated instruments including European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ-C15-PAL+4) plus four additional questions specifically relating to hair, a visual analogue scale (VAS) to measure the perception of hair loss severity, and the total Chemotherapy-Induced Alopecia Distress Scale (CADS). Results: Nine patients with brain metastases from melanoma (6), breast (2) and lung (1) cancer were enrolled at the Mater Sydney Hospital, Crows Nest, Australia. At 4 weeks, 5 patients were evaluable: 4 reported moderate alopecia (CTCAE v4 Grade 2) and 1 reported mild alopecia (CTCAE v4 Grade 1). All 5 wore wigs or scarves to hide hair loss. Any amount of hair loss impacted QoL. Reduced hair loss compared to complete alopecia, as usually found with conventional WBRT, did not translate to a mean improvement in QoL. There was no symptomatic intracranial progression of disease while the patients remained on study. Two patients had MRI at 3 months, and both had evidence of intracranial progression of disease within the volume that had received prescription WBRT dose. From the data collected it seems that VMAT hair-sparing WBRT was well-tolerated. Conclusion: VMAT hair-sparing WBRT partially spared scalp hair at four weeks post WBRT and did not compromise symptomatic disease control during the study. The treating oncologists observed that the hair grew back quicker than with conventional WBRT, and that combined cytotoxic chemotherapy was additive to RT-induced alopecia. However, the study was not optimal in that data collection was hampered by patient availability. The patient population was too unwell to be followed up according to the protocol.

Does pain and hip function improve 2 years after reverse periacetabular osteotomy? A follow-up study of 74 patients.

Data on outcome in patients with acetabular retroversion (AR) treated with reverse periacetabular osteotomy (reverse PAO) are sparse. The aim of the study was to investigate changes in pain and hip function among patients with AR 2 years after reverse PAO and to examine whether changes in pain were associated with changes in hip function. In addition, to evaluate patient satisfaction and changes in quality of life (QoL). We present a prospective follow-up study with patient-reported outcome data from Aarhus University Hospital in Denmark. Pain at rest and during activity was measured with a Visual Analogue Scale (VAS), hip function with the Hip disability and Osteoarthritis Outcome Score (HOOS) and QoL with the Short-Form 36, pre-operatively and 2 years after reverse PAO in 74 patients. Changes were analysed using paired t-test and multiple linear regressions. Significant and clinically relevant mean improvements in pain and hip function were found. The numbers of responders achieving a minimal clinically important difference varied from 51 to 73%. Positive significant association between changes in pain and changes in hip function were found. Significant mean improvement in QoL was found. The study had a loss to follow-up of 23%. Two years after reverse PAO, patients diagnosed with AR showed significant and clinically relevant mean improvements in pain and hip function. Decreased pain was significantly associated with improved hip function. The majority of patients were satisfied with the result of surgery and QoL was similar to the Danish background population.

The Intervention of Brain Gym in Increasing the Quality of Life on The Elderly

This research aims to find the effect of Brain Gym interventions in improving the quality of life in the elderly after controlling with the confounding variables are age, sex, and education. This research is experimental research with pre and post-test group design and randomizes design. The sample determination based on the inclusion criteria. The sample is 66 people, divided into two groups of 33 respondents respectively. The determination of the group by using the randomize table, then conducted a pre-test in both groups by using the WHOQOL-BREF's questionnaire. Group 1 was given 10 minutes gym/exercise with the frequency of three times a week and physical activity, while group 2 was a control. The brain gym and physical activity interventions were given for a month and then conducted a post-test. The research data were analyzed by using a paired sample t-test independent sample t-test, ANCOVA, Chi-Square, and Kolmogorov-Smirnov. The result showed that p = 0,000 &lt;0,05 and the mean quality of life improvement in group gym for 10 minutes/exercise with the frequency of three times in a week were 9.48 ± 3.104 while in group 2 as the control was 2.15 ± 1.372. The brain gym for 10 minutes/exercise with the frequency of three times a week affects improving the quality of life in the elderly.

Another Therapeutic Role for Intravesical Botulinum Toxin: Patients with Long-stay Catheters and Refractory Bladder Pain and Catheter Bypass Leakage

BackgroundBotulinum neurotoxin (BotN) is used to treat detrusor overactivity (DO) refractory to medical treatment. Catheterised patients with symptoms of bladder spasm and catheter bypass leakage are challenging to manage and the efficacy of BotN is not established. ObjectiveTo review our experience using intravesical BotN to treat refractory bladder pain and catheter bypass leakage in patients with long-term indwelling catheters. Design, setting, and participantsWe carried out a review of data prospectively collected for patients with indwelling urethral or suprapubic catheters receiving BotN for the treatment of bladder spasms and catheter bypass leakage in a UK tertiary centre. An unvalidated structured questionnaire was used to ascertain quality of life (QoL) outcomes. Outcome measurements and statistical analysisQualitative data were collected for patient-reported symptoms and QoL. Paired Student t tests were applied for statistical analysis. Results and limitationsOf the 54 catheterised patients who received BotN, 14 (26%) were male and 40 (74%) were female. The mean follow-up was 38mo. Of the patients, 34 (63%) had a neurological aetiology and 94% had experienced failure of medical therapy before BotN administration. The BotN starting dose was 100 or 200U and 17 patients (31%) required dose escalation. All 34 neurogenic and six non-neurogenic patients started on 200U. After treatment, 63% of patients managed their catheter with intermittent drainage and 37% managed on free drainage; 51 patients (94%) reported that their symptoms were controlled and 38% reported being treated for a urinary tract infection following BotN. Patients reported a mean improvement in QoL of 7.7/10 following BotN, while 83% reported a significant reduction in urine leakage (p=0.0001). ConclusionsOutpatient intravesical BotN is safe and efficacious for patients with long-term catheters suffering from bladder pain and catheter bypass leakage. Patient summaryOutpatient administration of intravesical botulinum toxin is a safe and effective treatment for patients with a long-term indwelling catheter with bothersome urine storage symptoms. Attention should be paid to urine microbiology results before treatment to ensure appropriate prophylactic antibiotic treatment to reduce the incidence of urinary tract infections.

Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families

IntroductionThe impact of crisaborole ointment, a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD), on quality of life (QoL) was assessed in two identically designed phase 3 studies (AD-301: NCT02118766; AD-302: NCT02118792, both at http://www.clinicaltrials.gov).MethodsIn both studies, patients aged ≥ 2 years with mild to moderate AD per the Investigator’s Static Global Assessment were randomly assigned 2:1 to receive crisaborole or vehicle twice daily for 28 days. QoL was assessed using the Children’s Dermatology Life Quality Index (CDLQI) (2–15 years), the Dermatology Life Quality Index (DLQI) (≥ 16 years), and the Dermatitis Family Impact Questionnaire (DFI) (parents/caregivers/family of patients aged 2–17 years). Established QoL score severity bands provided clinical context.ResultsGreater mean improvement in QoL was observed in crisaborole-treated patients than in vehicle-treated patients at day 29 [mean change from baseline (∆BL), CDLQI: − 4.6 vs. − 3.0; P < 0.001; DLQI: − 5.2 vs. − 3.5; P = 0.015]. At baseline, more than half the patients had a “moderate effect” or higher of AD on QoL. At day 29, there was a trend toward more crisaborole- than vehicle-treated patients having “small effect” to “no effect”, The QoL of parents/caregivers/family improved more for crisaborole-treated than for vehicle-treated patients (∆BL, DFI: − 3.7 vs. − 2.7; P = 0.003).ConclusionCrisaborole treatment results in clinically meaningful improvement in QoL for patients and their parents/caregivers/families.Trial RegistrationAD-301: http://www.clinicaltrials.gov, NCT02118766; AD-302: http://www.clinicaltrials.gov, NCT02118792.FundingAnacor Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., New York, NY.

Impact of pharmacist-led collaborative patient education on medication adherence and quality of life of schizophrenia patients in a tertiary care setting

Schizophrenia is a chronic mental-disorder and one of the top 10 causes of disability globally. Nearly 4.3 million people suffer from schizophrenia in India but very few visit a hospital for diagnosis or treatment. Of those patients who receive treatment, medication non-adherence and decreased quality of life (QOL) are the major problems. The objective of study was to assess the impact of pharmacist-led collaborative patient education on medication adherence and QOL in schizophrenia patients in a psychiatry out-patient setting of a tertiary-care setting. Patients were randomized into two groups. Interventional patients received medication review, followed by patient education session using Patient-Information Leaflets (PILs) developed for the study. Control patients received usual-care. Patients data were collected at the beginning of the study and after each follow-up of one-month interval, till 3rd follow-up. Medication adherence and QOL were assessed using Medication Adherence Rating Scale and WHOQOL-BREF questionnaire respectively. Twenty-three patients completed the study, 13 were in the intervention and 10 in the control group. Majority of the study subjects were of age group 18–39years (69.56%) and female (65.21%). Medication adherence mean improvement was 0.7±0.67 and 1.75±0.2 in control and intervention groups respectively. Similarly, mean QOL improvement was 16.12±1.98 and 24.17±0.3 in control and intervention groups respectively. Statistically significant improvement in the mean medication adherence and QOL was observed in the intervention group. Results showed that pharmacist-psychiatrist collaborative care can significantly improve patients’ medication adherence and QOL.

Perceived quality of life, 6months after detoxification: Is abstinence a modifying factor?

PurposePatients with a substance use disorder (SUD), admitted for detoxification, often suffer from a poor quality of life (QoL). We set out to monitor QoL, together with substance use, in a departure from the usual norm of measuring substance use alone as a treatment outcome. Literature searches revealed scant knowledge of how QoL is influenced. With this in mind, we aimed to investigate whether total abstinence, prior to follow-up, could influence QoL.MethodsWe studied a prospective cohort of 140 patients admitted for inpatient detoxification treatment at Sørlandet Hospital (Norway), from September 2008 to August 2010. QoL was measured by a generic five-item questionnaire, the QoL-5. The extremes of this scale ranged from the worst possible rating of 0.1 to 0.9, as the best. A norm for the general population was benchmarked at 0.69. Change in QoL was calculated by subtracting baseline QoL from that achieved at the 6-month follow-up interview; linear regression modeling was used to study the influence of individual QoL predictors.ResultsThe mean QoL at baseline was 0.46, 39 % below that of the general reference population. By applying the clinical interpretation of the scale, we found a modest overall mean improvement in QoL at follow-up (0.11 points); the greatest increases were seen for patients with the lowest baseline QoL scores. Abstinence prior to follow-up correlated with improved QoL, while living alone and psychological distress were negative influences.ConclusionsFor patients with a SUD, clinicians should emphasize that abstinence may help to improve their QoL.

Does comorbid obesity impact quality of life outcomes in patients undergoing endoscopic sinus surgery?

Both obesity and chronic rhinosinusitis (CRS) are characterized by inflammation. Furthermore, both disease processes are independently associated with decreases in quality-of-life (QOL). We sought to investigate the role of comorbid obesity in QOL outcomes in CRS patients undergoing endoscopic sinus surgery (ESS). Adult patients with medically refractory CRS (n = 241) were prospectively enrolled into a multi-institutional treatment outcomes investigation. Body mass index (BMI) calculations were used to differentiate patient weight groups (normal weight: 18.5 to 24.9, overweight: 25.0 to 29.9; and obese: ≥30.0). Preoperative and postoperative QOL (Rhinosinusitis Disability Index [RSDI] and the 22-item Sino-Nasal Outcome Test [SNOT-22]) were evaluated compared across BMI groups and obesity subclasses. The prevalence of comorbid obesity was 41% (n = 99). Higher prevalence of comorbid disease was found across increasing BMI groups including diabetes mellitus, asthma, and depression. No significant differences were found in mean preoperative QOL measures between any BMI groups. Significant improvement between preoperative and postoperative QOL mean scores (p ≤ 0.050) was found for all BMI groups. Despite no significant difference in mean QOL improvement between BMI groups (p ≥ 0.142), overweight and obese patients reported reduced relative mean percentage (%) improvement compared to normal weight participants on the RSDI total score (33% and 37% vs 55%, respectively) and SNOT-22 total score (29% and 40% vs 48%, respectively). Patients with comorbid obesity experience significant improvement in average QOL gains following ESS though the percentage of relative improvement in QOL may be decreased in patients with comorbid obesity and CRS as compared to those without.

One-year outcome after CRT implantation in NYHA class IV in comparison to NYHA class III patients

The aim of the analysis was to compare the outcome of heart failure patients in New York Heart Association (NYHA) class IV to that of NYHA class III patients 1 year after implantation of a CRT device. The analysis was based on the 405 CRT patients enrolled in the MASCOT trial. At enrollment, 350 patients (86%) were in NYHA class III and 55 (14 %) were in NYHA class IV. At 1-year follow-up, the improvement of the ejection fraction was not statistically significantly different between NYHA class III (+7.6 ± 11.7%) and NYHA class IV patients (+9.2 ± 14.2 %; p = 0.78). NYHA class IV patients had a better mean NYHA class reduction with -1.93 ± 0.83 than NYHA class III patients with -0.93 ± 0.70 (p < 0.0001). There was a greater mean quality of life improvement in NYHA class IV (-27.2 ± 20.9) compared to NYHA class III (-17.7 ± 23.9; p = 0.02). All-cause mortality as well as cardiac mortality remained higher in NYHA class IV with 25.5 and 16.4% than in NYHA class III with 7.1 and 3.1% (p < 0.0001). In this study, 14% of all patients receiving a CRT device had NYHA class IV at implantation. The data support the concept to implant a CRT device in NYHA class IV patients, because at 1 year after implantation, they experienced better symptomatic improvement compared to NYHA class III patients. The higher cardiac as well as non-cardiac mortality resulted in a fivefold higher all-cause mortality compared to NYHA class III patients.

Quality‐of‐life outcomes following multiple revision endoscopic sinus surgery

Although overall success rates of endoscopic sinus surgery (ESS) range from 76.0% to 97.5%, ongoing or recurrent symptoms may require revision surgery. Previous studies have shown that revision status is not a predictor of outcomes following ESS, but no distinction has been made between patients undergoing a single or multiple revision procedure. The purpose of this study was to compare quality-of-life (QOL) outcomes and associated risk factors of patients undergoing primary ESS, first-revision ESS, and multiple-revision ESS (second, third, fourth, and fifth or more). Demographic and risk factor data were collected from a multi-institutional prospective cohort of 552 patients undergoing primary (n = 221) and revision (n = 331) ESS for chronic rhinosinusitis. Mean preoperative Lund-Mackay computed tomography (CT) scan scores, pre-/postoperative Lund-Kennedy endoscopy scores, Rhinosinusitis Disability Index (RSDI), and Chronic Sinusitis Survey (CSS) outcomes were analyzed using chi-square testing and 1-way analysis of variance (ANOVA). Mean preoperative RSDI and CSS measurements were similar between primary ESS and all revision groups. Significantly more primary ESS patients met rigorous criteria for a minimally important difference in QOL improvement than revision ESS patients (73.8% vs 61.6%; p = 0.003). There was no significant difference in mean QOL improvement between revision groups (all p ≥ 0.174) even when comparing patients with and without nasal polyposis (all p ≥ 0.312). Generally, patients undergoing primary, first-revision, and multiple-revision ESS showed postoperative improvement in QOL scores. More primary ESS patients had significant QOL improvement compared to revision ESS patients. There were no significant differences in mean QOL improvement between any of the individual revision groups. © 2012 ARS-AAOA, LLC.

A Us Study Of 5-grass Pollen Allergen Extract In Adults With Grass Pollen-induced Allergic Rhinoconjunctivitis - Results Of Secondary Efficacy Assessments

FEBRUARY 2012 AB46 Abstracts S A T U R D A Y 174 Improvement In Quality Of Life With Administration Of A 300 IR Sublingual Tablet Of 5-grass Pollen Allergen Extract In Adults With Grass Pollen-induced Allergic Rhinoconjunctivitis F. Horak, A. Didier, M. Worm, H. Malling, K. Abiteboul, A. Montagut, R. K. Zeldin; Allergy Centre Vienna, Vienna, AUSTRIA, Rangueil-Larrey Hospital, Toulouse, FRANCE, Allergie-Centrum-Charit, Klinik fr Dermatologie, Venerologie und Allergologie, Berlin, GERMANY, National University Hospital, Copenhagen, DENMARK, Stallergenes, Antony, FRANCE. RATIONALE: In single season studies, preand co-seasonal administration of a 300 IR sublingual tablet of 5-grass pollen allergen extract improves quality of life (QoL). Here we report the Year 1 to Year 4 QoL results from an ongoing 5 year study. METHODS: 633 adults were randomized to placebo or 300 IR preand co-seasonally for three grass pollen seasons. Active treatment was initiated 4 months [4M] or 2 months [2M] before each season and continued for its duration. Patients were followed during the subsequent, treatment-free, grass pollen season. Each year, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ, responses to 28 questions, 7-point Likert scale with low score 5 better QoL) was completed before and midway through the pollen season. An ANCOVA model was used to analyze differences vs. placebo. RESULTS: The LS mean changes from baseline in the placebo, 4M and 2Mgroupswere 1.67, 1.36 and 1.21 in Year 1, 1.45, 1.06 and 1.01 inYear 2, 1.36, 0.94 and 0.95 in Year 3 and 1.41, 0.95 and 0.88 in treatment-free, Y4. The relative LS mean QoL improvement in the 4M and 2M groups (vs. placebo) was 18.5% and 27.4% in Year 1, 27.0% and 30.6% in Year 2, 30.4% and 29.8% in Year 3 and 32.8% and 37.6% in Year 4, respectively (p<0.002). CONCLUSIONS: Discontinuous treatment with a 300 IR sublingual tablet of 5-grass pollen allergen extract resulted in significant improvement in QoL vs. placebo in each of three treatment seasons and the first pollen season post-treatment.

Quality of life and efficacy of nebivolol in an open-label study in hypertensive patients. The QoLaN study

Nebivolol is a highly selective beta-adrenoreceptor antagonist with vasodilating properties. This study investigated its effect on quality of life (QoL) and blood pressure (BP) in real life conditions. In total, 1468 patients were enrolled, 12% diabetics. Nebivolol was prescribed as monotherapy, add-on or switch medication. In this open-label, prospective study, the JNC-VII BP target values were used: < 140/90 and < 130/80 mmHg for diabetics. The responder rate and the QoL was determined at baseline and after 4 and 8 weeks. After 4 weeks, 27% of subjects reached target BP, 45% after 8 weeks. The responder rates were 92, 90 and 83% for the monotherapy, add-on and switch groups. Compared with baseline, all showed statistical significance at 8 weeks. Similarly to results for the QoL after 8 weeks, the mean improvement in QoL for all three groups was 9-10 points (total range: 0-88). The study demonstrates that nebivolol in mild to moderate hypertension is associated with overall improvements in QoL, with a marked BP-lowering effect, in monotherapy, add-on or switch, irrespective of the glucose tolerance status. It may be hypothesized that its dual mode of action explains its BP-lowering effect as well as the tolerability.

Quality of life and efficacy of nebivolol in an open-label study in hypertensive patients. The QoLaN study

Background. Nebivolol is a highly selective β1-adrenoreceptor antagonist with vasodilating properties. This study investigated its effect on quality of life (QoL) and blood pressure (BP) in real life conditions. In total, 1468 patients were enrolled, 12% diabetics. Nebivolol was prescribed as monotherapy, add-on or switch medication. Methods. In this open-label, prospective study, the JNC-VII BP target values were used: <140/90 and <130/80 mmHg for diabetics. The responder rate and the QoL was determined at baseline and after 4 and 8 weeks. Results. After 4 weeks, 27% of subjects reached target BP, 45% after 8 weeks. The responder rates were 92, 90 and 83% for the monotherapy, add-on and switch groups. Compared with baseline, all showed statistical significance at 8 weeks. Similarly to results for the QoL after 8 weeks, the mean improvement in QoL for all three groups was 9–10 points (total range: 0–88). Conclusions. The study demonstrates that nebivolol in mild to moderate hypertension is associated with overall improvements in QoL, with a marked BP-lowering effect, in mono-therapy, add-on or switch, irrespective of the glucose tolerance status. It may be hypothesized that its dual mode of action explains its BP-lowering effect as well as the tolerability

Effects of neridronate treatment in elderly women with osteoporosis

Osteoporosis is a common disorder, especially among elderly post-menopausal women. Elderly women are often affected by co-morbidities, impaired gastrointestinal function and reduced mobility; therefore, the treatment strategy for their osteoporosis can be difficult. In this randomized pilot study, we have investigated the effects of a 12-month treatment with neridronate on bone mineral density (BMD), bone turnover markers and quality of life (QoL). The study included 40 women (age, 65-80 yr; post-menopausal period, >15yr) from a single osteoporosis centre. Twenty women received a monthly im injection of 25 mg of neridronate associated with a daily dose of 500 mg of calcium and 400 U of vitamin D. Twenty women received calcium plus vitamin D supplements alone. Changes in BMD at the lumbar spine and femoral neck were measured by dual energy X-ray absorptiometry. Serum type I collagen C-telopeptide (sCTX), urinary free-deoxypyridinoline (ufDPD), bone alkaline phosphatase (ALP) and serum osteocalcin levels were determined. For the QoL assessment, the Italian version of the SF-36 test was administrated. Spine and hip BMD rose by 6.6 +/- 3 and 4.2 +/- 2.3%, respectively (p < 0.05), after 12 months of neridronate treatment. Markers of skeletal turnover significantly fell already after 3 months of neridronate treatment and decreased progressively thereafter within 12 months. The mean decrease at 12 months ranged from 38 +/- 11% for sCTX to 25.2 +/- 15% for ufDPD (p < 0.001, all). The mean improvement in QoL in the treated group was 45.7% for bodily pain, 37.5% for general health perception, 23.1% for vitality, 18% for emotional role functioning and 12% for physical role functioning. The changes observed in BMD, turnover markers and QoL in the untreated group were ns. The intermittent neridronate administration was easily manageable and well tolerated. In conclusion, neridronate currently represents a valid option for the treatment of osteoporosis, since it helps just as much as oral BPs in the improvement of BMD and in particular conditions it can be even more effective.

Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence.

This initial human study was performed to determine the safety and quality of life impact of transurethral radiofrequency energy (RFe) tissue micro-remodeling of the proximal urethra and bladder outlet in patients with stress urinary incontinence (SUI). Forty-one patients with SUI were sequentially enrolled into four treatment groups and then underwent rapid outpatient treatment under conscious sedation using an investigational RFe delivery device. The device is passed through the urethra and palpably positioned by the anchoring of a balloon within the bladder outlet. Four small needle electrodes are deployed into the proximal urethra and/or bladder outlet submucosa, and RFe is delivered. No patient has suffered a serious adverse event in 6 months of follow-up. At 6 months, 75%-80% of patients in all four groups have demonstrated an improvement in quality of life. Two groups demonstrated statistical significance in both mean quality of life improvement and incontinence frequency reduction at 6 months.