Average Symptom Score Research Articles

Electro-acupuncture combined with surface gastric pacing in the treatment of gastrointestinal dysfunction after spinal cord injury

Objective To explore the effects of electro-acupuncture combined with surface gastric pacing on gastrointestinal dysfunction for patients with spinal cord injury (SCI). Methods Seventy-five SCI patients with gastrointestinal dysfunction were divided randomly into an electro-acupuncture group (group A), a gastric pacing treatment group (group B) and a group for which electro-acupuncture was combined with gastric pacing (group C). There were 25 cases in each group. Members of group A were given 30 minutes of electro-acupuncture per day; those of group B had 30 minutes of gastric pacing treatment twice per day; group C was provided with both 30 minutes of electro-acupuncture and one 30-minute gastric pacing treatment per day. All of the interventions lasted ten days. Before and after the treatment, all patients were assessed using a clinical symptoms score and with electrogastrograms, and any adverse effects were observed. Results There was a significant improvement in upper abdominal pain and epigastric discomfort, bloating and early satiety, nausea, vomiting, as well as belching and loss of appetite in each group after treatment. Before treatment there was no significant difference in the average clinical symptom scores of the three groups. After treatment the values had decreased, and those of group C were significantly lower than group A or B. The average scores of groups B and A were not significantly different. The electrogastrogram results showed than after treatment there was significant improvement in N% and T% in groups A and B, and also significant improvement in N%, B% and T% in group C compared to before treatment. Group C's improvements were all significantly greater than those observed in groups A and B. Conclusion Electro-acupuncture or gastric pacing alone can give some improvement in gastrointestinal function and its electrophysiological indicators, but their combined effects are better than when either is used alone. Key words: Electro-acupuncture; Gastric pacing; Spinal cord injury

Health benefits of fermented milk containing Bifidobacterium bifidum YIT 10347 on gastric symptoms in adults

We conducted a preliminary open trial (trial 1) and a double-blind, placebo-controlled, crossover trial (trial 2) to examine how fermented milk containing the probiotic Bifidobacterium bifidum YIT 10347 affects gastric and lower abdominal symptoms in adults taking no medication. In trial 1, subjects with or without gastric and lower abdominal symptoms ingested fermented milk containing B. bifidum YIT 10347 daily for 2 wk. In trial 2, subjects with gastric symptoms ingested fermented milk containing B. bifidum YIT 10347 (active preparation) or placebo daily for 2 wk, followed by crossover for 3 wk after a washout period. Before (baseline) and 1 and 2 wk after ingestion, subjects completed a questionnaire. In trial 1 (305 subjects), the prevalence of gastric and lower abdominal symptoms was 46 and 58%, respectively, at baseline. Ingestion of B. bifidum YIT 10347 significantly decreased the prevalence of gastric and lower abdominal symptoms from 45 to 33% at 1 wk and to 28% at 2 wk, and from 57 to 40% at 2 wk, respectively. In subjects with gastric symptoms at baseline, the average gastric symptom score per subject significantly decreased by 0.9 at 1 wk and 1.2 at 2 wk. In trial 2 (27 subjects), ingestion of the active preparation significantly decreased the average gastric symptoms score per subject by 1.0 at 1 wk and 1.1 at 2 wk, but ingestion of placebo milk had no effect. No side effects were reported by any subjects in either trial. We conclude that fermented milk containing B. bifidum YIT 10347 has the potential to provide health benefits by alleviating gastric symptoms in subjects taking no medication.

Impact of a multi-trigger intervention on seasonal patterns of asthma symptoms in inner city children

Objectives: Peaks in childhood asthma symptoms and asthma morbidity occur universally in the fall and late winter/early spring. This study examines whether there is a time of the year best suited to implement environmental interventions to attenuate this pattern. Methods: From September 2006 to June 2010, mid-Atlantic inner-city children asthmatics with 1 asthma-related hospitalization (IP) or 2 emergency (ED) visits the year prior to enrollment received 5 in-home self-management education sessions which included multi-trigger avoidance techniques and supplies. Children’s daily asthma symptoms were recorded for 12 months by caregivers. Results: One-hundred and thirty-six children (48%) completed 12 months of symptoms diaries. Symptom days were reduced by 4.5 days at 12 months follow-up (p < 0.001). Symptom severity improved with a decreased severity score of 29.0 to 7.9 at month 12 (p < 0.001). Sixty-one percent of patients with ≥2 ED visits at baseline dropped to 0–1visits (p < 0.001). Eighty percent of patients with ≥1 IP visits dropped to 0 visits at 12 months (p < 0.001). Patients who received intervention in the summer months had half the average monthly symptoms score (10.8) as those who received intervention in the spring months (20.8). When controlling for environment and morbidity, the summer enrolled group had a significantly lower (p = 0.021) symptom score than those in other seasons. Conclusion: Home self-management/environmental interventions for this cohort appear to have the greatest effect for those receiving the intervention in the summer and fall. The largest impact occurs in the summer cohort. Further studies with a control group are necessary to confirm these findings.

P232 Treatment Of Allergic Rhinitis With Theophylline : A Double-blind, Randomised, Crossover Study

Background Allergic rhinitis and Asthma are considered as ‘one airway disease’. Theophylline has been used as a bronchodilator in asthma for decades but more recently its anti-inflammatory properties have been identified. We hypothesise that treatment with low dose theophylline in patients with persistent allergic rhinitis is likely to improve the total nasal symptom scores and there by demonstrate a clinically meaningful difference. Methods This was a single centre double- blind, randomised, placebo-controlled cross-over study of the effects of theophylline (one capsule of Theophylline 200 mgs as Uniphyllin continus twice a day for 4 weeks) in 21 patients with persistent allergic rhinitis in Norwich, U. K. Reference: NCT0113278. Primary outcome was Total Nasal Symptom Score (TNSS) after each intervention period. Secondary endpoint measures were differences in the domiciliary average total nasal symptom score, differences in nasal peak inspiratory flow (PNIF), differences in domiciliary nasal peak inspiratory flow and difference in Sino-Nasal Outcome Test (SNOT)-22. Results Primary Endpoint There was no significant (p = 0.276) difference in Total Nasal Symptoms scores during Theophylline treatment period and placebo period, mean (SD) ([Table][1]). The intention-to-treat analysis results were in keeping with the per protocol analysis. Secondary End points PNIF in the Theophylline period was 112.38(±43.49) compared to the placebo period 122.86(±53.77), p = 0.171 ([Table][1]). There was no change in SNOT-22 (p = 0.867) between treatment periods but there was a non-significant improvement with Theophylline (39.00 ± 19.78) compared to placebo (38.00 ± 19.63) treatment period. There was a non-significant improvement in the domiciliary total nasal symptom scores (TNSS) between Theophylline (3.53 ± 2.35) and placebo (2.81 ± 2.46). Nasal scrape samples were stained with HDAC2 antibodies and the signals were very week. Conclusion This is the first study evaluating Theophylline in persistent rhinitis. Low-dose Theophylline had no significant effects on Total nasal Symptom scores; Rhinosinusitis symptoms and nasal patency assessed using peak nasal inspiratory flow. There was a non-significant improvement in the total nasal symptom scores and sino-nasal outcome test and domiciliary nasal scores. View this table: Abstract P232 Table 1 Changes after intervention between treatments: Per Protocol Results [1]: #T1

Association of high symptom burden with oral oncolytic agents.

177 Background: Increasing numbers of cancer patients are being treated with oral oncolytics. This change represents a shift from frequent direct observation during intravenous therapy to periodic observation and increased necessity for improved monitoring and self-care management. Despite this shift, patients are at risk to develop many of the same chemotherapy-associated symptoms and toxicities. We sought to understand the symptom burden associated with use of oral oncolytics. Methods: Michigan Oncology Quality Consortium (MOQC) sponsored a quality improvement initiative focused on improving oral oncolytic care. Eight oncology practices participated. Patients were assessed with a modified Edmonton Symptom Assessment System (ESAS) prior to each outpatient visit. A total of 537 surveys were analyzed. 13 measures were categorized into mild (0 to 3), moderate (4 to 6), and severe (7 to 10) symptom burden. Results: Overall, the average ESAS symptom score was mild in 81% of patients, moderate in 13% of patients, and severe in 6% of patients. These average scores, however, obscure the significant burden in select ESAS domains. For example, 39% of patients categorized their overall well-being as being moderate/severely affected; 38% of patients felt they were moderate/severely fatigued, and 21% indicated moderate/severe neuropathy symptoms. Notably, 118/537 (24%) of the assessments had 4 or more symptoms rated moderate to severe. Conclusions: Patients taking oral oncolytics experience significant symptom burden that impacts quality of life. Intolerance of oral oncolytics may lead to adherence issues, potentially affecting expected outcomes. Given the prevalence of symptoms and potential for toxicity, self-care strategies to improve early recognition and treatment of symptoms by patients taking oral oncolytics are necessary. [Table: see text]

Medical treatment of adenoid hypertrophy with mometasone furoate monohydrate nasal spray

Background: Treatment of adenoid hypertrophy is generally planned in accordance with the degree of airwayobstruction and related morbidity. If surgical treatment is indicated, the individual risk/ benefit analysis of patients should be assessed in terms of anesthetic and postoperative complications. Although there are few alternative treatment options, intranasal steroid applications may be considered as a nonsurgical approach in less serious cases and have been presented in this study. Objectives: To assess the effect of mometasone furoate monohydrate nasal spray on adenoid hypertrophy and to determine how many patients will be excluded in the surgical treatment. Methodology: A prospective, randomized, placebo controlled study was done in Al-Sader medical city in Najaf in the period of 31 of Dec. 2012 to 31 of Dec. 2013. Patients indicated for surgery were randomly divided into two groups. The study group was treated by mometasone furoate monohydrate nasal spray (NSSnasal steroid spray) of 100 micrograms/day (50 micrograms for each nostril) for 12 weeks. The control group was treated by normal saline (NS) nasal drops in the same way. All the patients were followed-up every 4 weeks. Results: At the end of 12 weeks, statistically significant improvement (p &lt; 0.05) was observed in the NSS treated group compared to the NS treated group in terms of nasal airway obstruction, mouth breathing, and night cough. At the end of 12 weeks, the average total symptoms score of the NSS treated group dropped of 12.82 to 4.75 while the NS treated group's score changed in 12.53 to 12.18. After 12 weeks of NSS treatment the initial adenoid/choana (A/C) rate had dropped of 87.14 to 51.42% and a total decrease of 35.72% was observed. After 12 weeks of NS treatment the A/C rate dropped of 87.5 to 85% and a total decrease of 2.5% was observed. Conclusions: Treatment with mometasone furoate monohydrate nasal spray provides an effective alternative tosurgical treatment in children with adenoid hypertrophy. With the protocol applied in this study 77.2% of the patients were excluded of the surgery and removed of the surgical waiting list. Recommendations: The reliability of nasal steroids for the pediatric population is widely recognized. Althoughthe mechanism itself has not yet been clearly and totally explained. We recommend that it is important todetermine the role of intranasal corticosteroids in treating children with adenoid hypertrophy.

Hippocampal atrophy and subsequent depressive symptoms in older men and women: results from a 10-year prospective cohort.

Several studies have reported smaller hippocampal volume in patients with depression. However, the temporality of the association is undetermined. One hypothesis is that hippocampal atrophy might be a susceptibility factor for depression. In the present study, we assessed whether hippocampal atrophy was associated with subsequent depressive symptoms in a cohort of older French adults (n = 1,309) who were 65-80 years of age and enrolled into the study in 1999-2001 in Dijon, France. Subjects were followed for more than 10 years. Participants underwent 2 cerebral magnetic resonance imaging scans, one at baseline and one at the 4-year follow-up. We used linear mixed models to estimate the associations of hippocampal atrophy with 1) the average depressive symptom scores over follow-up (using the Center for Epidemiologic Studies-Depression scale) measured biennially over the subsequent 6 years and 2) changes in symptom scores over follow-up. In women, a 2-standard-deviation increase in annual hippocampal atrophy was associated with a 1.67-point (95% confidence interval: 0.59, 2.77) increase in the average depressive symptom score over follow-up and with a 1.97-point (95% confidence interval: 0.68, 3.24) increase in scores over the 2 subsequent years but not with later changes in symptoms. No association was detected in men. Accounting for potential selective attrition (using inverse probability weights) did not alter results. Hippocampal atrophy was associated with more subsequent depressive symptoms and with shorter-term worsening of symptoms in women.

Coronavirus-induced demyelination of neural pathways triggers neurogenic bladder overactivity in a mouse model of multiple sclerosis.

In the present study, we aimed to determine whether mice with coronavirus-induced encephalomyelitis (CIE) develop neurogenic bladder dysfunction that is comparable with the neurogenic detrusor overactivity observed in patients with multiple sclerosis. Adult mice (C57BL/6J, 8 wk of age, n = 146) were inoculated with a neurotropic strain of mouse hepatitis virus (A59 strain) and followed for 4 wk. Inoculation with the virus caused a significant neural deficit in mice with an average clinical symptom score of 2.6 ± 0.5 at 2 wk. These changes were accompanied by 25 ± 5% weight loss at 1 and 2 wk postinoculation (P ≤ 0.001 vs. baseline) followed by a recovery phase. Histological analysis of spinal cord sections revealed multifocal sites of demyelinated lesions. Assessment of micturition patterns by filter paper assay determined an increase in the number of small and large urine spots in CIE mice starting from the second week after inoculation. Cystometric recordings in unrestrained awake animals confirmed neurogenic bladder overactivity at 4 wk postinoculation. One week after inoculation with the A59 strain of mouse hepatitis virus, mice became increasingly sensitive to von Frey filament testing with responses enhanced by 45% (n = 8, P ≤ 0.05 vs. baseline at 4 g); however, this initial increase in sensitivity was followed by gradual and significant diminution of abdominal sensitivity to mechanical stimulation by 4 wk postinoculation. Our results provide direct evidence showing that coronavirus-induced demyelination of the central nervous system causes the development of a neurogenic bladder that is comparable with neurogenic detrusor overactivity observed in patients with multiple sclerosis.

Comparison of clinical effectiveness of acupuncture and a Western drug on allergic rhinitis: study protocol for a randomized controlled trial

ObjectiveTo compare the efficacy of an acupuncture regimen for persistent allergic rhinitis (PER), aimed at improving a patient's mind or Shen in Traditional Chinese Medicine, to that of a second-generation H1-receptor antagonist, cetirizine hydrochloride. MethodsThis multicenter, randomized, controlled clinical trial on PER will be conducted at three institutions in China. The total study period will be 9 weeks. After a 1-week preparatory screening period, 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy (1: 1) for 4 weeks with a 4-week follow-up. The primary outcome will be changes in 7-day average total nasal symptom score. Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score. ResultsThe presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis. No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported. ConclusionThe findings of the trial will allow us to determine the effects of the mind (Shen)-regulation treatment approach. We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride.

Using Patient-Reported Outcomes in Clinical Practice: A Promising Approach?

pletion only (attention-control), and no PRO completion (control). They found that the intervention improved discussion of symptoms but did not change treatment. Further, although the intervention demonstrated benefits in health-related quality of life (HRQOL) compared with the control group, there were no statistically significant differences in mean change scores between the intervention and attention-control group. This study by Wolfe et al 1 adds to this body of knowledge by investigating the use of PROs to aid treatment of pediatric patients with advanced cancer. The 104 patients and their parents enrolled in this trial completed a computerized battery of PRO questionnaires, at most once a week, and were monitored for 3 months, with the option of re-enrolling after each 3-month period. The PRO measures included a symptom assessment, an HRQOL questionnaire, and an overall sickness question. The results of these PRO assessments for the intervention group (n 51) were provided to both the oncologist and the families, with e-mail alerts to clinical team members for scores that exceeded predetermined thresholds. There was no feedback of the data in the control group. The investigators hypothesized that the intervention would lead to decreased symptom distress and improved HRQOL. They also assessed participant and provider satisfaction with the intervention. In the primary analysis, although changes were in the expected directions, there were no statistically significant differences between study arms on average symptom, HRQOL, or sickness scores over 20 weeks. Post hoc subgroup analyses found larger and statistically significant improvements on the HRQOL emotional domain scores and the sickness question for patients who survived longer than 20 weeks, particularly those who were at least 8 years old. There was also a suggestion that emotional function improved among children 8 years and older, regardless of length of survival, although this was not statistically significant. Likewise, children who both survived longer than 20 weeks and were at least 8-years old also demonstrated changes of marginal statistical significance on the total and physical HRQOL domains. In terms of satisfaction with the intervention, 28% of children and 54% of parents reported the intervention helped them talk to the doctor quite a bit or very much, and 75% of parents said the intervention often or almost always helped them understand how their child feels. Among the clinicians, 50% strongly agreed or agreed that the PRO reports were useful when speaking to patients, with 61%

O17 ‐ Assessment of efficacy and safety of sublingual tablets of house dust mite allergen extract in children and adolescents with allergic rhinitis

Methods Participants aged 5 to 17 years of age, with at least a 1year history of HDM-associated AR requiring regular intake of symptomatic treatment, a positive skin prick test to HDM, HDM-specific serum IgE ≥0.7 kU/L, and an Average Rhinitis Total Symptom Score (ARTSS, scale: 0-12) ≥5 during a 7-day screening period were randomized (1:1) to receive 300IR or placebo tablets once daily for a year. Participants recorded their rhinitis symptoms and use of rescue medication. The primary efficacy endpoint, Average Adjusted Symptom Score (AAdSS), which adjusts symptom score for rescue medication use, was assessed over the last 2 months of the treatment period and analyzed by ANCOVA.

The use of complementary and alternative medicine by women transitioning through menopause in Germany: Results of a survey of women aged 45–60 years

To describe prevalence rates of complementary and alternative medicine therapies (CAM) for the relief of menopausal complaints among German women. Furthermore, to investigate the perceived effectiveness of these therapies. A self-administered questionnaire was sent to 9785 randomly selected women in Germany aged between 45 and 60 years. A total of 1893 (19.3%) questionnaires have been sent back. The mean age of all participants was 52.6±4.3 years. 81% (n=1517) of the responding women stated that they had experienced menopausal complaints at least once. Symptoms ranged from vasomotor symptoms, including hot flushes and night sweats, in 71.2% of cases, to bladder problems in 42.7%. The average symptom score (MRS II total score, range 1-44) among the respondents was 12.76±9.6. More than half (56%; n=1049/1872) of the responding women had used some form of therapy to alleviate their symptoms at least once. The majority of women undertaking a therapy (64.8%; n=679/1049) had used only CAM interventions (either one or more type of CAM), 14.2% (n=149) had used hormone replacement therapy (HRT) only, while 21.1% (n=221/1049) had tried both CAM and HRT. Popular CAM interventions by the respondents were an alteration of lifestyle (28.7%), St. John's wort (18.3%) and homoeopathy (14.9%). An alteration in lifestyle was rated as the most effective CAM treatment with 84.9% (n=457). Other treatments like hormone yoga (79.2%; n=42), homoeopathy (73.7%; n=205) and TCM (59.1%; n=94) were also perceived to be effective. Phytoestrogens were rated as the most ineffective (45.5%; n=50). CAM interventions to alleviate menopausal complaints are popular among German women, with 48.2% (n=900/1872) of respondents reporting having used CAM either alone or in combination with HRT. However, the users rated the effects of CAM differently, with some reporting CAM to be highly effective, while others indicate lower effectiveness. Nevertheless, women with a significantly higher symptom scoring tend to use both CAM and a conventional therapy (HRT).

Improving Symptom Communication Through Personal Digital Assistants: The CHAT (Communicating Health Assisted by Technology) Project

Communication problems impede effective symptom management during chemotherapy. The primary aim of this pilot randomized controlled trial was to test the effects of a personal digital assistant-delivered communication intervention on pain, depression, and fatigue symptoms among breast cancer patients undergoing chemotherapy. Secondary aims included assessment of 1) study feasibility, 2) patient and clinician responses to study participation, and 3) intervention effects on health-related quality of life (HRQoL) and communication self-efficacy. Intervention group participants (n = 27) completed symptom inventories at baseline, once per week during treatment, and at posttreatment. Depending on symptom severity, they viewed race-concordant videos on how to communicate about pain, depression and/or fatigue, using the personal digital assistant. Symptom records were tracked and shared with clinicians. Control group participants (n = 23) received usual care. Longitudinal random effects modeling assessed the changes in average symptom scores over time. Descriptive statistics assessed study feasibility and intervention effects on HRQoL and communication self-efficacy. Postintervention focus groups, interviews, and surveys assessed responses to study participation. Mean age of the participants was 51.0 years; 42 participants (84%) were white. In comparison with control, intervention group participants reported lower average pain severity over time (P = .015). Mean pain interference scores over time were marginally different between groups (P = .07); mean depression and fatigue scores over time were statistically nonsignificant. Feasibility outcomes and perspectives about study participation were positive. Mean pre-post decreases in HRQoL were generally higher among intervention group participants; pre-post changes in communication self-efficacy were equivalent. Mixed findings of the study indicate the need for future research.

Dutasteride on Benign Prostatic Hyperplasia: A Meta-analysis on Randomized Clinical Trials in 6460 Patients

To investigate the clinical effectiveness of dutasteride in the treatment of benign prostatic hyperplasia by meta-analysis. Several databases were searched from inception to June 2013 for prospective clinical studies comparing dutasteride vs placebo. The continuous outcomes of therapeutic efficacy included International Prostate Symptom Score/American Urological Association Symptom Index, maximum flow rate, total prostate volume, and acute urinary retention (AUR). The dichotomous outcomes included surgery risk and the rate of sexual dysfunction. The relative risk for dichotomous outcome and the weighted mean difference for continuous outcomes were estimated using fixed effects model. Four studies met the inclusion criteria and were included, in which a total of 6460 patients received dutasteride and 6475 received placebo treatment. The average symptom score was improved by 1.98 with 95% confidence interval (CI) 1.77-2.19 (P<.00001); the average maximum flow rate was increased by 1.16 mL/s with 95% CI 0.63-1.70 (P<.0001); the total prostate volume was reduced by 13.86 mL (95% CI 12.76-14.96; P<.00001); the odds ratio for AUR was 0.35 (95% CI 0.27-0.47; P<.00001). The major side effect for dutasteride was the increased rate of sexual dysfunction compared with placebo, with odds ratio of 0.41 (95% CI 0.31-0.54; P<.00001). Dutasteride is highly effective in mitigating benign prostatic hyperplasia symptoms and reducing the size of enlarged prostate and the risks of AUR and surgical intervention. However, dutasteride therapy is related to an increased rate of sexual dysfunction.

Early Results from a United States Trial of Prostatic Artery Embolization in the Treatment of Benign Prostatic Hyperplasia

PurposeTo report early findings from a prospective United States clinical trial to evaluate the efficacy and safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH). Materials and MethodsFrom January 2012 to March 2013, 72 patients were screened and 20 patients underwent treatment. Patients were evaluated at baseline and selected intervals (1, 3, and 6 mo) for the following efficacy variables: American Urological Association (AUA) symptom score, quality of life (QOL)–related symptoms, International Index of Erectile Function score, peak urine flow rate, and prostate volume (on magnetic resonance imaging at 6 mo). Complications were monitored and reported per Society of Interventional Radiology guidelines. ResultsEmbolization was technically successful in 18 of 20 patients (90%); bilateral PAE was successful in 18 of 19 (95%). Unsuccessful embolizations were secondary to atherosclerotic occlusion of prostatic arteries. Clinical success was seen in 95% of patients (19 of 20) at 1 month, with average AUA symptom score improvements of 10.8 points at 1 month (P < .0001), 12.1 points at 3 months (P = .0003), and 9.8 points at 6 months (P = .06). QOL improved at 1 month (1.9 points; P = .0002), 3 months (1.9 points; P = .003), and 6 months (2.6 points; P = .007). Sexual function improved by 34% at 1 month (P = .11), 5% at 3 months (P = .72), and 16% at 6 months (P = .19). Prostate volume at 6 months had decreased 18% (n = 5; P = .05). No minor or major complications were reported. ConclusionsEarly results from this clinical trial indicate that PAE offers a safe and efficacious treatment option for men with BPH.

The efficacy, safety and cost‐effectiveness of hydrotalcite versus esomeprazole in on‐demand therapy of NERD: A multicenter, randomized, open‐label study in China

The aim of the study was to investigate whether hydrotalcite was comparable to esomeprazole, a proton pump inhibitor, in on-demand therapy for non-erosive reflux disease (NERD). This was a multicenter, randomized, open-label clinical trial with initial and on-demand therapy. Patients who had complete symptom relief in the initial therapy were randomized to either hydrotalcite or esomeprazole in the on-demand therapy. The percentage of patients who quit on-demand therapy in the two groups and the cost-effectiveness of the treatment were evaluated as primary end points. The rate of symptom relief and the improvement of symptom score for initial therapy and the weekly average symptom score and weekly average number of days on treatment for on-demand therapy were evaluated as secondary end points. In total, 398 patients were recruited in the initial therapy group, among whom 253 were included in on-demand therapy, with 127 patients in the hydrotalcite group and the remaining 126 in the esomeprazole group. 14 (11.0%) patients in the hydrotalcite group and six (4.8%) in the esomeprazole group quit the on-demand therapy due to unsatisfactory symptom control (P = 0.065). Cost-effectiveness calculated as the ratio of the cost of hydrotalcite to that of esomeprazole (per person/day) was 35.3% in the on-demand therapy. Similar number of patients achieved symptom relief in both groups. Hydrotalcite is a good option of on-demand therapy for NERD patients due to its cost-effectiveness and speed of action.

PWE-025 Assessing the Percent of Days Linaclotide Improved Abdominal Symptoms and Stool Frequency in Patients with Irritable Bowel Syndrome with Constipation (IBS-C): Pooled Analysis of 2 Phase 3 Trials

IntroductionLinaclotide (LIN), a minimally absorbed guanylate cyclase C agonist (GCCA), improved abdominal symptoms and bowel movement (BM) frequency in patients (pts) with IBS-C in 2 Phase 3 trials. This post-hoc...

Post‐treatment efficacy of discontinuous treatment with 300IR 5‐grass pollen sublingual tablet in adults with grass pollen‐induced allergic rhinoconjunctivitis

Sustained efficacy over three pollen seasons of pre- and co-seasonal treatment with 300IR 5-grass pollen sublingual tablet has been demonstrated in adults with moderate-severe grass pollen-associated allergic rhinoconjunctivitis. To assess the efficacy of discontinuous treatment with 300IR 5-grass pollen sublingual tablet during the post-treatment pollen season of this long-term study. Adults aged 18-50, sensitized to grass pollen, with a history of allergic rhinoconjunctivitis for more than two pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. Pre- and co-seasonal treatment with 300IR 5-grass pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.

2167 LASER PROSTATECTOMY IN THE SEVERELY ILL - OUTCOMES AND FEASIBILITY OF A RAPID AMBULATORY DISCHARGE PATHWAY

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy and New Technology (III)1 Apr 20132167 LASER PROSTATECTOMY IN THE SEVERELY ILL - OUTCOMES AND FEASIBILITY OF A RAPID AMBULATORY DISCHARGE PATHWAY Benjamin Herrick, Johann Ingimarsson, and Ronald Yap Benjamin HerrickBenjamin Herrick Lebanon, NH More articles by this author , Johann IngimarssonJohann Ingimarsson Lebanon, NH More articles by this author , and Ronald YapRonald Yap Concord, NH More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2076AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Laser prostate surgery is increasingly being used to treat BPH while potentially decreasing morbidity compared to standard electrosurgical resection. However, little is known in the urologic literature regarding the outcomes or feasibility of an ambulatory discharge pathway in high anesthetic risk patients who have undergone such procedures. METHODS A retrospective chart review was performed on patients undergoing holmium laser ablation of the prostate (HoLAP) between 2007 and 2011 by a single surgeon. Using the American Society of Anesthesiologists (ASA) physical status classification system, all patients with category 3 (“severe systemic disease”) or higher were included in this study. Patients were placed on a rapid ambulatory discharge pathway (RAD), discharged on the day of surgery with a urethral catheter in place with a voiding trial on post-operative day 3. Patients with less than 90 days of follow-up and patients that were planned post-operative admission were excluded. Preoperative, intraoperative, and postoperative outcomes and complications were analyzed using two-tailed Student t-tests (p <0.05). All complications within 90 days of surgery were included in the analysis. RESULTS 41 patients met inclusion criteria. Mean follow-up was 142 days. Average preoperative AUA symptom score (AUA-SS) and Quality of Life (QoL) scores were 20.4 and 3.5. Average prostate volume was 37 grams (range 20-100). The mean change in post-operative AUA-SS and QoL were -9.1 (p<0.05) and -1.1 (p<0.05). 33 patients (80%) remained on the RAD. Six patients (15%) were admitted: hematuria (3), urinary retention (1), CHF exacerbation (1), MI (1). Two patients (5%) visited the Emergency Department regarding catheter problems and were subsequently discharged. There was one death unrelated to surgery (passenger in a motor vehicle crash). CONCLUSIONS This series suggests that it is feasible and safe to perform ambulatory laser ablation prostate surgery on high anesthetic risk patients with small to medium size prostates. Even in patients with severe systemic illness (ASA 3 or 4) 80% of them successfully remained on the pathway and were discharged on the day of surgery. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e888 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Benjamin Herrick Lebanon, NH More articles by this author Johann Ingimarsson Lebanon, NH More articles by this author Ronald Yap Concord, NH More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

Constipation in children with isolated overactive bladders

ObjectiveTo evaluate the prevalence of constipation in children with isolated overactive bladder (IOAB) and no micturition complaints. Materials and methodsA questionnaire was used to evaluate constipation in 51 children with IOAB, as well as in a control group of 74 children between the ages of 4 and 14 years. The Rome III criteria for children were used to assess constipation. IOAB was defined as the presence of symptoms such as urgency with or without daytime incontinence or frequency, a bell-shaped uroflow, and no post-residual urine. ResultsMean patient ages were 7.94 (±2.8) and 8.28 (±3.4) years in the OAB and control group, respectively (p = 0.54). Twenty-eight (54.9%) of the OAB group were girls, and 34 (45.9%) were girls in the control group (p = 0.32). More of the children with IOAB had constipation than those without urinary symptoms (54.9% vs. 29.7%, p = 0.005; or 2.87, 95% CI: 1.3–6.0). The results were statistically significant regarding the following Rome III criteria: “history of stool retention”, “presence of painful or hard bowel movements”, “the presence of a large fecal mass in the rectum” and “large diameter stools which may obstruct the toilet”. Within the group with OAB, constipation was more common among males (p = 0.05). There was no association between the type of OAB symptoms and constipation. The average dysfunctional voiding symptom score was 9.76 (±4.1). Eleven children (21.6%) presented alterations on ultrasound. Girls with OAB presented more frequently with UTI than boys (18 vs. 10, p = 0.13). ConclusionThis was the first comparative study with respect to constipation in children with IOAB and without urinary symptoms. Children with IOAB have a greater risk of having constipation compared to those with no urinary symptoms.