Patient Assessment Of Constipation Research Articles

Results of medical treatment with psyllium, lactobacillus, and tryptophan (Plurilac® Trio) in obstructive defecation syndrome.

The term "obstructive defecation syndrome" (ODS) describes a complex condition characterized by defecatory disorders. Such a condition represents a significant proportion of patients, which is estimated to be up to 30% of patients affected by chronic constipation. Presently, a broad agreement has been reached on diagnostic studies, whereas the choice of treatment that aims to improve the quality of life and/or correct the prevalent abnormalities or all anatomical abnormalities remains controversial. This was a retrospective cohort study on 174 patients out of a total of 232 with ODS who were observed in a specialized university unit of surgical coloproctology between 2018 and 2022. Clinical assessment included examining the values of the Agachan-Wexner constipation score and Patient Assessment of Constipation (PAC)-quality of life (QoL) scores, a full digital anorectal examination, anoscopy, RX defecography, and a urogynecological consultation; a functional anorectal test, an endoanal ultrasound, and colonoscopy were performed in select patients. The patients were reevaluated after an 8-10-week course of medical treatment based on a high-fiber diet and fluid intake and 6 g of psyllium combined with lactobacillus and tryptophan b.i.d. The results were analyzed by means of the Wilcoxon rank-sum test, comparing pretreatment scores with the results at the first follow-up visit. After 8-10 weeks of conservative treatment, 128 patients declared full satisfaction, 29 reported moderate satisfaction, and 17 (9.7%) declared no improvement. Among these 17, there were 5 patients with paradoxical puborectal contractions. The value of the Agachan-Wexner constipation score after treatment decreased from the pretreatment Agachan-Wexner constipation score mean value of 23.4 ± 3.7 (mean ± SD range 15-27) to a mean value of 5.3 ± 0.7 (range 3-8, p < 0.001). The quality of life improved, as shown by the PAC-QoL score, indicating great improvement in social relationships. Given the benefits of conservative therapies, they represent a cornerstone in the treatment of ODS, a complex disorder. Diet and bulking agents are mandatory forms of treatment prior to making any surgical attempt, also considering the fact that the psychosomatic component of ODS is an essential prerequisite to match patient expectations.

Daily consumption of galactooligosaccharide gummies ameliorates constipation symptoms, gut dysbiosis, degree of depression and quality of life among sedentary university teaching staff: A double-blind randomized placebo control clinical trial.

Functional constipation affects approximately 10% of the Indian population and may reduce the quality of life (QOL)and increase gut dysbiosis. PURPOSEOF STUDY: The study aimed at assessing the impact of galactooligosaccharide (GOS) gummy supplementation on gut health, depression status and QOL of constipated subjects. A double-blind placebo control clinical trial (CTRI/2021/10/037474) was conducted on sedentary constipated adults (n = 35), who were split into an experimental group (n = 17) and a control group (n = 18), supplemented with 10g GOS and sugar gummies, respectively, for 30days. Relative abundance of fecal gut microbes, including Bifidobacterium, Lactobacillus, Clostridium and Bacteroides and phyla Bacteroidetes and Firmicutes using real-time polymerase chain reaction and short-chain fatty acids, was analyzed pre and post supplementation. Constipation profile was studied using Rome IV criteria and the Bristol stool chart. Depression status was studied using the Becks Depression Inventory. TheQOL was assessed using patient assessment of constipation. GOS gummy supplementation increased Bifidobacterium and Lactobacillus by 1230% and 322%, respectively, (p < 0.001; p < 0.01) with reduced Clostridium by 63%, phylum Firmicutes by 73% and Bacteroidetes by 85% (p < 0.01). The GOS-supplemented group demonstrated a higher F/B ratio (4.2) indicating improved gut health (p < 0.01) with reduced gut dysbiosis and constipation severity. GOS gummies enhanced acetic acid and butyric acid levels compared to the control group (p < 0.01; p < 0.001). Post supplementation, there was 40% reduction in depression (p < 0.01) and 22% improvement in QOL (p < 0.05). This research validates the predicted beneficial benefits of short-term GOS consumption on constipation profile, gut microflora, depression status and quality of life of constipated subjects.

Evaluation of Gastrointestinal Symptoms in an ALS Cohort (P10-8.007)

<h3>Objective:</h3> The aim in this study is to understand the frequency of gastrointestinal symptoms in persons with ALS and relationship to disease duration and severity. <h3>Background:</h3> Amyotrophic Lateral Sclerosis is a disorder of motor neurons in which involvement of the enteric nervous system (ENS) has been implicated. Delayed gastric emptying and slowing of colonic transit time are reported. These symptoms impact the use of anticholinergic agents for treatments and offer opportunities for interventions that improve quality of life. <h3>Design/Methods:</h3> Patients diagnosed with ALS were recruited from the MDA/ALS Center of Hope Clinic at Temple University and healthy control volunteers were accepted. Patient Assessment of GI symptoms (GI-SYM) and Patient Assessment of Constipation (PAC-SYM) questionnaires are patient reported severity of symptoms over a 2-week history on an ordinal level. ALS Functional Rating Scale – Revised (ALSFRS-R), a 12-item questionnaire, assesses functional disability across 4 domains: bulbar, fine motor, gross motor and respiratory. Data was analyzed using IBM SPSS Statistics software. <h3>Results:</h3> 31 subjects are enrolled in the study with 12 controls and 19 ALS cases. The median(IQR) GI-SYM, PAC-SYM, and ALSFRS-R scores were 4.5(8), 1(4.75), and 42.5(15), respectively. A two-tailed t test, assuming unequal variances, revealed significant differences in PAC-SYM scores between healthy controls and ALS cases (t(23.22) = −2.17, p = 0.041). Spearman Rank Correlation revealed positive correlation between GI-SYM and PAC-SYM (r(26) = 0.70, p &lt; 0.001) and negative correlation between ALSFRS-R and GI-SYM (r(26) = −0.44, p = 0.019). <h3>Conclusions:</h3> In this preliminary study, the 2-week history GI-SYM questionnaire negatively correlated with ALSFRS-R scores and there was significant difference in PAC-SYM scores between healthy controls and ALS cases, suggesting potential enteric nervous system involvement. Recent evidence of brain-gut interaction, importance of the ENS, and the role of the microbiome in ALS and other neurodegenerative diseases suggests these symptoms are in part disease related. <b>Disclosure:</b> Dr. Empeno has nothing to disclose. Mr. Furey has nothing to disclose. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ITF. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MTPA. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samus. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MTPA. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amylym. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cytokinetics.

SHORT-TERM SURGICAL AND FUNCTIONAL OUTCOMES AFTER ROBOT-ASSISTED SACROCOLPOPEXY IN A SINGLE INSTITUTION

(Objectives) This study aimed to evaluate the surgical outcomes and functional parameters of lower urinary tract and bowel symptoms in patients who have undergone robot-assisted sacrocolpopexy (RASC) due to pelvic organ prolapse. (Patients and methods) This retrospective study included 110 consecutive RASC cases in the urology department of Ageo Central General Hospital, Japan, from November 2020 to October 2021. The medical records of these patients were retrieved. Data on uroflowmetry, post-void residual urine test, and self-administered questionnaires on urination and defecation were assessed. (Results) The mean operating time was 146 min, and the estimated blood loss was 14.8 ml. The intraoperative, postoperative, and severe complication rates of cases classified as Clavien-Dindo grade IIIa or higher were 0%, 9.1%, and 0%, respectively. The maximum flow rate and post-void residual volume of urine significantly improved after the operation. Similarly, the quality of life (QOL) scores and overactive bladder symptom score (OABSS), as well as the responses for the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and Urinary Distress Inventory-6 (UDI-6), significantly improved one month after the operation and were sustained for six months. On the other hand, the total scores from the Constipation Scoring System (CSS) and the subscales of the Patient Assessment of Constipation (PAC) -QOL worsened. These scores, except for those of the PAC-QOL satisfaction subscale recovered to the preoperative levels; the PAC-QOL satisfaction subscale scores significantly improved six months postoperatively. The rates of de novo overactive bladder (OAB), stress urinary incontinence (SUI), and constipation one month postoperatively were 8%, 33%, and 10%, respectively. (Conclusions) RASC was performed safely in our institution with acceptable postoperative lower urinary tract and bowel outcomes.

Can Naloxegol Therapy Improve Quality of Life in Patients with Advanced Cancer?

Simple SummaryThe frequent use of opioid in-home palliative care settings is associated with a high incidence of opioid-induced constipation (OIC) that can significantly worsen a cancer patient’s quality of life. Laxative therapy is the first-line in OIC treatment, and although its application is recommended from the beginning of opioid therapy, in most cases it does not resolve the symptoms. Naloxegol is the specific target therapy for opioid-induced constipation. To our knowledge this is the first study aimed at evaluating the impact of a naloxegol therapy on the quality of life of advanced cancer patients with a short or very short life expectancy in a home palliative setting.This observational study aims to evaluate the efficacy of naloxegol therapy in resolving opioid-induced constipation (OIC) and in improving the quality of life in a home palliative care cancer setting. Advanced cancer patients with OIC (Rome IV criteria) not relieved by laxatives started a naloxegol therapy 25 mg/day for 4 weeks. Quality of life was evaluated by Patient Assessment of Constipation Quality-of-Life (PAC-QoL) at day 0 and day 28; background pain by Numerical Rating Scale, number of weekly spontaneous bowel movements and Bowel Function Index (BFI) were evaluated at day 0 and every week. Seventy-eight patients who completed the 4-week study improved all four PAC-QoL dimensions (physical and psychological discomfort, worries/concerns and satisfaction level). Weekly spontaneous bowel movements increased and BFI improved. Background pain reduced after seven days and remained lower during the following weeks. Seventy-two patients dropped out the study before day 28 with a reduced survival compared to patients completing the study. Even in these patients, an improvement of bowel function was observed after two weeks. Naloxegol was effective in improving the quality of life, resolving OIC and reducing overall pain in patients with advanced cancer.

Opioid-Induced Constipation in Advanced Cancer Patients.

The present study discusses opioid-induced constipation (OIC) in advanced cancer patients, focusing on the OIC definition, pathophysiology, and treatment. OIC is any change from baseline defecation patterns and bowel habits that developed after starting opioid therapy. The condition is characterized by bowel frequency reduction, worsening or development of straining, a sensation of incomplete defecation, or distress associated with bowel habits. OIC is common in advanced cancer patients, with a prevalence of approximately 51%-87% in patients taking opioids for pain management. Patients are likely to experience severe distress, work productivity reduction, poor quality of life, and increased healthcare utilization. OIC has a complex pathophysiology that involves propulsive and peristalsis impairment, intestinal mucosal secretion inhibition, intestinal fluid absorption enhancement, and anal sphincters function impairment. The Rome III criteria are used to assess and diagnose clinical OIC and can also be diagnosed through the Patient Assessment of Constipation (PAC) measures, including the symptom survey (PAC-SYM) and quality of life survey (PAC-QOL). Non-pharmacological treatment of OIC involves lifestyle habits and dietary adjustments, although these interventions might be insufficient to manage the condition. Pharmacological treatments involve the use of traditional laxatives and newer agents like peripherally acting mu-opioid receptor agonists (PAMORAs), including naldemedine, naloxegol, and methylnaltrexone. More novel treatments for OIC that target the pathophysiology are still needed and should be studied carefully for safety and efficacy.

Comparative evaluation of efficacy and safety of drotaverine versus mebeverine in irritable bowel syndrome

Background:Drotaverine and Mebeverine are used for alleviating the pain of IBS, but the evidence for their efficacy is scarce. In this randomised control study, we evaluated and compared their efficacy in improving severity, frequency of pain and its associated symptoms.Methods:Patients fulfilling the ROME III criteria of IBS were evaluated in this randomised control trial during 4 weeks of treatment. Group A (n = 100) received 80 mg Drotaverine and Group B (n = 100) received 135 mg Mebeverine three times a day, 1 hour before meals. Primary outcome measure was, the reduction in severity of pain (>30% reduction) assessed by VAS (0 to 10 scale) & PSS (patient symptoms scores).Results:The pain severity score fell from 6.02 to 4.8 on day 3 in Group A as compared to decrease from 6.72 to 6.62 in Group B (p < 0.01). This significant reduction in pain severity was observed till the end of the study, reducing from 6.02 to 1.78 (74% reduction) in Group A compared to 6.72 to 3.62 (46.1% reduction) in Group B (p < 0.05). There was a significant reduction in pain frequency, straining on stool, a change in one score in Bristol stool chart (BSC), achievement of complete spontaneous smooth bowel movement in Group A, compared to Group B patients. A significant improvement in Patient's evaluation of Global Assessment of Symptoms (p < 0.05) and Patient Assessment of Constipation – Quality Of Life (PAC-QOL) (p < 0.01) was observed in Group A compared to Group B.Conclusion:Drotaverine was significantly superior in efficacy as compared to Mebeverine in alleviating pain severity (starting from day 3), frequency and stools-elated symptoms of IBS.

Validity and Reliability of the Patient Assessment of Constipation: Symptoms (PAC-SYM ©) in the Indonesian Language

Introduction: Constipation is a very subjective symptom experienced by patients. Although ROME-IV could be used for diagnosis of functional constipation, it could not assess treatment response. The Patient Assessment of Constipation – Symptoms (PAC-SYM©) questionnaire was developed for this purpose. However, the PAC-SYM© had not been translated and adapted into Indonesian language.Methods: The original PAC-SYM© questionnaire was translated and adapted based on the available guidelines. The final version of the translation was then used to perform validity and reliability analysis. A total of 64 patients with chronic constipation from the local community in Jakarta, Indonesia was used for the psychometric evaluation. Principal component analysis and structural equation modeling were also attempted.Results: Most of the study subjects were female. The Cronbach’s alpha for the overall average score was 0.869 which showed good internal consistency. The intraclass correlation coefficient for the overall score was 0.743 which showed good test-retest reliability. Content validity was considered to be sufficient by experts. Each domain correlated strongly with the total score. PAC-SYM© had moderate correlation with PAC-QOL which showed concurrent validity. The multi-trait analysis showed scaling success. Question 7 showed a very high floor effect (84.4%), and therefore omitted from the factor analysis. The principal component analysis revealed a new ‘two-factors’ structure, with question from the original ‘rectal’ domain combined into the ‘stool’ domain. The structural equation modeling indicated good model fit.Conclusion: The Indonesian version of PAC-SYM© was valid and reliable to be used in clinical settings.

Short-Term Daily Intake of Polydextrose Fiber Does Not Shorten Intestinal Transit Time in Constipated Adults: A Randomized Controlled Trial

Chronic constipation (CC) remains a common gastrointestinal (GI) disorder that conveys a substantial healthcare burden. Expert guidelines recommend increasing fiber intake, yet the clinical evidence to support this needs strengthening for specific fibers. The aim was to evaluate changes in intestinal transit time and GI symptoms in CC patients who consumed polydextrose. In a randomized, double-blind, placebo-controlled trial, 128 adults with CC received 8 g or 12 g polydextrose, or placebo, daily for 4 weeks. Transit time, as primary outcome, was assessed by radiopaque marker distribution after 2-weeks intervention. Bowel habits, GI symptoms and quality of life (QOL) were assessed by questionnaire, including the Patient-Assessment of Constipation (PAC) Symptoms (SYM), and PAC-QOL. Following 2-weeks intervention, no reduction was seen in transit time in any group and following 2- or 4-weeks intervention, no improvements were seen in stool frequency or consistency in any group. After 2-weeks intervention with 8 g/day polydextrose an improvement was seen in the PAC-SYM rectal score (p = 0.041). After 4-weeks intervention both rectal (p = 0.049) and stool (p = 0.029) scores improved while improvement in the QOL satisfaction score did not reach significance (p = 0.071). Overall, the results suggest that 2-weeks consumption of 8 or 12 g/day polydextrose does not significantly improve physiological measures of gut function in CC adults. Longer term consumption may improve clinical measures, but further studies will be required to substantiate this.

Pelvic floor function following ventral rectopexy versus STARR in the treatment of obstructed defecation.

Obstructed defecation syndrome (ODS), most commonly found in females, can be treated by a transanal or abdominal approach with good success rate. Nevertheless, patients may experience de novo or persisting pelvic floor dysfunctions after surgery. The aim of this study was to compare the functional outcome of stapled transanal rectal resection (STARR) and ventral rectopexy (VRP) in a series of ODS patients. Forty-nine female patients who had surgery for ODS between 2006 and 2016 were retrospectively evaluated: 28 (median age 60years, IQR 54-69years) had VRP and 21 (median age 58years, IQR 51-66years) had STARR. ODS was scored with the ODS score while the overall pelvic floor function was assessed with the three axial perineal evaluation (TAPE) score. Quality-of-life was evaluated by the patient assessment of constipation quality-of-life (PAC-Qol) questionnaire administered preoperatively and after 1year of follow-up. The preoperative median ODS score and TAPE score were comparable in both groups. After a median follow-up of 12months (range 12-18months), the median ODS score was 12 (range 10-20) in the STARR group and 9 (range 3-15) in the VRP one (p = 0.02), while the median TAPE score was 70.5 (IQR 60.6-77.3) in the former and 76.8 (IQR 70.2-89.7) in the latter (p = 0.01). Postoperatively the physical domain of the PAC-QoL score had a median value of 2.74 (IQR 1.7-3.75) in the STARR group compared to 1.5 (IQR 1-2.5) in the VRP group (p = 0.03). No major complications were recorded in either group. VRP and STARR can improve defecation in patients with ODS with minimal complications, but the overall pelvic wellness evaluated by the TAPE score improves significantly only after VRP, suggesting a better performance of VRP than STARR when overall pelvic floor function is concerned.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial

BackgroundConstipation affects up to 20% of adults. Chronic constipation (CC) affects 1–2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice.Methods/designA three-arm, parallel-group, multicentre randomised controlled trial.Objectives: to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation–Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience.Hypotheses: (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST).Inclusion: chronic constipation in adults (aged 18–70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis.DiscussionThis trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015.

Normative Values for Colonic Transit Time and Patient Assessment of Constipation in Adults With Functional Constipation: Systematic Review With Meta-Analysis.

Availability of normative patient outcome data may assist in designing experiments and estimating sample sizes. The purpose of this review was to determine normative ranges for colonic transit time (CTT), Patient Assessment of Constipation-Symptoms (PAC-SYM), and Patient Assessment of Constipation-Quality of Life (PAC-QOL) in adults diagnosed with functional constipation per Rome III guidelines. Pooled estimates were derived from random-effects meta-analysis. Meta-regression was used to explore sources of heterogeneity among studies. A total of 24 studies (3786 patients) were included in the review. In 10 studies with 1119 patients, pooled CTT was 58 hours (95% confidence interval [CI]: 50-65 hours). Publication bias was not evident (Egger P = .51); heterogeneity was high (I2 = 92%, P < .001). In meta-regression, geographical location explained 57% of the between-study variance, with CTT significantly longer in studies conducted in Europe (71 hours) compared with Asia (49 hours) or the Americas (44 hours). In 9 studies with 2061 patients, pooled PAC-SYM was 1.70 (95% CI: 1.58-1.83). Publication bias was not evident (Egger P = .44). Heterogeneity was high (I2 = 90%, P < .001); however, no study or patient factor influenced PAC-SYM in meta-regression. In 12 studies with 1805 patients, pooled PAC-QOL was 1.97 (95% CI: 1.70-2.24). Publication bias was not evident (Egger P = .28); heterogeneity was high (I2 = 98%, P < .001). In meta-regression, age explained 52% of the between-study variance, with older age associated with lower PAC-QOL scores. Overall, in adults diagnosed with functional constipation per Rome III criteria, significant heterogeneity in CTT, PAC-SYM, and PAC-QOL exists among studies. Variability among studies may be explained by geography and patient factors.

Bisacodyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Patients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials

Background: Quality of life (QoL) is impaired in chronic constipation. Among nonprescription laxatives QoL data out of randomized controlled trials are available only for bisacodyl and sodium picosulfate (SPS). Methods: In two randomized, double-blind, placebo-controlled, parallel-group trials, the efficacy and safety of treatment with either bisacodyl or SPS, respectively, were assessed. After a 2-week baseline period patients with functional constipation were randomized to a 4-week treatment with either bisacodyl (2 tablets = 10 mg), SPS (18 drops = 10 mg), or matching placebo in a ratio of active drug to placebo of 2:1. Dose reduction as well as resuming the original dose was permitted. Patients who did not experience a bowel movement for more than 72 h were allowed to use a bisacodyl suppository. The primary endpoint was the mean number of Complete Spontaneous Bowel Movements (CSBMs) per week during the trial. QoL was assessed using the Patient Assessment of Constipation (PAC)-QoL questionnaire. Results: Active treatment led to a greater improvement of PAC-QoL scores for every domain. Active treatment was also superior to placebo for all individual questions of the questionnaire. Of note, SPS or bisacodyl not only improved satisfaction with stool patterns (“quite a bit/extremely satisfied” in 12.8% of patients on placebo and 50.3% on active treatment) but bloating was also considerably ameliorated (“not at all feeling bloated” in 24.5% on placebo and 41.4% on active treatment). Conclusion: Bisacodyl and SPS not only improve stool variables but also quality of life in patients with chronic functional constipation. (EudraCT Nos. 2007-001991-34 and 2007-002087-10).

Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response.

Treatment options for patients with opioid-induced constipation (OIC) and inadequate response to laxatives (LIR) are few. Assess the efficacy and safety of orally administered naloxegol in patients with prospectively confirmed OIC and LIR. We analyzed pooled data from two identical randomized, double-blind, placebo-controlled, Phase 3 trials of naloxegol in patients with non-cancer pain, OIC and LIR in which naloxegol (12.5 mg, n = 240; 25 mg, n = 241) or placebo (n = 239) were administered daily. We assessed the response rates, time to first post-dose laxation, spontaneous bowel movements (SBMs), OIC symptoms and patient-reported outcomes over 12 weeks. OIC response rates for the naloxegol 25-mg (p < 0.001) and the 12.5-mg (p = 0.005) LIR dose groups were higher than placebo. Median times to first post-dose SBM were 7.6, 19.2 and 41.1 hours for the naloxegol 25 mg, naloxegol 12.5 mg and placebo groups, respectively. Other SBM measures, daily symptoms of OIC, and both the Patient Assessment of Constipation - Symptoms and Patient Assessment of Constipation-Quality of Life scores improved from baseline with naloxegol treatment. Changes from baseline in opioid dose, pain scores and opioid withdrawal scores were similar among treatment groups. Naloxegol was efficacious, generally safe and well tolerated in the patients with OIC and LIR, while preserving opioid analgesia. ClinicalTrials.gov identifiers: NCT01309841; NCT01323790.

Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial.

To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids. In this double blind, randomized, active comparator trial, adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone (Amitza(®)), orally twice a day or Senna (generic) two capsules administered daily for six days. Subjects were assessed using the patient assessment of constipation (PAC)-symptoms (PAC-SYM) and the PAC-quality of life (PAC-QOL) scales measured at baseline and Day 7; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency, specific bowel symptom score (Nausea, cramping, straining, completeness, abdominal pain, time per lavatory attempt, assistance needed), adverse events and rescue medications required. Function was measured using the functional independence measure (FIM) at admission and discharge; length of stay (LOS) and missed treatments due to gastrointestinal symptoms were also assessed. 64 adults were enrolled; 56 participants (28 in each group) had baseline and follow up measures and were included in the intention to treat (ITT) analyses. 43 participants completed the study, 21 in the active lubiprostone and 22 in the active Senna group. The mean age of the participants was 71.5 years (SD = 11.4 years, range: 28-96 years). In the ITT analyses, participants showed significant improvement in bowel symptoms as measured by the PAC-SYM (mean ± SD, -0.28 ± 0.60, range: -1-2.33) and PAC-QOL (mean ± SD, 0.33 ± 0.81, range: -1.5-2.0) over time, but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM (-0.20 ± 0.60 vs -0.36 ± 0.61, P = 0.61 respectively) or the PAC-QOL (0.29 ± 0.76 vs 0.37 ± 0.87, P = 0.61 respectively). The mean change in each bowel symptom also did not significantly differ between treatment groups on ITT analyses, except for completeness of bowel movement, with the Senna group showing greater negative mean change in bowel movement completeness (-0.56 ± 1.01 vs -2.00 ± 1.41, P = 0.03) and for reduction of abdominal pain, favoring Senna (-0.14 ± 0.73 vs -0.73 ± 1.08, P = 0.04). Fifteen (75%) participants in the lubiprostone and in the Senna group requested rescue treatments. Participants made significant functional improvement from admission to discharge over a median LOS of 12 d, with a mean FIM change of 29.13 ± 13.58 and no significant between group differences (27.0 ± 9.2 vs 31.5 ± 16.6, P = 0.27). Both lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation, with no significant between-group differences.

Further validation of the psychometric properties of the Bowel Function Index for evaluating opioid-induced constipation (OIC)

Objective:The BFI (Bowel Function Index) is a 3-item questionnaire for assessing opioid-induced constipation (OIC). The aim of this study was to contribute to the validation of the psychometric properties of the BFI by confirming a constipation threshold, and through correlation with other validated tools: KESS (Knowles Eccersley Scott Symptom) score and generic (12-Item Short Form Health Survey, SF-12) and specific (Patient Assessment of Constipation–Quality of Life, PAC-QoL) quality-of-life scores.† BFI Copyright 2002, Mundipharma GmbH, City, Country; BFI is subject of European Patent Application Publication No. EP 1,860,988 and corresponding patents and applications in other countries.* PAC-QOL, Janssen Global Services, LLC, City, State, Country, USA.Methods:A survey on opioid-requiring cancer-patients was carried out in France. A questionnaire was filled out for all patients that recorded their demographic characteristics, an assessment of their constipation using BFI and KESS scores, and included a self-assessment of quality-of-life using PAC-QoL and SF-12. Correlation of BFI with KESS, PAC-QoL, and SF-12 was investigated.Results:Five hundred and twenty patients participated in the entire data collection with no loss. BFI was shown to be statistically correlated (r = 0.571; p < 0.0001) with the KESS score and matches up with PAC-QoL and to a lesser extent with the SF-12 generic quality-of-life questionnaire. A BFI threshold of 27–29 to discriminate constipated from non-constipated patients was confirmed.Key limitations:This cross-sectional study in a selected population of cancer pain patients has validated the psychometric properties of the BFI. Further confirmation of the validity of the BFI could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids.Conclusion:This study contributes to the validation of the psychometric properties of the BFI. It confirms the BFI as an easy-to-use tool to assess constipation and its impact on quality-of-life in chronic pain patients.

Lubiprostone Compared to Senna in the Treatment of Postoperative Opioid-Induced Constipation Following Orthopedic Procedures

Purpose: To assess the efficacy of lubiprostone compared to senna on bowel symptoms and bowel-related quality of life in patients undergoing inpatient rehabilitation following orthopedic procedures and who have opioid-induced constipation symptoms. Methods: In this double blind, randomized, active comparator trial, adults admitted to acute rehabilitation following orthopedic procedures exhibiting constipation symptoms and who required opioids for analgesia underwent baseline assessments which included the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation - Quality of Life (PAC-QOL) measured at baseline and study exit (Day 7); Secondary Measures included the Bristol Stool Scale Bowel Consistency. Specific Bowel Symptom Score (Nausea, cramping, straining, completeness, abdominal pain, time per lavatory attempt, assistance needed). Participants were randomized to one of two active treatment groups. lubiprostone (Amitza®), 24 μg orally twice a day or senna (generic) two capsules daily administered daily for six days and corresponding placebo tablets. Subjects were followed daily for symptom control, and questionnaires completed at Day seven. Results: Sixty-four adults were enrolled; 58 participants (28 in each group) completed baseline and Day seven assessments and were included in intention to treat (ITT) analyses. Forty-three participants completed the study, 21 in the active lubiprostone and 22 in the active senna group. The mean age of the participants was 71.5 (SD=11.4, range 28-96) years. In the ITT analyses, study participants showed significant improvement in bowel symptoms as measured by the PAC-SYM (mean change ± SD = -0.28±0.60, range -1 to 2.33) and PAC-QOL (mean change ± SD=0.33 ±0.81, range -1.5-2.0) over time, but there were no significant differences between the lubiprostone and senna groups for change in the PAC-SYM (mean change ± SD= -0.20±0.60 and mean change ± SD = -0.36±0.60, respectively) or the PAC-QOL (mean change ± SD=0.29 ±0.76 and mean change ± SD=0.37±0.87, respectively). The mean change in each bowel symptom also did not significantly differ between treatment groups for ITT analyses, nor did PAC-SYM subscales. Fifteen (75%) participants in the lubiprostone and 18 (78.2%) in the senna group requested rescue treatments (P value=1.00). Conclusion: Participants receiving either lubiprostone and senna demonstrated improved constipation-related symptoms and quality of life over the treatment period in the setting of opioid-induced constipation, however there were no significant differences noted between the two treatment groups in the outcomes measured. Despite daily scheduled use of these two laxative interventions, additional laxatives were frequently required for symptom control. Disclosure: Dr. Marciniak's Spouse - consultant Takeda. This research was supported by an industry grant from Takeda Pharmaceuticals.

Tu2029 Does Dyssynergy on High Resolution Anorectal Manometry Correlate With Specific Symptoms?

BACKGROUND: Although the pathophysiology and management of dyssynergic defecation (DD) differs from that of other types of constipation, it shares many of the same symptoms. The diagnosis of DD relies largely on anorectal manometry, defecography, or balloon expulsion tests, which are not available in all practices. Ideally, a specific symptom from the history could suggest DD, leading the physician to efficiently utilize these resources. METHODS: For 5months, data was prospectively collected frompatients undergoing high resolution anorectal manometry (HRARM) for an indication of constipation. Patients completed the validated questionnaire “patient assessment of constipation” (PAC-SYM) and a 7 item bowel habits questionnaire (BHQ) prior to HRARM. The BHQ was designed to further characterize the evacuation process such as need and frequency for digital extraction of stool (TABLE 1). HRARM was performed using a solid state catheter with 10 circumferential sensors spaced at 0.6cm intervals. Sensation was assessed by inflating the rectal balloon with saline at 10cc increments. HRARMs were analyzed and mean anorectal pressures were collected. Presence of a dyssynergy pattern (either paradoxical contraction or inadequate relaxation of the anal sphincter) was noted. Statistical analysis was performed using Spearman's correlation coefficient and the point biserial correlation coefficient. RESULTS: Thirty patients presenting for HRARM fully completed the questionnaires. The median age was 39, 83.4% patients were female, 16.6% male, 70% were white, 23.3% black, and 6.7% other races. The mean total PAC-SYM score was 21 (range 7-41) of which 0 is the minimum and 48 the maximum score possible. The mean total BHQ score was 6.7 (range 2-12) of which 0 is the minimum and 28 the maximum score possible. On HRARM, a dyssynergy pattern was seen in 70% of the patients, of which 58.8%were characterized by paradoxical contraction of the sphincter and 41.2% by inadequate relaxation. Impaired rectal sensation was seen in 79% of patients. There was no statistically significant correlation between the total PAC-SYM score, total BHQ score, or score from any individual question and the presence of dyssynergy. There was no significant correlation between the total PAC-SYM score, total BHQ score, or score from any individual question and the percent anal relaxation during bear down maneuvers (TABLE 2). CONCLUSION: Even with the inclusion of a customized bowel habit questionnaire that aimed totarget anorectal symptoms, a significant correlation between symptoms and dyssynergy could not be found. This highlights the importance of a focused rectal exam and physiologic testing such as anorectal manometry in the diagnosis of DD. Bowel Habits Questionnaire (BHQ)

Tu2030 A Ghrelin Enhancer, Rikkunshito, Ameliorates Anorexia in Cachexia Model of Pulmonary Fibrosis

BACKGROUND: Although the pathophysiology and management of dyssynergic defecation (DD) differs from that of other types of constipation, it shares many of the same symptoms. The diagnosis of DD relies largely on anorectal manometry, defecography, or balloon expulsion tests, which are not available in all practices. Ideally, a specific symptom from the history could suggest DD, leading the physician to efficiently utilize these resources. METHODS: For 5months, data was prospectively collected frompatients undergoing high resolution anorectal manometry (HRARM) for an indication of constipation. Patients completed the validated questionnaire “patient assessment of constipation” (PAC-SYM) and a 7 item bowel habits questionnaire (BHQ) prior to HRARM. The BHQ was designed to further characterize the evacuation process such as need and frequency for digital extraction of stool (TABLE 1). HRARM was performed using a solid state catheter with 10 circumferential sensors spaced at 0.6cm intervals. Sensation was assessed by inflating the rectal balloon with saline at 10cc increments. HRARMs were analyzed and mean anorectal pressures were collected. Presence of a dyssynergy pattern (either paradoxical contraction or inadequate relaxation of the anal sphincter) was noted. Statistical analysis was performed using Spearman's correlation coefficient and the point biserial correlation coefficient. RESULTS: Thirty patients presenting for HRARM fully completed the questionnaires. The median age was 39, 83.4% patients were female, 16.6% male, 70% were white, 23.3% black, and 6.7% other races. The mean total PAC-SYM score was 21 (range 7-41) of which 0 is the minimum and 48 the maximum score possible. The mean total BHQ score was 6.7 (range 2-12) of which 0 is the minimum and 28 the maximum score possible. On HRARM, a dyssynergy pattern was seen in 70% of the patients, of which 58.8%were characterized by paradoxical contraction of the sphincter and 41.2% by inadequate relaxation. Impaired rectal sensation was seen in 79% of patients. There was no statistically significant correlation between the total PAC-SYM score, total BHQ score, or score from any individual question and the presence of dyssynergy. There was no significant correlation between the total PAC-SYM score, total BHQ score, or score from any individual question and the percent anal relaxation during bear down maneuvers (TABLE 2). CONCLUSION: Even with the inclusion of a customized bowel habit questionnaire that aimed totarget anorectal symptoms, a significant correlation between symptoms and dyssynergy could not be found. This highlights the importance of a focused rectal exam and physiologic testing such as anorectal manometry in the diagnosis of DD. Bowel Habits Questionnaire (BHQ)

Stapled transanal rectal resection and sacral nerve stimulation - impact on faecal incontinence and quality of life

The aim of the study was to assess the impact of stapled transanal rectal resection (STARR) on pre-existing faecal incontinence and quality of life in patients suffering from obstructive defaecation syndrome (ODS) and to evaluate the efficiency of sequential sacral nerve stimulation (SNS) for improvement of persistent incontinence after STARR. Thirty-one patients with ODS and major faecal incontinence prior to STARR were prospectively enrolled. The outcome was measured using the Cleveland Clinic Constipation and Incontinence score (CCS, CCIS), Faecal Incontinence Qualities-of-Life Index (FIQL), Patient Assessment of Constipation Quality-of-Life (PAC-QOL) and EuroQol visual analogue scale (EQ-VAS). The overall levels of constipation (CCS from 13.1 ± 3.8 to 6.2 ± 5.4; P < 0.001) and incontinence (CCIS from 12.6 ± 3.2 to 9.4 ± 5.1; P = 0.005) were significantly improved after STARR; concordantly, the global and specific quality of life were significantly improved. Following postoperative constipation and incontinence, three different groups of patients were differentially referred to SNS. In group I (n = 16, 52%), both constipation (CCS from 12.6 ± 4.0 to 3.6 ± 1.9; P < 0.001) and incontinence (CCSI from 12.43 ± 3.2 to 5.1 ± 1.9; P < 0.001) were improved. In group II (n = 8, 25%), only constipation was improved (CCS from 12.3 ± 2.3 to 3.3 ± 2.2; P < 0.001), while incontinence persisted (CCIS from 12.8 ± 2.9 to 13.1 ± 3.1; P > 0.05). In group III (n = 7, 23%) there was no improvement at all. Sacral nerve stimulation was successfully carried out in six (85%) of seven patients in group II (post-SNS CCSI 6.1 ± 1.7; P = 0.01) but failed in five of five patients in group III. Stapled transanal rectal resection improves quality of life in ODS patients with both severe constipation and faecal incontinence. Sacral nerve stimulation may efficiently improve persisting incontinence after STARR in selected patients.