Patient Assessment Of Constipation Symptoms Scores Research Articles

Network meta-analysis of probiotics, prebiotics, and synbiotics for the treatment of chronic constipation in adults.

To compare the outcomes associated with the use of probiotics, prebiotics, and synbiotics for the treatment of chronic constipation in adults. We searched eight electronic databases from database inception to July 11, 2023, to identify randomized controlled trials (RCTs) that report efficacy and safety for the treatment of chronic constipation. The risk of bias in the included RCTs was evaluated according to the Cochrane tool, and the certainty of the evidence was assessed using the Confidence in Network Meta-Analysis framework. The analysis was conducted using R version 4.3.0. Out of the 37 RCTs, a total of 21 different types of interventions were reported, involving 3,903 patients. This NMA demonstrated that both prebiotics and synbiotics resulted in an increase in frequency of stool movements per week. Compared to placebo, lactulose (Mean difference [MD] = 3.39, 95% Confdence interval [CI] [1.13, 5.65], moderate certainty), mix2 (consisting of Lactulose and Bacillus coagulans) (MD = 3.63, 95% CI [1.37, 5.89], moderate certainty), mix6 (consisting of Lactulose and Bifidobacterium coagulans) (MD = 4.30, 95% CI [1.04, 7.54], low certainty), and mix7 (consisting of Lactulose, Bifidobacterium subtilis, and Enterococcus faecium) (MD = 4.58, 95% CI [1.35, 7.78], moderate certainty) exhibited a significant effect. Notably, mix7 demonstrated the highest probability of being the most effective intervention (94.8%). Furthermore, when compared to L. plantarum, four probiotics and two synbiotics showed significant advantages in the Patient Assessment of Constipation Symptoms (PAC-SYM) score. L. reuteri (MD = -13.74, 95% CI [-22.20, -4.66], very low certainty) exhibited a significant effect in improving the Patient Assessment of Constipation Quality of Life (PAC-QoL) score. In terms of safety, there were no statistically significant differences between the intervention and control groups in all adverse event analyses. Moderate to very low evidence supports the use of lactulose and synbiotics to increase the number of weekly stool movements in patients, particularly highlighting the significant impact of synbiotics in increasing the number of weekly stool movements in patients with constipation. The use of L. paracasei showed improvements in PAC-SYM scores, while L. reuteri demonstrated enhancements in PAC-QoL scores.

Effect of oral naloxone on opioid-induced constipation in methadone maintenance treatment patients, a double-blind, placebo-control, clinical trial.

Opioid-induced constipation (OIC) is the most prevalent side effect of methadone maintenance therapy (MMT). Naloxone could reduce the OIC. Fifty-six MMT cases (< 75mg/day methadone, > 3months) were entered randomly into four groups of a trial. They received placebo or naloxone tablets (0.5, 2, or 4mg/day) once a day for 2weeks. They continued their conventional laxative. Their constipation and opiate withdrawal (OWS) were evaluated by the Bristol Stool Form Scale (stool consistency and frequency), Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire, Constipation Scoring System (CSS), and the Subjective Opiate Withdrawal Scale (SOWS) before starting treatment and at the end of the first and second weeks. The dose of 4mg/day naloxone was excluded from the study due to severe OWS. The precipitantsof groups had similar ages, methadone dose and duration, laxative use, and constipation scores at the start of the trial. However, 2mg of naloxone could change the stool consistency (PV = 0.0052) and frequency (P = 0.0133), 0.5mg/day dose only improved the stool consistency (P = 0.0016). The patients' CSS and PAC-SYM scores were reduced by naloxone after the 1st week of treatment. However, there was no significant difference in the mean score of SOWS at different assessment times and groups. Also, 3 and 4 cases of 0.5 and 2mg/day groups, respectively, withdrew from the study due to OWS. Oral naloxone at doses of 0.5 and 2mg/day was significantly more effective than placebo on OIC in MMT. However, the dose of 4mg induced intolerable OWS.

Laparoscopic ventral mesh rectopexy vs. transperineal mesh repair for obstructed defecation syndrome associated with rectocele: comparison of selectively distributed patients

PurposeObstructed defecation syndrome represents 50–60% of patients with symptoms of constipation. We aimed to compare the two frequently performed surgical methods, laparoscopic ventral mesh rectopexy and transperineal mesh repair, for this condition in terms of functional and surgical outcomes.MethodsThis study is a retrospective review of 131 female patients who were diagnosed with obstructed defecation syndrome, attributed to rectocele with or without rectal intussusception, enterocele, hysterocele or cystocele, and who underwent either laparoscopic ventral mesh rectopexy or transperineal mesh repair. Patients were evaluated for surgical outcomes based on the operative time, the length of hospital stay, operative complications, using prospectively designed charts. Functional outcome was assessed by using the Initial Measurement of Patient-Reported Pelvic Floor Complaints Tool.ResultsFifty-one patients diagnosed with complex rectocele underwent laparoscopic ventral mesh rectopexy, and 80 patients diagnosed with simple rectocele underwent transperineal mesh repair. Mean age was found to be 50.35 ± 13.51 years, and mean parity 2.14 ± 1.47. Obstructed defecation symptoms significantly improved in both study groups, as measured by the Colorectal Anal Distress Inventory, Constipation Severity Instrument and Patient Assessment of Constipation-Symptoms scores. Minor postoperative complications including wound dehiscence (n = 3) and wound infection (n = 2) occurred in the transperineal mesh repair group.ConclusionLaparoscopic ventral mesh rectopexy and transperineal mesh repair are efficient and comparable techniques in terms of improvement in constipation symptoms related to obstructed defecation syndrome. A selective distribution of patients with or without multicompartmental prolapse to one of the treatment arms might be the preferred strategy.

Efficacy and safety of vibrating capsule for functional constipation (VICONS): A randomised, double-blind, placebo-controlled, multicenter trial

SummaryBackgroundFunctional constipation (FC) is an intractable disease that carries large financial burden as well as emotional and physical stress. We aimed to assess the efficacy and safety of the newly developed smartphone-controlled vibrating capsule (VC) in patients with FC.MethodsFrom December 2018 to February 2020, we did a multicenter, blinded, placebo-controlled randomised trial in six top general hospitals in China focusing on patients aged 18 to 80 with FC. Patients were randomly assigned in a 1:1 ratio to receive VCs or placebo treatment for six weeks (two capsules per week) after a two-week baseline period. The primary outcome was the responder rate, defined as the proportion of patients with an increase of at least one complete spontaneous bowel movement (CSBM) per week during treatment compared to baseline in the full analysis set. This trial is registered with ClinicalTrials.gov, number NCT04671264, and is completed.Findings107 patients aged from 18 to 74 were randomly assigned to receive VC (n = 53) or placebo treatment (n = 54). The responder rate in the VC group was significantly higher than that in the placebo group (64·2% vs. 35·8%; difference, 27·7% [95% CI, 10·4–45·1]; P = 0·005). More patients in the VC group reported weekly CSBMs ≥ 1 for at least four weeks during treatment (difference, 22·7% [95% CI, 8–46]; P = 0·022) and follow-up period (difference, 17.3% [95% CI, 0–35]; P = 0·048). The mean Patient Assessment of Constipation-Symptoms score and Patient Assessment of Constipation-Quality of Life score differed significantly from the baseline in both groups (all P < 0·0001). The most common adverse event associated with VC was abdominal discomfort (3·7%).InterpretationVCs can promote defecation, as well as ameliorating symptoms and improving the quality of life in patients with FC with sustained efficacy. VC appears to be a potential alternative physical treatment for FC with the exact mechanism and parameters warranting further investigation.FundingThe study was supported by "One hundred leading scientists for 21st century" of Health Department of Shanghai Municipal Government (to ZL, No.2017BR005).

The Efficacy and Safety of Fecal Microbiota Transplantation Combined With Biofeedback for Mixed Constipation: A Retrospective Cohort Study.

This study aims to assess the effectiveness and safety of fecal microbiota transplantation (FMT) combined with biofeedback for patients with mixed constipation. Patients who received biofeedback (biofeedback group, n = 40) and those who received FMT combined with biofeedback (FMT combination group, n = 45) were enrolled. Spontaneous bowel movements (SBMs) frequency, Bristol Stool Form Scale (BSFS), and Patient Assessment of Constipation Symptoms (PAC-SYM) score were analyzed to evaluate the effect of treatment. Gastrointestinal Quality of Life Index (GIQLI) scores of patients were used to assess the quality of life, and the safety of FMT combination therapy was evaluated by the presence of adverse events. The 16S rRNA gene sequencing was performed on the fecal samples of 12 donors, feces of 31 patients before and after receiving FMT combination treatment. Comparing the biofeedback group and the FMT combination group 1 month after the treatment, significant differences were observed in the mean value of SBM frequency, BSFS, and PAC-SYM scores, which were 2.15 ± 1.05 vs. 3.61 ± 0.89 (p = 0.0031), 2.1 ± 0.9 vs. 2.5 ± 1.2 (p = 0.008), and 2.4 ± 0.5 vs. 2.2 ± 0.6 (p = 0.0021), respectively. Meanwhile, FMT combination therapy had long-term beneficial effects according to the data collected at six months and 12 months after the treatment. With respect to the quality of life, GIQLI scores were higher in the FMT combination group (103.6 ± 15.1) compared with that in the biofeedback group (88.7 ± 10.1) one month after administration (p = 0.0042). In addition, there were no significant differences between the two groups in adverse events, including abdominal pain, diarrhea, dizziness, nausea, vomiting, and other side effects. Results of 16S rRNA gene sequencing showing some well-known probiotics had significantly increased after FMT combination treatment compared with pre-FMT samples, such as Prevotella and Bifidobacterium. Findings of this study suggested that FMT combined with biofeedback could be effective and safe for patients with mixed constipation.

Prevalence of self-reported abdominal symptoms among 50\u201374-years-old men and women eligible for colorectal cancer screening \u2013a cross-sectional study

BackgroundScreening is defined as the identification of unrecognized disease in an apparently healthy population. Symptomatic individuals are recommended to contact a physician instead of participating in screening. However, in colorectal cancer (CRC) screening this approach may be problematic as abdominal symptoms are nonspecific. This study aimed at identifying the prevalence of self-reported abdominal symptoms among screening-eligible men and women aged 50–74 years.MethodsThis cross-sectional survey study included 11,537 individuals aged 50–74 years invited for CRC screening from 9 to 23 September 2019. Descriptive statistics of responders experiencing alarm symptoms of CRC, Low Anterior Resection Syndrome Score (LARS) and the Patient Assessment of Constipation-Symptoms (PAC-SYM) were derived. The association between abdominal symptoms and demographic and socioeconomic variables were estimated by prevalence ratio (PR) using a Poisson regression model with robust variance.ResultsA total of 5488 respondents were included. The respondents were more likely women, of older age, Danish, cohabiting and had higher education and income level compared to non-respondents.Abdominal pain more than once a week was experienced by 12.0% of the respondents. Of these, 70.8% had been experiencing this symptom for >1 month. Fresh blood in the stool was experienced by 0.7% and of these 82.1% for >1 month. About one third of those experiencing alarm symptoms more than once a week for >1 month had not consulted a doctor. A total of 64.1% of the respondents had no LARS, 21.7% had minor LARS and 14.2% had major LARS. The median PAC-SYM score was 0.33 (Interquartile range (IQR): 0.17;0.75), the median abdominal score was 0.50 (IQR: 0.00;1.00), median rectal score 0.00 (IQR:0.00;0.33) and median stool score 0.40 (IQR: 0.00;0.80). Men and those aged 65–74 reported less symptoms than women and those aged 50–64 years, respectively.ConclusionsThis study illustrated that abdominal symptoms were frequent among screening-eligible men and women. This should be taken into account when implementing and improving CRC screening strategies. A concerning high number of the respondents experiencing alarm symptoms had not consulted a doctor. This calls for attention to abdominal symptoms in general and how those with abdominal symptoms should participate in CRC screening.

Establishing Minimal Clinically Important Differences in Quality of Life Measures in Opioid-Induced Constipation

Opioids have a role in chronic pain management. However, opioid-induced constipation may cause patients to skip or reduce opioid doses, leading to inadequate pain relief and negatively impacting quality of life. We sought to establish a minimal clinically important difference to understand whether changes in quality of life scores are of value to patients. Integrated data from the double-blind, controlled, phase 3 COMPOSE-1 and COMPOSE-2 trials of naldemedine in chronic noncancer pain and opioid-induced constipation were used to determine minimal clinically important differences using Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires. Patients completed the questionnaires (5-point Likert scale; predose, Weeks 2, 4, and 12), kept a daily log of Bowel Movement and Constipation Assessment, and rated satisfaction at end of study. Minimal clinically important differences were computed using an anchor-based method with 6 anchors: 5 from the Bowel Movement and Constipation Assessment and 1 from patient satisfaction. Threshold values for each anchor were set to define responders versus nonresponders based on score definitions. Clinically meaningful cutoff values for changes in PAC-SYM and PAC-QOL scores were determined using receiver operating characteristic curves. Data from 1095 patients (549, naldemedine; 546, placebo) were analyzed. The area under the curve for the receiver operating characteristic curves (ranges, 0.719 to 0.798 for PAC-SYM and 0.734 to 0.833 for PAC-QOL) indicated that both instruments can discriminate responders and nonresponders for each anchor. PAC-SYM cutoff values ranged from-1.04 to-0.83; PAC-QOL cutoff values ranged from-0.93 to-0.82. Based on data derived from the anchor method, reductions in PAC-SYM and PAC-QOL scores of >1.0 in patients with chronic noncancer pain and opioid-induced constipation are clinically meaningful. gov Registration: NCT01965158; NCT01993940.

The efficacy of docusate sodium and senna glycoside for the treatment of constipation after rotator cuff repair: A randomized controlled study.

Although stool softeners and laxatives are commonly prescribed for postoperative constipation, it is unclear if they are effective during the postoperative period. The data gained from this study will be beneficial for advanced practitioners when examining for postoperative constipation concerns. This study aimed to investigate the efficacy of docusate sodium and senna glycoside in the prevention and treatment of constipation following rotator cuff repair (RCR). Patients (n = 107) were randomized to receive docusate sodium, senna glycoside, or nothing (control) in addition to a standardized postoperative protocol. Patients maintained a daily bowel-movement log for postoperative days 0-10. Constipation symptoms and quality of life were assessed preoperatively and at 2 and 6 weeks postoperatively using the Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires. Sixty-seven percent of patients experienced constipation. There was no difference in the prevalence of constipation in the docusate, senna, and control groups (71.4%, 66.7%, and 64.3%, respectively; p = .88). Neither PAC-SYM nor PAC-QOL scores significantly differed between the 3 groups at any time point during 6-week follow-up (p > .05). The majority (67%) of patients experience postoperative constipation following RCR. Although docustate sodium and senna glycoside are common first-line agents for the treatment of constipation, they are ineffective during the postoperative period. Providers need to explore other treatment modalities for postoperative constipation pain.

Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial.

Study Objective To assess the effect of common bowel care regimens on return of bowel function following total laparoscopic hysterectomy (TLH). Design A prospective three-arm randomized controlled trial (Canadian Task Force Classification I). Setting Single academic-affiliated institution. Patients or Participants Women aged 18-85 years, without preexisting gastrointestinal disorders, undergoing TLH for benign indications. Interventions Patients were randomized to one of three arms using an equal allocation ratio to receive either no bowel care regimen (control group), docusate sodium, or polyethylene glycol 3350 (PEG) for the first five days following surgery. The primary outcome was time to first bowel movement postoperatively. Secondary outcomes were time to first flatus, total narcotic use in the first five days postoperatively, constipation score, and the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire score. Measurements and Main Results There were no significant differences in time to first bowel movement postoperatively amongst those receiving no bowel care regimen, docusate sodium, or PEG (2.64 ± 1.19, 2.80 ± 1.08, 3.06 ± 1.18 days; p=0.436). Similarly, there were no significant differences in time to first flatus: 1.06 days (interquartile range 0.89-1.70) in the control group, 1.05 days (interquartile range 0.78-1.37) in the docusate sodium group, and 1.11 days (interquartile range 0.82-1.40) in the PEG group (p=0.975). Total narcotic use in the first five days postoperatively, constipation score, and the PAC-SYM score did not vary significantly amongst the groups. Body mass index (BMI) was a significant predictor of time to first bowel movement with an increased BMI associated with a shorter time to first bowel movement [HR 1.05 (1.01, 1.10); p=0.013]. Conclusion In those undergoing laparoscopic hysterectomy for benign indications without any preexisting gastrointestinal disorders, the prescription of a bowel care medication does not significantly affect return of bowel function.

Breath Methane Does Not Correlate With Constipation Severity or Bloating in Patients With Constipation.

We aimed to study (1) if the breath methane level on glucose breath testing (GBT) was associated with constipation severity and (2) compare methane levels between patients with constipation and diarrhea. The breath methane level has been associated with constipation and its severity. However, a few recent studies have questioned these associations. Patients presenting consecutively to a tertiary care gastroenterology motility laboratory for GBT were included. GBT was performed using 75-g glucose load following a standard, institutional protocol. Constipation and irritable bowel syndrome (IBS) severity was measured using Patient Assessment of Constipation Symptoms (PAC-SYM) and IBS-symptom severity scale (IBS-SSS). In the cohort of 79 constipated patients, there was no significant correlation between baseline or maximum methane levels with total PAC-SYM score. IBS-SSS or bloating severity also did not correlate with baseline or maximum methane levels. The baseline or maximum methane levels of ≥3 and 5 ppm were equally distributed among those with constipation (n=79) and diarrhea (n=122). Only baseline methane levels of ≥10 and ≥20 ppm significantly correlated with constipation (P<0.001 for both). We found that constipation and bloating severity did not correlate with methane levels on GBT. In addition, only higher baseline methane levels (≥10 and ≥20 ppm) significantly correlated with constipation as baseline methane levels up to 5 ppm were equally common in patients with diarrhea and constipation. Baseline methane levels had better correlation with constipation compared with maximum levels of methane achieved.

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

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

P2.16-18 Opioid-Induced Constipation in Patients with Cancer Pain in Japan (OIC-J study): A Post-Hoc Analysis of Lung Cancer Patients

Opioid-Induced Constipation (OIC) is a common side effect of opioid analgesic therapy. OIC-J study was a multicenter, prospective, observational study of cancer patients who started opioid therapy in Japan (UMIN000025864). The aim of this post-hoc analysis was to clarify the OIC burden focusing on lung cancer patients. This post-hoc analysis was conducted by using a lung cancer patient’s data from OIC-J study. The incidence of OIC was determined by ROME IV diagnostic criteria based on the record of patient diary for 2 weeks, physician’s assessment, spontaneous bowel movement (SBM; <3 SBM/week), Bowel Function Index (BFI; score >28.8) and Patient’s assessment. The change in the Patient Assessment of Constipation-Symptoms (PAC-SYM) score and the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) score in 2 weeks after starting opioids were compared between OIC patients and non-OIC patients determined by ROME IV diagnostic criteria. 67 lung cancer patients from 212 in total cancer patients who were registered in OIC-J study were included in this analysis. The incidence of OIC was 48.0% (ROME IV diagnostic criteria), 59.1% (physician’s assessment), 39.1% (SBM) and 53.0% (BFI), respectively. The incidence of OIC by patient’s assessment was 43.5% in 2 weeks after starting opioids (40.3% at a week after staring opioids). The change in PAC-SYM and PAC QOL score in OIC-patients compared to non-OIC patients were 0.399 vs -0.122 (p=0.0031) and 0.214 vs -0.016 (p=0.0540), respectively. The OIC can occur quickly after the initiation of opioid therapy in lung cancer patients and can have an impact on patient’s QOL. These results suggest that an OIC management focusing on a quality and patient’s feeling of bowel movement in early stage in opioid analgesic therapy is important for lung cancer patients.

Efficacy and safety of Gelidium elegans intake on bowel symptoms in obese adults: A 12-week randomized double-blind placebo-controlled trial.

Background/aims:Gelidium elegans (GE) is known to have antiobesity effects and beneficial effects on functional bowel symptoms in preclinical studies. The aim of this study was to determine the efficacy and safety of GE intake on bowel symptoms in obese human adults.Methods:This 12-week single-center randomized double-blind placebo-controlled study was performed from September 2016 to May 2017. Consecutive obese subjects were randomly assigned (1:1) to either GE (1 g) or placebo (1 g) once daily group for 12 weeks. Patients’ bowel symptoms were evaluated using the Bristol Stool Form Scale, Constipation Scoring System (CSS), and Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire.Results:The stool symptom score of PAC-SYM significantly improved in the GE group compared with the placebo group after the 12-week treatment (P = .041). Abdominal discomfort score of CSS significantly decreased at 12 weeks compared to that at baseline in the GE group (P = .003), but not in the placebo group (P = .398). In addition, abdominal discomfort score of CSS slightly decreased in the GE group compared with the placebo group after the 12-week treatment (P = .060). However, stool consistency, total CSS score, and PAC-SYM score did not change significantly in both GE group and the placebo group over the 12-week treatment period.Conclusions:GE treatment for 12 weeks improved the stool symptom score on the PAC-SYM and abdominal discomfort score on the CSS in obese adults. However, further research is needed in large-scale human studies.

Naldemedine in Japanese patients with opioid-induced constipation and chronic noncancer pain: open-label Phase III studies.

IntroductionNaldemedine is a peripherally-acting µ-opioid-receptor antagonist, approved in Japan for opioid-induced constipation (OIC). In two open-label, single-arm, Phase III studies, we evaluated the safety and efficacy of naldemedine in Japanese patients with OIC receiving regular-use opioids (COMPOSE-6) or prolonged-release oxycodone (COMPOSE-7) for chronic noncancer pain.MethodsEligible Japanese adults with OIC and chronic noncancer pain received once-daily oral naldemedine 0.2 mg for 48 weeks, irrespective of food intake. Primary end points included measures of treatment-emergent adverse events (TEAEs), pain intensity, and opioid withdrawal. Secondary efficacy end points were evaluated at treatment week 2. Patient Assessment of Constipation Symptoms (PAC-SYM) and Quality of Life (PAC-QOL) scores were evaluated in both 48-week studies.ResultsOf patients enrolled in COMPOSE-6 (N = 43) and COMPOSE-7 (N = 10), TEAEs were reported in 88% (95% CI 74.9–96.1) and 90% (95% CI 55.5–99.7), respectively. The most frequently reported TEAEs, nasopharyngitis and diarrhea, were mostly mild or moderate in severity. Assessments of pain intensity and opioid withdrawal remained stable over the 48-week treatment periods of both studies. The proportion of spontaneous bowel-movement responders at week 2 in COMPOSE-6 was 81.0% (95% CI 65.9–91.4) and 90.0% (95% CI 55.5–99.7) in COMPOSE-7. Significant and sustained improvements in PAC-SYM and PAC-QOL scores were also observed in both studies (all P<0.05).ConclusionSide effects that occurred with naldemedine were mostly mild or moderate in severity, and the data suggested that naldemedine can improve bowel function and QOL in Japanese patients with OIC receiving regular-use opioids or prolonged-release oxycodone for chronic noncancer pain.

Effects of a proposed physical activity and diet control to manage constipation in middle-aged obese women.

BackgroundObesity is very common worldwide and is related to critical morbidity and mortality. It has a large number of impacts on the human body. Constipation has a prevalence from 4% to 29% in various parts of the world and is considered to be a major health problem, with an estimated incidence of 5% in males and 15% in females. There is a strong association between obesity and constipation. This study aimed to investigate the effect of physical activity and a low-calorie diet on constipation in middle-aged obese women.MethodsThis study included 125 obese women (age 20–40 years) who had chronic constipation. Participants were randomly assigned to two groups. Group A included 62 women who received a suggested protocol of physical activity, a low-calorie diet, and the routine standard care for constipation, whereas Group B included 63 women who received only the standard medical care for constipation and a low-calorie diet. Both groups followed the program for 12 weeks. Changes in the Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment Quality of Life (PAC-QOL) scores, and in the body mass index (BMI) were recorded in study subjects, both at baseline and at the end of the study program.ResultsThere were no statistically significant differences in the baseline characteristics of patients in the two groups. After 12 weeks of intervention, both groups showed significant intra-group differences (p < 0.05) in all of the measured variables, except the BMI which showed a nonsignificant difference (p > 0.05) in Group B. Between-groups comparison showed significant differences (p < 0.05) in all of the measured parameters in favor of Group A.ConclusionPhysical activity and weight reduction improve PAC-SYM and PAC-QOL scores in middle-aged, premenopausal women with constipation in the short term (up to 12 weeks).

Treatment of Severe Pain and Opioid-induced Constipation: An Observational Study of Quality of Life, Resource Use, and Costs in Sweden.

IntroductionOpioid-induced constipation (OIC) is a common and costly side effect of opioid treatment affecting patients’ quality of life (QoL). The combination oxycodone/naloxone reduces OIC while providing effective analgesia in patients with moderate to severe pain. The objective of this observational study was to compare health-related quality of life (HRQoL), healthcare resource use, and costs in patients with severe pain who were initially treated with oxycodone and laxatives and then subsequently switched to treatment with oxycodone/naloxone.MethodsData were collected by means of questionnaires completed by patients with OIC before and after the initiation of oxycodone/naloxone treatment at different clinical centers in Sweden. The questionnaires included questions on healthcare resource use and absence from work and also consisted of the Patient Assessment of Constipation-QoL (PAC-QoL) instrument, the EuroQol five dimensions questionnaire (EQ‐5D), the Patient Assessment of Constipation Symptoms (PAC-SYM) instrument, and the Bowel Function Index (BFI).ResultsThe analysis included 37 patients. Resource utilization was lower after treatment with oxycodone/naloxone, in terms of both the number of healthcare contacts and the purchases of medicine for the treatment of constipation. According to the BFI score, patients had fewer problems with OIC after the initiation of oxycodone/naloxone. The PAC-QoL score showed a positive change for patients in both the 96-point dissatisfaction index and the 16-point satisfaction index. PAC-SYM scores was lower after the initiation of oxycodone/naloxone treatment, indicating fewer constipation-related problems.ConclusionTreatment with oxycodone/naloxone had an overall positive effect on patients, consisting mainly of decreasing the severity of the constipation problems, increasing HRQoL, and decreasing the use of healthcare resources. Funding: Mundipharma AB, Gothenburg, Sweden.

Identifying Factors That Predict Worse Constipation Symptoms in Palliative Care Patients: A Secondary Analysis.

The aim of this work was to investigate whether variables identified as likely to impact the experience of constipation in other clinical settings similarly affected the experiences of constipated palliative care patients. The majority of palliative care patients with cancer are likely to be bothered by constipation symptoms at some point in their disease trajectory. Despite this, it remains unclear as to which factors predict more severe problems. This study was conducted in a sample of 94 constipated palliative care patients who were asked to voluntarily complete a series of questions regarding their demographic and other characteristics, including whether they had chronic constipation symptoms, that is, constipation symptoms for 12 months. Other variables included age, body mass index, sex, performance status, and regular opioids and their doses. At the same time, they were asked to complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires. Descriptive statistics summarized baseline data. Unadjusted associations between the selected variables on PAC-SYM were examined by using bi-variate analyses. Significant variables identified on bi-variate analyses were included in a multivariate analysis. The final results identified that only the chronicity of constipation symptoms predicted more severe symptoms. This relationship persisted when this single variable was retained in the final model, illustrating that PAC-SYM scores are 0.41 higher in patients with chronic constipation compared with those without it (p = 0.02). In contrast, regular opioid use was not identified as a significant factor (p = 0.56). This study suggests that the factor most likely to predict worse constipation symptoms was the duration that people had experienced problems. Further, those who perceived their constipation symptoms to be more severe had a poorer quality of life. More work is required to better define constipation risk factors and ways to best modify a patient's experiences.

Impact of Linaclotide and Stool Form on Bowel Movement Satisfaction in Patients with Irritable Bowel Syndrome with Constipation or Chronic Idiopathic Constipation: Results from the CONTOR Study

Introduction: Our objective is toevaluate factors influencing bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Methods: Fully-insured patients aged ≥18 years were identified from a large, geographically diverse, US health plan based on claims from 12/2012 to 6/2015. Criteria included: ≥1 pharmacy claim for linaclotide or lubiprostone; or ≥1 medical claim for constipation, IBS, or abdominal pain, plus a claim for a stool softener/laxative. Respondents completed a self-administered survey and 7-day daily diary of BMs at baseline. Survey measures included the Patient Assessment of Constipation Symptoms (PAC-SYM) and Quality of Life (PAC-QOL) questionnaires. Diary entries included time of each BM, treatments taken for constipation in the prior 24 hours, patients' 1-word description of each BM, and whether the BM was satisfactory. Binary variables were created for: linaclotide use in the past 24 hours, whether the 1-word BM description implied a loose or watery stool (LoWS) consistency, symptom severity and quality of life (QOL) based on median PAC-SYM and PAC-QOL scores. An interaction term between linaclotide use and LoWS was also created. Logistic regressions (with generalized estimating equations controlling for repeated measures and with and without the interaction term) analyzed the relationship between BM satisfaction and treatment, age (≥45), gender (male), race (white), PAC-SYM (≥median [i.e., greater severity]), PAC-QOL (≥median [i.e., lower quality of life]), and years with constipation symptoms (≥10). Results: Of 18,590 patients invited to participate, 2052 eligible patients completed surveys and 1747 completed BM diaries. Overall, of 15,264 BM diary entries, 7449 (49%) BMs were rated satisfactory. Patients who reported taking linaclotide in the prior 24 hours had higher odds of reporting their BMs as satisfactory (odds ratio (OR): 1.40 p < 0.001) than those who had not; the interaction term indicated that the odds were even greater among linaclotide users with LoWS (OR: 1.84 p < 0.001). Patients of white race, those with more severe symptoms, and worse QOL had lower odds of reporting their BMs as satisfactory (OR: 0.74, 0.60, and 0.69, respectively, all p≤0.001).Table 1: Model ResultsConclusion: Patients were more likely to report BMs as satisfactory when linaclotide was taken in the prior 24 hours, particularly when stool consistency was described by patients as loose and/or watery.

Treatment patterns, symptom reduction, quality of life, and resource use associated with lubiprostone in irritable bowel syndrome constipation subtype

Objectives Real-world patient outcomes data is scarce concerning the high disease burden of IBS-C. The aim of this study was to compare patient-reported symptom control, health-related quality of life (HRQoL), resource utilization, and treatment satisfaction of lubiprostone vs non-lubiprostone treatment for irritable bowel syndrome–constipation (IBS-C).Research design and methods An observational, retrospective US chart review and computer-assisted telephone patient survey was conducted March to August 2013 recruiting women over 18 years old with physician-confirmed IBS-C who had initiated new treatment from inadequate relief of previous treatments and who had been on the new treatment ≥3 months. Multiple IBS-C treatments were permitted. IBS-C severity, time since diagnosis, age, and race were controlled using inverse probability of treatment weighting. Weighted outcomes were compared using t-tests (continuous outcomes) and chi-squared tests (categorical outcomes).Main outcomes measures Instruments included Patient Assessment of Constipation Symptoms (PAC-SYM) and IBS quality of life (IBS-QoL). A single item assessed current treatment satisfaction.Results Of 162 patients (mean age 45.9 [SD 15.3] years old, 71% white, 61.1% with moderate IBS-C), 76 switched to lubiprostone and 86 to non-lubiprostone. Groups were similar in clinical and demographic characteristics and previous 30 day IBS-C treatment. After weighting, all PAC-SYM scores were lower for lubiprostone (P < 0.05). All IBS-QoL subscales were higher for lubiprostone including overall, dysphoria, social reaction, sexual, and relationship scores (P < 0.05.) More lubiprostone patients reported positive treatment satisfaction (92.3% vs 71.0%, P < 0.001).Conclusions In IBS-C patients with inadequate response to previous therapies, lubiprostone improved patient-reported symptom control, treatment satisfaction, and HRQoL. Key limitations include lack of measurement of patient-reported outcomes at treatment start and potential data gaps in chart documentation.

Bilateral transcutaneous tibial nerve stimulation for chronic constipation

Chronic constipation is difficult to treat when symptoms are intractable. Colonic propulsion may be altered by distal neuromodulation but this is conventionally delivered percutaneously. Transcutaneous tibial nerve stimulation is noninvasive and cheap: this study aimed to assess its efficacy in chronic constipation. Eighteen patients (median age 46years, 12 female) with chronic constipation were recruited consecutively. Conservative and behavioural therapy had failed to improve symptoms in all 18. Thirty minutes of daily bilateral transcutaneous tibial nerve stimulation was administered by each patient at home for 6weeks. The primary outcome measure was a change in the Patient Assessment of Constipation Quality of Life (PAC-QoL) score. Change in Patient Assessment of Constipation Symptoms (PAC-SYM), weekly bowel frequency and visual analogue scale (VAS) score were also measured. Fifteen patients (12 female) completed the trial. The PAC-QoL score improved significantly with treatment [pretreatment, median 2.95, interquartile range (IQR) 1.18; posttreatment, median 2.50, IQR 0.70; P=0.047]. There was no change in PAC-SYM score (pretreatment, median 2.36, IQR 1.59; posttreatment, median 2.08, IQR 0.92; P=0.53). Weekly stool frequency improved as did VAS score, but these did not reach statistical significance (P=0.229 and 0.161). The PAC-QoL and PAC-SYM scores both improved in four (26%) patients. Two patients reported complete cure. There were no adverse events reported. Bilateral transcutaneous tibial nerve stimulation appears to be effective in a quarter of patients with chronic constipation. Carefully selected patients with less severe disease may benefit more. This requires further study.