Patient Assessment Of Constipation Quality Of Life Scores Research Articles

Effectiveness of acupoint stimulation combined with neurogenic bowel training on constipation in stroke patients: a retrospective study

Objective To analyze the effectiveness of acupoint stimulation combined with neurogenic bowel training on constipation in stroke patients. Methods A retrospective analysis was conducted on the clinical data of 89 stroke patients with constipation admitted to our hospital from July 2022 to January 2024. All patients met the inclusion and exclusion criteria. The control group (n = 42) received neurogenic bowel training intervention, while the experimental group (n = 47) received finger acupoint stimulation combined with neurogenic bowel training intervention. Four outcome measures including intervention effects, bowel movements, Constipation Scoring System (CSS), and Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) were compared between the two groups. Results The total intervention effective rate in the experimental group (91.49%) was significantly higher than that in the control group (73.81%) (p < 0.05). Two weeks after intervention, the experimental group had significantly better first bowel movement time, average bowel movement time, and bowel movement interval time compared to the control group (p < 0.05). One and 2 weeks after intervention, the CSS and PAC-QOL scores in the experimental group were significantly better than those in the control group (p < 0.05). Conclusion Acupoint stimulation combined with neurogenic bowel training significantly improves constipation in stroke patients. Compared to neurogenic bowel training alone, the combined application of acupoint stimulation further improves bowel movements, reduces constipation severity, and enhances the quality of life in patients. Therefore, it is worthy of clinical promotion.

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.

Transcriptomic Signatures Associated With Gray Matter Volume Changes in Patients With Functional Constipation.

Functional constipation, which belongs to the functional gastrointestinal disorder (FGID), is a common disease and significantly impacts daily life. FGID patients have been progressively proven with functional and structural alterations in various brain regions, but whether and how functional constipation affects the brain gray matter volume (GMV) remains unclear; besides, which genes are associated with the GMV changes in functional constipation is largely unknown. On account of the structural MRI image from the 30 functional constipation patients and 30 healthy controls (HCs), GMV analysis showed that functional constipation patients had significantly decreased GMV in the right orbital prefrontal cortex (OFC), left precentral gyrus (PreG), and bilateral thalamus (THA). Correlation analysis showed that the self-rating depressive scale, patient assessment of constipation quality of life (PAC-QOL), and Wexner constipation scores were negatively correlated with GMV of the OFC and negative correlations between PAC-QOL score and GMV of the bilateral THA. Based on the Allen Human Brain Atlas, a cross-sample spatial correlation was conducted and found that 18 genes’ expression values showed robust correlations with GMV changes in functional constipation patients. These outcomes highlight our recognition of the transcriptional features related to GMV changes in functional constipation and could be regarded as candidates to detect biological mechanisms of abnormality in functional constipation patients.

Efficacy of Electroacupuncture Compared With Transcutaneous Electrical Stimulation for Severe Chronic Constipation: A Randomized Controlled Pilot Trial.

To treat severe chronic constipation, both electroacupuncture (EA) therapy and transcutaneous electrical stimulation (TES) are safe and effective, but there is a lack of comparison between the 2 treatments. We sought to compare the therapeutic effect of EA relative to TES for the treatment of severe chronic constipation. We conducted a pilot randomized controlled trial. Seventy participants with severe chronic constipation were randomly allocated to the EA group or TES group. The acupoints in both groups are bilateral Tianshu (stomach 25), Fujie (spleen 14), and Shangjuxu (stomach 37). Each participant received 24 sessions of EA or TES during the treatment period of 8 weeks. Outcome measures were the proportion of participants with an increase from baseline of 1 or more complete spontaneous bowel movements (CSBMs) at week 8 and changes in the number of CSBMs and spontaneous bowel movements, stool character, difficulty in defecation, Patient Assessment of Constipation Quality of Life (PAC-QOL); the proportion of participants using rescue medicine and adverse reactions. Participants were followed for 24 weeks after the treatment. Sixty of the 70 eligible participants completed the whole trial, 32 participants (91.43%) in the EA group and 28 participants (80.00%) in the TES group. There were 10 participants (14.29%) who dropped out during the whole study, 3 (8.57%) in the EA group, and 7 (20.00%) in the TES group. At weeks 20 and 32, 22 of 32 (68.75%) and 19 of 32 (59.38%) in the EA group met the clinical outcome of an increase of 1 or more CSBMs from the baseline, compared with 10 of 28 (35.71%) and 9 of 28 (32.14%) in the TES group ( P =0.019 and 0.042, respectively). At the same time, the proportions of participants having 3 or more CSBMs per week were 18 of 32 (56.25%) and 15 of 32 (46.88%) in the EA group, respectively, compared with 6 of 28 (21.43%) and 5 of 28 (17.86%) in the TES group ( P =0.008 and 0.027, respectively). Statistical differences between the 2 groups were maintained in the change from baseline in CSBMs during the follow-up period ( P =0.007 and 0.013, at week 20 and 32, respectively) and in the change from baseline in spontaneous bowel movements at week 20 ( P =0.007). Statistical significance was also observed in the decrease of PAC-QOL score after 8 weeks of treatment (mean±SD, EA: 19.06±14.41 vs. TES: 12.48±9.13, P =0.031). No significant difference was noted between the 2 groups in defecation difficulty, stool character, and the use of rescue medicine. For the treatment of severe chronic constipation, EA performed better than TES in long-term follow-up and improving the quality of life. TES could be a better choice for patients with severe chronic constipation who are afraid of acupuncture because it is noninvasive. Well-designed and more rigorous clinical trials with larger sample sizes are needed.

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.

Effectiveness of naloxegol in patients with cancer pain suffering from opioid-induced constipation

PurposeNaloxegol, an oral once-daily peripherally acting mu-opioid receptor antagonist, is indicated for the treatment of opioid-induced constipation (OIC) with inadequate response to laxative(s), in cancer and non-cancer patients. This study mainly aimed to assess in real-life conditions the efficacy and safety of naloxegol in cancer pain patients and the evolution of their quality of life.MethodsA non-interventional, 4-week follow-up study was conducted in 24 French oncology and pain centers between 2018 and 2019. Eligible patients were aged ≥ 18 years, treated with opioids for cancer pain, and started naloxegol for OIC with inadequate response to laxatives. The rate of the response to naloxegol (primary criterion) was assessed at W4. The evolution of quality of life was measured using the Patient Assessment of Constipation Quality of Life (PAC-QOL).ResultsA total of 124 patients were included (mean age, 62 ± 12 years; ECOG ≤ 2, 79%; primary cancer, lung 18%, breast 16%, prostate 11%, head and neck 9%, digestive 9%…; metastatic stage, 80%). At inclusion, the median opioid dosage was 60 mg of oral morphine or equivalent. At W4, the response rate was 73.4% (95% CI [63.7–83.2%]), and 62.9% (95% CI [51.5–74.2%]) of patients had a clinically relevant change in quality of life (decrease in PAC-QOL score ≥ 0.5 point). Adverse events related to naloxegol were reported in 8% of patients (7% with gastrointestinal events; one serious diarrhea).ConclusionThis real-world study shows that naloxegol is effective and well tolerated in cancer pain patients with OIC and that their quality of life improves under treatment.

Functional and sexual outcome of laparoscopic ventral mesh rectopexy vs transperineal mesh repair in the treatment of rectocele: a retrospective analysis

This study aimed to compare functional outcomes and quality of life, between transperineal mesh repair (TPMR) and laparoscopic ventral mesh rectopexy (LVMR) in the treatment of rectocele. Consecutive women with symptomatic rectocele without associated internal rectal prolapse or enterocele who underwent TPMR (n = 15) or LVMR (n = 20) from January 2013 to February 2019 were included. This study was a retrospective review of a prospectively maintained database. Patient demographics and postoperative complications were evaluated. Altomare’s obstructed defecation (OD) and Cleveland Clinic Incontinence Scores (CCIS), Patient Assessment of Constipation Quality of Life (PAC-QoL), Short-Form 36 Health Survey (SF-36) and Female Sexual Function Index (FSFI) were compared before, 3 months, and 12 months after surgery. The median follow-up was 49 (range 13–65) and 28 (range 13–60) months in the TPMR (mean age 47.8 ± 11.7, years) and LVMR (mean age of 52.4 ± 9.9 years) cohort, respectively. Incontinence, OD, and PAC-QoL scores significantly improved at 3 and 12 months after surgery in both groups. FSFI did not deteriorate 3 and 12 months after LVMR. FSFI scores significantly improved 3 months after TPMR, but a significant deterioration was observed 12 months after TPMR. A gradual increase observed for SF-36 3 months after surgery in both groups, and six of the eight subscale scores improved at 12 months, but social functioning in both groups and vitality in the TPMR group returned to baseline scores. TPMR and LVMR improved defecation. Sexual function was not worsened after LVMR, and some individual domains of FSFI worsened after TPMR.

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.

Efficacy of Electro-acupuncture in Treatment of Functional Constipation: A Randomized Controlled Trial.

Functional constipation (FC) is a chronic disease that significantly affects the life quality of patients. Acupuncture has been used for the treatment of FC for many years, but its effectiveness has not been scientifically assessed. The present study aimed to evaluate the efficacy of electro-acupuncture (EA) in relieving the symptoms, mental states and quality of life (QOL) of FC patients. A total of 96 FC patients were randomly allocated into EA, mosapride & sham EA group (MS) and mosapride control group (MC). In the EA group, patients were treated with 16 sessions of needling at Quchi (LI11) and Shangjuxu (ST37) bilaterally, 5 times a week in the first 2 weeks, and 3 times a week in the last 2 weeks. In the MC group, patients were treated with 5 mg mosapride citrate three times a day for 4 weeks. In the MS group, patients underwent sham EA and the same mosapride citrate treatment as in the MC group. The primary outcome was the number of weekly spontaneous bowel movements (SBMs). The secondary outcomes included stool consistency, intensity of defecating difficulty, 36-Item Short-Form Health Survey (SF-36), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation-Quality of Life (PAC-QOL). The results showed that as compared with the baseline, EA significantly improved the weekly SBMs, stool consistency and intensity of defecating difficulty (P<0.05). It also partly ameliorated the PAC-QOL, SF-36, SDS and SAS scores when compared with MC or MS group (P<0.05). However, no significant difference was observed between MS and MC groups in bowel function outcomes and QOL scores. It was concluded that EA could effectively improve bowel function, mental states and QOL of FC patients.

Ultrasonic Chinese herbal medication penetration therapy at Tiānshū (天枢 ST25) for opioid-induced constipation with liver stagnation and spleen deficiency

ObjectivesTo observe the clinical effect on opioid-induced constipation of liver stagnation and spleen deficiency treated with the ultrasonic penetration of the No.1 constipation herbal formula at Tiānshū (天枢 ST25). MethodsA total of 126 patients that were in compliance with the inclusion criteria were randomized into an acupoint group (41 cases), a Chinese medication group (42 cases) and a western medication group (43 cases). In the acupoint group, the ultrasonic penetration of the No.1 constipation herbal formula at bilateral Tiānshū (天枢 ST25) were given. In the Chinese herbal medication group, the No.1 constipation herbal formula was prescribed for oral administration. In the western medication group, polyethylene glycol electrolyte powder was prescribed for oral administration. The treatment was given once a day, for 14 days totally. Before and after treatment, the constipation symptom score, the score of the patient assessment of constipation quality of life (PAC-QOL), the situation of nitric oxide synthetase (NOS) in serum were observed in each group. The safety indicators in the observation included diarrhea, allergic reaction, liver dysfunction, skin lesions, etc. ResultsA total of 122 cases accomplished the trial. The total effective rate was 82.5% in the acupoint group, 80.48% in the Chinese medication group and 78.04% in the western medication group. The constipation symptoms were all relieved in the three groups, indicating the statistical significance as compared with those before treatment (P < 0.01, P < 0.05). In the acupoint group and the western medication group, the improvements in the three symptom items, i.e. distention or scurrying pain in the chest, hypochondriac region or the bilateral sides of the abdomen, depression or irritability and poor appetite, were better than the western medication group (P < 0.01, P < 0.05). The improvements in all of the symptoms in the acupoint group were better than the Chinese medication group (all P < 0.05). The PAC-QOL score was improved in each group after treatment and it was different significantly in statistics as compared with that before treatment in each group. After treatment, the improvement of PAC-QOL score in the acupoint group and the Chinese medication group was better than that in the western medication group (both P < 0.05), and the improvement in the acupoint group was better than the Chinese medication group (P < 0.05). As to serum NOS, after treatment, it was different significantly as compared with that before treatment in each group (all P < 0.05), the improvement in the acupoint group was better than that of either the Chinese medication group or the western medication group, indicating the statistical significance (both P < 0.05). The incidence of adverse reaction in the acupoint group was less and different significantly as compared with the western medication group (P < 0.01), and it was different statistically as compared with the Chinese medication group (P < 0.05). ConclusionThe ultrasonic penetration of the No.1 constipation herbal formula at Tiānshū (天枢 ST25) is effective on opioid-induced constipation of liver stagnation and spleen deficiency. This therapy achieves the significant therapeutic effect and presents the good compliance in treatment. Hence, it deserves to be further promoted in clinical application.

Elobixibat alleviates chronic constipation in hemodialysis patients: a questionnaire-based study

BackgroundHemodialysis patients are prone to constipation, which can adversely affect their quality of life (QOL). Elobixibat, a highly selective inhibitor of the ileal bile acid transporter, can increase the bile acid level in the colon and, subsequently, enhance colonic motility and secretion. In hemodialysis patients with chronic constipation, it may have a novel action mechanism. However, the effect of elobixibat on such patients’ QOL had not been reported. This study aimed to evaluate the effect of elobixibat on the QOL of hemodialysis patients with chronic constipation.MethodsThis was a multicenter, observational study that used the Japanese version of the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire on 27 patients (18 men and nine women, age range 47–90 years), who satisfied the Rome 3 diagnostic criteria for functional constipation and were already taking other drugs for constipation. These patients were administered elobixibat 10 mg/day and were asked to respond to the PAC-QOL questionnaire at baseline and after 4 weeks. Bayesian statistics were used to confirm our results.ResultsThe number of spontaneous bowel movements per week increased significantly from 2.6 ± 1.2 to 4.1 ± 2.1 (p < 0.001), and the Bristol Stool Form Scale score significantly improved from 1.9 ± 0.8 to 3.6 ± 0.7 (p < 0.001). The Cronbach’s alpha was 0.95, and the Guttman split-half reliability coefficient was 0.90. There were significant decreases in the physical discomfort scores from 1.94 ± 0.79 to 0.97 ± 0.72 (p < 0.001); psychosocial discomfort from 1.16 ± 0.93 to 0.63 ± 0.58 (p < 0.001); worries/ concerns from 1.84 ± 0.73 to 1.27 ± 0.59 (p < 0.001), and satisfaction from 2.79 ± 0.61 to 1.98 ± 0.77 (p < 0.001). The total PAC-QOL score significantly decreased from 1.83 ± 0.79 to 1.17 ± 0.56 (p < 0.001). Bayesian statistics confirmed the results’ significance.ConclusionsElobixibat reduced the PAC-QOL scores for hemodialysis patients with chronic constipation and improved the patients’ QOL. It may serve as a new option for treating constipation in hemodialysis patients.

Relationship between Stool Form and Quality of Life in Patients with Chronic Constipation: An Internet Questionnaire Survey

Introduction: Chronic constipation (CC) is a highly prevalent functional bowel disorder with low treatment satisfaction and impaired quality of life (QOL). However, physicians tend to emphasize only “stool frequency,” and relationship between “stool form” and QOL remains unclear. In this study, we aimed to investigate the actual situation of CC treatment in Japan and elucidate the relationship between stool form and QOL in patients with CC. Methods: We conducted an online questionnaire survey in September 2018 targeting Japanese adult patients already diagnosed with CC and taking prescribed drugs. Assessments included the type of drug treatment, treatment duration, frequency of drug use, frequency of bowel movements (BMs), Bristol Stool Form Scale (BSFS), and Japanese version of the Patient Assessment of Constipation QOL (PAC-QOL) scores. Relationship between BSFS and Japanese PAC-QOL scores was analyzed, and most important factor that influences QOL was investigated. Results: A total of 614 subjects were enrolled. Of these, 398 (64.8%) regularly used magnesium oxide and 162 (26.4%) used stimulant laxative, especially 81 (50.0%) used stimulant laxative “everyday.” Mean score of the PAC-QOL was 1.29 ± 0.74, and the lowest score (highest QOL) of 0.94 ± 0.61 was observed in BSFS type 4. Significant difference was seen between BSFS type 4 and all the other types except type 7. Multivariate analysis revealed that normal stool form (BSFS type 4) and BMs ≥3/week are strongly related to decreases of PAC-COL score. In BSFS types 6 and 7, 36% of individuals experienced self-discontinuation of prescribed drugs and 53% self-reduced drug intake because of excessive effects. Conclusions: Stool form and frequency of BMs are relevant to QOL, especially normal stool form (BSFS type 4) is important for improving the QOL in patients with constipation. Physicians should focus on “stool form” and reconsider the prescription especially in BSFS types 6–7 patients.

The Efficacy and Safety of Transcutaneous Acupoint Interferential Current Stimulation for Cancer Pain Patients With Opioid-Induced Constipation: A Prospective Randomized Controlled Study

Introduction. Opioid-induced constipation (OIC) is a principal complication secondary to analgesic therapy for cancer pain patients who suffer moderate to severe pain. In this study, we observe the efficacy and safety of transcutaneous acupoint interferential current (IFC) stimulation in those patients with OIC. Methods. A total of 198 patients were randomly allocated to the IFC group and control group in a 1:1 ratio. Finally, 98 patients in the IFC group received 14 sessions administered over 2 weeks, whereas 100 patients in the control group took lactulose orally during the same period. Observation items were documented at management stage and at follow-up stage according to Cleveland Constipation Scales (CCS), pain Numeric Rating Scales (NRS) and Patient Assessment of Constipation Quality of Life (PAC-QoL). Results. The total curative effects of the IFC group and the control group were indistinguishable (76.5% vs 70.0%, P = .299). Regarding CCS and PAC-QoL scores, no significant difference was observed between the 2 groups during the management time and at the follow-up stage of week 3 (P > .05, respectively), but groups were distinguished at the follow-up stage of week 4 (P < .001 and P = .031, respectively). The pain NRS decreased significantly at management stage week 2 and follow-up stage week 3 and week 4 (P = .013, P = .041, P = .011, respectively). Conclusions. Transcutaneous acupoint IFC therapy over acupoints of Tianshu (ST25) and Zhongwan (RN12) may improve constipation and quality of life in cancer patients receiving opiates; further studies are worthwhile.

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.

Translating Clinical Findings into the Patient’s Perspective: Post-hoc Pooled Analysis of Bowel Movement Changes as a Predictor of Improvement in Patients’ Opioid-induced Constipation Symptoms and Outcomes

PurposeOpioid-induced constipation (OIC) is a bothersome side effect of opioid use for the management of noncancer pain, affecting patients’ health-related quality of life and chronic-pain management. The objective of this study was to examine the relationship between changes in the frequency of spontaneous bowel movements (SBMs) and changes in patient-reported outcomes (PROs) among patients with OIC treated with naloxegol. MethodsPost hoc analyses were conducted using pooled data from two Phase III 12-week, placebo-controlled trials of naloxegol for the treatment of OIC (NCT01309841 and NCT01323790). Patients completed the Patient Assessment of Constipation–Quality of Life (PAC-QOL) and PAC–Symptoms (PAC-SYM) at each study visit, and the Straining Scale and Bristol Stool Scale (BSS) with each bowel movement for the study duration. Four subgroups were created based on improvements from baseline in mean frequency of SBMs per week: 0 or worse (no change), +1 SBM, +2 SBMs, and +≥3 SBMs. Spearman correlations assessed the association between mean SBM changes from baseline and mean changes from baseline in PROs; analysis of covariance was used to compare changes from baseline. FindingsA total of 1337 patients with mean (SD) age of 52.2 (11.0) years were included in this analysis. The patient population was predominantly white (79.0%) and female (62.4%). At baseline, mean SBM frequency was 1.4 (1.0) per week. At study end, all 4 SBM-change subgroups experienced improvements in PAC-QOL, PAC-SYM, Straining Scale, and BSS scores, and these changes were significantly correlated with mean changes from baseline in SBMs per week. The subgroup of patients with an increase in SBMs of ≥3 per week experienced the greatest improvements in PROs. ImplicationsIn these patients with OIC, an improvement in the frequency of SBMs by ≥3 per week was associated with consistent improvements in PROs, providing support for the use of improvements in SBMs as a clinical outcome surrogate for managing patients with OIC. Further research is needed to determine a threshold for change in SBMs that is clinically meaningful in both research and clinical settings. A key limitation was the post hoc nature of the study, which was not powered prospectively to examine these relationships.

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.

The Effect of Abdominal Massage on Constipation and Quality of Life.

This study was a randomized controlled trial aimed to find the impact of abdominal massage application on constipation and quality of life among patients. The sample included 30 intervention (abdominal massage) and 30 control subjects. To collect data, the following were utilized: Patient Information Form, Gastrointestinal Symptom Rating Scale, Constipation Severity Instrument, Bristol Scale Stool Form, Patient Assessment of Constipation Quality of Life (PAC-QOL) Scale, and European Quality of Life Instrument (EQ-5D). The data were collected from among patients in the morning and evening on the fourth, fifth, and sixth days postoperatively. No significant findings were discovered between experimental and control groups in terms of individual characteristics and characteristics that might influence constipation (p > .05). It was found that patients who received abdominal massage application defecated more often following their surgery than patients in the control group, which led to a statistically high level of significant difference between the groups (p ≤ .001). It was also found that the experimental group displayed higher average PAC-QOL and EQ-5D scores on discharge. Findings indicated that abdominal massage applied to patients diagnosed with postoperative constipation reduced symptoms of constipation, decreased time intervals between defecation, and increased quality of life.

The impact of opioid-induced constipation among chronic pain patients with sufficient laxative use.

The impact of sufficient laxative use on opioid-induced constipation (OIC) is not known. To understand the experience and symptom burden over time among chronic non-cancer pain patients with OIC who are sufficient laxative users. A prospective longitudinal study was conducted in United States, Canada, Germany and UK which included medical record abstraction, patient surveys and physician surveys. Patients on daily opioid therapy for ≥ 4 weeks for chronic non-cancer pain with OIC were recruited from physician offices and completed the survey at Baseline and Weeks 2, 4, 6, 8, 12, 16, 20 and 24. Sufficient laxative use was defined as at least one laxative remedy 4 or more times in the prior 2 weeks. Of the 489 patients who completed the Baseline survey and met OIC criteria, 234 (48%) were categorised as sufficient laxative users; 65% were female; 90% were white and 75 (32%) maintained sufficient laxative use for > 7 of the 8 follow-up periods. Patient Assessment of Constipation-Symptom (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) scores indicated moderate symptom severity and impact. PAC-SYM and PAC-QOL scores remained relatively unchanged over time with a maximum score change of 0.5 points. Work productivity and activity impairment remained relatively constant. Mean per cent activity impairment because of constipation was 37% at Baseline and 34% at Week 24. These findings demonstrate constipation persists despite sufficient laxative use with little improvement in symptoms, HRQL or activity impairment. This ongoing burden emphasises the need to identify more efficacious constipation therapies for this chronic pain patient population.

Factors Associated With Efficacy of Nurse-led Bowel Training of Patients With Chronic Constipation

It is not clear whether nurse-led bowel training (NBT), an individually tailored biofeedback strategy designed to improve the physiological process of defecation by operant conditioning and trial and error learning, is effective for patients with chronic constipation. We assessed the ability of NBT to reduce symptoms and increase quality of life in patients with constipation at a large tertiary medical center. We performed a retrospective analysis of data from 347 patients (median age, 50 years) who underwent a median 3 sessions of NBT for chronic constipation from January 2011 through December 2013 at St Marks Hospital in the United Kingdom. The NBT comprised a combination of sensory retraining, pelvic floor conditioning, and advice on diet and toileting behavior. Data on patient demographics (age, sex, type of constipation) were collected alongside their assessments of constipation, which were based on Patient Assessment of Constipation Quality of Life (PAC-QoL) and patient satisfaction scores. We performed binary logistic regression analysis. Each variable was tested first at the univariate level; those with significance (P < .10) were included in a multivariate model. At the end of NBT, 62.5% of the patients (217/347) reported reduced symptoms, and 40.2% of the patients (41/102) reported a reduction of at least 1 point on the PAC-QoL score. The mean PAC-QoL scores before and after NBT were 2.42 and 1.41, respectively (P = .001). Multivariate analysis demonstrated that increasing age (odds ratio [OR], 1.71; 95% confidence interval [CI], 1.02-2.87; P = .042), greater number of sessions (OR, 4.14; 95% CI, 2.09-8.20; P < .001), and non-irrigation (OR, 4.39; 95% CI, 1.89-10.19; P = .001) were independent predictors of patient satisfaction. Data collected immediately after patients with chronic constipation received NBT indicate that it is an effective treatment for most patients. Older patients with dyssynergic defecation benefit most from at least 4 sessions.

Validity and reliability of the patient assessment of constipation quality of life questionnaire for the Turkish population

There are few specific evaluation forms for evaluating the quality of life among patients with chronic constipation. Our study aimed to determine the validity and reliability of the translated Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire for the Turkish population because evidence of its reliability and validity is required to justify its use in other studies and clinical practice. This study included 154 patients with constipation who were treated at the Department of Gastroenterology, Dokuz Eylül University Hospital between January and June 2012. The translated PAC-QOL questionnaire was completed by patients at the clinic and also at a 2-week follow-up to test its reliability. Cronbach's alpha coefficient (internal consistency) was 0.91 (good) for the translated PAC-QOL questionnaire. Time validity was evaluated using the intraclass correlation coefficient (ICC) method, and the ICC value for all questions was confirmed as 0.68 at the 2-week follow-up. The validity of the tool in the study group was evaluated using factor analysis, and the results were highly significant (Kaiser-Meyer-Olkin value: 0.857; Bartlett's test: p=0.001). Questions were categorized according to six factors based on the factor analysis, and these factors explained 65.1% of the total variation. For hypothesis verification of the tool, the correlation coefficient for PAC-QOL and PAC Symptoms (PAC-SYM) was r=0.577 (p<0.001), whereas the correlation coefficient for PAC-QOL and constipation severity score was r=0.457 (p<0.001). The PAC-QOL questionnaire was reliable, although not valid because of the limited sample group.