Patient Assessment Of Constipation Quality Of Life Research Articles

Estimating minimal clinically important difference (MCID) for gastrointestinal symptoms in cystic fibrosis

BackgroundMinimal clinically important difference (MCID) is important to establish as a meaningful outcome in research when using patient reported outcome measures (PROMs). We determined the MCID using the distribution-based approach for three measurements used as part of the GALAXY study, which is an observational prospective study on gastrointestinal (GI) symptoms in cystic fibrosis (CF). MethodsFour hundred and two persons with cystic fibrosis (PwCF) participated in the GALAXY study, all with baseline values available for all questionnaires. Mean age was 20.9 years (2.1- 61.1) with 75 females and 94 males under the age of 18 (42.04 %) and 118 females and 115 males aged 18 or older (57.99 %). MCID was measured for Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Upper Gastrointestinal Symptoms (PAGI-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL) and their subscales. Two distribution-based approaches, defined as multiplications of the standard deviation (SD) or standard error of the mean (SEM), were used to approximate the MCID. ResultsThe two distribution-based approaches for determining the MCID estimates produced comparable results in trends in MCIDs across the subscales and total scores. In general, MCID estimates of subscales for all three measurements were higher than their total score MCIDs. The one-half SD- and SEM-based MCID estimates for total scores of each questionnaire are as follows: PAC-SYM: 0.26 and 0.14; PAGI-SYM: 0.32 and 0.15; PAC-QOL: 0.27 and 0.18, respectively. ConclusionThis paper establishes initial MCIDs estimated by the distribution-based approach for the PAC-SYM, PAGI-SYM and PAC-QOL that can now be used to evaluate interventional studies that may impact gastrointestinal symptoms in PwCF.

Quality of life in patients with chronic slow-transit constipation according to the PAC-QOL questionnaire and the effectiveness of conservative therapy

Objective — to assess the quality of life (QOL) of patients with chronic slow‑transit constipation (CTC) according to the PAC‑QOL (Patient Assessment of Constipation Quality of Life) questionnaire, as well as the effectiveness of conservative therapy. Materials and methods. The study included 246 patients with chronic (more than 5 years) slow‑transit constipation (CSTC group) and 70 patients without CSTC (reference group). These individuals were examined and treated in the clinics of Bogomolets National Medical University from 2014 to 2023. The onset of chronic slow‑transit constipation often occurred at an average age of 22.2±0.8 years (from 1 year to 67 years) and lasted 20.2±0.7 years (from 5 to 53 years). The average duration of the delayed passage of stool was 9.4±0.3 days (from 3 to 22 days). All patients received an adjusted course of conservative treatment according to the Rome guidelines. The nosospecific PAC‑QOL questionnaire was used to evaluate the patients’ quality of life on their initial visit and 6—8 months after conservative therapy. Results. During the initial assessment, the CSTC group had a mean score of 3.03±0.56 on the «Physical Discomfort» subscale, while the reference group had a mean score of 1.19±0.29. On the «Psychosocial Discomfort» subscale, the CSTC group had a mean score of 2.21±0.52 compared to 0.84±0.18 in the reference group. The mean score for the «Worries and Concerns» subscale was 2.49±0.41 in the CSTC group and 0.77±0.24 in the reference group. The mean score for the «Satisfaction» subscale was 3.31±0.43 in the CSTC group and 0.86±0.28 in the reference group. The PAC‑QOL questionnaire total score was 2.63±0.26 in the CSTC group and 0.87±0.12 in the reference group (p <0.001 for all). After conservative treatment, the PAC‑QOL scores improved by an average of 40.4±20.0% (to 0.68—2.71 points). The cluster analysis revealed that after the course of conservative therapy, the PAC‑QOL questionnaire scores formed three distinct clusters: Cluster I — 0.68—1.39 points (49.2% of patients), Cluster II — 1.40—1.99 points (17.5% of patients), and Cluster III—2.0—2.8 points (33.3% of patients). These clusters represent good, satisfactory, and unsatisfactory results. Conclusions. The PAC‑QOL questionnaire revealed a statistically significant decline in QOL in patients with CSTC (2.63±0.26 points compared to 0.87±0.12 points in the reference group). Modern conservative treatment improved quality of life in 49.2% of cases. 17.5% of cases showed a satisfactory result, while the remaining ones exhibited insignificant or no improvement. Other treatment options, including surgery, should be considered for patients who do not respond to conservative therapy.

Effectiveness of Abdominal Massage Versus Kinesio Taping in Women With Chronic Constipation: A Randomized Controlled Trial.

Chronic constipation is an important public health problem and significantly affects women's lives. It is important to investigate nonpharmacological applications that can be used in the treatment of chronic constipation. The aim is to assess how abdominal massage and Kinesio taping impact constipation severity, quality of life (QOL), and perception of subjective improvement in women with chronic constipation. Following the Rome IV diagnostic criteria, women with constipation were randomly sorted into 3 distinct groups for study: massage group (lifestyle recommendations + abdominal massage, n = 22), taping group (lifestyle recommendations + Kinesio taping, n = 22), and control group (lifestyle recommendations, n = 22). Constipation Severity Instrument (CSI) (for constipation severity), 7 days bowel diary (for bowel function), Patient Assessment of Constipation QOL (PAC-QOL) questionnaire (for QOL), 4-item Likert-type scale (for perception of subjective improvement) was used. The group x time interaction effect was significant in all CSI, bowel diary and PAC-QQL parameters, except for incomplete evacuation and PAC-QOL-worries/concerns, and a large effect size was found (Partial η2 > 0.14). Improvement scores of all parameters (except CSI-obstructive defecation, incomplete evacuation, PAC-QOL-worries/concerns) were similar in the massage and taping groups and were better than the control group. Noteworthy perceptions of subjective improvement and normalization of stool type predominantly manifested in the massage group (P < 0.05). Abdominal massage and Kinesio taping are recommended as initial conservative interventions for managing chronic constipation within the therapeutic spectrum.

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.

A Novel Herbal Composition Alleviates Functional Constipation, Reduces Gastrointestinal Transit Time, and Improves Bowel Function in Adults: A Double-Blind, Randomized Clinical Study

Background and objective A recent proof-of-concept pilot clinical study has demonstrated that consumption of CL18100F4, a proprietary herbal blend of Withania somnifera root and Abelmoschus esculentus fruit extracts, significantly relieved the participants from functional constipation and improved their quality of life. The objective of the present randomized, double-blind, placebo-controlled study was to reevaluate the efficacy and tolerability of CL18100F4 in a larger number of subjects. Methods Male and female subjects (n = 135; age: 25–60 years), selected through Rome-IV criteria for functional constipation, were randomized into placebo and 300 or 500 mg of CL18100F4 groups and supplemented daily over 60 consecutive days. The primary efficacy outcome measure was Patient Assessment of Constipation-Symptoms (PAC-SYM), evaluated at baseline and on days 7, 30, and 60 of supplementation. The secondary efficacy parameters included Patient Assessment of Constipation-Quality of Life (PAC-QOL), Gastrointestinal Symptom Rating Scale (GSRS) scores, Gastrointestinal Transit Time (GIT), and Complete Spontaneous Bowel Movement (CSBM). Serum levels of Interleukin (IL)-6, IL-10, cortisol, gastrin, serotonin, Diamine oxidase (DAO), and Zonulin were measured. Results CL18100F4 supplementation significantly (p < 0.001) reduced the PAC-SYM, PAC-QOL, GSRS scores, and GIT and improved CSBM scores. CL18100F4 significantly improved (p < 0.001) sleep quality and decreased depression and anxiety symptoms in the participants. Notably, relief in constipation symptoms and improved gastrointestinal (GI) function were reported starting from day 7. Furthermore, CL18100F4 supplementation significantly (p < 0.001) increased the serum levels of IL-10, DAO, serotonin, gastrin, reduced IL-6, cortisol, and Zonulin. No major adverse events were observed. Participants’ vital signs, hematology, clinical biochemistry, and urinalysis parameters were within the normal ranges. Conclusion The present investigation demonstrates that CL18100F4 is tolerable and efficacious in relieving functional constipation, alleviating GI dysfunction, and improving associated non-GI factors in male and female adults.

Effectiveness and safety of digital rectal stimulation and abdominal massage for neurogenic bowel dysfunction in stroke patients: a randomized controlled trial protocol

BackgroundNeurogenic bowel dysfunction (NBD) is a prevalent complication among stroke patients, significantly affecting their quality of life, duration of hospitalization, medical expenses, and even mortality. Although current guidelines suggest a conservative strategy for addressing bowel dysfunction, which includes techniques such as digital rectal stimulation (DRS) and abdominal massage, the availability of interventions remains limited in healthcare facilities.MethodsThis study follows a prospective randomized controlled parallel-group clinical trial design. The control group will receive standard care, while the intervention group will undergo a program that combines DRS and abdominal massage in addition to standard care. The duration of the intervention for both groups will be 6 weeks. The primary outcome measures will be the Wexner score. Furthermore, secondary outcomes measure will be assessed, including Bristol score, Patient Assessment of Constipation-Quality of Life (PAC-QoL), and Fecal Incontinence Quality of Life (FI-QoL).DiscussionThis study aims to evaluate the effectiveness and safety of a bowel rehabilitation program for stroke patients with NBD. The findings will provide information that can contribute to the formulation of bowel management strategies.Trial registrationThe study has been registered in the Chinese Clinical Registry under the number ChiCTR2300071709. This registration was completed on May 23, 2023. All items from the World Health Organization Trial Registration Data set are described in this manuscript.

A blend of Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit extracts relieves constipation and improves bowel function: A proof-of-concept clinical investigation

Ethnopharmacological relevanceWithania somnifera (L.) Dunal (WS) and Abelmoschus esculentus (L.) Moench (AE) are known as Ashwagandha and Okra, respectively, important herbs in traditional medicine for their diverse therapeutic values. WS root is an adaptogen that relieves stress and anxiety and promotes sleep. AE fruit or Okra is widely consumed as a vegetable and is traditionally used to treat diabetes, gastric irritations, ulcers, and obesity. Aim of the studyThe present randomized, double-blind, placebo-controlled study aimed to establish a proof-of-concept evaluating the efficacy and tolerability of a proprietary blend of standardized extracts of WS root and AE fruit, CL18100F4 in relieving constipation and improving quality of life in adults. Materials and methodsForty-eight male and female participants (age: 25–60 years) with functional constipation (following Rome-III criteria) were randomized into placebo, 300 or 500 mg of CL18100F4 groups, and supplemented for fourteen consecutive days. ResultsCL18100F4 supplementation significantly (p < 0.0001) reduced the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), and Gastrointestinal Symptom Rating Scale (GSRS) scores. CL18100F4 supplementation improved sleep quality and reduced stress (p < 0.0001). At the end of the study, CL18100F4-500 subjects showed significant increases in serum serotonin, gastrin, and interleukin-10 and decrease in interleukin-6 and cortisol levels. Participants’ hematology, total blood chemistry, vital signs, and urinalysis parameters were within the normal ranges. No adverse events were reported. ConclusionsThis short-duration, single-site clinical investigation demonstrates that CL18100F4 supplementation is tolerable, helps relieve constipation, reduces stress, and improves gastrointestinal function, sleep quality, and general wellness in adults. Trial registrationClinical Trials Registry- India (CTRI/2020/11/029320); Registered on 24/11/2020. Available at: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=49391&EncHid=&userName=CL18100F4.

The Effect of Electrolyzed Hydrogen-Rich Alkaline Reduced Water on Patients with Chronic Constipation—A Clinical Trial

Chronic constipation is a common symptom-based disorder that affects patient quality of life. Electrolyzed hydrogen-rich alkaline reduced water (EHARW) helps treat gastrointestinal disorders owing to its various bioactive properties. This single-arm, open-labelled study aimed to investigate the improvement of EHARW (pH 9.5; H2 ≈ 0.5 mg/L) in chronic constipation patients. Thirty patients with chronic constipation were enrolled after screening as intention-to-treat (ITT). During the intervention period, two patients dropped out, and 28 patients completed the study as per protocol (PP). The selected patients were instructed to drink EHARW (pH 9.5; H2 ≈ 0.5 mg/L) (20 mL/kg body weight/day) generated from a home medical device for four weeks. Complete spontaneous bowel movement (CSBM) frequency was measured as the primary outcome, and Bristol stool form, patient assessment of constipation–symptoms (PAC-SYM) score, and patient assessment of constipation–quality of life (PAC-QOL) score were measured as the secondary outcomes after the 4-week intervention compared to baseline. As a result of EHARW treatment, no adverse events were observed during the study period. Moreover, the frequency of CSBM/week (29.8%, p &lt; 0.05) and Bristol stool form score (24.6%, p &lt; 0.01) significantly increased compared to baseline. Finally, the overall and subscale scores of the PAC-SYM (58.0%) and PAC-QOL (54.2%) questionnaires significantly decreased (p &lt; 0.001). These results suggest that daily ingestion of EHARW (pH 9.5; H2 ≈ 0.5 mg/L) can improve CSBM frequency as a primary outcome in chronic constipation patients. Likewise, EHARW (pH 9.5; H2 ≈ 0.5 mg/L) improved Bristol stool form score, symptoms and the quality of life as a secondary outcome in patients with chronic constipation through a home-based intervention.

Clinical Characteristics of Adult Functional Constipation Patients with Rectoanal Areflexia and Their Response to Biofeedback Therapy.

The London Classification for anorectal physiological dysfunction specifically proposes rectoanal areflexia (RA), which means the absence of a rectoanal inhibitory reflex (RAIR) based on a manometric diagnosis. Although RA is not observed in healthy people, it can be found in adult patients with functional constipation (FC). This study describes the clinical manifestations of adult patients with FC and RA and their response to biofeedback therapy (BFT). This retrospective study reviewed the reports of high-resolution anorectal manometry (HR-ARM) and the efficacy of BFT in adult patients with FC. In addition, the Constipation Scoring System (CSS) scale, Patient Assessment of Constipation Symptoms (PAC-SYM) scale, Patient Assessment of Constipation Quality of Life (PAC-QOL) scale, Zung's Self-Rating Anxiety Scale (SAS), Zung's Self-Rating Depression Scale (SDS), balloon expulsion test (BET), and the use of laxatives were assessed. A total of 257 adult patients diagnosed with FC were divided into the RA group (n = 89) and the RAIR group (n = 168). In the RA and RAIR groups, 60 (67.4%) and 117 (69.6%) patients, respectively, had dyssynergic defecation (DD) during simulated defecation. Type II pattern of dyssynergia was most frequently observed in both groups. Compared with the RA group, the RAIR group showed a higher CSS score, physical discomfort score, and prevalence of inadequate relaxation of the anal sphincter (p &lt; 0.001, p = 0.036, and p = 0.017, respectively). The anxiety and depression scores were not different between the two groups. The proportion of patients using volumetric and stimulant laxatives and their combination was significantly higher in FC patients with RA, whereas the efficacy of BFT was significantly lower (p&amp;nbsp;= 0.005, p &lt; 0.001, p = 0.045, and p = 0.010, respectively). Adult FC patients with RA may suffer more severe constipation and have a lower efficacy of BFT compared with those with RAIR.

Sustained ameliorating effects and autonomic mechanisms of transcutaneous electrical acustimulation at ST36 in patients with chronic constipation.

The treatment of chronic constipation is still a great challenge in clinical practice. This study aimed to determine the efficacy and sustained effects of transcutaneous electrical acustimulation (TEA) at acupoint ST36 on the treatment of chronic constipation and explore possible underlying mechanisms. Forty-four patients with chronic constipation were recruited and randomly assigned to a TEA group or sham-TEA group. A bowel diary was recorded by the patients. The Patient Assessment of Constipation Symptom (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaires were administered during each visit. Anal and rectal functions were evaluated with anorectal manometry. Autonomic functions were assessed by the special analysis of heart rate variability derived from the ECG recording. Compared with sham-TEA, 2-week TEA treatment significantly increased the number of spontaneous bowel movements (SBMs) (5.64 ± 0.54 vs. 2.82 ± 0.36, P < 0.001) and lowered the total scores of PAC-SYM (0.90 ± 0.14 vs. 1.35 ± 0.13, P < 0.001) and PAC-QoL (0.89 ± 0.13 vs. 1.32 ± 0.14, P < 0.05). TEA improved symptoms, as reflected by a reduction in the straining (P < 0.001), the incomplete defecation (P < 0.05), the frequency of emergency drug use (P < 0.05), the days of abdominal distension (P < 0.01) and an increase in intestinal satisfaction (P < 0.01). Interestingly, the effects of TEA on the improvement of weekly SBMs sustained four weeks after the cessation of treatment (P < 0.001). Anorectal manometry indicated that 2-week treatment of TEA lowered the threshold of first sensation (P < 0.05), desire of defecation (P < 0.01) and maximum tolerable volume (P < 0.001) compared with sham-TEA group. TEA also significantly enhanced vagal activity, reflected by high-frequency band of heart rate variability, compared with sham-TEA (57.86 ± 1.83 vs. 48.51 ± 2.04, P < 0.01). TEA ameliorates constipation with sustained effects, which may be mediated via improvement of rectal sensitivity and enhancement of vagal activity. [https://clinicaltrials.gov/], identifier [ChiCTR210004267].

Elexacaftor/tezacaftor/ivacaftor and gastrointestinal outcomes in cystic fibrosis: Report of promise-GI

BackgroundElexacaftor/tezacaftor/ivacaftor (ETI) improves pulmonary disease in people with cystic fibrosis (PwCF), but its effect on gastrointestinal symptoms, which also affect quality of life, is not clear. MethodsPROMISE is a 56-center prospective, observational study of ETI in PwCF >12 years and at least one F508del allele. Gastrointestinal symptoms, evaluated by validated questionnaires: Patient Assessment of Upper Gastrointestinal Disorders-Symptom (PAGI-SYM), Patient Assessment of Constipation-Symptom (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL)), fecal calprotectin, steatocrit and elastase-1 were measured before and 6 months after ETI initiation. Mean difference and 95% confidence intervals were obtained from linear regression with adjustment for age and sex. Results438 participants fully completed at least 1 questionnaire. Mean (SD) for baseline PAGI-SYM, PAC-SYM, and PAC-QOL total scores were 0.56 (0.59), 0.47 (0.45), and 0.69 (0.53) out of maximum 5, 4, and 5, respectively (higher score indicates greater severity). Corresponding age- and sex-adjusted 6 months mean changes (95% CI) in total scores were -0.15 (-0.21, -0.09) for PAGI-SYM, -0.14 (-0.19, -0.09) for PAC-SYM, and -0.15 (-0.21, -0.10) for PAC-QOL. While statistically significant, changes were small and unlikely to be of clinical importance. Fecal calprotectin showed a change (95% CI) from baseline of -66.2 µg/g (-86.1, -46.2) at 6 months, while fecal elastase and steatocrit did not meaningfully change. ConclusionsAfter 6 months of ETI, fecal markers of inflammation decreased. Gastrointestinal symptoms improved, but the effect size was small. Pancreatic insufficiency did not improve.

The effects of synbiotics on indoxyl sulphate level, constipation, and quality of life associated with constipation in chronic haemodialysis patients: a randomized controlled trial

BackgroundGut microbiota dysbiosis in patients with chronic kidney disease on haemodialysis (CKD-HD) creates an increase in proteolytic bacteria activity, leading to an increase in the production of uraemic toxins, such as indoxyl sulphate, worsening of constipation symptoms and reducing patients’ quality of life. Improving gut microbiota dysbiosis is expected to improve this condition. This study aimed to evaluate the effect of synbiotics on indoxyl sulphate levels, constipation symptoms, and constipation-related quality of life in haemodialysis patients.MethodsThis was a double-blinded randomized controlled clinical trial with a parallel design involving haemodialysis patients. We included chronic haemodialysis patients with gastrointestinal complaints, difficulty defecating, faeces with hard consistency, or a bowel movement frequency of fewer than three times per week. Patients were randomly divided into two groups (synbiotics (Lactobacillus acidophilus and Bifidobacterium longum 5x109 CFU) and placebo) for 60 days of oral intervention. All participants, caregivers, and outcome assessors were blinded to group assignment. The primary outcome was a decrease in indoxyl sulphate toxin levels. Meanwhile, improvement in constipation symptoms (measured using the Patient Assessment of Constipation: Symptoms (PAC-SYM) questionnaire) and improvement in constipation-related quality of life (measured using the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire) were assessed as secondary outcomes.ResultsWe included 60 patients (30 intervention; median age of 51.23 (13.57) years, 33.3% male; 30 control; median age of 52.33 (11.29) years, 36.7% male). There was no significant difference in terms of pre- and postintervention indoxyl sulphate toxin levels in the synbiotics group compared to the placebo group (p=0.438). This study found an improvement in constipation symptoms (p = 0.006) and constipation-related quality of life (p=0.001) after synbiotic administration.ConclusionTwo months of synbiotic supplementation did not lower indoxyl sulphate toxin levels. Nevertheless, it had a major effect in improving constipation and quality of life affected by constipation in patients undergoing chronic haemodialysis.Trial registrationNCT04527640 (date of first registration: 26/08/2020)

Comparison of the Effects of Abdominal Massage and Oral Administration of Sweet Almond Oil on Constipation and Quality of Life among Elderly Individuals: A Single-Blind Clinical Trial.

Background Constipation is a common digestive disorder in the elderly population, which has a considerable impact on various aspects of their lives. Traditional and complementary medicines are two common treatments for constipation. This study was aimed at comparing the effects of abdominal massage and oral administration of sweet almond oil on constipation and quality of life among elderly people. Methods In this single-blind study, 90 eligible elderly people were randomly selected according to ROME IV diagnostic criteria from October 2020 to May 2021 and were divided into three groups using block randomization (n = 30). In the oral consumption group, 126 ml sweet almond oil was administered during seven sessions held over two weeks (18 ml every other day). The abdominal massage group was provided with abdominal massage with the same amount of sweet almond oil during seven sessions in two weeks. Finally, the third group (i.e., the control group) received no interventions. Constipation was measured using the Constipation Assessment Scale (CAS) and the Bristol Stool Form Scale (BSFS) at baseline and on the 15th day of the intervention. Patient Assessment of Constipation-Quality of Life (PAC-QOL) was also applied before and after the intervention (day 15). The data were entered in to the SPSS 22 software and were analyzed using chi-square t-test, paired t-test, independent t-test, and ANOVA. p ≤ 0.05 was considered statistically significant. Results The results revealed a significant decrease in the CAS score in the oral consumption group (i.e., oral administration of sweet almond oil; from 7.81 ± 2.62 to 1.15 ± 1.08, p < 0.0003) compared to the abdominal massage group (i.e., abdominal massage; from 8 ± 2.57 to 2.26 ± 1.81, p < 0.0002) and the control group (from 7.73 ± 2.53 to 6 ± 2.74, p < 0.0002). Additionally, the stool consistency score in BSFS was significantly higher in the oral consumption group in comparison to the two other groups (p < 0.0003) before and after the intervention. Furthermore, the quality of life score decreased more significantly in the oral consumption group (from 75.04 ± 7.66 to 28.15 ± 3.30, p < 0.0003) than in the abdominal massage group (from 81.15 ± 5.15 to 43.26 ± 4.13, p < 0.0001) and the control group (from 79.62 ± 4.76 to 62.31 ± 6.40, p < 0.0008). Conclusion Since the oral administration of sweet almond oil and abdominal massage was highly influential in the participants' constipation scores and quality of life, these cost-effective methods with low complication rates are recommended to be used alongside other treatments in managing constipation among older adults.

Effectiveness of Naldemedine Compared with Magnesium Oxide in Preventing Opioid-Induced Constipation: A Randomized Controlled Trial.

Simple SummaryOpioids are used in cancer pain management, however, their continuous use may not be tolerable owing to adverse effects such as constipation, sleepiness, nausea, and respiratory depression. Opioid-induced constipation reduces the quality of life of patients, and osmotic laxatives are conventionally recommended for preventing opioid-induced constipation. Recently, naldemedine, a peripherally acting μ-opioid receptor antagonist, can be used to safely and effectively treat opioid-induced constipation based on its etiological mechanism, without affecting central analgesia. In this study, we compared the effectiveness of magnesium oxide with that of naldemedine in preventing opioid-induced constipation. Naldemedine significantly prevented deterioration in the quality of defecation (the Japanese Patient Assessment of Constipation Quality of Life and complete spontaneous bowel movement) and reduced gastrointestinal adverse effects, mainly nausea, compared with magnesium oxide during 12-week administration.Opioid-induced constipation (OIC) may occur in patients receiving opioid treatment, decreasing their quality of life (QOL). We compared the effectiveness of magnesium oxide (MgO) with that of naldemedine (NAL) in preventing OIC. This proof-of-concept, randomized controlled trial (registration number UMIN000031891) involved 120 patients with cancer scheduled to receive opioid therapy. The patients were randomly assigned and stratified by age and sex to receive MgO (500 mg, thrice daily) or NAL (0.2 mg, once daily) for 12 weeks. The change in the average Japanese version of Patient Assessment of Constipation QOL (JPAC-QOL) from baseline to 2 weeks was assessed as the primary endpoint. The other endpoints were spontaneous bowel movements (SBMs) and complete SBMs (CSBMs). Deterioration in the mean JPAC-QOL was significantly lower in the NAL group than in the MgO group after 2 weeks. There were fewer adverse events in the NAL group than in the MgO group. Neither significant differences in the change in SBMs between the groups nor serious adverse events/deaths were observed. The CSBM rate was higher in the NAL group than in the MgO group at 2 and 12 weeks. In conclusion, NAL significantly prevented deterioration in constipation-specific QOL and CSBM rate compared with MgO.

Effect of Fresh Dendrobe Juice Consumption on Senile Habitual Constipation for Older People: A Four-Week Randomized Controlled Trial

Background: In Chinese medicine, it is believed that fresh dendrobe juice, which is mild in nature, can relieve the symptom of constipation. Methods: A pilot research design was conducted. Fifty-six older people with senile habitual constipation were recruited and randomly enrolled into control or experimental groups, each with 28 people. The control group was offered water routinely in a day. In addition, the experimental group received 125 mL of dendrobe juice twice a day for four weeks. Quality of life for the old people was evaluated by the Patient Assessment of Constipation Quality of Life (PAC-QOL) Score and the symptom of constipation was assessed by Wexner score. Results: The four-week intervention brought significant performance improvement in all the measured parameters in the experimental group in comparison with the control group. These included significantly more frequency and shorter durations of defecation (p &lt; 0.01, respectively), improved quality of life based on constipation score (PAC-QOL) (experimental group: 50.41 ± 3.46 vs. control group: 70.25 ± 2.35; p &lt; 0.05), and improved score on the Wexner constipation scale (experimental group: 6.56 ± 0.89 vs. control group: 15.50 ± 0.64; p &lt; 0.05). Conclusions: Fresh dendrobe beverage therapy is effective in improving stool frequency, reducing duration of defecation, and enhancing quality of life.

Does Postoperative Anxiety/Depression Impair the Long-Term Functional Outcomes of Laparoscopic Ventral Rectopexy for Obstructed Defecation?

Purpose: This study aimed to investigate the relationship between postoperative anxiety/depression and functional outcomes of laparoscopic ventral rectopexy (LVR) for obstructed defecation (OD). Methods: Patients who received LVR for OD between March 2014 and July 2020 were enrolled. Patient demographics were recorded before surgery. The validated Cleveland Clinic Constipation Score (CCCS) and Patient Assessment of Constipation Quality of Life (PAC-QoL) were evaluated to assess functional outcomes and QoL, respectively. The self-rating anxiety scale and self-rating depression scale were used to measure anxiety and depression, respectively. Results: Twenty-five patients were recruited. Significant improvement was found at last available follow-up (LAFU) in CCCS (P = .001), and three PAC-QoL subsets, physical discomfort (P = .003), satisfaction (P = .014), and worries/concerns (P = .033) during follow-up of 60 (11-84) months. In the patients with anxiety/depression (n = 11), significant improvement was found at LAFU in CCCS (P = .024) and the PAC-QoL subset, psychosocial discomfort (P = .038). In the patients without anxiety/depression (n = 14), improvement was found in CCCS (P = .009) and the PAC-QoL subset, physical discomfort (P = .018). Conclusion: The long-term functional outcomes of LVR for OD in patients with overt pelvic structural abnormalities are not undermined by postoperative anxiety/depression.

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.

Effect of Portulaca Oleracea L. extract on functional constipation: A randomized, double-blind, placebo-controlled trial.

Background:This study aimed to investigate the efficacy of P. oleracea in the management of patients with functional constipation.Methods:A total of 60 patients with functional constipation as defined by the Rome IV criteria were enrolled in this randomized, double-blind, placebo-controlled study; 70% ethanol extracts of the aerial parts of P. oleracea were used for the intervention. Patients were randomly assigned to the P. oleracea or placebo groups. Treatment response, quality of life, and changes in colonic transit time (CTT) were evaluated.Results:Complete spontaneous bowel movement (CSBM) improved significantly in the P. oleracea group compared with that in the placebo group over 8 weeks of treatment (P = 0.003). Overall Patient Assessment of Constipation Quality of Life (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) score improvements were observed in the P. oleracea group (P < 0.05). Moreover, CTT decreased from 44.5 ± 22.0 h to 33.7 ± 22.7 h in the P. oleracea group after 7 weeks of treatment (P = 0.04). There were no significant differences in the Bristol Stool Form Scale (BSFS) or adverse events between the groups.Conclusions:Compared to placebo, the use of P. oleracea in patients with functional constipation significantly improved CSBM, severity of symptoms, and quality of life. Further large studies are required to assess the benefits of P. oleracea in the treatment of functional constipation.

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.