Patient Assessment Of Constipation Symptoms 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.

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.

Efficacy and mechanism of acupuncture for functional constipation in older adults: study protocol for a randomized controlled trial.

Functional constipation (FC) is a common functional gastrointestinal disorder in clinical practice, with the prevalence of which increasing with age. With the increasing aging of the population worldwide, this problem is bound to become more prominent. Acupuncture is effective and recommended for the treatment of FC. However, little is known about how acupuncture affects the gut microbiota and inflammatory cytokines and thus improves gut function. Meanwhile, there are few high-quality clinical trials specifically focusing on acupuncture in treating FC in older people. The objective of this study is to assess the efficacy and safety of acupuncture in treating FC in older people. Additionally, the research aims to explore the mechanism of action of acupuncture in treating FC in older people by affecting intestinal microbiota and inflammation cytokines. This study is designed as a single-center, randomized, sham-controlled clinical trial. A total of 98 eligible FC patients will be randomized in a 1:1 ratio into an acupuncture group and a sham acupuncture group. Both groups will receive 24 treatments over 8 weeks with a 12-week follow-up. The primary outcome of the study is the treatment response rate, which is the proportion of participants with ≥3 mean weekly Complete Spontaneous Bowel Movements (CSBMs) over weeks 3-8. The secondary outcomes will include the proportion of participants with ≥3 mean weekly CSBMs during other assessment periods; the percentage of patients with ≥1 increase in mean weekly CSBMs from baseline; the average changes in CSBMs; Patient Assessment of Constipation-Symptoms (PAC-SYM), Bristol Stool Scale, Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and weekly usage of emergency bowel medications. Adverse events will be recorded throughout the study. Data for the outcomes will be collected at Week 0 (baseline), Week 4 (the intervention period), Week 8 (the post-treatment), Week 12 (the follow-up period) and Week 20 (the follow-up period). In addition, changes in intestinal microbiota will be analyzed using 16S rRNA high-throughput detection, and the concentration of relevant inflammatory cytokines in serum will be measured by ELISA based on blood samples. The intention-to-treat analysis will be performed in this study.Clinical trial registration: [https://www.chictr.org.cn/], identifier [ChiCTR2300070735].

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.

Auricular Acupressure Improve Constipation of Patients With Schizophrenia: A Pilot Randomized Controlled Study.

Background. Constipation is a common distressing problem in patients with schizophrenia that can cause complications and impair quality of life. Objective. The objective of this study was to investigate the efficacy of applying auricular acupressure (AA) treatment in improving constipation in patients with schizophrenia. Methods. A crossover randomized controlled trial design was performed from April 2022 to December 2023 at four psychiatric rehabilitation care centers. A total of 23 patients with schizophrenia received an AA intervention or usual care according to the designated treatment sequences. Measurements comprised subjective assessment of constipation by the Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, an objective assessment of the stool pattern rated by a Bristol stool form scale, and heart rate variability. A generalized estimating equation model was used for data analyses. Results. After completing an 8-week AA intervention stimulating the Shenmen, San Jiao, Large intestine and Rectum, the AA group exhibited lower scores in the PAC-SYM total score (difference = -12.66, ,0.001), and the subscales: abdominal (difference = -3.36, p < .001), rectal (difference = -3.51, p < .001), and stool (difference = -5.79, p < .001), compared to those receiving usual care. The cases of constipation indicated by type 1 and type 2 of the BSF scale significantly decreased after the 8-week AA intervention. Moreover, the AA group displayed more parasympathetic dominance compared to the usual care group, with a low frequency to high frequency ratio of -1.15. Conclusion. AA is an effective non-pharmacological method for improving subjective constipation symptoms and objective stool pattern in patients with schizophrenia.

Evaluation of the impact of overlapping upper gastrointestinal symptoms on the clinical characteristics of patients with functional constipation, along with risk factor analysis.

Functional constipation (FC), a common functional gastrointestinal disorder, is usually overlapping with upper gastrointestinal symptoms (UGS). We aimed to explore the clinical characteristics of patients with FC overlapping UGS along with the related risk factors. The differences in the severity of constipation symptoms, psychological state, quality of life (QoL), anorectal motility and perception function, autonomic function, and the effect of biofeedback therapy (BFT) among patients with FC in different groups were analyzed, along with the risk factors of overlapping UGS. Compared with patients with FC alone, those with FC overlapping UGS had higher scores in the Patient Assessment of Constipation Symptoms and Self-Rating Anxiety Scale and lower scores in the Short Form-36 health survey (P < 0.05). Patients with FC overlapping UGS also had lower rectal propulsion, more negative autonomic nervous function, and worse BFT efficacy (P < 0.05). Overlapping UGS, especially overlapping functional dyspepsia, considerably affected the severity of FC. Logistic regression model showed that age, body mass index (BMI), anxiety, exercise, and sleep quality were independent factors influencing overlapping UGS in patients with FC. Overlapping UGS reduces the physical and mental health and the QoL of patients with FC. It also increases the difficulty in the treatment of FC. Patient's age, BMI, anxiety, physicalexercise, and sleep quality might be predictors for FCoverlapping UGS.

Association between fecal short-chain fatty acid levels and constipation severity in subjects with slow transit constipation.

We measured the fecal levels of short-chain fatty acids (SCFAs) in subjects with slow transit constipation (STC) and assessed the correlation between SCFA levels and disease severity as well as quality of life. We isolated the supernatant from fecal samples of healthy and STC subjects and measured the SCFA levels. To assess the correlation between fecal SCFA levels and disease severity as well as quality of life, we used the Constipation Scoring System, Patient Assessment of Constipation Symptoms, and Patient Assessment of Constipation Quality of Life questionnaires. 16 STC subjects and 16 healthy controls were enrolled. STC subjects had lower SCFA levels, but the difference was not statistically significant (475.85 ± 251.68 vs. 639.77 ± 213.97 µg/ml, P = 0.056). Additionally, STC subjects had lower acetic and propionic acid levels (149.06 ± 88.54 vs. 261.33 ± 109.75 µg/ml and 100.60 ± 60.62 vs. 157.34 ± 66.37 µg/ml, respectively, P < 0.05) and higher isobutyric and isovaleric acid levels (27.21 ± 15.06 vs. 18.16 ± 8.65 µg/ml and 31.78 ± 18.81 vs. 16.90 ± 10.05 µg/ml, respectively, P < 0.05). At 252.21 µg/ml acetic acid, the specificity and sensitivity to distinguish healthy from STC subjects were 93.7% and 56.3%, respectively. In STC subjects, there were significant negative correlations between acetic and propionic acid levels and Constipation Scoring System scores. Fecal SCFA, acetic acid, and propionic acid levels decreased in STC subjects. There were significant negative correlations between the levels of the two acids and constipation severity.

Perioperative outcomes and continence following robotic-assisted radical cystectomy with mainz pouch II urinary diversion in patients with bladder cancer

PurposeTo present the widely unknown perioperative outcomes and continence status of bladder cancer patients following robotic-assisted radical cystectomy (RARC) with Mainz pouch II urinary diversion (UD).Materials and methodsFrom November 2020 to December 2023, 37 bladder cancer patients who underwent RARC with Mainz pouch II UD were retrospectively assessed (ChiCTR2300070279). The results, which included patient demographics, perioperative data, continence, and complications (early ≤ 30 days and late ≤ 30 days) were reported using the RC-pentafecta criteria. RC-pentafecta criteria included ≥ 16 lymph nodes removed, negative soft tissue surgical margins, absence of major (Grade III–IV) complication at 90 days, absence of clinical recurrence at ≤ 12 months, and absence of long-term UD-related sequelae. A numeric rating scale assessed patient satisfaction with urinary continence 30 days after surgery. The validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire was used to evaluate bowel function. The Kaplan-Meier curve was used to evaluate overall survival (OS).ResultsOf the 37 patients evaluated over a median (range) follow-up period of 23.0 (12.0-36.5) months. The median (range) age was 65 (40–81) years. The median (range) time to urinary continence after surgery was 2.3 (1.5-6) months. Of the 37 patients, 31 (83.8%) were continent both during the day and at night, 34 (91.9%) were continent during the day, 32 (86.5%) were continent at night, 35 (94.6%) were satisfied with their urinary continence status, and 21 (56.8%) were very satisfied. The mean (range) voiding frequency was 6 (4–10) during the day and 3 (2-5.5) at night. The mean (range) PAC-SYM total score was 9.50 (4.00–15.00). In 12 (32.4%) of the patients, RC-pentafecta was achieved, and achieving RC-pentafecta was linked to better satisfaction scores (7.3 vs. 5.5, p = 0.034). There was no significant difference between RC-pentafecta and No RC-pentafecta groups in terms of OS (25.6 vs. 21.5 months, p = 0.16). 7 (19.4%) patients experienced late complications.ConclusionsMainz pouch II UD following RARC in bladder cancer patients results in a satisfactory continence rate. Achieving RC-pentafecta was correlated with better satisfaction scores. The intracorporeal approach to Mainz pouch II UD is beneficial for female patients due to its reduced invasiveness.Trial registrationChiCTR2300070279; Registration: 07/04/2023, Last updated version: 01/06/2023. Retrospectively registered.

Efficacy in bowel movement and change of gut microbiota on adult functional constipation patients treated with probiotics-containing products: a systematic review and meta-analysis

ObjectivesThis study aimed to pool the efficacy in bowel movement and explore the change of gut microbiota on adult functional constipated patients after probiotics-containing products treatment.DesignSystematic review and meta-analysis.Data sourcesPubMed,...

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.

The effectiveness of preventive use of partially hydrolyzed dietary fibers of cyamopsis tetrahedral (OptiFibre®) in patients with benign prostatic hyperplasia and chronic functional constipation

Anatomical proximity of the prostate gland and colon, common innervation, blood and lymph circulation create prerequisites for the involvement of the intestine in the pathological process in prostate diseases.&#x0D; Aim To evaluate the effectiveness of preventive treatment of chronic constipation (CC) with the use of partially hydrolyzed dietary fibers of cyamopsis tetrahedral (OptiFiber®) in patients with benign prostatic hyperplasia (BPH) who are shown to have a prostate tour and its effect on the course of the postoperative period.&#x0D; Materials and methods. We examined 60 patients with BPH who were referred for surgical treatment (transurethral resection of the prostate), who had chronic functional constipation. By random sampling, the patients were divided into two groups of 30 people. In group 1, standard preparation for surgical treatment was carried out for 1 month. In group 2, patients, in combination with standard preparation for surgical treatment, took partially hydrolyzed dietary fibers of cyamopsis tetrahedral (OptiFiber®) with food for the first 3 days – 1 sachet (5 g) per day, from the 4th to the 6th day – 2 sachets per day. From day 7, patients in group 2 were divided into two subgroups. In subgroup 2a, patients whose bowel function returned to normal continued taking the drug at a dose of 2 sachets per day. Those patients in whom the effect of restoring the regularity of bowel function was not satisfactory, took 3 sachets a day from the 7th day and were assigned to subgroup 2b. In the preoperative period, patients were examined on the 1st day (visit 1), 15th day (visit 2) and 30th day (visit 3) of observation. The average number of acts of defecation during the previous week, the severity and dynamics of clinical manifestations of constipation were evaluated on the basis of the Patient Assessment of Constipation Symptoms (PAC-SYM questionnaire), according to the totality of symptoms in points, as well as for each criterion separately. Evaluation of the effectiveness of treatment in the postoperative period was carried out on the basis of dynamic observation for 5–7 days.&#x0D; Results. Initially, all patients in the two groups had signs characteristic of BPH and chronic functional constipation, the groups were homogeneous. According to the results obtained in group 1 for 30 days of follow-up before surgery, none of the studied parameters significantly changed (p0.05). In group 2, after 15 days of follow-up, a significant (p0.05) positive dynamics was revealed for all the studied indicators, both in comparison with group 1 and in comparison with the results obtained at visit 1. By visit 3, despite the absence of statistically significant dynamics in the indicators of both group 1 and group 2, in comparison with visit 2, significant (p0.05) differences remained between the groups. During the study, subgroup 2a included 19 patients who took 2 sachets of OptiFiber® per day, and subgroup 2b included 11 men who took 3 sachets per day from the 7th day of observation. Restoration of intestinal motility in patients taking dietary fiber occurred at an earlier time, while the differences were also statistically significant (p0.05). In group 1, 14 cases of early postoperative complications were registered, and in group 2–9 cases, which is 35.7% less. The number of cases of antibiotic-associated diarrhea in group 1 was 3, while in group 2 there was 1 such case, which is 66.7% less. When analyzing the results obtained, there were no significant differences in the studied parameters in the postoperative period between subgroups 2a and 2b. All 30 (100%) patients of group 2 gave a positive review of partially hydrolyzed dietary fibers of cyamopsis tetrahedral (OptiFiber®), and plan to continue taking them after completing participation in the study.&#x0D; Conclusion. Thus, according to the results of the study, we consider it appropriate to use partially hydrolyzed dietary fibers of cyamopsis tetrahedral (OptiFiber®) in the treatment of CC in patients with BPH who are shown to have a prostate tour as a means to effectively eliminate the manifestations of CC, improve the results of surgical treatment and improve the quality of life of this category of patients.

Effects of Polydextrose Supplementation on Intestinal Function in Hemodialysis Patients: A Double-Blind, Randomized, Placebo-Controlled Trial

Intestinal constipation is a frequent complication in hemodialysis (HD) patients. Polydextrose (PDX), a nondigestible oligosaccharide, has been reported as a fermentable fiber with potential benefits. This study aimed to investigate the possible influence of PDX supplementation on intestinal function in HD patients. This randomized, double-blind, placebo-controlled trial included 28 patients who received daily oral supplementation with 12g of PDX or placebo (corn starch) for 2months. ROME IV criteria were used to define constipation and questionnaires were applied to patient assessment of constipation symptoms (PAC-SYM) and their impact on the patient assessment of constipation quality of life. The Bristol scale was used to assess stool consistency. Commercial Enzyme-Linked Immuno Sorbent Assay kits were used to evaluate the interleukin-6 and tumor necrosis factor-α plasma levels. 25 patients completed the study; 16 in the PDX group [7 females, 48.5years (IQR=15.5)] and 9 in the control group [3 females, 44.0years (IQR=6.0)]. According to ROME IV criteria, 55% of patients were diagnosed with constipation. PAC-SYM faecal symptoms domain was reduced after 2months of PDX supplementation (P=.004). We also observed a significant reduction in the PAC-QoL-concerns domain (P=.02). The average values for PAC-SYM and patient assessment of constipation quality of lifewere reduced significantly after intervention with PDX. There were no significant changes after the intervention period concerning biochemical variables, food intake, and inflammation markers. No adverse effects were observed during the supplementation period. The results of the present study suggest that short-term PDX supplementation may have favourable results on intestinal function and the quality of life of chronic kidney disease patients in HD.

Effectiveness of auricular acupressure on constipation and related quality of life among the older people in the residential care home: a randomized clinical trial

IntroductionConstipation can be one of the biggest health problems for the older people that has negative effects on their quality of life. Some studies have reported that new non-pharmacological interventions such auricular acupressure have promising results in the management of constipation. This study was performed to investigate the effect of auricular acupressure on constipation and health-related quality of life in the older people living in the residential care home.MethodsSample of this randomized clinical trial consisted of 53 older people with chronic constipation living in a residential care home in the southeast of Iran (Kerman city). The participants were randomly assigned to intervention (n = 27) and control (n = 26) groups. Auricular acupressure was applied to seven auricular acupoints (large intestine, rectum, San Jiao, spleen, lung, sympathetic, and subcortex) using Vaccaria seeds for the intervention group and for the control group, seedless auricular plasters were used at the seven auricular acupoints for 10 days. Data were collected before the intervention, end of the intervention, and 10-day follow-up using demographic and clinical, Patient Assessment of Constipation-Symptom, and Patient Assessment of Constipation-Quality of Life questionnaires. The SPSS-22 software was used for data analysis.ResultsThe difference between groups and times was significant in constipation and related quality of life and scores. The mean score of constipation at the end of intervention was 0.41 less in the intervention group than the control group (P < 0.0001). This mean score, in the intervention group also on the 10-day follow-up was 0.09 less than the control group (P = 0.004), which indicates a decrease in the severity of constipation symptoms. In the intervention group, mean score of quality of life related to constipation at the end of intervention and the 10-day follow-up was 0.56 and 0.19 less than the control group (Decrease in the mean score of quality of life related to constipation indicates an improvement in the quality of life) (P < 0.0001).ConclusionThe results showed the positive effect of auricular acupressure on reducing the severity of constipation symptoms and improving the quality of life in old patients living in the residential care home. This non-pharmaceutical practice can be used by nurses as an inexpensive, safe, acceptable, and non-invasive nursing care for older people with constipation in homes, medical centers, or nursing homes.

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.

A clinical study to observe the efficacy and safety of Besunyen Detox Tea for constipation.

Introduction:Functional constipation (FC) is a common functional gastrointestinal disease and is one of the most common outpatient diseases. The purpose of this study was to investigate the efficacy and safety of the traditional Chinese medicine Besunyen Detox Tea (BDT) for FC and to compare the effect of BDT between constipation patients with and non-dryness-heat syndrome.Methods and analysis:This multicenter, prospective, observational registry study included 1000 participants diagnosed with FC. This study will collaborate with 3 comprehensive hospitals and 15 community hospitals and recruit patients into the registry between July 2022 and July 2023. After enrollment, we will collect the individual characteristics of each patient, anthropometric data and general condition, bowel movement, patient assessment of constipation symptoms, patient assessment of constipation quality of life, TCM syndrome scale, and time to take the laxative product again after treatment. We will also record adverse events and economic indicators at each visit.Discussion:This is the first registry-based study to collect real-world data of participants diagnosed with FC receiving BDT treatment. The results of this registry may also reflect these characteristics and provide direct clinical evidence to verify the importance of syndrome differentiation and treatment for the use of TCM health care products.

Probiotics for constipation and gut microbiota in Parkinson's disease

IntroductionConstipation is one of the common non-motor symptoms in Parkinson's disease that significantly impacts patient quality of life. Probiotics supplementation may improve constipation symptoms, but its effect on the gut microbiota population is unclear. MethodsIn this randomized controlled study, 46 PD patients with constipation according to Rome Ⅲ criteria were recruited. The number of complete bowel movements per week, degree of defecation effort, Bristol stool Scale (BSS), Patient Assessment of Constipation symptom (PAC-SYM) and Patient assessment of constipation quality of life questionnaire (PAC-QOL) were collected pre- and post-intervention to evaluate the constipation symptoms. In addition, fresh feces of subjects before and after intervention and healthy controls were collected for 16s rRNA gene V3–V4 region sequencing to compare bacterial flora differences. ResultsCompared with the control group, the treatment group increased the average number of complete bowel movements per week (1.09 ± 1.24 vs. 0.04 ± 0.64, P < 0.001). Probiotics supplementation reduced the BSS score (0.65 ± 0.93 vs. −0.17 ± 0.94, P = 0.004), PAC-SYM score (4.09 ± 6.31 vs. −1.83 ± 4.14, P < 0.001), PAC-QOL score (10.65 ± 16.53 vs. 0.57 ± 12.82, P = 0.042), and degree of defecation effort score (1.00 ± 0.80 vs. 0.00 ± 0.30, P < 0.001). The improvement rate of constipation in the probiotics group was significantly higher than that in the control group (52.2% vs. 8.7%, P = 0.001). PD patients showed intestinal flora disorders compared to healthy controls. After 12 weeks of probiotics treatment, g_Christensenella_sp._Marseille-P2437 significantly increased, while g_Eubacterium_oxidoreducens_group, g_Eubacterium_hallii_group and s_Odoribacter_sp._N54.MGS-14 decreased (p < 0 0.05). ConclusionsProbiotics treatment can effectively improve the constipation symptoms of PD patients and positively affected the gut microbiota.

Clinical and urodynamic presentations of young men with dysfunctional voiding

Objective:To evaluate the urodynamic presentations of men <50 years of age with dysfunctional voiding (DV) and their presenting refractory lower urinary tract, bowel and sexual dysfunction symptoms. Patients and methods:We prospectively analysed the video-urodynamics and clinical data of 218 consecutive men <50 years of age without neurological disease who had a video cystometrogram. The patients were subdivided into three best-fit groups based on the pressure/flow relationship. Group 1; Low-pressure-low flow (BOOI < 20), Group 2: High-pressure-low flow; Bladder Outlet Obstruction Index (BOOI) > 20 from the ICS nomogram, Group 3; Patients with an interrupted flow secondary to intermittent sphincteric contractions. Bowel function was assessed using the patient assessment of constipation-symptoms (PAC-SYM) questionnaire. Sexual dysfunction was evaluated using the International Index of Erectile Function (IIEF) questionnaire. Results:The mean age of the cohort was 36.5 (range 18–50) years. 136/218 (62%) demonstrated voiding dysfunction (VD). 39% (n = 53) of the 136 men with VD were diagnosed with DV. 14, 19 and 20 men voided with low-pressure-low-flow, high-pressure-low flow and an intermittent pattern respectively. Patients in group 3 had significantly lower PVRs than patients in group 1 and 2 (mean ∼152 ml). Bowel symptoms and sexual function questionnaire results were available in 25 patients with DV. 15/25 patients reported bothersome bowel and/or sexual dysfunction. Conclusion:DV was observed in almost 14 of young men presenting with LUTS. The presenting LUTS, P/F patterns and association with bowel and sexual dysfunction is highly variable. This may suggest heterogeneity in aetiology and/or cross-sectional sampling of patients at different timelines on the natural history.