Effective bowel management in spinal cord injury during inpatient rehabilitation: data from the Dutch spinal cord injury database.

STUDY DESIGN: Retrospective Observational Study. OBJECTIVES: To describe bowel management in individuals with a recently acquired spinal cord injury (SCI) both at admittance and discharge from first inpatient rehabilitation, and to determine factors that contribute to effective bowel management (EBM) at discharge. SETTING: Specialized rehabilitation centers in the Netherlands. METHODS: Data from the Dutch Spinal Cord Injury Database (DSCID) collected between 2015 and 2019 was used. EBM was defined by the variables of stool frequency and fecal incontinence. After univariate analysis, a multivariate regression analysis was conducted. RESULTS: Of 1,210 participants, 818 (68%) did not have EBM at admittance. At discharge, 308 (38%) did still not have EBM (in total 33% of all participants). The odds of having EBM at discharge was 2.82 times higher for participants with ASIA Impairment Scale (AIS) D compared to those with AIS-A (95% CI: 1.38-5.78). Participants with non-traumatic SCI had higher odds of having EBM than those with traumatic SCI (OR: 0.59, 95% CI 0.38-0.91). Use of suppositories, small enema, medication influencing bowel function, and oral laxatives at admittance did not influence EBM significantly at discharge. CONCLUSIONS: Bowel management improves during first inpatient rehabilitation. However, realizing EBM after a recently acquired SCI is a challenge. This endorses the importance of bowel management during inpatient rehabilitation, especially for people with AIS-A and non-traumatic etiology.

A trial-based economic evaluation of peppermint oil for the treatment of irritable bowel syndrome.

BACKGROUND: Irritable Bowel Syndrome (IBS) is a prevalent, chronic gastrointestinal disorder that imposes a substantial socioeconomic burden. Peppermint oil is a frequently used treatment for IBS, but evidence about cost-effectiveness is lacking. OBJECTIVE: We aimed to assess cost-effectiveness of small-intestinal release peppermint oil versus placebo in IBS patients. METHODS: In a multicenter randomized placebo-controlled trial, cost-effectiveness was evaluated from a societal perspective. The incremental cost-effectiveness ratios (ICERs) were expressed as (1) incremental costs per Quality Adjusted Life Years (QALY), and (2) incremental costs per successfully treated patient, that is per abdominal pain responder (according to FDA definitions), both after an eight-week treatment period with placebo versus peppermint oil. Cost-utility and uncertainty were estimated using non-parametric bootstrapping. Sensitivity analyses were performed. RESULTS: The analysis comprised 126 patients (N = 64 placebo, N = 62 small-intestinal release peppermint oil). Peppermint oil was a dominant treatment compared to placebo in 46% of bootstrap replications. Peppermint oil was also more effective but at higher cost in 31% of replications. The net-benefit acceptability curve showed that peppermint oil has a 56% probability of being cost-effective at a conservative willingness-to-pay threshold of €10.000/QALY. Peppermint oil was also a dominant treatment per additional successfully treated patient according to FDA definitions, that is in 51% of replications. In this case, the acceptability curve showed an 89% probability of being cost-effective. CONCLUSIONS: In patients with IBS, small-intestinal release peppermint oil appears to be a cost-effective treatment although there is uncertainty surrounding the ICER. When using abdominal pain responder as outcome measure for the ICER, peppermint oil has a high probability of being cost-effective. The use of peppermint oil, which is a low-cost treatment, can be justified by the modest QALY gains and slightly higher proportion of abdominal pain responders. More research and long-term data are necessary to confirm the cost-effectiveness of peppermint oil. NCT02716285.

Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome.

BACKGROUND & AIMS: Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil. METHODS: We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal-release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events. RESULTS: Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal-release peppermint oil group had a response (46.8%, P = .170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P = .385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P = .317 and 1.6%, P = .351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P = .016), discomfort (P = .020), and IBS severity (P = .020). Adverse events, although mild, were more common in both peppermint oil groups (P < .005). CONCLUSIONS: In a randomized trial of patients with IBS, we found that neither small-intestinal-release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal-release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.

An outpatient nursing nutritional intervention to prehabilitate undernourished patients planned for surgery: A multicentre, cluster-randomised pilot study.

BACKGROUND & AIMS: To improve the nutritional status of surgical patients before hospital admission, an Outpatient Nursing Nutritional Intervention (ONNI) was developed. The ONNI comprehends five components: determining causes of undernutrition, performing a nutritional care plan including tailored and general advice, self-monitoring of nutritional intake and eating patterns, counselling and encouragement, and conducting a follow-up telephone call to discuss improvements in nutritional behaviour. Here, we evaluate the feasibility and effectiveness of the ONNI. METHODS: In a multi-centred, cluster-randomised pilot study, nurses from outpatient clinics were randomly allocated to usual care (UC) or the ONNI. Patients planned for elective surgery were included if they were at increased risk for undernutrition based on the Malnutrition Universal Screening Tool (MUST) and hospital admission was not planned within seven days. Feasibility outcomes included participation rate, extent of intervention delivery, and patient satisfaction. Nutritional intake was monitored for two days before admission. Body weight, BMI and MUST scores at hospital admission were compared to measurements from the outpatient clinic visit. Data were analysed on an intention-to-treat basis by researchers who were blinded for patients and caregivers. RESULTS: Forty-eight patients enrolled the feasibility phase. Participation rate was 72%. Nurses delivered all intervention components adequately in the end of the implementation period. Finally, 152 patients (IG: n = 66, 43%) participated in the study. A significant difference in mean energy intake (870 kcal/d, 95%CI:630-1109 p < 0.000) and mean protein intake (34.1 g/d, 95%CI: 25.0-43.2; p < 0.000) was observed in favour of the IG. Nutritional energy requirements were achieved in 74% (n = 46) of the IG and in 17% (n = 13) of the UC group (p < 0.000), and protein requirements were achieved in 52% (n = 32) of the IG, compared to 8% (n = 6) of the UC group (p < 0.000). Body weight, BMI and MUST scores did not change in either group. CONCLUSIONS: The ONNI is a feasible and effective intervention tool for nurses at outpatient clinics. Patients in the IG had more nutritional intake and fulfilled nutritional requirements significantly more often than patients receiving UC. Further research is required to determine the optimal pre-operative timing of nutritional support and to measure its effect on other patients groups. CLINICAL TRIAL REGISTRATION: The study protocol was registered at the ClinicalTrial.gov website with the following identifier: NCT02440165.

Patient's Dietary Beliefs and Behaviours in Inflammatory Bowel Disease.

BACKGROUND: The inflammatory bowel disease (IBD) is a chronic lifelong inflammation that may affect the entire gastro-intestinal tract in Crohn's disease and the colon in ulcerative colitis (UC). Diet plays an important role in IBD patients and many of them follow strict diet restriction in order to reduce complaints and prolong remission intervals. The aim of this study was to assess dietary beliefs, dietary behaviour and nutrition knowledge in Dutch adults with IBD to enable considering the patient's perspective on dietary advice. METHODS: A self-administered online questionnaire assessing general characteristics, dietary beliefs and behaviour, nutrition knowledge and sources and dietary advice was devised. The questionnaire was distributed to members of the Dutch Crohn and UC patient association of whom 294 participated in the study. RESULTS: Fifty-nine per cent of the patients valued nutrition to be either more or equally important compared to medication for their treatment and 62% believed diet to be more important in influencing the disease course. Sixty-two per cent reported to be successful in controlling disease symptoms through dietary adaptations. Avoiding certain foods was preferred over eating more beneficial foods or following specific diets (77 vs. 57% and 48% respectively). Dietary supplements were used by 68% of the IBD patients. Although over 71% had received dietary advice mainly by dieticians, 81% stated that the main source of their nutritional knowledge related to IBD was their own experience. CONCLUSION: A subgroup of IBD patients considered diet to be a more important and successful managing tool than medication to relieve their disease symptoms.

Surplus vitamin B12 use does not reduce fatigue in patients with Irritable Bowel Syndrome or inflammatory bowel disease: A randomized double-blind placebo-controlled trial.

OBJECTIVE: In non-conventional care, high doses of vitamin B12 supplementation are used for the treatment of fatigue even in case of normal vitamin B12 blood levels. We performed a randomized placebo controlled trial to investigate the effect of surplus oral vitamin B12 supplementation on fatigue in patients with IBS or IBD. METHODS: This randomized double-blind, placebo-controlled trial included 95 out-clinic IBS and IBD patients with deactivating fatigue and normal vitamin B12 blood levels (≥150 pmol/l) aged 18-65 years. Participants were randomly assigned to receive 1000 µg vitamin B12 daily or a placebo supplement for 8 weeks. The primary outcome measure was fatigue (Checklist Individual Strength (CIS)). In addition, measures of quality of life and depression were examined. RESULTS: No significant difference in scores of the CIS subscale 'subjective fatigue' was observed between the intervention group and the control group with changes in scores of -8.1 ± 9.5 and -8.3 ± 10.6 (95% CI -11.65 to 6.71), respectively. The scores on the CIS subscale 'motivation' improved with a significant change in scores of -2.2 ± 4.6 (95% CI -4.4 to -0.04). No significantly increased scores were observed for depression or quality of life in the intervention group compared to the control group. CONCLUSION: This study did not confirm the expected effect of non-conventional surplus vit B12 supplementation on fatigue in IBS or IBD patients. In addition, no positive effect was observed on depression or quality of life. We conclude that surplus treatment with vitamin B12 in IBS and IBD patients suffering from fatigue has no beneficial clinical effect.

Dietary supplement use is not associated with recurrence of colorectal adenomas: a prospective cohort study.

Diet and lifestyle influence colorectal adenoma recurrence. The role of dietary supplement use in colorectal adenoma recurrence remains controversial. In this prospective cohort study, we examined the association between dietary supplement use, total colorectal adenoma recurrence and advanced adenoma recurrence. Colorectal adenoma cases (n = 565) from a former case-control study, recruited between 1995 and 2002, were prospectively followed until 2008. Adenomas with a diameter of ≥1 cm and/or (tubulo)villous histology and/or with high grade dysplasia and/or ≥3 adenomas detected at the same colonic examination were considered advanced adenomas. Hazard ratios (HRs) and 95% confidence intervals (CIs) for dietary supplement users (use of any supplement during the past year) compared to nonusers and colorectal adenoma recurrence were calculated using stratified Cox proportional hazard models for counting processes and were adjusted for age, sex, educational level and number of colonoscopies during follow-up. Robust sandwich covariance estimation was used to adjust for the within subject correlation. A number of 165 out of 565 adenoma patients had at least one colorectal adenoma recurrence during a median person-time of 5.4 years and of these, 37 patients had at least one advanced adenoma. One-third of the total study population (n = 203) used a dietary supplement. Compared to no use, dietary supplement use was neither statistically significantly associated with total colorectal adenoma recurrence (HR = 1.03; 95% CI 0.79-1.34) nor with recurrent advanced adenomas (HR = 1.59; 95% CI 0.88-2.87). This prospective cohort study did not suggest an association between dietary supplement use and colorectal adenoma recurrence.

Increased consumption of fatty and lean fish reduces serum C-reactive protein concentrations but not inflammation markers in feces and in colonic biopsies.

Fish consumption is associated with a reduced colorectal cancer risk. A possible mechanism by which fish consumption could decrease colorectal cancer risk is by reducing inflammation. However, thus far, intervention studies investigating both systemic and local gut inflammation markers are lacking. Our objective in this study was to investigate the effects of fatty and lean fish consumption on inflammation markers in serum, feces, and gut. In an intervention study, participants were randomly allocated to receive dietary advice (DA) plus either 300 g of fatty fish (salmon) or 300 g of lean fish (cod) per week for 6 mo, or only DA. Serum C-reactive protein (CRP) concentrations were measured pre- and postintervention (n = 161). In a subgroup (n = 52), we explored the effects of the fish intervention on fecal calprotectin and a wide range of cytokines and chemokines in fecal water and in colonic biopsies. Serum CRP concentrations were lower in the salmon (-0.5 mg/L; 95% CI -0.9, -0.2) and cod (-0.4 mg/L; 95% CI -0.7, 0.0) groups compared with the DA group. None of the inflammation markers in fecal water and colonic biopsies differed between the DA group and the groups that consumed extra fish. In conclusion, increasing salmon or cod consumption for 6 mo resulted in lower concentrations of the systemic inflammation marker CRP. However, exploratory analysis of local markers of inflammation in the colon or feces did not reveal an effect of fish consumption.

Isolated isoflavones do not affect the circulating insulin-like growth factor system in men at increased colorectal cancer risk.

Epidemiological studies show that increased insulin-like growth factor (IGF)-I concentrations are related to increased colorectal cancer risk. A reduced colorectal cancer risk has been associated with isoflavones, which might affect the IGF-system because of their weak estrogenic activity. We conducted a randomized, placebo-controlled, double-blind crossover study to investigate the effect of an 8-wk isolated isoflavone supplementation (84 mg/d) on serum concentrations of total IGF-I, free IGF-I, total IGF-II, IGF binding protein (BP)-1, IGFBP-2, and IGFBP-3. Additionally, we investigated whether IGF-system component differences were related to concentrations of the more potent estrogenic isoflavone metabolite, equol. Our study population consisted of 37 men with a family history of colorectal cancer or a personal history of colorectal adenomas. Isoflavone supplementation did not significantly affect serum total IGF-I concentrations (relative difference between serum total IGF-I concentrations after isoflavone supplementation and after placebo: -1.3%, 95% CI -8.6 to 6.0%). Neither free IGF-I, nor total IGF-II, IGFBP-1, IGFBP-2, or IGFBP-3 concentrations were significantly altered. Interestingly, the change in serum IGF-I concentrations after isoflavone supplementation was negatively associated with serum equol concentrations (r=-0.49, P=0.002). In conclusion, isolated isoflavones did not affect the circulating IGF-system in a male high-risk population for colorectal cancer. However, to our knowledge, this is the first study that suggests isoflavones might have an IGF-I lowering effect in equol producers only. This underlines the importance of taking into account equol status in future isoflavone intervention studies.

Diarrhea caused by enterotoxigenic Escherichia coli infection of humans is inhibited by dietary calcium.

BACKGROUND & AIMS: In several rat infection experiments, we have shown that dietary calcium inhibits intestinal colonization and translocation of invasive salmonella. The aim of the present study was to find out whether calcium is also protective against enterotoxigenic Escherichia coli (ETEC) infection. This was first tested in our rat model and subsequently verified in a human infection study. METHODS: Rats were fed a purified diet with either a low or a high amount of calcium phosphate and orally infected with ETEC. In addition, a parallel, double-blind, placebo-controlled intervention study of 3 weeks was performed with 32 healthy men. Subjects largely maintained their habitual diet and consumed either regular milk products (calcium supply, 1100 mg/day) or placebo milk products (calcium supply, 60 mg/day). On day 10, subjects ingested a live but attenuated ETEC strain (strain E1392/75-2A), able to induce mild although short-lived symptoms. Primary outcomes studied were infection-induced diarrhea (total fecal output and relative fecal dry weight) and fecal mucin excretion. RESULTS: In humans, ETEC induced diarrhea in both groups, in that total fecal output doubled and mean relative fecal dry weight dropped from 25% to 20%. Additionally, fecal mucin excretion was increased in both groups. All these fecal parameters were completely normalized in the calcium group on the second infection day, in contrast to the placebo group, which recovered on the third infection day. Likewise, supplemental calcium inhibited ETEC colonization and diarrhea in rats. CONCLUSIONS: Calcium in milk products improves human resistance to ETEC infection as it inhibits infectious diarrhea.