Barostat or syringe-assisted sensory biofeedback training for constipation with rectal hyposensitivity: A randomized controlled trial.

BACKGROUND: Rectal hyposensitivity (RH) is a well-known pathophysiological dysfunction in chronic constipation. Whether biofeedback training improves RH and restores bowel function is unknown. AIM: To investigate the efficacy of barostat-assisted sensory training (BAST) with syringe-assisted sensory training (SAST) in patients with RH in a randomized controlled trial. METHODS: Patients with RH and chronic constipation (Rome III) were randomized to receive 6 biweekly sessions of BAST or SAST. Verbal/visual feedback was provided during repeated rectal distensions to improve defecation desire/urge and first sensations with either 10-cm balloon connected to barostat (BAST) or 4-cm balloon connected to syringe and manometry probe (SAST). Sensory thresholds, bowel symptoms, and therapist and patient's rating of treatments were compared. The primary outcome (responders) was the improvement in ≥2 sensory thresholds. RESULTS: Sixty-six patients were enrolled: 32 received BAST, 34 received SAST, and 56 completed study. There were significantly more responders in BAST group than SAST (78% vs. 53%, p = 0.0320). Rectal sensation normalized in 81% with BAST compared to 56% with SAST (p = 0.0270). When compared to baseline, desire and urge to defecate thresholds and bowel satisfaction improved with BAST (p = 0.0013; p = 0.0002; p = 0.0001) and SAST (p = 0.0012; p = 0.0001; p < 0.0001) and number of complete spontaneous bowel movements with BAST (p = 0.0029) but without inter-group differences. Therapists rated BAST as superior to SAST (p < 0.0001), but patients rated both equally. CONCLUSIONS: Sensory biofeedback training was effective and significantly improved rectal sensation and constipation symptoms. Although both techniques were useful, the novel BAST was more efficacious and easier to administer for treating RH.

Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence.

BACKGROUND: Biofeedback therapy is useful for treatment of fecal incontinence (FI), but is not widely available and labor intensive. We investigated if home biofeedback therapy (HBT) is non-inferior to office biofeedback therapy (OBT). METHODS: Patients with FI (≥1 episode/week) were randomized to HBT or OBT for 6 weeks. HBT was performed daily using novel device that provided resistance training and electrical stimulation with voice-guided instructions. OBT consisted of six weekly sessions. Both methods involved anal strength, endurance, and coordination training. Primary outcome was change in weekly FI episodes. FI improvement was assessed with stool diaries, validated instruments (FISI, FISS, and ICIQ-B), and anorectal manometry using intention-to-treat analysis. KEY RESULTS: Thirty (F/M = 26/4) FI patients (20 in HBT, 10 in OBT) participated. Weekly FI episodes decreased significantly after HBT (Δ ± 95% confidence interval: 4.7 ± 1.8, compared with baseline, p = 0.003) and OBT (3.7 ± 1.6, p = 0.0003) and HBT was non-inferior to OBT (p = 0.2). The FISI and FISS scores improved significantly in HBT group (p < 0.02). Bowel pattern, bowel control, and quality of life (QOL) domains (ICIQ-B) improved significantly in HBT arm (p < 0.023). Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences. CONCLUSIONS & INFERENCES: Home biofeedback therapy is non-inferior to OBT for FI treatment. Home biofeedback is safe, effective, improves QOL, and through increased access could facilitate improved management of FI.

Translumbosacral Neuromodulation Therapy for Fecal Incontinence: A Randomized Frequency Response Trial.

INTRODUCTION: Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. The aim of this study was to investigate the optimal dose frequency, clinical effects, and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. METHODS: Patients with FI were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1, 5, or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensorimotor function, and quality of life were compared. Primary outcome measure was the change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. RESULTS: Thirty-three patients with FI participated. FI episodes decreased significantly (∆ ±95% confidence interval, 4.2 ± 2.8 (1 Hz); 2 ± 1.7 (5 Hz); 3.4 ± 2.5 (15 Hz); P < 0.02) in all 3 groups when compared with baseline. The 1 Hz group showed a significantly higher (P = 0.04) responder rate (91 ± 9.1%) when compared with the 5 Hz group (36 ± 18.2%) or 15 Hz (55 ± 18.2%); no difference was found between the 5 and 15 Hz groups (P = 0.667). Anal neuropathy, squeeze pressure, and rectal capacity improved significantly only in the 1 Hz (P < 0.05) group compared with baseline, but not in other groups. Quality of life domains improved significantly (P < 0.05) with 1 and 5 Hz groups. No device-related serious adverse events were noted. DISCUSSION: TNT significantly improves FI symptoms in the short term, and the 1 Hz frequency was overall better than 5 and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and noninvasive treatment for FI (see Visual Abstract, Supplementary Digital Content 3, http://links.lww.com/AJG/B598).

Acute Effects of Red Chili, a Natural Capsaicin Receptor Agonist, on Gastric Accommodation and Upper Gastrointestinal Symptoms in Healthy Volunteers and Gastroesophageal Reflux Disease Patients.

The effects of chili on gastric accommodation (GA) in gastroesophageal reflux disease (GERD) patients have not been explored. METHODS: In total, 15 healthy volunteers (HV) and 15 pH-positive non-erosive GERD (NERD) patients underwent single-photon emission computed tomography after ingesting 2 g of chili or placebo in capsules in a randomized double-blind crossover fashion with a one-week washout period. GA was the maximal postprandial gastric volume (GV) after 250 mL of Ensure® minus the fasting GV. Upper gastrointestinal symptoms were evaluated by using a visual analog scale. RESULTS: NERD patients but not HV had significantly greater GA after chili compared to a placebo (451 ± 89 vs. 375 ± 81 mL, p < 0.05). After chili, the postprandial GVs at 10, 20, and 30 min in NERD patients were significantly greater than HV (10 min, 600 ± 73 vs. 526 ± 70 mL; 20 min, 576 ± 81 vs. 492 ± 78 mL; 30 min, 532 ± 81 vs. 466 ± 86 mL, all p < 0.05). In NERD, chili was associated with significantly less satiety, more severe abdominal burning (p < 0.05), and a trend of more severe heartburn (p = 0.06) compared to the placebo. In HV, postprandial symptoms after chili and placebo ingestion were similar (p > 0.05). CONCLUSIONS: Chili enhanced GA in NERD patients but not in HV. This suggests that the modulation of GA in NERD is abnormal and likely involves transient receptor potential vanilloid 1 (TRPV1) sensitive pathways.

Cortico-anorectal, Spino-anorectal, and Cortico-spinal Nerve Conduction and Locus of Neuronal Injury in Patients With Fecal Incontinence.

BACKGROUND & AIMS: The neuropathophysiology of fecal incontinence (FI) is incompletely understood. We examined the efferent brain-anorectal and spino-anorectal motor-evoked potentials (MEP) to characterize the locus of neuronal injury in patients with FI. METHODS: We performed bilateral transcranial, translumbar, and transsacral magnetic stimulations in 27 patients with FI (19 female) and 31 healthy individuals (controls, 20 female) from 2015 through 2017. MEPs were recorded simultaneously from the rectum and anus using 4 ring electrodes. The difference in MEP latencies between the transcranial (TMS) and translumbar transsacral magnetic stimulations was calculated as cortico-spinal conduction time. MEP data were compared between patients with FI and controls. Patients filled out questionnaires that assessed the severity and effects of FI. RESULTS: The MEP latencies with TMS were significantly longer in patients with FI than controls at most sites, and on both sides (P < .05). Almost all translumbar and transsacral MEP latencies were significantly prolonged in patients with FI vs controls (P < .01). The cortico-spinal conduction time were similar, on both sides, between patients with FI and controls. Ninety-three percent of patients had 1 or more abnormal translumbar and transsacral latencies, but neuropathy was patchy and variable, and not associated with sex or anal sphincter function or defects. CONCLUSIONS: Patients with FI have significant neuropathy that affects the cortico-anorectal and spino-anorectal efferent pathways. The primary loci are the lumbo-rectal, lumbo-anal, sacro-rectal, and sacro-anal nerves; the cortico-spinal segment appears intact. Peripheral spino-anal and spino-rectal neuropathy might therefore contribute to the pathogenesis of FI.

Factors Associated With Response to Biofeedback Therapy for Dyssynergic Defecation.

BACKGROUND & AIMS: Biofeedback therapy is effective for dyssynergic defecation (DD), but it is not widely available or reimbursed, and is labor intensive. It is therefore important to select the appropriate patients for this treatment. We investigated symptoms and demographic, manometric, and other factors associated with outcomes of biofeedback therapy in patients with DD. METHODS: We performed a post hoc analysis of 2 prospective studies of biofeedback therapy in 127 adult outpatients (18-75 years old, 120 female) with chronic constipation who failed to respond to treatment with dietary fiber or laxatives (>1 year) and were diagnosed with DD based on standard criteria. In each study, patients received 1-hour, biweekly office biofeedback therapy (6 sessions) or home biofeedback therapy with a device. A therapist used visual feedback, postural, and diaphragmatic breathing techniques to teach subjects to improve defecation. Treatment success was defined by a composite of normalization of dyssynergia pattern and increase of 20 mm in baseline bowel satisfaction score. Factors were compared between the treatment success and failure groups. Intention-to-treat analysis was performed. RESULTS: Of the 127 patients enrolled, 77 (61%) had treatment success. Dyssynergia was corrected in 78% of patients and bowel satisfaction improved in 64% of patients. Baseline demographic features, constipation symptoms, manometric and sensory parameters, balloon expulsion time, and colonic transit results were similar between treatment failure and success groups. Patients with lower baseline bowel satisfaction score (P = .008) and patients who used digital maneuvers (P = .04) were more likely to have successful biofeedback therapy. CONCLUSIONS: Biofeedback therapy is successful in more than 60% of patients with DD. Patients who used digital maneuvers and patients with lower baseline levels of bowel satisfaction were more likely to have treatment success, whereas other factors were not associated with success. Biofeedback therapy should be offered to all patients with DD, irrespective of baseline symptoms or anorectal physiology findings.

Diagnosis and management of chronic constipation in adults.

Constipation is a heterogeneous, polysymptomatic, multifactorial disease. Acute or transient constipation can be due to changes in diet, travel or stress, and secondary constipation can result from drug treatment, neurological or metabolic conditions or, rarely, colon cancer. A diagnosis of primary chronic constipation is made after exclusion of secondary causes of constipation and encompasses several overlapping subtypes. Slow-transit constipation is characterized by prolonged colonic transit in the absence of pelvic floor dysfunction. This subtype of constipation can be identified using either the radio-opaque marker test or wireless motility capsule test, and is best treated with laxatives such as polyethylene glycol or newer agents such as linaclotide or lubiprostone. If unsuccessful, subspecialist referral should be considered. Dyssynergic defecation results from impaired coordination of rectoanal and pelvic floor muscles, and causes difficulty with defecation. The condition can be identified using anorectal manometry and balloon expulsion tests and is best managed with biofeedback therapy. Opioid-induced constipation is an emerging entity, and several drugs including naloxegol, methylnaltrexone and lubiprostone are approved for its treatment. In this Review, we provide an overview of the burden and pathophysiology of chronic constipation, as well as a detailed discussion of the available diagnostic tools and treatment options.

Chili Peppers, Curcumins, and Prebiotics in Gastrointestinal Health and Disease.

There is growing evidence for the role of several natural products as either useful agents or adjuncts in the management of functional GI disorders (FGIDs). In this review, we examine the medical evidence for three such compounds: chili, a culinary spice; curcumin, another spice and active derivative of a root bark; and prebiotics, which are nondigestible food products. Chili may affect the pathogenesis of abdominal pain especially in functional dyspepsia and cause other symptoms. It may have a therapeutic role in FGIDs through desensitization of transient receptor potential vanilloid-1 receptor. Curcumin, the active ingredient of turmeric rhizome, has been shown in several preclinical studies and uncontrolled clinical trials as having effects on gut inflammation, gut permeability and the brain-gut axis, especially in FGIDs. Prebiotics, the non-digestible food ingredients in dietary fiber, may serve as nutrients and selectively stimulate the growth and/or activity of certain colonic bacteria. The net effect of this change on colonic microbiota may lead to the production of acidic metabolites and other compounds that help to reduce the production of toxins and suppress the growth of harmful or disease-causing enteric pathogens. Although some clinical benefit in IBS has been shown, high dose intake of prebiotics may cause more bloating from bacterial fermentation.

Outcome of biofeedback therapy in dyssynergic defecation patients with and without irritable bowel syndrome.

AIM: The Rome II and III diagnostic criteria for dyssynergic defecation require the exclusion of irritable bowel syndrome (IBS). To prospectively study whether the presence of IBS affects the outcome of biofeedback therapy in dyssynergic defecation patients. METHODS: Consecutive patients with dyssynergic defecation underwent biofeedback therapy. Dyssynergic defecation was diagnosed based on symptoms, anorectal manometries, balloon expulsion tests, and colonic transit studies. The defecation dynamics and balloon expulsion time were evaluated at the end of the biofeedback therapy in all patients. IBS symptoms were graded before and 4 weeks after the biofeedback therapy using a 4-point Likert scale. Failure of the biofeedback therapy was defined as <50% improvement of constipation symptoms, which were evaluated using a 10 cm long visual analog scale before and 4 weeks after biofeedback therapy. RESULTS: Fifty patients completed the study. The biofeedback therapy was successful in 30 patients. Twenty-nine patients fulfilled the Rome II criteria for IBS. Patients with or without IBS demonstrated similar responses to the biofeedback therapy (16 of 29 vs. 14 of 21, P>0.05). The disappearance of IBS symptoms was observed more frequently in patients with an improved defecation index compared with those with no improvement (8 of 12 vs 4 of 17, P<0.05). A high pretreatment constipation symptom score, a high rectal sensory threshold, and a delayed colonic transit time were associated with a poor treatment outcome. CONCLUSIONS: The presence of IBS in dyssynergic defecation did not affect the outcome of biofeedback therapy. In addition, treating dyssynergic defecation patients with IBS by biofeedback therapy improved both constipation and IBS symptoms.