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Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial.

ABSTRACT: Current clinical guidelines identify several psychological treatments for irritable bowel syndrome (IBS). IBS patients, however, have elevated trauma, life stress, relationship conflicts, and emotional avoidance, which few therapies directly target. We tested the effects of emotional awareness and expression training (EAET) compared to an evidence-based comparison condition-relaxation training-and a waitlist control condition.Adults with IBS (N=106; 80% female, Mean age=36 years) were randomized to EAET, relaxation training, or waitlist control. Both EAET and relaxation training were administered in three, weekly, 50-minute, individual sessions. All patients completed the IBS Symptom Severity Scale (primary outcome), IBS Quality of Life, and Brief Symptom Inventory (anxiety, depressive, and hostility symptoms) at pretreatment and at 2 weeks posttreatment and 10 weeks follow-up (primary endpoint).Compared to waitlist controls, EAET, but not relaxation training, significantly reduced IBS symptom severity at 10-week follow-up. Both EAET and relaxation training improved quality of life at follow-up. Finally, EAET did not reduce psychological symptoms, whereas relaxation training reduced depressive symptoms at follow-up (and anxiety symptoms at posttreatment).Brief emotional awareness and expression training that targeted trauma and emotional conflicts reduced somatic symptoms and improved quality of life in patients with IBS. This emotion-focused approach may be considered an additional treatment option for IBS, although research should compare EAET to a full cognitive-behavioral protocol and determine which patients are best suited for each approach. Registered at clinicaltrials.gov (NCT01886027).

SUBMITTER: Thakur ER

PROVIDER: S-EPMC5690851 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial.

Thakur E R ER Thakur E R ER Holmes H J HJ Lockhart N A NA Carty J N JN Ziadni M S MS Doherty H K HK Lackner J M JM Schubiner H H Lumley M A MA

Neurogastroenterology and motility 20170622 12

<h4>Background</h4>Current clinical guidelines identify several psychological treatments for irritable bowel syndrome (IBS). IBS patients, however, have elevated trauma, life stress, relationship conflicts, and emotional avoidance, which few therapies directly target. We tested the effects of emotional awareness and expression training (EAET) compared to an evidence-based comparison condition-relaxation training-and a waitlist control condition.<h4>Methods</h4>Adults with IBS (N=106; 80% female, ...[more]

PMID: 28643436

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Project description:Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS).Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47 ± 18 with IBS diagnosed by Rome III criteria and with a score ? 150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as "placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes" or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL).Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2 ± 1.0 vs. 4.0 ± 1.1, p<.001) and at 21-day endpoint (5.0 ± 1.5 vs. 3.9 ± 1.3, p =?.002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p =?.008 and p =?.03) and adequate relief (IBS-AR, p =?.02 and p =?.03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (p =?.08).Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent.ClinicalTrials.gov NCT01010191.

Project description:BackgroundIrritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. A global perspective given by the World Gastroenterology Organization (WGO) points out that IBS can impact the quality of an individual's daily life, cause socioeconomic problems and potentially impair the patient-physician relationship. It remains a problem to treat IBS due to the complicated pathophysiology. Acupuncture is an alternative therapy recommended for IBS. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for patients with IBS. We also want to explore the correlation between IBS-gene subtypes and acupuncture effect.Methods/designA multicenter randomized controlled trial will be performed in seven hospitals. Six hundred participants will be stratified into two strata (IBS-C or IBS-D). Then, patients within each stratum will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture while the control group is treated with Western medicine. All the patients will receive a 6-week treatment and a 3-month follow-up. The primary outcome is the IBS-Symptom Severity Score (IBS-SSS), the secondary outcome is the score of the IBS-Quality of Life (IBS-QoL).The correlation between IBS-gene subtypes and acupuncture effect will be detected based on polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Outcome measures (including primary and secondary outcome measures) are collected at baseline,1 week, 2 weeks, 4 weeks, and 6 weeks of the intervention, and 12 weeks after the intervention.DiscussionThis is a multicenter randomized controlled trial for IBS in China. It may clarify the efficacy of acupuncture as an alternative therapy for IBS. This is the first time ever that the potential mechanism of IBS based on genomics has been investigated.Trial registrationChinese Clinical Trials Register, ID: ChiCTR-IOR-15006259 . First registered on 14 April 2015.

Project description:AimTo examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters.MethodsNinety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed.ResultsBaseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, P < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (P < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ(2)-test for trend = 11.5, P < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (P = 0.013) and 80 mg OB (P = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB.ConclusionThis dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period.

Project description:BackgroundIrritable bowel syndrome (IBS) is a debilitating and costly disorder. Cognitive behavior therapy (CBT) is effective in the treatment of IBS, both when delivered over the internet and in face-to-face settings. CBT consists of different components and little is known about their relative importance. We have in an earlier study showed that inclusion of exposure in the CBT for IBS makes it even more effective. In the present study we wanted to evaluate the economic effects for society of inclusion vs exclusion of exposure in an internet delivered CBT for IBS.MethodsWe used data from a previous study with 309 participants with IBS. Participants were randomized to internet delivered CBT with (ICBT) or without exposure (ICBT-WE). We compared direct and indirect costs at baseline, after treatment, and 6 months after treatment (primary endpoint; 6MFU). Data was also collected on symptom severity and time spent by therapists and participants. The relative Incremental Cost Effectiveness Ratio (ICER) was calculated for the two treatment conditions and the return on investment (ROI).ResultsResults showed that ICBT cost $213.5 (20%) more than ICBT-WE per participant. However, ICBT was associated with larger reductions regarding both costs and symptoms than ICBT-WE at 6MFU. The ICER was - 301.69, meaning that for every point improvement on the Gastrointestinal Symptom Rating Scale-IBS version in ICBT, societal costs would be reduced with approximately $300. At a willingness to pay for a case of clinically significant improvement in IBS symptoms of $0, there was an 84% probability of cost-effectiveness. ROI analysis showed that for every $1 invested in ICBT rather than ICBT-WE, the return would be $5.64 six months after treatment. Analyses of post-treatment data showed a similar pattern although cost-savings were smaller.ConclusionsIncluding exposure in Cognitive Behavior Treatment for IBS is more cost-effective from a societal perspective than not including it, even though it may demand more therapist and patient time in the short term.Trial registrationThis study is reported in accordance with the CONSORT statement for non-pharmacological trials [1]. Clinicaltrials.gov registration ID: NCT01529567 (14/02/2013).

Project description:Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder significantly decreasing patients' lives of quality and placing huge economic burden on our society. Existing studies indicated that the therapeutic effects maintained for a period of time after the treatments were discontinued. It is clinically important to assess these post-treatment therapeutic effects (PTTE), which prevent IBS from relapsing. To assess the PTTE in pinaverium treatment and obtain high-quality evidence to justify the use of PTTE for long-term IBS management, we performed this controlled, double blind study on patients with IBS who were randomized to pinaverium 50 mg (n = 132) or placebo (n = 132), three times daily, for 4 weeks, and were followed up for 57 weeks after the treatments. The primary endpoints were abdominal pain and stool consistency. The secondary endpoints were pain frequency and stool frequency. The tertiary endpoints were global overall symptom and adverse events. Three days after pinaverium was discontinued, endpoints rebounded only 23.2-42.8% (P < 0.015 cf. placebo). The PTTE (P < 0.05 cf. placebo) lasted 9-17 weeks, which is similar to other antispasmodics with a 15-week treatment in striking contrast to ≥ 1 year PTTE in cognitive behavior therapy and < 1 week PTTE in serotonin antagonist treatment indicating that PTTE length markedly depends on the medication class used for the treatment and less depends on treatment length. After 17 weeks, the stage could be considered as an IBS natural history [no significant differences between pinaverium and placebo (all endpoints' P's > 0.05)], during which an average of 51.5-56.4% of patients (pool pinaverium and placebo data together) had IBS symptoms. These results provide clinical insights into efficient and cost-effective management of refractory IBS, and lend support to the IBS management that the selection of a therapy should consider both its effectiveness during treatment and its PTTE after the treatment.Trial registration number: NCT02330029 (16/08/2016).

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Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial.

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Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial.

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