Two controlled evaluations of multicomponent psychological treatment of irritable bowel syndrome. A controlled evaluation of group cognitive therapy in the treatment of irritable bowel syndrome. Behavioural psychotherapy in the treatment of irritable bowel syndrome. Clinical trial: short- and long-term benefit of relaxation training for irritable bowel syndrome. Stress management for irritable bowel syndrome: a controlled trial. Relaxation training as a treatment for irritable bowel syndrome. Cognitive behaviour therapy in addition to antispasmodic treatment for irritable bowel syndrome in primary care: randomised controlled trial. A controlled trial of psychological treatment for the irritable bowel syndrome. A randomized controlled trial of cognitive behavior therapy, relaxation training, and routine clinical care for the irritable bowel syndrome. The cost-effectiveness of psychotherapy and paroxetine for severe irritable bowel syndrome. A controlled comparison of cognitive therapy and self-help support groups in the treatment of irritable bowel syndrome. [Psychotherapy of irritable colon]. Controlled study of psychotherapy in irritable bowel syndrome. The effects of relaxation response meditation on the symptoms of irritable bowel syndrome: results of a controlled treatment study. Yogic versus conventional treatment in diarrhea-predominant irritable bowel syndrome: a randomized control study. Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. The combination of medical treatment plus multicomponent behavioral therapy is superior to medical treatment alone in the therapy of irritable bowel syndrome. Cognitive therapy for irritable bowel syndrome.
We report two controlled comparisons of a previously validated multicomponent (relaxation, thermal biofeedback, and cognitive therapy) treatment for irritable bowel syndrome (IBS) to an ostensible attention-placebo control (pseudo-meditation and EEG alpha suppression biofeedback) and to a symptom-monitoring control. In Study 1 (n = 10 per condition) there were nonsignificant trends for the multicomponent treatment to be superior to the attention-placebo condition. In Study 2 (n = 30 per condition), we found no advantage for the multicomponent treatment over the attention-placebo condition. Subjects in both treatment conditions showed significant reductions in GI symptoms, as measured by daily symptom diaries, and significant reductions in trait anxiety and depression. The GI symptom reductions held up over a 6 month follow-up. Possible explanations for the results are explored. We randomized, at two sites, 210 patients with Rome II diagnosed irritable bowel syndrome (IBS), of at least moderate severity, to one of three conditions: group-based cognitive therapy (CT; n=120), psychoeducational support groups (n=46) as an active control, or intensive symptom and daily stress monitoring (n=44). One hundred eighty-eight participants completed the initial treatment. Those in symptom monitoring were then crossed over to CT. For an intent to treat analysis on a composite GI symptom measure derived from daily symptom diaries, both CT and the psychoeducational support groups were significantly more improved than those in the intensive symptom monitoring condition, but the CT and psychoeducational support group did not differ. Among treatment completers on the same composite measure of GI symptoms, again, both CT and psychoeducational support groups were statistically superior to symptom monitoring but did not differ on the symptom composite, or on any other measure. On individual IBS symptoms, both CT and psychoeducational support were statistically superior to symptom monitoring on reductions in abdominal pain and tenderness and for flatulence. Patient global ratings at the end of treatment showed the two active conditions statistically superior to symptom monitoring on change in Bowel Regularity, with CT superior to symptom monitoring on reduction in overall pain and in improvement in sense of well-being. Three-month follow-up data on 175 patients revealed maintenance of significant improvement or continued significant improvement on all IBS symptoms, including the McGill Pain Questionnaire. Group CT and psychoeducational support groups continued not to differ on any measure. We thus conclude that group CT is not superior to an attention placebo control condition. The irritable bowel syndrome is a highly prevalent condition whose underlying aetiology is not understood. While many patients respond to a combination of gastrointestinal antispasmodics, bulking agents and dietary manipulation, controlled clinical trials have suggested that the benefit is only marginal and is due mainly to the large placebo effect found in this condition, which has been calculated to range between 54 and 81%. Associations between the syndrome and psychological and social stresses suggest, however, that treatment involving a systematic approach to the management of symptoms may hold out real therapeutic possibilities. In the current study, 42 IBS patients were randomly allocated to either medical treatment or to behavioural psychotherapy with a nurse therapist. They were assessed initially and at 4 and 9 months. There was a general improvement over the 9 months on a number of physical and psychological symptoms measured. However, no differences were found between treatment groups except for changes in two avoidance scores. A significant correlation was found, however, between improvement in the bowel symptoms of IBS (stomach pain and diarrhoea) and improvement in the psychological symptoms measured by the Clinical Interview Schedule, suggesting a close interrelationship between the two. Psychotherapy is effective in treating irritable bowel syndrome, but the effect of relaxation training, a brief psychological group intervention, is not known.
                To determine the efficacy of relaxation training in a large cohort of irritable bowel syndrome patients.
                Ninety-eight irritable bowel syndrome patients were included in this randomized controlled trial. Forty-six patients received standard medical care (CON) and 52 received four 90-min sessions of relaxation training in small groups in addition to standard medical care. Irritable bowel syndrome symptom severity, medical consumption and quality of life were assessed at baseline in patients and in 38 healthy controls and evaluated in patients at 3, 6 and 12 months after intervention.
                Irritable bowel syndrome symptom severity was significantly reduced in the relaxation training group compared to CON at 3, 6 and 12 months after treatment (time-by-treatment interaction, P = 0.002). The number needed to treat for long-term improvement was 5. Quality of life had improved (general health, P = 0.017; health change, P = 0.05). Frequency of doctor visits was reduced (P = 0.039).
                Relaxation training is a brief group intervention that significantly improves symptom severity, general health perception and medical consumption in irritable bowel syndrome patients immediately after, as well as 6 and 12 months after intervention. Thirty-five patients with irritable bowel syndrome were randomized to receive treatment in a stress management programme or conventional therapy which included the antispasmodic Colpermin. The stress management programme involved a median of six 40-min sessions with a physiotherapist during which patients were helped to understand the nature of their symptoms, their relationship to stress and were taught relaxation exercises. Two thirds of those in the stress management programme found the programme effective in relieving symptoms and experienced fewer attacks of less severity. This benefit was maintained for at least 12 months. Few of those given conventional management had any benefit. A stress management programme would appear to be of value for patients with irritable bowel syndrome. Although there have been many successful, controlled demonstrations of the clinical efficacy of multicomponent treatments for irritable bowel syndrome (IBS), in the present study we sought to evaluate a single component of many of these regimens, relaxation training. Eight IBS patients received a 10-session (over 8 weeks) regimen of abbreviated progressive muscle relaxation with regular home practice while 8 comparable patients merely monitored GI symptoms. Based on daily GI symptom diaries collected for 4 weeks before and 4 weeks after treatment (or continued symptom monitoring), the Relaxation condition showed significantly (p = .05) more improvement on a composite measure of primary GI symptom reduction than the Symptom Monitoring condition. Fifty percent of the Relaxation group were clinically improved at the end of treatment. To assess the efficacy of cognitive behaviour therapy delivered in primary care for treating irritable bowel syndrome.
                Randomised controlled trial.
                10 general practices in London.
                149 patients with moderate or severe irritable bowel syndrome resistant to the antispasmodic mebeverine.
                Cognitive behaviour therapy delivered by trained primary care nurses plus 270 mg mebeverine taken thrice daily compared with mebeverine treatment alone.
                Primary measures were patients' scores on the irritable bowel syndrome symptom severity scale. Secondary measures were scores on the work and social adjustment scale and the hospital anxiety and depression scale.
                Of 334 referred patients, 72 were randomised to mebeverine plus cognitive behaviour therapy and 77 to mebeverine alone. Cognitive behaviour therapy had considerable initial benefit on symptom severity compared with mebeverine alone, with a mean reduction in score of 68 points (95% confidence interval 103 to 33), with the benefit persisting at three months and six months after therapy (mean reductions 71 points (109 to 32) and 11 points (20 to 3)) but not later. Cognitive behaviour therapy also showed significant benefit on the work and social adjustment scale that was still present 12 months after therapy (mean reduction 2.8 points (5.2 to 0.4)), but had an inconsistent effect on the hospital anxiety and depression scale.
                Cognitive behaviour therapy delivered by primary care nurses offered additional benefit over mebeverine alone up to six months, although the effect had waned by 12 months. Such therapy may be useful for certain patients with irritable bowel syndrome in primary care. One hundred two patients with irritable bowel syndrome were studied in a controlled trial of psychological treatment involving psychotherapy, relaxation, and standard medical treatment compared with standard medical treatment alone. Patients were only selected if their symptoms had not improved with standard medical treatment over the previous 6 months. At 3 months, the treatment group showed significantly greater improvement than the controls on both gastroenterologists' and patients' ratings of diarrhea and abdominal pain, but constipation changed little. Good prognostic factors included overt psychiatric symptoms and intermittent pain exacerbated by stress, whereas those with constant abdominal pain were helped little by this treatment. This study has demonstrated that psychological treatment is feasible and effective in two thirds of those patients with irritable bowel syndrome who do not respond to standard medical treatment. Psychological treatments are considered to be useful in the irritable bowel syndrome (IBS), although the evidence is based on small, often flawed trials. Although cognitive behavior therapy (CBT) and relaxation therapy have both been promising, we hypothesized that CBT would be superior to relaxation and standard care alone in IBS patients. The objective of this study was to test this assumption by comparing the effects of cognitive behavior therapy with relaxation therapy and routine clinical care alone in individuals with IBS.
                Patients (n = 105) with Rome I criteria for IBS were recruited from advertisement (n = 51) and outpatient clinics (n = 54); those patients with resistant IBS were not included. A randomized controlled trial with three arms (standard care for all groups plus either CBT or relaxation) for 8 wk was conducted, which applied blinded outcome assessments using validated measures with 1 yr of follow-up. The primary outcome for this study was bowel symptom severity.
                Of 105 patients at the commencement of treatment, the mean bowel symptom frequency score for the whole sample was 21.1 and at the end of treatment had fallen to 18.1; this persisted at the 52-wk follow-up, with a significant linear trend for scores to change over time (F = 39.57 p < 0.001). However, there were no significant differences among the three treatment conditions. Significant changes over time were found for physical functioning (F = 4.37, p < 0.001), pain (F = 3.12, p < 0.05), general health (F = 2.71, p < 0.05), vitality (F = 2.94, p < 0.05), and the social functioning scales on the Medical Outcomes Study Short Form 36 (F = 4.08, p < 0.05); however, all three arms showed similar improvement. There were significant reductions in anxiety, depression, and locus of control scales, but no significant differences among the treatment groups were detected.
                Cognitive behavior and relaxation therapy seem not to be superior to standard care alone in IBS. Psychotherapy and antidepressants are effective in patients with severe irritable bowel syndrome (IBS), but the cost-effectiveness of either treatment in routine practice has not been established.
                Patients with severe IBS were randomly allocated to receive 8 sessions of individual psychotherapy, 20 mg daily of the specific serotonin reuptake inhibitor (SSRI) antidepressant, paroxetine, or routine care by a gastroenterologist and general practitioner. Primary outcome measures of abdominal pain, health-related quality of life, and health care costs were determined after 3 months of treatment and 1 year later.
                A total of 257 subjects (81% response rate) from 7 hospitals were recruited; 59 of 85 patients (69%) randomized to psychotherapy and 43 of 86 (50%) of the paroxetine group completed the full course of treatment. Both psychotherapy and paroxetine were superior to treatment as usual in improving the physical aspects of health-related quality of life (SF-36 physical component score improvement, 5.2 [SEM, 1.26], 5.8 [SEM, 1.0], and -0.3 [SEM, 1.17]; P < 0.001), but there was no difference in the psychological component. During the follow-up year, psychotherapy but not paroxetine was associated with a significant reduction in health care costs compared with treatment as usual (psychotherapy, $976 [SD, $984]; paroxetine, $1252 [SD, $1616]; and treatment as usual, $1663 [SD, $3177]).
                For patients with severe IBS, both psychotherapy and paroxetine improve health-related quality of life at no additional cost. Thirty-four patients with irritable bowel syndrome were randomly assigned to 1 of 3 treatment conditions: individualized cognitive treatment (CT), self-help support group (SG), or symptom-monitoring waiting-list control (WL). Each of the 3 conditions lasted approximately 8 weeks. Pre- to posttreatment analyses revealed significantly greater reductions in both individual gastrointestinal (GI) symptoms and in a composite index for GI symptom change for the CT condition than for the SG or WL conditions. When compared with the SG and WL conditions, the CT condition also showed significant improvement on psychological measures of depression and anxiety. At 3-month follow-up, the results for the CT condition were maintained and revealed further numerical improvements. 16 patients with an irritable colon were examined psychologically and independent of the result of the diagnostics of neuroses additionally distributed to two groups of treatment. One group was treated symptomatically, the other additionally psychotherapeutically (above all with autogenous training). Two thirds of the patients showed a neurosis. Psychotherapy was very useful only in those patients with a neurosis, measured as the result of the treatment one year after the beginning of the therapy. When an obstinate irritable colon is present, a diagnostics of neuroses is indicated. If a neurosis is proved, an individual psychotherapy is indicated, in which case the autogenous training as basis therapy apparently stood the test. 101 outpatients with irritable bowel syndrome were randomly allocated to two treatment groups. Both groups received the same medical treatment, but patients in one group also received dynamically oriented individual psychotherapy in ten hour-long sessions spread over 3 months. After 3 months there was a significantly greater improvement in somatic symptoms in the psychotherapy group. The difference became more pronounced a year later, with the patients given psychotherapy showing further improvement, and the patients who received medical treatment showing some deterioration. The combination of medical treatment with psychotherapy improves outcome, not only in the short term but also in the long run. In this study, Herbert Benson's (1975) Relaxation Response Meditation program was tested as a possible treatment for Irritable Bowel Syndrome (IBS). Participants were 16 adults who were matched into pairs based on presence of Axis I disorder, primary IBS symptoms and demographic features and randomized to either a six week meditation condition or a six week wait list symptom monitoring condition. Thirteen participants completed treatment and follow-up. All subjects assigned to the Wait List were subsequently treated. Patients in the treatment condition were taught the meditation technique and asked to practice it twice a day for 15 minutes. Composite Primary IBS Symptom Reduction (CPSR) scores were calculated for each patient from end of baseline to two weeks post-treatment (or to post wait list). One tailed independent sample t-tests revealed that Meditation was superior to the control (P=0.04). Significant within-subject improvements were noted for flatulence (P=0.03) and belching (P=0.02) by post-treatment. By three month follow-up, significant improvements in flatulence (P<0.01), belching (P=0.02), bloating (P=0.05), and diarrhea (P=0.03) were shown by symptom diary. Constipation approached significance (P=0.07). Benson's Relaxation Response Meditation appears to be a viable treatment for IBS. This study was conducted to evaluate the comparative effect of yogic and conventional treatment in diarrhea-predominant irritable bowel syndrome (IBS) in a randomized control design. The patients were 22 males, aged 20-50 years, with confirmed diagnosis of diarrhea-predominant IBS. The conventional group (n = 12, 1 dropout) was given symptomatic treatment with loperamide 2-6 mg/day for 2 months, and the yogic intervention group (n = 9) consisted of a set of 12 asanas (yogic poses, i.e., Vajrasana, Shashankasana, Ushtrasana, Marjariasana, Padhastasana, Dhanurasana, Trikonasana in two variations, Pawanmuktasana, and Paschimottanasana) along with Surya Nadi pranayama (right-nostril breathing) two times a day for 2 months. All participants were tested at three regular intervals, at the start of study--0 month, 1 month, and 2 months of receiving the intervention--and were investigated for bowel symptoms, autonomic symptoms, autonomic reactivity (battery of five standard tests), surface electrogastrography, anxiety profile by Spielberger's Self Evaluation Questionnaire, which evaluated trait and state anxiety. Two months of both conventional and yogic intervention showed a significant decrease of bowel symptoms and state anxiety. This was accompanied by an increase in electrophysiologically recorded gastric activity in the conventional intervention group and enhanced parasympathetic reactivity, as measured by heart rate parameters, in yogic intervention group. The study indicates a beneficial effect of yogic intervention over conventional treatment in diarrhea-predominant IBS. Studies of antidepressants and psychological treatments in functional bowel disorders (FBD) are methodologically limited. The aim of this study was to assess the clinical efficacy and safety of cognitive-behavioral therapy (CBT) against education (EDU) and desipramine (DES) against placebo (PLA) in female patients with moderate to severe FBD (irritable bowel syndrome, functional abdominal pain, painful constipation, and unspecified FBD). We also evaluated the amenability of clinically meaningful subgroups to these treatments.
                This randomized, comparator-controlled, multicenter trial enrolled 431 adults from the University of North Carolina and the University of Toronto with moderate to severe symptoms of FBD. Participants received psychological (CBT vs. EDU) or antidepressant (DES vs. PLA) treatment for 12 weeks. Clinical, physiologic, and psychosocial assessments were performed before and at the end of treatment.
                The intention-to-treat analysis showed CBT as significantly more effective than EDU (P = 0.0001; responder rate, 70% CBT vs. 37% EDU; number needed to treat [NNT ], 3.1). DES did not show significant benefit over PLA in the intention-to-treat analysis (P = 0.16; responder rate, 60% DES vs. 47% PLA; NNT, 8.1) but did show a statistically significant benefit in the per-protocol analysis (P = 0.01; responder rate, 73% DES vs. 49% PLA; NNT, 5.2), especially when participants with nondetectable blood levels of DES were excluded (P = 0.002). Improvement was best gauged by satisfaction with treatment. Subgroup analyses showed that DES was beneficial over PLA for moderate more than severe symptoms, abuse history, no depression, and diarrhea-predominant symptoms; CBT was beneficial over EDU for all subgroups except for depression.
                For female patients with moderate to severe FBD, CBT is effective and DES may be effective when taken adequately. Certain clinical subgroups are more or less amenable to these treatments. Although the standard treatments for the irritable bowel syndrome (IBS) are medical, growing evidence indicates the substantial therapeutic value of psychological therapy. However, it has not been investigated whether the combination of multicomponent behavioral therapy plus medical treatment is more effective than medical treatment alone. The aim of this study was to investigate this question in patients consulting a tertiary gastrointestinal (GI) referral center.
                Twenty-four IBS outpatients were randomly assigned to the combination of standardized multicomponent behavioral therapy plus standard medical treatment (SMBT) or standard medical treatment alone (SMT). SMBT included IBS information and education, progressive muscle relaxation, training in illness-related cognitive coping strategies, problem-solving, and assertiveness training in 10 sessions over 10 wk. SMT included standardized symptom-oriented medical treatment and regular visits to a gastroenterologist every second week. Posttreatment outcome measures consisted of quantification of GI, vegetative, and psychological symptoms by means of daily symptom diaries and the assessment of changes in rectovisceral perception thresholds, as well as of questionnaire measures on psychological distress, overall well-being, illness-related coping abilities, and quality of life. Follow-ups were conducted at 3- and 6-month intervals.
                Pre- and posttreatment evaluations showed significantly (p < 0.01) greater IBS symptom reduction as measured by daily symptom diaries for the SMBT group than for the SMT group. Rectovisceral perception remained unchanged by either treatment. Overall well-being significantly improved in the SMBT group but remained unchanged in the SMT group. Subjects in the SMBT group, unlike those in the SMT group, felt significantly more in control of their health, and quality of life was significantly improved in the SMBT group but remained unchanged in the SMT group.
                The data provide evidence that the combination of medical treatment plus multicomponent behavioral treatment is superior to medical treatment alone in the therapy of IBS. Twenty patients with irritable bowel syndrome (IBS) were randomly assigned either to intensive, individualized cognitive therapy (10 sessions over 8 weeks) or to 8 weeks of daily gastrointestinal (GI) symptom monitoring. Pre- to posttreatment evaluations showed significantly (p = .005) greater GI symptom reduction for those receiving cognitive therapy than for those in symptom monitoring. At posttreatment, 80% of the cognitive therapy group showed clinically significant improvement, whereas only 10% of the monitoring group showed this. Results held up well at a 3-month follow-up. Within the cognitive therapy group, GI symptom reductions correlated significantly with increases in positive and reductions in negative automatic thoughts.
Psychological interventions may be slightly superior to usual care or waiting list control conditions at the end of treatment although the clinical significance of this is debatable. Except for a single study, these therapies are not superior to placebo and the sustainability of their effect is questionable. The meta-analysis was significantly limited by issues of validity, heterogeneity, small sample size and outcome definition. Future research should adhere to current recommendations for IBS treatment trials and should focus on the long-term effects of treatment.