Long-Term Follow-up of Individual Therapist Delivered and Standardized Hypnotherapy Recordings in Pediatric Irritable Bowel Syndrome or Functional Abdominal Pain.

OBJECTIVES: We previously showed that standardized home-based gut-directed hypnosis exercises with compact disc (CD) is non-inferior to individual hypnotherapy (iHT) by a therapist in the treatment of children with irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)). Aim of this follow-up study was to investigate the long-term effects of standardized-hypnosis-recordings at home in comparison to iHT. METHODS: All participants from our previous randomized controlled trial were invited to complete: 1) an online standardized abdominal pain dairy, on which pain frequency and intensity were scored, and 2) an online questionnaire including adequate relief (AR), anxiety/depression scores, somatization, quality of life (QOL), pain beliefs, school and/or work absenteeism and health care utilization. RESULTS: 227 out of 250 (91%) participants completed this study. After a median duration of 6 years follow-up (5.8-6.2), 80.0% in the CD group vs 86.6% in the iHT group reported AR of their abdominal complaints (P=.22). Compared to the 1-year follow-up, AR percentages were stable. Treatment success was seen in 67.6% in the CD group vs 71.3% in the iHT group (P=.66). Anxiety and depression scores, somatization, pain beliefs, health care utilization and school/work absenteeism also improved significantly in both study groups compared with baseline. No differences were found in QOL-scores. CONCLUSIONS: Both home-based treatment with standardized-hypnosis-recordings and iHT given by a therapist show persisting positive results in more than 80% of children with IBS and FAP(S) after 6 years of follow-up. These results support the rationale for implementation of this easy-to-use, widely available and cost-effective home-treatment in daily practice.

Skills or Pills: Randomized Trial Comparing Hypnotherapy to Medical Treatment in Children With Functional Nausea.

BACKGROUND & AIMS: The potential effectiveness of gut-directed hypnotherapy (HT) is unknown for pediatric chronic nausea. This randomized controlled trial compared HT with standard medical treatment (SMT). METHODS: One hundred children (ages, 8-18 y) with chronic nausea and fulfilling functional nausea (FN) or functional dyspepsia (FD) criteria were allocated randomly (1:1) to HT or SMT, with a 3-month intervention period. Outcomes were assessed at baseline, at the halfway point, after treatment, and at the 6- and 12-month follow-up evaluation. Children scored nausea symptoms in a 7-day diary. The primary outcome was treatment success, defined as a reduction in nausea of 50% or more, at the 12-month follow-up evaluation. Secondary outcomes included adequate relief of nausea. RESULTS: After treatment and at the 6-month follow-up evaluation, there was a trend toward higher treatment success in the HT group compared with the SMT group (45% vs 26%, P = .052; and 57% vs 40%, P = .099, respectively). At 12 months, treatment success was similar in both groups (60% in the HT group and 55% in the SMT group; P = .667). In the FN group, significantly higher success rates were found for HT, but no differences were found in patients with FD. Adequate relief was significantly higher in the HT group than in the SMT group at the 6-month follow-up evaluation (children: 81% vs 55%, P = .014; parents: 79% vs 53%; P = .016), but not at the 12-month follow-up evaluation. CONCLUSIONS: HT and SMT were effective in reducing nausea symptoms in children with FN and FD. In children with FN, HT was more effective than SMT during and after the first 6 months of treatment. Therefore, HT and SMT, applied separately or in combination, should be offered to children with FN as a treatment option (Clinical trials registration number: NTR5814).

Hypnotherapy for Irritable Bowel Syndrome-Type Symptoms in Patients with Quiescent Inflammatory Bowel Disease: A Randomized, Controlled Trial.

BACKGROUND AND AIMS: Many inflammatory bowel disease [IBD] patients in remission have persisting symptoms, compatible with irritable bowel syndrome [IBS-type symptoms]. We aimed to compare the effectiveness of gut-directed hypnotherapy vs standard medical treatment [SMT] for IBS-type symptoms in IBD patients. METHODS: In this multicentre, randomized, controlled, open-label trial, patients aged 12-65 years with IBD in clinical remission [global assessment] and biochemical remission [faecal calprotectin ≤100 µg/g, or ≤200 µg/g without inflammation at endoscopy] with IBS according to Rome III criteria were randomized to hypnotherapy or SMT. Primary outcome was the proportion with ≥50% reduction on a visual analog scale for symptom severity, as measured with the Irritable Bowel Syndrome Severity Scoring System [IBS-SSS] at week 40 [i.e. 6 months after finishing the intervention], compared to baseline. Secondary outcomes included total IBS-SSS score, quality of life, adequate relief, IBS-related cognitions, and depression and anxiety scores. RESULTS: Eighty patients were included, of whom 70 received at least one session of the allocated treatment and were included in the modified intention-to-treat-population. Seven patients were excluded because of missing baseline data required for the primary outcome. The primary outcome was met in nine [27%] of 33 patients randomized to SMT and nine [30%] of 30 patients randomized to hypnotherapy [p = 0.81]. Adequate relief was reported in 60% and 40% of subjects, respectively. Exploratory analyses of secondary outcomes revealed no apparent differences between the two treatment groups. CONCLUSIONS: Hypnotherapy was not superior to SMT in the treatment of IBS-type symptoms in IBD patients. Both treatment strategies are reasonable options from a clinical perspective.

Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial.

INTRODUCTION: The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea. METHODS AND ANALYSIS: To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8-18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months' follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months' follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea. ETHICS AND DISSEMINATION: Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands. TRIAL REGISTRATION NUMBER: NTR5814.

Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial.

Importance: Individual gut-directed hypnotherapy (HT) is effective in pediatric irritable bowel syndrome (IBS) and functional abdominal pain or functional abdominal pain syndrome (FAP[S]). It is, however, unavailable to many children. Objective: To compare the effectiveness of HT by means of home-based self-exercises using a CD with that of individual HT (iHT) performed by qualified therapists. Design, Setting, and Participants: This noninferiority randomized clinical trial with a follow-up of 1 year after the end of treatment was conducted from July 15, 2011, through June 24, 2013, at 9 secondary and tertiary care centers throughout the Netherlands. A total of 303 children were eligible to participate. Of those, 260 children (aged 8-18 years) with IBS or FAP(S) were included in this study. Children were randomized (1:1 ratio) to home-based HT with a CD (CD group) or iHT performed by qualified therapists (iHT group). No children withdrew from the study because of adverse effects. Interventions: The CD group was instructed to perform exercises 5 times per week or more for 3 months. The iHT group consisted of 6 sessions during 3 months. Main Outcomes and Measures: Primary outcomes were treatment success directly after treatment and after 1-year follow-up. Treatment success was defined as a 50% or greater reduction in pain frequency and intensity scores. The noninferiority limit was set at 50% treatment success in the CD group, with a maximum of 25% difference in treatment success with the iHT group after 1-year follow-up. Modified intention-to-treat analyses were performed. Results: A total of 132 children were assigned to the CD group and 128 to the iHT group; 250 children were analyzed (126 in the CD group and 124 in the iHT group) (mean [SD] age, 13.4 [2.9] years in the CD group and 13.3 [2.8] years in the iHT group; 94 female [74.6%] in the CD group and 85 [68.5%] in the iHT group). Directly after treatment, 46 children (36.8%) in the CD group and 62 (50.1%) in the iHT group were successfully treated. After 1-year follow-up, the 62.1% treatment success in the CD group was noninferior to the 71.0% in the iHT group (difference, -8.9%; 90% CI, -18.9% to 0.7%; P = .002). Conclusions and Relevance: Long-term effectiveness of home-based HT with a CD is noninferior to iHT performed by therapists in pediatric IBS or FAP(S). Treatment with hypnosis using a CD provides an attractive treatment option for these children. Trial Registration: trialregister.nl Identifier: NTR2725.

Gut-directed hypnotherapy in children with irritable bowel syndrome or functional abdominal pain (syndrome): a randomized controlled trial on self exercises at home using CD versus individual therapy by qualified therapists.

BACKGROUND: Irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)) are common pediatric disorders, characterized by chronic or recurrent abdominal pain. Treatment is challenging, especially in children with persisting symptoms. Gut-directed hypnotherapy (HT) performed by a therapist has been shown to be effective in these children, but is still unavailable to many children due to costs, a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent(s). Home-based hypnotherapy by means of exercises on CD has been shown effective as well, and has potential benefits, such as lower costs and less time investment. The aim of this randomized controlled trial (RCT) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP(S). METHODS/DESIGN: 260 children, aged 8-18 years with IBS or FAP(S) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year. Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months.The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up. Treatment success is defined as at least 50% reduction in both abdominal pain frequency and intensity scores. Secondary outcomes include adequate relief, cost-effectiveness and effects of both therapies on depression and anxiety scores, somatization scores, QoL, pain beliefs and coping strategies. DISCUSSION: If the effectiveness of home-based HT with CD is comparable to, or only slightly lower, than HT by a therapist, this treatment may become an attractive form of therapy in children with IBS or FAP(S), because of its low costs and direct availability. TRIAL REGISTRATION: Dutch Trial Register number NTR2725 (date of registration: 1 February 2011).

Long-term follow-up of gut-directed hypnotherapy vs. standard care in children with functional abdominal pain or irritable bowel syndrome.

OBJECTIVES: We previously showed that gut-directed hypnotherapy (HT) is highly effective in the treatment of children with functional abdominal pain (FAP) and irritable bowel syndrome (IBS). Aim of this follow-up study was to investigate the long-term effects of HT vs. standard medical treatment plus supportive therapy (SMT). METHODS: All 52 participants of our previous randomized controlled trial (RCT) were invited to complete a standardized abdominal pain diary, on which pain frequency and pain intensity were scored. Furthermore, the Children's Somatization Inventory (CSI) and a general quality of life (QOL) questionnaire were filled out. Clinical remission was defined as > 80% improvement in pain scores compared with baseline. RESULTS: All 27 HT patients and 22 out of 25 SMT patients participated in this study. Two patients of the SMT group were lost to follow-up and one refused to participate. After a mean duration of 4.8 years follow-up (3.4-6.7), HT was still highly superior to conventional therapy with 68 vs. 20% of the patients in remission after treatment (P = 0.005). Pain intensity and pain frequency scores at follow-up were 2.8 and 2.3, respectively, in the HT group compared with 7.3 and 7.1 in the SMT group (P < 0.01). Also, somatization scores were lower in the HT group (15.2 vs. 22.8; P = 0.04). No differences were found in QOL, doctors' visits, and missed days of school or work between the two groups. CONCLUSIONS: The beneficial effects of gut-directed HT are long lasting in children with FAP or IBS with two thirds still in remission almost 5 years after treatment, making it a highly valuable therapeutic option.

Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial.

BACKGROUND & AIMS: Functional abdominal pain (FAP) and irritable bowel syndrome (IBS) are highly prevalent in childhood. A substantial proportion of patients continues to experience long-lasting symptoms. Gut-directed hypnotherapy (HT) has been shown to be highly effective in the treatment of adult IBS patients. We undertook a randomized controlled trial and compared clinical effectiveness of HT with standard medical therapy (SMT) in children with FAP or IBS. METHODS: Fifty-three pediatric patients, age 8-18 years, with FAP (n = 31) or IBS (n = 22), were randomized to either HT or SMT. Hypnotherapy consisted of 6 sessions over a 3-month period. Patients in the SMT group received standard medical care and 6 sessions of supportive therapy. Pain intensity, pain frequency, and associated symptoms were scored in weekly standardized abdominal pain diaries at baseline, during therapy, and 6 and 12 months after therapy. RESULTS: Pain scores decreased significantly in both groups: from baseline to 1 year follow-up, pain intensity scores decreased in the HT group from 13.5 to 1.3 and in the SMT group from 14.1 to 8.0. Pain frequency scores decreased from 13.5 to 1.1 in the HT group and from 14.4 to 9.3 in the SMT group. Hypnotherapy was highly superior, with a significantly greater reduction in pain scores compared with SMT (P < .001). At 1 year follow-up, successful treatment was accomplished in 85% of the HT group and 25% of the SMT group (P < .001). CONCLUSIONS: Gut-directed HT is highly effective in the treatment of children with longstanding FAP or IBS.