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.

Gastrointestinal manifestations on impaired quality of life in systemic sclerosis.

OBJECTIVE: To analyze the impact of gastrointestinal manifestations on quality of life in patients with systemic sclerosis (SSc) and to provide clinical evidence for their early treatment and health-related management. METHODS: Altogether 65 patients admitted to the Peking Union Medical College Hospital selected from a disease cohort and 127 matched controls were enrolled. A self-assessment questionnaire was completed by all participants. Each participant completed scleroderma gastrointestinal tract 1.0 (SSC-GIT 1.0) questionnaire (including reflux or indigestion, diarrhea, constipation, distention, emotional well-being, and social functioning). Autoimmune antibodies were tested in SSc patients. RESULTS: Among these SSc cases, gastrointestinal manifestations were seen in 84.6%. Reflux/indigestion and diarrhea were more common in SSc patients than in the control group (67.7% vs 27.8%; 27.7% vs 10.2%, P < 0.05). SSc patients had a significantly higher percentage of abnormal social functioning than the control group (33.8% vs 3.9%, P < 0.05). SSc patients with abnormal social functioning and abnormal emotional well-being had worse distention, diarrhea, and constipation statuses. Patients with reflux or indigestion and diarrhea had lower anti-Scl-70 level than those without (both P < 0.05). Patients with distention had higher levels of anti-RNP and anti-SSA than those without distention (both P < 0.05). Patients with diarrhea had higher levels of anti-RNP than those without diarrhea (P = 0.014). CONCLUSIONS: Gastrointestinal involvement is frequent in SSc, with reflux or indigestion as the most common symptom. The impaired quality of life in patients with SSc indicates that early and active management should be considered.

Changes in symptoms and lifestyle factors in patients seeking healthcare for gastrointestinal symptoms: an 18-year follow-up study.

BACKGROUND: Gastrointestinal symptoms and lifestyle change over time. The data from this 18-year longitudinal study are intended to further elucidate the long-term natural course of functional gastrointestinal (GI) symptoms and possible influencing factors. AIM: The aim of this study was to evaluate the correlation between lifestyle factors over time by reassessing symptom profiles in patients who presented with GI symptoms in 1990. METHOD: The study population comprises a subset of individuals enrolled in the Swedish Dyspepsia Study, which commenced in 1990. In 1990, each participant in the Swedish Dyspepsia Study underwent physical assessment and completed a computer-based questionnaire on eight GI symptoms and lifestyle factors. An identical questionnaire was completed in 2008. RESULTS: In total, 137 participants, 85 women and 52 men, were included in the follow-up study. None of the symptoms increased in frequency. Four of the symptoms decreased in frequency: abdominal pain [odds ratio (OR) 2.70], flatulence (OR 4.09), nausea (OR 3.05), and acid regurgitation (OR 1.59). Significant lifestyle changes included increased BMI (P<0.0001), decreased tobacco smoking (P<0.0001), and milk drinking (P=0.0080). Increased exercise was correlated with a decrease in acid regurgitation (OR 3.05) and vomiting (OR 7.38), but an increase in diarrhea (OR 0.23) and nausea (OR 0.33). Decreased smoking was correlated with a decrease in acid regurgitation (OR 3.45) and heartburn (OR 2.91). CONCLUSION: The results indicated that the lifestyle changes in the studied population followed the same pattern as seen in the general population, and changes in lifestyle factors may have an impact on GI symptoms and may guide symptom management in the patient, all in order to reduce personal suffering and healthcare costs in the form of fewer visits to the doctor and lower numbers of drug prescriptions.

Impact of gastroesophageal reflux disease on the quality of life of Spanish patients: the relevance of the biometric factors and the severity of symptoms.

BACKGROUND: Gastroesophageal reflux disease (GERD) has a negative impact on health-related quality of life (HRQoL). AIM: (i) To evaluate HRQoL in the general Spanish population with GERD. (ii) To analyze the influence of biometric factors and symptoms profile on HRQoL. MATERIALS AND METHODS: A multicenter and population-based evaluation was performed. Surveys were sent out to the general population and 335 responders (16%) fulfilled symptomatic criteria of GERD. They filled out two HRQoL questionnaires [Short Form-36 (SF-36) and Quality of Life in Reflux and Dyspepsia]. Biometric factors and symptoms profile were collected. The SF-36 physical and mental component summary scores were calculated. RESULTS: Two hundred and fifty-two individuals (75.2%) participated. SF-36 and Quality of Life in Reflux and Dyspepsia (QoLRAD) punctuations were lower compared with the general population. Female sex, severity of symptoms, and nocturnal symptoms were associated with a greater deterioration of HRQoL. Obese participants had a negative impact on the physical component summary score, but mental component summary score was better than in participants with normal weight. Adjusted by age, punctuations of smokers, exsmokers, and nonsmokers were similar. No differences in HRQoL with regard to alcohol consumption were observed. CONCLUSION: In participants who fulfill symptomatic criteria of GERD, the HRQoL is very deteriorated. The factors that worsen the QoL are being female, increase in BMI, and nocturnal symptoms.