Introduction
Cyclic vomiting syndrome (CVS) is a disorder of gut-brain interaction defined by episodes of uncontrollable vomiting and retching. CVS has four phases (inter-episodic, prodrome, emetic, recovery) and affects both children and adults. There is a lack of published qualitative research on disease-related and phase-specific symptoms that impact patients with CVS.
Aims & Methods
Two qualitative, cross-sectional, observational interview studies were conducted in adults (18-65 years) and adolescents (12-17 years) with CVS. The studies aimed to explore the patient experience, identify the symptoms and understand their relevance to patients with CVS. The two studies included participants clinically diagnosed with CVS and followed at the tertiary care CVS programs at Froedtert hospital (adults) and Children’s Wisconsin (adolescents). Adolescents participated in a dyad interview with their caregiver or separately. Interviews were conducted remotely using a semi-structured interview guide and analysed with an “open coding” approach using ATLAS.ti 9.0 (adults) or 22.0 (adolescents).
Results
Semi-structured concept elicitation interviews (each up to 90 minutes long) were conducted with 13 adults (mean ± SD age 45.3 ± 13.1 years) and 15 adolescents (mean ± SD age 14.6 ± 1.8 years) by professional qualitative interviewers. Each participant described their symptoms during the prodrome and emetic phases. Most frequently reported symptoms during the prodrome were nausea (92.3%), anxiety (76.9%) and abdominal pain (69.2%) in adults; and nausea (100%), abdominal pain (73.3%), headache (73.3%) and pale skin (73.3%) in adolescents. During the emetic phase, the most frequently reported symptoms were nausea (100%), tiredness (100%), dry heaves (100%), vomiting (92.3%) and retching (92.3%) in adults; and nausea (100%), vomiting (100%), abdominal pain (93.3%), dehydration (86.7%), tiredness (86.7%) and light-headedness (86.7%) in adolescents. The patients most frequently reported nausea (5/13 adults, 6/15 adolescents) and vomiting (5/13 adults, 5/15 adolescents) as the most bothersome CVS symptom. Adults reported anxiety (associated with an impending vomiting episode; 5/13); missing work (2/13); inability to: perform daily tasks (1/13), plan their life (1/13), or parent to their full capacity (1/13); being homebound (1/13); reduced emotional well-being (1/13); and avoiding events (1/13) as the most bothersome impact of CVS symptoms. Adolescents reported impact on school (7/13 with data); missing out on sports (4/13); impacts on: social activities (4/13), sleep (1/13), friendships (1/13), or emotions (1/13); and anxiety (1/13) as the most bothersome impact of CVS symptoms (some provided >1 response). Caregivers reported the emotional impact of seeing their child suffer from CVS (5/11 with data); impact on: their child’s schooling (3/11), social activities (2/11); sports, friends/social activities, effect on their child’s future, work, daily planning, and travel planning (1/11 each) as the factor most difficult for them or their family.
Conclusion
Patients with CVS experience considerable gastrointestinal as well as extra-intestinal symptoms during both the prodrome and emetic phases. The majority suffer from nausea, vomiting and abdominal pain; the associated anxiety in adults is also notable. The study also confirmed major impact of CVS on daily life such as work/school absences, lost time with family/friends and reduced emotional well-being. CVS also markedly affects caregivers to patients with CVS.
Disclosure
Katja Kovacic reports medical advisory board from AbbVie, and is a consultant for Neurogastrx. Yaozhu J. Chen, Melody Wu, Camilla A. Richmond and James Williams are employees of the study sponsor, Takeda, and hold Takeda stock or stock options. Danielle Rodriguez is an employee of Evidera, which were contracted by Takeda for work relating to this study. Karin S. Coyne is an employee of Evidera, which were contracted by Takeda for work relating to this study, and a scientific consultant to Takeda. Thangam Venkatesan reports consultancy fees from Takeda.
