The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double‐blind, placebo‐controlled, phase 3 trials

Abstract

BackgroundFew clinical trials in chronic idiopathic constipation (CIC) patients have evaluated abdominal symptom severity and whether CIC patients with abdominal symptoms respond similarly to patients with limited abdominal symptoms.AimsTo examine abdominal symptom severity and relationships between symptoms and global measures at baseline; compare linaclotide's effect on symptoms in subpopulations with more or less abdominal pain; and assess relationships between symptom improvement and global measures in these two subpopulations.MethodsIn two phase 3 trials, patients meeting modified Rome II CIC criteria were assigned to linaclotide 145 μg, 290 μg, or placebo once daily. Patients rated abdominal and bowel symptoms daily during 2-week pre-treatment and 12-week treatment periods. Linaclotide's effect on symptoms and global measures [constipation severity, health-related quality of life (HRQOL), treatment satisfaction] and their inter-relationships were assessed in post hoc analyses of abdominal pain subpopulations.ResultsOf 1271 CIC patients, 23%, 32%, and 43% reported moderate-to-severe abdominal pain, discomfort, and bloating, respectively, during baseline. In more-severe abdominal pain patients, abdominal symptoms were more strongly correlated than bowel symptoms with global measures, but in less-severe abdominal pain patients, abdominal and bowel symptoms were similarly correlated with global measures, at baseline and post-treatment. Linaclotide significantly improved all symptoms and global measures in both subpopulations.ConclusionsWhen abdominal pain is present in CIC, abdominal and not bowel symptoms may drive patient assessments of constipation severity, HRQOL, and treatment satisfaction. Linaclotide (145 μg and 290 μg) is an effective treatment for both abdominal and bowel symptoms, even in CIC patients with more severe abdominal pain at baseline. (Clinicaltrials.gov: NCT00765882, NCT00730015).

Prevalence and impact of self‐reported painful and non‐painful constipation in the general population

“…In addition, these results confirm that several other symptoms beside constipation can be prevalent in these patients even though these are not included in the diagnostic criteria. Previous work on the impact of abdominal pain on global measures in patients with chronic idiopathic constipation has shown that the presence of multiple abdominal symptoms positively correlates with ratings of constipation severity . Similar results were observed in our study suggesting that the increased number of additional bowel symptoms could contribute to an increased symptom perception.…”

“…Previous work on the impact of abdominal pain on global measures in patients with chronic idiopathic constipation has shown that the presence of multiple abdominal symptoms positively correlates with ratings of constipation severity. 15 Similar results were observed in our study suggesting that the increased number of additional bowel symptoms could contribute to an increased symptom perception. The reporting of many other symptoms underlines again that disorders of brain-gut interaction can be part of a continuum and that overlap between these disorders is highly prevalent.…”

Systematic review: health‐related quality of life in children and adults with eosinophilic oesophagitis—instruments for measurement and determinant factors

“…However, a majority of studies in the topic are exclusively available as abstracts presented in congresses. Third, none of the multiple randomised controlled trials published until now that assessed the efficacy of therapy in EoE have considered improvements in QoL as a relevant study outcome, which contrasts with the central importance granted to HRQoL in other chronic digestive diseases . Finally, validated versions of the specific questionnaires to measure HRQoL in other languages to English have not been developed yet (except for a Spanish version of the EoE‐QoL‐A questionnaire), which limits the level of credibility of such instruments, according to Cohen's criteria …”

Hospitalized pain patients have recently doubled: a retrospective case series study in Shenzhen Nanshan People's Hospital of China

“…Based on the pain cases recorded in pain clinics, many disease-associated studies have been conducted in western countries [15][16][17]. However, reports regarding the epidemiology of detailed patient profiles admitted into pain clinics in China are still rare.…”