Patient dissatisfaction with medical therapy for chronic constipation or irritable bowel syndrome with constipation: analysis of N‐of‐1 prospective trials in 81 patients

Abstract

Summary Background Patients with chronic constipation (CC) or with irritable bowel syndrome with constipation are often dissatisfied about their medical therapy, but their condition remains poorly defined. Aim To evaluate the patients’ satisfaction rates and which factors predict favourable outcomes through the aggregate analysis of N‐of‐1 trials. Methods Eighty‐one outpatients with CC or with irritable bowel syndrome with constipation underwent N‐of‐1 trials with at least a one‐month cycle of effective treatment. Three primary endpoints (satisfaction with therapy, improvement after treatment and an extended satisfaction criterion including both endpoints) were adopted to define satisfaction with therapy. Dyssynergia, resting anal pressure, colonic transit time and somatisation were assessed. The Patient Assessment of Constipation‐Symptoms (PAC‐SYM) questionnaire and its Modified version (M‐PAC‐SYM) measured constipation severity. Straining at defecation, stool frequency and form were daily recorded. K statistics for agreement and logistic regression were used at statistical analysis. Results Satisfaction with therapy was not achieved by 43% of patients, who had a significantly lower Body Mass Index (BMI) and more severe constipation at baseline. Only the change in constipation severity according to M‐PAC‐SYM remained significantly associated with satisfaction with therapy (OR = 4.3; P < 0.001) at multivariate analysis. Conclusions Satisfaction with therapy is often an unmet need for patients with CC or with irritable bowel syndrome with constipation. Lower BMI and more severe constipation are associated with worse outcome. Changes in M‐PAC‐SYM reflect satisfaction with therapy. ClinicalTrials.gov no. NCT02813616.

A Low-FODMAP Diet for Irritable Bowel Syndrome: Some Answers to the Doubts from a Long-Term Follow-Up

“…Although it is not a life-threatening disease, it deeply changes the patients’ quality of life. This is also because adequate therapies to treat this syndrome are not yet available and the therapeutic strategy focuses mainly on treating the different symptoms, without a global approach, often obtaining partial and unsatisfactory results [ 2 , 3 , 4 , 5 ].…”

Impact of guideline awareness in public pharmacies on counseling of patients with acute or chronic constipation in a survey of pharmacy personnel

“…A sizeable fraction of patients report constipation that does not meet the Rome criteria [17], a phenomenon named No Rome Constipation [18]. Many patients with self-reported constipation do not seek advice by a physician [17] and patients with chronic constipation who are in professional care are often unsatisfied with the treatments they have been offered [19]. When certain causes have been excluded and a functional constipation has been established, self-management of patients by lifestyle modification as well as medicinal products are considered recommended treatment steps according to guidelines [3].…”

Editorial: symptom improvement does not equal satisfaction with treatment for constipation—authors’ reply

“…Declaration of personal interests : The authors’ declarations of personal and financial interests are unchanged from those in the original article …”

“…Single‐item questions based on binary end points or Likert scales such as the one used in our paper have several advantages: They are comprehensive yet simple and accordingly they can be easily re‐administered to patients in studies such as ours that require multiple evaluations in the same patient. In the absence of complete knowledge on the construct underlying patient dissatisfaction, a single‐item question allows the patient to integrate all or the most relevant symptoms into a single item that takes into account the patient’s own reference system of improvement A global end point accounts for more variance than the more specific scales, suggesting a general treatment satisfaction factor …”