Discussion
OIC, chronic functional constipation, cancer, cancer pain, bowel movements, gastrointestinal drug, constipation-associated, constipation, gastrointestinal tract
CANCER, CHRONIC FUNCTIONAL CONSTIPATION
To our knowledge, this is the first multicenter randomized clinical trial to evaluate the efficacy of EA for OIC in patients with cancer. This trial demonstrated that 8-week EA, as compared with SA, is more likely to produce a significant and continuous increase in weekly SBMs. However, the between-group differences for mean weekly SBMs and CSBMs were less than 1, arguing against the clinical significance of EA over SA. Although EA had no effects on stool consistency, cancer pain severity, or opioid dosage, EA did decrease defecation straining and improve quality of life for patients with OIC.The US Food and Drug Administration recommends overall responder analysis as the primary evaluation for gastrointestinal drug development.The higher percentage of overall SBM responders in the EA group showed that EA was promising in normalizing bowel movements, which was also observed in a previous trial of EA for chronic functional constipation.In the EA group, although the increase in weekly SBMs was 1 or more at week 4 and maintained through week 8, the increase in weekly CSBMs in the EA group was consistently less than 1 throughout the study. An increase of 1 or more CSBMs per week from baseline represents a clinically significant change,Relieving constipation symptoms and increasing constipation-associated well-being are the primary considerations when caring for individuals with an advanced illness such as cancer.Opioids cause constipation primarily through activation of the opioid receptors in the gastrointestinal tract,