Outcomes
OIC, cancer pain, illness, pain
The primary outcome was the proportion of overall responders, defined as those having at least 3 SBMs per week and an increase from baseline of at least 1 SBM per week for at least 6 of the 8 weeks of treatment. An SBM was defined as a bowel movement occurring without the use of any rescue medicine or other interventions in the previous 24 hours.Secondary outcomes included change from baseline in the mean weekly SBMs and complete SBMs (CSBMs; defined as SBMs with the feeling of complete evacuation) during weeks 1 to 8 and weeks 13 to 16; the proportion of patients with 3 or more mean weekly SBMs and CSBMs, and those with an increase of 1 or more mean weekly SBM and CSBMs from baseline during weeks 1 to 8 and weeks 13 to 16; change from baseline in the mean Bristol Stool Form Scale score (range, 1-7 indicating different stool consistency, where 1 indicates separate hard lumps and 7 indicates entirely liquid)Patients’ expectations of acupuncture for general illness and OIC were assessed at baseline. Safety assessments included AEs, changes in opioid dosage, and cancer pain score. All AEs were classified by acupuncturists and oncologists within 24 hours of their occurrence as treatment related or nontreatment related. Changes in opioid dosage were monitored and captured as the number of patients with a 30% or greater weekly mean increase or decrease in opioid dosage from baseline, and cancer pain was rated using the Numerical Rating Scale (range, 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) in the preceding week.