Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China: A Randomized Clinical Trial.

Importance: Opioid-induced constipation (OIC) is prevalent among patients treated with opioids for cancer pain. Safe and effective therapies for OIC in patients with cancer remain an unmet need. Objective: To determine the efficacy of electroacupuncture (EA) for OIC in patients with cancer. Design, Setting, and Participants: This randomized clinical trial was conducted at 6 tertiary hospitals in China among 100 adult patients with cancer who were screened for OIC and enrolled between May 1, 2019, and December 11, 2021. Interventions: Patients were randomized to receive 24 sessions of EA or sham electroacupuncture (SA) over 8 weeks and then were followed up for 8 weeks after treatment. Main Outcomes and Measures: The primary outcome was the proportion of overall responders, defined as patients who had at least 3 spontaneous bowel movements (SBMs) per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period. All statistical analyses were based on the intention-to-treat principle. Results: A total of 100 patients (mean [SD] age, 64.4 [10.5] years; 56 men [56.0%]) underwent randomization; 50 were randomly assigned to each group. Among them, 44 of 50 patients (88.0%) in the EA group and 42 of 50 patients (84.0%) in the SA group received at least 20 (≥83.3%) sessions of treatment. The proportion of overall responders at week 8 was 40.1% (95% CI, 26.1%-54.1%) in the EA group and 9.0% (95% CI, 0.5%-17.4%) in the SA group (difference between groups, 31.1 percentage points [95% CI, 14.8-47.6 percentage points]; P < .001). Compared with SA, EA provided greater relief for most OIC symptoms and improved quality of life among patients with OIC. Electroacupuncture had no effects on cancer pain and its opioid treatment dosage. Electroacupuncture-related adverse events were rare, and, if any, all were mild and transient. Conclusions and Relevance: This randomized clinical trial found that 8-week EA treatment could increase weekly SBMs with a good safety profile and improve quality of life for the treatment of OIC. Electroacupuncture thus provided an alternative option for OIC in adult patients with cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT03797586.

PEG vs. sennosides for opioid-induced constipation in cancer care.

PURPOSE: This randomized double-blind, double-dummy, 2-treatment, 2-period crossover study aimed to compare the efficacy and tolerability of polyethylene glycol (PEG) and sennosides in ambulatory cancer patients with opioid-induced constipation. METHODS: Outpatients ≥ 18 years old with cancer, at risk of or already experiencing opioid-induced constipation, were randomly assigned to begin a standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation. After 3 weeks, the patients switched to the alternate active product and dummy preparation. Constipation was assessed using the revised Victoria Bowel Performance Scale (rBPS) at the end of each of the 2 consecutive 21-day study periods for the number of days with a satisfactory bowel movement, the time in days to goal rBPS (G), and the treatment preference of each patient. RESULTS: Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods. For the typical patient, the expected number of days with a satisfactory bowel movement per days of treatment was found to be 1.21 times higher on PEG than on sennosides in a particular period (95% credible interval 0.96 to 1.55). Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94). There was no evidence of a difference in patient preference between laxatives. CONCLUSION: Our study found weak evidence that PEG is superior to sennosides with respect to overall effectiveness in cancer patients with opioid-induced constipation.