Electroacupuncture was safe and effective for patients with chronic severe functional constipation, a recent sham-controlled trial found.
Researchers randomized 1,075 patients diagnosed with the condition to receive either electroacupuncture (n=536) or a sham procedure (n=539) from trained acupuncturists at 15 hospitals in China. Electroacupuncture is similar to standard acupuncture except that a low-level current, generally less than 100 milliamperes (similar to current levels utilized for transcutaneous electrical nerve stimulation [TENS]), is passed through implanted acupuncture needles to provide continuous stimulation. The study results were published online Sept. 13 by Annals of Internal Medicine.
Patients in the study met Rome III diagnostic criteria for functional constipation and had 2 or fewer complete spontaneous bowel movements per week for more than 3 months. They completed stool diaries during the 22-week study period, which included 2 weeks of baseline assessment, 8 weeks of treatment, and 12 weeks of follow-up without treatment.
Both treatments consisted of 30-minute sessions: 5 sessions in each of the first 2 weeks and 3 in each of the following 6 weeks, for a total of 28 sessions. In the electroacupuncture group, the change from baseline in mean complete spontaneous bowel movements per week during the treatment period was 1.76 (95% CI, 1.61 to 1.89). The sham group had a change from baseline of 0.87 (95% CI, 0.73 to 0.97), with a between-group difference of 0.90 (P<0.001).
Treatment effects were even greater after patients stopped attending the sessions. During the follow-up period, the change from baseline was 1.96 (95% CI, 1.78 to 2.11) in the electroacupuncture group and 0.89 (95% CI, 0.69 to 0.95) in the sham group, for a between-group difference of 1.09 (P<0.001).
In the electroacupuncture group, the proportions of patients having 3 or more mean complete spontaneous bowel movements per week were 31.3% over weeks 1 to 8 and 37.7% over weeks 9 to 20. These proportions were similar to those reported in a trial of 1 to 2 mg of prucalopride (a novel, selective, high-affinity serotonin [5-HT4] receptor agonist with enterokinetic activity) for 12 weeks (37.9%), the researchers noted. In the sham group, the respective proportions of patients reaching this benchmark were 12.1% and 14.1%, presenting between-group differences of 19.3 and 23.6 percentage points (P<0.001).
The most common acupuncture-related adverse events were hematoma, sleeplessness, and sharp pain. These adverse events occurred in 5.8% of those in the electroacupuncture group and 4.5% of those in the sham group (P=0.32).
The study authors noted limitations of the trial, such as how they did not assess longer-term follow-up and how acupuncturists could not be blinded. They also noted that 28 sessions of electroacupuncture could be burdensome for patients. Nonetheless, they concluded that “Electroacupuncture could provide an alternative to conventional medications for the management of [chronic severe functional constipation].”