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Transabdominal interferential electrical stimulation effectively reduced refractory constipation in women compared with a sham therapy, maintaining response and better quality of life 3 months after therapy, a small pilot trial found.

Treated women were four times more likely to achieve three or more spontaneous bowel movements a week than those receiving sham stimulation, reported Judith S. Moore, MSc, RN, and colleagues at Monash University in Melbourne, Australia.

"This is a novel and economical means of treating patients [and] needs larger studies to give more strength to these findings," the team wrote online in .

The researchers noted that chronic constipation, which affects approximately 15% of the general population, is challenging to manage and that neuromodulation is thought to modify bowel function via electrical stimulation of .

The single-blind study of women ages 18 to 75 randomly assigned 45 participants in two arms with mean ages of 44 and 45, respectively, to receive either interferential stimulation with crossing of electric currents or sham stimulation with no crossing of currents for 1 hour a day for 6 weeks. Patients were taught to apply the stimulation devices themselves, which passed currents back and forth from the abdomen to the back, and to record their symptoms in diaries.

In the final analysis at the treatment's end, nine of 17 women (53%) remaining in the active therapy group met the primary outcome of three or more spontaneous bowel movements per week compared with two of 16 (12.5%) in the sham group (P=0.02).

Interferential therapy resulted in the following reductions:

• Patient Assessment of Constipation-Symptoms (P=0.03)

• Overall symptom severity score on a visual analog scale measured at baseline, the midpoint of stimulation, the end of treatment, and 3 months after treatment ended (P=0.05)

• Laxative use by at least 50% of participants: 66% of those in the intervention arm vs 14% in the sham arm (P= 0.01)

Patient Assessment of Constipation-Quality of Life also improved in the treatment group (P=0.001), and significantly so at 3 months after treatment cessation, and there were no treatment-related adverse effects, the investigators reported.

They added that further research is needed to determine the optimal delivery duration and frequency, define the mechanisms of action, and determine predictors of response.

Asked for his perspective, Kyle D. Staller, MD, MPH, director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital in Boston, who was not involved with the study, said "This small trial certainly suggests that transabdominal interferential electrical stimulation may be a promising treatment modality for our patients who are dissatisfied with their current laxative regimen. And we know that a sizable number of patients with constipation are not satisfied with currently available therapies."

He said the study benefited from a robust sham treatment and demonstrated a significant treatment effect despite its small sample size. "Additionally, many of these patients were quite constipated without laxatives, having zero spontaneous bowel movements, and so it would seem that this type of treatment could be effective for more severe cases of constipation," Staller told 麻豆传媒.

He said that although the results did not reach the rigor of larger constipation trials in which complete, spontaneous bowel movements are the usual primary endpoint, "this is an impressive pilot study that makes a compelling case for larger randomized trials using the traditional endpoints we are used to seeing from trials in chronic idiopathic constipation."

Staller noted that electrical neuromodulation via electric impulses is being widely investigated in other functional gastrointestinal diseases, as evidenced by recent trials for nausea and vomiting and fecal . "How these modalities affect nerves, where they affect them, and whether they have more of an effect on sensory or motor dysfunction are all still open questions," he said.

Moore and co-authors said limitations of their study included its small size and the unblinded coordinator. A spontaneous complete bowel motion would have been a more robust outcome in line with current guidelines, but the pilot study was underpowered to detect a significant difference despite evidence of a trend, the researchers noted.

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