A randomized, controlled, crossover study of sacral nerve stimulation for irritable bowel syndrome

Post on June 9, 2014 by André Broussard, D.C.

Annals of Surgery, 06/09/2014 > Evidence Based Medicine  Clinical Article
Annals of Surgery: July 2014 – Volume 260 – Issue 1 – p 31–36

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Fassov JL, et al. – IBS affects 3% to 22% of the population worldwide, but most patients continue to have symptoms despite treatment. The aim is to investigate whether sacral nerve stimulation reduces irritable bowel syndrome (IBS)–specific symptoms by a randomized, controlled, crossover study. Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS.

Methods

  • Patients included from the tertiary center had diarrhea–predominant or mixed IBS, with a minimum baseline IBS symptom score (Gastrointestinal Syndrome Rating Scale–IBS questionnaire) of 40 points reduced by a minimum of 30% during the percutaneous nerve evaluation before permanent implantation.
  • Patients were randomized (1:1) to have the stimulator ON or OFF for 1 month and then the opposite for another month. Investigators and patients were not informed of the setting.
  • IBS–specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires.
  • Primary endpoint was the IBS–specific symptom score.

Results

  • Twenty–one patients were randomized.
  • Ten were eligible for analysis in each group. IBS–specific symptom scores were significantly reduced during stimulation: the median difference in the ON–OFF group was 12 (range, –22 to 44) and in the OFF–ON group –17.5 (range, –48 to –1) (P = 0.0009).
  • IBS–specific quality–of–life scores improved significantly during stimulation: the median difference in the ON–OFF group was 16 (range, –24 to 69) and in the OFF–ON group –42.5 (range, –77 to 0) (P = 0.0003).
  • At 1–year follow–up, the median IBS–specific symptom score (25; range, 13–65) was significantly lower than that at baseline (62; range, 45–80) (P = 0.0001).

    Abstract

    Objective: To investigate whether sacral nerve stimulation reduces irritable bowel syndrome (IBS)-specific symptoms by a randomized, controlled, crossover study.

    Background: IBS affects 3% to 22% of the population worldwide, but most patients continue to have symptoms despite treatment.

    Methods: Patients included from our tertiary center had diarrhea-predominant or mixed IBS, with a minimum baseline IBS symptom score (Gastrointestinal Syndrome Rating Scale–IBS questionnaire) of 40 points reduced by a minimum of 30% during the percutaneous nerve evaluation before permanent implantation. Patients were randomized (1:1) to have the stimulator ON or OFF for 1 month and then the opposite for another month. Investigators and patients were not informed of the setting. IBS-specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires. Primary endpoint was the IBS-specific symptom score.

    Results: Twenty-one patients were randomized. Ten were eligible for analysis in each group. IBS-specific symptom scores were significantly reduced during stimulation: the median difference in the ON-OFF group was 12 (range, −22 to 44) and in the OFF-ON group −17.5 (range, −48 to −1) (P = 0.0009). IBS-specific quality-of-life scores improved significantly during stimulation: the median difference in the ON-OFF group was 16 (range, −24 to 69) and in the OFF-ON group −42.5 (range, −77 to 0) (P = 0.0003). At 1-year follow-up, the median IBS-specific symptom score (25; range, 13–65) was significantly lower than that at baseline (62; range, 45–80) (P = 0.0001).

    Conclusions: Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS.

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