Bilateral transcutaneous tibial nerve stimulation for chronic constipation

Iqbal, Fareed; Collins, Brigitte; Thomas, G. P.; Askari, Alan; Tan, Emile; Nicholls, R. J.; Vaizey, C. J.

doi:10.1111/codi.13105

Cited by 40 publications

(46 citation statements)

References 47 publications

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“…Over 18 clinical studies have used the PAC-SYM, since its validation in 1999: 14 of these have been reported since 2010. [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] Moreover, these trials have examined a range of interventions including sacral nerve stimulation, 20 lifestyle changes 19 and pharmacological agents. 6,11 Historically, a reduction in total score of 1 point or more has been used as the cut-off to define a positive response to treatment, 2 implying that this is a meaningful improvement.…”

Section: Introductionmentioning

confidence: 99%

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

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SummaryBackgroundThe Patient Assessment of Constipation‐Symptoms (PAC‐SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC‐SYM score used to define a clinical response on this 0‐4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.AimTo determine the minimal important difference in PAC‐SYM score, and the optimum cut‐off value for defining responders.MethodsThe minimal important difference was estimated using data from six international phase 3/4, double‐blind, randomised controlled trials of prucalopride in patients with chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), with anchor‐ and distribution‐based approaches. Five appropriate patient‐reported outcomes were selected as anchors. In addition, receiver operating characteristics (ROC) curve analyses were used to investigate responder discrimination for each anchor.ResultsData from 2884 patients were included. Minimal important difference estimates ranged from –0.52 to –0.63 across the five anchors. Estimates were not affected by study location but were consistently lower for rectal symptoms than for abdominal and stool symptoms. Distribution‐based estimates were considerably lower than anchor‐based estimates. ROC curve analyses showed optimum cut‐off scores for discriminating responders to be similar to anchor‐based minimal important difference estimates.ConclusionsAnchor‐based methods gave consistent results for the minimal important difference, at approximately –0.6, and this value was close to the ROC‐determined optimal cut‐off scores for responder discrimination. This value could be considered in clinical practice. A slightly more conservative threshold (eg –0.75) could be used in clinical trials to reduce the placebo response rate.

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Section: Introductionmentioning

confidence: 99%

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

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“…Transcutaneous tibial nerve stimulation (TTNS) is reportedly beneficial for fecal and urinary incontinence. 7,8 A review of the literature showed that there are very few studies in which TTNS has been used and shown to be effective for constipation 9 however, there are practically no studies carried out exclusively on geriatric patients.…”

Section: Introductionmentioning

confidence: 99%

Effects of bilateral transcutaneous tibial nerve stimulation on constipation severity in geriatric patients: A prospective clinical study

Gökçe

2019

Geriatrics Gerontology Int

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Aim: Constipation is the most common digestive complaint in the general population, and one of the most frequently encountered health problems in the geriatric population. In the present study, we aimed to determine whether bilateral transcutaneous tibial nerve stimulation affects constipation severity in geriatric patients with refractory chronic constipation.Methods: Bilateral transcutaneous tibial nerve stimulation was carried out three times per week for 30 min in geriatric patients aged >65 years with less than three defecations per week. The patients were evaluated, and constipation severity was compared before the treatment, at the end of the 6-week treatment and 12 weeks after the end of the treatment.Results: Assessment carried out using the Constipation Severity Instrument showed that the scores for subscales; that is, obstructive defecation, colonic inertia and pain, improved significantly by the end of the treatment compared with the scores obtained before the treatment. Furthermore, the improvement in pain continued for 12 weeks after the treatment, and although there was a slight decrease in the scores for the other subscales, they significantly improved compared with the scores obtained before the treatment.Conclusions: During the 12-week follow-up period, bilateral transcutaneous tibial nerve stimulation significantly improved constipation severity in geriatric patients with refractory chronic constipation. We believe that this easy-to-use and low-cost method can be applied to eligible geriatric patients who cannot be treated through dietary adjustments and/or medical interventions.

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“…Neuromodulation has recently been introduced for the treatment of FC, such as sacral nerve stimulation [ 5 ] and tibial nerve stimulation [ 6 ] with inconclusive results and largely unknown mechanisms. In a previous study, we reported a promising ameliorating effect of transcutaneous neuromodulation (TN) in FC patients [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Home‐Based Transcutaneous Neuromodulation Improved Constipation via Modulating Gastrointestinal Hormones and Bile Acids

Duan

Yang

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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This study aims to investigate the role of transcutaneous neuromodulation (TN) on the regulation of gastrointestinal hormones and bile acids in patients with functional constipation (FC). Twenty FC patients were treated with TN for four weeks. The effects of TN on symptoms were evaluated by questionnaires. Plasma levels of serotonin (5-HT), motilin, somatostatin, and vasoactive intestinal peptide (VIP) were measured by ELISA and 12 individual bile acids assayed by liquid chromatography tandem mass spectrometry. Results were as follows. (1) TN treatment increased the frequency of spontaneous bowel movement, improved the Bristol Stool Score, and reduced Patient Assessment of Constipation Symptom score and Patient Assessment of Constipation Quality of Life score. (2) FC patients showed decreased plasma levels of 5-HT, motilin, and VIP and an increased plasma level of somatostatin (P < 0.05). Four-week TN treatment increased plasma levels of 5-HT and motilin and decreased the plasma level of somatostatin in the FC patients (P < 0.05). (3) Taurocholic deoxycholate, taurocholic acid, and taurocholic lithocholic acid were increased in the FC patients (P < 0.005) but reduced by TN treatment (P < 0.05). This study has suggested that the therapy may improve the symptoms of FC by alleviating the disorders of gastrointestinal hormones and bile acids.

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Bilateral transcutaneous tibial nerve stimulation for chronic constipation

Abstract: Bilateral transcutaneous tibial nerve stimulation appears to be effective in a quarter of patients with chronic constipation. Carefully selected patients with less severe disease may benefit more. This requires further study.

Cited by 40 publications

References 47 publications

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Effects of bilateral transcutaneous tibial nerve stimulation on constipation severity in geriatric patients: A prospective clinical study

Home‐Based Transcutaneous Neuromodulation Improved Constipation via Modulating Gastrointestinal Hormones and Bile Acids

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