Summary of findings for the main comparison.
Transcutaneous electrical stimulation for treating chronic constipation in children
| Research question: In children with chronic constipation, does the use of transcutaneous electrical stimulation (TES) improved bowel motion, symptoms and other major outcomes compared with the use of sham stimulation? | ||||||
| Patient or population: children with chronic constipation Setting: hospital clinics Intervention: transcutaneous electrical stimulation (TES) Comparison: sham stimulation | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with sham stimulation | Risk with transcutaneous electrical stimulation | |||||
| Number of participants with improved complete spontaneous bowel movement (CSBM) of greater than three times per week at two‐month follow‐up | 714 per 10001 | 764 per 1000 (529 to 1000) | RR 1.07 (0.74 to 1.53) | 42 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,3 | |
| Number of participants with improved colonic transit assessed with: Radioisotope studies | 143 per 10001 | 714 per 1000 (113 to 1000) | RR 5.00 (0.79 to 31.63) | 21 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,34, | |
| Colonic transit rate (geometric centre of radioactive substance). Unit indicates position along with intestinal tract. Scale from: 1 (small intestine) to 5 (rectosigmoid area). | The mean colonic transit rate (geometric centre of radioactive substance) was 3.27 unit in the "Distance of geometric centre along the intestinal tract" | The mean colonic transit rate (geometric centre of radioactive substance) in the intervention group was 1.05 unit more (0.36 more to 1.74 more) | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,3,4 | |
| Number of participants with improved symptoms related to soiling | 333 per 10001 | 693 per 1000 (287 to 1000) | RR 2.08 (0.86 to 5.00) | 25 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,3 | |
| Number of participants with improved quality of life assessed with: Peds QL 4.0 Generic Scales (higher scores indicates better quality of life) Scale from: 0 to 100 | 125 per 10001 | 500 per 1000 (70 to 1000) | RR 4.00 (0.56 to 28.40) | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,3 | |
| Self‐perceived QoL (change from baseline) measured using Peds QL 4.0 Generic Core Scales, scoring 0‐100 points, higher score indicates better quality of life) | The mean self‐perceived QoL (change from baseline) was 3.2 points | The mean change in self‐perceived QoL in the intervention group was 5 points higher (1.21 lower to 11.21 higher) | ‐ | 33 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,3 | |
| Parent‐perceived QoL (change from baseline) measured using PedsQL 4.0 Generic Core Scales, scoring 0‐100 points, higher score indicates better quality of life) |
The mean parent‐perceived QoL (change from baseline) was 0.4 points | The mean change in parent‐perceived QoL in the intervention group was 0.2 points lower (7.57 lower to 7.17 higher) | ‐ | 33 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,3 | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 The sham group risk estimate comes from the control arm of the included trial.
2 We downgraded one level due to unclear risk of selection bias and high risk of performance and detection bias with some subjective outcomes assessed
3 We downgraded two levels due to serious imprecision with very few events in the outcomes concerned, as they were far short of the optimal information size.
4 Indirectness, improved radiologically‐assessed colonic transit might not translate to important improvement in clinical symptoms or increased bowel motion.