Summary of findings for the main comparison. Acupuncture versus sham acupuncture for irritable bowel syndrome.
| Acupuncture versus sham acupuncture for irritable bowel syndrome | ||||||
| Patient or population: patients with irritable bowel syndrome Settings: Canada (1), Germany (1), UK (1), US (2) Intervention: True acupuncture Comparison: Sham acupuncture | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Sham acupuncture | True acupuncture | |||||
| symptom severity (continuous outcome) IBS Severity Scoring System (IBS‐SSS)1. Scale from: 0 to 500. Follow‐up: 3‐13 weeks2 | The mean symptom severity (continuous outcome) in the control groups was 193 points3 | The mean symptom severity (continuous outcome) in the intervention groups was 9.2 lower (29.2 lower to 10.8 higher)4(Better values are indicated by lower scores.) | 281 (4 studies) | ⊕⊕⊕⊝ moderate5 | SMD ‐0.11 (‐0.35 to 0.13) | |
| quality of life (continuous outcome) IBS Quality of Life (IBS‐QOL) Scale6. Scale from: 0 to 100. Follow‐up: 3‐5 weeks2 | The mean quality of life (continuous outcome) in the control groups was 73.8 points3 | The mean quality of life (continuous outcome) in the intervention groups was .53 lower (4.8 lower to 3.9 higher)7(Better values are indicated by higher scores.) | 253 (3 studies) | ⊕⊕⊕⊝ moderate5 | SMD ‐0.03 (‐0.27 to 0.22) | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 The IBS Severity Scoring System (IBS‐SSS) possesses responsiveness, face and construct validity (Francis 1997), and is one of the most widely used IBS symptom severity outcome measures. Better values are indicated by lower scores. 2 This outcome is for the short‐term follow‐up time point, defined as the time point closest to 8 weeks and less than or equal to 3 months after randomization. Outcomes were measured at the end of the treatment period in all studies, and because in all studies the end of treatment time point coincided with the time point closest to 8 weeks and less than or equal to 3 months, our short term outcome time points were the end of treatment for all trials. 3 We used the Lembo 2009 trial as the representative trial for the final value scores of symptom severity and quality of life in the control group because this trial was sufficiently large; the patient characteristics and the baseline means and SDs of symptom severity and quality of life in the control group of this trial were similar to and representative of the other trials; and this trial used the familiar IBS‐SSS scale for symptom severity and the well‐validated IBS‐QoL for quality of life. 4 The standardized mean difference (SMD) was re‐expressed into a mean difference by applying the calculated SMD back into the Lembo 2009 study and depicted on the IBS‐SSS scale used in that study. This calculation was made by multiplying the post‐treatment standard deviation of the IBS‐SSS score of the sham group in the Lembo trial by the pooled SMD. 5 Imprecision due to sparse data (less than 400 events ) and confidence intervals include possibility of benefit. 6 The IBS Quality of Life measure (IBS‐QoL) (Patrick 1998) is an extensively validated IBS quality of life scale (Bijkerk 2003; Irvine 2006). Better values are indicated by higher scores. 7 The standardized mean difference (SMD) was re‐expressed into a mean difference by applying the calculated SMD back into the Lembo 2009 study and depicted on the IBS‐QoL scale used in that study. This calculation was made by multiplying the post‐treatment standard deviation of the IBS‐QoL score of the sham group in the Lembo trial by the pooled SMD.