Summary of findings 6. Physical activity advice plus placebo compared to no physical activity advice plus omega 3 for participants with quiescent IBD.
| Physical activity advice plus placebo compared to no physical activity advice plus omega 3 for participants with quiescent IBD | ||||||
| Patient or population: participants with quiescent IBD Setting: outpatients from a single centre in the United Kingdom Intervention: physical activity advice plus placebo Comparison: no physical activity advice plus omega 3 | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with no physical activity advice plus omega 3 | Risk with physical activity advice plus placebo | |||||
| Fatigue assessed with: FACIT‐F follow‐up: 12 weeks | The mean fatigue score was 32.1 | MD 9 higher (1.64 higher to 16.36 higher) | ‐ | 29 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | FACIT‐F scores ranged from 0 to 52, with higher scores indicating less fatigue. |
| Fatigue assessed with: MFI follow‐up: 12 weeks | The mean fatigue score was 14.1 | MD 1.4 lower (4.39 lower to 1.59 higher) | ‐ | 29 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | MFI scores ranged from 0 to 84, with higher scores indicating greater fatigue. |
| Fatigue assessed with: IBDF Section 1 follow‐up: 12 weeks | The mean fatigue score was 9.6 | MD 2.8 lower (5.93 lower to 0.33 higher) | ‐ | 29 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | IBD‐F Section I scores ranged from 0 to 20, with higher scores indicating greater levels of fatigue. |
| Fatigue assessed with: IBDF Section 2 follow‐up: 12 weeks | The mean fatigue score was 34.8 | MD 15.4 lower (30.51 lower to 0.29 lower) | ‐ | 29 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | IBD‐F Section II scores ranged from 0 to 120, with higher scores indicating greater impact of fatigue. |
| Adverse events: assessed with: Medication diary follow‐up: 12 weeks | There were four reported adverse events in the physical activity advice plus placebo group and fourteen reported adverse events in the no physical activity advice plus omega 3 group, including epigastric pain, diarrhoea, bloating, nausea and vomiting, IBD flare, joint pain, and ankle injury. | ‐ | 29 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | Adverse events were recorded in the medication diary and assessed by the researcher during the 6 follow‐up contact time points. | |
| Serious adverse events ‐ not reported | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. | |
| Withdrawal due to adverse events ‐ not reported | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. | |
| *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 certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded two levels due to very serious imprecision as the number of participants was small, confidence interval was wide and per protocol analyses used.
2 Downgraded one level due to high risk of bias for blinding of participants and personnel and blinding of outcome assessments.