Summary of findings 1. Non‐nutritive sweeteners for diabetes mellitus.
| Non‐nutritive sweeteners compared with sucrose, placebo, or a nutritive, low‐calorie sweetener for diabetes mellitus | ||||||
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Patient: people with diabetes mellitus Settings: outpatients Intervention: non‐nutritive sweeteners (aspartame, rebaudioside A, saccharin, sodium‐cyclamate, sucralose, steviol glycoside) Comparison: sucrose; placebo; nutritive, low‐calorie sweetener (tagatose) | ||||||
| Outcomes/Comparisions | Comparator (sucrose; placebo; nutritive, low‐calorie sweetener) | Non‐nutritive sweeteners (aspartame, rebaudioside A, saccharin, sodium‐cyclamate, sucralose, steviol glycoside) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments |
| Health‐related quality of life | Not reported | |||||
| Diabetes complications | Not reported | |||||
| All‐cause mortality | Not reported | |||||
| Non‐serious adverse events (N) | ||||||
| NNS versus sugar | Not reported | |||||
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NNS versus placebo NNS: aspartame, rebaudioside A, steviol glycoside Follow‐up: 16 to 18 weeks |
356 per 1000 | 278 per 1000 (139 to 555) | RR 0.78 (0.39 to 1.56) | 231 (3) | ⊕⊝⊝⊝a very low | |
| NNS versus nutritive, low‐calorie sweetener | Not reported | |||||
| HbA1c (%) | ||||||
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NNS versus sugar NNS: aspartame, saccharin, sodium‐cyclamate Follow‐up: 4 to 6 weeks |
The mean HbA1c ranged across control groups from 6.8% to 7.5% | The mean HbA1c in the NNS group was 0.4% higher (0.5% lower to 1.2% higher) | ‐ | 72 (3) | ⊕⊝⊝⊝b very low | |
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NNS versus placebo NNS: aspartame, rebaudioside A, steviol glycoside Follow‐up: 13 to 16 weeks |
The mean final HbA1c ranged across control groups from 7.3% to 11.4% | The mean HbA1c in the NNS and placebo groups did not differ (MD 0%, −0.1% lower to 0.1% higher) | ‐ | 360 (4) | ⊕⊝⊝⊝c very low | The 95% prediction interval ranged between −0.3% and 0.3% |
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NNS versus nutritive, low‐calorie sweetener (tagatose) NNS: sucralose Follow‐up: 16 weeks |
The mean HbA1c in the control group was 7.3% | The mean HbA1c in the NNS group was 0.3% higher (0.1% higher to 0.4% higher) | ‐ | 354 (1) | ⊕⊝⊝⊝d very low | |
| Body weight (kg) | ||||||
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NNS versus sugar NNS: aspartame, saccharin, sodium‐cyclamate Follow‐up: 4 to 6 weeks |
The mean body weight in the control groups was 66.8 kg to 75.9 kg | The mean body weight in the intervention groups was 0.1 kg lower (2.7 kg lower to 2.6 kg higher) | ‐ | 72 (3) | ⊕⊝⊝⊝e very low | |
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NNS versus placebo NNS: aspartame, rebaudioside A Follow‐up: 12 to 16 weeks |
The mean final body weight ranged across control groups from to 79.4 to 98.4 kg | The mean body weight in the intervention groups was 0.2 kg lower (1 kg lower to 0.6 kg higher) | ‐ | 184 (2) | ⊕⊝⊝⊝f very low | |
| NNS versus nutritive, low‐calorie sweetener | Not reported | |||||
| Socioeconomic effects | Not reported | |||||
| *The basis for the assumed risk (e.g. the median control group risk across trials) 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; HbA1c: glycosylated haemoglobin A1c; MD: mean difference; NNS: non‐nutritive sweetener; RR: risk ratio. | ||||||
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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. | ||||||
aDowngraded by one level because of inconsistency (no consistent direction of effect) and two levels because of serious imprecision (CI consistent with benefit and harm, small sample size, and small number of studies) ‐ see Appendix 18. bDowngraded by one level because of inconsistency (point estimates varied widely, not all CIs overlapped, no consistent direction of effect); one level because of indirectness (surrogate outcome, insufficient time frame); and one level because of serious imprecision (CI consistent with benefit and harm, small sample size, and small number of studies) ‐ see Appendix 17. cDowngraded by one level because of indirectness (surrogate outcome) and two levels because of serious imprecision (small sample size and small number of studies) ‐ see Appendix 18. dDowngraded by one level because of risk of bias (attrition bias and selective reporting); one level because of indirectness (surrogate outcome); and one level because of imprecision (small number of included studies) ‐ see Appendix 19. eDowngraded by one level because of inconsistency (no consistent direction of effect) and two levels because of serious imprecision (CI consistent with benefit and harm, small sample size, and small number of studies) ‐ see Appendix 17. fDowngraded by one level because of risk of bias (selective reporting) and two levels because of serious imprecision (small sample size and small number of included studies) ‐ see Appendix 18.