Table 4.
| Randomization Process | Confounding Factors | Selection of Participants | Classification of Interventions | Deviations from Intended Interventions | Missing Data | Measurement of Outcomes | Selection of Reported Result | Overall Bias | |
|---|---|---|---|---|---|---|---|---|---|
| ROB2 1 | |||||||||
| Ito et al. RCT (2001) | Low risk | N/A | N/A | N/A | Low risk | Low risk | Low risk | Low risk | Low risk |
| Meston et al. RCT (2002) | Low risk | N/A | N/A | N/A | Low risk | Low risk | Low risk | Low risk | Low risk |
| Ito et al. RCT (2006) | Low risk | N/A | N/A | N/A | Low risk | Low risk | Low risk | Low risk | Low risk |
| Bottari et al. RCT (2012) | Low risk | N/A | N/A | N/A | Some concerns | Low risk | Low risk | Low risk | Some concerns |
| Stanislavov et al. RCT (2014) | Some concerns | N/A | N/A | N/A | Low risk | Low risk | Low risk | Low risk | Some concerns |
| ROBINS-I 2 | |||||||||
| Bottari et al. NRCT (2013) | N/A | Serious concerns | Low risk | Moderate risk | Low risk | Some concerns | Serious concerns | Low Risk | Serious risk |
| Cesarone et al. NRCT (2019) | N/A | Serious concerns | Low risk | Moderate risk | Low risk | Low risk | Serious concerns | Low Risk | Serious risk |
Abbreviations: NRCT: nonrandomized controlled trial, RCT: randomized controlled trial. 1 Confounding factors, Selection of participants and classification of interventions are not included in the ROB2 tool. 2 ROBINS-I does not account for randomization as these studies are nonrandomized controlled trials.