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. 2022 Sep 8;17(9):e0273733. doi: 10.1371/journal.pone.0273733

Table 1. Characteristics of included studies.

M0, induction BCG therapy only; M1, 1-year BCG maintenance therapy; M2, BCG maintenance therapy for more than 1 year.

Category Study Methods Study design BCG strain No. of Patients Mean/median follow-up period Recurrence Quality assessment (SIGN)
M0 vs. M1 Mohamed et al. 2020 [13] M0 Prospective Pasteur 27 40 months 15 2+
M1 26 35 months 5
Yoo et al. 2012 [14] M0 Retrospective OncoTICE 34 16.5 months 16a 1+
M1 92 43 months 21a
Okamura et al. 2011 [15] M0 Retrospective Tokyo 27 66 months 13b 1+
M1 48 102 months 8b
Koga et al. 2010 [16] M0 Randomized controlled Tokyo 27 28.7 months 7a 2+
M1 24 26.5 months 1a
Akaza et al. 1995 [17] M0 Randomized controlled Tokyo 55 42 months 20 1+
M1 52 48 months 22
M0 vs. M2 Miyake et al. 2021 [18] M0 Retrospective Tokyo or Connaught 874 48 months 175a 2+
M2 405 41a
Koguchi et al. 2020 [19] M0 Retrospective Tokyo 40 36.2 months 14 2+
M2 38 5
Joshua et al. 2019 [20] M0 Retrospective Not addressed 40 Not addressed 8a 1+
M2 61 7a
Yuk et al. 2018 [21] M0 Retrospective Not addressed 29 63 months 14 2+
M2 26 5
Nakai et al. 2016 [22] M0 Randomized controlled Connaught 42 51 months 9b 2+
M2 46 9b
Martínez-Piñeiro et al. 2015 [23] M0 Randomized controlled Connaught 195 103 months 80b 2+
M2 202 102 months 68b
Muto et al. 2013 [24] M0 Retrospective Connaught 64 42.3±33.1 months 23b 1+
M2 40 51.1±34.6 months 6b
Hinotsu et al. 2011 [25] M0 Randomized controlled Connaught 42 Not addressed 14a 1+
M2 41 5a
Palou et al. 2001 [26] M0 Randomized controlled Connaught 61 77.8 months 16 2+
M2 65 10
Lamm et al. 2000 [27] M0 Randomized controlled Connaught 192 Not addressed 113b 2+
M2 192 77b
Badalament et al. 1987 [28] M0 Randomized controlled Pasteur 46 22 months 3 1+
M2 47 6
Hudson et al. 1987 [29] M0 Randomized controlled Pasteur 21 17.2 months 6 1+
M2 21 5
M1 vs. M2 Gupta et al. 2020 [30] M1 Randomized controlled Moscow 38 Not addressed 5b 2+
M2 40 6b
Oddens et al. 2013 [31] M1 Randomized controlled OncoTICE 339 7.1 years 145 2+
M2 338 131

aDuring the 2-year follow-up;

bduring the 5-year follow-up.

The quality assessment was indicated by Scottish Intercollegiate Guidelines Network (SIGN) checklist. 1+ means well-conducted RCT with a low risk of bias. 1- means RCT with a high risk of bias. 2+ means well-conducted cohort studies with a low risk of bias. 2- means cohort studies with a high risk of bias.