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Table 4 Safety Outcomes and Immunological Reactions

From: World Health Organization (WHO) antibiotic regimen against other regimens for the treatment of leprosy: a systematic review and meta-analysis

Side Effects
Study Patients Comparison Follow up RR 95% CI p value
Balagon, 2010 [18] PB MDT vs. 28 days of RFP + ofloxacin for 4w then 5 m of placebo 12 m 0.38 0.10–1.39 0.14
Gunawan 2018 [32] MB MDT vs. CDC 3 m Unable to analyze
Tejasvi, 2006 [39] MDT vs. RFP + sparfloxacin + clarithromycin + minocycline 12 m 0.1 0.01–1.56 0.1
Shaw, 2003 [37] MDT vs. RFP + clofazimine+ acedapsone + dapsone 24 m 1.42 0.58–3.47 0.44
Type I reaction
Study Patients Comparison Follow up RR 95%CI p value
Orege, 1990 [26] PB MDT vs. MDT + RFP + dapsonea 6 m 1.15 0.58–2.27 0.69
Fernandes Pena 2012 [31] MB MDT vs. Monthly RFP, dapsone and clofazimine daily × 6 m 60 m 1.1 0.86–1.41 0.44
Sampoonachut, 1997 [36] MDT vs. MDT + ofloxacin 12 m 2.11 0.21–21.36 0.53
MDT vs. Ofloxacin + clofazimine, then MDT 1 0.16–6.38 1
Shaw, 2003 [37] MDT vs. RFP + Clofazimine+ Acedapsone + dapsone 24 m 1.78 0.53–5.97 0.35
Tejasvi, 2006 [39] MDT vs. RFP + sparfloxacin + clarithromycin + minocycline 12 m 0.21 0.01–3.71 0.29
Villahermosa, 2004 [40] MDT vs. ROM 96 m 0.91 0.37–2.23 0.83
Type II reaction
Study Patients Comparison Follow up RR 95% CI p value
Babu, 1997 [17] PB MDT vs. ROM 18 m No events reported
Balagon, 2011 [28] MB MDT 1y vs. MDT 2y 24 m 1.53 1.05–2.23 0.03
Fernandes Pena 2012 [31] MDT vs. Monthly RFP, dapsone and clofazimine daily × 6 m 60 m 1.15 0.72–1.84 0.56
Jadhav, 1992 [33] MDT vs. RFP + dapsone + clofazimine 24 m 0.22 0.07–0.72 0.01
Maghanoy, 2018 [34] MDT vs. MDT + 12 months of clofazimine 24 m 0.86 0.52–1.40 0.54
Sampoonachut, 1997 [36] MDT vs. MDT + ofloxacin. 24 m 0.7 0.13–3.75 0.68
MDT vs. ofloxacin + clofazimine, then MDT   1 0.16–6.38 1
Shaw, 2003 [37] MDT vs. RFP + clofazimine+ acedapsone + dapsone 24 m 0.44 0.04–4.45 0.49
Tejasvi, 2006 [39] MDT vs. RFP + sparfloxacin + clarithromycin + minocycline 12 m No events reported
Villahermosa, 2004 [40] MDT vs. ROM 96 m 0.91 0.16–5.30 0.92
Neuritis
Study Patients Comparison Follow up RR 95% CI p value
Manickam, 2012 [24] PB MDT vs. ROM 6 m 0.5 [0.05, 5.49] 0.57
Bathe, 1986 [19] MDT vs. MDT+ clofazimine 24 m 4 [0.47, 34.24] 0.21
Katoch, 1999 [22] MDT vs. MDT+ clofazimine 24 m No events reported
Fernandes Pena 2012 [31] MB MDT vs. RFP, dapsone and clofazimine × 6 m 60 m 0.64 0.45, 0.92 0.01
Jadhav, 1992 [33] MDT vs. RFP + dapsone + clofazimine 24 m 0.29 0.03–2.69 0.28
Sampoonachut, 1997 [36] MDT vs. MDT + ofloxacin 24 m 2.11 0.21, 21.36 0.53
MDT vs. ofloxacin + clofazimine, then MDT 1 0.16–6.38 1
Shaw, 2003 [37] MDT vs. RFP + clofazimine+ acedapsone + dapsone 24 m 1.19 0.31–4.51 0.8
  1. Abbreviations - BI Bacillary index, CDC Clarithromycin+dapsone+clofazimine, RFP Rifampin; m: months, MDT Multidrug treatment, ROM, rifampin, ofloxacin and minocycline
  2. aIncluded a period of direct observation,