Table 4.
Safety Outcomes and Immunological Reactions
| 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 | |
Abbreviations - BI Bacillary index, CDC Clarithromycin+dapsone+clofazimine, RFP Rifampin; m: months, MDT Multidrug treatment, ROM, rifampin, ofloxacin and minocycline
aIncluded a period of direct observation,