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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,