Table 2– Outcome results of comparative randomised controlled trials (RCTs)
OutcomesStudiesFDCSeparate drug formulationRisk ratio (95% CI)Heterogeneity
Subjects% (95% CI)Subjects% (95% CI)I-squaredp-value
Comparative RCTs (pooled)
 Treatment failure or disease relapse1527504.2 (2.6–5.8)28803.1 (1.9–4.2)1.28 (0.99–1.7)00.46
 Acquired drug resistance411130.26 (0–0.7)14050.08 (0–0.35)1.6 (0.5–5.4)00.04
 Tuberculosis culture conversion after 2 months of treatment12235494 (91–96)244391 (89–92)1.03 (1.01–1.04)130.32
 Adverse drug reaction10241616 (9–23)219520 (11–28)0.88 (0.75–1.03)23.70.23
Patients' adherence to treatment#
 RCTAI [22]19577 (67–85)10173 (64–82)1.05 (0.89–1.23)66.50.02
 Cowie and Brink [23]+16958 (46–70)8184 (74–91)0.69 (0.55–0.86)
 Macnab et al. [27]§112165 (55–73)7957 (45–68)1.13 (0.90–1.43)
 Teo [33]115495 (90–98)15397 (93–99)0.97 (0.93–1.02)
 Su and Perng [35]ƒ15770 (57–82)4867 (52–80)1.05 (0.81–1.37)
Treatment satisfaction#
 Teo [33]##115492 (86–95)15390 (84–94)1.02 (0.95–1.09)97.80.00
 Bartacek et al. [17]¶¶141181 (77–85)42257 (52–61)1.43 (1.30–1.58)
  • Data are presented as n, unless otherwise stated. FDC: fixed-dose combination; RCTAI: Research Committee of the Tuberculosis Association of India. #: Results were not pooled because of significant heterogeneity between them and because of inconsistent methods for measurement of the outcome; : assessment of adherence was based on monthly home visits and count of the number of remaining capsules; +: assessment of adherence was based on urine tests and reports from medical staff; §: assessment of adherence was based on completion of ≥75% of the treatment doses; ƒ: assessment of adherence was based on the loss of follow-up and alteration of treatment regimen; ##: assessment of satisfaction was based on spontaneous complaints; ¶¶: assessment of satisfaction was based on patient's acceptance of the tablet number and size and complaints of swallowing problems.