Table 1– Summary of the comparative randomised controlled trials studied
Author [Ref.]Year of publicationLocation of studyMean age yearsMale %Treatment regimenFDC formulationDOTProper allocation sequenceAllocation concealmentFollow-up completion#Non-selective outcomesFree of bias+
RCTAI [22]1989India29§70HRZRifater/RifinahNoYesUnclearYesYesYes
Cowie and Brink [23]1990South Africa38100HRZ±SRifaterYesNoƒYesYesYesNo##
HKCS and BMRC [24, 25]1991, 1989China35§66HRZ±SRifaterYesUnclearUnclearYesYesYes
Glatthaar et al. [26]1991South AfricaNSNSHRZERifaterYesUnclearUnclearYesYesUnclear
Macnab et al. [27]1994South AfricaNSNSHRZERifaterYesNoƒUnclearNo¶¶YesUnclear
Chaulet and colleagues [28–30]1995, 1990, 1989Algeria28§75HRZ++NSNo§§UnclearUnclearYesYesYes
Zhang et al. [31]1996China41§65HRZRifater/RifinahYesYesUnclearYesYesYes
Zhu et al. [32]1998China37§70HRZRifater/RifinahNSUnclearUnclearYesYesYes
Teo [33] and STS and BMRC [34]1999, 1991Singapore39§66HRZ±SRifaterYesUnclearUnclearYesYesYes
Su and Perng [35]2002TaiwanNS89HRZRifater/RifinahNoUnclearUnclearNo¶¶YesUnclear
Munteanu et al. [36]2004Romania37§63HRZENSYesƒƒUnclearUnclearYesYesYes
Xu et al. [37]2004China4976HRZENSNSNoƒUnclearYesYesUnclear
Suryanto et al. [15] and Gravendeel et al. [38]2008, 2003Indonesia3757HRZESvizeraNoYesNo###YesYesUnclear
Bartacek et al. [17]20095 countries¶¶¶3769HRZERimstar/RimactazidNSYesYesYesYesYes
Lienhardt et al. [16]20119 countries+++3467HRZE++SvizeraYesYesYesYesYesYes
  • FDC: fixed dose combination; DOT: direct observed therapy; RCTAI: Research Committee of the Tuberculosis Association of India; HKCS: Hong Kong Chest Service; BMRC: British Medical Research Council; STS: Singapore Tuberculosis Service; H: isoniazid; R: rifampicin; Z: pyrazinamide; S: streptomycin; E: ethambutol; NS: not specified. #: Complete follow-up for ≥75% of subjects, and assessment of the reasons for incomplete follow-up; : free of selective outcome (i.e. reporting all expected or pre-specified outcomes); +: equivalent subject characteristics and management between comparison groups, and the sample population had no specific risks that could influence their treatment outcomes; §: the mean was estimated from a stratified age distribution; ƒ: allocation based on even versus odd generated numbers; ##: streptomycin was added to the treatment of only one of the two groups; ¶¶: <75% of subjects completed the follow-up; ++: during the continuation phase, FDC was given to both groups; §§: treatments were under direct supervision only during the first 3 weeks of therapy; ƒƒ: DOT was given only during the initial phase of treatment; ###: the subjects were alternatively allocated to each study group; ¶¶¶: Egypt, India, Pakistan, Philippine and Thailand; +++: Algeria, Colombia, Guinea, Vietnam, Nepal, Peru, Mozambique, Tanzania and Bolivia.