Table 1– Summary of the comparative randomised controlled trials studied

Author [Ref.]	Year of publication	Location of study	Mean age years	Male %	Treatment regimen	FDC formulation	DOT	Proper allocation sequence	Allocation concealment	Follow-up completion^#	Non-selective outcomes^¶	Free of bias⁺
RCTAI [22]	1989	India	29^§	70	HRZ	Rifater/Rifinah	No	Yes	Unclear	Yes	Yes	Yes
Cowie and Brink [23]	1990	South Africa	38	100	HRZ±S	Rifater	Yes	No^ƒ	Yes	Yes	Yes	No^##
HKCS and BMRC [24, 25]	1991, 1989	China	35^§	66	HRZ±S	Rifater	Yes	Unclear	Unclear	Yes	Yes	Yes
*Glatthaar et al.* [26]**	1991	South Africa	NS	NS	HRZE	Rifater	Yes	Unclear	Unclear	Yes	Yes	Unclear
Macnab *et al.* [27]	1994	South Africa	NS	NS	HRZE	Rifater	Yes	No^ƒ	Unclear	No^¶¶	Yes	Unclear
Chaulet and colleagues [28–30]	1995, 1990, 1989	Algeria	28^§	75	HRZ⁺⁺	NS	No^§§	Unclear	Unclear	Yes	Yes	Yes
*Zhang et al.* [31]**	1996	China	41^§	65	HRZ	Rifater/Rifinah	Yes	Yes	Unclear	Yes	Yes	Yes
*Zhu et al.* [32]**	1998	China	37^§	70	HRZ	Rifater/Rifinah	NS	Unclear	Unclear	Yes	Yes	Yes
Teo [33] and STS and BMRC [34]	1999, 1991	Singapore	39^§	66	HRZ±S	Rifater	Yes	Unclear	Unclear	Yes	Yes	Yes
Su and Perng [35]	2002	Taiwan	NS	89	HRZ	Rifater/Rifinah	No	Unclear	Unclear	No^¶¶	Yes	Unclear
*Munteanu et al.* [36]**	2004	Romania	37^§	63	HRZE	NS	Yes^ƒƒ	Unclear	Unclear	Yes	Yes	Yes
Xu et al. [37]	2004	China	49	76	HRZE	NS	NS	No^ƒ	Unclear	Yes	Yes	Unclear
*Suryanto et al.* [15] and Gravendeel et al. [38]**	2008, 2003	Indonesia	37	57	HRZE	Svizera	No	Yes	No^###	Yes	Yes	Unclear
*Bartacek et al.* [17]**	2009	5 countries^¶¶¶	37	69	HRZE	Rimstar/Rimactazid	NS	Yes	Yes	Yes	Yes	Yes
*Lienhardt et al.* [16]**	2011	9 countries⁺⁺⁺	34	67	HRZE⁺⁺	Svizera	Yes	Yes	Yes	Yes	Yes	Yes

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.