Efficacy of Mycobacterium vaccae immunotherapy for patients with tuberculosis: A systematic review and meta-analysis

Figures & data

Figure 1. Flow diagram of study selection.

Table 1. Basic characteristics of included studies.

Author (publication year)	Study design	Number of patients	Intervention	Age (y)	Male (%)	Type of M. tuberculosis
Butov (2013)^15	RCT	20	M. vaccae	36.8 (12)	80%	Drug-sensitive: 45% Drug-resistant: 35% Retreated TB: 20%
		21	Placebo	39.9 (10)	90%	Drug-sensitive: 67% Drug-resistant: 28% Retreated TB: 5%
Efremenko (2013)^7	RCT	22	M. vaccae	41.9 (10)	68%	n/a
		21	Placebo	44.3 (11)	81%
Dlugovitzky (2006)^12	RCT	12	M. vaccae	33.1 (14.8)	100%	n/a
		10	Placebo	36.8 (12.8)	80%
Johnson (2004)^16	RCT	664	M. vaccae	30.7 (9.1)	66%	n/a
		673	Placebo	30.6 (9.5)	63%
Mwinga (2002)^17	RCT	559	M. vaccae	30.5 (8.7)	58%	n/a
		586	Placebo	30.5 (8.7)	54%
Luo (2001)^18	RCT	171	M. vaccae	18–65	n/a	n/a
		171	Placebo
Luo (2000)^11	RCT	28	M. vaccae	18–65	n/a	n/a
		28	Placebo
Mayo (2000)^19	RCT	102	M. vaccae	36.4 (16.9)	n/a	n/a
		102	Placebo	35.1 (15.9)
Johnson (2000)^20	RCT	61	M. vaccae	26.4 (6.6)	66%	n/a
		59	Placebo	29.2 (8.1)	78%
Durban Immunotherapy Trial Group (1999)^21	RCT	172	M. vaccae	32 (9)	77%	Drug-sensitive: 98% Drug-resistant: 2%
		175	Placebo	32 (10)	75%	Drug-sensitive: 95% Drug-resistant: 5%
Dlugovitz (1999)^22	RCT^*	23	M. vaccae	40.4 (12.3)	n/a	n/a
		17	Placebo	39.4 (16.7)
Corlan (1997)^23	RCT	56	M. vaccae	44.1(12.9)	84%	Drug-resistant: 98%
		46	Placebo	40.3 (11.3)	70%	Drug-resistant: 89%
Corlan (1997)^24	RCT	97	M. vaccae	36.0 (13.1)	49%	Drug-resistant: 20%
		109	Placebo	36.2 (13.9)	52%	Drug-resistant: 16%

n/a, not available.

* The trial was partially blinded. Patients, radiologists, and staff carrying out laboratory investigations were blinded to the arm of the study to which patients were allocated; however, the clinicians caring for the patients knew the treatments that their patients received.

Figure 2. Forest plots for (A) sputum smear conversion to negative at 1 or 2 months and (B) sputum smear conversion to negative at 6 months.

Figure 3. Forest plots for (A) improvement of chest X-ray findings, (B) sputum culture negative at 1 or 2 months, (C) sputum culture negative at 6 months, (D) erythrocyte sedimentation rate (ESR), (E) hemoglobin, (F) leukocyte count, (G) weight gain, and (H) mortality.

Figure 3. (Continued)

Figure 4. Sensitivity-analysis for (A) sputum smear conversion to negative at 1 or 2 months, (B) sputum smear conversion to negative at 6 months, (C) improvement of chest X-ray findings, (D) sputum culture negative at 1 or 2 months, (E) sputum culture negative at 6 months, (F) erythrocyte sedimentation rate (ESR), (G) hemoglobin, (H) leukocyte count, (I) weight gain, and (J) mortality.

Figure 4. (Continued)

Figure 4. (Continued)

Figure 5. Publication bias analysis for sputum smear conversion to negative at 1 or 2 months.

Figure 6. Quality assessment of the included studies. (A) Risk of bias summary. (B) Overall assessment of risk of bias.

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