Meta-analysis
Management of spinal
tuberculosis: a systematic
review and meta-analysis
Journal of International Medical Research
41(5) 1395–1407
! The Author(s) 2013
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DOI: 10.1177/0300060513498023
imr.sagepub.com
Xifeng Zhang1, Jianfei Ji2 and Bo Liu3
Abstract
Objective: A systematic review and meta-analysis of randomized controlled trials (RCTs)
studying the clinical benefit of chemotherapy with surgical intervention over chemotherapy alone
for the treatment of spinal tuberculosis.
Methods: Relevant RCTs were identified by computerized database searches. Trial eligibility and
methodological quality were assessed and data were extracted and analysed using odds ratios with
95% confidence intervals. The primary outcome measure was kyphosis angle.
Results: The literature search identified two RCTs conducted in the 1970s and 1980s and a
Cochrane Database Systematic Review published in 2006. There were no significant betweengroup differences in kyphosis angle, bony fusion, bone loss or development of neurological deficit.
Conclusions: There is no obvious statistically significant clinical precedence to suggest that
routine surgery will improve the prognosis of patients with spinal tuberculosis.
Keywords
Spinal tuberculosis, Pott disease, kyphosis, bony fusion, bone loss, neurological deficit, metaanalysis, systematic review
Date received: 1 February 2013; accepted: 9 February 2013
Introduction
Spinal tuberculosis (TB) or Pott disease was
first reported in 1779 and represents <1% of
all TB cases.1–3 Given the increasing prevalence of TB worldwide, spinal TB is a
significant healthcare issue,4 with the
1
Department of Orthopaedics, Chinese PLA General
Hospital, Beijing, China
2
Department of Orthopaedics, Zhejiang Provincial Corps
Hospital, Chinese People’s Armed Police Force, Jiaxing,
Zhejiang, China
3
Department of Orthopaedics, First Affiliated Hospital of
Chongqing Medical University, Chongqing, China
incidence of neurological complications
varying between 10% and 43%.1
The standard management protocol for
spinal TB is isoniazid, rifampicin and pyrazinamide chemotherapy for a minimum of
6 months.5–7 In addition, debridement of
diseased tissues is routinely performed via
Corresponding author:
Dr Jianfei Ji, Department of Orthopaedics, Zhejiang
Provincial Corps Hospital, Chinese People’s Armed Police
Force Jiaxing, 16 Nanhu Road, Jiaxing, Zhejiang 314000,
China.
Email: jianfee399@126.com
1396
an anterolateral extrapleural approach,8–11
transpleural anterior approach8,12,13 or posterior spinal fusion.14,15 Pre- and postsurgical debridement chemotherapy is commonly
employed.16
A review article suggested that surgery in
spinal TB is an incidental decision, with no
established protocol for the decision-making
process and few randomized controlled
trials regarding indications for surgery.17
Surgical intervention decisions are based on:
(i) patient age; (ii) presence of comorbidities;
(iii) location of bony loss; (iv) relative position of the compressive lesion with regard
to the dura, and density of the compressive
lesion; (v) number of segments involved; (vi)
kyphosis angle; and (vii) region of focal
infection,17,18 with the major contraindications being high cost and risk of postoperative complications.17 It is imperative
to perform surgery only if the outcome will
be more beneficial than treatment with
chemotherapy alone. The objective of the
current review of randomized controlled
trials was to compare the outcome of
chemotherapy alone or a combination of
surgery and chemotherapy in patients with
spinal TB.
Materials and methods
Data sources and searches
Computerized searches were performed to
identify randomized controlled human trials
listed in Ovid MEDLINEÕ (1970 – December
2012), Ovid EMBASEÕ (1974 – December
2012), SCOPUS (1996 – December 2012),
Web of ScienceÕ databases including Science
Citation Index ExpandedTM (1996 –
December 2012), Conference Proceedings
Citation Index – ScienceSM (1990 –
December 2012), Database of Abstracts of
Reviews of Effects (DARE) (Issue 3 of 4, July
2012), Cochrane Central Register of
Controlled Trials (CENTRAL) (Issue 3 of 4,
July 2012) and ClinicalTrials.gov (up to
December 2012). Both database-specific
Journal of International Medical Research 41(5)
controlled vocabulary and general free text
terms were used to maximize retrieval. MeSH
terms used were: Pott disease; tuberculosis;
spinal tuberculosis; tuberculous spondylitis;
medical management; chemotherapy; surgery;
surgical intervention; randomized controlled
trial. Hand searching of key article reference
lists was used to locate additional relevant
articles.
Assessment of methodological quality
Eligibility assessment and data extraction
were both performed independently in an
unblended standardized manner by two
independent reviewers (X.Z. and B.L.)
according to Critical Appraisal Skills
Programme (CASP) guidelines.19 The inclusion of all randomized participants in the
final analysis was evaluated and at least 60%
completeness of follow-up at each time point
was fixed as the threshold. The physicians
treating the patients were not blinded either
during treatment or follow-up. Scars were
visible on X-radiographs of patients
included in the studies used in the metaanalysis.
Data extraction, synthesis and analysis
The results of all searches were combined
and duplicate articles were removed.
Inclusion criteria were: (i) 1 year followup after initiation of treatment regimen; (ii)
confirmed diagnosis of active TB of the
thoracic and/or lumbar spine, including the
upper sacral vertebra S1; (iii) diagnosis
based on X-radiographs showing loss of
thin cortical outline and rarefaction of the
affected vertebral bodies; (iv) intervention
was chemotherapy alone or chemotherapy
plus surgery.
Statistical analyses
The outcomes (kyphosis angle, bone loss,
bony formation and neurological deficit) of
Zhang et al.
the collected manuscripts were synthesized
in piloted forms independently and in duplicate (X.Z. and B.L.) and formed the basis
for meta-analysis, which was performed
according to Cochrane Collaboration and
the Quality of Reporting of Meta-analyses
(QUORUM) guidelines.20 Odds ratios (OR)
were used to analyse all dichotomous outcome measures, and data were presented
with 95% confidence intervals (CI). The risk
of bias of each relevant article was assessed
using the 12 criteria recommended by the
Cochrane Back Review Group.19 Criteria
were scored ‘yes’ (criterion met), ‘no’ (criterion not met) or ‘unsure’ (not enough
information to make the decision). Articles
that met six of the 12 criteria were considered to have a low risk of bias. Potential
publication bias was tested using a funnel
plot. Data were compared using 2-test.
Statistical analyses were performed using
SPSSÕ version 18.0 (SPSS Inc., Chicago, IL,
USA) for WindowsÕ . P-values <0.05 were
considered to be statistically significant.
Results
The literature search identified 35 potentially relevant articles, of which 2816,21–47
were excluded (Table 1, Figure 1). In addition, a systematic review published in 2006
was identified,17 which analysed seven
papers reporting on two randomized controlled trials (total n ¼ 331) (Table 2).48–54
Both trials were initiated by the British
Medical
Research
Council
(MRC)
Working Party on Tuberculosis of the
Spine, with one performed in cooperation
with the Indian Council of Medical
Research (ICMR). These trials formed the
basis of the current analysis.
The characteristics of the study participants are summarized in Table 3. The
methods used to generate allocation
sequences were unclear in both trials, but
allocation concealment was adequate.
Completeness of follow up in the MRC
1397
1974 trial48,49 was adequate after 3 and
5 years (72% and 62%, respectively). In
the ICMR/MRC 1989 trial,50–54 follow-up
was adequate at 3, 5 and 10 years (83%,
82% and 78%, respectively). Analysis in the
both trials was by intention to treat.
Kyphosis angle was a primary outcome
measure in both trials. The mean kyphosis
angle was reported to be within the same
range at 18 months and at 3, 5 and 10 years
(Table 4), but it was not possible to assess
statistical significance in the present analysis
as standard deviations were not provided.
Deterioration in kyphosis angle >10 at
5 years had an OR of 1.02 (95% CI 0.41,
2.55) and 1.17 (95% CI 0.41, 3.29) in the
ICMR/MRC 1989 and MRC 1974 studies,
respectively. In ICMR/MRC 1989 at 10
years follow-up, a baseline kyphosis angle
of >30 deteriorated (increased) with a mean
of 10–30 .48–52 A subgroup effect was
reported in the chemotherapy group of the
ICMR 1989 trial, where patients aged <15
years (initial angle >30 ) had a mean deterioration of 30 compared with patients aged
>15 years (initial angle >30 ) who deteriorated with a mean of 10 (P ¼ 0.001).51,53,54
There were no statistically significant
between-group differences in the number of
patients with >10 deterioration at 3 years
(n ¼ 78, 1 trial) or 5 years (n ¼ 144, 2
trials).50–54
Both trials reported on the neurological
status of the participants. No participants
who were free from neurological deficit on
entry developed any deficit, and there were
no statistically significant changes over time
in the numbers of patients with neurological
deficit (n ¼ 23 at entry, n ¼ 23 at 18 months,
n ¼ 23 at 3 years and 20 at 5 years).48–54
There was no statistically significant difference between the intervention and control
at 18 months (n ¼ 261, two trials), 3 years
(n ¼ 262, two trials), 5 years (n ¼ 244, two
trials) and 10 years (n ¼ 156, one trial).48–54
There was no statistically significant difference between chemotherapy plus surgery
1398
Journal of International Medical Research 41(5)
Table 1. Characteristics of studies excluded from a review of the medical management of spinal
tuberculosis.
Study
Reason for exclusion
21
Bakhsh 2010
Guo et al. 201022
Fu et al. 200916
Park et al. 200723
Wang et al. 200724
Sai Kiran et al. 200725
Chadha et al. 200726
Kotil et al. 200727
Jain et al. 200428
Loembe 199429
MRC 197330
MRC 197331
MRC 197432
MRC 197633
MRC 197834
MRC 198235
MRC 198536
MRC 198637
MRC 199338
MRC 199839
Rajasekaran et al. 199840
Rajeswari et al. 199741
Seddon 197642
Upadhyay et al.
Upadhyay et al.
Upadhyay et al.
Upadhyay et al.
Upadhyay et al.
199343
199444
199445
199446
199647
Not randomized
Not randomized
Not randomized
Not randomized
Not randomized
Not randomized
Not randomized
Not randomized
Not randomized
Not randomized
No surgical group
No surgical group
All participants had surgery
No surgical group
All participants had surgery
All participants had surgery
No surgical group
All participants had surgery
No surgical group
No randomization for conservative or surgical treatment; two
locations, Korea (all chemotherapy without surgery) and
Hong Kong (all chemotherapy plus surgery)
No surgical group
Not a randomized controlled trial, poor methodological quality,
randomization method and concealment unclear
Description of several MRC studies, not a study itself
All participants had surgery
All participants had surgery
All participants had surgery
All participants had surgery
All participants had surgery
ICMR, Indian Council of Medical Research; MRC, Medical Research Council.
and chemotherapy alone on the presence of
bone loss at 18 months (n ¼ 256, two trials),
3 years (n ¼ 247, two trials), 5 years (n ¼ 236,
two trials), or 10 years (n ¼ 156, one trial)
(Table 5).48–54 It was not possible to assess
the statistical significance of data regarding
bone loss due to the absence of standard
deviations; however, the majority of bone
loss (vertebral destruction) was present at
the time of diagnosis with limited further
destruction occurring during treatment and
the subsequent follow-up period.48–54
Publication bias within the studies were
assessed both visually, using a funnel plot
(Figure 2), as well as the 12 criteria recommended by the Cochrane Back Review
Group19 (Figure 3). There was no evidence
of publication bias on the funnel plot, and
the number of criteria met was 9/12 in both
studies. All of the studies included in the
current meta-analyses were thus considered
to have a negligible risk of bias. None of the
included studies had an adequate description of withdrawals or drop outs (Figure 3).
Zhang et al.
1399
Figure 1. Schematic diagram of literature search performed in the current systematic review and metaanalysis of the management of spinal tuberculosis.
Discussion
The objective of this systematic review and
meta-analysis was to compare chemotherapy plus surgery with chemotherapy alone
for treatment of spinal TB. There was no
statistically significant benefit of routine
surgery, and surgery had no effect on
kyphosis angle. The incidence of progressive
kyphosis and the kyphosis angle at study
entry were high (>30 ) for all participants.48–54 Spinal surgeons generally consider kyphosis >30 to be unacceptably high
and an indication for surgical correction.18
The current review revealed no betweengroup difference in bony fusion, which is
often considered the best evidence of healing.46,47 Data on the speed of bony fusion
were not provided in either trial, and it was
therefore not possible to assess differences
130
201
MRC 197448,49
ICMR/MRC
198950–54
(i) Clinical and radiographic
evidence of tuberculosis of
any vertebral body from
the first thoracic to the
first sacral, inclusive, that is
excluding cervical and
sacral disease
(ii) Disease active clinically
and/or radiographically
(iii) Radiographically active
disease:
(a) loss of the thin cortical
outline, and
(b) rarefaction of the
affected vertebral bodies)
(iv) Availability for observation over a period of 3
years
Inclusion criteria
(i) Paraplegia or paraparesis
severe enough to prevent
walking
(ii) Active tuberculosis in a
lower limb requiring bed
rest
(iii) Management complicated
by pulmonary tuberculosis
(iv) Previous antituberculosis
chemotherapy for 12
months
(v) Serious nontuberculous
disease likely to prejudice
the response to treatment
or its assessment
(vi) Contraindication to
treatment methods
Exclusion criteria
ICMR, Indian Council of Medical Research; MRC, Medical Research Council.
n
Study
(i) Chemotherapy:
(a) adults 45 kg: 1 g streptomycin sulphate/day intramuscular injection for 3 months,
plus 300 mg isoniazid/day and
10 g para-aminosalicylate
sodium/day for 18 months
(b) children (<15 years old) and
adults <45 kg: 20 mg/kg
bodyweight streptomycin sulphate/day intramuscular injection for 3 months, plus 6 mg/kg
bodyweight isoniazid/day (max
300 mg) and 0.2 mg/kg bodyweight para-aminosalicylate
sodium/day (maximum 10 g)
for 18 months
Participants randomized to this
regimen or the same regimen
without the initial 3 months of
streptomycin
(ii) Chemotherapy plus surgery
(removal of all necrotic and
diseased tissue without
reconstruction)
(i) Chemotherapy –
isoniazid plus rifampicin (1 dose
daily for 6 months)
(ii) Chemotherapy plus surgery
(debridement and stabilization
with a bone graft
[reconstruction])
Interventions
Table 2. Characteristics of studies included in a review of the medical management of spinal tuberculosis.
(i) Kyphosis angle
(ii) Neurological deficit
(iii) Bony fusion
(iv) Absence of spinal
tuberculosis
(v) Death from any cause
(vi) Regained activity level
(vii) Change of allocated
treatment
Outcomes
1400
Journal of International Medical Research 41(5)
Zhang et al.
1401
Table 3. Characteristics of patients included in two randomized controlled trials comparing chemotherapy
and chemotherapy plus surgery for treatment of spinal tuberculosis.
Characteristic
MRC 197448,49
ICMR/MRC 198950–54
n
n at follow up
3 years
130
201
94 (47 in each group)
168 (85 in surgical group and 83
in chemotherapy group)
5 years: 164 (82 in each group)
5 years
80 (45 in surgical group and 35 in
chemotherapy group)
–
10 years
Agea
<15 years
15 years
Sexa
Involved vertebrae
1–2
>2
Location of lesions
Mean kyphosis angle at entry
Surgical group
Chemotherapy group
Mean total bone loss at entry, U
Chemotherapy group
Surgical group
Incomplete paraplegia on entrya
10 years: 156 (78 in each group)
16
78
52 male/42 female
63
105
Not given
70
24
Thoracic 39
Thoracolumbar 10
Lumbar 45
115
53
Thoracic/thoracolumbar 84
Lumbar/lumbosacral 84
27
24
29
29
0.7
0.8
12
1.0
0.8
11
Data presented as n of patients or mean (SD not available).
a
Includes patients available at 3-year follow up.
ICMR, Indian Council of Medical Research; MRC, Medical Research Council.
Table 4. Comparison of mean kyphosis angle in two randomized controlled trials comparing chemotherapy
and chemotherapy plus surgery for treatment of spinal tuberculosis.
MRC 197448,49
Parameter
Location of lesions
Kyphosis angle, entry
18 months
3 years
5 years
10 years
ICMR/MRC 198950–54
Chemotherapy
plus surgery
Chemotherapy
alone
Chemotherapy
plus surgery
Chemotherapy
alone
T1–S1
T1–S1
T1–L2
T1–L2
27
40
40
39
–
24
30
32
30
–
29
41
41
37
41
29
41
42
40
47
(continued)
1402
Journal of International Medical Research 41(5)
Table 4. Continued.
MRC 197448,49
Parameter
Increase in angle,
18 months
3 years
5 years
10 years
ICMR/MRC 198950–54
Chemotherapy
plus surgery
Chemotherapy
alone
Chemotherapy
plus surgery
Chemotherapy
alone
13 (n ¼ 40)
13 (n ¼ 40)
12 (n ¼ 34)
–
6 (n ¼ 33)
8 (n ¼ 33)
6 (n ¼ 24)
–
12 (n ¼ 34)
12 (n ¼ 34)
8 (n ¼ 34)
12 (n ¼ 28)
12 (n ¼ 42)
13 (n ¼ 42)
11 (n ¼ 45)
18 (n ¼ 41)
Data presented as mean (SD not available).
ICMR, Indian Council of Medical Research; MRC, Medical Research Council.
Table 5. Comparison of bone loss (U) in MRC 197448,49 and ICMR/MRC 198950–54 randomized controlled
trials comparing chemotherapy and chemotherapy plus surgery for treatment of spinal tuberculosis.
Deterioration, years
Trial
Intervention
Fraction
loss: start
3
5
10
Total bone
loss: 5 years
MRC 197448,49
Chemotherapy plus surgery
Chemotherapy
Chemotherapy plus surgery
Chemotherapy
0.8
0.7
0.8
0.95
0.2
0.1
0.3
0.4
0.3
0.1
0.3
0.5
0.2
0.0
0.3
0.5
1.0
0.7
1.1
1.45
ICMR/MRC 198950–54
ICMR, Indian Council of Medical Research; MRC, Medical Research Council.
Figure 2. Funnel plot of studies included in the current meta-analysis of randomized controlled trials
comparing chemotherapy and chemotherapy plus surgery for treatment of spinal tuberculosis. There was no
evidence of publication bias.
Zhang et al.
1403
Figure 3. Overall quality of the evidence for each outcome in studies included in the current meta-analysis
of randomized controlled trials comparing chemotherapy and chemotherapy plus surgery for treatment of
spinal tuberculosis (MRC 197448,49 and ICMR/MRC 198950–54). Quality was assessed using an adapted
GRADE approach, as recommended by the Cochrane Back Review Group.19 The quality of the evidence
for a specific outcome was based on the study design, risk of bias, consistency of results, directness
(generalizability), precision (sufficient data) and potential bias for the reporting of results across all studies that
measured that particular outcome. ITT, intention to treat.
during early phases of treatment. The
amount of bone is considered important
for the stability of the spine; as both studies
excluded patients with >3 U total bone loss,
the role of surgery in these more severe cases
could not be assessed. A small number of
participants had neurological deficit at study
entry, but there were no statistically significant between-group differences in the
improvement of this deficit. Deterioration
of neurological deficit or persisting deficit
with spinal cord compression can be an
indication for surgery,17 and a small group
of patients (n ¼ 5/130) in the chemotherapy
group required surgery to decompress the
spinal cord.48–52
The current analysis has several limitations, the most important of which is the
availability of only two relevant studies,
severely restricting the value of the metaanalysis findings. In addition, there was inadequate follow-up data for the MRC trial48,49
at any time point, and at 10 years in the
ICMR/MRC trial.50–54 Finally, both trials
were performed almost three decades ago and
their current clinical relevance is difficult to
determine given the advances in medical and
surgical management of spinal TB. It is
therefore imperative that randomized controlled trials are initiated to assess the benefits
of surgery in spinal TB in the current setting.
Several small-scale non-randomized studies
1404
have been performed more recently,21–47 but
the results of the present analysis suggest that
routine surgery cannot be recommended
unless within the context of a large, well
conducted randomized controlled trial.
Journal of International Medical Research 41(5)
7.
8.
Declaration of conflicting interest
The authors declare that there is no conflict of
interest.
Funding
9.
10.
This research received no specific grant from any
funding agency in the public, commercial or notfor-profit sectors.
11.
Acknowledgements
We thank everyone who helped with this study.
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