a meta-analysis of the efficacy of albendazole c
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8/19/2019 A meta-analysis of the efficacy of albendazole c
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http://localhost/var/www/apps/conversion/tmp/scratch_7/dx.doi.org/10.1016/j.actatropica.2015.09.023mailto:escobedo@infomed.sld.cuhttp://crossmark.crossref.org/dialog/?doi=10.1016/j.actatropica.2015.09.023&domain=pdfhttp://www.elsevier.com/locate/actatropicahttp://www.sciencedirect.com/science/journal/0001706Xhttp://localhost/var/www/apps/conversion/tmp/scratch_7/dx.doi.org/10.1016/j.actatropica.2015.09.023
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122 A.A. Escobedo et al. / Acta Tropica 153 (2016) 120–127
2.3. Study selection and data extraction process
A spreadsheet recorded data on: study design, randomization
method, andparticipant numbers by treatmentarmand sex, pres-
ence of signs and/or symptoms at diagnosis, diagnostic method
used to assess parasitological cure, follow-up times, and par-
asitological cure frequencies. Data from included studies were
abstractedby two authors (A. A. E. and P.A.),whereas other author
(J.B.) checked the data extracted. Anydiscrepancywasresolved by
discussion between the authors, until a consensuswas reached to
ensure that accurate data were obtained.
2.4. Outcome
The outcome measure was parasitological cured (defined as
above)at the endof the treatmentin at least two consecutive faecal
microscopic examination performed at the last follow-up.
2.5. Evaluation of study quality
The assessment of the internal validity of the clinical trials was
performed using the risk of bias tool of the Cochrane Coopera-
tion (Higgins et al., 2011), and the overall quality of the evidence
gathered was assessed by the GRADE guidelines (Balshem et al.,
2011). Thequality of parasitological diagnosticmethods was sepa-
rately assessed by the scoring systemutilised by Zaat et al., (1997)
and Solaymani-Mohammadi et al., (2010). This method evaluates
whether techniques are sufficiently described and adequate.
2.6. Analysis
Meta-analysis wasused to calculate thepooledestimatesof thetreatmentefficacy, comparing TNZvs ABZ. Weused the I 2 index to
estimate the proportion of total variability in point estimates that
could be attributed to between-trials heterogeneity, rather than
by a chance (Higgins et al., 2003). The relative risk (RR) was the
effect size to analyze with values >1meaning TNZ was better than
ABZ.Individualeffect sizeswere combinedby theMantel–Haenszel
methodusinga randomeffectsmodel and a predictive RR estimate
was obtained (Higgins et al., 2009).
Sensitivity analysis was performed to assess the consistency
of the overall findings on the magnitude of the effect when trials
were removed – one at the time – from the full analysis set. This
would also allow us to check the impact of excluding the trial that
utilised themostinsensitive parasitologicalmethods, i.e. direct fae-
cal microscopy with brine flotation technique employed (Chan delPinoetal., 1999). Thelattermethod,unlike theethersedimentation
methodusedin the rest of studies, is just a concentrationtechnique
for the diagnosis of intestinal helminth infections, not for intesti-
nalprotozoa(GarcíaandBruckner,1993).Asensitivityanalysiswas
also performedwiththe two articleswith follow-uplonger than 14
days (Chandel Pinoet al., 1999; Mendoza et al., 2003), considering
that faecal specimens – at least in endemic countries – should be
obtained during the first 12 days after completion of therapy (the
number of days needed for a Giardia infection to become patent)
( Jokipii and Jokipii, 1977).
Asmallstudybias analysiswasplannedonlyincasewe retrieved
an appropriate number of studies for themeta-analysis (about10).
All analyses were performed with the R package (R Core Team,
2014) using the meta library (Schwarzer, 2014).
Fig. 1. Flow chart of study selection.
3. Results
3.1. Study selection
The review process is shown in Fig. 1 and the selected papers
meeting the inclusion criteria are summarised it Table 1.
3.2. Study characteristics
Oursearchidentified5RCTswhichcomparedABZwithTNZ,rep-
resentinga total of 423 childrenwithGiardia infection included for
thecurrentreview (ChandelPinoetal., 1999;Mendoza et al., 2003;
Pengsaa et al., 1999, 2002; Escobedo et al., 2003). Trialswere pub-
lished between 1999 and 2003. One trial was conducted in Peru;
two were conducted in Thailand and the other two in Cuba, all
of them are countries where Giardia infection is endemic. At the
last follow-up visit, 220 and 203 children were evaluated for ABZ
and TNZ, respectively. All studies were open label trials with ran-
dom allocation of children to ABZ or TNZ. TNZ was prescribed at
a single 50mg/kg dose. However, the dosages of ABZ ranged from
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Table 1
Characteristicsof the randomised controlled trials included in themeta-analysis.
Author, year (country) Study design No. of randomised participants Age (y) Sex(M/F) Disease
characteristics
Diagnostic test Antigiardi
regimens
(No. of
participan
Chan del Pino (1999)
(Peru)
Open-label, RCT
5 parallel arms
79 3–13 NS Symptomatica Directwet mount
and brineflotation
techniques
ABZ, 400m
days (17)
TNZ,50m
Pengsaa (1999)
(Thailand)
Open-label, RCT
2 parallel arms
131 3–15 71/73 Symptomatic and
asymptomatic
Directsmear in
0.9% salineand
ether
sedimentation
method
ABZ, 400m
days (68)
TNZ,50m
2g) s.d. (6
Pengsaa (2002)(Thailand)
Open-label, RCT3 parallel arms
84 7–15 NS Symptomatic Direct smears andiodine stained after
ether-
sedimentation
concentration
ABZ, 800m(26)
TNZ,50m
2g) s.d. (2
Mendoza (2003)
(Cuba)
Open-label, RCT
2 parallel arms
92 2–5 47/45 Symptomatic and
asymptomatic
Directwet mount
andafter formol
ether
sedimentation
ABZ, 400m
days (49)
TNZ,50m
2g) s.d. (4
Escobedo (2003)
(Cuba)
Open-label, RCT
3 parallel arms
165 2–15 58/57 Symptomatic Direct wet mount
andafter formol
ether
sedimentationtechniquemethods
ABZ, 400m
days (60)
TNZ,50m
2g) s.d. (5
a As childrenwere included after a screeningmaybe some of them could be asymptomatic.
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124 A.A. Escobedo et al. / Acta Tropica 153 (2016) 120–127
Table 2
Parasitological quality of included studies.
Study Parasitological examination
Description Adequate Repeated Interobserver variation Totalb
Chan del Pino etal. (1999) 2 0 3 0 5
Pengsaa et al. (1999) 2 3 3 0 8
Pengsaa et al. (2002) 2 3 3 0 8
Mendoza et al. (2003) 2 3 3 0 8
Escobedo et al. (2003) 2 3 3 0 8
b Range0–15; 15 indicates optimal laboratory technique.
Fig. 2. Forestplot showing theeffects of albendazole and tinidazole in giardiasis in children.
800mg given as a single dose (Pengsaa et al., 2002) to 400mg/d
for 5 consecutive days (Chan del Pino et al., 1999; Mendoza et al.,
2003; Escobedo et al., 2003). In 2 studies, children included have
both symptomatic and asymptomatic Giardia infections (Pengsaa
et al., 1999; Mendoza et al., 2003); other 2 studies included only
symptomatic children (Pengsaa et al., 2002; Escobedo et al., 2003);
the other study also included symptomatic children; however,
according to thetest used to include childrenaftera parasitological
screening, it is possible that some children could be asymptomatic
(Chandel Pino et al., 1999). Follow-up periods ranged from7 to 21
days (ChandelPinoet al., 1999;Mendozaet al., 2003;Pengsaa et al.,
1999,2002;Escobedoet al.,2003). Lossoffollow-updidnotoccur in
3studies(Mendozaetal.,2003;Pengsaa etal.,2002;Escobedoet al.,
2003), whereas 2 studies reported withdrawals and/or dropouts
(Chan del Pino et al., 1999; Pengsaa et al., 1999) (Table 1).
3.3. Parasitological examination
In all studies, the absence of detectable Giardia trophozoites
and/or cysts in the faecalmicroscopy during the follow-up period
was required to declare the children cured. The mean score on our
parasitological quality index was 7.4 (range 5–8) out of a maxi-
mumof 15,indicating amodestquality (Table 2). Four trials scored
8 points, mainly due to the relatively great weight of the item
‘repeatedexaminationsat follow-up’. Inter-observer variation was
notdescribed inany trial.In 4 studies, thediagnosis of Giardia infec-
tion was based on direct faecal microscopy in combination with
etherconcentrationtechnique (Mendoza etal., 2003;Pengsaa etal.,
1999, 2002; Escobedo et al., 2003), and the remaining study (Chan
del Pino et al., 1999) used direct faecal microscopy in combina-
tion with brine flotation technique, which is not specific for the
diagnosis of intestinal protozoa.
3.4. Meta-analytical results
In all ABZ dosage subgroups, TNZ significantly outperformedABZ (see forest plot in Fig. 2). The overall RR estimate was 1.61
(95% CI: 1.40, 1.85) P
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A.A. Escobedo et al. / Acta Tropica 153 (2016) 120–127 125
Table 3
Influential analysis (random effects model).
Study omitted [Ref.] RR 95% CI P value
Chan del Pinoet al. (1999) 1.65 [1.42; 1.91]
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