Table 1 Summary of 15
included trials.
|
|
Age of children |
Clinical Question |
Patient Numbers |
SIGN 50 Grade |
Outcomes or Results (% of patients cured*) |
P Value / 95% CI |
Reviewers Comments & Assessment of Methodology
|
|
Hall et al. 1993 |
5-10 years |
Albendazole (MTZ) |
Phase1:
Albendazole 600mg:n= 103; Albendazole 400mgx3d:n= 116; Metronidazole: 375
mgx5d): n= 115 Phase
II: Albendazole 800mg:n= 114; Alb 400mgx 5 days: n= 115; Met: 375mg x 5d 115 Total of 768 children, with 678
cases of infection among 426 children. |
1++ |
Phase 1 ABZ 600mg: 62.1%; ABZ 400mg x
3d: 81.0%; MTZ 375mg x5d: 97.4% Phase 2 ABZ 800mg: 74.6; ABZ 400mg x5d:
94.8; MTZ 375 x 5d: 97.4% . |
All treatments
sig. different from each other:
p<0.05 except ABZ 400mg x 5 which p>0.05 than MTZ |
Excellent randomisation and
parasitology descriptions in methods. Very large study. 2 phase study,
retested with different doses. Not necessarily symptomatic children or
mono-infection. Followed up for 15 months. |
|
Dutta et al |
2-10 years |
400mg of ABZ daily as a single dose for 5d. or MTZ 7.5
mg/kg/dose x TDS x 5 day |
N=150 75:75 |
1++ |
97% cure rate for both ABZ and MTZ |
None given |
Patients described as attending
hospital, not clear if they are attending for GI symptoms or just enrolled
opportunistically. Excluded if acutely febrile. Multicenter Study Well designed trial let down by
its poor description of its parasitological methodology. |
|
Misra et al. India1995 [iii] |
2-12 yrs |
ABZ vs. MTZ |
N=64 32 in each arm |
1- |
All were clear (100%) within 7 days. But ABZ was (mean)
3.7 days (+/-1.4) and MTZ was 4.5 +/- 1.1 days). |
Not given |
Performed
on children who were not acutely unwell. Funded
by SmithKline Beecham |
|
Yereli et
al. 2004 |
3-15 yrs |
ABZ vs. MTZ |
N=107 52
ABZ, 55 MTZ |
1+ |
By day 14
90.4% of ABZ and 89.1% with MTZ cured No SEs
reported. |
P= 0.92 |
No SEs reported but methodology
to record them is not given. |
|
Pengsaa et al. |
7-15 yrs |
Comparison of ABZ/ Praziquantel (PZ); ABZ and Tinidazole
(TDZ) |
N=84 I: ABZ/PZ:31
II: ABZ:26 III: TDZ: 27 |
RCT 1+ |
I: 74.2%;
II: 50%; III: 92.6% SEs- two
cases of “severe” (i.e. needing treatment) were recorded with combined
treatment (abdominal pain). |
P=0.01 between all three. But P>0.05 between combined
treatment and either of the other two |
Directly observed therapy.
School children not hospital patients. |
|
Escobedo
2003 (B) |
2-15 yrs |
Chloroquine
(CQ) vs. ABZ vs. TDZ |
N=165, ABZ:60; TNZ:
55 and CQ: 50 |
RCT 1+ |
TDZ cure: 91%, CQ: 86% ABZ: 62%. ABZ significantly less effective than other two, which
were not significantly different from each other. |
TDZ vs. CQ p>0.05. ABZ vs both others p=<0.01 |
|
|
Canete et al.
(A) Cuba 2006 [vii] |
5-15 years |
1 day with 600mg of MBZ (200mg TDS) vs 50mg/kg of TDZ in a
single dose |
N=122 61 in each arm |
RCT 1+ |
MBZ 39 (64%) vs TNZ
50 (82%) |
None given |
|
|
Cañete et al. (B) 2006, Cuba [viii] |
5-15 yrs |
Mebendazole
vs. Quinacrine |
N=122 61 children in each arm |
RCT 1+ |
MBZ: 78.7% QC: 83.6%. |
p> 0.05 |
|
|
Sadjjadi, 2001, |
7-12 yrs |
Comparison of MBZ and MTZ |
50: 50 |
RCT 1- |
MBZ cure rate: 43/50 (86%); MTZ:
45/50 (90%). Using chi sq. no stat. difference found. Only MTZ had SEs. |
Not given |
School
children recruited rather than patients acutely presenting to health care
services. Concept
of blinding never addressed. |
|
Al-Waili et al. 1992, Iraq [x] |
3-13 yrs |
MBZ: 200mg TDS for 5 days vs. MTZ 200mg TDS for 5 days |
44
patients: 23 in MBZ and 21 with MTZ |
RCT 1- |
100% parasitological cure in both arms. Some mild SEs in
MTZ |
None given |
Very brief
report many details not given. Can’t read how many SEs and where took place
and how recruited not explained |
|
Bulut et al. 1996 [xi] |
6- 13 yrs |
Comparison of 1d mebendazole; 7d mebendazole, MTZ 7 days,
single dose ODZ |
Total 60:
17, 17, 15, 11 |
RCT 1- |
Group I: 41.7& (CI 6.2-77.2); II: 58.3%
(CI22.8-93.8); III: 92.6% (CI 74.4-100.0); IV: 100% (CI: 100) |
See left |
School
children recruited rather than patients acutely presenting to health care
services. |
|
Escobedo et al. 2003 (A) Cuba [xii] |
5- 15yrs |
MBZ vs Secnidazole (SCZ) |
N=146; 73 x 2 |
RCT 1+ |
MBZ 78.1%; SCZ 79.4%. |
P> 0.05 |
|
|
Rastegar-Lari e al Iran, 1996 [xiii] |
3- 14 yrs |
SCZ vs. MTZ |
N=52 27 SCZ: 27 and MTZ: 25 |
RCT 1+ |
SCZ: 100% cure, MTZ: 96% |
P = 0.41 |
Some
asymptomatic carriers included. |
|
Ortiz et al, 2001 [xiv] |
6- 11 yrs |
Nitazoxanide (NZN) vs. MTZ |
N=110: 55 in each arm. |
RCT 1+ |
NZN: 71% and MTZ: 75%. |
P>0.83 95% CI:
-20.1%-12.6% |
Intention
to treat analysis included. Funded by Romark Laboratories, (inventors of
Nitazoxanide). |
|
Talari et al., 2006, |
5-12 yrs |
MTZ vs. Furazolidone (FLD) |
62 MTZ, 60 FLD
(120 total) |
RCT 1- |
MTZ 87% , FLD 81.7% parasite free at 4 weeks |
Not given |
Concept
of blinding never addressed. |
