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. 2015 Jul 23;2015(7):CD000371. doi: 10.1002/14651858.CD000371.pub6
Methods RCT
Length of follow‐up: 36 weeks
Participants All children living in endemic area
Number analysed for primary outcome: 410
Age range: 0 to 11 months
Inclusion criteria: infants under 11 months of age in the local area
Exclusion criteria: not stated
Interventions Multiple doses vs placebo
  1. Anti‐Giardia (secnidazole every 4 weeks) and anthelminthic (albendazole every 12 weeks);

  2. Anti‐Giardia treatment only (secnidazole every 4 weeks) and placebo;

  3. Placebo and placebo.


Secnidazole: a 70 mg/mL suspension with about 0.5 g of sweetener was made up, and 0.5 mL per kg body weight was given by spoon. If the infant was sick immediately, secnidazole was re‐administrated.
Albendazole: a 200 mg (5 mL) suspension given by spoon.
Outcomes
  1. Haemoglobin (g/L) (endpoint week 36).


Not included in review:
  1. Height‐for‐age z‐score (endpoint week 36);

  2. Weight‐for‐age z‐score (endpoint week 36);

  3. Weight‐for‐height z‐score (endpoint week 36);

  4. Plasma albumin (g/L) (endpoint week 36);

  5. IgG (g/L) (endpoint week 36);

  6. Alpha‐1‐acid glycoprotein (g/L) (endpoint week 36);

  7. Giardia‐specific IgM titre (endpoint week 36);

  8. Lactulose/mannitol ratio (endpoint week 36);

  9. Prevalence ofGiardia‐specific IgM titre, % (week 0, 12, 24, 36);

  10. Prevalence of Giardia cysts, % (week 0, 12, 24, 36);

  11. Prevalence of Ascaris/Trichuris, % (week 0, 12, 24, 36);

  12. Prevalence of Intestinal mucosal damage, % (week 0, 12, 24, 36);

  13. Prevalence of Anaemia,% (week 0, 12, 24, 36).

Notes Location: Dhamrai Upazila, located 40 km northwest of Dhaka, Bangladesh.
Community category: 3. "Prevalences and intensities of geohelminths were consistently low throughout the intervention".
Drug source: Dhaka, Bangladesh (Essential Drugs Company Ltd for secnidazole; Square Pharmaceuticals Ltd for the secnidazole placebo; Opsonin Chemical Industries Ltd for albendazole; and UniMed and UniHealthManufacturing Ltd for albendazole placebo).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated.
Randomized on the basis of their age, sex, height‐for‐age, weight‐for‐age and weight‐for‐height z‐scores, socio‐demographic and economic data and presence of any parasitic infection.
Allocation concealment (selection bias) Unclear risk Unclear whether the allocation was concealed since patients were randomized by their characteristics.
Blinding (performance bias and detection bias) All outcomes Low risk Double‐blind.
"Bottles containing the two medications and placebo suspensions were labelled with different colours corresponding to the three intervention groups, but the assistants did not know the relationship between the colour codings and the contents of the bottles."
Incomplete outcome data (attrition bias) All outcomes Low risk 394/410 (96.10%) of randomized participants were evaluated.
"A total of 16 infants were excluded from the trial, as they had either moved away from the trial area (n = 12), or were absent during the trial period (n = 2) or the parents subsequently refused to participate (n = 2). Of the infants who completed the trial (n = 394), data on 96 infants was incomplete (ie they did not provide information for all the ten z‐scores and four intestinal permeabilities, serological variables and prevalences of parasite infections), and severe anaemic infants were also omitted from the trial". Inclusion of all randomized participants (number evaluable/number randomized): 96% (394/410).
Selective reporting (reporting bias) Low risk All stated outcomes reported.
Other bias Low risk No obvious other source of bias.