Skip to main content
. 2014 Jan 20;2014(1):CD010927. doi: 10.1002/14651858.CD010927

Ashley 2004b THA.

Methods Trial design: A RCT
Follow‐up: Temperature and blood smears daily until clearance of fever and parasites, then weekly attendance until day 63
Adverse event monitoring: Adverse events defined as signs or symptoms that occurred or became more severe after treatment started. A subset of 55 patients in the DHA‐P group had full blood counts, urea, electrolyte, creatinine and liver function tests at days 0 and 7. Thirty‐two patients from the DHA‐P group also had ECG monitoring before and after treatment.
Participants Number of participants: 355
Inclusion criteria: Age 1 to 65 yrs, symptomatic P. falciparum parasitaemia, informed consent
Exclusion criteria: Pregnancy or lactation, signs or symptoms of severe malaria, > 4% of red blood cells parasitized, contraindication to mefloquine, treatment with mefloquine in the previous 60 days
Interventions 1. DHA‐P, fixed dose combination (Artekin: Holleykin)
  • Total dose: 6 mg/kg DHA and 48 mg/kg P in 4 divided doses at 0, 8, 24, and 48 hrs


2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Mequin: Atlantic)
  • AS 4 mg/kg once daily for 3 days

  • MQ 8 mg/kg once daily for 3 days


All doses were supervised.
Outcomes
  1. Cure rate at day 63, PCR‐adjusted and PCR‐unadjusted

  2. P. vivax during follow‐up, and mean time to reappearance

  3. Gametocyte development during follow‐up

  4. Mean haematocrit at days 0 and 7

  5. Adverse events


Not included in this review:
  1. Fever clearance time

  2. Parasite clearance time

Notes Country: Thailand
Setting: Four clinics on the Thai‐Myanmar border
Transmission: Unstable low and seasonal transmission
Resistance: Multiple‐drug resistance
Dates: Jul 2002 to Apr 2003
Funding: Wellcome Trust of Great Britain
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The randomisation was computer generated (STATA; version 7; Statacorp)". Randomized in blocks of 9.
Allocation concealment (selection bias) Unclear risk "The treatment allocation was concealed in sealed envelopes labelled with the study code", unclear if these were sequentially numbered or opaque.
Blinding for microscopy outcomes (performance bias and detection bias) Low risk "Laboratory staff reading the blood smears had no knowledge of the treatment received".
Blinding for adverse events (performance and detection bias) Unclear risk No other blinding described.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Similar losses to follow‐up in all groups (12.8% DHA‐P versus 13.6% AS+MQ).
Selective reporting (reporting bias) Low risk All WHO outcomes reported.
Other bias Low risk No other sources of bias identified.