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

Ashley 2004a THA.

Methods Trial design: A 3‐arm RCT
Follow‐up: All patients admitted to hospital for 28 days, oral temperature taken every 6 hrs, parasite counts 12‐hourly until negative then daily for 28 days
Adverse event monitoring: Adverse events defined as signs or symptoms that occurred or became more severe after treatment started. All patients had full blood counts, urea, electrolytes, creatinine, and liver function tests at days 0 and 7.
Participants Number of participants: 134
Inclusion criteria: Age > 14 yrs, weight > 40 kg, symptoms of malaria, 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, sulphonamides or 4‐aminoquinolones present in urine on admission.
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 28, all reappearances of parasites presumed to be recrudescences as patients hospitalized for duration

  2. Adverse events


Not included in this review:
  1. Fever clearance time

  2. Parasite clearance time

Notes Country: Thailand
Setting: Bangkok Hospital for Tropical Diseases
Transmission: Low transmission
Resistance: Multiple‐drug resistance
Dates: Jul 2002 to Apr 2003
Funding: Mahidol University, Tak Malaria Initiative Project, supported by Bill and Melinda Gates Foundation, 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 six.
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 loss to follow‐up in all groups (10.6% DHA‐P versus 11.9% AS+MQ).
Selective reporting (reporting bias) Low risk The WHO recommends 63 days follow‐up in studies of AS+MQ. Day 28 outcomes are likely to underestimate treatment failure with AS+MQ and DHA‐P.
Other bias Low risk No other sources of bias identified.