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)
2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Mequin: Atlantic)
All doses were supervised. |
|
Outcomes |
Not included in this review:
|
|
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. |