Evaluation and pharmacovigilance of projects promoting cultivation and local use of Artemisia annua for malaria.

BACKGROUND: Several non-governmental organisations (NGOs) are promoting the use of Artemisia annua teas as a home-based treatment for malaria in situations where conventional treatments are not available. There has been controversy about the effectiveness and safety of this approach, but no pharmacovigilance studies or evaluations have been published to date. METHOD: A questionnaire about the cultivation of A. annua, treatment of patients, and side-effects observed, was sent to partners of the NGO Anamed in Kenya and Uganda. Some of the respondents were then selected purposively for more in-depth semi-structured interviews. RESULTS: Eighteen partners in Kenya and 21 in Uganda responded. 49% reported difficulties in growing the plant, mainly due to drought. Overall about 3,000 cases of presumed malaria had been treated with A. annua teas in the previous year, of which about 250 were in children and 54 were in women in the first trimester of pregnancy. The commonest problem observed in children was poor compliance due to the bitter taste, which was improved by the addition of sugar or honey. Two miscarriages were reported in pregnant patients. Only four respondents reported side-effects in other patients, the commonest of which was vomiting. 51% of respondents had started using A. annua tea to treat illnesses other than malaria. CONCLUSIONS: Local cultivation and preparation of A. annua are feasible where growing conditions are appropriate. Few adverse events were reported even in children and pregnant women. Where ACT is in short supply, it would make sense to save it for young children, while using A. annua infusions to treat older patients who are at lower risk. An ongoing pharmacovigilance system is needed to facilitate reporting of any adverse events.

A clinical trial of the traditional medicine Vernonia amygdalina in the treatment of uncomplicated malaria.

BACKGROUND: The leaves of the shrub Vernonia amygdalina Del (Compositae) are widely used in Africa to treat malaria. It is widely available, accessible, and affordable in many remote areas that do not have ready access to modern medicines. INTERVENTION: This study examined the efficacy and safety of an infusion of fresh V. amygdalina leaves for the treatment of uncomplicated malaria in patients aged 12 years and over. OUTCOME MEASURES: The primary outcome measure was an adequate clinical response. The secondary outcome measure was incidence of adverse events, assumed to be side-effects of the medicine. RESULTS: The remedy was associated with an adequate clinical response (ACR) at day 14 in 67% of cases. However, complete parasite clearance occurred in only 32% of those with ACR, and of these, recrudescence occurred in 71%. There was no evidence of significant side-effects or toxicity from the medication. There was a trend toward a reduction in hemoglobin between day 0 and day 28, although this did not reach statistical significance. CONCLUSIONS: Further studies are needed to determine whether the efficacy can be improved by increasing the dose, changing the preparation, or adding other antimalarial plants.