Protocol for prevention and treatment of dengue fever and its complications

Background : Dengue virus (DENV) currently infects 50-100 million people/year, causing about 500,000 cases of severe complications (dengue haemorrhagic fever; dengue shock syndrome) and 20-25,000 deaths. From USD 1.35 billions/year Brazil spends in dengue, USD one billion is allocated to the vector control programme. All attempts at control of the mosquito vector have systematically failed, and there is no specific treatment or vaccine currently available. Homeopathy has a long record of success in the treatment of epidemic diseases. Although recent experiences pointed to the possible efficacy of homeopathic prophylaxis and treatment in dengue, with low cost, satisfactory acceptance by the targeted population, and lack of adverse events, clinical trials reported controversial results.

Aim : To assess the effectiveness of homeopathic intervention in the prevention and treatment of dengue fever.

Study design : Multicentre study including Brazilian counties with high incidence and prevalence of DENV infection, and where primary healthcare staff include homeopathic doctors. Stage 1: Training of multi-professional staff and preparation of infrastructure. Stage 2: Selection of the epidemic medication by an expert panel based on the signs and symptoms exhibited by 20 confirmed cases. Stage 3–Prophylaxis: will include all 18-60 year-old individuals spontaneously visiting the participating centres; sample size: 500/group to detect minimum difference of .132 with α=.05, power=.8, 1:1 randomisation. Stage 4–Treatment: will include 18-60 year-old individuals with notified dengue, presenting with muscle pain and headache until disease day 3, and available for blood sample collection at the beginning and end of the study; sample size: 120/group; α=.05, power=.8; estimated effect=20%, 1:1 randomisation. Exclusion criteria: mental disorders, pregnancy. Exit criteria: disease complications. In Stages 3 and 4, the epidemic medication will be randomly administered to 50% of the exposed population; the other 50% will be given a placebo. Stage 3: 1 single dose of dilution 30cH. Stage 4: medication/placebo in dilution 30cH every 4 h for 2 days and every 8 h for 5 days. Both staff and volunteers will be blinded as to the treatment given. Variables: clinical; laboratory (CBC; NS1 antigen; IgM/IgG).

Outcomes : Stage 3: reduction of the number of dengue cases in the exposed population according to the study records and reports by governmental sanitary surveillance agencies. Stage 4: reduction of the intensity and duration of muscle pain and headache; use of analgesics (type and amount); number of days off work/other activities; end of fever; changes in risk grade (A to D).