ΚΛΙΝΙΚΕΣ ΜΕΛΕΤΕΣ

1. Hebrew University - Hadassah Medical School and Hadassah University Hospital, Jerusalem, Israel

STUDY RESULTS REPORTED IN MEDICAL JOURNAL: 1st Med Assoc. Journal, 2002Oct; 4(10): 790-3,”The in vivo pediculicidal efficacy of a natural remedy”; Mumcuoglu KY, Zamir C, Zentner G., Helbin V., Ingber A.

ABSTRACT:

Background: Head louse infestations are prevalent worldwide. Over the past 20-25 years, 15-20% of all children in Israel between 4 and 13 years of age have been infested with head lice. This is mainly due to the existence of ineffective pediculicides on the market.

OBJECTIVE:

To examine the pediculicidal efficacy and safety of a natural remedy and to compare it in an open clinical study with a known pesticide spray.

Method: The natural remedy, which contains coconut oil, anise oil and ylang ylang oil, was applied to the hair of infested children three times at 5 day intervals. Each treatment lasted for 15 minutes. The control pediculicide was a spray formulation containing permethrin, malathion, piperonyl butoxide, isododecane and propellant gas, which was applied twice for 10 minutes with a 10 day interval between applications.

Results: Of 940 children, aged 6-14 years, from six schools in Jerusalem who were examined for head louse infestation, 199 (21.2%) were infested with lice and eggs, while 164 (17.4%) were infested only with nits. Altogether, 119 children were randomly treated with either the natural remedy or the control product.

Treatment was successful:

with the natural remedy in 60 children (92.3%)

with the control pediculicide in 59 children (92.2%)

There were no significant side effects associated with either formulation

Conclusions:

The natural remedy was very effective in controlling louse infestations under clinical conditions and caused no serious side effects


2. Conducted at: Medical Entomology Center, Cambridge, UK

STUDY RESULTS REPORTED IN MEDICAL JOURNAL:

Eur. J. Pediat. April 2009, ”Clinical trial showing superiority of a coconut and anise spray over permethrin 0.43% lotion for head louse infestation, ISRCTN96469780”; Ian F. Burgess, Elizabeth R. Brunton, Nazma A. Burgess

ABSTRACT:

Permethrin is the most widely used pediculicide, but evidence of resistance from several countries and anecdotal reports from Germany suggest that permethrin lotion is now less effective. We designed a randomized, controlled, parallel group trial involving 100 participants with active head louse infestation to investigate the activity of a coconut and anise spray and to see whether permethrin lotion is still effective, using two applications of product 9 days apart.

The spray was significantly more successful(41/50, 82.0%) cures compared with permethrin (21/50, 42.0%; p<0.0001, difference 40.0%, 95% confidence interval of 22.5% to 57.5%). Per-protocol success was 83.3% and 44.7%, respectively.