Objectives. The emergence of drug-resistant lice has created the need for new therapies. This study assesses a new method without neurotoxins, extensive household cleaning, or nit removal.
Methods. One hundred thirty-three subjects participated in 2 open clinical trials. In the first trial, 93 subjects completed treatment using a nontoxic, dry-on, suffocation-based, pediculicide lotion, minimal household cleaning measures, and physical removal of the nits. In the second trial, 40 subjects completed treatment using an identical protocol except that the nits were not removed. Head lice infestation was defined as a wet combing test showing lice. Cure was defined as a wet combing test showing no lice, with an absence of symptoms. Subjects were contacted 6 months later, for assessment of their disease status.
Results. Cure was achieved for 97% of the patients in the first trial and 95% in the second trial. Remission at the follow-up assessment was reported for 77 of 82 subjects (94%) in the first trial and 36 of 38 subjects (95%) in the second trial. There was no statistical difference in cure rates or remission rates between the protocols with and without nit removal. The overall cure rate was 96%, with a remission rate of 94%. There were no adverse effects.
Conclusions. Dry-on, suffocation-based, pediculicide lotion effectively treats head lice without neurotoxins, nit removal, or extensive house cleaning. These results are comparable or superior to the results previously reported for treatments with permethrin, pyrethrin, and malathion.
Comments
Response to Dr. Aronson�s Comments
I thank Dr. Aronson for her interest in this article and welcome her concerns about its design. I think her point about the next step being a well controlled trial is an excellent idea.
I would offer the following responses to concerns:
1) Placebo controlled trial: My local county health department expressed quite understandable concerns about such an experimental design. To first prove that all the kids have head lice, then knowingly give half the kids a sham therapy knowing that these kids will continue to go to school and expose other kids to contagious lice, was untenable. Thus I did an open clinical trial in which all the subjects were treated.
2) Wet combing test: This design did not cure patients by the first wet combing test alone. Lice were noted in the subjects' subsequent wet combing tests. Furthermore Roberts et al showed that when wet combing is done twice a week for several weeks you only get a 38% cure. (Roberts RJ, Casey D, Morgan DA, Petrovic M. Comparison of wet combing with malathion for treatment of head lice in the UK: a pragmatic randomized controlled trial. Lancet. 2000; 356:540-544.)
3) "...in fact not have been infested at the time of this treatment" We know subjects were infested at the time they started treatment because they first had a positive wet combing test.
4) "...suffocation of insects is hard to achieve since many can use anaerobic metabolism for extended periods": I am aware nits may have an anerobic metabolism for perhaps the first 2 days of gestation, however I have not heard this for nymph and adult phase lice. In in vitro studies, lice kept in dried on suffocation pediculicide greater than 6 hours never survived.
5) "...the same procedures without the Nuvo lotion to be more certain that the results are valid": In the absence of Nuvo lotion, the only procedure in this trial which might kill lice would be the heat from the hair dryer. However, many of these kids before entering the trial had routinely used hair dryers but still had head lice. It is known that it requires a 140 degree dryer temperature in the clothes dryer to kill lice. This temperature cannot be reached on the child's head because it would burn them.
Sincerely, Dale Pearlman, MD
Don't jump to use this remedy for lice
It would be helpful to have an independent collaboration of the claims made in this article, rather than the inventor's un-blinded, non- randomized trial of his product. It sounds at least as promising as many other claims touted without verification -- claims that later proved bogus. Among the troublesome elements in this study are the lack of double blind application of the remedy and a placebo; entry into the study using the wet combing test may have removed the lice; patients had been subjected to other treatments and were considered resistent to treatment, but may have had other reasons for treatment failure or in fact not have been infested at the time of this treatment; suffocation of insects is hard to achieve since many can use anaerobic metabolism for extended periods. Eight hours may be enough and the method (application for 8 hours with blow-drying of hair, personal object delousing including hair brushes and bedding) may work. We need an independent, randomly assigned, controlled trial involving the same procedures without the Nuvo lotion to be more certain that the results are valid.