ALSUntangled systematically reviews alternative and off label treatments (AOTs) to try and help patients with ALS make more informed decisions about them. The basic structure of all our reviews revolves around a “Table Of Evidence”. In this, each AOT is graded across 5 different categories: mechanistic plausibility, preclinical models, cases, trials and risks. Grades in each category range from A (best) to F (worst), with U meaning we could not find any useful disclosable evidence for the AOT in that category. Final grades are crowd-sourced across an international team of more than 100 clinicians and scientists from across 11 different countries.
There are many alternative and off label treatments (AOTs) advertised for ALS on the Internet. Internet information about AOTs is not always accurate. In order to help patients and families make more informed decisions about Internet AOTs, we started ALSUntangled in 2009. This paper describes our original background and methodology.
To try and make our reviews as objective as possible, we created a structure called the Table of Evidence. Each AOT is examined across 5 different categories: Mechanistic Plausibility, Pre-Clinical, Cases, Trials and Risks. Within each category, we assign a letter grade based on the strength of the evidence we find. Grades range from A (best) to F (worst). We assign a grade of U when we cannot find any useful disclosable information for an AOT in a particular category.
Ten Red Flags
To try and help patients considering AOTs we have not reviewed, we applied our experience from years of training, caring for PALS, and ALSUntangled writings to construct and crowd-source a list of 10 things to be wary of. In our opinion, all of the things on this list are problematic, and they tend to be associated with treatments we assigned lower grades to. The more of these “ten red flags” patients find associated with an AOT, the more wary we think they should be.