As of July 2023 we found no new information that would warrant any TOE grade changes
As of 4/12/21, we found 2 new preclinical studies in which bee venom injected into a specific acupoint called ST36 resulted in reduced markers of inflammation (Toxins 2015;7:846-858, Toxins 2015;7:2835-44) and improved motor neuron survival (Toxins 2015;7:846-858). These are by the same group as the previous studies we cited and have the similar methodological flaws. These do not warrant a change in our “Pre-Clinical” grade. We found no other new literature to warrant any grade changes. Of interest, a trial of bee venom in people with Parkinson’s disease was completed and showed no benefit (PLoS One 2016;11:e0158235). Our conclusion remains unchanged: we do not currently advise bee venom as a treatment for ALS.
Key Information
In our opinion, BV has biological effects that could potentially be useful in ALS. Two ALS-animal studies in which BV was injected into an unusual anatomic location showed positive effects on motor preservation and inflammatory markers; one showed improved survival. However, there are some significant problems with these animal studies. They do not meet methodological standards for preclinical animal research (14, 15) for the following reasons: treatment allocation was not randomized, power arguments are not presented, sample sizes are too small, potential confounders such as gender and copy number variation are not adequately addressed, criteria for determining symptomatic disease onset are not defined, blinding is not described, outcome measures in control animals are not compared to those in other studies to demonstrate external validity, and replication of results is via the same, rather than an independent group of authors. Furthermore, it is not currently possible to replicate pre-symptomatic drug delivery in humans with sporadic ALS. Many other compounds given pre-symptomatically to ALS-animals have failed to yield any positive benefit in human patients (16); indeed one immune-modulator that worked in ALS-animals actually appeared to accelerate disease progression in patients with sporadic ALS (17). It may not be possible to replicate the dosage of BV that was used in future human studies; by one estimate, for a 70g human this would require 70,000 bee stings twice a week (18). Finally and most importantly, we found very little data of any kind on BV exposure in humans with ALS; the two anecdotal reports describe unverified, non-overlapping benefits. Given all this, and the costs and risks of BV (which include death), ALSUntangled does not support the use of BV by patients with ALS outside of a study at this time. Replication of the animal studies via an independent group following published methodological guidelines and using a dosing regimen that could eventually be translated to human studies would be a reasonable next step.