As of September 21, 2024, we found no new studies that would warrant any TOE Grade Changes.
Since our previous review, a 16 patient, randomized, double-blind, placebo controlled trial of Penicillin G/Hydrocortisone was completed (Michael A. Van Es, Ruben P.A. Van Eijk, Tommy M. Bunte & Leonard H. Van Den Berg (2020) A placebo-controlled trial to investigate the safety and efficacy of Penicillin G/Hydrocortisone in patients with ALS (PHALS trial), Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, DOI: 10.1080/21678421.2020.1788093). While likely underpowered, this failed to show any benefit of this treatment on ALS progression. As a result of this, we change our “trials” grade from “U” to “F.” We change the last sentence of our conclusion to: “In light of the lack of a convincing mechanism and this negative clinical trial, we do not recommend that PALS take this expensive and risky combination of penicillin G and hydrocortisone.”
Key Information
In our opinion, there is no convincing evidence that GABA overload plays a role in ALS progression. PNG/HC has other theoretical mechanisms by which it could slow ALS progression, but previous human trials involving steroids and a trial of a b lactam with more potent effects on glutamate did not help. We have not been able to confirm the diagnoses, nor the improvements described in the case series of 3 PALS taking PNG/HC; however, even if these treatment effects were real, these improvements were transient and quickly became unresponsive to treatment. Unless the ongoing placebo-controlled trial shows objective and sustained clinical improvements, we do not recommend that PALS take this expensive and risky combination of penicillin G and hydrocortisone.
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