Post

1) 🇨🇦 The results of Luis Nacul's trial of low-dose naltrexone (LDN) have been published. Unfortunately, it shows that LDN didn't improve fatigue, pain and other symptoms in patients who developed ME/CFS after COVID-19. A brief breakdown of the main results. 👇

2) The trial enrolled 160 participants with what they call "Post-COVID-19 fatigue syndrome (PCFS)." Patients met the 2015 Institute of Medicine ME/CFS criteria, except that symptoms were required to follow COVID-19 and to have lasted at least 3, rather than 6 months.

3) Participants received placebo or LDN for 16 weeks. LDN was given orally, starting at 1 mg daily and increasing to 4.5 mg as tolerated. The drug was relatively safe but there were more grade 3 or higher adverse events with LDN and ca. 25% weren't able to build up to 4.5 mg.

5) The trial includes several other outcomes such as pain (VAS), post-exertional malaise (PQSymp-12), quality of life (EQ-5D-5L), activity levels (steps per day measured over 7 days with a pedometer). None of these showed an effect.

6) They also included several physical assessments such as POTS, orthostatic hypotension, handgrip strength and a sit-to-stand test for physical fitness. These showed no significant difference either.

7) Overall, this looks like a clear null result. The authors write: "our results contrast with suggested benefits of LDN in open uncontrolled studies in Long COVID or ME/CFS and the broad support for its use by clinicians and patients internationally."