This seems super intriguing, but I noticed a few red flags (to me) and wondered if others might have better insight.
Low journal quality - The RCT is published in Medicines (published by MDPI, known predatory journal); the case study, Frontiers in Medicine (published by Frontiers, which while not necessarily predatory doesn’t have a stellar reputation). Given the results of the RCT, you’d think the authors would have tried for something more prestigious.
The authors of the RCT are employed by the manufacturers of ImmunoSEB and ProbioSEB. Major potential for conflict of interest.
The follow-up was 1 day after stopping treatment. How durable are these results? Absolutely no idea.
Those limitations alone weren’t enough to make me seriously doubt the credibility of the results. I’ve published in Frontiers journals; at least in my experiences there has been rigorous peer review - they aren’t out there publishing just anything. I’ve worked closely with investigators and sponsors with clear potential for conflict of interest who genuinely do want to follow the science where it leads regardless of its impact on their bottom line. Additionally, the actual methodology (as far as trial design and statistics is concerned; I can’t speak to disease-specific considerations) is solid, if old-school.
Then I got to the safety analysis.
I’m a clinical trials coordinator. I cannot believe that 200 people 4 to 87 days out from a Covid infection didn’t report *any* adverse events and didn’t miss *any* study drug for 15 days. I’ll grant that the trial was conducted under unusual circumstances (May-June of 2021), but this is unrealistic.
An adverse event (AE) is any untoward event negatively impacting the participant’s health during the study, regardless of whether they think it was caused by the study drug or not. Headaches count. Episodes of dizziness or lightheadedness count. Bruising. Straining your wrist, pulling a muscle, catching a cold. Either the study coordinators did not properly assess for AEs, the study doctors did not properly report AEs (“manifestations of the disease under study” are often up to study doctor discretion whether to report as an AE), or these participants just happened to be very lucky. Maybe I’m particularly unlucky, but every time I’ve had Covid, I had at least one headache per week for months afterward.
Then there’s the study drug compliance. I just… how. Maybe it’s the short study duration - it isn’t hard to stick to something for just 14 days. But to take medicine (within certain windows of eating or not eating) 3 times per day while dealing with brain fog… How do I get these people into my trials?? My patients forget to take the stop-itching pill or the let-me-breathe pill all the damn time. It’s not that they want to be non-adherent to their medications, they just have busy lives.
Another minor quibble: *all* vitals were within normal range? In patients recovering from Covid? Okay, sure.
Again, this kind of trial is outside my area of expertise, and I was not patient-facing during quarantine so maybe there are factors at play that I don’t understand. I also don’t know what barriers may prevent the study authors from publishing in more reputable journals. I *want* this to be a fast-acting, safe solution for lots of Long Covid and other chronic fatigue sufferers like myself. I just worry this is snake oil.
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