Trial Report Beneficial Effects on Exercise Capacity Associated with a Combination of Lactoferrin, Lysozyme, Lactobacillus, Resveratrol, Vitamins…, 2024, Marra+

SNT Gatchaman

SNT Gatchaman

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Beneficial Effects on Exercise Capacity Associated with a Combination of Lactoferrin, Lysozyme, Lactobacillus, Resveratrol, Vitamins, and Oligoelements in Patients with Post-COVID-19 Syndrome: A Single-Center Retrospective Study
Marra, Alberto Maria; Giardino, Federica; Anniballo, Andrea; Ferazzoli, Simona; Salzano, Andrea; Arcopinto, Michele; D’Assante, Roberta; De Mare, Andrea; Esposito, Giorgia; Saldamarco, Lavinia; Rurgo, Sara; Sarnelli, Giovanni; Cittadini, Antonio

BACKGROUND AND OBJECTIVES
Although long-term COVID-19 symptoms are common, little is known about the management of post-COVID-19 condition. The aim of the current report is to evaluate the effects of a combination of lactoferrin, lysozyme, lactobacillus, resveratrol, vitamins, and oligoelements (PIRV-F20®) on the exercise capacity of post-COVID-19 patients.

METHODS
A retrospective analysis of consecutive patients referred to a specific outpatient clinic dedicated to post-COVID-19 condition from April 2022 to April 2023 was conducted. Subjects of both sexes, aged ≥18 years, with previous COVID-19 in the preceding 12 months, persistent symptoms consistent with post-COVID syndrome, and initial exercise impairment were included. Exclusion criteria were as follows: active cancer, end-stage conditions, severe musculoskeletal conditions, or patients with a history of limited functional capacity, pregnancy, or breastfeeding. Patients who reported having taken PIRV-F20® for at least 6 weeks were compared to patients who refused this treatment. Six-minute walking distance was the primary endpoint.

RESULTS
Forty-four patients (56.8% women, aged 49.1 ± 18.1 years) were included in the study. The group of patients who reported having taken PIRV-F20® exhibited a significant improvement of 6MWD (median: +40 m; IQR: 10–65 m, p vs. baseline: 0.02), which was significantly superior (p: 0.01) when compared to the controls (median: +10 m; IQR: −5–30 m). No differences were found with regard to muscular strength, echocardiographic parameters, and perception of symptoms.

CONCLUSIONS
Post-COVID-19 individuals who reported having taken PIRV-F20® for at least six weeks showed a significant improvement in exercise capacity. This finding should be confirmed in larger, prospective, randomized controlled trials.

Link | PDF (Journal of Clinical Medicine) [Open Access]
 
We performed a retrospective observational chart analysis of patients referred to a specific outpatient clinic dedicated to post-COVID-19 syndrome comparing individuals who reported having taken PIRV-F20 ® to subjects who refused such treatment.
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Not well matched for age, BMI, hypertension, although parameters worse in controls who refused the treatment.
 
The group of individuals who reported having taken PIRV-F20 ® exhibited a statistically significant difference (p = 0.02 vs. 0.20) in terms of 6MWD after the treatment, expressed as mean ± standard deviation (342.1 ± 56.8 at T0 vs. 389.3 ± 77.3 at T1 compared with 384.5 ± 17.9 at T0 vs. 396.9 ± 39.6 for the control group)—see Figure 2—and the difference in the T1-T0 of the 6MWD between the two groups (p = 0.01) was represented as median and interquartile range (median: +40 m and IQR: 10–65 m for the group of individuals who reported having taken the treatment vs. median: +10 m and IQR: −5–30 m for the control group).
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This may be statistically significant, but I think it's clinically negligible. 389m is still below healthy (even elderly healthy). I think all this study might be showing is that people inclined to try the therapy may be more prepared to push themselves.
 
SNT Gatchaman said:
Not well matched for age, BMI, hypertension, although parameters worse in controls who refused the treatment.
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Using those who refused the treatment isn't the same as having a control - they don't make it actually clear, but it seems the 'refused' is actually those who reported they didn't take it?. I initially thought as a patient that if I was feeling more unwell at a point in time ie on a downward trajectory it might make me more or less likely to try something depending on what it is, particularly as I know I might be 'more sensitive' to certain things (than I am normally) on the other hand if it was risk free ie wouldn't do any real harm but might have benefit then whether I give it a go might also relate to things like access - is it hard to get hold of etc.

I had a look up to see what it is and it seems to be a long list of trace minerals and I wonder whether there is another issue in the 'refusers' - I could only look up the general oligominerals for detail but it makes me wonder what the source is of some of these, particularly if any subjects were vegetarian or vegan.

Anyway, a retrospective that I don't know whether all the other listed 'treatments' were also optional, and due to clarity might actually just be that they didn't complete the course rather than 'refused to try' - but interestingly focussing on the 6min walking test as the measure. Yet none of the other measures, like cardio measures, were statistically different.

Is there something to be said for them benefitting from the fact that if someone feels they are on an upward trajectory, and these things aren't causing side effects, being provided for free and are no hassle to get means 'if I'm doing well I guess I might as well keep taking them in case' - as at least they probably aren't doing any harm if I'm doing a bit better than I was.

Whereas if you realise that you are getting worse, ie on a downward trajectory at any point then, particularly where it seems these things are optional, then you'd basically stop bothering. Or even stop in case they were making things worse. Or because for example you had more nausea and could stand fewer things.

So is this reverse cart-before-horse? I can't tell if it is utilising the same or the opposite of the Krypton factor drop-out that getting a load of people with chronic fatigue to do GET did for filtering out the most ill so the group left all had apparently better averages.


But my point is, isn't it a pretty natural inclination that if you start feeling worse then you at best are probably going to think that the combination of whatever you are taking isn't helping you - so was it 'refused' from the start? Or was it 'didn't complete'?
 
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