I listened to the Renegade Research webinar about an informal observational study on Truvaga and the forthcoming SIGNAL project (which is, as far as I can see, another informal observational study on Truvaga, but also the red-light therapy Vielight.
It was recorded and will be uploaded to the Renegade Research website
I was trying to do other things while listening, so there are a few gaps.
Rivka Solomon is part of Renegade Research. She says that she had a good response to Truvaga, she seems to be part of the reason it has been pushed so strongly. She noted that she has bought shares in the Truvaga company, only a small amount. For sure, she genuinely believes in the product. She thinks it has improved things for her by about 25% although it doesn't prevent crashes.
Tess Fallor of Renegade has also used it and was saying positive things.
There was this initial 'informal observational study'. 13 of the 20 people who started it completed the 5 week trial. 9/20 reported side effects.
Two participants in this study were on the webinar:
Giovanni reported that maybe he improved by 25% but he noted that some of the improvement might have been due to other things. When later asked if he was still using it, he said that he had used it a bit more through the lending library (that seems to give people free use for 3 months), but that he wasn't using it now. So, that would seem to suggest that Truvaga wasn't life-changing for him, or even worth the $500 less discount that a unit would have cost him.
Malcolm kept getting crashes and becoming irritable and so he discontinued use of the unit.
Both men were asked several times how it all was for them, and they said they enjoyed being part of the study. I try to keep an open mind about all sorts of treatments until there is evidence to discount them. I think these outcomes are pretty telling, as it seems Renegade Research tried to pick someone who was a 'responder' (Giovanni) and someone for whom it didn't work. Rivka apparently checked in with all the participants on the trial regularly, so I imagine there was some bias when the participants filled out the surveys - she so clearly wants people to be better on Truvaga. If you watch it, you will see the two men trying so hard to say positive things, and you can see Giovanni taking a breath before admitting that he's not still using Truvaga.
Jessica Maya of Solve ME spoke briefly and enthusiastically , saying SolveME was really really pleased to be funding the forthcoming SIGNAL project, praising the translational patient-centred approach.
Liisa Selin reported on immune cells changes. I missed whose blood was sampled, I think it was two people who did the Truvaga treatment for months, presumably responders? From the bit I saw, it seemed that some things went up in one person and went down in the other. If both felt that they were better at the end than at the beginning, it is possible that there was some natural improvement. Any good changes would not necessarily be due to Truvaga.
I didn't get the impression that Liisa thought that much of Truvaga. She said that she tried it herself, but she got severe muscle cramps and had to stop. However she said that she had been hypothyroid at the time. She felt that Truvaga alone would not be enough and it would need to be supplemented with another immunomodulator and an 'anti pathogen reagent' (?). She seems to be a fan of Inspiratol.
Liisa raised a concern about high blood pressure, due to noticing that blood pressure increases with it. Peter Staats, the Truvaga man, said that there had been a big trial in Europe in healthy people and that people with high blood pressure had seen it lower and that people with normal blood pressure had had no change. However, then people seemed to realise that they had to back peddle a bit, and there was suggestions of 'working with your doctor'. Tess Fallor said that maybe they would send a blood pressure cuff out with the device in the SIGNAL trial so that people could self-monitor.
Peter Staats noted that 'some of these companies' ...pause... tuts...'are fraudulent. There is no science behind what they say, just slick marketing.' He clearly believes in his product. He mentioned that he worries that there might be some interference with pacemakers, that worries him a bit. I wonder if Renegade had thought about managing that issue.
I asked two questions in the chat, neither of my questions were read out. One was about whether they had concerns about bias with that trial structure, and I mentioned the radically different results from the MitoQ trial that had one arm blinded with a placebo and another arm open label. Another one was whether they had concerns about promoting the product to desperate people before there was any proof that it works.
Like I say, neither question was acknowledged but at the end Rivka said that they wanted to be very clear that this webinar was not promoting Truvaga. I find that naive - even if it is not intended to be a promotion of the product, it absolutely was. You can't have people influential in the ME/CFS community saying that they have got much better with a product, without it increasing interest in the product. There was a question about a discount code, and Rivka said there was no public discount code yet, but that they are working on it. Peter Staat's closing remarks were that Truvaga is 'a wellness device and not a medical device' and people should work with their doctor. Liisa Selin said that different things work for different people.
So, yeah. The webinar served to make me more skeptical about Renegade Research's ability to carry out a research study ethically and effectively and more convinced that Truvaga is not useful. I'm concerned that a lot of people are confusing action with progress.
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