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posted by martyb on Wednesday January 19, @10:36PM   Printer-friendly
from the it's-[almost]-all-in-your-head? dept.

More Than Two-Thirds of Adverse COVID-19 Vaccine Events Are Due to Placebo Effect:

The placebo effect is the well-known phenomenon of a person's physical or mental health improving after taking a treatment with no pharmacological therapeutic benefit – a sugar pill, or a syringe full of saline, for example. While the exact biological, psychological, and genetic underpinnings of the placebo effect are not well understood, some theories point to expectations as the primary cause and others argue that non-conscious factors embedded in the patient-physician relationship automatically turn down the volume of symptoms. Sometimes placebo effects can also harm –the so-called "nocebo effect" occurs when a person experiencing unpleasant side effects after taking a treatment with no pharmacological effects. That same sugar pill causing nausea, or that syringe full of saline resulting in fatigue.

In a new meta-analysis of randomized, placebo-controlled COVID-19 vaccine trials, researchers at Beth Israel Deaconess Medical Center (BIDMC) compared the rates of adverse events reported by participants who received the vaccines to the rates of adverse events reported by those who received a placebo injection containing no vaccine. While the scientists found significantly more trial participants who received the vaccine reported adverse events, nearly a third of participants who received the placebo also reported at least one adverse event, with headache and fatigue being the most common. The team's findings are published in JAMA Network Open.

"Adverse events after placebo treatment are common in randomized controlled trials," said lead author Julia W. Haas, PhD, an investigator in the Program in Placebo Studies at BIDMC. "Collecting systematic evidence regarding these nocebo responses in vaccine trials is important for COVID-19 vaccination worldwide, especially because concern about side effects is reported to be a reason for vaccine hesitancy."

Haas and colleagues analyzed data from 12 clinical trials of COVID-19 vaccines. The 12 trials included adverse effects reports from 22,578 placebo recipients and 22,802 vaccine recipients. After the first injection, more than 35 percent of placebo recipients experienced systemic adverse events – symptoms affecting the entire body, such as fever – with headache and fatigue most common at 19.6 percent and 16.7 percent, respectively. Sixteen percent of placebo recipients reported at least one local event, such as pain at site of injection, redness, or swelling.

In comparison after the first injection, 46 percent of vaccine recipients experienced at least one systemic adverse event and two-thirds of them reported at least one local event. While this group received a pharmacologically active treatment, at least some of their adverse events are attributable to the placebo – or in this case, nocebo – effect, as well given that many of these effects also occurred in the placebo group. Haas and colleagues' analysis suggested that nocebo accounted for 76 percent of all adverse events in the vaccine group and nearly a quarter of all local effects reported.

Journal Reference:
Julia W. Haas, Friederike L. Bender, Sarah Ballou, et al. Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials [open], JAMA Network Open (DOI: 10.1001/jamanetworkopen.2021.43955)

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  • (Score: 1) by Coligny on Thursday January 20, @02:44AM (3 children)

    by Coligny (2200) on Thursday January 20, @02:44AM (#1214034)

    On which country ?
    Because most consider omicron to be the tamest variant so far.

  • (Score: 5, Informative) by Mykl on Thursday January 20, @06:19AM (2 children)

    by Mykl (1112) on Thursday January 20, @06:19AM (#1214080)

    Yes, most agree Omicron is the least deadly. It still kills though, and there are FAR more people catching it. If it's half as deadly, but four times as many people get it, then it follows that about twice as many people will die. Stop thinking in individual data points and look at the bigger picture.

    This also ignores the issues associated with Long COVID, which remains a major issue.

    • (Score: 0) by Anonymous Coward on Friday January 21, @03:38PM (1 child)

      by Anonymous Coward on Friday January 21, @03:38PM (#1214509)

      Saying "it still kills" makes it sound scary, but could be misleading as it doesn't have any context!

      To try to determine a reasonable, personal response to the CoVid risk, I need solid info that is meant to inform me, not meant to try to manipulate me. This is lacking from most media sources (especially the older more traditional ones) and I am personally in favor of revoking their assigned radio and TV frequency ranges due to their no longer serving the role they promised to fill.

      Is anyone actually trying to help the average US resident make an informed response? I would like to see numbers of how many people are actually getting seriously ill from CoVid vs say a strong cold or mild flu. We know that there are people who are so close to death that anything going wrong will push them over the edge, so is CoVid actually creating a strong enough effect to make this a much large group?

      Is the vaccine relatively safe and if so, does the protection it provides significant enough to justify us paying for it and taking it? I personally believe it is safe (for most people - your doctor can help with this) and am a relatively high-risk individual, so have taken 3 doses of Moderna. As a high-risk person I take many medications and have actually read the side effect list that came with most of them. Those lists are pretty terrifying (many of them include death or other really bad things), so am not really too scared by reports of a tiny portion of people having issues with vaccines. What does scare me is the efforts to silence any negative reports and it makes reasonable people believe that there is something to hide. The ONLY way to overcome this is by being completely honest and allowing people who are nervous about it to voice their concerns and ask questions. This is not currently the case and there is a concerted effort going on to silence anyone who isn't spouting the approved message. What I don't know is if it is just arrogance ("I know better than those dumb rednecks") or if its something like corruption ("my producer said he'd pay me another $10,000,000 to say these lies.") My guess is both are occurring.

      • (Score: 2) by Mykl on Sunday January 23, @10:18PM

        by Mykl (1112) on Sunday January 23, @10:18PM (#1215113)

        I think what you're seeing from most of the medical profession and certainly the current administration is a frustrated response to the straight-out lies being told by the anti-vax side of the media (e.g. 2020/2021 Fox News, plus Newsmax, OAN etc).

        While it would be better to have a nuanced discussion about the pros and cons of the different vaccines available etc, that has unfortunately been made impossible by the noise generated by those who believe that the "Vaxx" contains 5G chips and is a conspiracy cooked up by Fauci and the Chinese Communist Party to bring down Amerika. What's also very prominent in my mind is the fear that people generally have of medical risks (I'm specifically thinking about the ongoing damage done by Andrew Wakefield when he invented the "vaccines cause autism" lie in order to personally profit from the fallout).

        I live in Australia, so I've seen a milder form of this. The local Murdoch press were predictably anti-vax at first, but most of their criticism was about our lockdowns being too harsh, rather than crazy conspiracy theories. We did have a vaccine that had some significant side-effects in the early days (AstraZeneca) - this was widely reported in most media in a fairly balanced way and the government decided to only make it available to older people (it still made sense for them due to the relative risk profiles of AstraZeneca and COVID). Now that supply of other vaccines (most notably Pfizer) has improved, the government has dropped AstraZeneca altogether.

        As of today, 92.9% of all people in Australia aged 16 and over are double-vaccinated. We've just turned the corner of the peak of Omicron cases at the moment (31,660 cases in the past 24 hours and 41 deaths), but I think this would've been far worse if we'd allowed conspiracy theories to spread unchecked.