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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: 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.

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