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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: 5, Informative) by rigrig on Thursday January 20, @12:53AM (5 children)

    by rigrig (5129) Subscriber Badge <> on Thursday January 20, @12:53AM (#1214014) Homepage

    Placebo group: 35% has adverse effects, so they assume 35% of all people suffer from the placebo effect, as it doesn't depend on what's in the needle.
    Vaccine group: 46% has adverse effects, leaving 11% not caused by the placebo effect.

    So for the vaccinated group: 35%/46% = 76% was caused by the placebo effect.

    That calculation is a bit wonky: it ignores people affected by both mechanisms, but two-thirds is definitely in the right ballpark.

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  • (Score: 1, Troll) by ChrisMaple on Thursday January 20, @01:21AM (1 child)

    by ChrisMaple (6964) on Thursday January 20, @01:21AM (#1214019)

    There's a need for at least 2 more "placebo" groups. One stuck with a needle but receiving no injection, and another with no medical activity whatsoever.

    • (Score: 0) by Anonymous Coward on Friday January 21, @12:56AM

      by Anonymous Coward on Friday January 21, @12:56AM (#1214412)

      I agree. The latter would be quite defective at being a placebo.

  • (Score: 2) by Common Joe on Thursday January 20, @04:16AM (1 child)

    What concerns me about this study is that the adverse affects reported are "like headache and fatigue". I've tried to avoid the political muck that the Covid catastrophy has generated, but the concerns my family talk about isn't about headache and fatigue for a day or two. They are very concerned about serious life-altering side effects of the vaccine. If such a great number of people don't trust the vaccine to that level and they believe it will do bodily harm, I'm surprised that this study is mentioning only "headache and fatigue".

    In addition, the people who take the vaccine (and are in a study about it) are those who typically believe in the positive effects of it. This 1/3 number seems very high. Too high.

    Although I'm all boostered and believe the vaccine does a lot more good than harm, this particular study smells like political manipulation instead of real science.

    • (Score: 0) by Anonymous Coward on Friday January 21, @01:37AM

      by Anonymous Coward on Friday January 21, @01:37AM (#1214419)

      I'm going to go out on a limb here and guess that they are primarily mentioning headache and fatigue because these are the most commonly reported adverse reactions.

  • (Score: 2) by JoeMerchant on Thursday January 20, @04:08PM

    by JoeMerchant (3937) on Thursday January 20, @04:08PM (#1214198)

    Lumping all adverse event reports into the same bucket is the biggest distortion, IMO. They do say [] this:

    Severity of AEs

    Aside from the presence or absence of AEs, the severity of AEs could serve as an additional indicator to quantify the influence of nocebo responses. In exploratory analyses of the 2 largest trials reporting details on severity,38,39 we found that the proportion of severity grades for participants reporting any systemic AEs after the first dose were similar in the placebo and vaccine groups (eFigures 1 and 2 in the Supplement). However, whereas the pattern of severity grading after the second dose stayed the same for placebo participants, there were proportionally more moderate and severe AEs in the vaccine groups after the second dose.

    The bar charts buried here [] tell a much clearer story on severity. The two things I note: 1) it's the 2nd vaccine dose that gets the more severe adverse events, and 2) N of the study was small enough to avoid the messy complication of observing any grade 4 adverse events.

    Personally, it's the grade 4 adverse events I'm interested in, and not just those that appear in the first 72 hours after injection.

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