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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: 0) by Anonymous Coward on Thursday January 20, @12:25AM (7 children)

    by Anonymous Coward on Thursday January 20, @12:25AM (#1214005)

    Gosh, I was hoping for a car analogy.

  • (Score: 5, Insightful) by Thexalon on Thursday January 20, @04:49AM (6 children)

    by Thexalon (636) on Thursday January 20, @04:49AM (#1214068)

    You want a car analogy? I've got one.

    People not wearing their seat belts in a car are about 45 times more likely to die in a car crash than people wearing seat belts. The risk isn't ridiculously huge - many people will be able to drive to where they're going without a seat belt without dying - but it's definitely there. Some of the people who are driving around without a seat belt will get into accidents they end up surviving as well, and if they're really lucky they might also avoid serious injury. Also, sometimes people who are wearing their seat belt will die anyways if they end up in a really severe wreck. But it helps enough that the vast majority of professionals with the training and data to understand the issue agree that seat belts are a valuable and worthwhile safety measure, so much so that vehicles are required by law to have them in order to be sold or allowed on public roads, and in many jurisdictions people who don't wear seat belts can be fined or even go to jail for it.

    Vaccination against a potentially fatal disease, in this context, is approximately the same as seat belts, except it's not just your own safety but the safety of everyone around you at stake.

    --
    Alcohol makes the world go round ... and round and round.
    • (Score: 2) by Mykl on Thursday January 20, @06:12AM (2 children)

      by Mykl (1112) on Thursday January 20, @06:12AM (#1214077)

      Would rate you +2 if I could. It's a better analogy than my earmuff one by far.

      • (Score: 2) by Rich on Thursday January 20, @01:42PM (1 child)

        by Rich (945) on Thursday January 20, @01:42PM (#1214143) Journal

        The best analogy I've heard is that the vast majority of football (soccer for the 'merkins) goals are made with the goalkeeper on his position. :)

        • (Score: 2) by driverless on Saturday January 22, @10:24AM

          by driverless (4770) on Saturday January 22, @10:24AM (#1214752)

          That's a great analogy. No idea what it's an analogy for, but it's a good analogy nevertheless.

    • (Score: 1, Informative) by Anonymous Coward on Thursday January 20, @03:20PM

      by Anonymous Coward on Thursday January 20, @03:20PM (#1214176)

      Thank you, dear Thexalon, for answering my plea for an apt car analogy. Well done. I will share it with my adult relatives.

      Somebody gift this man a SN subscription. (I would, but I'm tapped out, my furnace is busted and house taxes are due. True story.)

    • (Score: 1, Insightful) by Anonymous Coward on Friday January 21, @12:14AM (1 child)

      by Anonymous Coward on Friday January 21, @12:14AM (#1214393)

      Don't forget that seat belts in a car also protect the other occupants too. The benefits aren't quite as direct, but an unsecured passenger can cause a lot of damage to the other occupants as that person bounces around inside the cabin like a ragdoll or they can hit the other occupants on their way out. I've seen more times than I care to count that some future organ donor isn't wearing a seat belt in the back seat and the serious injuries of those in the front seats is from being hit from behind by the passenger on their way out. If there was a seat belt, all passengers would be alive and everyone would have walked away with minor injuries. And don't get me started on meat crayons and road pizza not wearing proper safety gear on donorcycles.

      • (Score: 2) by driverless on Saturday January 22, @10:27AM

        by driverless (4770) on Saturday January 22, @10:27AM (#1214753)

        Years ago a friend of mine worked at a NY hospital and was complaining about the lack of organs for transplants. Someone who'd been working there for longer than him commented "there's rain forecast for next week, we'll have plenty of motorcyclist donors soon".