Tag Archives: clinical trial

Homeopathy ‘Research’ Seriously Sucks

A homeopathic treatment being sold in Germany.
Photo: Oskar Poss/ullstein bild (Getty Images)

Research on homeopathy, a 200-year-old form of alternative medicine, is often biased to make it look more effective than it really is, according to a new study out this week. Homeopathy researchers routinely neglect to register the details of their clinical trials before they publish their results, and unregistered trials usually provide rosier results than registered ones, the study found. Over a third of registered homeopathy trials in the past two decades have also never been published, which can be a sign of burying unflattering findings.

Homeopathy was invented by German physician Samuel Hahnemann just around the turn of the 19th century. It’s claimed to work on a principle of “like treats like.” In practice, this means finding a substance known to cause similar symptoms as whatever illness a person is experiencing, then diluting it in water so thoroughly that essentially nothing of the original substance should even be present. This “memory” left behind in the water is supposed to unlock its therapeutic potential and can be given to someone as is (or sprinkled onto a sugar pill) to cure what ails them.

To be clear, homeopathy’s theory of medicine isn’t supported by modern science, nor are its purported benefits, and scientists routinely remind people of just that. Even if homeopathy’s underlying principles don’t pass the sniff test, though, it still has its fans and practitioners. Absurdly, homeopathic treatments can be found in big pharmacy chains like CVS. But because they fall under the same umbrella as dietary supplements in many countries, including the U.S., there’s often little regulation of these products or their claims.

Since homeopathic treatments aren’t as closely scrutinized as approved drugs, the authors of this new study note, the scientific literature is really the only way to know whether the products actually work. And perhaps unsurprisingly, the literature on homeopathy looks to be just as shoddy as the theory behind it.

Researchers in Austria and the U.S. looked at registries containing clinical trials of homeopathic treatments dating back to the early 2000s. Trial registration is an important but often optional part of ethical clinical research. By registering trials beforehand, other scientists can better double check the work for signs of research bias or even outright fraud. Researchers who veer off course and conduct analyses of their results that weren’t outlined in their registered plan, for instance, might do so because their first findings didn’t give them what they wanted. Similarly, scientists might register but never publish a study because the results weren’t what they hoped for.

These issues are sadly systemic throughout science, but the field of homeopathy seems to be an especially bad culprit, the researchers found. Since 2002, they found, 53% of published homeopathy trials were never registered, and about 38% of registered trials went unpublished. Unregistered trials also claimed to show larger treatment effects on average than did registered trials. But even when researchers did publish the results of registered trials, they changed the outcomes they were looking for from the original plan about a quarter of the time.

Any one of these things may not be so bad in isolation, but put together they’re exactly the recipe for inflating how effective homeopathic treatments look in the clinical trial literature.

“Overall, the findings suggest a concerning lack of scientific and ethical standards in the field of homeopathy and a high risk for reporting bias,” the scientists wrote in their paper, published Wednesday in the journal BMJ Evidence Based Medicine.

Again, this shouldn’t come as a surprise, given that nothing about homeopathy makes much sense. But journals still publish these studies, some countries still endorse its use (including during the pandemic), and plenty of people will buy homeopathic “medicine” at their local pharmacy without knowing any better. While these products are usually little more than a fancy placebo, they can sometimes be so poorly made that they actually contain the poison that was supposed to be diluted away—accidents that have landed people in the emergency room and likely led to a string of infant deaths in recent years.

Homeopathy is probably the clearest modern day example of junk medicine still around, and as this new research suggests, so too is the science meant to support it.

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NIH launches trial to study allergic reactions to COVID-19 mRNA vaccine

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Scientists Try, Fail to Find a DIY Hangover Cure That Actually Works

Photo: Jamie Squire (Getty Images)

No one really knows how to cure a hangover, a new roundup of scientific studies has found. The review found little good evidence for any one particular hangover cure, with existing studies generally being of low quality.

The review was conducted by researchers in the UK and backed by the National Institute for Health Research (NIHR), the country’s largest government funder of clinical research. The team reviewed 21 different clinical trials testing out a variety of purported hangover cures. These included curcumin (the primary ingredient that gives turmeric spice its bright yellow color), red ginseng, NSAID painkillers like loxoprofen, probiotics, artichoke extract, pear juice, and the supplement n-acetyl-l-cysteine (NAC), among others.

Most of the studies failed to find any benefit for hangover symptoms from these treatments, the team found. And even for those that did find a statistically significant effect for some symptoms, the researchers weren’t too impressed by the quality of the data collected. None of the studies looked at the same hangover cure, nor were any results independently replicated by other researchers, which is needed to validate whether something in medicine works as advertised.

The team also noticed some glaring flaws in many hangover cure experiments. Eight of the studies, for instance, excluded women entirely. Studies also had very different designs from one another, which can make it hard to compare results. Some involved food, others didn’t, and several different types of alcohol were used to get people intoxicated. Other common hangover remedies, like acetaminophen or aspirin, have seemingly never been studied in randomized and controlled trials.

The findings were published in the journal Addiction.

“We have a limited number of poor quality research studies which examine treatments for hangover,” lead author Emmert Roberts, a clinical researcher at the National Addiction Center of King’s College London, told Gizmodo in an email.

Out of the various cures they studied, three did appear to show promise when compared to placebo. These were clove extract, tolfenamic acid (an NSAID painkiller available in the UK) and pyritinol (an analog of vitamin B6). These treatments are the most likely to warrant a rigorous clinical trial, Roberts said. Ideally, any future studies should use more universal and validated standards, including one for measuring hangover symptoms. They should also be pre-registered, relatively large, and more representative of the population, women included.

For now, though, there’s only one clear method to avoid a hangover. “The surest way of avoiding hangover symptoms is to drink in moderation or abstain from alcohol,” Roberts said. “However, very low quality evidence suggests that clove extract, tolfenamic acid and pyritinol have the strongest evidence of reducing overall hangover symptoms when compared to placebo, and all appeared to be safe.”

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Alzheimer’s Disease Nasal Vaccine To Be Tested At Brigham And Women’s Hospital – CBS Boston

BOSTON (CBS) – Brigham and Women’s Hospital is going to test a nasal vaccine for Alzheimer’s Disease.

The hospital announced the launch of a clinical trial Tuesday to test the safety and efficacy of the medicine, which has been researched for nearly 20 years.

According to the Brigham, the nasal vaccine is “intended to prevent and slow the progression of Alzheimer’s.”

Sixteen people between the ages of 60 and 85 with early, symptomatic Alzheimer’s will be studied. They’ll each get two doses of the vaccine one week apart.

“Potentially it could be a treatment for people with the disease and even more important it could be something to prevent people from ever getting the disease,” lead researcher Dr. Howard Weiner said.

The vaccine uses something called Protollin to stimulate the immune system. That is expected to activate white blood cells in the lymph nodes in the neck and send them to the brain to clear out beta amyloid plaques, a distinctive feature of Alzheimer’s.

“For 20 years, there has been growing evidence that the immune system plays a key role in eliminating beta amyloid. This vaccine harnesses a novel arm of the immune system to treat AD,” principal investigator Dr. Tanuja Chitnis said in a statement.

Clinton Kershaw was diagnosed with Alzheimer’s four years ago at the age of 57. With the new trial, he’s hopeful for the future. “Living with Alzheimer’s Disease is devastating, so it’s exciting to see something new come across the board,” Kershaw said.

The Alzheimer’s Association calls this year an exciting time due to a rise in recent treatments and trials. In June the FDA granted accelerated approval for the very first Alzheimer’s drug. “I really do believe now that the first survivor -going to be young- is out there because of the incredible work the science community is doing,” CEO Jim Wessler said.

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Coronavirus Updates: Restrictions to be lifted on fully-vaccinated, non-American travelers Monday

NEW YORK (WABC) — The U.S. is lifting restrictions on foreign travelers who are fully vaccinated against COVID, starting Monday.

The Biden administration is expecting long lines and delays at airports with travelers possibly pouring into the states.

When the announcement was made, online searches for international flights jumped 338%.

Delta Airlines saw bookings shoot up by 450%, and United Airlines says it will be bringing 30,000 travelers into the U.S. on Monday alone.

Here are more of today’s COVID-19 headlines:

Novavax says its vaccine could win over skeptics

The biotechnology company Novavax plans to submit complete data to the US Food and Drug Administration soon for possible emergency use authorization of its coronavirus vaccine, CEO Stanley Erck told CNN in a phone interview Friday. Novavax’s vaccine, called NVX-CoV2373, is made using somewhat more conventional methods than the vaccines already authorized for use in the US.

US cancels vaccine maker’s multimillion dollar deal
The federal government has canceled a multimillion dollar deal with Emergent BioSolutions, a Maryland-based vaccine manufacturer with facilities in Baltimore that were found to have produced millions of contaminated Johnson & Johnson vaccine doses this spring, the Washington Post reported. Emergent disclosed the development Thursday in a conference call discussing its latest financial results, the Post reported. Emergent said it will forgo about $180 million due to the contract’s termination, according to the Post. Emergent BioSolutions played a role in the Trump administration’s effort to speed up vaccine development and distribution. But after winning a contract from the previous administration, Emergent quickly ran into production problems. In March, ingredients intended for use in producing the Oxford-AstraZeneca vaccine shots contaminated 15 million doses of the Johnson & Johnson vaccine. The problems with the vaccines caused a monthslong delay in production. After that, the Biden administration put Johnson & Johnson in direct control of vaccine production there.

15 unions reach COVID vaccine mandate deal with NYC, talks continue with outliers
New York City employees who don’t want to get vaccinated have until Friday to file for a religious or medical exemption if they have any hope of staying on the payroll, this as the city announces more deals with unions representing municipal workers. Mayor Bill de Blasio said Friday that 15 unions, including city’s largest, DC 37, have signed onto the deal. The unions represent more than 100,000 city workers covered by this most recent mandate that took effect last week, but the police and fire unions are not included and are still trying to hash out their own deals. Around 92% of city workers under the mandate are vaccinated, including 90% of EMS, 79% of firefighters, 85% of sanitation workers, and 85% of NYPD employees.

COVID vaccine refusal 10th highest reason for job cuts in 2021, report says
While experts say we’re still in the so-called “Great Resignation,” a recent Jobs Cut Report uncovered vaccine refusal as the 10th highest reason for job cuts this year. Numbers released by Chicago-based outplacement and business and executive coaching firm Challenger, Gray & Christmas, Inc. came on on the same day President Biden announced new federal guidance and deadline for tens of millions of workers to get vaccinated.
“Roughly 5,000 people that lost their jobs in the last month due to COVID vaccine refusal made up actually 22% of the total number of people that we tracked being let go across the country,” the firm’s Senior VP Andy Challenger told our sister station KGO-TV.

Pfizer’s COVID-19 pill reduces risk of being hospitalized or dying by 89%, company says

A course of pills developed by Pfizer can slash the risk of being hospitalized or dying from COVID-19 by 89% if taken within three days of developing symptoms, according to results released Friday by the pharmaceutical company. In a study of more than 1,200 COVID-19 patients with a higher risk of developing serious illness, people who took Pfizer’s pills were far less likely to end up in the hospital compared to people who got placebo pills. None of the people who got the real pills died, but 10 people who got placebo pills died, according to results summarized in a Pfizer press release.
SantaCon returns
After taking a year off due to the pandemic, SantaCon is returning to New York City. The event requires a $13 donation for all-inclusive Santa Badge access to the official SantaCon venues. The location of a Yuletide kickoff party won’t be disclosed until closer to the December 11 SantaCon date.

Turkey Day troubles? Smaller birds, popular Thanksgiving sides could be harder to find in 2021
Consumers may have to trim their list of trimmings for their highly anticipated Thanksgiving meal this year. Top turkey seller Butterball said it doesn’t expect an overall gobbler shortage, but that those in search of a smaller size bird could have a hard time.
“Typically a 10- to 12-pound (turkey) up to 14 pounds is going to be more difficult,” Butterball CEO Jay Jandrain told “Good Morning America” on Friday. “Anything over 16 pounds, they’ll certainly be more readily available.”

Q&A: What to know about COVID-19 vaccines for kids aged 5-11
Vaccinations finally are available to U.S. children as young as 5, to the relief of some parents even as others have questions or fears. Late Tuesday, the Centers for Disease Control and Prevention gave the final OK for youngsters age 5 to 11 to get kid-size doses of the vaccine made by Pfizer and its partner BioNTech. Pediatricians and other doctors’ groups praised the move and are gearing up to help families decide whether to vaccinate their children. The shots could be available as soon as Wednesday and will be offered at pediatricians offices, clinics and pharmacies. Like COVID-19 vaccines for adults, they are free. Here’s everything you need to know.

Will the supply chain issues impact holiday shopping? Here’s what the experts say

With the holiday shopping suddenly upon us, it appears that getting that perfect gift or preparing that perfect meal will be far more challenging than in years past due to supply chain issues. Shoppers are noticing that it’s difficult to find a variety of items, and virtually everything from food to Christmas trees are more expensive. The price increase is being caused by gridlock at major seaports and a truck driver shortage across the country. Analysts say the forecast for the holiday season is not looking better.

MORE CORONAVIRUS COVID-19 COVERAGE

New York City COVID-19 Vaccine Tracker
New Jersey COVID-19 Vaccine Tracker
Centers for Disease Control and Prevention on coronavirus

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