What Does That Study Mean?

My daughter recommended the topic for my last post: Hospital Quality and Care. She had seen a number of advertisements by drug companies that claimed their drug would help cancer patients. I commonly comment on these types of advertisements and she wanted to me explain to you how I determine when drugs are good or bad.

I didn’t write about that because I am not the one who can answer that question. People are trained to can answer that question for you, doctors. I can’t. You can’t. Doctors who are good at their job can. They know about the newest drugs and they know the side effects, which they should share with you if asked. They have easy means to find out if they don’t know. It is more important for a patient to have the right hospital and doctor and, as I said, if the hospital is of high enough quality, good doctors will be found there.

There is another part to her suggestion though. It once again leads in a direction she might not have expected. That is, how does the layperson decide if news about a drug is correct? How can people make sense of  articles when those articles are claiming horrendous side effects or amazing advantages of drugs?

I will walk you through a way to find out and I’ll use Ibuprofen as the guide because this drug has been in the news lately. Recent articles have said Ibuprofen increases the risk of heart attacks. In an article by CNN That information is coupled with a British statistic that 200,000 people in the United Kingdom go to the hospital for heart related illness each year. Ibuprofen may be part of the problem. That sounds like scary news to me. I want the facts.

If you Google Ibuprofen on the day I am writing this post, the first web pages that come up (after the Ad for Ibuprofen) are both at Drugs.com. Click here to see the Drugs.com page about Ibuprofen side effects. The list of side effects is lengthy. Should it be believed? Like the news, it runs on ads and on your clicks. The more it excites you to look at it, the more you click it. Given that, it might be exaggerating, adding side effects that aren’t really a big deal so you will click or leaving off side effects because Ibuprofen manufacturers asked them to do so when they advertise on their site.

One excellent way to determine the believably of such news and such sites is to look for the references. Those will be at the bottom of the page. On the Drugs.com site for Ibuprofen (not the page with the side effects of Ibuprofen) this appears.

 References

1. “Product Information. Motrin (ibuprofen).” Pharmacia and Upjohn, Kalamazoo, MI.
2. Cerner Multum, Inc. “Australian Product Information.” O 0
3. “Product Information. Caldolor (ibuprofen).” Cumberland Pharmaceuticals Inc, Nashville, TN.
4. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
5. “Product Information. NeoProfen (ibuprofen).” Ovation Pharmaceuticals Inc, Deerfield, IL.
6. “Product Information. Ibuprofen (ibuprofen).” Par Pharmaceutical Inc, Spring Valley, NY.
Not all side effects for ibuprofen may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

If you want to see this click here. You need to scroll down to find it.

These references don’t help much. They are pharmaceutical companies and you can’t click on the reference and go directly to the pertinent information. That is true even for the FDA. When you go to their website you have to search for the drug. When you do, this is what you get.

• NSAIDs may cause an increased risk of serious
cardiovascular thrombotic events, myocardial infarction,
and stroke, which can be fatal. This risk may increase
with duration of use. Patients with cardiovascular
disease or risk factors for cardiovascular disease may
be at greater risk (see WARNINGS).

That is only part of the warning. To see all of the FDA warning click here.

I made some of their words Bold. Those are serious conditions, killing conditions. I want to know more. I want to know what study or studies cause them to feel so strongly about Ibuprofen that it gave such a strong warning.

For that I will return to CNN’s story about the increased risk of heart attack when using Ibuprofen. See it here. This story ran in May of 2017. Was there a recent study that caused them to run this? Yes. It was published in May as well. Is the information CNN shared about that study realistic? Or is it just scary news to make you click? To decide, I need information.

bmj journal logo

First – does the CNN story include any references to the studies so I can look at them? Not exactly but It does tell us who did the study and where the study was published and that is enough. We can find the article at the bmj, The British Medical Journal.

I searched the author, which is given in the CNN article as ‘Bally’. So I searched ‘Bally Ibuprofen’ and found the paper at the bmj, which is the journal CNN cited as one of their sources. It is a scholarly article full of medical terminology and research parameters that would confuse most laypeople. That doesn’t matter. There is an easy way for people without deep understanding of medical terminology and statistics to glean some pertinent information without becoming specialists.

There are parts to any scholarly article that will be somewhat clear to the average person. Those are the parts you want to look at.

Scholarly articles are divided into sections. Take a look at Bally’s article about Ibuprofen here. Scroll down past the Abstract (which is simply a summary of the whole thing) and you will see the parts; Introduction, Methods, Results, Discussion, Conclusion. The Methods and Results parts will be heavy with words most of us won’t understand. I would have to Google many of them for definitions. The writing will be boring for a layperson to read, tedious, and go out of the way to impress the author’s colleges about the validity of the study rather than inform a layperson. I glance at that for some information but I don’t try to understand it all.

We want to look at the Introduction and the Conclusion and we want to look for particular things to determine if the study is worthy of us believing it. Three things will help answer this.

First, does it have enough subjects, that is enough people or animals, involved in the study to get a good sample of results? The more the better. Thousands is great. Less than a hundred, and it is time to start scoffing and stop believing. In between, be skeptical but optimistic.

Second, does the study have references? It will have them if it is published in a respectable medical journal. Look at the bottom of the page like you did at the Drugs.com site. Are the references all from one source? If they are, start scoffing. Are they long and from many sources? That’s good. Bally’s paper has 76 references from many different journals and authors. Look through them for other papers you might want to see.

By the way, the names of the journals, or magazines, referenced in such papers are in italics. The longer names are often abbreviated. Eur J Intern Med is the European Journal of Internal Medicine just as the bmj is the British Journal of Medicine.

So far Bally’s paper looks good. We can trust it.

Third, what does it say? Parts of it will be somewhat clear to most readers. Look at the Introduction and the Conclusion. See if they say the same thing as the CNN article. If they do, and if the study includes a big enough group, which it does, then believe the article and the study.

In this particular case, I didn’t need to look at Bally’s paper except to find out details that the CNN article left out. I knew once I saw the FDA warning that Ibuprofen isn’t for me or anyone with a heart condition. The small risk for a heart attack is multiplied as much as 95% when taking the drug. That is what Bally reported and that was what CNN reported.

 

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