How effective are common medications: ... meta-analyses of major drugs, 2015, Leucht et al

[leokitten]

A meta-analysis review worth reading, giving pause to how truly (in)effective many common FDA approved are compared to placebo.

How effective are common medications: a perspective based on meta-analyses of major drugs. Leucht et al. BMC Medicine (2015)

Abstract
The vastness of clinical data and the progressing specialization of medical knowledge may lead to misinterpretation of medication efficacy. To show a realistic perspective on drug efficacy we present meta-analyses on some of the most commonly used pharmacological interventions. For each pharmacological intervention we present statistical indexes (absolute risk or response difference, percentage response ratio, mean difference, standardized mean difference) that are often used to represent efficacy.

We found that some of the medications have relatively low effect sizes with only 11 out of 17 of them showing a minimal clinically important difference. Efficacy was often established based on surrogate outcomes and not the more relevant patient-oriented outcomes. As the interpretation of the efficacy of medication is complex, more training for physicians might be needed to get a more realistic view of drug efficacy. That could help prevent harmful overtreatment and reinforce an evidence-based, but personalized medicine.​

To me it’s a stark reminder that we shouldn’t have any higher expectations for a phase 3 clinical trial for any treatment of ME, especially given all the additional confounders, lack of diagnostic criteria, and lack of any basic pathological understanding that plague this disorder.

 

[Hutan]

Efficacy was often established based on surrogate outcomes and not the more relevant patient-oriented outcomes.

To me it’s a stark reminder that we shouldn’t have any higher expectations for a phase 3 clinical trial for any treatment of ME, especially given all the additional confounders, lack of diagnostic criteria, and lack of any basic pathological understanding that plague this disorder.

or we should be expecting better of trials in general...

 

[ME/CFS Skeptic]

Interesting article, thanks for posting. I was a bit surprised to see how (in)effective antidepressants are in this overview in figure 1

 

[leokitten]

Interesting article, thanks for posting. I was a bit surprised to see how (in)effective antidepressants are in this overview in figure 1
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Or statins for preventing major cardiovascular events. It could be that ok the drugs aren’t bad it’s that people taking them think ok now I don’t have to change my lifestyle one bit and all is well. All is not well no drug is magic.

 

[leokitten]

or we should be expecting better of trials in general...

Very true, but I just don’t think we are going to overhaul the clinical trial and regulatory approval system on top of trying to find a treatment for ME. This is a tremendous problem in medicine and partly because the incentives are all screwed up (at least in the US). We already have so many fundamental issues to deal with in our community and are at such a disadvantage that I feel it would not be possible to take this on too, especially since ME has error-prone diagnosis of exclusion criteria and no biomarkers.

To me this strongly highlights that even drugs that work and are approved don’t work for a lot of properly diagnosed people. Even physicians need to be trained better because they don’t seem to know this and have unrealistic expectations (as the paper states).

We should expect the same from any ME treatment trial, including something like Abilify or similar (which got me thinking about this). If 30% of pwME respond to it that seems like it would be a relative success, which is not great at all but par for the course it seems for drug approval.

 

[Creekside]

Or statins for preventing major cardiovascular events.

I had slightly reduced 'good' cholesteral, so my doctor recommended omega-3 supplements or statins. I did my own online research and found that statins weren't all that effective (and had worrisome side-effects) and that omega-3's lacked any reliable research findings that indicated more than a slight possible reduction in heart attacks. What did turn up was plenty of evidence that even moderate daily walking reduced those risks by 75% or more ... yet the doctor didn't bother to mention that. I don't recall him asking about my diet, since diet seems to be responsible for a large proportion of heart attacks.

No 'frequent prescriber points' for prescribing healthy diet and exercise?

 

[Sean]

Proton pump inhibitors definitely work for me, so it is good to see that reflected in the clinical trials.

And a little surprising to see that Aspirin has almost no effect on vascular disease and events.

 

[Midnattsol]

I had slightly reduced 'good' cholesteral, so my doctor recommended omega-3 supplements or statins. I did my own online research and found that statins weren't all that effective (and had worrisome side-effects) and that omega-3's lacked any reliable research findings that indicated more than a slight possible reduction in heart attacks. What did turn up was plenty of evidence that even moderate daily walking reduced those risks by 75% or more ... yet the doctor didn't bother to mention that. I don't recall him asking about my diet, since diet seems to be responsible for a large proportion of heart attacks.

No 'frequent prescriber points' for prescribing healthy diet and exercise?

In Norway we have something called a "green prescription", which is diet and lifestyle help, including access to certain easily accessible gyms (I wouldn't really call them gyms, but I'm unsure what other word I would use in english). It's been a thing for years but many GP's don't know about it.

 

[Arnie Pye]

Proton pump inhibitors definitely work for me, so it is good to see that reflected in the clinical trials.

Many people with indigestion, heartburn, and acid reflux actually have too little stomach acid, not too much. Rather than suppressing acid even more as PPIs do many people who try it find benefit in adding acid to their stomach when they eat.

The valves at top and bottom of the stomach are controlled by stomach acidity. If the stomach is acid enough those valves should stay tightly closed when necessary. If the stomach isn't acid enough those valves can act in a way that allows stomach contents to escape up or down and cause all sorts of problems.

There are cases where PPIs are worth taking e.g. in people taking NSAIDs for example, and no doubt some other drugs and medical conditions as well. It's ironic that in many cases people take PPIs (or need them) because of damage done by too little stomach acid. But for anyone who has taken PPIs and the body has adjusted to them, then coming off them can be a nightmare because of rebound hyper-secretion of gastric acid.