Determining "clinical significance" for Lyrica in Fibro: VAS goes from 6 to 5.6 after 14 weeks

[DrCommonSense]

Why is Lyrica considered "clinically significant" in pain control for Fibro when the studies they are quoting show a difference of VAS from 6 to 5.6 after 14 weeks?

Seems odd that a 4% benefit in score allows at 700/month prescription with many side effects is somehow clinically acceptable?

How does that work?

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[ampaphb]

Pregabalin for pain in fibromyalgia in adults. - PubMed - NCBI

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[DrCommonSense]

Pregabalin for pain in fibromyalgia in adults. - PubMed - NCBI

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How is .4 difference in VAS significant? Who determines this?

 

[Ducttape]

please quote the article you are talking about, so that it can be discussed and critiqued.

otherwise, its like posting fake news.

 

[Blitz2006]

Somewhat thread jacking, but what do you guys prefer for fibro, savella or cymbalta?

 

[ampaphb]

Depends if they also have a neuropathic component to their pain

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[Ducttape]

mindful meditation and aggressive home exercise program (yoga, tai chi)

 

[Aether2000]

The most accepted and brutal measure of clinical significance is NNT. This is the number of patients needed to achieve 50% improvement in one patient. Of course if the clinical improvement is only 4%, the NNT would be Trumpian huge.

 

[Tapspatellas]

Somewhat thread jacking, but what do you guys prefer for fibro, savella or cymbalta?

Psych and exercise. Nothing else usually helps, but I still try. Savella is usually my last of the 3 FDA approved meds. Usually give LDN a spin even before that

 

[DrCommonSense]

The most accepted and brutal measure of clinical significance is NNT. This is the number of patients needed to achieve 50% improvement in one patient. Of course if the clinical improvement is only 4%, the NNT would be Trumpian huge.

actually the NNT for most patients treated with statins for prevention of MIs or death is in the 100s

 

[clubdeac]

The most accepted and brutal measure of clinical significance is NNT. This is the number of patients needed to achieve 50% improvement in one patient. Of course if the clinical improvement is only 4%, the NNT would be Trumpian huge.

algos do you know how low that number needs to be to show "clinical or statistical significance"?

 

[Ducttape]

No concrete number determines clinical significance for all studies. It varies based on the researchers use of statistical model.

Look at Wikipedia or go talk to your neighborhood statistician...

Clinical significance - Wikipedia


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[ampaphb]

Statistical significance: p < 0.05

Minimum clinically important difference: Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain. - PubMed - NCBI

Numbers Needed To Treat. Medical statistic information | Patient

 

[BobBarker]

Don't TCA's have the best NNT of the standard neuropathic pain meds? Around 3.5 or so I think.

 

[Aether2000]

The degree of improvement must be specified when discussing NNTs. Treatment and prevention have different NNT thresholds. For treatment at the level of 50% improvement in general, anything up to NNT 5 is significant and NNT >5 is , and 5-10 is minimally significant, over 10 is insignificant. For 100% improvement, under 10 would be significant, under 5 would be highly significant. NNT more than 10 is insignificant. For prevention, the numbers are higher. In pain medicine, the improvement levels in studies range from 10% to 50% with most set at 10-30% range. So those claiming a 10% improvement are probably suspect regardless of the NNT, since patients in some studies have been shown to require an improvement of at least 20% to show reproducible perceptibility. A 30% improvement with NNT of 2-3 would be considered clinically significant. A 50% improvement with NNT <5 would be clinically significant. Pain studies almost never measure clinical improvement at a level of >50%. These are average values but a generalized formula would be Significant Clinically if % Improvement/NNT is 10 or greater

 

[painfree23]

Why is Lyrica considered "clinically significant" in pain control for Fibro when the studies they are quoting show a difference of VAS from 6 to 5.6 after 14 weeks?

Seems odd that a 4% benefit in score allows at 700/month prescription with many side effects is somehow clinically acceptable?

How does that work?

What else r u going to give these patients ? Placebo pills...? If only that was legal.

 

[bedrock]

What else r u going to give these patients ? Placebo pills...? If only that was legal.

seriously not a bad idea.... if it was legal.

I only write for cheap generic such as TCA or cymbalta for these patients if I prescribe anything at all. Agree with Dr. Commonsense that way too much money is spend on lyrica scrips for FMS patients, that doesn't really accomplish anything meaningful.

 

[NOSfan]

Placebo pills...? If only that was legal.

seriously not a bad idea.... if it was legal.

I don't believe that's it's illegal to prescribe placebo pills.......however, it does raise ethical questions.

Regards

 

[ampaphb]

I think the issue might be what code you could bill

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[clubdeac]

The bad thing about our specialty is there are really no great meds to treat pain. The meds that work the best (opioids) unfortunately have the highest risk and therefore are off the table for most patients.

 

[hyperalgesia]

You might be able to get away with administering placebo by saying something like, "There is a chance this 'sucrose pill' may be effective in your case". I think if you explain the risks and benefits of a pill, you don't necessarily have to pound it into their head that you think their pain is psychosomatic. I tell pts all the time there is a placebo effect associated with everything we do. If sucrose helps fibromyalgia, does it really matter the mechanism?

 

[lobelsteve]

You might be able to get away with administering placebo by saying something like, "There is a chance this 'sucrose pill' may be effective in your case". I think if you explain the risks and benefits of a pill, you don't necessarily have to pound it into their head that you think their pain is psychosomatic. I tell pts all the time there is a placebo effect associated with everything we do. If sucrose helps fibromyalgia, does it really matter the mechanism?

It is the placebo and not the sucrose. Placebo response does not mean psychosomatic illness.

 

[hyperalgesia]

It is the placebo and not the sucrose. Placebo response does not mean psychosomatic illness.

I'm using psychosomatic as an example of a pt with few options.

If you tell the pt you are giving her sucrose and she obtains a response from the pill, I submit that the sucrose worked. It is incidental whether the sucrose acted chemically or psychologically. My point is maybe it's justifiable and legal to tell a pt what you are prescribing, discuss the risks and benefits and obtain informed consent (verbally), even if you expect the main MOA is placebo effect...

 

[Ducttape]

I don't believe that's it's illegal to prescribe placebo pills.......however, it does raise ethical questions.

Regards

technically, every time we prescribe a nonsteroidal, muscle relaxant, neuromodulator (gabapentin/lyrica/TCA), one can find some study that states that we are prescribing a placebo....

 

[DrCommonSense]

What else r u going to give these patients ? Placebo pills...? If only that was legal.

Generic TCAs, Cymbalta and Neurontin mostly. Try to avoid Lyrica due to excessive costs and it being nothing special compared to much cheaper alternatives.

 

[DrCommonSense]

technically, every time we prescribe a nonsteroidal, muscle relaxant, neuromodulator (gabapentin/lyrica/TCA), one can find some study that states that we are prescribing a placebo....

Very true indeed