Double Blind Controlled Trials - Where are they?

[Charlie]

Firstly I thought I would post up this video which clearly explains how Double Blind Controlled Trials are performed.

http://www.youtube.com/watch?v=aSP2OMiFxhg

I have been looking for Double Blind Controlled Trials for the two main treatments discussed on this forum - Physical therapy and PNE surgery. I can not find a single one.

I appreciate it is almost impossible to perform a blinded study for both of these treatments so I decided to look for just randomized studies. I can find two.

One of these was for myofascial physical therapy which was compared to a regular full body massage. This study was performed on IC patients. This study demonstrated that for the symptom of pain ( measured on a scale of 1-10 ) myofascial therapy did not have a significantly greater effect than a regular massage. The drop in pain levels was small. A trial study from this same team on prostatitis patients yielded similar results.

The second study was for the TG PNE surgery performed by the Nantes team which compared this surgery with a non surgery group. This study did show the validity of the surgery - ''At 12 months, 71.4% of the surgery group compared with 13.3% of the non-surgery group were improved''. Although only half of the surgery sample sustained their improvement after 4 years and the non surgery group were not followed up at the 4 year point to compare. So this study is not a great endorsement for the surgery they are performing.

It seems that this illness involves us as patients having to experiment with treatments for which there is little or no evidence for. We are faced with a desert of evidence based treatments.

The strange paradox is that I have been to see practitioners who have claimed tremendous success rates. I have seen PT's who claim they have a 90% or 80% cure rate. A PNE neurosurgeon in L.A makes a claim of an 87% success rate. When practitioners lay claim to such extraordinary success rates we as patients should apply more pressure for such practitioners to back up these claims with well designed studies.

[Celeste]

When practitioners lay claim to such extraordinary success rates we as patients should apply more pressure for such practitioners to back up these claims with well designed studies.

I think what you're saying is completely reasonable, Charlie. My feeling is that in order to say that, the patient would have to feel certain that he or she could wait until such time as the study was accomplished. That's a lot to ask of someone who feels they cannot go on in the pain that they're in...and I'm certain that most doctors would take advantage of that. Studies take time and cost money. Pr. Robert is,to my mind, the most passionate and curious of the lot, and he's been at this the longest. It doesn't surprise me that if someone's gone forward to make the first attempt, it's him.

In any case, what do you suggest would be the best way to "apply more pressure"? Individually? As a group? As a group interested in one particular procedure? As a group interested in one particular doctor? I'm just thinking out loud in terms of effort mobilization.

[Charlie]

When practitioners lay claim to such extraordinary success rates we as patients should apply more pressure for such practitioners to back up these claims with well designed studies.

My feeling is that in order to say that, the patient would have to feel certain that he or she could wait until such time as the study was accomplished. That's a lot to ask of someone who feels they cannot go on in the pain that they're in...and I'm certain that most doctors would take advantage of that. Studies take time and cost money. Pr. Robert is,to my mind, the most passionate and curious of the lot, and he's been at this the longest. It doesn't surprise me that if someone's gone forward to make the first attempt, it's him.

I agree Celeste. Most of us are in a high levels of pain and you do not really have a choice but to try these different treatments. I applaud the Nantes team for trying to construct a study that can back up their claims. It is not an ideal study but it shows a commitment to at least try and back up their claims.

I think many are convinced by the stamp of 'Peer Review'. I certainly used to be. Peer reviewed articles are rarely checked. In fact many articles in Peer Reviewed journals turn out to be completely wrong. The author David Freedman discusses this in his book Wrong: Why Experts Keep Failing Us—and How to Know When Not to Trust Them. Below is an extract from an interview with him

In fact, David H. Freedman argues in his new book Wrong: Why Experts Keep Failing Us—and How to Know When Not to Trust Them, most scientific and medical studies that you see or hear mentioned in news reports turn out to be incorrect, misleading or irrelevant to most people. And, unfortunately, that's true even if they're published in a major peer-reviewed journal. Other commonly offered expert advice, on everything from investing to home repair, is equally suspect, Freedman says.

The forces pushing bad research to the forefront are plentiful, he argues. They start with a bias for publishing surprising new results, and are compounded by a range of researchers' sins, including mismeasurement, manipulation of data, conflicts of interest, ineptitude and outright fraud.

Whats important is how the study is designed and having at least a control group is important.

In any case, what do you suggest would be the best way to "apply more pressure"? Individually? As a group? As a group interested in one particular procedure? As a group interested in one particular doctor? I'm just thinking out loud in terms of effort mobilization.

I think this forum can question study results. That is something that it already does so I am not complaining about it. We should welcome people who challenge hypothesis. Science is about disproving hypothesis not looking for everything that backs it up.

As Individuals I think it is okay to politely challenge people's claimed success rates. If a PT claims a 90% success rate then I think it is okay to ask how they came to this conclusion. We should ask 'How do you track your patients?, For how long do you track your patients after they leave the clinic? , How do you measure success?'. I made the mistake of believing in PT success rates largely because I wanted to and it was comforting to be reassured. When I finally asked these tough questions the reply I received was along the lines of '' well they don't come back so they must be better'' which translates as ''I make up my success rates.''

[Celeste]

[When I finally asked these tough questions the reply I received was along the lines of '' well they don't come back so they must be better'' which translates as ''I make up my success rates.''

Well, I think I might factor in provider intent here. It could be argued that someone optimistically presumes that patients don't return because they are now well. Fabrication of success rates translates to me as an attempt to mislead. I think those are very different intents, and wouldn't want to ascribe the wrong one to a given provider.

I'm saying this because I had my pain clinic call me at one point after I quit booking appointments. The staffer excitedly asked me how I was doing since the last treatment and was my condition now cured. I said no, not at all, and in fact I moved on to somebody else. The letdown in her reply was immediate. I think she really wanted to tell the doctor who'd asked her to call that he'd been successful. This is how I know somebody would completely believe that if you don't keep come back, it means you must be recovered.

[A's Mommy]

I think this is a great thread, and thanks Charlie for the research you have done on this. I also applaud Robert for at least trying something.

For now, let's just be real and post what the surgeons' are claiming.

I will post Hibner because he is my doctor:

33% cured
33% improved
33% no change
1% worse

A's Mommy

[Violet M]

When practitioners lay claim to such extraordinary success rates we as patients should apply more pressure for such practitioners to back up these claims with well designed studies.

I completely agree with you on this thread, Charlie; however, I don't fault the docs for not doing more research because research takes a lot of time and funding and we know how busy these docs are. I think if we want that to happen we are going to have to help it happen which is one of the reasons HOPE organized. But with all volunteers it takes time to lay the groundwork to apply for research funding when there are so many rules you have to comply with.