News SGB PTSD Treatment Article

[IchBin]

I was not on any medication, save self-medicating with various legal and illegal substances. After the shot I felt almost no need to continue using such things. I have no idea what effects Cymbalta has on dreams, so I can't comment on that.

But my really vivid dreams did eventually level off, though it took perhaps a month or two - maybe longer. I'm really glad to hear that your night terrors have subsided substantially, that is for sure a great sign.

As far as triggers go, I just don't get them any longer. I feel like I just "lost them", which really is remarkable; it's almost like they were never there at all. And yes, I had my shots done at Lipov's clinic in Chicago.

Here's yet another fairly recent article with some updates about research by the armed forces in San Diego and Lipov's article re: SGB that he published this past February: [DLMURL]http://www.beckersorthopedicandspine.com/pain/item/10476-6-points-on-treating-post-traumatic-stress-disorder-with-stellate-ganglion-block[/DLMURL]

 

[IchBin]

I actually found a copy of the article --

 

[anthony]

There seems to be one hell of a lot of data missing, as he has only published an existing data analysis set based on 8 people, all of whom only sat a 17 question assessment to determine PTSD status, stating 6 out of the 8 felt improved relief, yet again, the mean averages varied from slight relief to 73% relief.

Lipov is not doing himself any justice by releasing such limited data sets and claims.

I would like to see something substantial from an SGB trial, ie. psychiatric assessed veterans with a full psychiatric assessment score, atleast a good 500 people included in the data, then establish some real results.

It seems a lot of results are not being published, both positive and negative, which is disturbing in itself if Lipov wants some credibility towards his hypothesis.

 

[Girl3]

The article listed is more like an informercial - and informercials are not science. When you see a published scientific article it will discuss methodology, the study type (randomized controlled, case controlled, case series, etc), the statistical relevance using appropriate statistical tests, follow-up results that were rigorously collected, and a discussion - including types of bias.

Actually 200 patients would be a feasible starting point to look for an effect - null hypothesis stating that SGB would have no more effect than placebo or sham, meaning up tp 40% of patients could see improvement. To do such a study requires the following: IRB approval - that takes any where from 3 months to a year, depending on how much scientific basis you can find to "bolster" your cause, and how many times the IRB returns your study outline for recommended changes. It costs money - average is around 1500.00 for a small study. (Having done this a number of times, I can tell you it is a rigorous process and time consuming, but is designed to keep patients safe. IRB approval came about because of things like the Tuskegee experiments and the elderly patients injected with live cancer cells at JCDH in Brooklyn.) Next you need to recruit for the study - getting two hundred patients for a study would take about 3 years because not everyone who signs up shows up, qualifies, or follows up. Recruiting costs money because people have to collect the data stringently, keep it HIPAA safe, and stay in contact with patient participants. Then there is the cost of the procedure itself - cost of fluroscopy, the specialized needles, Ropivicaine, and staff costs. Doctors who own their own equipment amortize the cost of that equipment and their malpractice with their fees. In University settings, those costs are institutional and can either be "free" because of institutional support of the study or grants/industry funding pays it. But let's say that 5000.00 would cover the recruitment, procedure, and follow-up (it wouldn't but it makes the math easier.) A study of two hundred patients for SGB does it have an effect would cost one million dollars to produce. Then there is statistical analysis which costs another 1500.00 or more. Putting the data understatistical analysis takes more time - a year even. So for those who want to see results from a study on SGB have a few years to wait for results.

As for the incresed safety of using 7cc versus 10cc is not really scientifically significant. If you look at the space which is being injected you could argue that 4cc placed directly under fluoroscopy would be much safer - and it might be sufficient. But since no one has studied the range of doses required to achieve the desired effect, it remains an unknown. For that matter - if someone does a large randomized controlled trial of SGB for PTSD, the study will likely include a up/down dosing schedule or a randomized dosing schedule wherein some patients will get 10cc of radio-opaque dye (sham group) and other patients will get amounts of local that may vary from 1-10cc of local anesthetic.

In the mean time, I have discussed with one of my colleagues who does roughly 150 SGB a year for chronic pain syndromes if he would do SGB for PTSD based on Lipov's work. He declines to do so because of the malpractice implications of performing experimental therapies. I asked if he would do it for 3000.00 and he said no - not without better scientific evidence.

 

[anthony]

Nice reading Girl3. Thanks for the insight and medical aspects.

I think that Lipov is manipulating results at present due to SGB already being approved by the FDA, just not how he is doing it for PTSD. I believe he is using that pre-approved method to justify safety and such, yet he is giving it not for pain, but for mental illness.

It reminds me more of pharmaceutical company's methods of taking an approved medication and claiming it can be used in all these other off-label uses, most of which have never been established via study, though end of the day the medication has been deemed safe by the FDA.

In the mean time, I have discussed with one of my colleagues who does roughly 150 SGB a year for chronic pain syndromes if he would do SGB for PTSD based on Lipov's work. He declines to do so because of the malpractice implications of performing experimental therapies. I asked if he would do it for 3000.00 and he said no - not without better scientific evidence.

That is very interesting information from another within the direct field.

 

[IchBin]

It worked for me, that is all.

 

[anthony]

It worked for me, that is all.

This is the problem though IchBin... why hasn't Lipov used you and others in a trial. If he started this right from the beginning and ran it over a period of years, collecting the data from each patient after sending them for a psychiatric screening to assess severity... then he would have accumulative data to represent a more accurate result set.

Shit, if he came out and could state it worked for 40% of people, that is 40% of PTSD sufferers that could get relief. The problem though is that these people are all aiming for all or nothing. They want credit for a cure instead of being happy with a major change group. 40% is nothing to be sneezed at.

The top four therapies for PTSD have a success rates ranging from 40% - 80%, yet they're deemed the four major therapies due to capturing such significant portions.

Lipov does himself an injustice by releasing, as Girl3 said best, more an infomercial approach using 8 people, claiming a 70% success rate. As stated, he is trying to claim big numbers from small numbers, instead of going for diverse numbers to release an accurate data range. That could put SGB up with the four top therapies... it may show the risks far outweigh the successes.

This seems to be the problem with most fly by night hypotheses. They want all or nothing, thus they go nowhere fast using that approach.

 

[IchBin]

You're omitting the fact that he has tried very hard to get funding to run larger studies -- at the moment the money is coming from the foundation that he set up, and it doesn't have that much. I really doubt he's got some sort of ulterior motive in mind. He was so proud to show me a map with dots on it of the people who he has helped treat, and he has spoken in front of Congress to try and get federal funding for his study. You seem to be quite negative and critical of him -- why not be optimistic and encouraging instead? He's working hard to try and help people with a debilitating disorder, and if it turns out to help nobody at all (which I think is doubtful), than at least he tried. I might add that the two biggest critics of the efficacy of SGB on this site have never tried it. Just a thought.

At the very least the Navy has thrown some support behind the research and hopefully we'll start to see some larger and more statistically powerful studies come out in the near future. Science works by incrementalism, not fiat, and I think the best approach in the end is one that combines various methods for solving the PTSD puzzle.

Cheers to that --

 

[anthony]

At present I am neither negative nor positive about SGB, because the results simply aren't there.

As Girl3 outlined above, it costs $1500 for him to have a formally recognised study in which he can establish a duration over years, asking his patients (the little dots) whether they would allow him to anonymously use their data within his study results.

Why hasn't this been done at the minimum? Why does it take money from congress to achieve, when all other physicians can run studies without hundreds of thousands of dollars?

I am critical of Lipov's claims at present, not critical of SGB, being an already known. What is not known is whether this established procedure does affect his claimed 70% of PTSD patients successfully or not.

He has this map with dots all over it, as by your own admission, yet these people aren't included in any anonymous data results released. Instead, we get infomercial data sheets containing 8 patients claiming 70% success of lowering PTSD between 30% - 73% or thereabout results.

Again, not positive or negative, critical, yes!

 

[Girl3]

I'm not against any treatment, but it needs to be vetted appropriately. Ich Bin - I'm glad you feel better. Studied in a scientific manner, they may find one day that there is a subset of patients for whom SGB will be helpful. Or they may find it's like marijuana - short term bouancy resulting in long term sinking.

The study of PTSD is still in its infancy - most of the things they've been using/trying on people are based on one of two methods: "lets throw sh#* at the wall and see if it sticks" or "well the imaging/blood/saliva,etc studies show there's too much/too little of X in the patient - so let's give them X or block X and see if that helps." SGB falls into the latter group - too much sympathetic tone is the problem, well then decrease the sympathetic tone. That is how Prazosin and clonidine also work. But decreasing the sympathetic tone relieves symptoms but has not been shown to re-wire the faulty circuits.

[DLMURL]http://www.medscape.com/viewarticle/749564[/DLMURL] comments on one of the studies I participated in - finding out what receptors are changed in PTSD, how the signalling differs - those studies will aid immensely the progress of treating PTSD.

[DLMURL]http://archpsyc.jamanetwork.com/article.aspx?volume=68&issue=9&page=892[/DLMURL] is another portion - like part 2 of the study.

My psychiatrist is now working on another imaging study as well as a drug that will specifically change the CB1 receptors (kind of like anti-marijuana - pot works short term because of the plethora of CB1 receptors, but makes things worse down the road.) None of these studies are going to cure me in the short run, but I feel it is absolutely necessary to figure out "direct" therapies, not symptom cosmetics.

Even in randomized controllled trials where they are just throwing stuff at the wall - someone is keeping real data. Because they do periodic statistical analysis in RCTs, some studies will be shut down early: if they find no benefit or harm, they get closed down. That is why I will only participate in real research.

Not saying that Lipov would do anything underhanded, but there isn't anyone looking over his shoulder, no one is keeping true statistics. If you aren't being seen by a blinded (doesn't know whether you are in the treatment arm or placebo arm.) psychiatrist or psychologist, filling out a bunch of questionaires that are validated (while no single test is perfect for diagnosing PTSD, fulfilling diagnosis criteria is important so that you aren't treating people who don't have PTSD) - then who is going to stop the study if it shows at 6 months people are worse, or no different?

Remember Laetril? The cancer cure? http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/laetrile.html

Even in real studies people can get hurt - but there is a protocol in place to take care of that person. They won't simply disappear because they screw up the statistical curve.

 

[Powder]

What about remission of PTSD symptoms? I had long periods with few symptoms that fit PTSD. Could PTSD be more tricky and hard to trace due to stress's role and the seemingly randomness of good or bad times?

 

[Girl3]

The latency of PTSD and environmental triggers are variables that are known to experts in PTSD, so yes Muse there can be periods where people with PTSD may have few or no symptoms for long periods.