Monday, July 25, 2016

Acupuncture for Chronic Low Back Pain: Treatment Score = 0

I want all medical treatments (Western, Eastern, herbal, alternative) to work all the time with 100% effectiveness. Who would not want this? That would be a great world! —where everyone got cured all the time. I want acupuncture to work, and to work all the time, for everything it is used for.

Doing science-based medicine is a lot like committing murder. There are these medical studies out there and when you first glance at them you really like them. You want to believe what they say. Then you start doing science. You take an ax and you chop off one leg, then an arm, pretty soon another leg, and then another arm. Pretty soon that study is dead. Often, it’s a very unpleasant death and emotionally unsatisfying. You wanted that treatment to work. You wanted the scientific evidence to be there! You wanted that treatment to be alive and well for the benefit of all humankind.

"Killing Your Babies"
Unbiased, objective, science-based medicine is hard. Evidence-based medicine is hard. You must be prepared to “kill your babies.” This means that you must be able to critique and destroy all those medical studies that you once thought were beautiful and deserving.

I have read many books about writing and several have given the advice that you must, “kill your babies.” To be a good writer, you must be able to take something that you have written, which you love, and delete it, because during the editing process you realize it’s not so good after all. I’m not sure who deserves credit for inventing the phrase, “kill your babies.” (If you know please let me know.)

William Faulkner, allegedly deserves credit for, “In writing, you must kill your darlings.” And, the English writer, Sir Arthur Quiller-Couch, allegedly said in a lecture at Cambridge University, “murder your darlings.”

Stephen King wrote in his book, On Writing: A Memoir of the Craft: “Kill your darlings, kill your darlings, even when it breaks your egocentric little scribbler’s heart, kill your darlings.”

When it comes to science-based medicine you must be able to kill your darlings: studies that look good at first, but do not deliver statistical certainty.

Why the Emotional Digression?
Why do I digress before writing about acupuncture? Because it can be so emotionally unsatisfying to do science-based medicine that much of the world simply ignores science. But you are not alone. Others have had to toughen up before you.

Dr. John PA Ioannides is with You
If you believe in science-based medicine, Dr. John PA Ioannidis is a hero. He
famously wrote, “Why Most Published Research Findings Are False.”
(http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124)

More recently he wrote, “Why Most Clinical Research Is Not Useful.”
(http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002049
2016http://dx.doi.org/10.1371/journal.pmed.1002049)

Acupuncture for Chronic Low Back Pain
Because of the emotion sometimes involved, I have given a lot of background explanation before going into the science about why the Treatment Score = 0 for acupuncture for low back pain (at least in this prototype example).

The National Institutes of Health says that: “About 80 percent of adults experience low back pain at some point in their lifetimes.”
(http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm)

If you talk to people, all kinds of treatments for chronic low back pain are bandied about without any “specifications” about how well they actually work. Today it’s different. My physician colleagues and I are on a mission to quantify all medical treatments for all diagnoses. We have invented Treatment Scores (in this form).

First Look
My goal is a simple demonstration of the concept of Treatment Scores, not to create the final product. It will take time to completely develop the Treatment Scores system into everything it needs to be.

What is the Treatment Score for acupuncture for chronic low back pain? By my calculations, the Treatment Score = 0, based on reviewing only one randomized controlled trial as an example, which is why this is a concept essay and not a final product.

The Treatment Score = the net treatment benefit for the patient.

Shared Decision-Making
Do you believe in shared decision-making? Reviewing acupuncture as a treatment for chronic low back pain creates a fantastic example of how shared decision-making should work in the real world. Medicine used to be a dictatorship (paternalistic or maternalistic). The doctor told you “the best thing to do.” With the rise of the Internet, we are starting to have transparency. You now have access to what used to be secret inside information. You and your physician can look at the data together and you, and him or her, can make decisions together. That’s shared decision-making!

The Quality of Studies
A colleague suggested a randomized controlled trial about acupuncture for chronic low back pain to me. I’m grateful, because reading the study has turned into an incredible lesson about the quality of medical studies.

At First Glance
At first glance it looked like an amazing study. It’s a randomized controlled trial! There are 1,549 patients in the acupuncture arm of the study, there are 1544 patients in the control arm of the study. Interestingly, there were 8,537 patients who did not want to be randomized, but did still want to receive acupuncture, and the authors collected data on those patients. That’s an excellent twist to the study.

The study found the “gross treatment benefit” for acupuncture for chronic low back pain at 3 months to be 9.4%.

The Study
This is the study:

"Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain." by Witt CM, Jena S, Selim D, Brinkhaus B, Reinhold T, Wruck K, Liecker B, Linde K, Wegscheider K, and Willich SN.  Am J Epidemiol. 2006 Sep 1;164(5):487-96. Epub 2006 Jun 23.
(http://www.ncbi.nlm.nih.gov/pubmed/16798792)

The full text of this study is available free online:
http://aje.oxfordjournals.org/content/164/5/487.long

The Diagnosis and Personalized Medicine
The diagnosis = chronic low back pain.

But that is not a specific enough diagnosis. Today we want personalized medicine. Therefore, we want to personalize the diagnosis as much as possible to the patient. In this particular situation, I wanted the diagnosis to align exactly with the patients in the study.

The diagnosis = chronic low back pain. However...

The diagnosis = chronic low back pain (in patients with no bulging or herniated discs, no neurologic symptoms, no previous surgery, no infection, no inflammation, no cancer, no autoimmune diseases, and no congenital deformities).

When you eliminate all these things, the diagnosis is basically common chronic low back pain in the typical adult who strained their back.

Follow-Up
The follow-up time period in this study was three months.

Treatment
The patients were treated, on average, with 10 sessions of acupuncture using acupuncture needles. The control group was not treated with acupuncture, but after three months without treatment, they were treated with acupuncture. This was another nice twist to the study.

The Outcome Measure = Main Statistic
The main outcome measure of this study is the Hannover Functional Ability Questionnaire (HFAQ), which is a symptom score to quantify the symptoms of chronic low back pain.

Rating the Study
When doing Treatment Scores, we rate studies on a 100% scale. With 100 being a perfect randomized controlled trial. Normally, randomized controlled trials are rated (in the didecile) between 81 to 100 (Grade A) depending upon how good they are.

Blinding
In a single-blind study, the patients don’t know whether they are receiving the treatment or a placebo. In a double-blind study, the patients don’t know what treatment they are receiving, and the physicians don’t know what treatment they are administering. In a triple blind study, the patients don’t know which treatment they are getting, the physicians don’t know which treatment they are administering, and the people who are doing the medical statistics to report the results for the study don’t know who received the treatment and who received the placebo. Blinding is very important because it removes bias! Without removing bias you cannot get the truth.

Placebo versus Sham
A placebo is a pill that doesn’t work. A placebo pill is also called a “dummy pill.” In the old days, it used to be a sugar pill. Today, a placebo may contain starch or saline, both of which are inactive. When it comes to things like surgery, a placebo is not ideal, because the patient can tell whether they’ve had surgery or not. Therefore, the highest quality randomized controlled trial will use “sham” surgery. An example of “sham surgery” of the knee would be where one group gets put under with anesthesia and then gets the real surgery, but the “sham surgery” group gets put under with anesthesia, but only gets a superficial incision without any actual internal surgery.

An example of “sham acupuncture” would be where one group gets real acupuncture with needles in the traditional acupuncture locations, but where another group gets needles in “sham locations” that have nothing to do with traditional acupuncture.

There is a systematic review of studies that have used sham acupuncture here: (http://www.ncbi.nlm.nih.gov/pubmed/19250001)

With sham acupuncture the needles are inserted in the “wrong points,” that is in locations that are not acupuncture points. With real acupuncture, the needles are inserted into the body in “meridians” as taught by acupuncturists. The meridians are said to correspond to certain areas of the body. You can see an example on YouTube:
https://www.youtube.com/watch?v=CAZ9sL4SMvo

Blinding and Sham Control are Extremely Important!
When I first read the abstract of the study I thought I was going to rate it 82% in quality. However, by the time I was done, I only rated the study 0%. To translate that, instead of rating this study 82 out of 100, or 82% in quality, I rated it 0%.

That’s dismal. The reason the quality rating is so low, is because this study is not blinded or sham controlled. The patients know whether they got acupuncture or not, and they are subject to the placebo effect. They are very likely to report that they received benefit from the treatment when in fact the treatment was no better than placebo.

The gross treatment benefit of 9.4% now has to be modified for lack of certainty. It could all be due to the placebo effect. Mathematically, the gross treatment benefit drops from 9.4% to 0%, because the mathematical certainty of the 9.4% being true is 0%.

All this may seem counter-intuitive. The bottom line is that for a statistic to believable it has to be without bias and without the placebo effect.

So, the gross treatment benefit that I can believe is now 0%. The placebo effect has been proven over and over again in medical studies. It has also been proven to occur with acupuncture.

It’s a shame. The authors spent a lot of time and money doing this study. In many ways, the authors did a nice study. It is randomized; it is controlled. They have a method for handling the patients who refused to be randomized. But by not using blinding and by not doing sham control, they basically turned a randomized controlled trial into a low quality case series study. The gross treatment benefit they published basically cannot be trusted, because it can easily be attributed to the placebo effect.

Emotional Distress
It hurts! I was talking to a physician colleague and we talked about the emotional distress when we review a treatment using science-based medicine and it doesn’t work nearly as well as we had been led to believe. We happened to be talking about amoxicillin for the treatment of otitis media in children. Naturally we wanted amoxicillin to be 100% effective. It’s not nearly that effective. (Stay tuned to this blog for the Treatment Score for that situation later.)

I’m unhappy acupuncture did not do better. I have a physician colleague who very much wants to believe in acupuncture. My preconceived notion was that acupuncture worked, perhaps only mildly, but that it worked. Maybe it does work for other specific diagnoses and based upon other randomized controlled trials. Eventually we will review every diagnosis and treatment using Treatment Scores. Using “big data” techniques and database technology every existing study will be able to be taken into account. This is not the last word on acupuncture, this is a demonstration about Treatment Scores in a specific situation using only one study.

Treatment Scores are still in their infancy and there is more work to do. One of the goals of Treatment Scores is to eventually get all the most objective and highest-quality statistics possible as the starting point.

The Treatment Score Calculator™
If one wanted to get more detailed, the situation may be even worse for acupuncture according to what we know right now from this one study. The Treatment Score may be less than zero. Remember, I started out with a “gross treatment benefit” of 9.4%.


Then when I took the quality of the study into account, the “gross treatment benefit” dropped to 0%, because the study was not blinded or sham controlled.


But the whole purpose of Treatment Scores is to get to the “net treatment benefit.” You can see in the expanded Treatment Score Calculator™ below, that we have a gross treatment benefit of 0%. There were some other potential “positive side benefits” to acupuncture, as there was a 7.9% improvement on the Low Back Pain Rating Scale, and a 1.8% improvement on the Quality of Life Short Form scale.


However, just like 9.4% improvement on the Hanover Functional Ability Questionnaire, those potential benefits also drop to 0%, because of the flaws of the study: no blinding and no sham controls.



That leaves us with only the negative side effects with which to adjust the Treatment Score.



The Net Treatment Benefit
This brings us back to the formula:

The Treatment Score (net treatment benefit) = gross treatment - side effects

When we take the gross treatment benefit of 0 and subtract the negative side effects, we are going to come up with a Treatment Score in the negative range.

It’s hard for people to conceptualize this, because we are dealing with different scales. The main statistic on the left is on one scale, and the secondary statistics on the right are all on an “event rate” scale, and if you look at each statistic individually they are each on their own individual scale.

It’s like gross income and net income. The main statistic on the left is in dollars, and you have to subtract the things on the right which are in different currencies: euros, pounds, francs, and pesos, to come up with the net treatment benefit, which equals the Treatment Score.


When I take the gross treatment score = 0 and subtract the negative side effects of:

54% minor bleeding or hematoma
21% other side effects (not specified)
x% pain caused by getting out and in and out of the car to travel for acupuncture
17% pain from acupuncture needling
0.2% decreased quality of life as measured on the quality of life short form
x% loss of time from undergoing 10 acupuncture sessions
8% suffering negative vegetative symptoms (vegetative functions are things like eating, sleeping, menstruation, bowel function, bladder activity, and sexual performance, that can be made worse by undergoing a painful or emotionally draining treatment)

I can easily justify a Treatment Score of -25%. That’s a negative 25%. For me, the time needed to go to acupuncture treatments is a huge negative. The effort to travel to acupuncture treatments when suffering from low back pain is a huge negative. The 54% incidence of bleeding and hematoma is a serious negative. The 21% incidence of unspecified side effects is a negative. The 17% incidence of pain from the acupuncture treatments is a negative. The 8% incidence of vegetative side effects is a negative.

It’s tricky, because the event rates for the negative side effects on the right have to be converted onto the scale on the left. And those conversions DEPEND ON YOU, THE PATIENT. Eventually, we will show all the math and logic for doing these types of conversions and everything will be transparent. There are things that will help us do such conversions mathematically such as “quality of life studies,” “quality adjusted life-years” and “disability adjusted life-years.”

Shared Decision-Making
The above Treatment Score Calculator™ gives us the ability to do shared decision-making. The patient needs to have input on how much weight to give the side effects on the right side of the Treatment Score Calculator™. For example, one of the negative side effects of acupuncture is the time it takes to undergo 10 sessions. Each session may take two hours between travel time, checking in at the clinic, getting prepared for the acupuncture session, and then undergoing the acupuncture itself. How big of a negative all that time is will vary from patient to patient. However, when you have a Treatment Score Calculator™ like this you can discuss these issues with your physician and do shared decision-making together. This will help you to determine what the Treatment Score is for you, as opposed to somebody telling you what the Treatment Score is for you without knowing your preferences. In other words, you as the patient are now more powerful and can have input into the shared decision-making process. You now have the benefit of treatment transparency.

Caveats
This is only one demonstration example to show the potential of Treatment Scores. This is not the final product of what a Treatment Score will be. In this essay, we only used one randomized controlled study, not the entire body of existing medical literature. This was proof of concept.

Conclusion
We have created a demonstration of how to do a Treatment Score. We have used one randomized controlled study to demonstrate that the Treatment Score for acupuncture for low back pain = 0 or less than zero (if we limit ourselves to the information from this one randomized controlled trial only).

What Needs to Be Done
In the future, we will review the top randomized, sham controlled trials on acupuncture for chronic low back pain. We will see if the Treatment Score moves up or down when other studies are taken into account.

A Study That Needs to Be Done
There needs to be a study that tests if “randomly” sticking acupuncture needles into the human body helps with chronic low back pain. There are theories as to why such needling might work such as:

  • endorphin release
  • the gate theory of pain (stimulating nerves with something different shuts the gate on the stimulation from pain)
  • the triggering of autonomic reflexes
  • triggering the release of neurotransmitters

It’s possible, for example, that physicians without any acupuncture training could place a few acupuncture needles into the lower back of patients with chronic low back pain and achieve all the benefits of the placebo effect, or even do better than the placebo effect. Such treatment might work just as well as acupuncture.

A Final Word
Treatment Scores are in no way against Eastern medical treatments, herbal treatments, or any other form of alternative medical treatment. In fact, we want to report that such treatments work when the science says they work. We already have positive examples. Treatment Scores are for science, they are not for or against any treatment or treatment philosophy.

Treatment Scores are about collecting the hard scientific data and figuring out the net treatment benefit according to the existing medical literature. When we do this, sometimes alternative medical treatments have positive Treatment Scores and sometimes they do not. We will follow the math and science, without bias, wherever they take us, and we will get better at this over time. (See the disclaimers below.)

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DISCLAIMERS:
You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

COPYRIGHT:
Copyright © 2016 Treatment Scores, Inc.

Thursday, July 14, 2016

Why You Need Treatment Scores!

When you do your taxes, you figure out your gross income and net income. Before you undergo a medical treatment, you need to figure out the “gross benefit” and the “net benefit” of that treatment.

Why is this such a big deal? It’s a big deal, because the medical system has never provided Treatment Scores before.

The Treatment Score = the net benefit of the treatment.

Treatment Scores have been a secret, a mystery, unable to be calculated, and have been hidden from you until now (because they are mathematically difficult).

To repeat, the Treatment Score represents the “net treatment benefit for the patient,” which is a long phrase so we simply call it the Treatment Score.

However in the real world:

The Treatment Score = "the net absolute treatment benefit for the patient as determined by the patient during shared decision-making with the physician.”

You can see why we simply call it the Treatment Score!

When you get sick with a disease, you need to review the medical literature for a list of treatments for that disease. In general, the more treatments that exist for a disease, the less effective the treatments are. For example, there are 130 treatments for insomnia, because most of the treatments for insomnia don’t work very well.

There are 57 treatments for an acute migraine headache, because most treatments for an acute migraine headache don’t work very well. There are only a few treatments for stage 1 testicular cancer, because those treatments DO WORK WELL.

When you get diagnosed with any disease, for each and every treatment for that disease, you need to figure out the “gross treatment benefit” for patients that have been treated in the past. Then, you need to figure out the “net treatment benefit” for those same patients, which is the Treatment Score.

Physicians Do Not Know Treatment Scores
You would think that physicians could help you with the "net treatment benefit." They can't. A randomized survey across 8 countries demonstrated that physicians do not understand treatment effects. In that study of 531 physicians, up to 80% of physicians could not correctly identify treatment effects. You have to be your own healthcare advocate. You need to ask, "What is the Treatment Score?" You need to lead the revolution for treatment transparency by asking, "What is the Treatment Score?" to every healthcare non-profit organization and every healthcare provider that you can. Call a disease-related non-profit today and ask them for the Treatment Score (the net treatment benefit) for a treatment listed on their website.
(Source: http://www.cmaj.ca/content/early/2015/10/26/cmaj.150430)

It has always been extremely difficult to produce Treatment Scores. Today, programming makes it possible to create Treatment Scores. Search engine technology makes it possible to find the statistics and database technology makes it possible to organize the statistics. Finally, new statistical methods enable us to calculate Treatment Scores. We have invented the technology you need.

What does all this mean for you? It means for the first time in your life you should ask your physician, “What’s the Treatment Score for that?”

Got breast cancer?
Ask for the Treatment Score for every treatment.

Got prostate cancer?
Ask for the Treatment Score for every treatment.

Got pancreatic cancer?
Ask for the Treatment Score for every treatment.

Got lung cancer?
Ask for the Treatment Score for every treatment.

Call a disease-related non-profit organization and ask:
"What's the Treatment Score for every treatment listed on your website?"

(See the disclaimers below.)

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DISCLAIMERS:
You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

COPYRIGHT:
Copyright © 2016 Treatment Scores, Inc.

Wednesday, July 13, 2016

Transparency of Medical Research

In my practice I see many shoulder injuries.  Patients often come in with shoulder pain, and a rotator cuff tear is diagnosed.  I am not a surgeon, so I typically advise conservative treatment for these patients, to start, unless they are a young athlete with an acute injury, as I have seen many people return to full function without the need for surgery.  I recommend strengthening exercises, steroid injections, PRP injections, and osteopathic manipulations, depending on the medical history and the clinical symptoms.  Most patients vastly improve with these modalities alone.  I do, however, have some patients that end up requiring surgical intervention.

I decided it would be a good idea for me to calculate the "net treatment benefit" of conservative treatment and surgery, for rotator cuff tears.  I wanted to know the Treatment Score for each modality.  This way I could actually inform my patients of the success of conservative treatment versus surgical intervention, so as to give my patients the best possible chance for a full recovery, in the shortest amount of time.

I went to PubMed to look up studies on surgery versus conservative treatment for rotator cuff tears.  I actually found 2 studies on just this!  I went to the first study, which is titled, "Surgery or conservative treatment for rotator cuff tear:  a meta-analysis."  I was able to pull up the abstract, and saw that the conclusion was that conservative treatment was, in fact, just as good as surgery.  I wanted to know more:  how was the study done, what exactly was the difference in outcomes between the two treatment modalities, what is the actual percent improvement in each treatment?  I really was excited to enter these numbers into the STAR blocks.  I then tried to pull up the full text in order to fully understand the study, and was not able to.  I would be billed if I wanted to read the rest of the study!  My search was then over.  I cannot actually quantify the net treatment benefit of surgery or of conservative treatment for my patients.  I cannot go back and tell my patients that I have clear evidence that one way to treat their rotator cuff tear is better than another way.

This is a big problem with medicine these days.  Neither physicians, nor patients, can easily access all good studies, and determine what the best treatment is.  Studies need to be made public so that physicians and patients, alike, can determine the best possible treatment for every disease and injury out there.  Research needs to be transparent for full understanding.  If we can quantify and compare every treatment for every disease, then we would be able to more effectively eradicate and fix injuries and diseases that affect us every day.

Here at Treatment Scores, I am aiming to consolidate this information into an unbiased, and freely accessible source of information so that we can truly move forward in the healing and health of the world.

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DISCLAIMERS:
You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

COPYRIGHT:
Copyright © 2016 Treatment Scores, Inc.


Thursday, July 7, 2016

Stem Cells for Treatment of Hip Osteonecrosis in Sickle Cell Patients

Stem cell treatment for a variety of conditions is becoming more and more mainstream.  More and more research is being done to evaluate the efficacy of stem cell treatments in a variety of diseases.  I became interested in this particular subject, as I recently had a patient with osteonecrosis of the femoral neck.  Hip necrosis can be found in a variety of patient types.  It is common in children, young athletes, and patients who suffer from sickle cell disease.  It can also be seen in patients who have used short term or long term steroids.  The typical treatment for this condition is a hip replacement.  This is generally not a good option for young people, as it will require more hip replacements down the line.

I found a physician in my area that is treating these young people with bone marrow stem cells.  I was fascinated with his new approach to this disease, as it seems to absolve the need for a hip replacement.  This treatment has not been around for very long, so long term outcomes are still pending.  However, short term outcomes are very promising.

Anyhow, I decided to get online and see if any longer term studies have been done on this subject. The only study that I could find evaluated the use of bone marrow stem cells in patients with sickle cell disease.  The study I found was a prospective, uncontrolled study.  This made it simple to put into a STAR™ block.



As you can see above, there was only a 17.4% improvement in the Harris Hip Score after the procedure.  However, after taking into consideration the risk of infection from the procedure, the overall treatment grade decreased slightly.  Once I added back some points for no longer needing surgery, decrease cost to the patient, and less time lost from work, the overall treatment grade remained the same, despite the number itself increasing.  

The Treatment Score may decrease further as we continue to implement guidelines for Treatment Scores. We are learning to compare the certainty of statistics from different types of studies. A randomized, blinded, placebo-controlled study might have a different outcome, and possibly a much lower improvement on the Harris Hip Score. The point we want to make with our early examples is that treatments can be quantified to create treatment transparency. (See the disclaimers above and below.)




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DISCLAIMERS:
You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

COPYRIGHT:
Copyright © 2016 Treatment Scores, Inc.

Wednesday, July 6, 2016

NEEDLES IN MY BACK? (PART 1)

Shooting, stabbing or even throbbing pain radiating from your back to buttock, upper thigh and even your toes! Tingling and numbness, muscle aches and spasms. Limited flexibility. If you can relate to these symptoms, then you probably know all about chronic back pain (CBP). CBP is low back pain that persists for more than 3 months and can make life miserable. It is very common and unfortunately, has no specific pathology. This means any possible treatments prescribed are done so to alleviate the pain and increase range of motion rather than to cure. Effectiveness of conventional standard treatments, such as drug therapy or surgery, has yet to be clearly established. There are, however, many adjunctive and alternative therapies that have been shown to provide some temporary relief from pain. Therapy options may include acupuncture, exercise/physical therapy, and spinal manipulation.
I will be concentrating on acupuncture, which is used by 11% of people afflicted with CBP. Witt et al. investigated the effectiveness of acupuncture in the treatment of CBP in a randomized control trial (RCT) plus a nonrandomized cohort. The study was very interesting and insightful when comparing the effects of acupuncture in randomized and nonrandomized groups. I started filling out the STARTM Blocks with the details of the study. I placed my Main Statistic as “Pain Resolution” and then realized that this would be troublesome since pain is subjective and difficult to score. Therefore, I used the same main outcome as the RCT, “Back Function” where the Hannover Functional Ability Questionnaire was used for scoring. You will notice that my Relevance score (out of a maximum 100) is 90. Even though this is a very well designed RCT with a control group, it has some limitations. These include no blinding of the providers (physicians) or patients to the treatment and a fairly short follow-up time of 3 months. Hence my score of 90. The study details can be found below:






  
The Treatment Grade for acupuncture in CBP patients is “E”. 







I was surprised by this score, especially since the study was a well-controlled RCT and had highly significant results showing acupuncture was associated with marked clinical improvements.

But what about the side effects, whether positive or negative, of acupuncture? Do they have an effect on the Treatment Grade? Tune in to Part 2 to see if my prediction of the Treatment Grade changing once I readjust the Treatment Score based on positive and negative side effects such as quality of life and needle pain, respectively. In part 3, I will create more STARTM Blocks by including additional RCTs comparing acupuncture to sham and routine treatments for CBP in order to strengthen my Treatment Score. (See the disclaimers below)
References:

  1. Last AR et al. Chronic low back pain: evaluation and management. Am Fam Physician 2009;79(12):1067-74.
  1. Witt CM et al. Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. Am J Epidemiol 2006;164:487-496.
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DISCLAIMERS:
You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

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Copyright © 2016 Treatment Scores, Inc.​



Monday, July 4, 2016

IV Chelation: Decreasing your Risk of Cardiovascular Death: Treatment Score = 33

Four years ago, a study was completed, which evaluated the effects of IV chelation on cardiovascular disease.  This was a huge study, researched over 5 year's time, with almost 2,000 participants.  Many physicians in the traditional medical world believed that alternative medical practitioners were "quacks" if they treated their patients with IV chelation. According to traditional physicians, there was no proof that IV chelation actually worked to reduce cardiovascular disease. It was thought that alternative medical doctors were unnecessarily taking money from patients for costly interventions. Alternative medical physicians, on the other hand, argued that traditional medical doctors were, in fact, the ones doing unnecessarily costly procedures to patients, in the name of medicine. While I'm not going to presently evaluate the effectiveness of more traditional cardiac procedures such as stents and angioplasty, I will discuss the recent findings of the TACT study (Trial to Assess Chelation Therapy).

The TACT study separated patients into 2 IV chelation groups (with supplements and with placebo supplements) and 2 placebo chelation groups (with supplements and with placebo supplements). The study involved a total of 1,708 patients. The patients selected had a prior heart attack and were over 50 years old. During the trial, the patients were also encouraged to continue their present medications. After 5 years of studying these patients, and each patient receiving 40 total chelations, the results were actually astounding! It was found that the patients who underwent IV chelation had an 18% reduction, as compared to placebo, in all cause mortality (heart attack, stroke, coronary revascularization or hospitalization for angina). In the diabetic patients who were treated with IV chelation, their risk of all cause mortality decreased by 41%!

Once the numbers were placed into the treatment score calculator, the results were as follows:


As you can see from above, despite diabetic patients having such great outcomes, the final Treatment Score is still only a 33. This low score is taking into account that the non-diabetic patients did not have as good results as the diabetic patients.  I also had to take into account, the cost and time it would take patients to do these infusions weekly.  After I added and subtracted all of these numbers, a Treatment Score of 33 was given to IV chelation for heart disease. (Eventually, all the mathematical calculations will be made transparent in the system and will be visible for review. Treatment Scores are in the early stages of development.)

This study was very eye opening to traditional medical physicians.  In fact, they are presently trying to replicate this study (something that is never done), since the results were truly unbelievable for many "traditional" practicing physicians. (See the disclaimers below and also those linked to at the top of the blog.)

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You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

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Sunday, July 3, 2016

Steroid injections, a success?

It has been common medical practice for years, to use steroid injections throughout the body to help control inflammation and pain.  I have many patients who constantly ask me if steroid injections are just a "bandaid" for their pain, or if the steroid injection is actually going to help treat their pain long term.

The Treatment Score = the net treatment benefit for the patient.

The knee is a very common location of pain and osteoarthritis.  It makes sense, then, that this would be the first location that I would chose to research for the efficacy of steroid injections.  There have been many articles published that relate to knee osteoarthritis and the efficacy of steroid injections.  After I looked up many articles, I realized that it would be almost impossible to compare more than one article.  One reason for this is that, in order for people to study a particular disease, and get the outcomes that they desire, they have so many different inclusion criteria for participants.  Some studies cut off participants based on age, some are based on perceived level of pain, and others are based on MRI findings.  No of these studies can be compared to the other, as the patient populations all tend to be different.  In medicine, we cannot assume that just because one treatment works for one particular group of people, that it will have the same effects on another group.

I decided to pick a study that used pain as the basis for their inclusion criteria.  This study also measured synovial tissue volume, which is a direct measurement of inflammation in the joint.  What I found was actually incredible!



The part of this study that amazes me, is that it had to be divided into "responders" and "non responders" due to the high (71%) rate of people who relapsed within 6 months.  Above is the score for the non responders, and below is the score for the responders.  Despite the poor response to steroid injections of the majority of the participants, the authors still concluded that steroid injections are a good treatment option for patients with knee osteoarthritis.  This conclusion actually blows my mind!  As you can see above, the main statistic for the non responders is a zero.  I had to increase that score to a 1, just so that it would register in our treatment calculator and get a grade.  But, after 6 months, most of the people in the study had increased pain as compared to baseline.  I'd say this is a good enough reason for a low grade.

Below is the score for the responders (23% of participants).  This score was increased due to a decrease in pain and a decrease in inflammation after 6 months.





As you can see above, the treatment grade overall for steroid injections to the knee is extremely low. Admittedly, I only graded the injection at the 6 month follow up point.  Had I used the 1 week point of follow up, the score definitely would have been higher, as people did respond quickly to the injection.  But this is not what I was interested in.  Though some people are interested in short term relief of painful symptoms, most patients at least want to know long term outcomes of treatment.

Though patients did have decreased knee pain after a week, most patients had increased pain from baseline after 6 months.  I would not call this a successful treatment.  Additionally, in this study, higher doses of steroids were used than in a typical practice, which may make the results appear even better than they may have if using therapeutic doses of steroids and not supratherapeutic dosing.

As you can see, results like this make it difficult to actually understand which treatments are beneficial to patients.  Knowing this information, I will personally use steroids more judiciously.  I am not saying that they don't have a place (like if someone needs immediate, short term, pain relief). I am just saying that we cannot rely just on what has been taught to us for years, and we, as physicians, need to more fully understand the actual efficacy of each treatment we prescribe to our patients.  It is our hopes, through Treatment Scores, that we can help increase both patient and physician knowledge in this way and positively affect the practice of medicine. (See the disclaimers below.)

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DISCLAIMERS:
You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

COPYRIGHT:
Copyright © 2016 Treatment Scores, Inc.