Would you believe that clinical research is important?

An example of why clinical research is important to the practicing doctor

by Henry Davld Nava Dlmaano on Saturday, July 9, 2011 at 3:33pm

A longtime friend of mine, whom I'll refer to here as P.A., happens to be consulting me for chronic low back pain with radiating pain/numbness/pins-&-needles sensation to both left & right legs.  The symptoms started over a year ago (nearly two years now), particularly for the left leg & back.  Now, her right leg also has symptoms.  She happens to be a year older than me, is athletic, does gym & other physical activities, has a healthy lifestyle with no vices.  

She's never had any major trauma, but she was part of the Judo team back when she was a college student.  No medical problems other than this one.  taking her cue from my prior advice, she's had an MRI scan done for her lower back at National Kidney Transplant Institute (she spent about P9k for it, about as much as you'd spend if you had it done here in Cebu City).  What it revealed was L4-L5 and L5-S1 bilateral foraminal stenosis stemming from degenerative disc disease & facet joint hypertrophy of the same levels.  So I've advised her to consider surgery, especially since she's symptomatic for nerve impingement for over a year now (going past the 1-year mark is normally not a good idea, as recovery of nerve function following decompressive surgery is significantly poorer if you've allowed the nerve under impingement to remain so for more than a year).  Her main setback is the cost of undergoing surgery; so right now, she's managing the BACK pain symptoms using acupuncture.

Here's a transcript of our most recent conversation via live chat:

P.A.

The doc here at the acupuncture clinic says that with the [acupuncture] treatment we should be able to address the injury [she means the degenerative spine disease], not just the pain -- and I may not need surgery. Is that possible?

 

H.D.

he's going to REVERSE the degenerative process with acupuncture? hmm.  seems like i'm going to have to give you a crash course on clinical medical research methodology here.  Hold on to your seat.

okay.  well, you can always try going alternative while you're waiting for a shot at definitive surgery.  i don't know the PROVEN clinical impact of acupuncture (OTHER THAN for pain relief) well enough to vote for or against that claim.  but the good thing is, you can always ask your acupuncturist for HARD CLINICAL RESEARCH DATA that proves acupuncture can do what he says it can do -- remove the need for surgical decompression.  and by "remove the need for surgery", i don't mean just the short-term effects; we measure the clinical benefit of surgery in terms of YEARS (with 2-year post-operative follow-ups being the MINIMUM requirement for efficacy surveillance).  so i guess you'd want to see hard data from THOUSANDS of acupuncture patients with the SAME DISEASE AS YOU -- and you'd want to see how acupuncture can save their impinged nerves without them having to later undergo surgery anyway (as compared to patients who DON'T undergo acupuncture AND instead have surgical treatment for their radiculopathies).

without clinical research data like that to convince you about the SAFETY & EFFICACY PROFILE of the treatment in question, i'd say the claim that acupuncture can CURE YOU TOTALLY is about as good as saying MX3 or Circulan can cure you totally.  (we always say that the first precept of medical practice is "first, do no harm".  treatments don't always work; but even if they don't, the least you can do is make sure the patient doesn't end up with a complication in the process of treatment. hence, the need for research data that can prove SAFETY, and preferably, EFFICACY of the treatment.  take your acupuncture for example: it's both safe & effective for controlling your back pain, or any other type of pain -- and THAT'S PROVEN BY RESEARCH.  but the question here is: can it safely & effectively cure degenerative lumbar radiculopathy without the need for later surgery?)

now here's what you need to do: ask your acupuncturist for STUDIES (yes, more than one research) that are "clinical trials" or "prospective clinical cohorts" with "adequately powered samples" & "clinical outcome measures that are blinded".  (nevermind what that means -- if the research has any of these features, it will likely declare itself as having such.)

in particular, you'd like the research data to have the ff features:

> LARGE clinical trial or LARGE prospective cohort (preferably a multi-center study);

> must be something that actually compares ACUPUNCTURE versus SURGICAL DECOMPRESSION as treatments;

> must include patients that actually have lumbosacral RADICULOPATHY -- patients that are strictly screened for, and fit the clinical description of, a patient suffering from lumbosacral nerve impingement due to narrowed canals (no more, no less);

> must have at least 2 years' worth of post-treatment ff-up data (each patient is regularly checked up for 2 years right after the treatment protocol is FINISHED -- not 2 years after the symptoms start, or, not 2 years after the patient enters the study pool);

> the sample of patients at the END of the study must relatively be equivalent to the sample at the BEGINNNING (i.e., not many patients were lost to ff-up during the entire duration of the study -- about 80% of the original patients should still be accounted for at the end, in order for the study to be credible);

> there must be NO TREATMENT CROSS-OVERs -- where patients undergoing acupuncture later cross over to the surgery side, or patients who had surgery cross over to the acupuncture side;

> treatment success must be measured by ANY OR ALL of the ff CLINICAL OUTCOME MEASUREMENT TOOLS -- the VAS score for pain (back pain AND leg pain), the Roland-Morris Disability Questionnaire for degenerative spine disease, the Oswestry Disability Index for back pain, and maybe even the SF-36 questionnaire (these are all world-accepted VALIDATED TOOLS for evaluating clinical functionality of patients with back problems; any other means of measuring or defining "treatment success" just won't cut it);

> outcome measurement (as mentioned above) must be "blinded" -- i.e., the research person doing the measurement(s) over the entire ff-up period MUST NOT KNOW if the patient he/she is evaluating is a patient belonging to the acupuncture group or the surgery group (in order to prevent BIAS TO TREATMENT EFFECTS from occurring on the part of the evaluator);

> the complication rates of both acupuncture & surgical decompression must be reported in detail -- and remember that "failure of primary treatment" is in itself a complication (e.g., you get the acupuncture, symptoms are relieved for a while, but then they come back, and you eventually need surgery for it).  [note also that there are other complications to consider: risk of getting an infection from bacteria or viruses; risk of delay of definitive treatment; risk of developing chronic pain which is non-responsive to any treatment; risk of paralysis; even risk of dying from a procedure, although that's actually close to nil, even for spine surgery.]

if your acupuncturist can show you at least 3 studies [i wouldn't want to settle for just ONE study, i'd like to at least base my decisions on a consensus of 3 studies] which meet all these requirements, then you have my vote for going alternative instead of having the surgery.  i know it seems too technical; but you see, saving patients' lives is a technical task to begin with -- which is why the research & evidence-gathering involved is also quite technical.  think of it as proof that we doctors don't take our patients' problems lightly.  ^_^

and besides, any medical practitioner who knows what he/she is doing should also intimately know the hard basis for whatever he/she does.  if you don't know the hard science behind your practices, how would you be sure that your practices are SAFE & EFFECTIVE, right?  (by "science", i am referring to the scientific method of research.)  this is, to a large extent, what you pay good money for -- to make sure that your medical care provider actually knows his/her stuff.  because why would any patient bother spending good money on a practitioner who doesn't really know if what he's doing is rational or not?

bottom line: is it possible for him to do what he says acupuncture can do? yes -- but he has to first show some hard evidence that it really can.

P.A.

what he said was that I MAY not need surgery, not that I definitely won't need it.  in any case, it's good for the pain so that's what I keep going back for :)

when he told me that what I said was that I am definitely getting another MRI before surgery if only so we can see if there has been any improvement to my back.

H.D.

what he's implying is that you may not FEEL THE NEED to have surgery done if you are kept pain-free (which is most likely true for any patient -- no symptoms, no need for any further treatment).  but the question that you have to ask him is, can he guarantee that you're nerves won't get damaged from progressive degenerative compression just the same, EVEN THOUGH THE ACUPUNCTURE KEEPS YOU PAIN-FREE?  because i'm pretty sure that no amount of acupuncture (or any other treatment offering mere symptomatic, non-decompressive releif) can reverse the degenerative changes in your spine that are causing nerve compression.

i'll make him a bet. get the MRI after his treatment is done. if it shows any improvement in the size of your foraminal canals [compared to the first MRI scans from last month], i'll pay for the MRI. but if it doesn't show any change, he pays for it. deal

i'm serious with that bet. i say put your money where your mouth is.

P.A.

hahaha ... I'll have to tell him that first. :D

 

H.D.

for the sake of image uniformity, you have to get the MRI repeat scan also in NKTI, where you had the first one done.

although essentially, from the standpoint of orthopedics, you don't need a repeat MRI -- not unless your symptoms grow worse and/or you end up waiting maybe more than a year from the first MRI scan before you have any surgery done. if your symptoms don't worsen, we can assume that the involved levels of your lumbar spine are status quo. although it's highly likely that the canals will get narrower over time. how much time till things worsen PARTLY depends on how much load you place on your back.

P.A.

I will surely do that. the equipment is good and the price is even better :)