Prolo GIGO: Critque the **** out of this!

[drusso]

Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain.

Hauser RA1, Lackner JB2, Steilen-Matias D1, Harris DK3.
Author information
Abstract
OBJECTIVE:
The aim of this study was to systematically review dextrose (d-glucose) prolotherapy efficacy in the treatment of chronic musculoskeletal pain.

DATA SOURCES:
Electronic databases PubMed, Healthline, OmniMedicalSearch, Medscape, and EMBASE were searched from 1990 to January 2016.

STUDY SELECTION:
Prospectively designed studies that used dextrose as the sole active prolotherapy constituent were selected.

DATA EXTRACTION:
Two independent reviewers rated studies for quality of evidence using the Physiotherapy Evidence Database assessment scale for randomized controlled trials (RCTs) and the Downs and Black evaluation tool for non-RCTs, for level of evidence using a modified Sackett scale, and for clinically relevant pain score difference using minimal clinically important change criteria. Study population, methods, and results data were extracted and tabulated.

DATA SYNTHESIS:
Fourteen RCTs, 1 case-control study, and 18 case series studies met the inclusion criteria and were evaluated. Pain conditions were clustered into tendinopathies, osteoarthritis (OA), spinal/pelvic, and myofascial pain. The RCTs were high-quality Level 1 evidence (Physiotherapy Evidence Database ≥8) and found dextrose injection superior to controls in Osgood-Schlatter disease, lateral epicondylitis of the elbow, traumatic rotator cuff injury, knee OA, finger OA, and myofascial pain; in biomechanical but not subjective measures in temporal mandibular joint; and comparable in a short-term RCT but superior in a long-term RCT in low back pain. Many observational studies were of high quality and reported consistent positive evidence in multiple studies of tendinopathies, knee OA, sacroiliac pain, and iliac crest pain that received RCT confirmation in separate studies. Eighteen studies combined patient self-rating (subjective) with psychometric, imaging, and/or biomechanical (objective) outcome measurement and found both positive subjective and objective outcomes in 16 studies and positive objective but not subjective outcomes in two studies. All 15 studies solely using subjective or psychometric measures reported positive findings.

CONCLUSION:
Use of dextrose prolotherapy is supported for treatment of tendinopathies, knee and finger joint OA, and spinal/pelvic pain due to ligament dysfunction. Efficacy in acute pain, as first-line therapy, and in myofascial pain cannot be determined from the literature.

KEYWORDS:
dextrose; evidence-based medicine; musculoskeletal pain; osteoarthritis chronic pain; prolotherapy; systematic review

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[DrCommonSense]

Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain.

Hauser RA1, Lackner JB2, Steilen-Matias D1, Harris DK3.
Author information
Abstract
OBJECTIVE:
The aim of this study was to systematically review dextrose (d-glucose) prolotherapy efficacy in the treatment of chronic musculoskeletal pain.

DATA SOURCES:
Electronic databases PubMed, Healthline, OmniMedicalSearch, Medscape, and EMBASE were searched from 1990 to January 2016.

STUDY SELECTION:
Prospectively designed studies that used dextrose as the sole active prolotherapy constituent were selected.

DATA EXTRACTION:
Two independent reviewers rated studies for quality of evidence using the Physiotherapy Evidence Database assessment scale for randomized controlled trials (RCTs) and the Downs and Black evaluation tool for non-RCTs, for level of evidence using a modified Sackett scale, and for clinically relevant pain score difference using minimal clinically important change criteria. Study population, methods, and results data were extracted and tabulated.

DATA SYNTHESIS:
Fourteen RCTs, 1 case-control study, and 18 case series studies met the inclusion criteria and were evaluated. Pain conditions were clustered into tendinopathies, osteoarthritis (OA), spinal/pelvic, and myofascial pain. The RCTs were high-quality Level 1 evidence (Physiotherapy Evidence Database ≥8) and found dextrose injection superior to controls in Osgood-Schlatter disease, lateral epicondylitis of the elbow, traumatic rotator cuff injury, knee OA, finger OA, and myofascial pain; in biomechanical but not subjective measures in temporal mandibular joint; and comparable in a short-term RCT but superior in a long-term RCT in low back pain. Many observational studies were of high quality and reported consistent positive evidence in multiple studies of tendinopathies, knee OA, sacroiliac pain, and iliac crest pain that received RCT confirmation in separate studies. Eighteen studies combined patient self-rating (subjective) with psychometric, imaging, and/or biomechanical (objective) outcome measurement and found both positive subjective and objective outcomes in 16 studies and positive objective but not subjective outcomes in two studies. All 15 studies solely using subjective or psychometric measures reported positive findings.

CONCLUSION:
Use of dextrose prolotherapy is supported for treatment of tendinopathies, knee and finger joint OA, and spinal/pelvic pain due to ligament dysfunction. Efficacy in acute pain, as first-line therapy, and in myofascial pain cannot be determined from the literature.

KEYWORDS:
dextrose; evidence-based medicine; musculoskeletal pain; osteoarthritis chronic pain; prolotherapy; systematic review

Dont have much to say negative about this meta-analysis. Seems pretty comprehensive.

What do you find problematic with it?

 

[drusso]

Dont have much to say negative about this meta-analysis. Seems pretty comprehensive.

What do you find problematic with it?

Does this presage the development of Medicaid Prolotherapy clinics? I could see this penciling out in a HOPD with an employed NP.

 

[DrCommonSense]

Does this presage the development of Medicaid Prolotherapy clinics? I could see this penciling out in a HOPD with an employed NP.

Dont see any issue with this for soft tissue pathology to be honest. PRP data looks even better.

I would think PRP and Prolo would be good options for tendon and ligament pathology unless there is a full thickness tear.

For discogenic back pain, the MSCs are showing superior results to fusion or other conservative treatments as well in multiple RCTs. There are multiple level 1 good quality studies confirming this treatment vs placebo as well with Phase 3 trials going on with the FDA.

 

[clubdeac]

Dont see any issue with this for soft tissue pathology to be honest. PRP data looks even better.

I would think PRP and Prolo would be good options for tendon and ligament pathology unless there is a full thickness tear.

For discogenic back pain, the MSCs are showing superior results to fusion or other conservative treatments as well in multiple RCTs. There are multiple level 1 good quality studies confirming this treatment vs placebo as well with Phase 3 trials going on with the FDA.

can you point me in the direction of these MSC for disc pain studies? Where are they harvesting the MSC's from? A lot of guys in my area are using adipose tissue for their stem cells. This is a pretty bad source from what I've heard, correct?

 

[Ducttape]

Dont see any issue with this for soft tissue pathology to be honest. PRP data looks even better.

I would think PRP and Prolo would be good options for tendon and ligament pathology unless there is a full thickness tear.

For discogenic back pain, the MSCs are showing superior results to fusion or other conservative treatments as well in multiple RCTs. There are multiple level 1 good quality studies confirming this treatment vs placebo as well with Phase 3 trials going on with the FDA.

Didn’t u in the past state that there are no good level 1 studies in all of interventional surgery/medicine????

 

[DrCommonSense]

Didn’t u in the past state that there are no good level 1 studies in all of interventional surgery/medicine????

I never said "all", I said most.

This is largely a product of most procedures/devices/surgeries coming on the market before the concept of double blinded RCTs were ever considered necessary in general.

From stents to stable CAD, to most of orthopedic surgery, to back surgery, etc., very few of these fields had strong "level 1 evidence".

When a large RCT trial over 10 years was done on stents for most stable CAD, it showed no benefit in terms of mortality (COURAGE trial) which was followed up by no benefit over sham for angina pain (LANCET article).

This has been true for almost all of Ortho as well.

In fact, Prolo therapy would have more evidence than most arthroscopic surgeries, shoulder surgeries, etc.

So the vast majority of procedures either lack level 1 evidence or have evidence showing they don't work. Now where do we go from there in terms of policy decisions?

Device companies (Medtronic, Boston Scientific, St Jude's, Stryker), hospitals, physician salaries and even insurance companies would go out of business if we only allowed for procedures that had strong "level 1 evidence" that had a long term followup interval.

Imagine what would happen to Medtronic stock if stents were only allowed for patient pops that had "level 1 evidence"?

 

[clubdeac]

I never said "all", I said most.

This is largely a product of most procedures/devices/surgeries coming on the market before the concept of double blinded RCTs were ever considered necessary in general.

From stents to stable CAD, to most of orthopedic surgery, to back surgery, etc., very few of these fields had strong "level 1 evidence".

When a large RCT trial over 10 years was done on stents for most stable CAD, it showed no benefit in terms of mortality (COURAGE trial) which was followed up by no benefit over sham for angina pain (LANCET article).

This has been true for almost all of Ortho as well.

In fact, Prolo therapy would have more evidence than most arthroscopic surgeries, shoulder surgeries, etc.

So the vast majority of procedures either lack level 1 evidence or have evidence showing they don't work. Now where do we go from there in terms of policy decisions?

Device companies (Medtronic, Boston Scientific, St Jude's, Stryker), hospitals, physician salaries and even insurance companies would go out of business if we only allowed for procedures that had strong "level 1 evidence" that had a long term followup interval.

Imagine what would happen to Medtronic stock if stents were only allowed for patient pops that had "level 1 evidence"?

But how do you make a good control arm for surgery. Isn't it often times extremely difficult to impossible to perform a sham surgery in these cases?

 

[DrCommonSense]

But how do you make a good control arm for surgery. Isn't it often times extremely difficult to impossible to perform a sham surgery in these cases?

Not that complicated for arthroscopic surgeries or stents. Just fake an incision without doing anything else.

All of the "sham" trials concluded these surgeries were no better than sham. They most recent one had to do with shoulder surgery.

 

[clubdeac]

Placebo is a powerful thing