N.I.H.'s MEDLINE - CLINICAL TRIAL SUMMARY REPORTS Check out these clinical trial reports on the efficacy of Depo-Medrol epidurals from NIH's Medline. These summary reports prove that ESI's are worthless. Based on these horrible test results, the FDA and the AMA appear to be operating in a vacuum since they both haven't spoke up. Are they honorary members of the "Flat Earth Society"? You be the judge.
| American Academy of Orthopaedic Surgeons - AAOS
| | March 10-14, 2004 · San Francisco, CA
Podium Presentations | Effects of Epidural Steroids in the Lumbar Spine: A Double Blind Randomized Control Trial Paper No: 188 To Be Held On Friday, March 12, 2004
11:54 AM - 12:00 PM Location: Room 250-262 Daniel Steinitz, MD Belleville ON Canada
Edward J Harvey, MD Montreal QC Canada (*)
Max Aebi, MD Bern Switzerland (*)
Philip Lander, MD Montreal QC Canada (*)
Vincent Arlet, MD Montreal QC Canada (*)
Dante Marchesi Montreal QC Canada (*) Moderator(s) will be: Behrooz A Akbarnia, MD La Jolla CA (e - DePuy Spine)
John A Glaser, MD Charleston SC Spine: This paper reports the results of a randomized, blinded, control trial evaluating the efficacy of epidural and translaminar steroid injections. Hypothesis: The addition of steroid to epidural lumbar injection may provide a measurable functional improvement after treatment.
Method: The high incidence of lumbar pain syndromes has driven the search for an effective strategy for dealing with these patients. Much debate over the efficacy of lumbar steroid injection exists and many studies show conflicting results. Fifty patients were randomized by the even/ odd last digit of their hospital unit number. All patients with previous spinal injection or spinal surgery were excluded. All patients received an epidural injection of Xylocaine and Marcaine and the even group received additional 12mg of betamethasone. All injections were performed by the same interventional radiologist and all injections were confirmed with fluoroscopy and 2ml Omipaque dye. Patients completed all outcome measure questionnaires preinjection, two weeks post injection and two months post injection. All testing was performed by the same blinded research assistant. Summary of results: No differences were found between patients receiving steroids and those that did not, with reference to any outcome measure. Musculoskeletal Functional Assessment (p < 0.29, p<0.68), Bother Index (p<0.50, p,0.22), Functional Index (p<0.22, p<0.73), Oswestry Score (p<0.16, p<0.11), Visual Pain Analogue Score (p<0.50, p<0.18) Conclusion: No significant differences could be detected between patients that did or did not receive steroid injection. This study may provide evidence against the use of steroids in epidural lumbar spinal injections. Floor discussion will immediately follow presentation. J Neurol Neurosurg Psychiatry 2001; 70:433-443 ( April ) Review Intraspinal steroids: history, efficacy, accidentality, and controversy with review of United States Food and Drug Administration reports D A Nelsona b, W M Landauc a Department of Neurology, Thomas Jefferson University Medical College, Philadelphia, PA, USA, b Section of Neurology, Christiana Care Health Systems, Wilmington, DE, USA, c Department of Neurology and Neurological Surgery (Neurology), Washington University School of Medicine, 660 S Euclid Avenue, St Louis, MO 63110-1093, USA
Received 13 March 2000 and in revised form 30 August 2000; Accepted 22 November 2000 Here's the link if you wish to read it: http://jnnp.bmjjournals.com/cgi/content/full/70/4/433
J Bone Joint Surg Am 1985 Jan;67(1):63-6 | | The Use Of Epidural Steroids In The Treatment Of Lumbar Radicular Pain. A Prospective, Randomized, Double-Blind Study. Cuckler JM, Bernini PA, Wiesel SW, Booth RE Jr, Rothman RH, Pickens GT. Seventy-three patients with lumbar radicular pain syndromes were treated in a prospective, randomized, double-blind fashion with either seven milliliters of methylprednisolone acetate, Depo-Medrol, and procaine or seven milliliters of physiological saline solution and procaine. All patients had radiographic confirmation of lumbar nerve-root compression, consistent with the clinical diagnosis of either an acute herniated nucleus pulposus or spinal stenosis. No statistically significant difference was observed between the control and experimental patients with either acute disc herniation or spinal stenosis. Long-term follow-up, averaging twenty months, failed to demonstrate the efficacy of a second injection of epidural steroids administered to the patients whose pain did not respond within twenty-four hours to an injection of either eighty milligrams of methylprednisolone acetate, Depo-Medrol, combined with five milliliters of 1 per cent procaine or two milliliters of sterile saline combined with five milliliters of 1 per cent procaine. Therefore, a decision to use epidural steroids must be made with the realization that we failed to demonstrate its clinical efficacy in this study and that reports of serious complications of this procedure have been published.
Publication Types: Clinical Trial Randomized Controlled Trial PMID: 3155742 [PubMed - indexed for MEDLINE]
| Clin Orthop 1988 Mar;(228):270-2 | | A Retrospective Analysis Of The Efficacy Of Epidural Steroid Injections. Rosen CD, Kahanovitz N, Bernstein R, Viola K. Hospital for Joint Diseases Orthopaedic Institute, New York, New York 10003. Forty patients were studied retrospectively to evaluate the effect of epidural steroid injections on low back pain and sciatica characteristic of spinal stenosis or a herniated lumbar disc. All but one of these patients had radicular symptoms. The average age was 55 years, and the average follow-up time was eight months. All patients were injected by the same anesthesiologist with 2 cc of Depomedrol-40. Thirty-six patients received either one, two, or three injections. Four patients received either four or five injections. The overall results were poor, with about 60% of patients reporting varying degrees of relief from leg and back pain immediately after injection. However, at follow-up examination, only 24% were asymptomatic; 40% reported no change in preinjection numbness, weakness, or pain; and approximately 35% had varying degrees of relief with no consistent pattern. Of those who had complete relief, there was no correlation between relief of pain, age, or number of injections. From this study, it appears that approximately 50% of patients with radicular symptoms may receive temporary relief with steroid injection. However, long-term relief occurs in less than 25% of patients. PMID: 2963720 [PubMed - indexed for MEDLINE] Wish to read more? Go to the "Wecome Page" and click on LINKS.
| | Acta Orthop Scand 1977;48(6):635-41 | | Double Blind Evaluation Of Extradural Methyl Prednisolone For Herniated Lumbar Discs. Snoek W, Weber H, Jorgensen B. A double blind study was carried out in 51 patients suffering from lumbar root compression syndrome of 12 days to 36 weeks duration. All patients had signs, symptoms and radiological abnormalities related to a herniated lumbar disc. Each patient received an extradural injection of either 2 ml (80 mg) methyl prednisolone or 2 ml normal saline solution. Neurological examination and interview of the patients with the aid of a questionnaire before and after extradural injection failed to demonstrate any statistically significant difference in outcome between the two groups. At follow-up 14 +/- 6 months after extradural injection 58.3 per cent of the patients in the control group and 51.9 per cent of the patients in the treatment group had undergone surgical treatment with laminectomy. Our results indicate that a single extradural injection of methyl prednisolone (80 mg) is no more effective than a placebo injection in relieving chronic symptoms due to myelographically demonstrable lumbar disc herniation. Publication Types: Clinical Trial Controlled Clinical Trial PMID: 343479 [PubMed - indexed for MEDLINE]
| Pain 1986 Mar;24(3):277-95 | | Epidural steroid injections for low back pain and lumbosacral radiculopathy. Benzon HT. Non-surgical treatments of back pain may have prolonged and lasting benefit. Epidural steroid injections is one of the non-operative managements of back pain. These injections are recommended in patients with signs and symptoms of nerve root irritation. Relief of pain is attributed to the anti-inflammatory effect of the steroid. Patients with acute radiculopathy have better response compared to patients with chronic symptoms. Improvement may not be noted until 6 days after the injection. The depression of the hypothalamic-pituitary-adrenal (HPA) axis lasts 3 weeks. While complications have been reported, these are rare. Intrathecal steroid injection is not advisable since polyethylene glycol, the vehicle used in depot steroid preparations, may cause arachnoiditis. Publication Types: Clinical Trial Review PMID: 3008063 [PubMed - indexed for MEDLINE]
Epidural Corticosteroid Injections For Sciatica Due To Herniated Nucleus Pulposus. Carette S, Leclaire R, Marcoux S, Morin F, Blaise GA, St-Pierre A, Truchon R, Parent F, Levesque J, Bergeron V, Montminy P, Blanchette C. Department of Medicine, Laval University, Quebec City, Canada. BACKGROUND: Although epidural corticosteroid injections are commonly used for sciatica, their efficacy has not been established. METHODS: In a randomized, double-blind trial, we administered up to three epidural injections of methylprednisolone acetate, Depo-Medrol (80 mg in 8 ml of isotonic saline) or isotonic saline (1 ml) to 158 patients with sciatica due to a herniated nucleus pulposus. All patients had Oswestry disability scores higher than 20 (on a scale of 1 to 100, with scores of 20 or less indicating minimal disability, and higher scores greater disability). RESULTS: At three weeks, the Oswestry score had improved by a mean of -8.0 in the methylprednisolone group and -5.5 in the placebo group (95 percent confidence interval for the difference, -7.1 to 2.2). Differences in improvements between the groups were not significant, except for improvements in the finger-to-floor distance (P=0.006) and sensory deficits (P=0.03), which were greater in the methylprednisolone group. After six weeks, the only significant difference was the improvement in leg pain, which was greater in the methylprednisolone group (P=0.03). After three months, there were no significant differences between the groups. The Oswestry score had improved by a mean of -17.3 in the methylprednisolone group and -15.4 in the placebo group (95 percent confidence interval for the difference, -9.3 to 5.4). At 12 months, the cumulative probability of back surgery was 25.8 percent in the methylprednisolone group and 24.8 percent in the placebo group. CONCLUSIONS: Although epidural injections of methylprednisolone may afford short-term improvement in leg pain and sensory deficits in patients with sciatica due to a herniated nucleus pulposus, this treatment offers no significant functional benefit, nor does it reduce the need for surgery. Publication Types: Clinical Trial Multicenter Study Randomized Controlled Trial PMID: 9171065 [PubMed - indexed for MEDLINE] | |
|
