Controversia-advertencia sobre esteroides epidurales en la FDA.
Epidural steroid warning controversy still dogging FDA.
Manchikanti L, Candido KD, Singh V, Gharibo CG, Boswell MV, Benyamin RM, Falco FJ, Grider JS, Diwan S, Hirsch JA. Pain Physician. 2014 Jul-Aug;17(4):E451-74. Abstract On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence. PDF
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Inyección torácica epidural interlaminar en el manejo del dolor crónico del tórax. Estudio randomizado....
Thoracic interlaminar epidural injections in managing chronic thoracic pain: a randomized, double-blind, controlled trial with a 2-year follow-up.
Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM.
Pain Physician. 2014 May-Jun;17(3):E327-38
Abstract
BACKGROUND: Reports of prevalence of spinal pain indicate the prevalence of thoracic pain in approximately 13% of the general population compared to 32% of the population with neck pain and 43% of the population with low back pain during the past year. Even though, thoracic pain is less common than neck or low back pain, the degree of disability resulting from thoracic pain disorders seems to be similar to other painful conditions. Interventions in managing chronic thoracic pain are also less frequent, leading to the paucity of literature about various interventions in managing chronic thoracic pain. Thoracic intervertebral discs and thoracic facet joints have been shown to be pain generators, even though thoracicradicular pain is very infrequent. Thoracic epidural injections are one of the commonly performed procedures in managing thoracic pain. The efficacy of thoracic epidural injections has not been well studied. STUDY DESIGN: A randomized, double-blind, active controlled trial. SETTING: Private interventional pain management practice and specialty referral center in the United States. OBJECTIVE: The primary objective was to assess the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief and improving function in patients with chronic mid and/or upper back pain. METHODS:
One hundred and ten patients were randomly assigned into 2 groups with 55 patients in each group receiving either local anesthetic alone (Group I) or local anesthetic with steroids (Group II). Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Outcomes were assessed utilizing Numeric Rating Scale (NRS), the Oswestry Disability Index (ODI) 2.0, employment status, and opioid intake. The patients experiencing greater than 3 weeks of significant improvement with the first 2 procedures were considered as successful. Others were considered as failed participants. Significant improvement was defined as a decrease of greater than 50% NRS scores and ODI scores with measurements performed at baseline, 3, 6, 12, 18, and 24 months post treatment.
RESULTS: Significant improvement was seen in 71% in Group I and 80% in Group II at the end of 2 years with all participants; however, improvement was seen in 80% and 86% when only successful patients were considered. Therapeutic procedural characteristics showed 5 to 6 procedures per 2 years with total average relief of 80 weeks in Group I and 78 weeks in Group II in the successful patient category; whereas, it was 71 and 72 weeks when all patients were considered. LIMITATIONS: Limitations of this assessment include lack of a placebo group.
CONCLUSIONS: Based on the results of this trial, it is concluded that chronic thoracic pain of non-facet joint origin may be managed conservatively with thoracic interlaminar epidural injections with or without steroids.
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