Intraspinal steroids: History, efficacy, accidentality, and controversy with review of United States Food and Drug Administration reports

Journal of Neurology Neurosurgery and Psychiatry

Volumn 70, Issue 4, 2001, Pages 433-443

  Nelson, D A ^a,b   Landau, W M ^c  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b CHRISTIANA CARE HEALTH SYSTEM   (United States)

^c WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CORTISONE;

DRUG EFFICACY; EPIDURAL SPACE; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; REVIEW; STEROID THERAPY; UNITED STATES;

EID: 0035056625     PISSN: 00223050     EISSN: None     Source Type: Journal    
DOI: 10.1136/jnnp.70.4.433     Document Type: Review

References (151)

1. Cathelin MF. Mode d'action de la cocaine injectee dans l'espace epidural par le procede du canal sacre. CR Soc Biol (Paris) 1901;53:478-9.
2. De Pasquier M, Leri M. Injections intra et extra-durales de cocaine a dose minime dans le traitement de la sciatique. Valeur comparee des deux methods: resultats immediats et tardifs. Bull Gen Ther 1901;142:196-223.
3. Sicard MA. Les injections medicamenteuses extra-durales par voie, sacro-coccygienne. CR Soc Biol (Paris) 1901;53: 396-8.
4. Viner N. Intractable sciatica: the sacral epidural injection: an effective method of giving relief. Can Med Assoc J 1925;15: 630-4.
5. Evans W. Intrasacral epidural injection in the treatment of sciatica. Lancet 1930;16:1225-28.
6. Mason HL, Myers CS, Kendall EC. The chemistry of crystalline substances isolated from the suprarenal gland. J Biol Chem 1936;114:613-31.
7. Mason HL, Myers CS, Kendall EC. Chemical studies of the suprarenal cortex II. The definition of a substance which possesses the qualitative action of cortin; its conversion into a diketone closely related to androstenedione. J Biol Chem 1936;116:267-76.
8. Hench PS, Kendall EC, Slocumb CH, et al. The effect of a hormone of the adrenal cortex (17-hydroxy-11-dehydrocorticosterone: compound E) and of pituitary adrenocorticotrophic hormone on rheumatoid arthritis; preliminary report. Proc Staff Meet Mayo Clin 1949;24: 181-97.
9. Hench PS, Kendall EC, Slocumb CH, et al. Effects of cortisone acetate and pituitary ACTH on rheumatoid arthritis, rheumatic fever and certain other conditions. Arch Intern Med 1950;85:545-66.
10. Hollander JL. The local effects of compound F (hydrocortisone) injected into joints. Bull Rheum Dis 1951;2:3-4.
11. Gifford RH. Corticosteroid therapy for rheumatoid arthritis. Med Clin North Am 1973;57:1179-89.
12. Wilkens RF, Dahl SL. Therapeutic controversies in the rheumatic diseases. Orlando, Grune and Stratton, 1987: 72-8.
13. Maddison PJ, Isenberg DA, Woo P, et al. Oxford textbook of rheumatology. Oxford, Oxford University Press, 1993: 334-6.
14. McCarty DJ, Koopman WJ. Arthritis and allied conditions. A textbook of rheumatology. Philadelphia, Lea and Febiger, 1993:715-18.
15. Schimmer BP, Parker KL. Adrenocorticotrophic hormone; adrenocortical steroids and their synthetic analogs; inhibitory of the synthesis and actions of adrenocortical hormones. In: Hardman JG, Limbird LE, eds. Goodman and Gillman's the pharmacological basis of therapeutics, 9th ed. New York, McGraw-Hill, 1996:1459-79.
16. Wilder RL. Corticosteroids. In: Kooperman WJ, ed. Arthritis and allied conditions, 13th ed. Baltimore Williams and Wilkins, MD:1997:731-17.
17. Robecchi A, Capra R. L'idrocortisone (composto F). Prime esperienze cliniche in campo reumatologico. Minerva Med 1952:2:1259-63.
18. Lievre JA, Bloch-Michel H, Pean G, et al. L'hydrocortisone en injection locale. Revue du Rhumatisme et des Maladies Osteo-articulares 1953;20:310-11.
19. Brown JH. Pressure caudal anesthesia and back manipulation. Northwest Med 1960;59:905-9.
20. Goebert HW, Jallo SJ, Gardner WJ, et al. Sciatica: treatment with epidural injections of procaine and hydrocortisone. Cleveland Clinic Quarterly 1960;27:191-7.
21. Goebert HW, Jallo SJ, Gardner WJ, et al. Painful radiculopathy treated with epidural injections of procaine and hydrocortisone acetate: results in 113 patients. Anesthesia Analg 1961;40:130-4.
22. Gardner WJ, Goebert HW, Sehgal AD. Intraspinal corticosteroids in the treatment of sciatica. Trans Am Neurol Assoc 1961;86:214-15.
23. Sehgal AD, Gardner WJ, Dohn DF. Pantopaque "arachnoiditis" treatment with subarachnoid injection of corticosteroids. Cleveland Clinic Quarterly 1962;29:177-88.
24. Winnie AP, Hartman JT, Meyers HL, et al. Pain clinic II: intradural and extradural corticosteroids for sciatica. Anesth Analg 1972;51:990-9.
25. El-Khoury GY, Ehara S, Weinstein JN, et al. Epidural steroid injection: a procedure ideally performed with fluoroscopic control. Radiology 1988;168:554-7.
26. Rosen CD, Kahanovitz N, Bernstein R, et al. A retrospective analysis of the efficacy of epidural steroid injections. Clin Orthop 1988;228:270-2.
27. Power RA, Taylor GJ, Fyfe IS. Lumbar epidural injection of steroid in acute prolapsed intervertebral discs a prospective study. Spine 1992;17:453-5.
28. Bowman SJ, Wedderburn L, Whaley A, et al. Outcome assesment after epidural corticosteroid injection for low back pain and sciatica. Spine 1993;18:1345-50.
29. Dullerud R. Morland TJ. Adhesive arachnoiditis after lumbar radiculography with Dimer-X and Depo-Medrol. Radiology 1976;119:153-5.
30. Duchesneau PM, Weinstein MA, Wesolowski DP. Lumbar arachnoiditis: long term effects of intrathecal Depo-Medrol (presented at annual meeting ASNR, New Orleans, Louisiana, 1978). Neuroradiol 1978;15:244.
31. Sehgal AD, Gardner WJ. Place of intrathecal methylprednisolone acetate in neurological disorders. Trans Am Neurol Assoc 1963;88:275-6.
32. Sehgal AD, Tweed DC, Gardner WJ, et al. Laboratory studies after intrathecal corticosteroids. Arch Neurol 1963;9:64-8.
33. Kamen GF, Erdman GL. Subdural administration of hydrocortisone in multiple sclerosis: effect of ACTH. J Am Geriatr Soc 1953;1:794-804.
34. Boines GJ. Remissions in multiple sclerosis following intrathecal methylprednisolone acetate. Del Med J 1961;33: 231-5.
35. Boines GJ. Predictable remissions in multiple sclerosis. Del Med J 1963;35:200-3.
36. Goldstein NP, McKenzie BF, McGuckin WF. Changes in cerebrospinal fluid of patients with multiple sclerosis after treatment with intrathecal methylprednisolone acetate: a preliminary report. Proc Mayo Clin 1962;37:657-68.
37. Van Buskirk C, Poffenbarger AL, Capriles LF, et al. Treatment of multiple sclerosis with intrathecal steroids. Neurology 1964;14:595-7.
38. Goldstein NP, McKenzie BF, McGuckin WF, et al. Experimental intrathecal administration of methylprednisolone acetate in multiple sclerosis. Trans Am Neurol Assoc 1970;95:243-1.
39. Nelson DA, Vates TS, Thomas RB. Complications from intrathecal steroid therapy in patients with multiple sclerosis. Acta Neurol Scand 1973;49:176-88.
40. Dilke TFW, Burry HC, Grahame R. Extradural corticosteroid injection in the management of lumbar nerve root compression. BMJ 1973;2:635-7.
41. Snoek W, Weber H, Jorgensen B. Double blind evaluation of extradural methyl prednisolone for herniated lumbar discs. Acta Orthop Scand 1977;48:635-41.
42. Klenerman L, Greenwood R. Davenport HE, et al. Lumbar epidural injections in the treatment of sciatica. Br J Rheumatol 1984;23:35-8.
43. Cuckler JH, Bernini PA, Wiesel SW, et al. The use of epidural steroids in the treatment of lumbar radicular pain. J Bone Joint Surg 1985;67A:63-6.
44. Carette S, Leclaire R, Marcoux S, et al. Epidural corticosteroid injections for sciatica due to herniated nucleus pulposus. N Engl J Med 1997;336:1634-40.
45. Fukusaki M, Kobayashi I, Hara T, et al. Symptoms of spinal stenosis after epidural steroid injection. Clin J Pain 1998;14:148-51.
46. Davis R, Emmons SE. Benefits of epidural methylprednisolone in a unilateral lumbar discectomy: a matched controlled study. J Spinal Disord 1990;3:299-307.
47. Lavyne MH, Bilsky MH. Epidural steroids, postoperative morbidity, and recovery in patients undergoing microsurgical lumbar discectomy. J Neurosurg 1992;77:90-5.
48. McNeill TW, Andersson GBJ, Schell B, et al. Epidural administration of methylprednisolone and morphine for pain after a spinal operation. J Bone Joint Surg 1995;77: 1814-18.
49. Lutze M, Stendel R, Vesper J, et al. Periradicular therapy in lumbar radicular syndromes: methodology and results. Acta Neurochir (Wien) 1997;139:719-24.
50. Lutz GE, Vad VB, Wisneski RJ. Fluoroscopic transforaminal lumbar epidural steroids: an outcome study. Arch Phys Med Rehabil 1998;79:1362-6.
51. Devulder J. Transforaminal nerve root sleeve injection with corticosteroids, hyaluronidase, and local anesthetic in the failed back syndrome. J Spine Disord 1998;11:151-4.
52. Kraemer J, Ludwig J, Bickert U, et al. Lumbar epidural perineural injection: a new technique. Eur Spine J 1997;6:357-61.
53. Marks RC, Houston T, Thulbourne T. Facet joint injection and facet nerve block: a randomized comparison in 86 patients with chronic low back pain. Pain 1992;49:325-8.
54. Needham CW. Painless lumbar surgery: morphine nerve paste. Connecticut Med 1996;60:141-3.
55. Hurlbert RJ, Theodore N, Drabier JB, et al. A prospective randomized double-blind controlled trial to evaluate the efficacy of an analgesic epidural paste following lumbar decompressive surgery. J Neurosurg 1999;4 Suppl:191-7.
56. Bannwarth B, Schaeverbeke T, Pehourcq F, et al. Prednisolone concentrations in cerebrospinal fluid after oral prednisone. Rev Rhum 1997;64:301-1.
57. Porsman O, Friis H. Prolapsed lumbar disk treated with intramuscularly administered desamethasonephosphate. A prospectively planned, double-blind, controlled clinical trial in 52 patients. Scand J Rheumatol 1979;8:142-4.
58. Oppenheimer JH, Reister WH. Influence of cortisone on leptomeningeal reaction induced by talc. Proc Soc Exp Biol Med 1953;83:844-7.
59. Feldman S, Behar AJ. Effect of intrathecal hydrocortisone on advanced adhesive arachnoiditis and cerebrospinal fluid pleocytosis. An experimental study. Neurology 1961;11: 251-6.
60. Pospiech J, Pajonk F, Stolke D. Epidural scar tissue formation after spinal surgery: an experimental study. Eur Spine J 1995;4:213-9.
61. Spaccarelli K. Lumbar and caudal epidural corticosteroid injections. Mayo Clin Proc 1996;71:169-78.
62. Rydevik BL, Cohen DB, Kostuik JP. Spine epidural steroids for patients with lumbar spinal stenosis. Spine 1997;22: 2313-17.
63. Saal JS, Franson RC, Dobrow R, et al. High levels of inflammatory phospholipase A2 activity in lumbar disc herniations. Spine 1990;15:674-8.
64. Haddox JD. Lumbar and cervical epidural steroid therapy. Anesthesiology Clinics of North America 1992;10:179-203.
65. Lindblom K, Rexed B. Spinal nerve injury in dorso-lateral protrusions of lumbar disks. J Neurosurg 1948;5:413-32.
66. Lindahl O, Rexed B. Histologic changes in the spinal nerve roots of operated cases of sciatica. Acta Orthop Scand 1951; 20:215-25
67. Gibbs M. Personal communication, April 14, 1999.
68. Bogduk N. Spine update epidural steroids. Spine 1995;20: 845-8.
69. Burn JM, Langdon L. Duration of action of epidural methyl prednisolone. A study of patients with the lumbosciatic syndrome. Am. J Phys Med 1974;53:29-34.
70. Johansson A, Hao J, Sjolund B. Local corticosteroid application blocks transmission in normal nociceptive C-fibers. Acta Anaesthesiol Scand 1990;34:335-8.
71. Ridley MG, Kingsley GH, Gibson T, et al. Outpatient lumbar epidural corticosteroid injection in the management of sciatica. Br J Rheumatol 1988;27:295-9.
72. Kaplan HI, Sadock BJ. Comprehensive textbook of psychiatry/V.5th ed. Vol 2. Baltimore: Williams and Wilkins, 1989:1289-90.
73. Raj PP. Practical management of pain. St Louis: Mosby Year book, 1992:76-7.
74. Vroomen PCAJ, deKrom MCTFM, Wilmink JT, et al. Lack of effectiveness of bed rest for sciatica. N Engl J Med 1999; 340:418-23.
75. Renfrew DL, Moore TE, Kathol MH, et al. Correct placement of epidural steroid injections: fluoroscopic guidance and contrast administration. AJNR Am J Neuroradiol 1991;12:1003-7.
76. Deveux JA, Vandenhaute A, Deheck M. Arachnoidite apporue au cours d'un traitment par les injections sousarachnoidiennes d'hydrocortisone. Rev Neurol 1956; 94:301-4.
77. Bernat JL. Intraspinal steroid therapy. Neurology 1981;31: 169-71.
78. Nelson DA. Intraspinal therapy using methylprednisolone acetate. Twenty-three years of clinical controversy. Spine 1993;18:278-86.
79. Nelson DA. Arachnoiditis from intrathecally given corticosteroids in the treatment of multiple sclerosis. Arch Neurol 1976;33:373.
80. Dougherty JH, Fraser RAR. Complications following intraspinal injections of steroids. J Neurosurg 1978;48: 1023-5.
81. Bernat JL, Sadowsky CH, Vincent FM, et al. Sclerosing pachymeningitis, a complication of intrathecal administration of Depo-Medrol for multiple sclerosis. J Neurol Neurosurg Psychiatry 1976;39:1124-8.
82. Roche J. Steroid-induced arachnoiditis. Med J Aust 1984; 140:281-1.
83. Johnson A, Ryan MD, Roche J. Depo-Medrol and myelographic arachnoiditis. Med J Aust 1991;155:18-20.
84. Wilkinson HA. Intrathecal Depo-Medrol: a literature review. Clin J Pain 1992;8:49-56.
85. Rivera VM. Safety of intrathecal steroids in multiple sclerosis. Arch Neurol 1989;46:718-19.
86. Nelson DA. Further warnings from Australia concerning intraspinal steroids. Arch Neurol 1991;48:259.
87. National Health and Medical Research Council. Epidural use of steroids in the management of back pain. Canberra: Commonwealth of Australia, NHMRC, 1994:1-76.
88. Goucke CR, Graziotti P. Extradural abscess following local anesthetic and steroid injection for chronic low back pain. Br J Anaesth 1990;65:427-9.
89. Bromage PR. Spinal extradural abscess: pursuit of vigilance. Br J Anaesth 1993;70:471-3.
90. Chan SZ, Leung S. Spinal epidural abscess following steroid injection for sciatica. Spine 1989;14:106-8.
91. Shealy CN. Dangers of spinal injections without proper diagnosis. JAMA 1966;197:1104-6
92. Roberts M, Sheppard Gl, McCormick RC. Tuberculous meningitis after intrathecally administered methylprednisolone acetate. JAMA 1967;200:894-6.
93. Elliott RH, Collett BJ. Delayed septicaemia after extradural steroid treatment. Br J Anaesth 1992;68:103-4.
94. White AH. Injection techniques for the diagnosis and treatment of low back pain. Orthop Clin North Am 1983;14:553-67.
95. Abel R, Nelson DA, Bernat JA, et al. Complications from methylprednisolone acetate (Depo-Medrol when injected into the orbit, subarachnoid, or subdural spaces. Del Med J 1977;49:331-13.
96. Nelson DA. Methylprednisolone acetate. Arch Neurol 1979; 36:661-2.
97. Gutknecht DR. Chemical meningitis following epidural injections of corticosteroids. Am J Med 1987;82:570.
98. Abram SE. In reply: Nelson DA. Perceived dangers from intraspinal steroid injections. Arch Neurol 1989;46:719-21.
99. Nelson DA. Dangers from methylprednisolone acetate by intraspinal injection. Arch Neurol 1988;45:804-6.
100. Haynes GH, Bailey MK, Davis S, Mahaffey JE. Use of methylprednisolone in epidural anesthesia. Arch Neurol 1989;46:1167.
101. Nelson DA. Pain in multiple sclerosis. Neurology 1989;39: 1000-1.
102. Nelson DA. Dangers from intraspinal steroid injections. Arch Neurol 1990;47:255.
103. Strong WE, Wesley R, Winnie AP. In reply: Nelson DA. Epidural steroids are safe and effective when given appropriately. Arch Neurol 1991;48:1012-13.
104. Siller KA, Panasci D, Geocadin R, et al. Catastrophic central nervous system dysfunction during methylprednisolone injection for refractory pain syndromes: report of 2 cases. Ann Neurol 1995;38:297-8.
105. McLain RF. Point of view. Spine 1997;22:1562.
106. Parent T. Carpenter's human neuroanatomy. 9th ed. Philadelphia: Williams and Wilkins, 1996:93-8.
107. Wilson RS, Havener WH, McGrew RN. Bilateral retinal artery and choriocapillaris occlusion following the injection of long-acting corticosteroid suspensions in combination with other drugs: I. clinical studies. Ophthalmology 1978;85:967-74.
108. Whiteman DW, Rosen DA, Pinkerton RMH. Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. Am J Ophthalmol 1980;89:851-3.
109. Thomas EL, Laborde RP. Retinal and choroidal vascular occlusion following intralesional corticosteroid injection of a chalazion. Ophthalmology 1986;93:405-7.
110. Shantha TR, Evans JA. The relationship of epidural anesthesia to neural membranes and arachnoid villi. Anesthesiology 1972;37:543-57.
111. Haymaker W, Adams RD. Histology and histopathology of the nervous system. Springfield, Illinois: Charles C Thomas, 1982:585-8.
112. Thompson SJ, Lomax DM, Collett BJ. Chemical meningism after lumbar facet joint block with local anesthetic and steroids. Anesthesia 1991;46:563-4.
113. Sugar O. Steroid injections. Surg Neurol 1983;19:91.
114. Hodges SD, Castleberg RL, Miller T, et al. Cervical epidural steroid injection with intrinsic spinal cord damage two case reports. Spine 1998;23:2137-42.
115. Victory RA, Hassett P, Morrison G. Transient blindness following epidural analgesia. Anesthesia 1991;46:940-1.
116. Ling C, Atkinson PL, Munton CGF. Bilateral retinal haemorrhages following epidural injection. Br J Ophthalmol 1993;77:316-17.
117. Kushner FH, Olson JC. Retinal hemorrhage as a consequence of epidural steroid injection. Arch Ophthalmol 1995;113:309-13.
118. Poulton TJ, Pero B, Defalque RJ, et al. In reply: Kushner FH, Olson JC, Williams RC, et al. Retinal hemorrhage as a consequence of epidural steroid injection. Arch Ophthalmol 1996;114:361-3.
119. Purdy EP, Ajimal GS. Vision loss after lumbar epidural steroid injection. Anesth Analg 1998;86:119-22.
120. Usubiaga JE, Usubiaga LE, Brea LM, et al. Epidural and subarachnoid space pressures and relation to postspinal anesthesia headache. Anesth Analg 1967;46:293-6.
121. Feldman S, Behar AJ. Effect of intrathecal hydrocortisone on advanced adhesive arachnoiditis and cerebrospinal fluid pleocytosis. An experimental study. Neurology 1961;11: 251-6.
122. Feldman S. Electrical activity of the brain following cerebral micro-infusion of cortisol. Epilepsia 1971;12:249-62.
123. Eldervik OP, Haughton VM, Ho K, et al. Ineffectiveness of prophylactic intrathecal methylprednisolone in myelography with aqueous media. Radiology 1978;129:99-101.
124. Wood KM, Arguelles J, Norenberg M. Degenerative lesions in rat sciatic nerves after local injections of methylprednisolone in sterile aqueous suspension. Regional Anesthesia 1980;5:13-15.
125. Mackinnon SE, Hudson AR, Gentili F, et al. Peripheral nerve injection injury with steroid agents. Plast Reconstr Surg 1982;69:482-9.
126. Selby R. To the editor. Neurosurgery 1983;12:591.
127. Benzon HT, Gissen AJ, Strichartz GR, et al. The effect of polyethylene glycol on mammalian nerve impulses. Anesth Analg 1987;66:553-9.
128. Abram SE, Marsala M, Yaksh TL. Analgesic and neurotoxic effects of intrathecal corticosteroids in rats. Anesthesiology 1994;81:1198-205.
129. Cicala RS, Turner R, Morgan E, et al. Methylprednisolone acetate does not cause inflammatory changes in the epidural space. Anesthesiology 1990;72:556-8.
130. Byrod G, Olmarker K, Konno S, et al. A rapid transport route between the epidural space and the intraneural capillaries of the nerve roots. Spine 1995;20:138-43.
131. Latham JM, Fraser RD, Moore RJ, et al. The pathologic effects of intrathecal betamethasone. Spine 1997;22:1558-62.
132. Hilda T, Chandler D, Arena JE, et al. Exsperimental and clinical observations of the intraocular toxicity of commercial corticosteroid preparations. Am J Ophthalmol 1986; 101:190-5.
133. Loewenstein A, Zemel E, Lazar M, et al. The effects of Depo-Medrol preservative on the rabbit visual system. Invest Ophthalmol Vis Sci 1991;32:3053-60.
134. Lowenstein A, Lazar M, Zemel E, et al. Corticosteroid vehicle toxicity. Ophthalmic Surgery 1992;23:367.
135. Kent GC. Comparative anatomy of the vertebrates. 7th ed. St Louis, MO: Mosby Year Book, 1992:612-14.
136. King CC, Hart LL. Epidural administration of methylprednisolone acetate preserved with benzyl alcohol. Ann Pharm 1994:28:59-60.
137. Stephenson MG. Dear doctor/pharmacist letter from The Upjohn Company: neza formulation of Depo-MedrolR.June 14, 1991. Kalamazoo, MI: Upjohn, 1991.
138. Winnie AP. Methylprednisolone acetate suspension (without benzyl alcohol). Regional Anesthesia 1991;16:301.
139. Freedman JM, Li DK, Drasner K, et al. Transient neurologic symptoms after spinal anesthesia. An epidemiclogic study of 1863 patients. Anesthesiology 1998;89:633-41.
140. Rallings MC. Celestone chronodose: epidural use. Anesthesia and Intensive Care 1991;19:302-3.
141. Koch-Weser J, Sellers EM, Zacest R. The ambiguity of adverse drug reactions. Eur J Clin Phannacol 1977;11:75-8.
142. Inman WH. Monitoring for drug safety. Philadelphia: JB Lippincott, 1980:36-7,115-26.
143. Faich GA. Adverse drug reaction monitoring. N Engl J Med 1986;314:1589-92.
144. Faich GA, Lawson DH, Tilson HH, et al. Clinical trials are not enough: drug development and pharmacoepidemiology. Journal of Clinical Research and Drug Development 1987;1:75-8.
145. Scott HD, Rosenbaum SE, Walters WJ, et al. Rhode Island physicians' recognition and reporting of adverse drug reactions. Rhode Island Medical Journal 1987;70;311-16.
146. Serradel J, Bjornson DC, Hartzema AG. Drug utilization study methodologies: national and international perspectives. Drug Intelligence and Clinical Pharmacy 1987;21:994-1001.
147. Strom BL, Tugwell P. Pharmacoepidemiology: current status, prospects, and problems. Ann Intern Med 1990;113: 179-81.
148. Begaud B, Yoride Y, Tubert-Bitter P, Chasliere A, Haramburu F. False positives in spontaneous reporting: should we worry about them? Br J Clin Phannacol 1994;38:401-1.
149. Goldman SA. The clinical impact of adverse event reporting. Rockwell, MD: Medwatch, Food and Drug Administration. MFDA, October 1996:1-11.
150. Nelson DA. Coccydynia and lumbar disk disease: historical correlations and clinical cautions. Perspect Biol Med 1991;34:229-38.
151. Justins DM. Management strategies for chronic pain. Ann Rheum Dis 1996;55:588-96.