Journal of the American Medical Association, 2007, 297:1757-1758

Epidurals: After Fifty Years, They Are Proven Useless.

The epidural injection of corticosteroids is a standard medical practice for patients with lower back pain and sciatica. Although it is a treatment that has been routinely given to patients for the past 50 years, researchers have only now discovered that the procedure is virtually useless.

Epidurals have some short-term benefit which can last from 2 to 6 weeks maximum but the American Academy of Neurology states that it is no longer a recommended treatment.

The change of heart is based on a study of 300 patients with back pain. It was found that the epidural steroid injection offered no long-term benefits. There was no pain relief or improved movement after 24 hours, nor again at 3, 6, and 12 month intervals. The only improvement was recorded between 2 and 6 weeks. This was so insignificant that it was no better than that offered by pain medications such as bupivacaine.

Overall, epidural injections did not help the patient in his or her day to day functioning, his or her need for surgery, or his or her long-term pain relief.

Tracy Hampton, PhD
ALTHOUGH GIVING EPIDURAL Corticosteroid injections to treat back pain with sciatica has been
an increasingly common practice over the past 50 years, the American Academy of Neurology said that a review of
the literature indicates that the procedure
may have little or no benefit outside of a 2- to 6-week window following treatment (ArmonCet al. Neurology.
2007;68:723-729).
Additional studies are needed, but based on the available evidence, the academy has stated that epidural steroid
injections for improving function,avoiding surgery, or providing long-term pain relief for patients with
radiating back pain are not recommended.
Chronic back pain can be debilitating and expensive. In 1998, for example,patients with back pain in the United
States incurred total health care expenditures of $90.7 billion (Luo X et al.Spine. 2004;29:79-86). Such costs are
generated from inpatient care, office based visits, prescription drugs, outpatient services, and emergency department
visits. Treatments for spinal pain include medical therapy, spinal cord stimulation, intrathecal narcotics, and
epidural steroid injections. For the latter, $49.9 million was claimed in 1999 through Medicare part B for 40.4 million
covered individuals (Carrino JA etal. Radiology. 2002;225:723-729).
While such injections date back to the 1950s, conflicting reviews over the past decade have muddied opinions on their efficacy and safety. “The procedures have been in use, but the kinds of data needed for a balanced assessment of their efficacy and safety are not abundant,” said Carmel Armon, MD, MHS, of their Baystate Medical Center in Springfield, Mass, and the Tufts University School of Medicine, in Boston. To get a better sense of the evidence supporting the use of epidural steroid injections for the treatment of lumbosacral pain that radiates down the leg (also called radicular pain), Armon and fellow members
of the academy’s Therapeutics and Technology Assessment Subcommittee conducted a literature search of relevant
studies. The search turned up 37 articles, but only 4 met the predetermined inclusion criteria: clear case definition, clear measure of pain relief using a standardized measure, use of a control group, randomization and blinding, prospective study design, and adequate statistical analysis. “We found a limited number of studies,
so a major recommendation of the subcommittee is to do additional rigorous studies with good outcome measures”
said Armon. The studies included in the analysis did not thoroughly examine important factors such as patient
responses related to underlying pathology,
duration of symptoms, injection approach, or number of injections.

LIMITED EFFECT
Of the studies assessed, which included approximately 300 patients, theauthors found that epidural steroid injections
may cause some improvement in radicular lumbosacral pain between 2 and 6 weeks after injection. But
the advantage of steroids over control medications such as bupivacaine was limited and usually of questionable
clinical significance. No efficacy was found at 24 hours postinjection, at 3 to 6 months, or 1 year later. The assessment also found that on average, epidural steroid injections had no impact on patients’ day-to-day functioning,
need for surgery, or long-term pain. These therapies are not without merit
for some, however, and they are approved by the National American Spine The American Academy of Neurology says a recent literature review indicates that epidural steroid injections offer little or no long-term benefit for back pain
with sciatica.
Alix/www.sciencesource.com
MEDICAL NEWS
& PERSPECTIVES
©2007 American Medical Association. All rights reserved. (Reprinted) JAMA, April 25, 2007—Vol 297, No. 16 1757
Downloaded from www.jama.com at Univ of Nevada School of Medicine, on February 11, 2008
Society and the American Academy for Orthopedic Surgeons as treatments that are reasonable and efficacious. Future studies of epidural steroid injections for low back pain compared with other therapies should more accurately determine the degree and duration of pain relief and which patients experience clinically meaningful responses, the authors wrote. More information also is needed on the number of treatments required and when they should be administered, as well as whether adverse events are of concern. Reported complications of epidural steroid injections are usually minor and transient, but rare major complications—including aseptic meningitis, bacterial meningitis, and epidural abscess—may result from improperly performed injections. There may be underreporting of complications, particularly from less experienced practitioners, said Armon.
The authors also looked for studies on the use of epidural steroid injections to treat radicular cervical (neck) pain, but
because these studies failed to meet the authors’ inclusion criteria, the academy could not make any recommendations
at this time.

Warning: Acetaminophen May Cause Respiratory Problems
Acetaminophen is a common pain reliever found in many popular over-the-counter drugs, including Tylenol, Anacin-3, and many popular children's cold and flu medications. Previous studies have shown a correlation between acetaminophen intake and an increase in asthma and other respiratory illnesses. Researchers investigated the relationship between analgesic use (i.e., acetaminophen, aspirin, ibuprofen) and the prevalence of asthma, chronic obstructive pulmonary disease (COPD), and lung functioning in adults, via a cross-sectional analysis.
Results: Among the participants, 6.9% had asthma, 11.8% had COPD, and 2.8% had both diseases. Ultimately, researchers concluded that the “study results are consistent with previous research demonstrating a positive association between acetaminophen use and prevalence of asthma. We also investigated the relation of acetaminophen with the prevalence of COPD and found a significant dose-response relation, which was of about the same magnitude as the association for asthma. Increased use of acetaminophen also was associated with decreased lung function, although this effect was seen only in participants reporting daily (or greater) use of acetaminophen.”
Reference: McKeever TM, Lewis SA, Smit HA, et al. The association of acetaminophen, aspirin, and ibuprofen with respiratory disease and lung function. American Journal of Respiratory and Critical Care Medicine 2005;171:966-971.
AHCPR Guidelines Recommend NSAIDs and Acetaminophen -- But How Safe Are They?
But how safe are acetaminophen and NSAIDs? The AHCPR guidelines warned that "high doses of acetaminophen can lead to liver damage, and massive single doses sometimes lead to fatal hepatic necrosis." A study just released in the New England Journal of Medicine1 suggests that 8-10 percent of the 50,000 annual kidney failures in the United States are caused by acetaminophen. A person who takes more than one tablet per day exposes themselves to twice the likelihood of kidney failure.
The paper concludes that a person taking a "cumulative dose of 5,000 or more pills containing NSAIDs" will be almost nine times (8.8) more likely to experience kidney failure. While this sounds like an astronomical intake, it averages out to just one pill every four days throughout the life of an average adult.
The problems don't stop with the liver and kidneys. A meta-analysis published in the Annals of Internal Medicine2 reviewed 16 studies on the potential of adverse gastrointestinal events for NSAIDs users. The authors found that people taking NSAIDs were almost three times as likely to experience serious gastrointestinal problems. And if you're 65 or older and use NSAIDs, you'll have five and one-half times the normal risk of gastrointestinal problems.
According to a study featured in Medical Toxicology,3 gastric pathology is the largest single cause of morbidity and mortality with NSAID use. The author presents a table showing the incidence of gastrointestinal (GI) symptoms in clinical reviews, ranging from 9-37 percent, depending on the particular drug. Ibuprofen had the least incidence of gastrointestinal symptoms, although other studies attribute a higher rate of more serious problems to the drug.
The literature also cites a number of very serious potential side effects including: asthma; bronchospasm; renal papillary necrosis; renal/cardiovascular; direct cell toxicity; chromosome abnormalities; and phototoxicity.
2
While new "pain relievers" are constantly being released on the market, the true incidence and severity of side effects are usually discovered only after the drug has been on the market for several years.
References
1.
Perneger TV, Whelton PK, Klag MJ. Risk of kidney failure associated with the use of acetaminophen, aspirin and nonsteroidal anti-inflammatory drugs. N Engl J Med 1994;331:1675-1678.
2.
Gabriel SE, Jaakkimainen l, Bombardier C. Risk for serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs. Ann Intern Med 1991;115:787-796.
3.
Fowler PD. Aspirin, paracetamol and non-steroidal anti-inflamatory drugs - a comparative review of side effects. Med Tox 1987;2:338-366.
A Dangerous Combination
Researchers interviewed 1,055 pregnant women immediately following conception and up to five months into their pregnancies. (Miscarriage is defined as a natural abortion that occurs prior to 20 weeks gestation.) Participants were asked about their prenatal use of non-steroidal anti-inflammatory drugs (NSAIDs), including inbuprofen, naproxen, or combination thereof (i.e., Advil, Motrin, Naprosyn); drugs containing aspirin (i.e., baby aspirin, Alka Seltzer, Excedrin, Soma); and paracetamol (acetaminophen)-containing drugs (i.e., Tylenol products, Theraflu, Triaminic, Vicodin).
Results: The study concluded that NSAID use was associated with an 80 percent increased risk for miscarriage; the association was even higher if NSAIDs were used around the time of conception or if use lasted for longer than one week. The use of aspirin was associated with a similar outcome; however the use of acetaminophen was not associated with increased risk, regardless of timing and duration of use.
Reference: Li DK, Liu L, Odouli R. Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study. British Medical Journal, Aug. 16, 2003: 327(368).
Beware: Tylenol Toxicity
An appeals court in October upheld a jury's $8 million award to a man whose liver was destroyed by five days of extra-strength Tylenol at normal doses. Apparently, the man's habit of drinking 3-4 glasses of wine each evening amplified the toxicity of the acetaminophen. The court decided that the manufacturer, knowing that a number of medical studies suggested a danger, did not adequately warn the public.
Reference: Associated Press, October 11, 1995.
NSAID Deaths
Advisors to the FDA are expressing concern over signs that many popular nonsteroidal anti-inflammatory drugs are more dangerous than doctors and the public think. Most NSAIDs are believed to contribute to gastrointestinal problems. Forty-one thousand hospitalizations and 3,300 deaths each year are blamed on such side effects. The consumer group Public Citizen is asking the FDA to ban piroxicam (sold as Feldene), a more potent form of this class of drugs used to treat arthritis. According to FDA records, 299 Americans deaths have been linked to this one drug since 1982.
Reference: Associated Press, October 11, 1995.
3
NSAID Use Increases Lymphoma Risk
The cause of Non Hodgkins Lymphoma (NHL) is largely unknown, although a recent study suggests use of nonsteroidal anti-inflammatory drugs (NSAIDs) might play a role in the onset of the disease. The family of NSAIDs includes several over-the-counter medications most people have used before, including aspirin, ibuprofen (Motrin, Advil) and naproxen (Aleve, Naprosyn), and some use at least one of these several times a week. This study evaluated the association between NSAID use and lymphoma risk in 27,290 postmenopausal women, using questionnaire data and a state cancer registry to calculate risks.
Results: Compared with women who did not use NSAIDs at all, women who used either aspirin exclusively or aspirin and another type of NSAID had a greater risk of developing NHL.
Reference: Cerhan JR, Anderson KE, Janney CA, et al. Association of aspirin and other non-steroidal anti-inflammatory drug use with incidence of non-Hodgkins lymphoma. International Journal of Cancer, June 2003:106(5), pp784-88.
Is Your Baby at Risk?
In a recent study in the journal Pediatrics, researchers examined over 7,000 adverse drug reactions in infants under age 2, all submitted to the Food and Drug Administration (FDA) between 1997 and 2000. The authors also determined whether the suspected drugs were transmitted from mother to infant during pregnancy, or if the infant was administered the drug directly.
Less than 1% of the nearly 2,000 drugs identified in the study were associated with over half of all serious or fatal side-effects. Deaths linked to side-effects were far more likely in the first few months after birth (41% in the first month). In a full quarter of cases, drugs were administered to the mother, not the infant, and then passed to the child through the womb or through breastfeeding. Included in the list of the drugs most likely to cause dangerous side-effects in children were ibuprofen and acetaminophen (drugs more commonly known by such brand names as Advil and Tylenol).
Reference: Moore TJ, Weiss SR, et al. Reported adverse drug events in infants and children under 2 years of age. Pediatrics 2002:110(5), p. e53.
Side Effects of Ibuprofen
Brand Name(s): Advil® Caplets®, Advil® Children's, Advil® Cold & Sinus Tablets as a combination product containing Ibuprofen and Pseudoephedrine Hydrochloride, Advil® Cold & Sinus® Caplets® as a combination product containing Ibuprofen and Pseudoephedrine Hydrochloride, Advil® Flu & Body Ache Caplets® as a combination product containing Ibuprofen and Pseudoephedrine Hydrochloride, Advil® Gel Caplets, Advil® Infants' Concentrated Drops, Advil® Junior Strength Chewable Tablets, Advil® Junior Strength Tablets, Advil® Liqui-Gels®, Advil® Migraine®, Advil® Tablets, Dristan® Sinus Caplets® as a combination product containing Ibuprofen and Pseudoephedrine Hydrochloride, Genpril® Caplets ®, Genpril® Tablets, Haltran®, IBU®, Ibu-Tab®, Menadol® Captabs®, Midol® Cramp, Motrin®, Motrin® Caplets®, Motrin® Children's, Motrin® Children's Cold as a combination product containing Ibuprofen and Pseudoephedrine Hydrochloride, Motrin® Drops, Motrin® IB Caplets®, Motrin® IB Gelcaps®, Motrin® IB Tablets, Motrin® Infants' Concentrated Drops, Motrin® Junior Strength, Motrin® Junior Strength Caplets®, Motrin® Migraine Pain Caplets®, Motrin® Sinus Headache Caplets® as a combination product containing Ibuprofen and Pseudoephedrine Hydrochloride, Vicoprofen® as a combination product containing Ibuprofen and Hydrocodone Bitartrate
People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as ibuprofen may have a higher risk of having a heart attack or a stroke than people who do not take these medications.These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time.
NSAIDs such as ibuprofen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or who drink 3 or more alcoholic drinks per day while taking ibuprofen.s
4
Ibuprofen may cause side effects: constipation, diarrhea, gas or bloating, dizziness, nervousness, ringing in the ears, unexplained weight gain, fever, blisters, rash, itching, hives, swelling of the eyes, face, throat, arms, hands, feet, ankles, or lower legs, difficulty breathing or swallowing, hoarseness, excessive tiredness, pain in the upper right part of the stomach, upset stomach, loss of appetite, yellowing of the skin or eyes, flu-like symptoms, pale skin, fast heartbeat, cloudy, discolored, or bloody urine, back pain, difficult or painful urination, blurred vision, changes in color vision, or other vision problems, red or painful eyes, stiff neck, headache, confusion, aggression
Source: http://www.righthealth.com/Health/side_effects_of_ibuprofen/-m-1-od-definition_medmaster_a682159-s
Tylenol (Generic Name: acetaminophen)
Acetaminophen side effects
Allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); blood problems (easy or unusual bleeding or bruising).
Acetaminophen may cause false urine glucose test results.
Source: http://www.drugs.com/mtm/tylenol-oral-rectal.html
The Dangers of Aspirin & NSAIDS
The second major cause for ulcers is irritation of the stomach arising from regular use of non-steroidal anti-inflammatory drugs, or NSAIDs.
What are the Complications of Ulcers?
•
Bleeding: Internal bleeding in the stomach or the duodenum.
•
Perforation: When ulcers are left untreated, digestive juices and stomach acid can literally eat a hole in the intestinal lining, a serious medical problem that requires hospitalization, and often surgery.
•
Obstruction: Swelling and scarring from an ulcer may close the outlet of the stomach, preventing food to pass and causing vomiting and weight loss.
Asymptomatic Patients—Patients Can Have an Ulcer or GI Bleeding without any obvious symptoms
An individual can develop damage to the intestinal lining without being aware of it—significant GI bleeding occurs frequently without any symptoms being present. Of particular concern are patients with arthritic conditions. More than 14 million such patients consume NSAIDs regularly. Up to 60% will have gastrointestinal side effects related to these drugs and more than 10% will cease recommended medications because of troublesome gastrointestinal symptoms.
Source: http://69.20.67.254/patients/women/asprin.asp
Warning On Aspirin, Ibuprofen Use
NSAIDs, including the pain medications aspirin, ibuprofen and naproxen, are one of the leading causes of stomach ulcers and have been associated with side effects ranging from stomach upset to stomach bleeding, which can be life threatening. In fact, NSAID use leads to more than 103,000 hospitalizations and 16,500
5
deaths each year in the United States. That's more deaths than from AIDS and more than four times as many deaths as those from cervical cancer.
Source: http://www.aphroditewomenshealth.com/news/20040424000521_health_news.shtml
Summary of Adverse Effects of Taking
Over The Counter (OTC) Pain Medications
o
Increase in asthma and other respiratory illnesses
o
High doses of acetaminophen can lead to liver damage, and massive single doses sometimes lead to fatal hepatic necrosis (DEATH).
o
Asthma; bronchospasm; renal papillary necrosis; renal/cardiovascular; direct cell toxicity; chromosome abnormalities; and phototoxicity
o
Stomach Ulcers (most common) (Patients Can Have an Ulcer or GI Bleeding without any obvious symptoms)
o
80 percent increased risk for miscarriage
o
Forty-one thousand hospitalizations and 3,300 deaths each year are blamed on such side effects
o
Increased Incidence of Non Hodgkins Lymphoma (Cancer) in women
o
Higher risk of having a heart attack or a stroke
o
Increased risk of Infant Death (Mother consuming NSAIDs) in the first few months of life
o
Allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); blood problems (easy or unusual bleeding or bruising).
o
False urine glucose test results
o
NSAIDs, including the pain medications aspirin, ibuprofen and naproxen, are one of the leading causes of stomach ulcers and have been associated with side effects ranging from stomach upset to stomach bleeding, which can be life threatening. In fact, NSAID use leads to more than 103,000 hospitalizations and 16,500 deaths each year in the United States. That's more deaths than from AIDS and more than four times as many deaths as those from cervical cancer.
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Doctors in denial
Survey Finds Physicians Often Dismiss Complaints About Drugs' Side Effects
http://www.washingtonpost.com/wp-dyn/content/article/2007/08/24/AR2007082401714.html?nav=rss_health
Washington Post Tuesday, August 28, 2007; HE04
According to a survey of 650 patients published in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients' concerns about statin side effects. Because the doctor makes no "adverse event report" to the Food and Drug Administration, the FDA underestimates the problem, and other doctors and patients may assume the drug is safer than it really is.
Statins such as Lipitor and Zocor side effects range from muscle injury to liver and kidney dysfunction. Harvard Medical School professor Jerry Avorn, author of "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs commented: "We already know that there is horrendous underreporting of side effects. Ninety to 99% of serious side effects are not reported by doctors," he said. Yet the FDA relies heavily on their reports. "A fifth of all drugs that fully pass FDA approval will ultimately have black box warnings or be withdrawn from market because of adverse effects," Golomb said.
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