 May-June 2007; Issue 9
Bleak Results in European Cancer Pain Study
Morphine For End-of-Life Pain Doesn’t Hasten Death
Chronic Pain Can Impair Memory, Attention
Activity Improves Health Ratings of Patients With Fibromyalgia
Gabapentin Reduces Pain & Symptoms of Fibromyalgia
Acupuncture Not Recommend for Fibromyalgia
Surgery vs Nonsurgical Therapy for Sciatica Pain Compared
Topical Anesthetic Better at Reducing Wound-Closure Pain
Male Migraineurs at Higher Risk for Cardiovascular Events
Barbiturates, Opioids May Be Overused As Migraine Therapy
Survey of CAM Therapy in Patients With Chronic Pain
Glucosamine, Ibuprofen Ineffective for Muscle Pain
Antioxidants Offer Pain Relief in Chronic Pancreatitis
Supplementary Omega-3 Polyunsaturated Fat Eases Pain
Hypnotherapy Effective for Abdominal Pain Relief in Children
Recent Drug and Device Approvals and Announcements
This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN [WD], and edited by Stewart B. Leavitt, MA, PhD [SBL]. Medical reviewers were: James D. Toombs, MD; Lee A. Kral, PharmD, BCPS; Steven Tucker, MD, FACP;
Paul W. Lofholm, PharmD, FACA. Posting Date: June 25, 2007.
Where noted, product brand names are for informational purposes only and are registered trademarks of their respective manufacturers. In some cases, additional brands may be available for specific products.
The European Pain in Cancer (EPIC) survey, involving more than 4,000 cancer patients in 12 countries across Europe, was the largest ever of its type to investigate the impact and treatment of pain in cancer. The survey revealed that 2 out of 3 persons with cancer are in pain and, despite the availability of medicines that can control their pain, and one third of the patients indicated that the pain is sometimes so bad they feel like they want to die.
The survey also revealed key factors relating to the impact of pain on the sufferer’s quality of life:
- Cancer patients who experienced pain during the last month reported that the pain was frequent and long lasting; almost 1 in 3 had endured pain for more than a year.
- More than half of patients reported moderate to severe pain levels; however, 1 in 5 of these patients were not receiving pain management treatment.
- More than two thirds of those interviewed felt that their cancer pain created difficulty in performing activities of daily living.
- 42% of patients felt their pain had affected their relationship with their family. Two-thirds of these patients felt that people around them did not understand how much pain they were experiencing.
- Nearly two thirds of patients reported that there were times when their prescribed treatment was not enough to control the pain. About 62% of those taking prescribed drugs for their pain still experienced intense bursts of pain – over half of these patients experienced breakthrough pain at least once a week, and 25% endured this type of pain daily.
- Only 36% of cancer patients reporting pain received a strong opioid analgesic.
- As adjunctive therapy, 66% of patients used alternative methods such as heat and massage to try to control their pain, while a third resorted to non-prescription painkillers.
Clinical Implications: The survey shows that pain can significantly reduce the quality of life in cancer patients and, oftentimes, appears to be inadequately treated. Unfortunately, most of the patients interviewed in this study reported that the topic of pain was only discussed when the patient was proactive in addressing it with the clinician. One quarter of patients reported that their doctor did not always ask about their pain, and one third perceived that their doctor did not have enough time to discuss their pain.
The implication here is that better communication is needed, and clinicians should be initiating a discussion of pain with each cancer patient. Additionally, one researcher asserted that practitioners should ensure that “less effective drugs are not continued when a stronger alternative could significantly improve pain management and, therefore, quality of life.”
 For more complete information on the EPIC survey released June 8, 2007, go to: http://www.paineurope.com/index.php?q=en/book_page/epic_survey (access checked 6/9/07).
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In palliative pain management, respiratory depression is the most feared opioid-related side effect and researchers at the Cleveland Clinic found that studies on this topic were lacking. They conducted a study to evaluate if parenteral-opioid titration for cancer pain was associated with evidence of hypoventilation as an indicator of respiratory depression.
Subjects with severe cancer pain were eligible if they were not oxygen-dependent and were admitted for parenteral-opioid titration to relieve poorly controlled pain. End-tidal carbon dioxide (ET-CO2), oxygen saturation, respiratory rate (RR), and vital signs were monitored daily until pain control was achieved. The primary outcome assessment was changes in ET-CO2 during opioid titration for optimal pain control.
For the 29 patients completing the study, results showed that mean ET-CO2 levels were not significantly different between baseline and the point of achieving pain control (p = 0.14). No patient had an ET-CO2 >/= 50 mmHg and all patients maintained oxygen saturation >/= 92%. Two patients experienced a transient drop in RR below 10/minute. The results suggest that patient death is not hastened by respiratory depression.
Clinical Conclusion: The researchers report that the safe use of morphine for palliative pain relief is dependent on physician’s knowledge of recent advances in understandings of opioid prescribing techniques. In an editorial published in the same issue of Palliative Medicine (p. 77), Rob George, MD, and Claud Regnard, MD, encourage clinicians to learn the facts about opioids and to “feel free to manage pain with doses adjusted to individual patients.”
Reference: Estfan B, Mahmoud F, Shaheen P, et al. Respiratory function during parenteral opioid titration for cancer pain. Palliat Med. 2007(Mar);21(2):81-86.
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Researchers at the University of Alberta, Canada, have confirmed that, besides physical discomfort, chronic pain can impair memory and concentration. Participants in their study (n=24) --all of whom had pain lasting 6 months or longer -- were given computerized tests of working memory and a neuropsychological test of attention on separate "pain" and "less pain" days.
On the "less pain day,” participants were tested after receiving a pain-reducing procedure as part of their ongoing treatment. On the "pain day,” participants were tested without having received a pain-reducing procedure, when their pain was reported to be at a high level. Sixteen participants (67%) showed significant cognitive impairment due to pain on their pain testing day.
The researchers suggest that pain may disrupt the maintenance of the memory trace that is required to hold information for processing and retain it for storage in longer-term memory. In other words, chronic pain can, quite literally, drive people to distraction.
Reference: Dick BD, Rashiq S. Disruption of attention and working memory traces in Individuals with chronic pain. Anesth Analg. 2007;104:1223-1229. Also reported in Science Daily.
[Commentary: According to the researchers, quoted in Science Daily, “The sample of individuals included in the study may be small, but the statistically significant findings are robust.” They further note that “as much as 44% of the population -- in Canada as well as in the US and Europe -- experience pain on a regular basis, and that in approximately one-quarter of this group the pain is severe." The implication is that ineffectively treated or untreated chronic pain could result in large numbers of persons in workplaces, driving cars or operating machinery, and the like who have cognitive deficits in attention and memory. This could pose a serious public safety hazard. Another concern is that these patients may have trouble complying with medication regimens, especially if they are complex. Both of these safety concerns are important reasons that effective treatments for chronic pain should be a priority for all healthcare practitioners. – SBL]
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Researchers at the Johns Hopkins School of Medicine tested the effects of a lifestyle physical activity (LPA) program on health status, pain, fatigue, and function in adults with fibromyalgia syndrome (FMS). Forty-eight sedentary adults with FMS were randomized to either LPA or an FMS-education control (FME) group. LPA participants gradually worked toward accumulating 30 minutes of self-selected moderate-intensity physical activity 5 to 7 days per week. Overall, 34 participants (71%) completed the study.
The LPA group increased their physical activity by 70%, as assessed by pedometer, and 71% of them reported that their health status was significantly improved, compared with only a quarter (25%) of the FME group (p = 0.013). However, there were no statistically significant post-intervention differences between LPA and FME groups in pain, fatigue, FMS impact, or 6-minute walk distance.
Clinical Implications: In this small study, LPA group members were able to increase their physical activity and, consequently, improve their global ratings of FMS-related health status. Although certain factors, such as pain or fatigue might not be improved, lifestyle physical activity could be an effective way of encouraging persons with FMS to become more active and better cope with their illness.
Reference: Fontaine KR, Haaz S. Effects of Lifestyle Physical Activity on Health Status, Pain, and Function in Adults with Fibromyalgia Syndrome. J Musculoskelet Pain. 2007(Mar);15(1):3-9.
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The objective of a study supported by the US National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMSD) was an evaluation of the efficacy and safety of gabapentin, an anticonvulsant, in patients with fibromyalgia. A randomized, double-blind 12-week trial compared gabapentin 1,200 mg/day to 2,400 mg/day (n=75 patients) with placebo (n=75 patients) to evaluate the efficacy and safety of treating the widespread muscle pain and tenderness that is often associated with fibromyalgia.
Average pain severity scores, assessed with an 11-point Brief Pain Inventory (BPI), were the primary outcome measure and treatment response was defined as a score reduction of =/> 30%. Treatment group patients demonstrated a significant improvement in BPI average pain severity score (p = 0.015) at week 12, and 51% of participants in the treatment group achieved response at end point compared with 31% of placebo-treated patients (p = 0.014). The gabapentin group also showed significant improvement in 6 additional measures of symptom relief when compared with placebo; however, improvements were not significant for the average tender-point pain threshold or depression rating scale. The drug was well tolerated by the majority of patients; dizziness and sedation, of mild to moderate severity in most cases, were the most common adverse effects.
Clinical Conclusion: Overall, patients taking gabapentin reported significant improvements in pain, as well as better sleep and less fatigue — good news because current fibromyalgia treatments are only modestly effective in this regard. Gabapentin has been FDA-approved as an anticonvulsant and was used off-label for this 12-week trial; therefore, longer study periods with a larger population are warranted. In a related news story (Science Daily), Lesley Arnold, MD, stated that the mechanism by which gabapentin works to reduce pain is uncertain, but adds that it is possible that the drug “reduces calcium flow into the nerve cells to reduce the release of some of the pain signaling molecules.”
Reference: Arnold LM, Goldenberg DL, Stanford SB, et al. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007(Apr);56(4):1336-1344.
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Investigators in the UK conducted an updated systematic review to explore the benefits of acupuncture for the symptomatic treatment of fibromyalgia. A search of 7 electronic databases discovered only 5 randomized controlled trials (RCTs) meeting inclusion criteria, all of which used acupuncture as an adjunct to conventional treatments. The methodological quality of the trials was mixed and frequently low, precluding a meta-analysis of data. Three RCTs (using electroacupuncture) suggested positive but mostly short-lived effects, and two studies yielded negative results. There was no significant difference in methodological quality between the negative and the positive RCTs.
Clinical Conclusion: The researchers asserted that acupuncture as an effective symptomatic treatment for fibromyalgia is not supported by the results from rigorous clinical trials. On the basis of this evidence, they believe acupuncture cannot be recommended for fibromyalgia.
Reference: Mayhew E, Ernst E. Acupuncture for fibromyalgia—a systematic review of randomized clinical trials. Rheumatology. 2007;46(5):801-804.
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A study in the New England Journal of Medicine reported an evaluation of pain relief afforded by lumbar-disk surgery in patients who experience sciatica. Patients (n=283) with a history of severe sciatica for at least 6 to 12 weeks were randomly assigned to either surgery or long-term conservative treatment (with later surgery if necessary).
About 90% of the 141 patients who were assigned early surgery had a microdiskectomy at an average of 2.2 weeks into the study. A total of 142 patients received conservative treatment with an option of surgery at a later date. Almost 40% (n=55) of these conservative-treatment patients were treated surgically at an average of just over 18 weeks from the beginning of the study.
The patients in the early surgical group experienced significantly faster pain relief (p = 0.001) and a faster rate of perceived recovery. However, there were no significant overall differences in disability scores during the first year between the 2 groups, and the probability of perceived recovery in both groups after 1 year of follow-up was 95%.
Clinical Conclusion: In a related news story (HealthDay News), Wilco Peul, MD, observed that “fifty percent of patients in the early surgery group were considered recovered within 4 weeks, while it would take 12 weeks of prolonged conservative care before 50 percent of those patients were recovered.” Additionally, he recommended that patients be encouraged to delay a decision in favor of surgery until about 3 to 6 months after the start of leg pain unless disabling pain prevents the patient from working or caring for self or family.
Reference: Peul WC, van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. NEJM. 2007(May);356(22):2245-2256.
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With the objective of reducing anesthetic injection pain in adults with open wounds, researchers at Harvard Medical School evaluated the effectiveness and safety of a topical anesthetic. Existing studies had previously evaluated topical anesthesia use for children with small wounds of the face and scalp.
In a randomized controlled trial 100 patients were assigned to either the treatment group receiving a “sequential layered application” of topical lidocaine and epinephrine (TLE), or the control group receiving 2% lidocaine infiltration anesthesia. Patients in the TLE group reported significantly less pain on application, with 66% reporting no pain versus 0% reporting no pain from the infiltration in the control group (p < 0.001). There was no difference in pain during wound repair between the 2 groups. In those patients who were interviewed during follow-up, 95% of TLE group subjects rated their experience regarding pain as “excellent,” compared with only 5% of patients in the control group (p < 0.001).
Clinical Conclusion: Based on the pain results and follow-up interviews, the researchers conclude that the sequential layered application of topical lidocaine and epinephrine is a safer and less painful procedure for a wide variety of laceration types and sizes. Many adults are needle-phobic and may benefit from effective pain reduction without injection in preparation for a wound closure.
Reference: Gaufberg SV, Walta MJ, Workman TP. Expanding the use of topical anesthesia in wound management: sequential layered application of topical lidocaine with epinephrine. Am J Emerg Med. 2007(May);25(4):379-384.
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The confirmed relationship between classical migraine headache and an increased risk of cardiovascular disease (CVD) in women (Kurth et al. 2006) prompted researchers at Harvard Medical School to evaluate the potential for a similar risk in men. A prospective cohort of 20,084 men, age 40 to 84 years, who were participants in the Physicians’ Health Study were questioned on data related to migraine, CVD risk factors, and the occurrence of CVD events (Kurth et al. 2007). Men who reported migraine headaches within the first 5 years of the study, and were free of CVD at the start of follow-up, were followed for report of a first major CVD event (a mean of 15.7 years).
Migraine was reported by a total of 1,449 men (7.2%) and, during the follow-up period 2,236 major CVD events occurred. When compared with nonmigraineurs, men who reported migraine had a significant 24% higher risk for major CVD (p = 0.008) and 42% higher risk for myocardial infarction (p < 0.001). A slightly increased 15% risk for angina was identified (p = 0.068), while risk differences for ischemic stroke, death due to ischemic CVD, or coronary revascularization were considered nonsignificant.
Practice Pointers: Classical migraine is considered a migraine with aura (such as the type implicated in the women’s study); however, researchers reported that data on the existence of aura was unavailable for this large study in men. Still, they conclude that migraine was associated with an increased risk of major CVD, led by myocardial infarction, in men. Practitioners have an opportunity to inform patients of the results of this study and promote the adoption of lifestyle modifications that might reduce CVD risk in migraineurs.
References:
Kurth T, Gaziano JM, Cook NR, et al. Migraine and risk of cardiovascular disease in men. Arch Intern Med. 2007(Apr);167(8):795-801.
Kurth T, Gaziano JM, Cook NR, et al. Migraine and risk of cardiovascular disease in women. JAMA. 2006(Jul);296(3):283-291
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Barbiturates, Opioids May Be Overused As Migraine Therapy
A survey of 502 patients and 201 physicians commissioned by the National Headache Foundation and conducted by Harris Interactive in January 2007 found that 20% of migraine patients were prescribed potentially addictive medications containing barbiturates or opioids. Although barbiturates and opioids are considered effective for short-term migraine relief, many doctors recommend against prescribing them for long-term use because of the potential for addiction and abuse. Additionally, physicians responding to the survey said that more of their patients taking opioids or barbiturates experience drug-related side effects than those taking triptans, which are FDA-approved for treating migraine.
The survey did find that 53% of migraine patients take triptans as the primary prescription medication for their condition. These agents stop a migraine attack after it begins by stimulating serotonin, which reduces inflammation and constricts blood vessels, thereby alleviating the symptoms of migraines such as pain, nausea, and sensitivity to light and sound.
Four out of five patients surveyed (82%) had taken more than one prescription medication for their migraines – the average number of medications was 4. Few physicians surveyed prescribe barbiturates or opioids (2% and 1% respectively) as a first-line acute treatment for migraines, but general practitioners are more likely than neurologists to prescribe opioids as a second-line treatment, the survey found.
Source: Survey: Migraine Patients Taking Potentially Addictive Barbiturate or Opioid Medications Not Approved by FDA as Migraine Treatment. TherapeuticsDaily.com (online). May. 15, 2007.
[Commentary: The survey did not report the percentage of patients actually taking barbiturates or opioids for migraine long-term. The implication is that these agents, which can be effective for short-term relief on a periodic basis, should not be viewed as a permanent substitute for FDA-approved migraine-specific medications such as the triptans. – SBL]
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Complementary and alternative medicine (CAM) has become increasingly common as adjuvant therapy to treat chronic pain syndromes. This study gathered information on the use and effectiveness of CAM therapy from 908 primary care patients receiving long-term opioid therapy for pain management. Subjects had an average duration of pain of 16 years and were treated for a variety of pain problems, including low back pain (38%), headaches (10%), and knee pain (6.5%). Their average morphine-equivalent opioid dose was 92 mg/day (median 41 mg/day).
In the 12 months prior to the survey, 44% of participants reported using CAM therapy, including: massage therapy (27%), chiropractic treatment (18%), acupuncture (8%), yoga (6%), herbs and supplements (7%), and prolotherapy (6%). CAM use was significantly related to age, female gender, pain severity, average income, pain diagnosis of neck and upper back pain, and negative report of illicit drug use. Medical insurance covered chiropractic treatment (82%) and prolotherapy (88%), while other CAM therapies were self-paid by patients. More than half of participants using CAM reported that one or more of the therapies were helpful for pain relief.
Clinical Implication: These study results suggest that CAM therapy is widely used by patients receiving opioids for chronic pain. Due to the benefits of maintaining the lowest effective opioid dose possible, investigators recommended that further studies should determine whether adjuvant CAM therapy can help reduce opioid consumption.
Reference: Fleming S, Rabago DP, Mundt MP, et al. CAM therapies among primary care patients using opioid therapy for chronic pain. BMC Complementary and Alternative Medicine. 2007(May);7(15). Available at: http://www.biomedcentral.com/1472-6882/7/15 (access checked 6/12/07).
Interested readers may want to explore the recently updated and expanded ‘Non-Opioid Therapies’ section at Pain-Topics.org containing many articles on complementary and alternative medicine. See: http://pain-topics.org/non_opioid_therapies/index.php
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The primary objective of a study conducted in Denmark was to compare the effects of ibuprofen or glucosamine sulphate versus placebo on post-exercise muscle soreness. Ibuprofen (1,200 mg/day), glucosamine sulphate (1,500 mg/day), or placebo was given orally daily for 22 days to 3 groups, each consisting of 20 healthy men (age 24 +/- 3 years) in a double-blind, randomized, controlled parallel group study. On day 14, subjects carried out an intensive exercise of the first dorsal interosseous muscle of the left hand using a standardized hand exerciser. Muscle tenderness was assessed at baseline, immediately after exercise, and during follow-up.
Muscle tenderness on days 0 and 14 (before exercise) was equivalent in the 3 groups; however, tenderness was significantly increased in the glucosamine sulphate group as compared with placebo on days 15 and 16 after the exercise (p < 0.03). There were no significant differences between ibuprofen and placebo. None of the participants reported any serious adverse effects.
Clinical Conclusion: Based on this limited experimental study, it appears that glucosamine sulphate may actually facilitate muscle soreness or tenderness after strenuous exercise, whereas systemic administration of ibuprofen is unhelpful in inhibiting such discomfort. This outcome might be of importance in counseling patients taking either of the agents prophylactically and still experiencing muscle discomfort after exercising.
Reference: Arendt-Nielsen L, Weidner M, Bartholin D, Rosetzsky A. A double-blind randomized placebo controlled parallel group study evaluating the effects of ibuprofen and glucosamine sulfate on exercise induced muscle soreness. J Musculoskelet Pain. 2007(Mar);15(1):21-28.
Other studies reported by Pain Treatment Topics have questioned the effectiveness of supplement glucosamine, as well as chondroitin, for the pain of osteoarthritis. See http://www.pain-topics.org/news_research_updates/premiere.php#joint and http://www.pain-topics.org/news_research_updates/issue8.php#chondroitininneffective.
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While oxidative stress is known to be implicated in the pathophysiology of chronic pancreatitis (CP), previous observational studies using antioxidant supplementation for pain relief have been short-term and on small numbers of participants. To further examine the effect of antioxidant supplementation on pain relief, researchers enrolled 127 consecutive patients with CP and abdominal pain. The average patient was 30 years of age and almost 70% were male; 92 patients had idiopathic CP, while 35 had alcoholic CP. Patients were randomized to receive for a period of 6 months either placebo (n=56) or a daily antioxidant combination (n=71) of 5 supplements including: 600 micrograms of selenium, 0.54 grams of vitamin C, 9000 international units of beta-carotene, 270 international units of vitamin E, and 2 grams of methionine.
Results showed that about 33% of antioxidant-supplemented patients were pain-free at the 6-month endpoint compared with only 13% of patients in the placebo group (p = 0.009). In patients with persisting pain, those in the treatment group averaged about half the painful days per month experienced by the placebo group (p = 0.012), and treatment-group patients needed less than half as much oral analgesia as placebo-group patients (p = 0.001).
Reference: Bhardwaj P, Garg PK, Saraya A, et al. Antioxidant supplementation for pain relief in chronic pancreatitis: a randomized, placebo-controlled double blind trial. Digestive Disease Week, May 19-24, 2007. Washington DC. Abstract #271.
[Commentary: In a related news story (MedPage Today Conference Report), Payal Bhardwaj, MD, and her colleagues hypothesized that the “inflammation created by the oxidative stress could cause the pain suffered by up to 90% of these patients.” Additionally, they stressed that antioxidants are a non-invasive, well-tolerated therapy for a condition that has few satisfactory options for treatment. – WD]
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In addition to the established benefits of Omega-3 polyunsaturated fatty acids (omega-3 PUFAs) for cardiovascular health, previous studies have reported their use to treat joint pain associated with several inflammatory conditions. Researchers in Canada conducted a meta-analysis of 17 randomized, controlled trials assessing the pain relieving effects of omega-3 PUFAs in patients with rheumatoid arthritis, joint pain secondary to inflammatory bowel disease, and dysmenorrhea.
Supplementation with omega-3 PUFAs for 3 to 4 months demonstrated significantly favorable outcomes in the following: 1) patient-assessed pain intensity, 2) duration of morning stiffness measured in minutes, 3) number of painful and/or tender joints, and 4) nonselective nonsteroidal anti-inflammatory drug consumption.
Clinical Conclusion: The researchers concluded that this meta-analysis recommends omega-3 PUFA supplementation as an attractive adjunctive treatment for joint pain associated with rheumatoid arthritis, inflammatory bowel disease, and dysmenorrhea.
Reference: Goldberg RJ, Katz J. A meta-analysis of the analgesic effects of omega-3 polyunsaturated fatty acid supplementation for inflammatory joint pain. Pain. 2007(May);129(1-2):210-223.
 NOTE: The FDA recommends consumption of no more than a “total of 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day from a dietary supplement.”
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Functional abdominal pain (FAP) and irritable bowel syndrome (IBS) are common conditions seen in pediatric practice and treatment usually consists of education, reassurance, and dietary modifications. In light of the fact that 25% to 66% of pediatric patients continue to experience symptoms, a study conducted in the Netherlands compared standard medical therapy (SMT) with “gut-directed” hypnotherapy (HT) which has previously been shown to be effective in adults with IBS.
Children between ages 8 and 18 (n=53; mean age 13) with longstanding complaints of either FAP or IBS were randomized to either HT or the control SMT group. Hypnotherapy consisted of 6 half-hour sessions during a 3 month period using a pediatric adaptation of the Manchester protocol of gut-directed hypnotherapy. Patients in the control group received standard medical care and 6 half-hour sessions of supportive therapy. Most patients (75%) were female and the mean duration of abdominal complaints was more than 3 years.
Pain intensity, pain frequency, and associated symptoms – like nausea, headache, and loss of appetite – were scored from the data entered in weekly abdominal pain diaries. At the end of treatment, results demonstrated that hypnotherapy significantly led to a pain cure (defined as >80% improvement in pain scores) in 59% of patients compared with only 12% in the SMT group. The associated symptoms decreased in all patients but no differences were found between the 2 treatment groups.
Clinical Conclusion: The results of this study suggest that gut-directed hypnotherapy can be highly effective for the treatment of longstanding pediatric FAP or IBS, both common causes of abdominal pain. The researchers stated that these results are preliminary and suggest that further studies are warranted to confirm these findings.
Reference: Vlieger A, Menko-Frankenhuis CM, Wolfkamp SC, et al. Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial. Digestive Disease Week, May 19-24, 2007. Washington DC. Abstract #914.
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Following are briefs on new pain-management drug or device approvals or announcements, as well as items related to safety concerns for existing products. If the FDA news website posted a specific announcement, the link to it has been provided below. All brand names are registered trademarks of their respective manufacturers.
Magnacet™ (oxycodone/acetaminophen-400 mg) Tablets Launched
Mallinckrodt Brand Pharmaceuticals announced in early June 2007 that it is providing a new pain management drug, called Magnacet™, which is the only available oxycodone product coupled with 400 mg of acetaminophen, a unique dosage that gives physicians flexibility in treating patients with moderate to moderately severe pain.
OxyContin® – FDA Alerts Healthcare Providers of False Marketing Claims
In a May 2007 announcement, the FDA released results of an investigation of Purdue Frederick to inform healthcare providers that the manufacturer was charged with criminal and civil liabilities in conjunction with marketing schemes aimed at increasing product sales. According to the FDA, sales representatives were trained to make false representations regarding the addictive characteristics of OxyContin®, a time-release formulation of the prescription pain reliever oxycodone. Representatives were falsely promoting the drug as being less addictive, less subject to abuse, and less likely to raise tolerance levels and cause withdrawal symptoms than other pain medications. Healthcare providers should be aware of the misrepresentations because prescribing decisions based on false information may increase health risks for patients.
 See the Pain Treatment Topics special report, Commonsense Oxycodone Prescribing & Safety, available at: http://www.pain-topics.org/opioid_rx/oxycodone.php#OxyRx (access checked 6/25/07).
Flector® (diclofenac epolamine)Topical Patch Approved by FDA
The FDA approved the Flector® Patch (also called Flector® Tissugel in non-US markets), a transdermal formulation of the nonsteroidal anti-inflammatory drug diclofenac, as a topical treatment for the acute pain of minor strains, sprains, and contusions. The product, approved in late January 2007, is intended to provide local analgesia and anti-inflammatory effects. Even though the systemic effect of diclofenac is minor, patients should be informed of the potential adverse effects of NSAIDs (cardiovascular effects, gastrointestinal symptoms) as well as dermal side effects (hypersensitivity, exfoliative dermatitis). This product should not be prescribed for patients with aspirin-sensitive asthma or those in late pregnancy.
Amrix® (cyclobenzaprine hydrochloride) – FDA Approves Extended-Release Formulation
An extended-release formulation of cyclobenzaprine hydrochloride was approved by the FDA in February 2007. Amrix® is available in 15 mg and 30 mg capsules and is intended for once-a-day dosing. As a skeletal-muscle relaxant, it is indicated as an adjuct to rest and physical therapy for the relief of the muscle pain and stiffness caused by sprains, strains, and muscle injuries. ECR Pharmaceuticals plans to market the product by late summer 2007.
Kadian® (morphine sulfate) in New 10 mg Strength Approved
The FDA approved a 10 mg capsule of Kadian®, an extended-release morphine sulfate product used for moderate-to-severe chronic pain relief. Kadian was developed as a convenient, around-the-clock pain reliever and its analgesic effects last for 12 to 24 hours. It is currently available in 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths; now the 10 mg formulation is also available for opioid-tolerant patients needing continuous individualized pain therapy.
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