Addiction to prescription painkillers has become a major problem; the National Survey on Drug Use and Health in 2007 found that 6.9 million people over the age of 12 years in the USA had used prescription psychotherapeutics nonmedically. The addiction usually starts when someone is prescribed pain killers for a common injury or surgery and then the individual feels as though they cannot live without it. In some communities, the abuse of prescription painkillers has overtaken that of cocaine, heroin and marijuana.
A large, multisite, randomized clinical trial carried out by Roger Weiss (McLean Hospital, MA, USA) and colleagues was the first of its kind to investigate the treatment of opioid addiction with suboxone. Suboxone is a combination of extended buprenorphine hydrochloride, a synthetic opioid used to treat opioid withdrawal and craving, and naloxone, an opioid receptor blocker that reduces abuse of the drug if it is not taken as a prescribed treatment.
The results of this study have been published recently in Archives of General Psychiatry. The study assessed more than 600 patients with opioid addiction in a two-phase format. Patients were randomized into a treatment only group or a treatment plus standard medical management group. All patients received suboxone for the first 1–2 weeks; the treatment was then tapered for 3–4 weeks, and the next 5–12 weeks were for follow-up. The patients demonstrating successful outcomes from this intervention exited the trial; the 360 patients from the original 600 who remained then carried on into phase 2 of the trial. Randomization was the same as for phase 1: treatment was administered for 12 weeks in both arms of the study and was then tapered for 4 weeks. The patients were then assessed for 8 weeks as follow-up.
It was found that after phase 1 of the study, the success rate of the suboxone treatment was only 6.6%; however, after phase 2, the treatment success rate had increased significantly to 49.2%. These results show that opioid-dependant patients are more likely to reduce opioid use after treatment with suboxone. It was seen that opioid dependant counseling had no effect on the outcome of the treatment.
The study found that after the 8-week follow-up post-phase 2, the success rate had dropped to 8.6%. Further studies are therefore warranted in order to investigate the long-term use of suboxone treatment in opioid-dependant individuals.
– Written by Claire Attwood
Sources: Weiss RD, Potter JS, Fiellin DA et al. Adjunctive counselling during brief and extended buprenorphine–naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch. Gen. Psychiatry doi:10.1001/archgenpsychiatry.2011.121 (2011) (Epub ahead of print); Suboxone is Most Effective in Treating Painkiller Addiction: www.mcleanhospital.org/news/press/current.php?kw=suboxone-is-most-effective-in-treating-painkiller-addiction&id=172
A recent study published in Arthritis & Rheumatism has found a potential link between sleep problems and an increased fibromyalgia (FM) risk in women.
The Fibromyalgia Association, UK states that according to a survey carried out in five European countries, the prevalence of FM is between 2.9 and 4.7%, and the American Fibromyalgia Syndrome Association, Inc. explains FM as “an extremely painful, fatiguing and often debilitating medical condition that affects 3% of the population.” Investigations have demonstrated that women represent up to 90% of FM patients. In the past, researchers have discovered that poor sleep is common in FM syndrome patients. What is unknown is whether sleep problems are causes or consequences of FM syndrome. The authors of the study state that “the aim of the current study was to prospectively investigate the association between self-reported sleep problems and the risk of FM among adult women.”
The investigators carried out a longitudinal study of 12,350 women who were FM-, musculoskeletal pain- and physical impairment-free between 1984 and 1986 (baseline). Adjusted relative risks of FM were calculated using a generalized linear model between 1995 and 1997 (follow-up).
Regarding the results, Paul Mork (Norwegian University of Science and Technology, Norway) explained, “Our findings indicate a strong association between sleep disturbance and FM risk in adult women. We found a dose–response relation, where women who often reported sleep problems had a greater risk of FM than those who never experienced sleep problems.”
Among the results, it was found that at follow-up, a total of 327 women developed FM. Furthermore, the authors state that the strong dose–response association between FM risk and sleep problems demonstrated by the data is “somewhat, although not significantly, stronger in middle-aged and old women compared to the younger women.”
Future investigation is required in order to determine whether FM risk in women is lessened as a result of the more rapid detection and treatment of sleep problems.
– Written by Roshaine Gunawardana
Sources: Mork PJ, Nilsen TI. Sleep problems and risk of fibromyalgia: longitudinal data from the Norwegian HUNT-study. Arthritis Rheum. doi:10.1002/art.33346 (2011) (Epub ahead of print); Wiley Press Room: http://eu.wiley.com/WileyCDA/PressRelease/pressReleaseId-101554.html; Fibromyalgia Association UK: www.fibromyalgia-associationuk.org/what-is-fm-highlights-203; The American Fibromyalgia Syndrome Association, Inc.: www.afsafund.org
A study recently published in the journal Pain has revealed an association between the antidepressant escitalopram and improved general pain. The study carried out by researchers from the Boston University School of Medicine (MA, USA) demonstrates that opioid-dependent patients treated with escitalopram experienced meaningful reductions in pain severity and pain interference during the first 3 months of therapy.
Longitudual data from a randomized controlled trial evaluating the effects of escitalopram on treatment retention in patients with depressive symptoms who were initiating buprenorphine/naloxone for treatment of opioid dependence were used in the study.
Study participants were randomized to receive escitalopram 10 mg or placebo daily. Several parameters were assessed during study duration, including changes in pain severity, pain interference and depression at 1-, 2- or 3-month visits, using the visual analog scale, Brief Pain Inventory and the Beck Depression Inventory II, respectively.
“This study found that treatment with escitalopram resulted in significantly decreased pain severity and interference over time, with a nearly 30% reduction in pain severity after 1 month compared with control,” explained lead author Judith Tsui, assistant professor of medicine at Boston University School of Medicine. “Adjusting for within-subject changes in depression scores did not affect the effects of escitalopram, suggesting the analgesic properties of escitalopram were independent of its antidepressant effects.”
According to the authors, antidepressants may provide an appealing option for treating pain in opioid-dependent patients due to the frequent coexistence of depression in this population. However, Tsui does state that more research is needed on the use of non-narcotic medication such as selective serotonin-reuptake inhibitors to treat pain in opioid-dependent populations. Tsui concluded, “Alternative, nonopioid pharmacologic therapies are needed to address pain in opioid-dependent populations.”
– Written by Paolo Reveglia
Source: Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Escitalopram is associated with reductions in pain severity and pain interference in opioid dependent patients with depressive symptoms. Pain 152(11), 2640–2644 (2011).
A recent announcement by Pacira Pharmaceuticals, Inc. has revealed that bupivacaine liposome injectable suspension, or EXPAREL™ 1.3%, a nonopioid local analgesic, has been approved by the US FDA for “administration into the surgical site to produce postsurgical analgesia.”
Harold Minkowitz (Memorial Hermann Memorial City Medical Center, TX, USA) states, “The inability to effectively manage postsurgical pain is a challenge anesthesiologists and surgeons deal with on a daily basis. Typically, the first 48–72 h after surgery are the most difficult from a pain management perspective, so a product like EXPAREL, which can provide pain relief with reduced opioid consumption for up to 72 h, represents a significant, much-needed addition to the currently available postsurgical pain management options.”
In one hemorrhoidectomy trial, EXPAREL was compared with placebo, and all patients who had inadequate pain control were administered opioids for rescue pain relief. The results demonstrated that EXPAREL employed “significant” reductions in cumulative pain scores, along with a decrease in consumption of opioids lasting up to 72 h.
Sonia Ramamoorthy (University of California, CA, USA) describes the approval as “Welcome news for surgeons, for whom patient safety, comfort and satisfaction are of primary importance.” She goes on to say, “Traditional opioid medications, while effective at providing pain relief, have a long list of unwanted side effects. EXPAREL, a single-dose administration, nonopioid therapy, has the potential to reduce or delay the use of opioids following inpatient and outpatient surgical procedures.”
EXPAREL combines bupivacaine with DepoFoam® – a product delivery technology that is able to administer medication across a set time-frame. This explains how EXPAREL can result in analgesia with lowered requirements for opioids for a period of up to 72 h. The company describes EXPAREL as “the first and only multivesicular liposome local anesthetic,” which can be used in the same way as other available local anesthetics both in a peri- or post-surgical environment. One advantage of using EXPAREL is that other local anesthetics are effective for a comparatively short duration of time.
– Written by Roshaine Gunawardana
Source: Pacira Pharmaceuticals, Inc.: http://investor.pacira.com/phoenix.zhtml?c=220759&p=RssLanding&cat=news&id=1623529
A new trial evaluating the Intracept® basivertebral nerve ablation procedure has begun, Relievant MedSystems Inc. (CA, USA) recently announced. This news comes after the announcement made by the company in August this year stating that it had received US FDA approval of an Investigational Device Exemption to commence their “pivotal” SMART trial.
The Intracept system is based on the research of Michael Heggeness (Baylor Spine Institute, TX, USA) and utilizes radiofrequency energy administered into the vertebral body via a small tube, in order to ablate the basivertebral nerve. It is thought that the basivertebral nerve plays a significant role in chronic low back pain, and once ablated, the nerve is unable to generate pain signals.
The Surgical Multicenter Assessment of Radiofrequency Ablation for the Treatment of Vertebrogenic Back Pain, also know as the SMART trial, plans to enroll 200 patients from medical centers in the USA and will evaluate how effective the Intracept procedure is in reducing pain in chronic axial low back pain patients. Data analysis is due to take place after the last participant of the SMART trial has concluded 6 months of follow-up. According to the National Institute of Neurological Disorders and Stroke – NIH, “Americans spend at least $50 billion each year on low back pain, the most common cause of job-related disability and a leading contributor to missed work.”
The SMART trial is described as a level 1, prospective, randomized, double-blind, sham-controlled clinical trial, and principal investigator Jeffrey S Fischgrund (Oakland University William Beaumont School of Medicine, MI, USA) states, “The Relievant Intracept procedure is a potential breakthrough for the treatment of chronic low back pain, which addresses the unmet medical need for patients who have failed traditional conservative treatment modalities.” According to Fischgrund, the Intracept procedure, which he states “could represent one of the most significant advances in the treatment of low back pain,” is simple and easy to perform, and he describes the results of the pilot study as “encouraging.”
Regarding the trial, Fischgrund comments, “I look forward to evaluating the Intracept procedure in the SMART trial, which also has the opportunity of treating patients without the morbidity and expense of more invasive procedures.”
– Written by Roshaine Gunawardana
Sources: Relievant – Sense Relief, Press Room: www.relievant.com/press.html; National Institute of Neurological Disorders and Stroke – National Institutes of Health: www.ninds.nih.gov/disorders/backpain/detail_backpain.htm
Investigators have found that cognitive–behavioral therapy administered via the telephone and an exercise program, carried out together or individually, could be potentially beneficial to fibromyalgia patients, as the study results demonstrated short- to medium-term improvements in patients suffering with chronic widespread pain.
In the study published in the Archives of Internal Medicine, the authors describe chronic widespread pain as an important aspect of fibromyalgia and state that it is, “associated with lost work productivity, mental ill health and reduced quality of life.”
A total of 442 patients with chronic widespread pain were randomized to receive 6 months of telephone-delivered cognitive–behavioral therapy (TCBT), graded exercise, combined intervention or treatment as usual – this latter category forming the control group.
The study investigators used a seven-point patient global assessment scale of change in health since trial enrollment in order to analyze the primary outcome. This measure was used at three time-points, namely baseline, at the end of intervention that was at 6 months postrandomization and finally at 9 months postrandomization. Patients scored themselves on a questionnaire or via a telephone-conducted interview. The seven-point scale ranged from ‘one‘ meaning “I feel very much worse” to ‘seven‘ meaning “I feel very much better.”
At the end of intervention (6 months), the results demonstrated that 29.9% of the group receiving TCBT reported positive outcomes, along with 34.8% of the group receiving graded exercise and 37.2% of the combined intervention group. This was in comparison with 8.1% of patients in the control group reporting positive outcomes at the 6-month stage. At the 9-month follow-up stage, positive outcomes were reported by 32.6, 24.2, 37.1 and 8.3% for the TCBT, graded exercise, combined intervention and control groups, respectively.
The authors concluded that TCBT was “associated with substantial, statistically significant and sustained improvements in patient global assessment.” Although the trial does have many strengths, the authors do describe limitations of the study, such as the complexity involved in assessing how accurate self-report consultation is.
– Written by Roshaine Gunawardana
Sources: McBeth J, Prescott G, Scotland G et al. Cognitive behavior therapy, exercise, or both for treating chronic widespread pain. Arch. Intern. Med. doi:10.1001/archinternmed.2011.555 (2011) (Epub ahead of print); JAMA and Archives – For the Media: http://pubs.ama-assn.org/media/2011a/1114.dtl#3