Reduction In Analgesic Use Research Articles

The effect of exercise referral schemes and self-management strategies on use of prescription analgesics among community-dwelling older adults: registry linkage with randomised controlled trials

Background and objectiveExercise referral schemes and self-management strategies have shown positive effects on patient-reported and objectively measured outcomes, such as increased functional capacity and physical activity level. However, the impact of these interventions on analgesic use remains uncertain. We hypothesised that exercise referral schemes, either utilised alone or in combination with self-management strategies, is more effective in reducing use of prescription analgesics compared with a self-management strategy only.Subjects and methodsWe utilised data from two completed randomised controlled trials, namely The Welfare Innovation in Primary Prevention (n = 121) and The SITLESS project (n = 338), and information from the national Danish health registries, including the National Prescription Registry. The two trials have investigated the effectiveness of interventions, which include exercise referral schemes and self-management strategies, on various aspects such as physical function and levels of physical activity among community-dwelling older adults. The studies were conducted in the period 2015–2020 and comprised older adults aged 65+ years, living in three different Danish municipalities. Participants were recruited through nationally regulated preventive home-visits. To estimate changes in use of prescription analgesics over time, a linear fixed effects regression model was applied. The outcome measure was the mean total yearly defined daily dose of analgesics.ResultsAll intervention groups showed a within-group increase in overall analgesic use, though not statistically significantly different from zero. There were no differences in estimated changes in mean total yearly defined daily dose when comparing the intervention groups to the group receiving the least extensive intervention (self-management strategies/control). The findings indicated that exercise referral schemes and self-management strategies, whether administrated individually or in combination, did not result in a reduction in analgesic use over time.

Durable effects of acupuncture for tension-type headache: A systematic review and meta-analysis

BackgroundAcupuncture may be effective in treating tension-type headache (TTH). The durability of its effects after treatment completion remains inconclusive. MethodsWe searched multiple databases and references from previous reviews for randomized controlled trials (RCTs) which investigated the effectiveness of acupuncture for TTH. We assessed the methodological quality of RCTs using the Cochrane Risk of Bias 2.0 (RoB 2) tool. Primary outcome was response rate, defined as the proportion of participants who reported at least a 50% reduction in monthly headache days from baseline after completion of treatment. Secondary outcomes included headache days, headache intensity, and analgesic use. Safety outcomes were also evaluated. ResultsA total of seven RCTs involving 3,221 participants with frequent episodic and chronic TTH were included. Individuals receiving acupuncture reported a significantly higher response rate versus sham acupuncture (SA) immediately and at 1–6 months after completion of treatment (P<0.05). Compared with SA, post-treatment results of headache days and headache intensity appeared consistent on the whole, showing associations favoring acupuncture. However, no significant reduction in analgesic use was found post-treatment. Acupuncture showed no superiority over physical training or relaxation training in headache days and headache intensity. Moreover, no serious adverse events associated with acupuncture were reported. ConclusionLimited evidence suggested that acupuncture might provide durable post-treatment effects in the management of frequent episodic and chronic TTH for up to 6 months compared with SA,with no severe treatment-related adverse events reported.

ԿՐԾՔԱԳՈՏԿԱՅԻՆ ՄԻՋՓԱԿԵՂԱՅԻՆ ՀԱՐԹՈՒԹՅԱՆ ՊԱՇԱՐՄԱՆ (THORACOLUMBAR INTERFASCIAL PLANE BLOCK - TLIP) ԿԻՐԱՌՈՒՄԸ ՈՂՆԱՇԱՐԻ ԳՈՏԿԱՅԻՆ ՀԱՏՎԱԾՈՒՄ ԿԱՏԱՐՎՈՂ ՎԻՐԱՀԱՏՈՒԹՅՈՒՆՆԵՐԻ ԺԱՄԱՆԱԿ․ ԳՐԱԿԱՆՈՒԹՅԱՆ ՏԵՍՈՒԹՅՈՒՆ

Pain management after spine surgery is challenging and usually not sufficient. Most patients suffer from severe postoperative pain. Numerous studies have demonstrated the effectiveness of various regional anesthetic techniques in postoperative pain management. In recent years, thoracolumbar interfascial plane block (TLIP) has become widely used for perioperative analgesia during lumbar spine surgeries. It is a type of ultrasound-guided plane block, during which a local anesthetic is injected into the fascial plane between the multifidus and longissimus muscles, with the aim of blocking the dorsal rami of the thoracolumbar nerves. TLIP block was first proposed by Hand et al. in 2015. The aim of this study is to review the scientific publications regarding the use of TLIP block in lumbar spine surgery in the most popular electronic databases, such as PubMed, Scopus, Google Scholar, Web of Science, and comparing lumbar spine surgeries with and without TLIP block according to the following criteria: postoperative pain intensity, postoperative analgesic requirement, intraoperative opioid use, incidence of postoperative nausea and vomiting, comparison with other regional anesthesia methods. Analysis of the reviewed literature shows that TLIP block in lumbar spine surgery reduces the requirement of perioperative analgesics, decreases the intensity of postoperative pain up to 24 hours postoperatively, reduces the frequency of postoperative nausea and vomiting, therefore, is an effective method and can be used in daily practice. At the same time, almost all researchers consider that obtained data quality is low and that more studies with a larger number of patients and a longer duration are needed to statistically confirm the obtained data. In particular, studies are needed to determine whether TLIP block is sufficiently effective compared to other regional anesthesia methods, especially erector spinae plane block (ESP), whether TLIP block reduces the incidence of chronic pain syndrome, whether it affects the duration of surgery, postoperative intensive care unit treatment and length of hospital stay, whether TLIP-block reduces intraoperative blood loss, whether it is possible to prolong and enhance the effect of TLIP block with adjuvants, in particular dexamethasone and dexmedetomidine. Thoracolumbar interfascial plane block (TLIP) is a promising method for perioperative analgesia, reduction of analgesic use and postoperative complications in lumbar spine surgery, however, further studies are needed to determine its effectiveness and optimal application methods.

Spinal versus general anesthesia for minimally invasive transforaminal lumbar interbody fusion: implications on operating room time, pain, and ambulation.

There has been increasing interest in the use of spinal anesthesia (SA) for spine surgery, especially within Enhanced Recovery After Surgery (ERAS) protocols. Despite the wide adoption of SA by the orthopedic practices, it has not gained wide acceptance in lumbar spine surgery. Studies investigating SA versus general anesthesia (GA) in lumbar laminectomy and discectomy have found that SA reduces perioperative costs and leads to a reduction in analgesic use, as well as to shorter anesthesia and surgery time. The aim of this retrospective, case-control study was to compare the perioperative outcomes of patients who underwent minimally invasive surgery (MIS)-transforaminal lumbar interbody fusion (TLIF) after administration of SA with those who underwent MIS-TLIF under GA. Overall, 40 consecutive patients who underwent MIS-TLIF by a single surgeon were analyzed; 20 patients received SA and 20 patients received GA. Procedure time, intraoperative adverse events, postoperative adverse events, postoperative length of stay, 3-hour postanesthesia care unit (PACU) numeric rating scale (NRS) pain score, opioid medication, and time to first ambulation were collected for each patient. The two groups were homogeneous for clinical characteristics. A decrease in total operating room (OR) time was found for patients who underwent MIS-TLIF after administration of SA, with a mean OR time of 156.5 ± 18.9 minutes versus 213.6 ± 47.4 minutes for patients who underwent MIS-TLIF under GA (p < 0.0001), a reduction of 27%. A decrease in total procedure time was also observed for SA versus GA (122 ± 16.7 minutes vs 175.2 ± 10 minutes; p < 0.0001). No significant differences were found in intraoperative and postoperative adverse events. There was a difference in the mean maximum NRS pain score during the first 3 hours in the PACU as patients who received SA reported a lower pain score compared with those who received GA (4.8 ± 3.5 vs 7.3 ± 2.7; p = 0.018). No significant difference was observed in morphine equivalents received by the two groups. A difference was also observed in the mean overall NRS pain score, with 2.4 ± 2.1 for the SA group versus 4.9 ± 2.3 for the GA group (p = 0.001). Patients who received SA had a shorter time to first ambulation compared with those who received GA (385.8 ± 353.8 minutes vs 855.9 ± 337.4 minutes; p < 0.0001). The results of this study have pointed to some important observations in this patient population. SA offers unique advantages in comparison with GA for performing MIS-TLIF, including reduced OR time and postoperative pain, and faster postoperative mobilization.

Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease

Objective To document longitudinal symptom, quality-of-life and imaging response in patients with recurrent gynecological tumors treated with magnetic resonance guided high intensity focused ultrasound (MRgHIFU), and compare changes in patients with intra- versus extra-pelvic lesions. Methods Eleven symptomatic patients with painful recurrent gynecological tumors were treated with MRgHIFU (Profound Sonalleve) in a prospective single center study (NCT02714621). Pain scores, analgesic intake and quality-of-life metrics, whole tumor volume, and perfused tumor volume from Gadolinium-enhanced T1W imaging documented before and up to 90 days after treatment were compared between patients with intra- and extra-pelvic tumors. Results Two of five patients with intra-pelvic and three of six patients with extra-pelvic tumors were classified as responders (>2 point reduction in NRS pain score without analgesia increase or a > 25% reduction in analgesic use). Cohort reductions in worst pain scores were not significant for either group. Emotional functioning for the whole cohort improved, although physical functioning did not. Ablative thermal temperatures were achieved in three patients with extra-pelvic tumors, but in none whose tumors were intra-pelvic. Pain response did not correlate with thermal dose. Tumor volume increased by 18% immediately post-treatment in the extra-pelvic but not in the intra-pelvic group. Ratio of perfused to whole lesion volume decreased by >20% by day 30 in extra-pelvic, but not intra-pelvic tumors although at day 30 both extra-pelvic and intra-pelvic tumors increased in volume. Conclusion MRgHIFU treatments can be delivered safely to patients with recurrent gynecological tumors. Extra-pelvic tumors responded better than intra-pelvic tumors and showed immediate swelling and reduction in perfused volume by day 30.

A Randomized Controlled Trial to Compare Analgesia and Functional Improvement After Continuous Neuroablative and Pulsed Neuromodulative Radiofrequency Treatment of the Genicular Nerves in Patients with Knee Osteoarthritis up to One Year After the Intervention.

To compare the analgesic and functional outcomes of continuous neuroablative radiofrequency (CNARF) and pulsed neuromodulative radiofrequency (PNMRF) treatment of genicular nerves up to 1 year after the intervention and to identify predictors associated with a successful outcome (defined as an at least 50% reduction in the pre-interventional visual analog scale [VAS] rating) after genicular radiofrequency treatment. A prospective randomized controlled trial. The Pain Department of the Jerez de la Frontera University Hospital, Cadíz, Spain, from January 2018 until May 2019. Patients with grade 3-4 gonarthritis suffering from knee pain, with a VAS score ≥5 for >6 months. Eligible participants were randomly assigned to receive either CNARF or PNMRF of the superior medial, superior lateral, and inferior medial genicular nerves. The VAS and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores were assessed before and at 1, 6, and 12 months after treatment. Medication use was quantified before and at 6 months after the intervention. Potential characteristics associated with the efficacy of radiofrequency intervention were explored by using multivariable statistical models. A total of 188 participants were included. The magnitude and duration of beneficial effect and reduction in analgesic use were significantly greater in the CNARF group. Success at 6 months after radiofrequency treatment decreased with grade 4 gonarthritis; higher pre-interventional VAS score; and concomitant depression, anxiety disorder, and diabetes mellitus. Therapeutic efficacy and reduction in analgesic consumption were superior after CNARF. Treatment success at 6 months after radiofrequency intervention decreased with more severe gonarthritis; higher pre-interventional pain intensity; and concomitant depression, anxiety disorder, and diabetes mellitus.

Dorsal root ganglion pulsed radiofrequency treatment for chronic cervical radicular pain: a retrospective review of outcomes in fifty-nine cases

We performed a retrospective review of outcomes in 59 patients who underwent this therapy over a 3-year period in our institution. We evaluated a reduction in pain, duration of pain relief, reduction in use of analgesics and progression to surgery. Our results demonstrated 49 patients experienced some relief. Forty patients of the 59 experienced an improvement in pain of 50% or more. The mean duration of relief in this group was 37weeks. Seven patients experienced complete resolution of their pain. In this group, the mean duration of relief was 39weeks. Regarding the 53 patients who were taking medication for pain prior to the procedure, 37 patients reduced or discontinued their usage after the procedure. Despite the limitations of a retrospective study, we feel our study adds to the growing evidence base that pulsed radiofrequency treatment adjacent to the cervical dorsal root ganglion has a role in the treatment of chronic cervical radicular pain.

Early efficacy and late gain in chronic and high-frequency episodic migraine with onabotulinumtoxinA.

The aim was to analyse the clinical characteristics of a long-term follow-up of patients with chronic and high-frequency episodic migraine in treatment with onabotulinumtoxinA. Patients diagnosed with high-frequency episodic migraine (HFEM) or chronic migraine (CM) according to the International Classification of Headache Disorders 3 beta were included. A comparative analysis was carried out at each study time point identifying outcome measures according to initial diagnosis and treatment duration. In all, 578 patients were recruited and after 24months outcome data were collected from 100 patients: 84.0% CM and 16.0% HFEM. After 24months, headache frequency was significantly reduced by 10.5days from baseline, 64.0% reported a ≥50% reduction in pain intensity and 70.0% of patients had ≥50% reduction in analgesic use. Comparing baseline diagnoses, at month 6 CM patients presented higher mean reduction in frequency (CM 44.3%±32.6% vs. HFEM 34.6%±24.8%) and analgesic use (CM 53.6%±35.4% vs. HFEM 39.3%±33.2%). At month 12, the mean reduction in frequency was similar in CM and HFEM patients (CM 44.7%±33.4% vs. HFEM 41.2%±28.2%). Improvement in pain intensity, analgesic use and Migraine Disability Assessment were proportional in both diagnoses. OnabotulinumtoxinA efficacy is significant at 6months in frequency and analgesic intake and remains stable during follow-up, whilst the intensity of pain decreases in a stepwise manner at each time point of the analysis. The improvement in CM and HFEM patients is proportional and significant after 1year of treatment.

Efficacy and Safety of Intravenous Ketorolac versus Nalbuphine in Relieving Postoperative Pain after Tonsillectomy in Children

BACKGROUND:Pain is a major postoperative complication worldwide, which in turn impairs normal body performance and increases postoperative morbidity, hospitalisation, and the susceptibility to infections which also lead to chronic pain development.AIM:The purpose of this study was to evaluate the efficacy of intravenous ketorolac versus nalbuphine as analgesia after adenotonsillectomy surgery to determine the optimal procedure for pain control and postoperative reduction of analgesic use.METHODS:A group of 100 pediatric patients undergoing tonsillectomy or adenotonsillectomy were assigned as follows to two equal groups: Group A: 50 patients received intravenous ketorolac 0.9 mg/Kg. Group B: 50 patients received intravenous nalbuphine 0.25 mg/Kg.RESULTS:FLACC (Face, Legs, Activity, Cry, Consolability) pain score was measured after recovery from anaesthesia (postoperative). There was a statistically significant difference concerning pain score between group ‘A’ and group ‘B’ as pain score in ’A’ (ranging from 3.18 ± 0.87 to 4.68 ± 0.74) is lower compared to ’B’ (ranging from 3.90 ± 0.76 to 5.54 ± 0.73) and probability value < 0.05 except at 90 & 120 min which was observed statistically insignificant. There was no serious postoperative complication detected in either group.CONCLUSION:It is concluded that intravenous ketorolac is more effective than intravenous nalbuphine in reducing pain intensity and postoperative analgesic requirements after adenotonsillectomy in children.

Analgesic reduction during an interdisciplinary pain management programme: treatment effects and processes of change.

Long-term use of opioid medication is associated with a host of negative effects on health and quality of life. Guidelines state that people with chronic pain taking high doses of opioids without benefit should be supported to discontinue them. Little research has investigated psychological processes associated with analgesic use and tapering. This study investigated (1) analgesic use pre- and post-participation in an interdisciplinary pain management programme and its relationship to functioning and (2) psychological processes associated with analgesic use. Opioid use was associated with poorer functioning at baseline. Participating in an interdisciplinary pain management programme was associated with reductions in opioid dose and number of classes of analgesics used. Reductions in analgesic use were associated with improvements in functioning. Psychological inflexibility was associated with using higher doses of opioid medication and with using a greater number of classes of analgesics. Psychological flexibility appears relevant in explaining analgesic use. Future research could focus on targeting this process to improve tapering outcomes.

Effect of resistance training on headache symptoms in adults: Secondary analysis of a RCT

BackgroundWhile strength training for the neck and shoulder muscles may be effective in reducing headache, the optimal combination of exercise frequency and duration is unknown. This study investigates the effect of different time-wise combinations of one weekly hour of strength training for the neck and shoulder muscles on headache frequency, intensity, and use of analgesics. MethodsA total of 573 office workers were randomly allocated at the cluster-level to five groups; 3 × 20 min a week of minimally supervised (3MS), 1 × 60 (1WS), 3 × 20 (3WS) or 9 × 7 (9WS) min a week of supervised high-intensity strength training for 20 weeks, or to a reference group without training (REF). Headache frequency, intensity, and use of analgesics in relation to headache were determined by questionnaire at baseline and follow-up. ResultsThe intention-to-treat analysis showed reduced headache frequency and intensity of approximately 50% in all training groups compared with REF at 20-week follow-up (P < 0.001). Use of analgesics was lower in the supervised training groups (1WS, 3WS and 9WS), but not in the group with minimal training supervision (3MS), compared with REF at follow-up. ConclusionOne hour of specific strength training – regardless of the distribution during the week - effectively reduced both headache frequency and intensity in office workers. Thus, a large time-wise flexibility exists when implementing specific strength training at the workplace. However, only supervised training led to a reduction in use of analgesics for headache.

Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine: an open-label study.

BackgroundMenstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine.MethodsFifty-six enrolled subjects (menstrual migraine, 9 %; menstrually related migraine, 91 %), 33 (59 %) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61 %) or as monotherapy (20/51; 39 %) on day −3 before estimated onset of menses through day +3 after the end of menses.ResultsThe number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean ± standard error, 7.2 ± 0.7 days) to the end of treatment (mean ± standard error, 4.7 ± 0.5 days; P < 0.001) (primary end point). Of all subjects, 39 % (95 % confidence interval: 26 %, 54 %) (20/51) had a ≥ 50 % reduction (secondary end point). For the other secondary end points, clinically meaningful reductions in analgesic use (mean change ± standard error, −3.3 ± 0.6 times per month; P < 0.001), 6-item Headache Impact Test score (mean change ± standard error, −3.1 ± 0.7; P < 0.001), and Migraine Disability Assessment score (mean change ± standard error, −11.9 ± 3.4; P < 0.001) were observed, along with a modest reduction in pain intensity (mean change ± standard error, −0.5 ± 0.2; P = 0.002). There were no safety/tolerability concerns.ConclusionsThese findings suggest that non-invasive vagus nerve stimulation is an effective treatment that reduces the number of menstrual migraine/menstrually related migraine days and analgesic use without safety/tolerability concerns in subjects with menstrual migraine/menstrually related migraine. Randomised controlled studies are warranted.

The impact of one fraction of 8 Gy radiotherapy in palliative treatment of multiple myeloma patients with painful bone destructions.

Radiotherapy is required to overcome pain and to promote recalcification in multiple myeloma (MM) patients. The aim of our prospective study was to evaluate the impact of one fraction of 8 Gy regimen in palliative treatment of MM. Forty-six patients with MM and painful bone destructions were treated by 8 Gy single fraction regimen. The visual analog scale was used for evaluation of pain. Analgesic use was measured prior to and after radiotherapy (4, 12, and 24 weeks). Recalcification was evaluated with radiographs before and after radiotherapy at 1 and 3 months. Quality of life questionnaires were completed before and 4 weeks after treatment. Decrease of pain was observed in 78.3% cases: according to the international consensus on palliative radiotherapy criteria, 43.5% were found to be completely and 34.8% partially responsive. Reduction of analgesic use was present in 68.4% and complete cessation in 31.6%. Recalcification was present in 55%: a complete response was observed in 35% and a partial response in 20%. The side effects after treatment were of the first grade and reversible. One fraction of 8 Gy regimen is effective in palliative treatment of MM patients with painful bone destructions.

Treatment of vertebral body compression fractures using percutaneous kyphoplasty guided by a combination of computed tomography and C-arm fluoroscopy with finger-touch guidance to determine the needle entry point.

This study aimed to evaluate the results and complications of image-guided percutaneous kyphoplasty (PKP) using computed tomography (CT) and C-arm fluoroscopy, with finger-touch guidance to determine the needle entry point. Of the 86 patients (106 PKP) examined, 56 were treated for osteoporotic vertebral compression fractures and 30 for vertebral tumors. All patients underwent image-guided treatment using CT and conventional fluoroscopy, with finger-touch identification of a puncture point within a small incision (1.5 to 2 cm). Partial or complete pain relief was achieved in 98% of patients within 24 h of treatment. Moreover, a significant improvement in functional mobility and reduction in analgesic use was observed. CT allowed the detection of cement leakage in 20.7% of the interventions. No bone cement leakages with neurologic symptoms were noted. All work channels were made only once, and bone cement was distributed near the center of the vertebral body. Our study confirms the efficacy of PKP treatment in osteoporotic and oncological patients. The combination of CT and C-arm fluoroscopy with finger-touch guidance reduces the risk of complications compared with conventional fluoroscopy alone, facilitates the detection of minor cement leakage, improves the operative procedure, and results in a favorable bone cement distribution.

48.: The effect of brief biofeedback intervention on headache disability and analgesic use in episodic or chronic migraine and chronic tension type headache

Chronic headache and migraine are highly prevalent in Australia. Pharmacological treatment has low efficacy, often compounded by overuse of medication, and psychological distress in this population is common. Thus, easily accessible, non-pharmacological interventions that address psychological components of headache and migraine are needed. This study explored the effectiveness of biofeedback as a mechanism for change in analgesic use. Forty people diagnosed by a neurologist as experiencing either chronic or episodic migraine or tension type headache were given psycho-education and relaxation during two sessions of biofeedback. The present study utilized two sessions of biofeedback (which has shown promise in meta-analysis) as a mechanism for change. Biofeedback sessions were of 1 hour duration and repeated at 1 month. Using a pre-post experimental design, the Migraine Disability Score (MIDAS), affective distress (DASS5) and analgesic use were recorded before commencing biofeedback and by mail survey at 3 month follow up. Paired sample t-test was used to explore differences in MIDAS score and analgesic use from baseline to 3 month follow-up using 95% confidence intervals. Mean difference from baseline to follow-up in MIDAS scores was 23.43 (8.53, 38.3), t(1, 36) = 3.19, p = .003. Mean analgesic use difference was 9.47 (4.02, 14.92), t(1, 34) = 3.53, p = .001. These changes indicate a 56% improvement in headache disability scores and 58% reduction in analgesic use. Psychological interventions such as biofeedback may reduce both the burden of headache and reliance on medication for patients, simultaneously impacting on the cost of health care provision and lost work days due to headache disability. The 56% reduction in MIDAS scores could not be attributed to medication prophylaxis, which remained unchanged, or analgesic usage, which was reduced by 58% at 3 months. Further studies with a control group, larger cohort of patients and longer follow-up may determine a clinical benefit of biofeedback in the treatment of episodic and chronic migraine and chronic tension type headache.

Palliative embolisation for advanced bone sarcomas

Managing patients with advanced bone sarcomas - namely, recurrent, unresectable and metastatic - is mostly aimed at palliation. The role of embolisation for pain relief for these patients has not been previously reported. We therefore performed this study to emphasise the palliative role of embolisation for pain relief of advanced bone sarcoma patients. We retrospectively studied 43 patients with advanced bone sarcomas treated with palliative embolisation with N-2-butyl-cyanoacrylate from 2004 to 2011. All patients had primary treatments including chemotherapy, radiation therapy, radiofrequency thermal ablation, and/or surgery for their advanced sarcomas and were referred for embolisation as end-stage treatment for continuous severe local pain. The effect of embolisation was evaluated with a pain score scale and analgesic use. Mean follow-up was 7 (range, 1-19) months); all patients were dead at the last follow-up. In all patients, angiography showed increased pathological vascularisation of the sarcomas; three to six feeding vessels were embolised in each procedure. Almost complete pain relief and >50% reduction in analgesic use was experienced by 36 patients with highly hypervascular sarcomas and sarcomas in the pelvis and shoulder girdle. Moderate pain relief and 50% reduction in analgesic use was experienced by seven patients with spinal and sacral lesions. Within the available follow-up, no patient had recurrent pain with the same intensity as before embolisation. All patients experienced ischaemic pain at the site of embolisation that resolved completely with analgesics. Six patients with advanced pelvic bone sarcomas experienced paraesthesias at the distribution of the sciatic nerve that resolved completely with methylprednisolone. Embolisation is a safe and effective local palliative treatment for patients with advanced sarcomas, providing optimum pain relief with the least discomfort and the possibility of minor complications only.

Evaluation of Acupuncture in the Management of Chemotherapy-Induced Peripheral Neuropathy

To clinically evaluate the effectiveness of acupuncture when used in the management of chemotherapy-induced peripheral neuropathy (PN). During cancer treatment, certain chemotherapies can cause varying degrees of PN. Patients' quality of life can be seriously impaired through loss of sensation, pain or mobility problems. Conventional medications routinely used to manage neuropathic symptoms have poor side-effect profiles and there is little or no evidence justifying their use to treat chemotherapy-related neurotoxicities. There are studies suggesting that acupuncture may be an effective therapy in treating PN across a number of different aetiologies. Design A retrospective service evaluation. Patients (n=18) were referred for acupuncture by the medical staff and/ornurse specialists or they self-referred for treatment. A course of six weekly acupuncture sessions was offered to them, and their details were recorded on an evaluation form prior to session one. Points were selected by acupuncturists, based on patient presentation, and needles remained in situ for 30-45 min. Treatments took place in outpatient clinics, chemotherapy day case ward or a drop-in clinic based in a physiotherapy gym. The evaluation form was completed at the end of session 6 by a therapist who had not been involved in patient care. 82% (n=14) of patients reported an improvement in symptoms following their course of acupuncture; one patient with advanced disease died during the 6 weeks. Some patients derived additional benefits from the treatment including a reduction in analgesic use and improved sleeping patterns. The most common acupoints used were SP6 (n=18), ST36 (n=18) and LV3 (n=14). Although these results are encouraging, they are uncontrolled. They suggest that acupuncture could be an option for these patients and controlled trials using validated patient-reported outcome measures are justified.

Extended Cycles with the Combined Oral Contraceptive Chlormadinone Acetate 2 mg/Ethinylestradiol 0.03 mg

The prescribing of extended regimens of oral contraceptives (OCs) is increasing in routine gynaecological practice as a means of reducing the number of annual menstrual bleeds. Typically, this involves taking one pill per day for, say, 84 days continuously (4×21 days), followed by a 7-day pill-free interval. Low-dose OCs are suitable for extended use, and many gynaecologists in Germany prescribe the combination of chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (CMA 2 mg/EE 0.03 mg). The aim of the current study was to assess the risks and benefits of CMA 2 mg/EE 0.03 mg in extended regimens, using pooled data from observational studies. This pooled analysis of three large-scale, non-interventional, observational studies assessed the results in women receiving Belara® (CMA 2 mg/EE 0.03 mg) according to an extended regimen compared with conventional regimens documented in the summary of product characteristics. A total of 625 women were identified as extended-regimen users (mean±SD age 24.9±9.0 years). Extended-cycle use was associated with decreases in skin problems, dysmenorrhoea symptoms (as shown by reductions in analgesic use; absence from school, university, or work; and restrictions in leisure and sporting activities), cycle-dependent symptoms (e.g. headache/migraine, breast tenderness), withdrawal bleeding, bleeding duration and reduced libido. Mean bodyweight remained almost constant over 6 months. Only nine adverse drug reactions, none severe, were reported in eight women (1.3%). This pooled analysis confirms that extended regimens of CMA 2 mg/EE 0.03 mg reduce cycle-related complaints and are very well tolerated.

Abstract P1-13-02: Ibandronate Shows Marked Pain Relief and a Favorable Renal Safety Profile — Final Results of a Large-Scale Non Interventional Study in Breast Cancer Patients with Metastatic Bone Disease

Abstract Background: In patients (pts) with metastatic bone disease (MBD) due to breast cancer (BC) the incidence of skeletal related events (SRE) and the severity of bone pain are effectively reduced by bisphosphonates (BP), the current standard of care in this setting. As treatment with some BP may adversely affect kidney function, renal safety is a key determinant of BP risk/benefit assessment. Ibandronate (IBA), a BP available in IV and oral formulations, demonstrated sustained effects on skeletal related events (SRE) and bone pain with a low incidence of renal adverse events in randomized clinical trials (RCT). To verify those results under real life conditions, a large-scale non interventional study (NIS) was conducted in Germany. Patients and methods: In accordance with the terms of the marketing authorization, BC pts with MBD received 6 mg IBA IV every 3-4 weeks or 50 mg of oral IBA once daily (at the physician's discretion) for up to 24 weeks. Pain severity (VAS), use of analgesics (classified according to the WHO analgesic ladder), SRE, and renal function (estimated creatinine clearance, eCrCl; Cockcroft-Gault formula) were recorded in 4-week intervals. Results: 3515 pts, mean age 63.6 +11.7 years, were evaluated. 2320 (66%) were BP-naïve; 418 (12%) had received prior treatment with IBA, 777 (22%) with other BPs, including zoledronic acid (ZOL) (503; 14%) and pamidronate (256; 7%). At baseline, mean pain severity (VAS) was lower for pts pretreated with IBA (2.5 ± 2.1) compared to BP-naïve pts (3.2 ± 2.4; p &amp;lt; 0.0001) or pts pretreated with other BPs (3.1 ± 2.4; p &amp;lt; 0.0001) and analgesic use was less frequent (38% vs 47% and 44%, respectively). For the 2678 pts evaluable for renal function throughout the observation period, mean eCrCl at baseline was significantly lower in pts pretreated with ZOL (72.4 ± 31.7 ml/min) than in BP-naïve (79.5 ± 30.7 ml/min; P&amp;lt;0.0001) or IBA-pretreated pts (77.8 ± 28.8 ml/min; p=0.0090). 64% of the total study population achieved a decrease in pain severity on IBA treatment. In pts reporting pain at baseline, mean pain severity decreased throughout the observation period (3.1 ± 2.4 to 2.3 ± 2; p &amp;lt; 0.0001). In parallel, there was an overall reduction of analgesic use with 57% of pts not requiring analgesics at the last observation and more pts being switched to less potent or no analgesic treatment than patients requiring more analgesia. SRE were rare (7%), irrespective of prior treatment. Changes in renal function during IBA treatment were small and balanced across all subgroups; no severe renal adverse events were observed. Thirteen cases of osteonecrosis of the jaw were reported during the observation period, 8 of which had received ZOL as prior treatment. Overall tolerability of IBA treatment was rated as good or very good by 98% of physicians. Conclusion: In this NIS in BC pts with MBD, the largest-to-date study with IBA, IV and oral IBA showed marked and sustained pain relief with an overall reduction of analgesic use and a renal safety profile comparable to results of RCT. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-13-02.

Longitudinal Treatment Outcomes for Geriatric Patients with Chronic Non-Cancer Pain at an Interdisciplinary Pain Rehabilitation Program

This study examined depression, pain catastrophizing, psychosocial functioning, and physical and emotional health attributes for geriatric patients admitted to an interdisciplinary pain rehabilitation center compared with middle and younger age groups. Quasi-experimental time series. Interdisciplinary pain rehabilitation center at a tertiary referral medical center. In total, 411 patients with chronic non-cancer pain completed the pain rehabilitation program from October 2004 to April 2006. Patients were divided into three groups based on age: older (ages 60+; n = 78); middle-age (ages 40-59; n = 230) and younger (ages 18-39; n = 141). A 3-week outpatient interdisciplinary pain rehabilitation program based on a cognitive-behavioral model that incorporates opioid withdrawal. The Multidimensional Pain Inventory (MPI), Short Form-36 Health Status Questionnaire (SF-36), Pain Catastrophizing Scale (PCS), and Center for Epidemiological Studies-Depression Scale (CES-D) were administered at admission, discharge, and 6 months following treatment. The frequency of patients using opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and benzodiazepines at each assessment point were compared. Older patients reported reduced depression, catastrophizing, pain severity, and pain interference (P < 0.001) at discharge and 6 months follow-up. Older patients also reported increased perceived control, and physical and social functioning at discharge and follow-up (P < 0.001). Improvement in older patients was comparable in magnitude to that of middle-age patients on all variables, whereas younger patients exhibited greater improvement on four variables. Significant reductions in analgesic use were observed in all groups. Interdisciplinary pain rehabilitation incorporating opioid withdrawal can improve long-term psychological, social and physical functioning for geriatric chronic pain patients.