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Acupuncture to treat migraine: A multi-center randomized controlled trial
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Abstract / European Journal of Integrative Medicine 2 (2010) 175–215
overall study: 52 joined the high, 8 the medium and 10 the low intensity group program. Conclusion: MOCAM-back pain may prove that risk adapted multidisciplinary therapy is effective in maintaining the patients’ working ability or increasing the back to work rate. doi:10.1016/j.eujim.2010.09.046 OP-041 Effectiveness of integrated yoga therapy in treatment of chronic migraine: randomized controlled trial N. Sharma a,b,∗ , S. Sharma b , A. Verma b a
Brett Research (UK) Ltd, Centre of Alternative Medicine, Watford, United Kingdom b NMP Medical Research Institute, Jaipur, India
Question: Does the integrated yoga therapy program help reducing pain measures and depression in chronic migraine patients. Methods: To test the effectiveness of a integrated yoga therapy program for chronic migraine treatment in a low cost, nonclinical setting, a prospective, randomized, controlled trial was conducted in Jaipur, India. Subjects aged 18–65 years with 15 or more headache days per month, at least half of which were migraine/migrainous headaches, were randomized 1:1 to either yoga therapy or standard management. Seventy men and women were randomly assigned. The intervention group went through individualized yoga treatment for 12-weeks with four consecutive therapeutic sessions a week. Each therapy session lasting for about 60 min focusing on strengthening, relaxation, releasing muscular tension and increasing self efficacy. The control group consisted of standard care with the patient’s physician. Outcome measures included self-perceived pain intensity, frequency, and duration; functional status; depression; prescription and nonprescription medication use. Outcomes were measured at the end of the 12-week intervention and at a 6-month follow-up. Results: Thirty-one of 35 patients from the intervention group and all 35 patients from the control group completed the study. There were no statistically significant differences between the two groups before intervention. Intention to treat analysis revealed that the intervention group experienced statistically significant changes in self-perceived pain frequency (P = .000), pain intensity (P = .001), pain duration (P = .000), functional status (P = .000), medication used (P < 0.01) and depression (P = .000); these differences retained their significance at the 6-month follow-up. Conclusions: Positive health related outcomes in chronic migraine can be obtained with a low cost, group, integrated yoga in a community based nonclinical setting. doi:10.1016/j.eujim.2010.09.047
OP-042 Acupuncture to treat migraine: A multi-center randomized controlled trial Y. Li a,∗ , F.-R. Liang a , H. Zheng a , C. Witt b , S. Roll b , S.-G. Yu a , J. Yan c , G. Sun d , W.-J. Huang a , X.-R. Chang c , L. Zhao a , H.-X. Zhang d , D.-J. Wang c , L. Lan c , R. Zou d a
Chengdu University of TCM, Chengdu, China University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany c Human University of TCM, Changsha, China d Hubei University of Traditional Chinese Medicine, Hubei, China Key words: Acupuncture; Migraine; Randomized controlled trial b Charité
Context: Using acupuncture to treat patients with migraine is commonly used as a complementary and alternative therapy, but the reliable evidence of its efficacy is inadequate. Objective: To aim at testifying the effective of using acupuncture to treat migraine through comparing three acupuncture groups using different acupoints with one non-acupoints control group. Design, setting, and patients: A multi-center, single-blinded, randomized controlled trial involving 480 patients [394(82.77%) women, mean (SD) age of 36.90(12.29) years] with migraine was completed in nine hospitals of China from April 2008 to December 2009. Interventions: Three acupoints treatment groups, one nonacupoints control group. All of them were administered by specialized acupuncturists and consisted of 20 sessions with an observation period of 20 weeks. All patients were randomly assigned to one of the following four groups: (1) specific acupoints of Shaoyang meridians, (2) non-specific acupoints of Shaoyang meridians, (3) acupoints of other meridians, or (4) non-acupoints control group. Patients finished headache diaries during the 20 weeks observation period. Main outcome measures: The number of days with migraine in the 4-weeks? Period from week 5th to week 8th after randomization was defined as main outcome measure. Intensity of headache including headache intensity grade and visual analogue scale, frequency of migraine attacks, Migraine-Specific Quality-of-Life Questionnaire (MSQ) was also used as the secondary outcome measurement before and after randomization. Results: Of 1290 patients screened, 480 were finally randomly assigned to the above-mentioned groups. Three patients were excluded for erroneous inclusion and one was excluded for primary data missing. So 476 patients received acupuncture treatment. Due to missing values, 442 patients were finally included in the intention-to-treat population and 434 in the perprotocol population. The number of days from week 5th to 8th showed no significant difference among groups (P = 0.238), whereas from week 13th to 16th significant difference was found between three acupoints treatment groups and the non-acupoints group (P = 0.003). And the secondary outcomes showed signif-
Abstract / European Journal of Integrative Medicine 2 (2010) 175–215
icant difference between three acupoints treatment groups and the non-acupoints group (P < 0.05). Conclusion: Acupoints were superior to non-acupoints in long-term effect on migraine, however no significant difference was found between acupoints and non-acupoints in short-term effect. doi:10.1016/j.eujim.2010.09.048 OP-043 Patient characteristics and variation in treatment outcomes: Which patients benefit most from acupuncture for chronic pain? C. Witt a,∗ , L. Schützler a , R. Lüdtke b , K. Wegscheider c , S.N. Willich a a
Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany b Carstens Foundation, Essen, Germany c University Hospital Hamburg, Institute for Medical Biometry and Epidemiology, Hamburg, Germany Background: The aim of this paper was to quantify the influence of patients’ socio-demographic and disease-related characteristics on treatment outcome in acupuncture treatment of chronic pain. Methods: Patients visiting their physician because of chronic low back pain, headache, pain due to osteoarthritis of the knee or hip, or neck pain, were included in 4 multicenter, randomized, controlled studies. All patients received routine care; patients in the acupuncture group received additional acupuncture treatment (on average 10 sessions). Data were pooled, and the 3-month-change from baseline of the SF-36 bodily pain subscale was defined as the main outcome. To identify confounders and effect modifiers patients’ characteristics as well as their interaction with treatment were included in a mixed linear model predicting treatment outcome. Results: A total of 9990 patients (mean age 49.6 ± 13.6 years, 68% female) treated by 2781 physicians were analyzed. The outcome was markedly improved in the acupuncture group (p < .001). Younger age (<50 years; p < .001), higher school degree (>10 years; p < .001), shorter duration of illness (p = .021), more bodily pain at baseline (p < .001), and some concomitant diseases influenced outcome in both groups. Patients’ characteristics that acted as modifiers, i.e. enlarged the effect of acupuncture, were being female (p = .028), living in a multiperson household (p = .002), failure of other therapies prior to the study (p = .049), and former positive experience with acupuncture (p = .005). Conclusion: The results point out that women, people living in a multi-person household, and patients who might have higher expectation benefit more from acupuncture treatment in usual care than other patients. More research on gender aspects and expectation is needed. doi:10.1016/j.eujim.2010.09.049
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OP-044 All responders are not the same: Segregating the mechanisms of antidepressants and placebo in chronic pain K. Jensen a , F. Petzke b , S. Carville c , E. Choi c , P. Fransson a , R. Graceley d , Y. Mainguy e , H. Marcus b , S. Williams c , E. Kosek a , M. Ingvar a,∗ a Osher Center for Integrative Medicine, Clinical Neuroscience, Stockholm, Sweden b University of Cologne, Department of Anethesiology, Cologne, Germany c Kings College, Department of Rheumatology, London, United Kingdom d University North Carolina, Center for Neurosensory Disorders, Chapel Hill, United States e Pierre Fabre Médicament, Institut de Recherche, Boulogne, France Keywords: Fibromyalgia; fMRI; Milnacipran; Placebo
The use of antidepressant drugs is common in treatment of chronic pain but little is known about the mechanisms underlying the treatment effect. The aim of this study was to compare the cerebral and behavioral response in patients who reported positive treatment effects of antidepressants or placebo. 92 female Fibromyalgia patients participated in a 12-week, multicenter, double-blind, placebo controlled, randomized trial assessing the effect of the noradrenalin-serotonin re-uptake inhibitor milnacipran 100 mg b.i.d. Before and following treatment there were measures of brain activity using functional magnetic resonance imaging during individually calibrated painful pressures. Also, there were stimulus–response assessments of pressure pain and measures of weekly pain intensities, and overall Fibromyalgia impact. Responders were defined by patient’s own subjective ratings of change, using the Patient Global Impression of Change questionnaire. Following treatment, there was a segregated pattern of painevoked brain activity for milnacipran responders and placebo responders. Milnacipran responders, as opposed to placebo responders, exhibited significantly higher brain activity in the posterior cingulum, a region previously implicated in response to non-opioidergic pain treatment in chronic pain patients. Results also demonstrate that the mere exposure to milnacipran did not explain our findings. Responders to milnacipran exhibited increased pain-evoked activity in the posterior cingulum also in comparison to milnacipran non-responders. In accordance with brain imaging data, the stimulus–response assessments revealed a specific anti-nociceptive effect in milnacipran responders related to reduced intensity of spontaneous pain. This was not seen in placebo responders. Moreover, a short history of pain symptoms predicted a positive treatment response to milnacipran, pointing towards an attenuation of pain pathophysiology in response to the drug. In conclusion, we demonstrate segregated neural mechanisms for patients that report a positive treatment response to milnacipran and placebo. The increase of pain-evoked brain activity
Abstract / European Journal of Integrative Medicine 2 (2010) 175–215
overall study: 52 joined the high, 8 the medium and 10 the low intensity group program. Conclusion: MOCAM-back pain may prove that risk adapted multidisciplinary therapy is effective in maintaining the patients’ working ability or increasing the back to work rate. doi:10.1016/j.eujim.2010.09.046 OP-041 Effectiveness of integrated yoga therapy in treatment of chronic migraine: randomized controlled trial N. Sharma a,b,∗ , S. Sharma b , A. Verma b a
Brett Research (UK) Ltd, Centre of Alternative Medicine, Watford, United Kingdom b NMP Medical Research Institute, Jaipur, India
Question: Does the integrated yoga therapy program help reducing pain measures and depression in chronic migraine patients. Methods: To test the effectiveness of a integrated yoga therapy program for chronic migraine treatment in a low cost, nonclinical setting, a prospective, randomized, controlled trial was conducted in Jaipur, India. Subjects aged 18–65 years with 15 or more headache days per month, at least half of which were migraine/migrainous headaches, were randomized 1:1 to either yoga therapy or standard management. Seventy men and women were randomly assigned. The intervention group went through individualized yoga treatment for 12-weeks with four consecutive therapeutic sessions a week. Each therapy session lasting for about 60 min focusing on strengthening, relaxation, releasing muscular tension and increasing self efficacy. The control group consisted of standard care with the patient’s physician. Outcome measures included self-perceived pain intensity, frequency, and duration; functional status; depression; prescription and nonprescription medication use. Outcomes were measured at the end of the 12-week intervention and at a 6-month follow-up. Results: Thirty-one of 35 patients from the intervention group and all 35 patients from the control group completed the study. There were no statistically significant differences between the two groups before intervention. Intention to treat analysis revealed that the intervention group experienced statistically significant changes in self-perceived pain frequency (P = .000), pain intensity (P = .001), pain duration (P = .000), functional status (P = .000), medication used (P < 0.01) and depression (P = .000); these differences retained their significance at the 6-month follow-up. Conclusions: Positive health related outcomes in chronic migraine can be obtained with a low cost, group, integrated yoga in a community based nonclinical setting. doi:10.1016/j.eujim.2010.09.047
OP-042 Acupuncture to treat migraine: A multi-center randomized controlled trial Y. Li a,∗ , F.-R. Liang a , H. Zheng a , C. Witt b , S. Roll b , S.-G. Yu a , J. Yan c , G. Sun d , W.-J. Huang a , X.-R. Chang c , L. Zhao a , H.-X. Zhang d , D.-J. Wang c , L. Lan c , R. Zou d a
Chengdu University of TCM, Chengdu, China University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany c Human University of TCM, Changsha, China d Hubei University of Traditional Chinese Medicine, Hubei, China Key words: Acupuncture; Migraine; Randomized controlled trial b Charité
Context: Using acupuncture to treat patients with migraine is commonly used as a complementary and alternative therapy, but the reliable evidence of its efficacy is inadequate. Objective: To aim at testifying the effective of using acupuncture to treat migraine through comparing three acupuncture groups using different acupoints with one non-acupoints control group. Design, setting, and patients: A multi-center, single-blinded, randomized controlled trial involving 480 patients [394(82.77%) women, mean (SD) age of 36.90(12.29) years] with migraine was completed in nine hospitals of China from April 2008 to December 2009. Interventions: Three acupoints treatment groups, one nonacupoints control group. All of them were administered by specialized acupuncturists and consisted of 20 sessions with an observation period of 20 weeks. All patients were randomly assigned to one of the following four groups: (1) specific acupoints of Shaoyang meridians, (2) non-specific acupoints of Shaoyang meridians, (3) acupoints of other meridians, or (4) non-acupoints control group. Patients finished headache diaries during the 20 weeks observation period. Main outcome measures: The number of days with migraine in the 4-weeks? Period from week 5th to week 8th after randomization was defined as main outcome measure. Intensity of headache including headache intensity grade and visual analogue scale, frequency of migraine attacks, Migraine-Specific Quality-of-Life Questionnaire (MSQ) was also used as the secondary outcome measurement before and after randomization. Results: Of 1290 patients screened, 480 were finally randomly assigned to the above-mentioned groups. Three patients were excluded for erroneous inclusion and one was excluded for primary data missing. So 476 patients received acupuncture treatment. Due to missing values, 442 patients were finally included in the intention-to-treat population and 434 in the perprotocol population. The number of days from week 5th to 8th showed no significant difference among groups (P = 0.238), whereas from week 13th to 16th significant difference was found between three acupoints treatment groups and the non-acupoints group (P = 0.003). And the secondary outcomes showed signif-
Abstract / European Journal of Integrative Medicine 2 (2010) 175–215
icant difference between three acupoints treatment groups and the non-acupoints group (P < 0.05). Conclusion: Acupoints were superior to non-acupoints in long-term effect on migraine, however no significant difference was found between acupoints and non-acupoints in short-term effect. doi:10.1016/j.eujim.2010.09.048 OP-043 Patient characteristics and variation in treatment outcomes: Which patients benefit most from acupuncture for chronic pain? C. Witt a,∗ , L. Schützler a , R. Lüdtke b , K. Wegscheider c , S.N. Willich a a
Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany b Carstens Foundation, Essen, Germany c University Hospital Hamburg, Institute for Medical Biometry and Epidemiology, Hamburg, Germany Background: The aim of this paper was to quantify the influence of patients’ socio-demographic and disease-related characteristics on treatment outcome in acupuncture treatment of chronic pain. Methods: Patients visiting their physician because of chronic low back pain, headache, pain due to osteoarthritis of the knee or hip, or neck pain, were included in 4 multicenter, randomized, controlled studies. All patients received routine care; patients in the acupuncture group received additional acupuncture treatment (on average 10 sessions). Data were pooled, and the 3-month-change from baseline of the SF-36 bodily pain subscale was defined as the main outcome. To identify confounders and effect modifiers patients’ characteristics as well as their interaction with treatment were included in a mixed linear model predicting treatment outcome. Results: A total of 9990 patients (mean age 49.6 ± 13.6 years, 68% female) treated by 2781 physicians were analyzed. The outcome was markedly improved in the acupuncture group (p < .001). Younger age (<50 years; p < .001), higher school degree (>10 years; p < .001), shorter duration of illness (p = .021), more bodily pain at baseline (p < .001), and some concomitant diseases influenced outcome in both groups. Patients’ characteristics that acted as modifiers, i.e. enlarged the effect of acupuncture, were being female (p = .028), living in a multiperson household (p = .002), failure of other therapies prior to the study (p = .049), and former positive experience with acupuncture (p = .005). Conclusion: The results point out that women, people living in a multi-person household, and patients who might have higher expectation benefit more from acupuncture treatment in usual care than other patients. More research on gender aspects and expectation is needed. doi:10.1016/j.eujim.2010.09.049
195
OP-044 All responders are not the same: Segregating the mechanisms of antidepressants and placebo in chronic pain K. Jensen a , F. Petzke b , S. Carville c , E. Choi c , P. Fransson a , R. Graceley d , Y. Mainguy e , H. Marcus b , S. Williams c , E. Kosek a , M. Ingvar a,∗ a Osher Center for Integrative Medicine, Clinical Neuroscience, Stockholm, Sweden b University of Cologne, Department of Anethesiology, Cologne, Germany c Kings College, Department of Rheumatology, London, United Kingdom d University North Carolina, Center for Neurosensory Disorders, Chapel Hill, United States e Pierre Fabre Médicament, Institut de Recherche, Boulogne, France Keywords: Fibromyalgia; fMRI; Milnacipran; Placebo
The use of antidepressant drugs is common in treatment of chronic pain but little is known about the mechanisms underlying the treatment effect. The aim of this study was to compare the cerebral and behavioral response in patients who reported positive treatment effects of antidepressants or placebo. 92 female Fibromyalgia patients participated in a 12-week, multicenter, double-blind, placebo controlled, randomized trial assessing the effect of the noradrenalin-serotonin re-uptake inhibitor milnacipran 100 mg b.i.d. Before and following treatment there were measures of brain activity using functional magnetic resonance imaging during individually calibrated painful pressures. Also, there were stimulus–response assessments of pressure pain and measures of weekly pain intensities, and overall Fibromyalgia impact. Responders were defined by patient’s own subjective ratings of change, using the Patient Global Impression of Change questionnaire. Following treatment, there was a segregated pattern of painevoked brain activity for milnacipran responders and placebo responders. Milnacipran responders, as opposed to placebo responders, exhibited significantly higher brain activity in the posterior cingulum, a region previously implicated in response to non-opioidergic pain treatment in chronic pain patients. Results also demonstrate that the mere exposure to milnacipran did not explain our findings. Responders to milnacipran exhibited increased pain-evoked activity in the posterior cingulum also in comparison to milnacipran non-responders. In accordance with brain imaging data, the stimulus–response assessments revealed a specific anti-nociceptive effect in milnacipran responders related to reduced intensity of spontaneous pain. This was not seen in placebo responders. Moreover, a short history of pain symptoms predicted a positive treatment response to milnacipran, pointing towards an attenuation of pain pathophysiology in response to the drug. In conclusion, we demonstrate segregated neural mechanisms for patients that report a positive treatment response to milnacipran and placebo. The increase of pain-evoked brain activity