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Author Diener, H. C.; Kronfeld, K.; Boewing, G.; Lungenhausen, M.; Maier, C.; Molsberger, A.; Tegenthoff, M.; Trampisch, H. J.; Zenz, M.; Meinert, R. url  openurl
  Title Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial Type of Study RCT
  Year 2006 Publication The Lancet. Neurology Abbreviated Journal Lancet Neurol  
  Volume 5 Issue 4 Pages 310-316  
  Keywords CAM Control; Acu Versus > 1 Control; Acupuncture; AcuTrials; Penetrating Sham; Migraine; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Superficial Needling Depth; Sham Acupoint Control; Sham Control; Usual Care Control, Pharmaceutical; Traditional Diagnosis Based Point Selection; TCM Acupuncture Style; Headache Disorders  
  Abstract BACKGROUND: Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment. METHODS: This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23-26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557. FINDINGS: Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 .3 days (95% CI 1.9-2.7) in the verum acupuncture group, 1.5 days (1.1-2.0) in the sham acupuncture group, and 2.1 days (1.5-2.7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0.0001), but not across the treatment groups (p=0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133). INTERPRETATION: Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy  
  Address Department of Neurology, University Essen, Essen, Germany. h.diener@uni-essen.de  
  Publisher
  Language Number of Treatments 10  
  Treatment Follow-up 20 Weeks Frequency >1/WK Number of Participants 960  
  Time in Treatment 6 Weeks Condition Migraine
  Disease Category Headache Disorders OCSI Score (down) 96  
  Notes Approved no  
  Call Number Serial 245  
Permanent link to this record
 

 
Author Guerra de Hoyos, J. A.; Martin, Mdel C.; Leon, E. B.; Lopez, M. V.; Lopez, T. M.; Morilla, F. A.; Moreno, M. J. url  openurl
  Title Randomised trial of long term effect of acupuncture for shoulder pain Type of Study RCT
  Year 2004 Publication Pain Abbreviated Journal Pain  
  Volume 112 Issue 3 Pages 289-298  
  Keywords Acu Versus Sham; AcuTrials; Electroacupuncture; Fixed Acupuncture Protocol; Non Penetrating Sham, Electrical; RCT; Restricted Modalities, Acupuncture Only; Sham Control; Sham Electroacupuncture; Shoulder Pain; TCM Acupuncture Style; Verum Acupoint Control  
  Abstract The objective of the study is to compare the efficacy of electro-acupuncture with placebo-acupuncture for the treatment of shoulder pain. This study comprised of a prospective, randomized, placebo controlled trial, with independent evaluator set in a Public primary care clinic in Spain. The participants are patients aged from 25 to 83 years with shoulder pain. Patients were randomly allocated to two treatments over eight weeks, with electro-acupuncture or skin non-penetrating placebo-acupuncture, both able to take diclofenac if needed for intense pain. Primary outcome measure was the difference between groups in pain intensity (visual analogue scale-VAS). Secondary outcomes were differences between groups in pain intensity measured by Lattinen index, in range of motion (goniometer), functional ability (SPADI), quality of life (COOP-WONCA charts), NSAIDS intake, credibility (Borkoveck and Nau scale) and global satisfaction (10 points analogue scale). Assessments were performed before, during and three and six months after treatment. At six month follow-up after treatment the acupuncture group showed a significantly greater improvement in pain intensity compared with the control group [VAS mean difference 2.0 (95% CI 1.2-2.9)]. The acupuncture group had consistently better results in every secondary outcome measure than the control group. Acupuncture is an effective long-term treatment for patients with shoulder pain (from soft tissues lesions) in a primary care setting  
  Address Andalusia Public Health Service, C/La Maria 26, DP 41008 Sevilla, Spain  
  Publisher
  Language Number of Treatments 8  
  Treatment Follow-up 24 Weeks Frequency 1/WK Number of Participants 130  
  Time in Treatment 8 Weeks Condition Shoulder Pain
  Disease Category Shoulder Pain OCSI Score (down) 96  
  Notes Approved no  
  Call Number Serial 397  
Permanent link to this record
 

 
Author Brinkhaus, B.; Witt, C. M.; Jena, S.; Linde, K.; Streng, A.; Wagenpfeil, S.; Irnich, D.; Walther, H. U.; Melchart, D.; Willich, S. N. url  openurl
  Title Acupuncture in patients with chronic low back pain: a randomized controlled trial Type of Study RCT
  Year 2006 Publication Archives of internal medicine Abbreviated Journal Arch Intern Med  
  Volume 166 Issue 4 Pages 450-457  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; Back Pain; Low Back Pain, Chronic; Penetrating Sham; Low Back Pain; Pain; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Superficial Needling Depth; Sham Acupoint Control; Sham Control; Symptom Based Point Selection; TCM Acupuncture Style; Wait-List Control  
  Abstract BACKGROUND: Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain. METHODS: Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm). RESULTS: A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P<.001). Also, at 26 (P=.96) and 52 (P=.61) weeks, pain did not differ significantly between the acupuncture and the minimal acupuncture groups. CONCLUSION: Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain, whereas there were no significant differences between acupuncture and minimal acupuncture  
  Address Institute of Social Medicine, Epidemiology, and Health Economics, Charite, University Medical Center, Berlin, Germany. benno.brinkhaus@charite.de  
  Publisher
  Language Number of Treatments 12  
  Treatment Follow-up 44 Weeks Frequency >1/WK Number of Participants 298  
  Time in Treatment 8 Weeks Condition Low Back Pain, Chronic
  Disease Category Back Pain OCSI Score (down) 94  
  Notes Approved no  
  Call Number Serial 93  
Permanent link to this record
 

 
Author Streng, A.; Linde, K.; Hoppe, A.; Pfaffenrath, V.; Hammes, M.; Wagenpfeil, S.; Weidenhammer, W.; Melchart, D. url  openurl
  Title Effectiveness and tolerability of acupuncture compared with metoprolol in migraine prophylaxis Type of Study RCT
  Year 2006 Publication Abbreviated Journal Headache  
  Volume 46 Issue 10 Pages 1492-1502  
  Keywords Acu Versus Usual Care; Acupuncture; AcuTrials; Auricular Acupuncture; Migraine; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Usual Care Control, Pharmaceutical; TCM Acupuncture Style; Traditional Diagnosis Based Point Selection; Trigger Point Acupuncture Style; Headache Disorders  
  Abstract Objectives.-In a randomized controlled multicenter trial extending over 24 weeks, we investigated whether acupuncture is as effective and safe as metoprolol in the prophylactic treatment of migraine under conditions similar to routine care. Methods.-One hundred fourteen migraine patients could be randomized to treatment over 12 weeks either with acupuncture (8 to 15 sessions) or metoprolol (100 to 200 mg daily). Main outcome measure was the difference in the number of migraine days between baseline and the weeks 9 to 12 after randomization (derived from a headache diary). Results.-Two of 59 patients randomized to acupuncture withdrew prematurely from the study compared to 18 of 55 randomized to metoprolol. The number of migraine days decreased by 2.5 +/- 2.9 days (baseline 5.8 +/- 2.5 days) in the acupuncture group compared to 2.2 +/- 2.7 days (baseline 5.8 +/- 2.9 days) in the metoprolol group (P= .721). The proportion of responders (reduction of migraine attacks by >/=50%) was 61% for acupuncture and 49% for metoprolol. Both physicians and patients reported fewer adverse effects in the acupuncture group. Conclusions.-Due to missing the recruitment target (480 patients) and the high drop-out in the metoprolol group the results must be interpreted with caution. Still, they suggest that acupuncture might be an effective and safe treatment option for patients unwilling or unable to use drug prophylaxis. (Headache 2006;46:1492-1502)  
  Address  
  Publisher
  Language Number of Treatments 12  
  Treatment Follow-up 12 Weeks Frequency 1/WK Number of Participants 114  
  Time in Treatment 12 Weeks Condition Migraine
  Disease Category Headache Disorders OCSI Score (down) 94  
  Notes Approved no  
  Call Number Serial 1113  
Permanent link to this record
 

 
Author Vas, J.; Perea-Milla, E.; Mendez, C.; Navarro, C. S.; Leon Rubio, J. M.; Brioso, M.; Obrero, I. G. url  openurl
  Title Efficacy and safety of acupuncture for chronic uncomplicated neck pain: A randomised controlled study Type of Study RCT
  Year 2006 Publication Abbreviated Journal Pain  
  Volume Issue Pages -  
  Keywords Acu Versus Sham; Acupuncture; AcuTrials; Auricular Acupressure; Ear Seeds; Neck Pain; Non Penetrating Sham, Electrical; RCT; Restricted Modalities, Acupuncture + Other; Semi-Individualized Acupuncture Protocol; Sham Control; Symptom Based Point Selection; TCM Acupuncture Style; Verum Acupoint Control;  
  Abstract Chronic neck pain is highly prevalent. To determine the efficacy and safety of acupuncture, in comparison with transcutaneous nerve stimulation-placebo (TENS-placebo) in the treatment of chronic uncomplicated neck pain, a single blind prospective study was designed, to be carried out at a Primary Healthcare Centre, with random assignment to two parallel groups and with evaluation and analysis by independent evaluators. A random assignment was made from 123 patients of the 149 initially recruited. These patients had been diagnosed with uncomplicated neck pain and experienced neck motion-related pain intensity equal to or exceeding 30 on a visual analogue scale (VAS) from 0 to 100mm. The treatment with acupuncture was compared with TENS-placebo, applied over 5 sessions in three weeks. The primary endpoint was the change in maximum pain intensity related to motion of the neck, one week after the final treatment. Sensitivity was analysed per protocol (PP) and variant analyses were by intention to treat (ITT). Adjustment was made for confounders by multiple linear regression, including baseline values and rescue therapy. By ITT analysis, the change in the pain-VAS variable was greater among the experimental group (28.1 (95% CI 21.4-34.7)). The improvements in quality of life (physical aspect), active neck mobility and reduced rescue medication were clinically and statistically significant. In the treatment of the intensity of chronic neck pain, acupuncture is more effective than the placebo treatment and presents a safety profile making it suitable for routine use in clinical practice  
  Address Pain Treatment Unit, Dos Hermanas “A” Primary Healthcare Centre, Dos Hermanas, Sevilla, Spain  
  Publisher
  Language Number of Treatments 5  
  Treatment Follow-up 1 Week Frequency >1/WK Number of Participants 123  
  Time in Treatment 3 Weeks Condition Neck Pain
  Disease Category Neck Pain OCSI Score (down) 93  
  Notes Approved no  
  Call Number Serial 1205  
Permanent link to this record
 

 
Author Sze, F. K.; Wong, E.; Yi, X.; Woo, J. url  openurl
  Title Does acupuncture have additional value to standard poststroke motor rehabilitation? Type of Study RCT
  Year 2002 Publication Abbreviated Journal Stroke  
  Volume 33 Issue 1 Pages 186-194  
  Keywords Acu + Usual Care Versus Usual Care; Acupuncture; Stroke; AcuTrials; Cerebrovascular Accident; Exercise Therapy; Motor Skills; Occupational Therapy; Physical Therapy; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Speech Therapy; Usual Care Control, Multimodality; Stroke; TCM Acupuncture Style; Traditional Diagnosis Based Point Selection  
  Abstract BACKGROUND AND PURPOSE: A significant number of patients remain severely disabled after stroke despite rehabilitation with standard treatment modalities. Acupuncture has been reported as an alternative modality. This study aims to examine whether acupuncture has additional value to standard poststroke motor rehabilitation. METHODS: A prospective randomized controlled trial (RCT) was carried out in a stroke rehabilitation unit in Hong Kong. One hundred six Chinese patients with moderate or severe functional impairment were included at days 3 to 15 after acute stroke. They were stratified into the moderate and the severe groups before randomization into the control arm receiving standard modalities of treatment, which included physiotherapy, occupational and speech therapy, and skilled medical and nursing care, and the intervention arm receiving in addition traditional Chinese manual acupuncture. A mean of 35 acupuncture sessions on 10 main acupoints were performed over a 10-week period. Outcome measures included Fugl-Meyer assessment, Barthel Index, and Functional Independence Measure, respectively, at weeks 0, 5, and 10, performed by blinded assessors. RESULTS: At baseline, patients in each arm were comparable in all important prognostic characteristics. No statistically significant differences were observed between the 2 arms for any of the outcome measures at week 10 or outcome changes over time. CONCLUSIONS: Traditional Chinese manual acupuncture on the body has no additional value to standard poststroke motor rehabilitation  
  Address  
  Publisher
  Language Number of Treatments 35  
  Treatment Follow-up N/A Frequency >1/WK Number of Participants 106  
  Time in Treatment 10 Weeks Condition Stroke
  Disease Category Stroke OCSI Score (down) 92  
  Notes Approved no  
  Call Number Serial 1141  
Permanent link to this record
 

 
Author Berman, B. M.; Lao, L.; Langenberg, P.; Lee, W. L.; Gilpin, A. M.; Hochberg, M. C. url  openurl
  Title Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: A randomized, controlled trial Type of Study RCT
  Year 2004 Publication Annals of internal medicine Abbreviated Journal Ann Intern Med  
  Volume 141 Issue 12 Pages 901-910  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; Arthritis; Electroacupuncture; Fixed Acupuncture Protocol; Penetrating Sham; Non Penetrating Sham, Mechanical; Osteoarthritis; Osteoarthritis, Knee; Pain; RCT; Restricted Modalities, Acupuncture Only; Sham Acupoint Control; Sham Control; Standard Needling Depth; Usual Care Control, Educational; Verum Acupoint Control  
  Abstract BACKGROUND: Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal. OBJECTIVE: To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee. DESIGN: Randomized, controlled trial. SETTING: Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and 1 clinical trials facility. PATIENTS: 570 patients with osteoarthritis of the knee (mean age [+/-SD], 65.5 +/- 8.4 years). INTERVENTION: 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks. MEASUREMENTS: Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36). RESULTS: Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, -2.9 [95% CI, -5.0 to -0.8]; P = 0.01) but not in WOMAC pain score (mean difference, -0.5 [CI, -1.2 to 0.2]; P = 0.18) or the patient global assessment (mean difference, 0.16 [CI, -0.02 to 0.34]; P > 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, -2.5 [CI, -4.7 to -0.4]; P = 0.01), WOMAC pain score (mean difference, -0.87 [CI, -1.58 to -0.16];P = 0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P = 0.02). LIMITATIONS: At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis. CONCLUSIONS: Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups  
  Address University of Maryland School of Medicine, Baltimore, Maryland 21207, USA  
  Publisher
  Language Number of Treatments 23  
  Treatment Follow-up N/A Frequency <1/WK Number of Participants 570  
  Time in Treatment 26 Weeks Condition Osteoarthritis, Knee
  Disease Category Arthritis OCSI Score (down) 90  
  Notes Approved no  
  Call Number Serial 69  
Permanent link to this record
 

 
Author Linde, K.; Streng, A.; Jurgens, S.; Hoppe, A.; Brinkhaus, B.; Witt, C.; Wagenpfeil, S.; Pfaffenrath, V.; Hammes, M. G.; Weidenhammer, W.; Willich, S. N.; Melchart, D. url  openurl
  Title Acupuncture for patients with migraine: a randomized controlled trial Type of Study RCT
  Year 2005 Publication Abbreviated Journal JAMA  
  Volume 293 Issue 17 Pages 2118-2125  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; Penetrating Sham; Migraine; Pain; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Superficial Needling Depth; Sham Acupoint Control; Sham Control; Symptom Based Point Selection; TCM Acupuncture Style; Wait-List Control; Headache Disorders;  
  Abstract CONTEXT: Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce. OBJECTIVE: To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. DESIGN, SETTING, AND PATIENTS: Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany. INTERVENTIONS: Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization. MAIN OUTCOME MEASURES: Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization. RESULTS: Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, -0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group. CONCLUSION: Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control  
  Address Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universitat Munchen, Munich, Germany. Klaus.Linde@lrz.tu-muenchen.de  
  Publisher
  Language Number of Treatments 12  
  Treatment Follow-up 16 Weeks Frequency >1/WK Number of Participants 302  
  Time in Treatment 8 Weeks Condition Migraine
  Disease Category Headache Disorders OCSI Score (down) 90  
  Notes Approved no  
  Call Number Serial 729  
Permanent link to this record
 

 
Author Scharf, H. P.; Mansmann, U.; Streitberger, K.; Witte, S.; Kramer, J.; Maier, C.; Trampisch, H. J.; Victor, N. url  openurl
  Title Acupuncture and knee osteoarthritis: a three-armed randomized trial Type of Study RCT
  Year 2006 Publication Abbreviated Journal Ann Intern Med  
  Volume 145 Issue 1 Pages 12-20  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; Arthritis; Penetrating Sham; Osteoarthritis, Knee; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Superficial Needling Depth; Sham Acupoint Control; Sham Control; Usual Care Control, Pharmaceutical; TCM Acupuncture Style; Traditional Diagnosis Based Point Selection  
  Abstract BACKGROUND: Despite the popularity of acupuncture, evidence of its efficacy for reducing pain remains equivocal. OBJECTIVE: To assess the efficacy and safety of traditional Chinese acupuncture (TCA) compared with sham acupuncture (needling at defined nonacupuncture points) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee. DESIGN: Randomized, controlled trial. SETTING: 315 primary care practices staffed by 320 practitioners with at least 2 years' experience in acupuncture. PATIENTS: 1007 patients who had had chronic pain for at least 6 months due to osteoarthritis of the knee (American College of Rheumatology [ACR] criteria and Kellgren-Lawrence score of 2 or 3). Interventions: Up to 6 physiotherapy sessions and as-needed anti-inflammatory drugs plus 10 sessions of TCA, 10 sessions of sham acupuncture, or 10 physician visits within 6 weeks. Patients could request up to 5 additional sessions or visits if the initial treatment was viewed as being partially successful. MEASUREMENTS: Success rate, as defined by at least 36% improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 26 weeks. Additional end points were WOMAC score and global patient assessment. RESULTS: Success rates were 53.1% for TCA, 51.0% for sham acupuncture, and 29.1% for conservative therapy. Acupuncture groups had higher success rates than conservative therapy groups (relative risk for TCA compared with conservative therapy, 1.75 [95% CI, 1.43 to 2.13]; relative risk for sham acupuncture compared with conservative therapy, 1.73 [CI, 1.42 to 2.11]). There was no difference between TCA and sham acupuncture (relative risk, 1.01 [CI, 0.87 to 1.17]). LIMITATIONS: There was no blinding between acupuncture and traditional therapy and no monitoring of acupuncture compliance with study protocol. In general, practitioner-patient contacts were less intense in the conservative therapy group than in the TCA and sham acupuncture groups. CONCLUSIONS: Compared with physiotherapy and as-needed anti-inflammatory drugs, addition of either TCA or sham acupuncture led to greater improvement in WOMAC score at 26 weeks. No statistically significant difference was observed between TCA and sham acupuncture, suggesting that the observed differences could be due to placebo effects, differences in intensity of provider contact, or a physiologic effect of needling regardless of whether it is done according to TCA principles  
  Address University of Heidelberg, Heidelberg, Germany  
  Publisher
  Language Number of Treatments 10  
  Treatment Follow-up 20 Weeks Frequency >1/WK Number of Participants 1007  
  Time in Treatment 6 Weeks Condition Osteoarthritis, Knee
  Disease Category Arthritis OCSI Score (down) 90  
  Notes Approved no  
  Call Number Serial 1020  
Permanent link to this record
 

 
Author Vickers, A. J.; Feinstein, M. B.; Deng, G. E.; Cassileth, B. R. url  openurl
  Title Acupuncture for dyspnea in advanced cancer: a randomized, placebo-controlled pilot trial Type of Study RCT
  Year 2005 Publication Abbreviated Journal BMC Palliat Care  
  Volume 4 Issue Pages 5-  
  Keywords Acu + Usual Care Versus Sham + Usual Care; Acupuncture; AcuTrials; Auricular Acupuncture; Breast Cancer; Cancer; Dyspnea; Fixed Acupuncture Protocol; Lung Cancer; Sham Acupoint Control; Non Penetrating Sham, Mechanical; Pilot Study; Press Tacks; RCT; Respiratory Tract Diseases; Restricted Modalities, Acupuncture Only; Sham Control; Sham Intradermal Needles; TCM Acupuncture Style; Usual Care Control, Pharmaceutical; Neoplasms  
  Abstract BACKGROUND: Dyspnea, or shortness of breath, is a common symptom in patients with advanced cancer. Pharmacologic management is of proven benefit, but it does not help all patients. Preliminary data suggest that acupuncture can relieve dyspnea in a variety of populations, including cancer patients. We conducted a pilot study (ISRCTN89462491) preparatory to a fully powered randomized, placebo-controlled trial to determine whether acupuncture reduces dyspnea in patients with lung or breast cancer. METHODS: The study sample was comprised of forty-seven patients with lung or breast cancer presenting with dyspnea. Patients receiving symptomatic treatments were not excluded as long as no changes in management were planned during the trial. Patients were randomized to receive a single session of true or placebo acupuncture in addition to their existing dyspnea treatments. Semi-permanent acupuncture “studs” were then inserted: patients applied pressure to these studs twice a day to provide ongoing stimulation to acupuncture points. The subjective sensation of dyspnea was assessed with a 0-10 numerical rating scale immediately before and after acupuncture treatment and daily for a week thereafter. RESULTS: All but two of 47 randomized patients provided follow-up data. Dyspnea scores were slightly higher for patients receiving true versus placebo acupuncture, for both the period immediately following acupuncture treatment and for the daily one week follow-up (differences between means of 0.34, 95% C.I. -0.33, 1.02 and 0.56, 95% C.I. -0.39, 1.51). The 95% confidence interval excludes the prespecified minimum clinically significant difference of a 20% greater improvement in dyspnea for patients receiving acupuncture. CONCLUSION: The acupuncture technique used in this trial is unlikely to have effects on dyspnea importantly larger than placebo for patients with advanced cancer  
  Address Integrative Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, USA. vickersa@mskcc.org  
  Publisher
  Language Number of Treatments 1  
  Treatment Follow-up N/A Frequency N/A Number of Participants 47  
  Time in Treatment 1 Week Condition Dyspnea
  Disease Category Respiratory Tract Diseases OCSI Score (down) 89  
  Notes Approved no  
  Call Number Serial 1215  
Permanent link to this record
 

 
Author Assefi, N. P.; Sherman, K. J.; Jacobsen, C.; Goldberg, J.; Smith, W. R.; Buchwald, D. url  openurl
  Title A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia Type of Study RCT
  Year 2005 Publication Annals of internal medicine Abbreviated Journal Ann Intern Med  
  Volume 143 Issue 1 Pages 10-19  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; Adverse Effects; Fibromyalgia; Fixed Acupuncture Protocol; Penetrating Sham; Non Penetrating Sham, Mechanical; Non Specific Acupoint Control; Pain; RCT; Restricted Modalities, Acupuncture Only; Sham Acupoint Control; Sham Control; Standard Needling Depth; TCM Acupuncture Style; Verum Acupoint Control; Nervous System Diseases  
  Abstract BACKGROUND: Fibromyalgia is a common chronic pain condition for which patients frequently use acupuncture. OBJECTIVE: To determine whether acupuncture relieves pain in fibromyalgia. DESIGN: Randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. SETTING: Private acupuncture offices in the greater Seattle, Washington, metropolitan area. PATIENTS: 100 adults with fibromyalgia. INTERVENTION: Twice-weekly treatment for 12 weeks with an acupuncture program that was specifically designed to treat fibromyalgia, or 1 of 3 sham acupuncture treatments: acupuncture for an unrelated condition, needle insertion at nonacupoint locations, or noninsertive simulated acupuncture. MEASUREMENTS: The primary outcome was subjective pain as measured by a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst pain ever). Measurements were obtained at baseline; 1, 4, 8, and 12 weeks of treatment; and 3 and 6 months after completion of treatment. Participant blinding and adverse effects were ascertained by self-report. The primary outcomes were evaluated by pooling the 3 sham-control groups and comparing them with the group that received acupuncture to treat fibromyalgia. RESULTS: The mean subjective pain rating among patients who received acupuncture for fibromyalgia did not differ from that in the pooled sham acupuncture group (mean between-group difference, 0.5 cm [95% CI, -0.3 cm to 1.2 cm]). Participant blinding was adequate throughout the trial, and no serious adverse effects were noted. LIMITATIONS: A prescription of acupuncture at fixed points may differ from acupuncture administered in clinical settings, in which therapy is individualized and often combined with herbal supplementation and other adjunctive measures. A usual-care comparison group was not studied. CONCLUSION: Acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia  
  Address The Group Health Cooperative Center for Health Studies, and University of Washington, Seattle, Washington, USA  
  Publisher
  Language Number of Treatments 24  
  Treatment Follow-up 24 Weeks Frequency >1/WK Number of Participants 100  
  Time in Treatment 12 Weeks Condition Fibromyalgia
  Disease Category Nervous System Diseases OCSI Score (down) 88  
  Notes Approved no  
  Call Number Serial 42  
Permanent link to this record
 

 
Author Macklin, E. A.; Wayne, P. M.; Kalish, L. A.; Valaskatgis, P.; Thompson, J.; Pian-Smith, M. C.; Zhang, Q.; Stevens, S.; Goertz, C.; Prineas, R. J.; Buczynski, B.; Zusman, R. M. url  openurl
  Title Stop Hypertension with the Acupuncture Research Program (SHARP): results of a randomized, controlled clinical trial Type of Study RCT
  Year 2006 Publication Abbreviated Journal Hypertension  
  Volume 48 Issue 5 Pages 838-845  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; Auricular Acupuncture; Fixed Acupuncture Protocol; Hypertension; Individualized Acupuncture Protocol; Penetrating Sham; RCT; Restricted Modalities, Acupuncture + Other; Sham Acupoint Control; Sham Control; Standard Needling Depth; TCM Acupuncture Style; Cardiovascular Diseases  
  Abstract Case studies and small trials suggest that acupuncture may effectively treat hypertension, but no large randomized trials have been reported. The Stop Hypertension with the Acupuncture Research Program pilot trial enrolled 192 participants with untreated blood pressure (BP) in the range of 140/90 to 179/109 mm Hg. The design of the trial combined rigorous methodology and adherence to principles of traditional Chinese medicine. Participants were weaned off antihypertensives before enrollment and were then randomly assigned to 3 treatments: individualized traditional Chinese acupuncture, standardized acupuncture at preselected points, or invasive sham acupuncture. Participants received < or = 12 acupuncture treatments over 6 to 8 weeks. During the first 10 weeks after random assignment, BP was monitored every 14 days, and antihypertensives were prescribed if BP exceeded 180/110 mm Hg. The mean BP decrease from baseline to 10 weeks, the primary end point, did not differ significantly between participants randomly assigned to active (individualized and standardized) versus sham acupuncture (systolic BP: -3.56 versus -3.84 mm Hg, respectively; 95% CI for the difference: -4.0 to 4.6 mm Hg; P=0.90; diastolic BP: -4.32 versus -2.81 mm Hg, 95% CI for the difference: -3.6 to 0.6 mm Hg; P=0.16). Categorizing participants by age, race, gender, baseline BP, history of antihypertensive use, obesity, or primary traditional Chinese medicine diagnosis did not reveal any subgroups for which the benefits of active acupuncture differed significantly from sham acupuncture. Active acupuncture provided no greater benefit than invasive sham acupuncture in reducing systolic or diastolic BP  
  Address New England Research Institutes, Inc, 9 Galen St, Watertown, MA 02472, USA. EMacklin@NERIScience.com  
  Publisher
  Language Number of Treatments 12  
  Treatment Follow-up 52 Weeks Frequency >1/WK Number of Participants 192  
  Time in Treatment 8 Weeks Condition Hypertension
  Disease Category Cardiovascular Diseases OCSI Score (down) 88  
  Notes Approved no  
  Call Number Serial 799  
Permanent link to this record
 

 
Author Sator-Katzenschlager, S. M.; Wolfler, M. M.; Kozek-Langenecker, S. A.; Sator, K.; Sator, P. G.; Li, B.; Heinze, G.; Sator, M. O. url  openurl
  Title Auricular electro-acupuncture as an additional perioperative analgesic method during oocyte aspiration in IVF treatment Type of Study RCT
  Year 2006 Publication Abbreviated Journal Hum Reprod  
  Volume Issue Pages -  
  Keywords Acu + Usual Care Versus > 1 Control; AcuTrials; Analgesia; Auricular Acupuncture; Electroacupuncture; Fixed Acupuncture Protocol; In Vitro Fertilization; Penetrating Sham; Non Penetrating Sham, Electrical; Pain, Perioperative; RCT; Restricted Modalities, Acupuncture + Other; Sham Control; Sham Electroacupuncture; TCM Acupuncture Style; Verum Acupoint Control; Women's Health; Reproductive Techniques, Assisted; IVF; Fertilization In Vitro; Infertility, Female  
  Abstract BACKGROUND: The aim of this study was to compare the pain-relieving effect and the subjective well-being between auricular electro-acupuncture (EA) analgesia, auricular acupuncture (A) and conventional analgesia with remifentanil (CO). METHODS: A total of 94 women undergoing IVF were randomized to auricular acupuncture with (EA, n = 32) or without (A, n = 32) continuous 1 Hz auricular stimulation (using a battery-powered miniaturized stimulator, P-Stim) or with adhesive tapes instead of needles and no electrical stimulation (control group, CO, n = 30) at the auricular acupuncture points 29, 55 and 57. All patients received patient-controlled analgesia (PCA) with remifentanil. Pain intensity and psychological well-being were assessed by means of visual analogue scales (VAS); tiredness, nausea and vomiting and analgesic drug consumption were documented. RESULTS: Pain relief and subjective well-being were significantly greater in group EA during and after the procedure as compared with groups A and CO (P < 0.001). The patients were significantly more tired in group CO than in groups A and EA (P < 0.001). Consumption of the opioid remifentanil was significantly lower in group EA, comparable nausea (P < 0.001). CONCLUSION: Auricular EA significantly reduces pain intensity and analgesic consumption of the opioid remifen-tanil during oocyte aspiration in IVF treatment  
  Address Department of Anesthesiology and Intensive Care Medicine (B), University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria  
  Publisher
  Language Number of Treatments 1  
  Treatment Follow-up N/A Frequency N/A Number of Participants 94  
  Time in Treatment 1 Day Condition Fertilization In Vitro
  Disease Category Reproductive Techniques, Assisted OCSI Score (down) 88  
  Notes Approved no  
  Call Number Serial 1018  
Permanent link to this record
 

 
Author Smith, C.; Coyle, M.; Norman, R. J. url  openurl
  Title Influence of acupuncture stimulation on pregnancy rates for women undergoing embryo transfer Type of Study RCT
  Year 2006 Publication Abbreviated Journal Fertil Steril  
  Volume Issue Pages -  
  Keywords Acu Versus Sham; Acupuncture; AcuTrials; Embryo Transfer; Infertility, Female; IVF; Near Verum Acupoint Control; Non Penetrating Sham, Mechanical; RCT; Semi-Individualized Acupuncture Protocol; Sham Control; TCM Acupuncture Style; Traditional Diagnosis Based Point Selection; Women's Health; In Vitro Fertilization; Reproductive Techniques, Assisted  
  Abstract OBJECTIVE: To evaluate the effects of acupuncture on clinical pregnancy rates for women undergoing ET. DESIGN: Single-blind, randomized controlled trial using a noninvasive sham acupuncture control. SETTING: Repromed, The Reproductive Medicine Unit of The University of Adelaide. PATIENT(S): Women undergoing IVF. INTERVENTION(S): Women were randomly allocated to acupuncture or noninvasive sham acupuncture with the placebo needle. All women received three sessions, the first undertaken on day 9 of stimulating injections, the second before ET, and the third immediately after ET. MAIN OUTCOME MEASURE(S): The primary outcome was pregnancy. Secondary outcomes were implantation, ongoing pregnancy rate at 18 weeks, adverse events, and health status. RESULT(S): Two hundred twenty-eight subjects were randomized. The pregnancy rate was 31% in the acupuncture group and 23% in the control group. For those subjects receiving acupuncture, the odds of achieving a pregnancy were 1.5 higher than for the control group, but the difference did not reach statistical significance. The ongoing pregnancy rate at 18 weeks was higher in the treatment group (28% vs. 18%), but the difference was not statistically significant. CONCLUSION(S): There was no significant difference in the pregnancy rate between groups; however, a smaller treatment effect can not be excluded. Our results suggest that acupuncture was safe for women undergoing ET  
  Address School of Health Science, The University of South Australia, Adelaide, South Australia, Australia  
  Publisher
  Language Number of Treatments 3  
  Treatment Follow-up 18 Weeks Frequency >1/WK Number of Participants 228  
  Time in Treatment 1 Week Condition Embryo Transfer
  Disease Category Reproductive Techniques, Assisted OCSI Score (down) 88  
  Notes Approved no  
  Call Number Serial 1072  
Permanent link to this record
 

 
Author Streitberger, K.; Friedrich-Rust, M.; Bardenheuer, H.; Unnebrink, K.; Windeler, J.; Goldschmidt, H.; Egerer, G. url  openurl
  Title Effect of Acupuncture Compared with Placebo-Acupuncture at P6 as Additional Antiemetic Prophylaxis in High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation: A Randomized Controlled Single-Blind Trial Type of Study RCT
  Year 2003 Publication Abbreviated Journal Clin Cancer Res  
  Volume 9 Issue 7 Pages 2538-2544  
  Keywords Acu + Usual Care Versus Sham + Usual Care; AcuTrials; Cancer; Chemotherapy; Emesis; Fixed Acupuncture Protocol; Nausea; Non Penetrating Sham, Mechanical; RCT; Restricted Modalities, Acupuncture Only; Sham Control; TCM Acupuncture Style; Verum Acupoint Control; Vomiting; Vomiting, Anticipatory  
  Abstract PURPOSE: The purpose is to investigate an additional antiemetic effect to ondansetron with needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture in patients undergoing high-dose chemotherapy and autologous peripheral blood stem cell transplantation. Experimental Design: Eighty patients who were admitted to hospital for high-dose chemotherapy and autologous peripheral blood stem cell transplantation were included into a randomized placebo-controlled single-blind trial. The patients were randomized to receive acupuncture (n = 41) or noninvasive placebo acupuncture (n = 39) at the acupuncture point P6 30 min before first application of high-dose chemotherapy and the day after. All patients received 8 mg ondansetron/day i.v. as basic antiemetic prophylaxis. The main outcome measure was the rate of patients who either had at least one episode of vomiting or required any additional antiemetic drugs on the first 2 days of chemotherapy. RESULTS: The main outcome measure showed no significant difference (P = 0.82): 61% failure in the acupuncture group and 64% in the placebo acupuncture group (95% confidence interval of 3% difference: -18.1 and 24.3%). Comparing nausea, episodes of vomiting or retching and number of additionally required antiemetic drugs did not provide any discrepancy with the main result. CONCLUSIONS: This study suggests that in combination with ondansetron i.v., invasive needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture has no additional effect for the prevention of acute nausea and vomiting in high-dose chemotherapy  
  Address Departments of Anaesthesiology [K. S., M. F.-R.] and Medicine V [H. G., G. E.], and Coordination Centre for Clinical Trials [K. U.], University of Heidelberg, and Medizinischer Dienst der Spitzenverbande der Krankenkassen – Department of Evidence Bas  
  Publisher
  Language Number of Treatments 2  
  Treatment Follow-up N/A Frequency N/A Number of Participants 80  
  Time in Treatment 2 Days Condition Vomiting, Anticipatory
  Disease Category Vomiting OCSI Score (down) 88  
  Notes Approved no  
  Call Number Serial 1112  
Permanent link to this record
 

 
Author Melchart, D.; Streng, A.; Hoppe, A.; Brinkhaus, B.; Witt, C.; Wagenpfeil, S.; Pfaffenrath, V.; Hammes, M.; Hummelsberger, J.; Irnich, D.; Weidenhammer, W.; Willich, S. N.; Linde, K. url  openurl
  Title Acupuncture in patients with tension-type headache: randomised controlled trial Type of Study RCT
  Year 2005 Publication Abbreviated Journal BMJ  
  Volume 331 Issue 7513 Pages 376-382  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; Penetrating Sham; Pain; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Superficial Needling Depth; Sham Acupoint Control; Sham Control; Symptom Based Point Selection; TCM Acupuncture Style; Tension-Type Headache; Wait-List Control; Headache Disorders  
  Abstract OBJECTIVE: To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. DESIGN: Three armed randomised controlled multicentre trial. SETTING: 28 outpatient centres in Germany. PARTICIPANTS: 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache. INTERVENTIONS: Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks. MAIN OUTCOME MEASURE: Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries. RESULTS: The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. CONCLUSIONS: The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache. TRIAL REGISTRATION NUMBER: ISRCTN9737659  
  Address Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universitat Munchen, Kaiserstr 9, 80801 Munich, Germany  
  Publisher
  Language Number of Treatments 12  
  Treatment Follow-up 16 Weeks Frequency >1/WK Number of Participants 270  
  Time in Treatment 8 Weeks Condition Tension-Type Headache
  Disease Category Headache Disorders OCSI Score (down) 87  
  Notes Approved no  
  Call Number Serial 854  
Permanent link to this record
 

 
Author Park, J.; White, A. R.; James, M. A.; Hemsley, A. G.; Johnson, P.; Chambers, J.; Ernst, E. url  openurl
  Title Acupuncture for subacute stroke rehabilitation: a Sham-controlled, subject- and assessor-blind, randomized trial Type of Study RCT
  Year 2005 Publication Abbreviated Journal Arch Intern Med  
  Volume 165 Issue 17 Pages 2026-2031  
  Keywords Acu Versus Sham; Acupuncture; Stroke; AcuTrials; Cerebrovascular Accident; Korean Acupuncture Style; Near Verum Acupoint Control; Non Penetrating Sham, Mechanical; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Sham Control; Traditional Diagnosis Based Point Selection  
  Abstract BACKGROUND: Any adjunctive therapy that may reduce persistent disability after stroke should be considered. Acupuncture is used for this purpose, but there is conflicting evidence on its effectiveness. METHODS: Patients with a recent (<4 weeks) episode of stroke were randomized to receive 12 sessions of either real or sham acupuncture during 2 weeks. The primary outcome was the change in Barthel activities of daily living score at the end of treatment. Secondary outcome measures included National Institutes of Health Stroke Scale score, motoricity index, and quality of life (EQ-5D [ EuroQoL-5 Dimensional form] and EQ-VAS [EuroQoL-Visual Analog Scale]). Assessments were carried out by blinded physicians. RESULTS: A total of 116 patients (56 in the real acupuncture group and 60 in the sham group) were randomized, and 98 (real, 48; sham, 50) completed treatment and the 2-week assessment. Patient blinding by means of the sham acupuncture device was successful. Acupuncture was well tolerated except for 1 seizure during a real acupuncture session. The improvements in the Barthel scores were 4 points (interquartile range [IQR], 0-8) vs 3 points (IQR, 0-7) in the real and sham acupuncture groups, respectively (P = .38). The secondary outcome measures also essentially showed no significant effect of acupuncture. Post hoc analysis by baseline severity showed a greater improvement in leg function in the subgroup with baseline Barthel score less than the median (median score, 6): 22 points (IQR, 0-37) vs 4 points (IQR, 0-4) in the acupuncture and sham control groups, respectively (P = .02). CONCLUSIONS: Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients  
  Address Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, England. jongbae_park@hms.harvard.edu  
  Publisher
  Language Number of Treatments 11  
  Treatment Follow-up N/A Frequency >1/WK Number of Participants 98  
  Time in Treatment 2 Weeks Condition Stroke
  Disease Category Stroke OCSI Score (down) 87  
  Notes Approved no  
  Call Number Serial 935  
Permanent link to this record
 

 
Author Shen, J.; Wenger, N.; Glaspy, J.; Hays, R. D.; Albert, P. S.; Choi, C.; Shekelle, P. G. url  openurl
  Title Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial Type of Study RCT
  Year 2000 Publication Abbreviated Journal JAMA  
  Volume 284 Issue 21 Pages 2755-2761  
  Keywords Acu Versus > 1 Control; AcuTrials; Breast Cancer; Breast Neoplasms; Cancer; Chemotherapy; Electroacupuncture; Emesis; Fixed Acupuncture Protocol; Penetrating Sham; Nausea; Non Specific Acupoint Control; RCT; Restricted Modalities, Acupuncture Only; Superficial Needling Depth; Sham Control; Usual Care Control, Pharmaceutical; TCM Acupuncture Style; Vomiting; Women's Health  
  Abstract CONTEXT: High-dose chemotherapy poses considerable challenges to emesis management. Although prior studies suggest that acupuncture may reduce nausea and emesis, it is unclear whether such benefit comes from the nonspecific effects of attention and clinician-patient interaction. OBJECTIVE: To compare the effectiveness of electroacupuncture vs minimal needling and mock electrical stimulation or antiemetic medications alone in controlling emesis among patients undergoing a highly emetogenic chemotherapy regimen. DESIGN: Three-arm, parallel-group, randomized controlled trial conducted from March 1996 to December 1997, with a 5-day study period and a 9-day follow-up. SETTING: Oncology center at a university medical center. PATIENTS: One hundred four women (mean age, 46 years) with high-risk breast cancer. INTERVENTIONS: Patients were randomly assigned to receive low-frequency electroacupuncture at classic antiemetic acupuncture points once daily for 5 days (n = 37); minimal needling at control points with mock electrostimulation on the same schedule (n = 33); or no adjunct needling (n = 34). All patients received concurrent triple antiemetic pharmacotherapy and high-dose chemotherapy (cyclophosphamide, cisplatin, and carmustine). MAIN OUTCOME MEASURES: Total number of emesis episodes occurring during the 5-day study period and the proportion of emesis-free days, compared among the 3 groups. RESULTS: The number of emesis episodes occurring during the 5 days was lower for patients receiving electroacupuncture compared with those receiving minimal needling or pharmacotherapy alone (median number of episodes, 5, 10, and 15, respectively; P<.001). The electroacupuncture group had fewer episodes of emesis than the minimal needling group (P<.001), whereas the minimal needling group had fewer episodes of emesis than the antiemetic pharmacotherapy alone group (P =.01). The differences among groups were not significant during the 9-day follow-up period (P =.18). CONCLUSIONS: In this study of patients with breast cancer receiving high-dose chemotherapy, adjunct electroacupuncture was more effective in controlling emesis than minimal needling or antiemetic pharmacotherapy alone, although the observed effect had limited duration. JAMA. 2000;284:2755-2761  
  Address National Institutes of Health, Laboratory of Clinical Studies/NIAAA, Room 6 S-240, Mail Stop 1610, 10 Center Dr, Bldg 10, Bethesda, MD 20892-1610, USA  
  Publisher
  Language Number of Treatments 5  
  Treatment Follow-up 1.5 Weeks Frequency >1/WK Number of Participants 104  
  Time in Treatment 1 Week Condition Vomiting, Anticipatory
  Disease Category Vomiting OCSI Score (down) 87  
  Notes Approved no  
  Call Number Serial 1035  
Permanent link to this record
 

 
Author Shlay, J. C.; Chaloner, K.; Max, M. B.; Flaws, B.; Reichelderfer, P.; Wentworth, D.; Hillman, S.; Brizz, B.; Cohn, D. L. url  openurl
  Title Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomized controlled trial. Terry Beirn Community Programs for Clinical Research on AIDS Type of Study RCT
  Year 1998 Publication Abbreviated Journal JAMA  
  Volume 280 Issue 18 Pages 1590-1595  
  Keywords Acu Versus > 1 Control; Acupuncture; AcuTrials; HIV Infections; Acquired Immunodeficiency Syndrome; Penetrating Sham; Pain; Nervous System Diseases; Peripheral Neuropathy; RCT; Restricted Modalities, Acupuncture Only; Semi-Individualized Acupuncture Protocol; Sham Acupoint Control; Sham Control; Standard Needling Depth; Usual Care Control, Pharmaceutical; Symptom Based Point Selection; TCM Acupuncture Style  
  Abstract CONTEXT: Peripheral neuropathy is common in persons infected with the human immunodeficiency virus (HIV) but few data on symptomatic treatment are available. OBJECTIVE: To evaluate the efficacy of a standardized acupuncture regimen (SAR) and amitriptyline hydrochloride for the relief of pain due to HIV-related peripheral neuropathy in HIV-infected patients. DESIGN: Randomized, placebo-controlled, multicenter clinical trial. Each site enrolled patients into 1 of the following 3 options: (1) a modified double-blind 2 x 2 factorial design of SAR, amitriptyline, or the combination compared with placebo, (2) a modified double-blind design of an SAR vs control points, or (3) a double-blind design of amitriptyline vs placebo. SETTING: Terry Beirn Community Programs for Clinical Research on AIDS (HIV primary care providers) in 10 US cities. PATIENTS: Patients with HIV-associated, symptomatic, lower-extremity peripheral neuropathy. Of 250 patients enrolled, 239 were in the acupuncture comparison (125 in the factorial option and 114 in the SAR option vs control points option), and 136 patients were in the amitriptyline comparison (125 in the factorial option and 11 in amitriptyline option vs placebo option). INTERVENTIONS: Standardized acupuncture regimen vs control points, amitriptyline (75 mg/d) vs placebo, or both for 14 weeks. MAIN OUTCOME MEASURE: Changes in mean pain scores at 6 and 14 weeks, using a pain scale ranging from 0.0 (no pain) to 1.75 (extremely intense), recorded daily. RESULTS: Patients in all 4 groups showed reduction in mean pain scores at 6 and 14 weeks compared with baseline values. For both the acupuncture and amitriptyline comparisons, changes in pain score were not significantly different between the 2 groups. At 6 weeks, the estimated difference in pain reduction for patients in the SAR group compared with those in the control points group (a negative value indicates a greater reduction for the “active” treatment) was 0.01 (95% confidence interval [CI], -0.11 to 0.12; P=.88) and for patients in the amitriptyline group vs those in the placebo group was -0.07 (95% CI, -0.22 to 0.08; P=.38). At 14 weeks, the difference for those in the SAR group compared with those in the control points group was -0.08 (95% CI, -0.21 to 0.06; P=.26) and for amitriptyline compared with placebo was 0.00 (95% CI, -0.18 to 0.19; P=.99). CONCLUSIONS: In this study, neither acupuncture nor amitriptyline was more effective than placebo in relieving pain caused by HIV-related peripheral neuropathy  
  Address Denver Community Programs for Clinical Research on AIDS, Colo, USA. jshlay@dhha.org  
  Publisher
  Language Number of Treatments 20  
  Treatment Follow-up N/A Frequency >1/WK Number of Participants 250  
  Time in Treatment 14 Weeks Condition Peripheral Neuropathy
  Disease Category HIV Infections OCSI Score (down) 87  
  Notes Approved no  
  Call Number Serial 1052  
Permanent link to this record
 

 
Author Streitberger, K.; Diefenbacher, M.; Bauer, A.; Conradi, R.; Bardenheuer, H.; Martin, E.; Schneider, A.; Unnebrink, K. url  openurl
  Title Acupuncture compared to placebo-acupuncture for postoperative nausea and vomiting prophylaxis: A randomised placebo-controlled patient and observer blind trial Type of Study RCT
  Year 2004 Publication Anaesthesia Abbreviated Journal Anaesthesia  
  Volume 59 Issue 2 Pages 142-149  
  Keywords Acu Versus Sham; Acupuncture; AcuTrials; Emesis; Fixed Acupuncture Protocol; Nausea; Non Penetrating Sham, Mechanical; Postoperative Nausea and Vomiting; RCT; Restricted Modalities, Acupuncture Only; Sham Control; TCM Acupuncture Style; Verum Acupoint Control; Vomiting  
  Abstract This randomised, placebo-controlled, patient and observer blinded trial was conducted to determine whether acupuncture at the acupuncture point P6 is effective in preventing postoperative nausea and vomiting (PONV) compared to placebo acupuncture. Female patients (n = 220) scheduled for gynaecological or breast surgery were randomly assigned to two groups receiving either acupuncture (n = 109) or placebo acupuncture (n = 111). Each group was stratified for type of surgery and included two subgroups receiving intervention either before or after induction of anaesthesia. The incidence of PONV and/or antiemetic rescue medication within 24 h after surgery was the main outcome measure which showed no statistically significant difference between groups (43.7% acupuncture, 50.9% placebo, p = 0.27). The differences were more pronounced for patients having gynaecological surgery (48.9% acupuncture, 67.6% placebo, p = 0.07) than for those having breast surgery (38.7% acupuncture, 40.3% placebo, p = 0.86). The secondary outcome, vomiting, was significantly reduced by acupuncture from 39.6% to 24.8% (p = 0.03). Subgroup analysis showed no difference between applications of acupuncture before compared to after induction of anaesthesia  
  Address Research Fellow and Resident in Anaesthesiology Medical student Resident in Anaesthesiology Senior Anaesthesiologist Professor Director, Department of Anaesthesiology Research Fellow, Department of General Practice and Health Services Research Resear  
  Publisher
  Language Number of Treatments 1  
  Treatment Follow-up 1 day Frequency N/A Number of Participants 220  
  Time in Treatment N/A Condition Postoperative Nausea and Vomiting
  Disease Category Vomiting OCSI Score (down) 87  
  Notes Approved no  
  Call Number Serial 1111  
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