|   | 
Details
   web

Deprecated: preg_replace(): The /e modifier is deprecated, use preg_replace_callback instead in /home/acutrialsocom/public_html/refbase-ocom/includes/include.inc.php on line 5275
Records
Author Liu, Z.; Yan, S.; Wu, J.; He, L.; Li, N.; Dong, G.; Fang, J.; Fu, W.; Fu, L.; Sun, J.; Wang, L.; Wang, S.; Yang, J.; Zhang, H.; Zhang, J.; Zhao, J.; Zhou, W.; Zhou, Z.; Ai, Y.; Zhou, K.; Liu, J.; Xu, H.; Cai, Y.; Liu, B.
Title Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial Type of Study RCT
Year 2016 Publication Annals of Internal Medicine Abbreviated Journal Ann Intern Med
Volume 165 Issue 11 Pages 761-769
Keywords AcuTrials; RCT; Gastrointestinal Diseases; Constipation; Fixed Acupuncture Protocol; Restricted Modalities, Acupuncture Only; Electroacupuncture; TCM Acupuncture Style; Acu Versus Sham; Sham Control; Penetrating Sham; Superficial Needling Depth; Near Verum Acupoint Control
Abstract Background: Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce. Objective: To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC). Design: Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504). Setting: 15 hospitals in China. Participants: Patients with CSFC and no serious underlying pathologic cause for constipation. Intervention: 28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks. Measurements: The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20. Results: 1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P < 0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient. Limitations: Longer-term follow-up was not assessed. Acupuncturists could not be blinded. Conclusion: Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up. Primary Funding Source: Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.
Address From Guang'anmen Hospital, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing Traditional Chinese Medicine Hospital of Capital Medical University, Dongzhimen Hospital of Beijing University of Chinese Medicine, Huguosi Hospital of Chinese Medicine of Beijing University of Chinese Medicine, Beijing; West China Hospital of Sichuan University, Chengdu, Sichuan; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine, Shanghai; The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang; Guangdong Province Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin; Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu; Heilongjiang Province Academy of Chinese Medical Science, Ha'erbin, Heilongjiang; The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui; Wuhan Integrated Traditional Chinese Medicine and Western Medical Hospital, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China; and Daemen College, Physical Therapy Wound Care Clinic, Amherst, New York
Publisher
Language English Number of Treatments 8
Treatment Follow-up Frequency 1/WK Number of Participants 1075
Time in Treatment 8 Weeks Condition Constipation
Disease Category Gastrointestinal Diseases OCSI Score
Notes PMID:27618593 Approved yes
Call Number OCOM @ refbase @ Serial 2182
Permanent link to this record
 

 
Author Chou, R.; Deyo, R.; Friedly, J.; Skelly, A.; Hashimoto, R.; Weimer, M.; Fu, R.; Dana, T.; Kraegel, P.; Griffin, J.; Grusing, S.; Brodt, E.D.
Title Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline Type of Study Systematic Review
Year 2017 Publication Annals of Internal Medicine Abbreviated Journal Ann Intern Med
Volume 166 Issue 7 Pages 493-505
Keywords AcuTrials; Systematic Review; Back Pain; Low Back Pain; Musculoskeletal Disorders; Acupuncture
Abstract Background: A 2007 American College of Physicians guideline addressed nonpharmacologic treatment options for low back pain. New evidence is now available. Purpose: To systematically review the current evidence on nonpharmacologic therapies for acute or chronic nonradicular or radicular low back pain. Data Sources: Ovid MEDLINE (January 2008 through February 2016), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and reference lists. Study Selection: Randomized trials of 9 nonpharmacologic options versus sham treatment, wait list, or usual care, or of 1 nonpharmacologic option versus another. Data Extraction: One investigator abstracted data, and a second checked abstractions for accuracy; 2 investigators independently assessed study quality. Data Synthesis: The number of trials evaluating nonpharmacologic therapies ranged from 2 (tai chi) to 121 (exercise). New evidence indicates that tai chi (strength of evidence [SOE], low) and mindfulness-based stress reduction (SOE, moderate) are effective for chronic low back pain and strengthens previous findings regarding the effectiveness of yoga (SOE, moderate). Evidence continues to support the effectiveness of exercise, psychological therapies, multidisciplinary rehabilitation, spinal manipulation, massage, and acupuncture for chronic low back pain (SOE, low to moderate). Limited evidence shows that acupuncture is modestly effective for acute low back pain (SOE, low). The magnitude of pain benefits was small to moderate and generally short term; effects on function generally were smaller than effects on pain. Limitation: Qualitatively synthesized new trials with prior meta-analyses, restricted to English-language studies; heterogeneity in treatment techniques; and inability to exclude placebo effects. Conclusion: Several nonpharmacologic therapies for primarily chronic low back pain are associated with small to moderate, usually short-term effects on pain; findings include new evidence on mind-body interventions. Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42014014735).
Address From Oregon Health and Science University, Portland, Oregon, and University of Washington, Seattle, and Spectrum Research, Tacoma, Washington
Publisher
Language English Number of Treatments
Treatment Follow-up Frequency Number of Participants
Time in Treatment Condition Low Back Pain
Disease Category Back Pain OCSI Score
Notes PMID:28192793 Approved yes
Call Number OCOM @ refbase @ Serial 2181
Permanent link to this record
 

 
Author Liu, Z.; Yan, S.; Wu, J.; He, L.; Li, N.; Dong, G.; Fang, J.; Fu, W.; Fu, L.; Sun, J.; Wang, L.; Wang, S.; Yang, J.; Zhang, H.; Zhang, J.; Zhao, J.; Zhou, W.; Zhou, Z.; Ai, Y.; Zhou, K.; Liu, J.; Xu, H.; Cai, Y.; Liu, B.
Title Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial Type of Study Journal Article
Year 2016 Publication Annals of Internal Medicine Abbreviated Journal Ann Intern Med
Volume Issue Pages
Keywords
Abstract Background: Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce. Objective: To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC). Design: Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504). Setting: 15 hospitals in China. Participants: Patients with CSFC and no serious underlying pathologic cause for constipation. Intervention: 28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks. Measurements: The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20. Results: 1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P < 0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient. Limitations: Longer-term follow-up was not assessed. Acupuncturists could not be blinded. Conclusion: Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up. Primary Funding Source: Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.
Address
Publisher
Language English Number of Treatments
Treatment Follow-up Frequency Number of Participants
Time in Treatment Condition
Disease Category OCSI Score
Notes PMID:27618593 Approved no
Call Number OCOM @ refbase @ Serial 2156
Permanent link to this record
 

 
Author MacPherson, H.; Tilbrook, H.; Richmond, S.; Woodman, J.; Ballard, K.; Atkin, K.; Bland, M.; Eldred, J.; Essex, H.; Hewitt, C.; Hopton, A.; Keding, A.; Lansdown, H.; Parrott, S.; Torgerson, D.; Wenham, A.; Watt, I.
Title Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial Type of Study RCT
Year 2015 Publication Annals of Internal Medicine Abbreviated Journal Ann Intern Med
Volume 163 Issue 9 Pages 653-662
Keywords RCT; Neck Pain; Musculoskeletal Diseases; Acu + Usual Care Versus > 1 Control; Acupuncture; TCM Acupuncture Style; Individualized Acupuncture Protocol; Traditional Diagnosis Based Point Selection; Restricted Modalities, Acupuncture + Other; CAM Control; Alexander Technique; Usual Care Control, Multimodality
Abstract BACKGROUND: Management of chronic neck pain may benefit from additional active self-care-oriented approaches. OBJECTIVE: To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. DESIGN: Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). SETTING: U.K. primary care. PARTICIPANTS: Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. INTERVENTION: 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. MEASUREMENTS: NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). RESULTS: 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention. LIMITATION: Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings. CONCLUSION: Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. PRIMARY FUNDING SOURCE: Arthritis Research UK.
Address Department of Health Sciences, University of York, York YO10 5DD, United Kingdom
Publisher
Language English Number of Treatments 12
Treatment Follow-up 52 Weeks Frequency <1/WK Number of Participants 517
Time in Treatment 20 Weeks Condition Neck Pain
Disease Category Neck Pain OCSI Score
Notes PMID:26524571 Approved yes
Call Number OCOM @ refbase @ Serial 2016
Permanent link to this record
 

 
Author Cherkin, D. C.; Sherman, K. J.; Deyo, R. A.; Shekelle, P. G.
Title A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain Type of Study Systematic Review
Year 2003 Publication Annals of internal medicine Abbreviated Journal Ann Intern Med
Volume 138 Issue 11 Pages 898-906
Keywords Acupuncture; AcuTrials; Back Pain; Chiropractic; Cost Effectiveness; Low Back Pain; Massage; Pain; Adverse Effects; Spinal Manipulation; Systematic Review; Meta-Analysis
Abstract BACKGROUND: Few treatments for back pain are supported by strong scientific evidence. Conventional treatments, although widely used, have had limited success. Dissatisfied patients have, therefore, turned to complementary and alternative medical therapies and providers for care for back pain. PURPOSE: To provide a rigorous and balanced summary of the best available evidence about the effectiveness, safety, and costs of the most popular complementary and alternative medical therapies used to treat back pain. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. STUDY SELECTION: Systematic reviews of randomized, controlled trials (RCTs) that were published since 1995 and that evaluated acupuncture, massage therapy, or spinal manipulation for nonspecific back pain and RCTs published since the reviews were conducted. DATA EXTRACTION: Two authors independently extracted data from the reviews (including number of RCTs, type of back pain, quality assessment, and conclusions) and original articles (including type of pain, comparison treatments, sample size, outcomes, follow-up intervals, loss to follow-up, and authors' conclusions). DATA SYNTHESIS: Because the quality of the 20 RCTs that evaluated acupuncture was generally poor, the effectiveness of acupuncture for treating acute or chronic back pain is unclear. The three RCTs that evaluated massage reported that this therapy is effective for subacute and chronic back pain. A meta-regression analysis of the results of 26 RCTs evaluating spinal manipulation for acute and chronic back pain reported that spinal manipulation was superior to sham therapies and therapies judged to have no evidence of a benefit but was not superior to effective conventional treatments. CONCLUSIONS: Initial studies have found massage to be effective for persistent back pain. Spinal manipulation has small clinical benefits that are equivalent to those of other commonly used therapies. The effectiveness of acupuncture remains unclear. All of these treatments seem to be relatively safe. Preliminary evidence suggests that massage, but not acupuncture or spinal manipulation, may reduce the costs of care after an initial course of therapy
Address Center for Health Studies, Group Health Cooperative, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101
Publisher
Language Number of Treatments
Treatment Follow-up N/A Frequency N/A Number of Participants
Time in Treatment N/A Condition Low Back Pain
Disease Category Back Pain OCSI Score
Notes Approved no
Call Number Serial 163
Permanent link to this record
 

 
Author Berman, B. M.; Lao, L.; Langenberg, P.; Lee, W. L.; Gilpin, A. M.; Hochberg, M. C.
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 90
Notes Approved no
Call Number Serial 69
Permanent link to this record
 

 
Author Assefi, N. P.; Sherman, K. J.; Jacobsen, C.; Goldberg, J.; Smith, W. R.; Buchwald, D.
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 88
Notes Approved no
Call Number Serial 42
Permanent link to this record
 

 
Author Brinkhaus, B.; Ortiz, M.; Witt, C. M.; Roll, S.; Linde, K.; Pfab, F.; Niggemann, B.; Hummelsberger, J.; Treszl, A.; Ring, J.; Zuberbier, T.; Wegscheider, K.; Willich, S. N.
Title Acupuncture in patients with seasonal allergic rhinitis: a randomized trial Type of Study RCT
Year 2013 Publication Annals of internal medicine Abbreviated Journal Ann Intern Med
Volume 158 Issue 4 Pages 225-234
Keywords AcuTrials; Respiratory Tract Diseases; Rhinitis, Allergic, Seasonal; Acu + Usual Care Versus > 1 Control; RCT; Acupuncture; Semi-Individualized Acupuncture Protocol; TCM Acupuncture Style; Symptom Based Point Selection; Restricted Modalities, Acupuncture Only; Sham Control; Penetrating Sham; Superficial Needling Depth; Sham Acupoint Control; Usual Care Control, Pharmaceutical
Abstract Chinese translation BACKGROUND: Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence. OBJECTIVE: To evaluate the effects of acupuncture in patients with SAR. DESIGN: Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584) SETTING: 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. PATIENTS: 422 persons with SAR and IgE sensitization to birch and grass pollen. INTERVENTION: Acupuncture plus rescue medication (RM) (cetirizine) (n = 212), sham acupuncture plus RM (n = 102), or RM alone (n = 108). Twelve treatments were provided over 8 weeks in the first year. MEASUREMENTS: Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16 in the first year and week 8 in the second year after randomization, with predefined noninferiority margins of -0.5 point (RQLQ) and -1.5 points (RMS). RESULTS: Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point [97.5% CI, 0.2 to 0.8 point; P &lt; 0.001]; RM vs. acupuncture mean difference, 0.7 point [97.5% CI, 0.4 to 1.0 point; P &lt; 0.001]) and RMS (sham vs. acupuncture mean difference, 1.1 points [97.5% CI, 0.4 to 1.9 points; P &lt; 0.001]; RM vs. acupuncture mean difference, 1.5 points [97.5% CI, 0.8 to 2.2 points; P &lt; 0.001]). There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over the sham procedure were noted (RQLQ mean difference, 0.3 point [95% CI, 0.03 to 0.6 point; P = 0.032]; RMS mean difference, 1.0 point [95% CI, 0.2 to 1.9 points; P = 0.018]). LIMITATION: The study was not powered to detect rare adverse events, and the RQLQ and RMS values were low at baseline. CONCLUSION: Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.
Address Charite University Medical Center and German Red Cross Hospital Westend, Berlin, Germany.
Publisher
Language Number of Treatments 12
Treatment Follow-up 8 Weeks Frequency >1/WK Number of Participants 422
Time in Treatment 8 Weeks Condition Rhinitis, Allergic, Seasonal
Disease Category Respiratory Tract Diseases OCSI Score
Notes Approved no
Call Number Serial 90
Permanent link to this record