Browse > Article

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA) : Extending the CONSORT Statement  

Lee, Hyang-Sook (Acupuncture & Meridian Science Research Center, College of Korean Medicine, Kyung Hee University)
Cha, Su-Jin (Acupuncture & Meridian Science Research Center, College of Korean Medicine, Kyung Hee University)
Park, Hi-Joon (Acupuncture & Meridian Science Research Center, College of Korean Medicine, Kyung Hee University)
Seo, Jung-Chul (WooriKyunghee Oriental Medical Clinic)
Park, Jong-Bae J. (Asian Medicine and Acupuncture Research, Dept. of Physical Medicine & Rehabilitation, University of North Carolina at Chapel Hill)
Lee, Hye-Jung (Acupuncture & Meridian Science Research Center, College of Korean Medicine, Kyung Hee University)
Publication Information
Korean Journal of Acupuncture / v.27, no.3, 2010 , pp. 1-23 More about this Journal
Abstract
Objectives and methods : The Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. Results : The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. Conclusions : It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.
Keywords
Acupuncture; STRICTA; CONSORT; Intervention; Reporting; Checklist;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Scharf H. Mansmann U, Streitberger K, Witte S. Kramer J, Maier C, et al. Acupuncture and knee osteoarthritis. Ann Intern Med. 2006 145 : 12-20.   ScienceOn
2 Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 ; 328 : 702-8.   DOI   ScienceOn
3 MacPherson H. White A, Cummings M, Jobst K, Rose K, Niemtzow R et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA statement. Acupunct Med. 2002 : 20 : 22-5.   DOI   ScienceOn
4 MacPherson H, White A, Cumming, Jobst K. Rose K, Niemtzow R, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA statement. Clin Acupunet Oriental Med. 2002 : 3 : 6-9.   DOI   ScienceOn
5 Schnyer RN, Iulianu D, Kay J, Shields M, Wayne P, Development of protocols for randomized sham-controlled trials of complex treatment interventions: Japanese acupuncture for endometriosis-related pelvie pain. J Altern Complement Med. 2008 ; 14 : 515-22.   DOI   ScienceOn
6 MacPherson H, Thorpe L, Thomas K, Campbell M. Acupuncture for low back pain: traditional diagnosis and treatment of 148 patients in a clinical trial. Complement Ther Med. 2004 : 12 : 38-44.   DOI   ScienceOn
7 Plint AC, Moher D, Morrison A. Schulz K, Altman DG, Hill C. et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust. 2006 : 185 : 263-7.
8 Gibson D, Bruton A, Lewith GT, Mullee M. Effects of acupuncture as a treatment for hyperventilation syndrome: a pilot. randomized crossover trial. J Altern Complement Med. 2007 : 13 : 39-46.   DOI   ScienceOn
9 Moher D. Hopewell S. Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 ; 340 : c869-c869.   DOI
10 Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ. 2008 : 336 : 1472-4.   DOI   ScienceOn
11 Kawakita K, Standards for Reporting Interventions in Controlled Trials of Acupuncture: The STRICTA Recommendations. 2010. Available from: http://jsam.jp/activity/checklist.html
12 MacPherson H. Pragmatic clinical trials. Complement Ther Med. 2004 : 12 : 136-40.   DOI   ScienceOn
13 Brinkhaus B. Witt CM. Jena S, Linde K, Streng A, Irnich D. et al. Interventions and Physician Characteristics in a Randomized Multicenter Trial of Acupuncture in Patients with Low-Back Pain. J Altern Complement Med. 2006 : 12 : 649-57.   DOI   ScienceOn
14 Wayne PM. Kerr CE, Schnyer RN, Legedza ATR. Savetsky-German J. Shields MH. et al. Japanese-Style Acupuncture for Endometriosis- Related Pelvic Pain in Adolescents and Young Women : Results of a Randomized Sham- Controlled Trial. J Pediatr Adolesc Gynecol. 2008 ; 21 : 247-57.   DOI   ScienceOn
15 Elden H, Ladfors L, Olsen MF, Ostgaard H-C, Hagberg H. Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: Randomised single blind controlled trial. BMJ. 2005 ; 330 : 761-4.   DOI   ScienceOn
16 Linde K, Streng A, Jurgens S, Huppe A. Brinkhaus B. Witt C. et al. Acupuncture for patients With migraine: a randomized controlled trial. JAMA. 2005 : 293 : 2118-25.   DOI   ScienceOn
17 White P. Lewith G. Prescott P. Conway J. Acupuncture versus placebo for the treatment of chronic mechanical neck pain: a randomized, controlled trial. Ann Intern Med. 2004 : 141 : 911-9.   ScienceOn
18 Irnich D, Behrens N, Gleditsch JM. Stor W, Schreiber MA, Schops P, et al. Immediate effects of dry needling and acupuncture at distant points in chronic neck pain: results of a randomized. double-blind, sham-controlled crossover trial. Pain, 2002 : 99 : 83-9.   DOI   ScienceOn
19 Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement updated guidelines for reporting parallel group randomised trials. BMJ. 2010 : 340 : c332-c332.   DOI
20 Jubb RW, Tukmachi ES, Jones PW, Dempsey E, Waterhouse L, Brailsford S. A blinded randomised trial of acupuneture (manual and electroacuncture) compared with a non-penetrating sham for the symptoms of osteoarthritis of the knee. Acupunct Med. 2008 ; 26 : 69-78.   DOI   ScienceOn
21 Devereaux PJ, Bhandari M, Clarke M. Montori VM, Cook DJ, Yusuf S, et al. Need for expertise based randomised controlled trials. BMJ. 2005 ; 330 : 88.   DOI   ScienceOn
22 Skilnand E, Fossen D, Heiberg E. Acupuncture in the management of pain in labor. Acta Obstet Gynecol Scand. 2002 ; 81 : 943-8.   DOI   ScienceOn
23 Reynolds JA, Bland JM, MacPherson H. Acupuncture for irritable bowel syndrome an exploratory randomised Controlled trial. Acupunct Med. 2008 : 26 : 8-16.   DOI   ScienceOn
24 Liu Jianping. Standards for Reporting Interventions in Controlled Trials of Acupuneture: The STRICTA Recommendations. Zhongguo Zhong Xi Yi Jic Ho Za Zhi. 2005 ; 25 : 556-8.
25 Liu Xuemei, Zhang Mingming, Liu Huilin. Improving the Quality of Reports in Controlled Trials of Acupuncture by Using CONSORT and STRICTA. Zhongguo Zhen Jiu. 2003 : 23 : 699-701.
26 Kleinhenz. J, Streitberger K. Windeler J, Gussbacher A. Mavridis G, Martin E. Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis, Pain. 1999 ; 83 : 235-41.   DOI   ScienceOn
27 Ahn AC, Bennani T. Freeman R. Hamdy O. Kaptchuk TJ. Two styles of acupunclure for treating painful diabetic neuropathy - a pilot randomized control trial. Acupunct Med. 2007 ; 25:11-7.   DOI   ScienceOn
28 MacPherson H. White A, Cummings M. Jobst KA, Rose K, Niemtzow R. et al. Standards for Reporting Interventions in Controlled Trials of Acupuncture: the STRICTA recommendations. J Altern Complement Med. 2002 : 8 : 85-9.   DOI   ScienceOn
29 Hyangsook Lee, Jongbae Park, Jungehul Seo, Hijoon Park, Hyejung Lee. Standards for Rwporting Interventions in Controlled Trials of Acupuneture The STRICTA Recommendations. J Korean Soc Acupunet Moxibustion. 2002 :19 :134-54.
30 Forbes A. ,jackson S, Walter C. Quraishi S, Jacyna M. Pitcher M. Acupuncture for irritable bowel syndrome: A blinded placebo-controlled trial. World J Gastroenterol. 2005 ; 11 : 4040-4.
31 Gagnier JJ, Boon H, Rochon P. Moher D, Bares J. Bombardier C, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006 ; 144 : 364-7.   ScienceOn
32 Leung AY, Park J, Schulteis G, Duann JR, Yaksh T. The electrophysiology of de qisensations. J Altern Complement Med. 2006 : 2 : 743-50.
33 Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncturc as adjunctive therapy in osteoarthritis of the knee : a randomized, controlled trial. Ann Intern Med. 2004 ; 141 : 901-10.   ScienceOn
34 Zwarenstein M, Treweek S, Gagnier JJ, Altman DG. Tunis S. Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 : 337: a2390.   DOI   ScienceOn
35 MacPherson H. White A, Cumming, Jobst K, Rose K, Niemtzow R, et al Standards for reporting interventions in controlled trials of acupuneture: the STRICTA statement. Med Acupunet. 2002 : 13 : 9-11.
36 Di Blasi Z, Kleijnen J. Context effects. Powerful therapies or methodological bias? Eval Health Prof. 2003 : 26 : 1666-79.
37 MacPherson H, Altman DG. Improving the quality of reporting acupuncture interventions: describing the collaboration between STRICTA. CONSORT and the Chincese Cochrane Centre. J Evid Based Med. 2008 ; 2 : 1-4.
38 Acupuneture Trialists Collaboration. 2010. Available from: Home page: http://www.acupuncturetrialistscollaoration.org/.
39 Society for Acupuncture Research. 2010. Available from: Home page. http://www.acupunctureresearch.org.
40 Birch S. Felt R. Understanding Acupuncture Edinburgh : Churchill Livingstone. 1999
41 World Health Organisation. A Proposed Standard International Acupuncture Nomenclature: Report of a WHO Scientific Group. 1991. Available from: http://appps.who.int/medicinedocs/en/d/Jh2947e/. Accessed 2009 December :31.
42 Brinkhaus B, Hummelsberger J, Kohnen R, Seufert J, Hempen CH. Leonhardy H. et al. Acupuneture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trial. Allergy. 2004 ; 59 : 953-60.   DOI   ScienceOn
43 Strcitberger K, Steppan J, Mater C, Hill H. Backs J, Plaschke K. Effecls of verum acupuncture compared to placebo acupuncture on quantitative EEG and heart rate variability in healthy volunteers. J Altern Complement Med. 2008 : 14 : 505-13.   DOI   ScienceOn
44 Boutron I, Moher D, Altman D G, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: cxplanation and claboration. Ann Intern Med. 2008 : 148 : 295-309.   ScienceOn
45 Boutron I. Moher D. Altman DG. Schulz KF, Ravaud P. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic trcatments. Ann Intern Med. 2008 : 148 : W60-W66.
46 MacPhcrson H. vvhite A, Cummings M, Jobst K, Rose K, Niemtzow R. et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med, 2001 : 9 : 246-9   DOI   ScienceOn
47 Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006 : 295 : 1152-60.   DOI   ScienceOn
48 Vickers AJ, Feinstcin MB, Deng GE, Cassileth BR. Acupuncture for dyspnea in advanced cancer: A randomized, placebo-controlled pilot trial [ISRCTN89462491]. BMC Palliat Care. 2005 ; 4 : 5.   DOI
49 Ioannidis JP, Evans SJ, Gotzsehe PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension the CONSORT statement. Ann Intern Med. 2004 ; 141 : 781-8.   ScienceOn
50 Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR, Buchwald D. A randomiιzed clinical trial of acupuncture compared with sham acupuncture in fibromyalgia. Ann Intern Med. 2005 : 143 : 10-9.   ScienceOn
51 Prady SL, Richmond SJ, Morton VM, MacPherson H. A Systematic Evaluation of the Impact of STRICTA and CONSORT Recommendations on Quality of Reporting for Acupuneture Trials. PLoS ONE. 2008 : 3 : e1577. doi:10.1371/journal.pone.0001577.   DOI   ScienceOn
52 Hansson Y, Carlsson C, Olsson E, Intramuscular and periosteal acupuncture for anxiety and sleep quality in patients with chronic musculoskeletal pain-an evaluator blind. controlled study. Acupunet Med. 2007 : 25 : 148-57.   DOI   ScienceOn
53 Itoh K. Hirota S. Katsumi Y. Ochi H. Kitakoji H. Trigger point acupuncture for treatment of knee osteoarthritis - a preliminary RCT for a pragmatic trial. Acupunct Med. 2008 ; 26 : 17-26.   DOI   ScienceOn
54 Lao L, Bergman S, Hamilton GR, Langenberg P. Bernan B. Evaluation of acupuncture for pain control after oral surgery: a placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 1999 ; 125 : 567-72.
55 Hopewell S. Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008 : 5 : e20. oi:10.1371/journal.pmed.0050020.   DOI   ScienceOn
56 Hesse J. Mogelvang B, Simonsen H. Acupuncture versus metoprolol in migraine prophylaxis: a randomized trial of trigger point inactivation. J Intern Med. 1994 : 235 : 451-6.   DOI   ScienceOn
57 Foster NE, Thomas E, Barlas P, Hill JC, Young J, Mason E, et al. Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomisced controlled trial. BMJ. 2007 : 335 : 436.   DOI   ScienceOn
58 Hopewell S, Clarke M, Mother D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008 : 671 : 281-3.
59 Hay E, Barlas P, Foster N, Hill J. Thomas E, Young J. Is acupuncture a useful adjunet to physiotherapy for older adults with knee pain?: The "Acupuncture, Physiotherapy and Excreisc" (APEX) study. BMC Musculoskelet Disord. 2004 ; 5 : 31.   DOI   ScienceOn
60 Diener HC, Kronfeld K, Boewing G. Lungenhausen M. Maier C. Molsberger A. et al. Efficacy of acupuncture for the prophylaxis of migrainc: a multicentre randomised controlled clinieal trial. Lancet Neurol. 2006 : 5 : 310-6.   DOI   ScienceOn
61 Prady SL. MacPherson H. Assessing the utility of the standards for reporting trials of acupuneture(STRICTA): a survey of authors. J Altern Complement Med. 2007 : 13 : 939-43.   DOI   ScienceOn
62 Hopewell S. Altman DG, Mother D, Schulz KF. Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal edtors and journal 'Instructions to Authors'. Trials. 2008 : 9 : 20.   DOI   ScienceOn
63 Phillips KD, Skelton WD, Hand GA. Effect of acupuncture administered in a group setting on pain and subjective peripheral neuropathy in persons with human immunodeficiency virus disease. J Altern Complement Med. 2004 : 10 : 449-55.   DOI   ScienceOn