Original article

Acupuncture for the Treatment of Chronic Knee and Back Pain

Dtsch Arztebl 2007; 104(3): A-123

Endres, H G; Victor, N; Haake, M; Witte, S; Streitberger, K; Zenz, M

Introduction: Because the efficacy of acupuncture was not reliably substantiated by scientific data, the Joint Federal Committee initiated a project comparing the effectiveness of acupuncture to guideline-oriented conventional therapy for chronic pain. Four large, randomized studies were conducted as part of the "German Acupuncture Trials" (GERAC). Methods: For the studies on gonarthrosis and lumbalgia, 2 201 patients were randomised in eleven German states (399 outpatient practices) to verum acupuncture, sham acupuncture and guidelineoriented conventional therapy. Primary outcome parameter was pain-dependent scores six months after randomization. Parallel to the randomized studies, a Germany-wide cohort study was conducted from which several samples were drawn to determine severe adverse events (367 646 patients) and the efficacy of acupuncture under conditions of everyday medical practice. Results: 10 to 15 acupuncture sessions, verum as well as sham, alleviated symptoms more effectively than conventional therapy. The outcomes were comparable to the pain dependent scores of patients in the knee and back-pain cohort samples. Discussion: Body needle acupuncture is an effective method of pain reduction. Because of the results in GERAC, the Joint Federal Committee of Physicians and Health Insurance Plans (Gemeinsamer Bundesausschuss, G-BA) has recommended that acupuncture for both indications be treated as a covered benefit under German public health insurance plans. Dtsch Arztebl 2007; 104(3): A 123–30.
1.
Andersson GB: Epidemiological features of chronic low-back pain. Lancet 1999; 354: 581–5. MEDLINE
2.
AWM: Leitlinien der Orthopädie – Gonarthrose. Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie und Berufsverband der Ärzte für Orthopädie, 2002.
3.
Carragee EJ: Clinical practice. Persistent low back pain. N Engl J Med 2005; 352: 1891–8. MEDLINE
4.
Ostelo RW, van Tulder MW, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ: Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev 2005: CD002014. MEDLINE
5.
Watson MC, Brookes ST, Faulkner A, Kirwan JR: Non-aspirin, non-steroidal anti-inflammatory drugs for osteoarthritis of the knee. Cochrane Database Syst Rev 2006: CD000142. MEDLINE
6.
Brosseau L, MacLeay L, Robinson V, Wells G, Tugwell P: Intensity of exercise for the treatment of osteoarthritis. Cochrane Database Syst Rev 2003: CD004259. MEDLINE
7.
Kukuk P, Lungenhausen M, Molsberger A, Endres HG: Long-term Improvement in Pain Coping for cLBP and Gonarthrosis Patients Following Body Needle Acupuncture: A Prospective Cohort Study. Eur J Med Res 2005;10: 263–72. MEDLINE
8.
Von Korff M, Ormel J, Keefe FJ, Dworkin SF: Grading the severity of chronic pain. Pain 1992; 50: 133–49. MEDLINE
9.
Collins SL, Edwards J, Moore RA, Smith LA, McQuay HJ: Seeking a simple measure of analgesia for mega-trials: is a single global assessment good enough? Pain 2001; 91: 189–94. MEDLINE
10.
Stucki G, Meier D, Stucki S et al.: Evaluation einer deutschen Version des WOMAC (Western Ontario und McMaster Universities) Arthroseindex. Z Rheumatol 1996; 55: 40–9. MEDLINE
11.
Lungenhausen M, Endres HG, Kukuk P, Schaub C, Maier C, Zenz M: Überschätzen Ärzte die Effekte der Akupunkturbehandlung? Schmerz 2005;19: 506–12. MEDLINE
12.
Ware J Jr., Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220–33. MEDLINE
13.
Endres HG, Zenz M, Schaub C et al.: Zur Problematik von Akupunkturstudien am Beispiel der Methodik von gerac. Schmerz 2005; 19: 201–204, 206, 208–210 passim. MEDLINE
14.
Haake M, Müller HH, Schade-Brittinger C et al.: The German multicenter, randomized, partially blinded, prospective trial of acupuncture for chronic low-back pain: a preliminary report on the rationale and design of the trial. J Altern Complement Med 2003; 9: 763–70. MEDLINE
15.
Streitberger K, Witte S, Mansmann U et al.: Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856]. BMC Complementary and Alternative Medicine 2004; 4: 6. MEDLINE
16.
Molsberger AF, Streitberger K, Kraemer J et al.: Designing an acupuncture study II: The nationwide, randomized, controlled German acupuncture trials on low back pain and gonarthrosis (osteoarthritis). J Altern Complement Med 2006; 12: 733–42. MEDLINE
17.
Hahn RA: The nocebo phenomenon: concept, evidence, and implications for public health. Preventive Medicine 1997; 26: 607–11. MEDLINE
18.
Nybo Andersen AM, Olsen J: Do interviewers' health beliefs and habits modify responses to sensitive questions? A study using data collected from pregnant women by means of computer-assisted telephone interviews. Am J Epidemiol 2002; 155: 95–100. MEDLINE
19.
Goldsmith CH, Boers M, Bombardier C, Tugwell P: Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee. J Rheumatol 1993; 20: 561–5. MEDLINE
20.
Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL: Defining the clinically important difference in pain outcome measures. Pain 2000; 88: 287–94. MEDLINE
21.
Kohlmann T, Raspe H: Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Rehabilitation 1996; 35: I–VIII. MEDLINE
22.
Witt C, Brinkhaus B, Jena S et al.: Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet 2005; 366: 136–43. MEDLINE
23.
Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AMK, Hochberg MC: Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med 2004; 141: 901–10. MEDLINE
24.
Endres HG, Molsberger A, Lungenhausen M, Trampisch HJ: An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients. Eur J Med Res 2004; 9: 545–51. MEDLINE
25.
Scharf H-P, Mansmann U, Streitberger K et al.: Acupuncture and Knee Osteoarthritis: A Three-Armed Randomized Trial. Ann Intern Med 2006; 145: 12–20. MEDLINE
e1.
Bundesausschuss: HTA-Report Akupunktur – Zusammenfassender Bericht des Arbeitsausschusses „Ärztliche Behandlung“ des Bundesausschusses der Ärzte und Krankenkassen über die Beratungen der Jahre 1999 und 2000 zur Bewertung der Akupunktur gemäß § 135 Abs. 1 SGB V. www.kbv.de/hta/2393.html
e2.
Dionne CE, Von Korff M, Koepsell TD, Deyo RA, Barlow WE, Checkoway H: Formal education and back pain: a review. J Epidemiol Community Health 2001; 55: 455–68. MEDLINE
e3.
Elliott AM, Smith BH, Smith WC, Chambers WA: Changes in chronic pain severity over time: the Chronic Pain Grade as a valid measure. Pain 2000; 88: 303–08. MEDLINE
e4.
Underwood MR, Barnett AG, Vickers MR: Evaluation of two time-specific back pain outcome measures. Spine 1999; 24: 1104–12. MEDLINE
e5.
Resnick B, Nahm ES: Reliability and validity testing of the revised 12-item Short-Form Health Survey in older adults. J Nurs Meas 2001; 9: 151–61. MEDLINE
e6.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW: Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988; 15: 1833–40. MEDLINE
e7.
Bellamy N: Pain assessment in osteoarthritis: experience with the WOMAC osteoarthritis index. Semin Arthritis Rheum 1989; 18: 14–7. MEDLINE
e8.
Lautenschlager J, Mau W, Kohlmann T et al.: Vergleichende Evaluation einer deutschen Version des Health Assessment Questionnaires (HAQ) und des Funktionsfragebogens Hannover (FFbH). Z Rheumatol 1997; 56: 144–55. MEDLINE
e9.
Haase I, Schwarz A, Burger A, Kladny B: Der Funktionsfragebogen Hannover (FFbH) und die Subskala „körperliche Funktionsfähigkeit“ aus dem SF-36 im Vergleich. Rehabilitation (Stuttg) 2001; 40: 40–42. MEDLINE
e10.
Kohlmann T, Raspe H: Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Rehabilitation (Stuttg) 1996; 35: I–VIII. MEDLINE
e11.
Witte S, Scharf HP, Mansmann U et al.: Wirksamkeit und Sicherheit von Akupunktur bei gonarthrosebedingten chronischen Schmerzen: Multizentrische, randomisierte, kontrollierte Studie. In: Forschungsberichte Universität Heidelberg: 51. Forschungsbericht der Abteilung Medizinische Biometrie 2005; 1–190.
e12.
Schmidt B: G-BA und Akupunktur: „Der Kaiser ist nackt“/„Bundesausschuss: Akupunktur als Regelleistung“: Wissenschaftliche Ergebnisse werden missachtet. Dtsch Arztebl 2006; 103 (28–29): A-1952. VOLLTEXT
1. Andersson GB: Epidemiological features of chronic low-back pain. Lancet 1999; 354: 581–5. MEDLINE
2. AWM: Leitlinien der Orthopädie – Gonarthrose. Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie und Berufsverband der Ärzte für Orthopädie, 2002.
3. Carragee EJ: Clinical practice. Persistent low back pain. N Engl J Med 2005; 352: 1891–8. MEDLINE
4. Ostelo RW, van Tulder MW, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ: Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev 2005: CD002014. MEDLINE
5. Watson MC, Brookes ST, Faulkner A, Kirwan JR: Non-aspirin, non-steroidal anti-inflammatory drugs for osteoarthritis of the knee. Cochrane Database Syst Rev 2006: CD000142. MEDLINE
6. Brosseau L, MacLeay L, Robinson V, Wells G, Tugwell P: Intensity of exercise for the treatment of osteoarthritis. Cochrane Database Syst Rev 2003: CD004259. MEDLINE
7. Kukuk P, Lungenhausen M, Molsberger A, Endres HG: Long-term Improvement in Pain Coping for cLBP and Gonarthrosis Patients Following Body Needle Acupuncture: A Prospective Cohort Study. Eur J Med Res 2005;10: 263–72. MEDLINE
8. Von Korff M, Ormel J, Keefe FJ, Dworkin SF: Grading the severity of chronic pain. Pain 1992; 50: 133–49. MEDLINE
9. Collins SL, Edwards J, Moore RA, Smith LA, McQuay HJ: Seeking a simple measure of analgesia for mega-trials: is a single global assessment good enough? Pain 2001; 91: 189–94. MEDLINE
10. Stucki G, Meier D, Stucki S et al.: Evaluation einer deutschen Version des WOMAC (Western Ontario und McMaster Universities) Arthroseindex. Z Rheumatol 1996; 55: 40–9. MEDLINE
11. Lungenhausen M, Endres HG, Kukuk P, Schaub C, Maier C, Zenz M: Überschätzen Ärzte die Effekte der Akupunkturbehandlung? Schmerz 2005;19: 506–12. MEDLINE
12. Ware J Jr., Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220–33. MEDLINE
13. Endres HG, Zenz M, Schaub C et al.: Zur Problematik von Akupunkturstudien am Beispiel der Methodik von gerac. Schmerz 2005; 19: 201–204, 206, 208–210 passim. MEDLINE
14. Haake M, Müller HH, Schade-Brittinger C et al.: The German multicenter, randomized, partially blinded, prospective trial of acupuncture for chronic low-back pain: a preliminary report on the rationale and design of the trial. J Altern Complement Med 2003; 9: 763–70. MEDLINE
15. Streitberger K, Witte S, Mansmann U et al.: Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856]. BMC Complementary and Alternative Medicine 2004; 4: 6. MEDLINE
16. Molsberger AF, Streitberger K, Kraemer J et al.: Designing an acupuncture study II: The nationwide, randomized, controlled German acupuncture trials on low back pain and gonarthrosis (osteoarthritis). J Altern Complement Med 2006; 12: 733–42. MEDLINE
17. Hahn RA: The nocebo phenomenon: concept, evidence, and implications for public health. Preventive Medicine 1997; 26: 607–11. MEDLINE
18. Nybo Andersen AM, Olsen J: Do interviewers' health beliefs and habits modify responses to sensitive questions? A study using data collected from pregnant women by means of computer-assisted telephone interviews. Am J Epidemiol 2002; 155: 95–100. MEDLINE
19. Goldsmith CH, Boers M, Bombardier C, Tugwell P: Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee. J Rheumatol 1993; 20: 561–5. MEDLINE
20. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL: Defining the clinically important difference in pain outcome measures. Pain 2000; 88: 287–94. MEDLINE
21. Kohlmann T, Raspe H: Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Rehabilitation 1996; 35: I–VIII. MEDLINE
22. Witt C, Brinkhaus B, Jena S et al.: Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet 2005; 366: 136–43. MEDLINE
23. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AMK, Hochberg MC: Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med 2004; 141: 901–10. MEDLINE
24. Endres HG, Molsberger A, Lungenhausen M, Trampisch HJ: An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients. Eur J Med Res 2004; 9: 545–51. MEDLINE
25. Scharf H-P, Mansmann U, Streitberger K et al.: Acupuncture and Knee Osteoarthritis: A Three-Armed Randomized Trial. Ann Intern Med 2006; 145: 12–20. MEDLINE
e1. Bundesausschuss: HTA-Report Akupunktur – Zusammenfassender Bericht des Arbeitsausschusses „Ärztliche Behandlung“ des Bundesausschusses der Ärzte und Krankenkassen über die Beratungen der Jahre 1999 und 2000 zur Bewertung der Akupunktur gemäß § 135 Abs. 1 SGB V. www.kbv.de/hta/2393.html
e2. Dionne CE, Von Korff M, Koepsell TD, Deyo RA, Barlow WE, Checkoway H: Formal education and back pain: a review. J Epidemiol Community Health 2001; 55: 455–68. MEDLINE
e3. Elliott AM, Smith BH, Smith WC, Chambers WA: Changes in chronic pain severity over time: the Chronic Pain Grade as a valid measure. Pain 2000; 88: 303–08. MEDLINE
e4. Underwood MR, Barnett AG, Vickers MR: Evaluation of two time-specific back pain outcome measures. Spine 1999; 24: 1104–12. MEDLINE
e5. Resnick B, Nahm ES: Reliability and validity testing of the revised 12-item Short-Form Health Survey in older adults. J Nurs Meas 2001; 9: 151–61. MEDLINE
e6. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW: Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988; 15: 1833–40. MEDLINE
e7. Bellamy N: Pain assessment in osteoarthritis: experience with the WOMAC osteoarthritis index. Semin Arthritis Rheum 1989; 18: 14–7. MEDLINE
e8. Lautenschlager J, Mau W, Kohlmann T et al.: Vergleichende Evaluation einer deutschen Version des Health Assessment Questionnaires (HAQ) und des Funktionsfragebogens Hannover (FFbH). Z Rheumatol 1997; 56: 144–55. MEDLINE
e9. Haase I, Schwarz A, Burger A, Kladny B: Der Funktionsfragebogen Hannover (FFbH) und die Subskala „körperliche Funktionsfähigkeit“ aus dem SF-36 im Vergleich. Rehabilitation (Stuttg) 2001; 40: 40–42. MEDLINE
e10. Kohlmann T, Raspe H: Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Rehabilitation (Stuttg) 1996; 35: I–VIII. MEDLINE
e11. Witte S, Scharf HP, Mansmann U et al.: Wirksamkeit und Sicherheit von Akupunktur bei gonarthrosebedingten chronischen Schmerzen: Multizentrische, randomisierte, kontrollierte Studie. In: Forschungsberichte Universität Heidelberg: 51. Forschungsbericht der Abteilung Medizinische Biometrie 2005; 1–190.
e12. Schmidt B: G-BA und Akupunktur: „Der Kaiser ist nackt“/„Bundesausschuss: Akupunktur als Regelleistung“: Wissenschaftliche Ergebnisse werden missachtet. Dtsch Arztebl 2006; 103 (28–29): A-1952. VOLLTEXT

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