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J Acupunct Res > Volume 30(5); 2013 > Article
Han, Yoon, Jeong, Lee, and Jang: Review of the Acupuncture Randomized Trials(ART) and the Acupuncture in Routine Care(ARC): the Acupuncture Trials in Germany
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Abstract

Objectives:

The purpose is to review large-scale clinical researches, the acupuncture randomized trials(ART) and the acupuncture in routine care(ARC), concerning efficacy and effectiveness of acupuncture performed in Germany.

Methods and Results:

We have reviewed the studies that were searched by keyword ‘acupuncture’ as the title and ‘Witt CM’ as one of the main authors in PubMed. Sixteen clinical reports focused on the ART and ARC studies were analyzed among all thirty six were searched. Six studies were related with the ART and eight were focused on the ARC, and other two were on both. Finally, across all researches except osteoarthritis of knee trials in the ART, compared the acupuncture group with the control were significantly improved. On the other hand, ARC showed that additional acupuncture plus routine care was more effective than routine care alone and the response to treatment of the non-randomized group did not differ the one of the randomized acupuncture group.

Conclusions:

The results may suggest that acupuncture treatment has obvious clinical effectiveness. These results are expected to inspire domestic research and clinical applications in Korea, and more rigorous research on the efficacy of acupuncture should be guaranteed.

Fig. 1.
Clinical results on the migraine, tension type headache, chronic low back pain, and osteoarthritis of the knee in ART
acupunct-30-5-11-f1.gif
Fig. 2.
Clinical results on the headache, osteoarthritis of knee or hip, chronic neck pain and low back pain, allergic rhinitis, and dysmenorrhea in ARC
acupunct-30-5-11-f2.gif
Table 1.
Characteristics of the ART and ARC
ART ARC
Indication(n) Migraine(n=302) / tension-type headache(n=270) chronic low back pain(n=298) / osteoarthritis of the knee(n=294) Headache(n=15,056) / osteoarthritis of the knee or hip(n=3,633) chronic neck pain(n=14,161) / chronic low back pain(n=11,630) allergic rhinitis(n=5,237) / dysmenorrhea(n=649)

Method Multicenter, three armed RCT Multicenter, RCT plus a non-randomized cohort

Inventions Acupuncture group Sham acupuncture group Control group Acupuncture group Non-randomized acupuncture group Control group

Session 12 sessions per patient over 8 weeks Waiting list group Routine care + 15 sessions per patient over 3 months no acupuncture between 3 and 6 months Routine care alone

Physicians Trained at least 140 hours
(M, T : median 500 hours, experienced median 10 years)
(L : median 350 hours, experienced median 10 years)
Trained at least 140 hours (A-diploma)

Treatment / cost-effectiveness Basic points(M1, T2) local points and distant points(L3, O4) additional points(M, T, O5) bilaterally At least 5, 6 of 10 non-acupuncture points bilaterally, superficially, distant, fine needles Quality-adjusted life years(QALY) were calculated by adopting the area under the curve method8,18). The analysis is based on the utility values at each time point (baseline utility, utility after 3 months) and uses the common assumption of a linear change over time18). The ICER shows the additional costs for one extra quality-adjusted life year(QALY) gained compared with control treatment. Societal threshold value, which is often described as society’s willingness to pay for one QALY gained. If the ICER is below such a threshold value, the treatment can be regarded as cost-effective1419.

‘Deqi’, manual stimulation were achieved ‘Deqi’, manual stimulation were avoided

Measures H : the number of days with headache
M : days with moderate or severe headache O : WOMAC index
T : days with Headache N : neck pain and disability(NPAD scale by Wheeler)
L : visual Analog Scale Score L : back function score(Hannover functional ability questionnaire) HFAQ
O : WOMAC index A : rhinitis quality of life questionnaire(RQLQ)
D : the average pain intensity(NRS 0–10)

Result There was significant difference in efficacy between acupuncture group and control group.
(p=0.960 in M, 0.580 in T, 0.260 in L, <0.001 in O)2. There was a significant difference between acupuncture and minimal acupuncture only in osteoarthritis of the knee.
There was a significant difference between acupuncture and usual care alone at 3 months (p<0.001)2. Meanwhile, the difference in effectiveness between randomized acupuncture group and non-randomized acupuncture group is similar.

M : migraine. T : tension-type headache. L : chronic low back pain. O : osteoarthritis of the knee. H: headache. N : chronic neck pain. A : allergic rhinitis. D: dysmenorrhea.

1. GB20, 40 or 41 or 42, GV20, LR3, TE3 or 5, Taiyang(EX-HN5).

2. GB20, 21, LR3.

3. At least 4 local points(BL20 to 34; BL50 to 54; GB30; GV1, 3, 4, 5, and 6; and extraordinary points Huatojiaji(EX-B2) and Shiqizhuixia (EX-B8)), at least 2 distant points (SI3; BD40, 60, 62; KI3, 7; GB31, 34, 41; LR3; GV14, 20).

4. At least 6 local acupoints(ST34, 35, 36; SP9, 10; BD40; KI10; GB33, 34; LR8; extraordinary points Heding(EX-LE2), Xiyan(EX-LE5)), at least 2 distant points(SP4, 5, 6; ST6; BD20, 57, 58, 60, 62; KI3).

5. Additional points included body acupuncture points, ear acupuncture points, and trigger points.

V. References

1. Yoon J, Han K, Jeong J, Lee S, Jang I. Review of the Large-scale Clinical Researches on Acupuncture in Germany: ASH, ART, ARC, and GERAC. The Journal of Acupuncture. 2013;30(1):21–6.
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2. Witt CM. Clinical Research on Acupuncture: Concepts and Guidance on Efficacy and Effectiveness Research. Chin J Integr Med. 2011;Mar;17(3):166–72.
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3. Melchart D, Linde K, Streng A, et al. Acupuncture randomized trials(ART) in patients with migraine or tension-type headache-design and protocols. Forsch Komplementarmed Klass Naturheilkd. 2003;10:179–84.
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4. Linde K, Streng A, Jürgens S, et al. Acupuncture for Patients With Migraine A Randomized Controlled Trial. JAMA. 2005;May 4; 293(17):2118–25.
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5. Melchart D, Streng A, Hoppe A, et al. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005;Aug 13; 331(7513):376–82.
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6. Brinkhaus B, Witt CM, Jena S, et al. Acupuncture in Patients With Chronic Low Back Pain A Randomized Controlled Trial. Arch Intern Med. 2006;Feb 27; 166(4):450–7.
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7. Witt C, Brinkhaus B, Jena S, et al. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;Jul 9–15; 366(9480):136–43.
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8. Cummings M. Modellvorhaben Akupunktur: a summary of the ART, ARC and GERAC trials. Acupunct Med. 2009;Mar;27(1):26–30.
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9. Jena S, Witt CM, Brinkhaus B, Wegscheider K, Willich SN. Acupuncture in patients with headache. Cephalalgia. 2008;28:969–79.
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10. Jena S, Witt CM, Brinkhaus B, Wegscheider K, Willich SN. Acupuncture in Patients With Osteoarthritis of the Knee or Hip. Arthritis Rheum. 2006;Nov;54(11):3485–93.
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11. Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture for patients with chronic neck pain. Pain. 2006;Nov;125(1–2):98–106.
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12. Witt CM, Jena S, Selim D, et al. Pragmatic Randomized Trial Evaluating the Clinical and Economic Effectiveness of Acupuncture for Chronic Low Back Pain. Am J Epidemiol. 2006;Sep 1; 164(5):487–96.
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13. Brinkhaus B, Witt CM, Jena S, Liecker B, Wegscheider K, Willich SN. Acupuncture in patients with allergic rhinitis: a pragmatic randomized trial. Ann Allergy Asthma Immunol. 2008;Nov;101(5):535–43.
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14. Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol. 2008;Feb;198(2):166.e1–8.
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15. Reinhold T, Witt CM, Jena S, Brinkhaus B, Willich SN. Quality of life and cost-effectiveness of acupuncture treatment in patients with osteoarthritis pain. Eur J Health Econ. 2008;Aug;9(3):209–19.
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16. Witt CM, Reinhold T, Jena S, Brinkhaus B, Willich SN. Cost-effectiveness of acupuncture treatment in patients with headache. Cephalalgia. 2008;Apr;28(4):334–45.
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17. Brinkhaus B, Becker-Witt C, Jena S, et al. Acupuncture Randomized Trials (ART) in patients with chronic low back pain and osteoarthritis of the knee: design and protocols. Forsch Komplementarmed Klass Naturheilkd. 2003;10(4):185–91.
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18. Richardson G, Manca A. Calculation of quality adjusted life years in the published literature: a review of methodology and transparency. Health Econ. 2004;13(12):1203–10.
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19. Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000;320(7243):1197–200.
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