German acupuncture trials

Last updated
Needles being inserted into a patient's forearm Acupuncture1-1.jpg
Needles being inserted into a patient's forearm

The German acupuncture trials (German : GERAC-Studien [1] ) were a series of nationwide acupuncture trials set up in 2001 and published in 2006 on behalf of several German statutory health insurance companies because of a dispute as to the usefulness of acupuncture. [2] They consisted of one observational study on acupuncture side effects, and four randomized controlled trials (RCTs) investigating acupuncture treatment for low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. The trials are considered to be one of the largest clinical studies in the field of acupuncture. [2]

Contents

As a result of the GERAC trials, the German Federal Joint Committee ruled in April 2006 that the costs of acupuncture treatment for chronic back pain and knee osteoarthritis would be covered by public health insurers in Germany, [3] though no coverage was offered for headache or migraine. [4] However, because of the outcome of these trials, in the case of the other conditions, insurance corporations in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments. [5] No significant differences between acupuncture and sham acupuncture were found in any trial. [6] However, the trials also found that for chronic low back pain, the "effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy." [7]

According to Schweizer Fernsehen, the total cost of the trials amounted to 7.5 million Euros. [8] Several years after the committee's decision to incorporate acupunctural treatment into the healthcare of Germany was passed into law, the number of regular users of acupuncture in the country surpassed one million. [9]

History

In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly because of the lack of reliable evidence regarding its therapeutic efficacy. [10] This resulted in a heated debate, which led to Paul Rheinberger, Director of the Federal Committee of Physicians and Health Insurers, saying: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy." [11] [12]

In October 2000, the Federal Committee of Physicians and Health Insurers decided that acupunctural treatment may not be reimbursed by statutory health insurance companies except within the framework of experimental field studies. [13] [14] In 2001 the GERAC were set up at Bochum University [13] as a field study on behalf of six German statutory health insurance organizations. [2] [14]

Overview and results

The Ruhr University Bochum Audimax-Aussen.jpg
The Ruhr University Bochum

Beginning in 2001, the trials were carried out by Heidelberg University, the University of Marburg, the University of Mainz and the Ruhr University Bochum for low back pain, [13] [15] knee osteoarthritis, [13] [16] migraine prophylaxis, [13] and tension-type headache. [13] Apart from that, an observational study on adverse events of acupuncture was done. [14]

The RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment. [2] The number of patients randomized was one of the largest ever for acupuncture trials. [2] [14] For each indication, around 1000 test subjects were included. [17] The trials were conducted using sham acupuncture. [6] No significant differences between acupuncture and sham acupuncture were found in any trial. [6]

In 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria". [1] In 2006, Edzard Ernst, a professor of complementary medicine at the University of Exeter, noted that the studies had attracted criticism for not taking into account the risk of patient de-blinding, and that they "[failed] to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect". [18] In September 2007, NHS Choices commented on the news surrounding the study and said that "this trial seems to support the role of acupuncture as an effective alternative therapy for chronic lower back pain" but that "it will be important to try to tease apart the real treatment effects from those that occur through the placebo effect". [19] Highlighting the results of the placebo group, researchers refused to accept a placebo therapy as efficient. [4]

Domestic consequences

As a result of the GERAC trials, in April 2006 the German Federal Joint Committee, which sets health care reimbursement policy for Germany, determined that acupuncture for the treatment of low back pain and knee pain would be reimbursed by public health insurance [3] but coverage was not offered for headache or migraine. [4] In July 2006, the German Health Minister Ulla Schmidt confirmed the decision. [20] However, because of the outcome of these trials, in the case of the other conditions, insurance corporations in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments. [5]

In 2012, health insurers reported that after the committee's decision to incorporate acupuncture into the healthcare of Germany was passed into law, the number of users of acupuncture in the country had increased by about 20%, finding favour especially among women; in 2012 there were around one million estimated users. [9]

Media reception

The trials resulted in increased coverage of acupuncture in the German media. [21] According to the news broadcaster Deutschlandfunk, the GERAC trials were considered to be the world's largest set of clinical studies on acupuncture. [22] An article in Die Welt said that the results of the studies were "promising". [23] Der Spiegel said that the results of GERAC couldn't be brushed aside by the Federal Joint Committee. [2]

ABC News reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment. [24] Heinz Endres, one of the authors of the study, told the Canadian Broadcasting Corporation that "acupuncture has not yet been recommended as a routine therapy", but "we think this will change with our study". [25] The BBC stated that the study "echoes the findings of two studies published last year in the British Medical Journal , which found a short course of acupuncture could benefit patients with low back pain". [26] Nigel Hawkes, health editor of The Times , wrote that the trials "suggest that both acupuncture and sham acupuncture act as powerful versions of the placebo effect." [27]

See also

Related Research Articles

<span class="mw-page-title-main">Acupuncture</span> Pseudoscientific needling treatment

Acupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the body. Acupuncture is a pseudoscience; the theories and practices of TCM are not based on scientific knowledge, and it has been characterized as quackery.

<span class="mw-page-title-main">Migraine</span> Disorder resulting in recurrent moderate-severe headaches

Migraine is a genetically influenced complex neurological disorder characterized by episodes of moderate-to-severe headache, most often unilateral and generally associated with nausea and light and sound sensitivity. Other characterizing symptoms may include nausea, vomiting, cognitive dysfunction, allodynia, and dizziness. Exacerbation of headache symptoms during physical activity is another distinguishing feature. Up to one-third of migraine sufferers experience aura: a premonitory period of sensory disturbance widely accepted to be caused by cortical spreading depression at the onset of a migraine attack. Although primarily considered to be a headache disorder, migraine is highly heterogenous in its clinical presentation and is better thought of as a spectrum disease rather than a distinct clinical entity. Disease burden can range from episodic discrete attacks, consisting of as little as several lifetime attacks, to chronic disease.

<span class="mw-page-title-main">Acupressure</span> Alternative medicine technique similar to acupuncture

Acupressure is an alternative medicine technique often used in conjunction with acupuncture or reflexology. It is based on the concept of life energy, which flows through "meridians" in the body. In treatment, physical pressure is applied to acupuncture points, or ashi trigger points, with the aim of clearing blockages in these meridians. Pressure may be applied by hand, by elbow, or with various devices.

<span class="mw-page-title-main">Headache</span> Pain in the head or neck

Headache, also known as cephalalgia, is the symptom of pain in the face, head, or neck. It can occur as a migraine, tension-type headache, or cluster headache. There is an increased risk of depression in those with severe headaches.

<span class="mw-page-title-main">Pain management</span> Interdisciplinary approach for easing pain

Pain management is an aspect of medicine and health care involving relief of pain in various dimensions, from acute and simple to chronic and challenging. Most physicians and other health professionals provide some pain control in the normal course of their practice, and for the more complex instances of pain, they also call on additional help from a specific medical specialty devoted to pain, which is called pain medicine.

<span class="mw-page-title-main">Osteoarthritis</span> Form of arthritis caused by degeneration of joints

Osteoarthritis (OA) is a type of degenerative joint disease that results from breakdown of joint cartilage and underlying bone which affects 1 in 7 adults in the United States. It is believed to be the fourth leading cause of disability in the world. The most common symptoms are joint pain and stiffness. Usually the symptoms progress slowly over years. Other symptoms may include joint swelling, decreased range of motion, and, when the back is affected, weakness or numbness of the arms and legs. The most commonly involved joints are the two near the ends of the fingers and the joint at the base of the thumbs, the knee and hip joints, and the joints of the neck and lower back. The symptoms can interfere with work and normal daily activities. Unlike some other types of arthritis, only the joints, not internal organs, are affected.

<span class="mw-page-title-main">Sumatriptan</span> 5-HT receptor agonist medication used for migraines & cluster headaches

Sumatriptan, sold commonly under brand names Imitrex and Treximet among others, is a medication used to treat migraine headaches and cluster headaches. It is taken orally, intranasally, or by subcutaneous injection. Therapeutic effects generally occur within three hours.

Manual therapy, or manipulative therapy, is a physical treatment primarily used by physical therapists, physiotherapists, occupational therapists to treat musculoskeletal pain and disability; it mostly includes kneading and manipulation of muscles, joint mobilization and joint manipulation. It is also used by Rolfers, massage therapists, athletic trainers, osteopaths, and physicians.

Prolotherapy, also called proliferation therapy, is an injection-based treatment used in chronic musculoskeletal conditions. It has been characterised as an alternative medicine practice.

Regulation of acupuncture is done by governmental bodies to ensure safe practice.

Chronic headache, or chronic daily headache (CDH), is classified as experiencing fifteen or more days with a headache per month. It is estimated that chronic headaches affect "4% to 5% of the general population". Chronic headaches consist of different sub-groups, primarily categorized as chronic tension-type headaches and chronic migraine headaches. The treatments for chronic headache are vast and varied. Medicinal and non-medicinal methods exist to help patients cope with chronic headache, because chronic headaches cannot be cured. Whether pharmacological or not, treatment plans are often created on an individual basis. Multiple sources recommend multimodal treatment, which is a combination of medicinal and non-medicinal remedies. Some treatments are controversial and are still being tested for effectiveness. Suggested treatments for chronic headaches include medication, physical therapy, acupuncture, relaxation training, and biofeedback. In addition, dietary alteration and behavioral therapy or psychological therapy are other possible treatments for chronic headaches.

Tanezumab is a monoclonal antibody against nerve growth factor as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs. Tanezumab was discovered and developed by Rinat Neuroscience and was acquired by Pfizer in 2006.

Preventive treatment of migraine can be an important component of migraine management. Such treatments can take many forms, including everything from surgery, taking certain drugs or nutritional supplements, to lifestyle alterations such as increased exercise and avoidance of migraine triggers.

<span class="mw-page-title-main">Lasmiditan</span> Chemical compound

Lasmiditan, sold under the brand name Reyvow, is a medication used for the acute treatment of migraine with or without aura in adults. It is not useful for prevention. It is taken by mouth.

Occipital nerve stimulation (ONS), also called peripheral nerve stimulation (PNS) of the occipital nerves, is used to treat chronic migraine patients who have failed to respond to pharmaceutical treatments.

The Federal Joint Committee refers to a group of German public health agencies that were merged in 2004, under an independent chairman. It is authorized to make binding regulations growing out of health reform bills passed by lawmakers, along with routine decisions regarding healthcare in Germany.

Klaus Linde is a German physician and alternative medicine researcher. He works at the Centre for Complementary Medicine Research at the Technical University of Munich in Germany.

Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta. It is administered by intravenous infusion.

<span class="mw-page-title-main">Galcanezumab</span> Monoclonal antibody

Galcanezumab, sold under the brand name Emgality, is a humanized monoclonal antibody used for the prevention of migraine. It is also used for cluster headaches.

Fremanezumab, sold under the brand name Ajovy, is a medication used to prevent migraines in adults. It is given by injection under the skin.

References

  1. 1 2 Wenzel, K.-W (2005). "Akupunktur: Was zeigen die gerac-Studien?" [Acupuncture: What of the GERAC studies?]. Deutsche Medizinische Wochenschrift (in German). 130 (24): 1520. doi:10.1055/s-2005-870855. PMID   15942849.
  2. 1 2 3 4 5 6 Hackenbroch, Veronika (2004-10-25). "Die eingebildete Heilung" [The Imaginary Healing]. Der Spiegel (in German).
  3. 1 2 "Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur" (PDF) (in German). Federal Joint Committee (Germany). 2006-04-18.
  4. 1 2 3 TJ Hinrichs; Linda L. Barnes (2013). TJ Hinrichs; Linda L. Barnes (eds.). Chinese Medicine and Healing: An Illustrated History (1 ed.). Belknap Press. p. 314. ISBN   978-0674047372.
  5. 1 2 Stuart B. Porter (2013). Stuart B. Porter (ed.). Tidy's Physiotherapy (15 ed.). Churchill Livingstone. p. 408. ISBN   978-0702043444.
  6. 1 2 3 Novella, Steven (June 19, 2013). "Acupuncture Doesn't Work". Science-Based Medicine. Referencing this study: "Verum (or true) acupuncture and sham acupuncture treatments are no different in decreasing pain levels."
  7. ↑ Haake, Michael; Müller, Hans-Helge; Schade-Brittinger, Carmen; Basler, Heinz D.; Schäfer, Helmut; Maier, Christoph; Endres, Heinz G.; Trampisch, Hans J.; Molsberger, Albrecht (2007). "German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups". Archives of Internal Medicine. 167 (17): 1892–8. doi: 10.1001/archinte.167.17.1892 . PMID   17893311.
  8. ↑ "Akupunktur" [Acupuncture]. Schweizer Fernsehen. 2003-03-10.
  9. 1 2 "Frauen häufiger mit Akupunktur behandelt" [Women treated more often with acupuncture]. Rheinische Post (in German). 2012-08-30. Retrieved 2013-05-23.
  10. ↑ Singh, Simon; Ernst, Edzard (2008). Trick Or Treatment: The Undeniable Facts about Alternative Medicine (1st American ed.). New York: W.W. Norton. pp. 81–2. ISBN   9780393066616.
  11. ↑ Korzilius, Heike (2000). "Bundesausschuss: Streit um Akupunktur" (PDF). Deutsches Ärzteblatt (in German). 97 (30): A-2013–4. Retrieved 2013-11-26.
  12. ↑ Suess, Jochen; Scharl, Anton (2004). "Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?". Die Hebamme. 17 (4): 214–7. doi:10.1055/s-2004-860883.
  13. 1 2 3 4 5 6 Gemeinsamer Bundesausschuss (2007-09-27). Zusammenfassender Bericht des Unterausschusses 'Ärztliche Behandlung' des Gemeinsamen Bundesausschusses über die Bewertung gemäß §135 Abs.1 SGB V der Körperakupunktur mit Nadeln ohne elektrische Stimulation bei chronischen Kopfschmerzen, chronischen LWS-Schmerzen, chronischen Schmerzen bei Osteoarthritis [Summary report of the subcommittee 'Medical treatment' of the Federal Joint Committee on the assessment pursuant to § 135 SGB V, Section 1 of the body acupuncture with needles without electrical stimulation for chronic headache, chronic lumbar pain, chronic pain associated with osteoarthritis](PDF) (in German). pp. 1–527. Retrieved 2013-11-30.
  14. 1 2 3 4 Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; et al. (2007). "Akupunktur bei chronischen Kopfschmerzen" [Acupuncture for chronic headache]. Deutsches Ärzteblatt (in German). 104 (3): A-114, B-105, C-101.
  15. ↑ Pyne, D.; Shenker, N. G. (2008). "Demystifying acupuncture". Rheumatology. 47 (8): 1132–6. doi: 10.1093/rheumatology/ken161 . PMID   18460551.
  16. ↑ Scharf, Hanns-Peter; Mansmann, Ulrich; Streitberger, Konrad; Witte, Steffen; Krämer, Jürgen; Maier, Christoph; Trampisch, Hans-Joachim; Victor, Norbert (2006). "Acupuncture and knee osteoarthritis: a three-armed randomized trial". Annals of Internal Medicine. 145 (1): 12–20. doi:10.7326/0003-4819-145-1-200607040-00005. PMID   16818924. S2CID   53090249.
  17. ↑ Hessel, W. (2005). "Die Gerac-Akupunkturstudien". Skeptiker (1).
  18. ↑ Ernst, E. (2006). "Acupuncture - a critical analysis". Journal of Internal Medicine. 259 (2): 125–37. doi: 10.1111/j.1365-2796.2005.01584.x . PMID   16420542.
  19. ↑ "Acupuncture may ease back pain". NHS Choices. 2007-09-26. Retrieved January 2, 2019.
  20. ↑ "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 2006-07-03.
  21. ↑ "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften . Retrieved 2013-11-26.
  22. ↑ Vorsatz, William (2007-11-13). "Bestechendes Argument" (in German). Deutschlandfunk.
  23. ↑ "Studie belegt: Akupunktur hilft bei chronischen Schmerzen". Die Welt (in German). 2007-01-17.
  24. ↑ Williams, Carla (2007-09-24). "Fake or not, acupuncture helps back pain". ABC News . Retrieved 2013-11-25.
  25. ↑ "Acupuncture more effective than conventional treatments for back pain: Study". Canadian Broadcasting Corporation. 2007-09-27.
  26. ↑ "Needles 'are best for back pain'". BBC. 2007-09-25. Retrieved 2013-11-25.
  27. ↑ Hawkes, Nigel (2007-09-25). "Sticking needles in a bad back 'eases pain better than drugs'". The Times . Retrieved 2013-11-25.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.