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米国国立衛生研究所・鍼に関する合意声明

付・米国国立衛生研究所(NIH)よる「鍼に関する合意声明」について

主催:NIH研究医学適用室、同代替医学室 
共催:国立癌研究所、国立心臓・肺・血液研究所、国立アレルギー伝染病研究所、 国立関節炎・筋骨格・皮膚病研究所、国立薬物乱用研究所、NIH女性健康研究室 
翻訳:中村 一徳(未完成です)
参考:ジーニアス英和辞典(大修館書店)、医学大事典(南山堂)
(訳者より:日本語の語彙力、表現力の乏しさを痛感しています。おかしな所があれば、ご指摘下さいませ。)
Translated by K.Nakamura

107. Acupuncture 
National Institutes of Health 
Consensus Development Conference Statement 
November 3-5, 1997

  This statement was originally published as: Acupuncture. NIH Consens Statement 1997 Nov 3-5; 15(5):1-34. 

この声明は鍼治療について’97年11月3日NIH合意声明として独自に発表されたものである。

 For making bibliographic reference to consensus statement no. 107 in the electronic form displayed here, it is recommended that the following format be used:  Acupuncture. NIH Consens Statement Online 1997 Nov 3-5; month, day]; 15(5):1-34. 

ここに示される電子形式におけるno.107の合意声明に対する参考文献関連については”NIH Consens Statement Online 1997 Nov 3-5; month, day]; 15(5):1-34.”の鍼灸に関するものを参照下さい。 

  NIH Consensus Statements are prepared by a nonadvocate, non-Federal panel of experts, based on (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the consensus panel and is not a policy statement of the NIH or the Federal Government.

このNIH共同声明は、鍼治療の支持者でなく、また国家に関与する者でもない専門家らの委員会によって(1)2日間にわたる公開討論における共通の問題に関連する領域に取り組んでいる研究者らが提示している内容、(2)公開会議の一部である公開討論期間の会議出席者からの疑問と発表、そして(3)2日目の討論終了後と3日目の午前の間に委員会によってなされた非公開の審議、以上を基盤として、準備されたものである。この声明はNIHもしくは連邦政府による政治的声明ではなく、合意委員会の独立した報告である。

Abstract(抄録) 
Introduction(序論)

1. What Is the Efficacy of Acupuncture, Compared With Placebo or  Sham Acupuncture, in the Conditions  for Which Sufficient Data Are Available to Evaluate? 

1.十分なデータが評価に値する状況において、プラセボや偽の鍼治療と比較して、鍼治療の有効性はいかなるものか。 

2. What Is the Place of Acupuncture in the Treatment of Various Conditions for Which Sufficient Data Are Available, in Comparison  or in Combination With Other Interventions (Including No Intervention)?

2.他の介入(それがない状況も含む)との比較や組み合わせにおいて、十分なデータが利用できる色々な状況の治療において、鍼治療の位置づけはどの様なものであるか。

3. What Is Known About the Biological Effects of Acupuncture That Helps Us Understand How It Works? 

3.鍼治療の作用機序を理解する上で我々の助けとなる生物学的効果について何が知られているか。

4. What Issues Need To Be Addressed So That Acupuncture Can Be Appropriately Incorporated Into Today’s Health Care System? 

4.今日の健康管理システムに鍼治療が適切に組み込まれるためにはどの様な問題に焦点を当てなければならないのか。 

5. What Are the Directions for Future Research? 

5.将来の研究の方向性はどのようにすべきか。

Conclusions(結論)

Consensus Development Panel(合意発展委員会) 
Speakers(発言者) 
Planning Committee(企画委員会) 
Lead Organizations(主催団体) 
Supporting Organizations(支持団体) 
Bibliography(参考文献) 

Abstract(抄録) 
Objective.(目標) 

 To provide health care providers, patients, and the general public with a responsible assessment of the use and effectiveness of acupuncture for a variety of conditions

様々な状態に対する鍼治療の利用法及び有効性について信頼できる評価をヘルスケア提供者、患者そして一般市民に対して、提供すること 

Participants.(参加者) 

 A non-Federal, nonadvocate, 12-member panel representing the fields of acupuncture, pain, psychology, psychiatry, physical medicine and rehabilitation, drug abuse, family practice, internal medicine, health policy, epidemiology, statistics, physiology, biophysics, and the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 1,200. 

国家に関与せず、また鍼治療の支持者でない12人の委員会の構成員は、鍼医学、疼痛医学、心理学、精神医学、物理療法及びリハビリテーション、薬物乱用、家族療法、内科、健康政策、疫学、統計学、生理学、生物物理学の各領域を代表し、加えて一般市民である。更にこれら同様の領域から25人の専門家が委員会及び1,200人にのぼる会議の一般聴衆に資料を提出した。 

Evidence.(根拠) 

 The literature was searched through Medline, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience.

文献はアメリカのオンライン化された医学文献検索システムで検索され、広範な会議参考文献は委員会及び会議聴衆らに配布された。専門家らは文献からの関連のある引用を添えた抄録を用意した。科学的証拠は臨床的な個々の事例の経験に優位である。

Consensus Process.(会議経過) 

 The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel’s final revisions. 

事前に確定した疑問に答えるこの委員会は、公開フォーラムや科学的文献で示された科学的証拠に基づいて結論を展開させていった。委員会は草案発表をおこなったが、その草案は全てが読まれ、専門家と聴衆の間で、批評のために回覧された。その後、この委員会は矛盾する勧告を解決し、会議終了時には改訂された声明を発表した。委員会は会議終了後2、3週間以内に改訂版を完成させた。声明草案はこの会議におけるその発表に続いて直ちに全世界のインターネット上で閲覧可能となり、委員会の最終改訂版にアップデートされた。

Conclusions.(結論)

 Acupuncture as a therapeutic intervention is widely practiced in the United States. While there have been many studies of its potential usefulness, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups. However, promising results have emerged, for example, showing efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain. There are other situations such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma, in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. Further research is likely to uncover additional areas where acupuncture interventions will be useful. 

治癒法の介入としての鍼治療は米国において広くおこなわれている。その潜在的利用価値について多くの研究がある一方、これらの研究の多くは、計画、統計規模また他の要因のために不明瞭な結論となっている。プラセボ群や偽鍼治療群といった固有の困難な問題が、適切な管理手段の利用において、問題をかなり複雑にしている。しかしながら、期待できる結果が現れてきている。例えば、大人において手術後や化学療法によるむかつき、嘔吐や抜歯後疼痛において鍼治療の効果が示されているように、それらにおいては鍼治療が付加的療法として、また受容可能な代替療法として有用、もしくは包括的管理プログラムに含まれているだろう。また薬物中毒、脳卒中の機能回復訓練、頭痛、月経痛、テニス肘、筋肉痛、筋ー筋膜痛、骨関節炎、腰痛症、手根管症候群、喘息、そして研究が更に進めば、鍼治療の介入が有用であるさらなる領域が明らかになってゆくだろう。

Introduction(序論) 

 Acupuncture is a component of the health care system of China that can be traced back for at least 2,500 years. The general theory of acupuncture is based on the premise that there are patterns of energy flow (Qi) through the body that are essential for health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin. The practice of acupuncture to treat identifiable pathophysiological conditions in American medicine was rare until the visit of President Nixon to China in 1972. Since that time, there has been an explosion of interest in the United States and Europe in the application of the technique of acupuncture to Western medicine.

鍼治療は、少なくとも2,500年前に遡ることができる中国の健康管理法の一構成要素である。鍼治療の一般理論は、健康に不可欠で、体を巡る「気」と呼ばれるエネルギーの流れのパターンを前提としている。この流れのdisruptions(*注)が病気の原因であると考えられている。そして鍼治療は、皮膚に近く、disruptionのおきている場所と同一のポイントで気の流れのアンバランスを調整するようである。米国の医療において、病生理学的に確認しうるコンディションの治療のための鍼治療が行われることは、1972年のニクソン大統領の訪中までは殆ど見られなかった。しかし、そのときから、西洋医学への鍼治療の技術応用は、米国及びヨーロッパにおいて爆発的な関心を引き起こしているのである。 
(*注)disruption・・・混乱・中断・途絶といった訳は、「energy of flow」(気の流れ・専門用語で「経絡けいらく」)に関してどれも当てはまるので、そのままdisruptionとしている。

 Acupuncture describes a family of procedures involving stimulation of anatomical locations on the skin by a variety of techniques. There are a variety of approaches to diagnosis and treatment in American acupuncture that incorporate medical traditions from China, Japan, Korea, and other countries. The most studied mechanism of stimulation of acupuncture points employs penetration of the skin by thin, solid, metallic needles, which are manipulated manually or by electrical stimulation. The majority of comments in this report are based on data that came from such studies. Stimulation of these areas by moxibustion, pressure, heat, and lasers is used in acupuncture practice, but because of the paucity of studies, these techniques are more difficult to evaluate. 

鍼治療は、様々な技術で、皮膚上の解剖学的位置への刺激を伴う一群の手順であると言うことができる。中国、日本、韓国また他の国々からの伝統的医学と合体したアメリカの鍼治療においては、診断と治療について様々な取り組みが存在している。最もよく研究されている経穴(*注)への刺激に関するメカニズムは、手技的にもしくは電気的に操作される、細く堅い金属製の鍼による皮膚への貫通(刺入)を用いる。そしてこのレポートにおける論評の多くは、そういった鍼の経穴への刺入についての研究のデータに基づいている。灸治療、指圧、温熱そしてレーザーによるこれら領域(経穴)への刺激は、鍼治療の実際においては使用されているが、研究の不足のために、これらの手法は一層、評価が困難である。 
(*注)経穴・acupuncture point, acu-point 

 Acupuncture has been used by millions of American patients and performed by thousands of physicians, dentists, acupuncturists, and other practitioners for relief or prevention of pain and for a variety of health conditions. After reviewing the existing body of knowledge, the U.S. Food and Drug Administration recently removed acupuncture needles from the category of “experimental medical devices” and now regulates them just as it does other devices, such as surgical scalpels and hypodermic syringes, under good manufacturing practices and single-use standards of sterility. 

鍼治療は米国において数千人の医師、歯科医師、鍼灸師また他の医療従事者によって、様々な健康状態に対して、痛みの軽減や予防のために、数百万人の患者におこなわれている。そして、米国医薬品食品管理局は、存在している大量の情報を審査した後に、最近になり、鍼治療用の鍼を経験的治療器具のカテゴリーから除外し、現在は、良好な製造法、滅菌状態で1回のみの使用といった基準の下、外科用メスや皮下用注射器といった器具の類のものとして規定している。

 Over the years, the National Institutes of Health (NIH) has funded a variety of research projects on acupuncture, including studies on the mechanisms by which acupuncture may produce its effects, as well as clinical trials and other studies. There is also a considerable body of international literature on the risks and benefits of acupuncture, and the World Health Organization lists a variety of medical conditions that may benefit from the use of acupuncture or moxibustion. Such applications include prevention and treatment of nausea and vomiting; treatment of pain and addictions to alcohol, tobacco, and other drugs; treatment of pulmonary problems such as asthma and bronchitis; and rehabilitation from neurological damage such as that caused by stroke. 

何年かにわたり、NIH(米国国立衛生研究所)は臨床試験や他の研究と同様に、鍼治療がその効果を発現するメカニズムの研究を含んだ、鍼治療の研究プロジェクトに基金を出してきた。鍼治療の危険性や利益に関する国際的な文献もまた大量に存在し、そして世界保健機関は、鍼および灸治療の適応となる種々の医療上の状態をリストアップしている。その適応は、吐き気、嘔吐の予防と治療、痛みの治療、アルコール、タバコまた他の薬物中毒の治療、喘息。気管支炎といった呼吸器疾患、脳卒中によって引き起こされたような神経学上の障害の機能回復を含んでいる。

 To address important issues regarding acupuncture, the NIH Office of Alternative Medicine and the NIH Office of Medical Applications of Research organized a 2-1/2-day conference to evaluate the scientific and medical data on the uses, risks, and benefits of acupuncture procedures for a variety of conditions. Cosponsors of the conference were the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Dental Research, the National Institute on Drug Abuse, and the Office of Research on Women’s Health of the NIH. The conference brought together national and international experts in the fields of acupuncture, pain, psychology, psychiatry, physical medicine and rehabilitation, drug abuse, family practice, internal medicine, health policy, epidemiology, statistics, physiology, and biophysics, as well as representatives from the public.

鍼治療に関する重要な問題を絞り込むために、NIHの代替医学室・研究医学適用室は、種々の状態への鍼治療という行為の利用、危険性、利益における科学的医学的データを評価するために、2日半にわたる会議を計画した。会議共催は国立癌研究所、国立心臓・肺・血液研究所、国立アレルギー伝染病研究所、国立関節炎・筋骨格・皮膚病研究所、国立歯科学研究所、国立薬物乱用研究所、NIH女性健康研究室である。会議は国内外の専門家らと共に運営された。それら専門家らの領域は、鍼医学、疼痛医学、心理学、精神医学、物理療法及びリハビリテーション、薬物乱用、家族療法、内服薬、健康施策、疫学、統計学、生理学、生物物理学であり、一般からの代表者も同様である。

 After 1-1/2 days of available presentations and audience discussion, an independent, non-Federal consensus panel weighed the scientific evidence and wrote a draft statement that was presented to the audience on the third day. The consensus statement addressed the following key questions: 

一日半にわたる、利用可能な発表や聴講者の討論の後、独立し国家に関与せずに一致した委員会は、科学的根拠を比較考察し、3日目に聴講者に示された声明の草案を書き上げた。共同声明は次に掲げるような重要な疑問に焦点をあてた。

 What is the efficacy of acupuncture, compared with placebo or sham acupuncture, in the conditions for which sufficient data are available to evaluate?

十分なデータが評価に値する状況において、プラセボや偽の鍼治療と比較して、鍼治療の有効性はいかなるものか。

 What is the place of acupuncture in the treatment of various conditions for which sufficient data are available, in comparison or in combination with other interventions (including no intervention)?

他の創案(治療法・それがない状況も含む)との比較や組み合わせにおいて、十分なデータが利用できる色々なコンディションの治療において、鍼治療の位置づけはどの様なものであるか。

 What is known about the biological effects of acupuncture that helps us understand how it works? 

鍼治療の作用機序を理解する上で、我々の助けとなる生物学的効果について何が知られているか。

 What issues need to be addressed so that acupuncture can be appropriately incorporated into today’s health care system?

今日の健康管理システムに鍼治療が適切に組み込まれるためにはどの様な問題に焦点を当てなければならないのか。

 What are the directions for future research? 

将来の研究の方向性はどのようにすべきか。

1. What Is the Efficacy of Acupuncture, Compared With Placebo or Sham Acupuncture, in the Conditions for Which Sufficient Data Are Available to Evaluate?

十分なデータが評価に値する状況において、プラセボや偽の鍼治療と比較して、鍼治療の有効性はいかなるものか。

 Acupuncture is a complex intervention that may vary for different patients with similar chief complaints.  The number and length of treatments and the specific points used may vary among individuals and during the course of treatment. Given this reality, it is perhaps encouraging that there exist a number of studies of sufficient quality to assess the efficacy of acupuncture for certain conditions.

鍼治療は、よく似た主訴を持っていても異なる患者に対して変化する、複雑な治療法(*注1)である。また、鍼の数や長さ、そして使用される明確な経穴は、人によって、及び治療期間中に変化しうる。この現実を前にして、ある一定のコンディションに対する鍼治療の有効性を評価するために、沢山の良質の研究が存在している事は、おそらく励みになろう。(*注2) 
(*注1)intervention・1、介在、仲裁、調停(in)・2、(内政)干渉、介入。であるが、体への干渉、介入と言う意味で、治療法と意訳した。(変?) 
(*注2)Given the realityという分詞構文の主語は何?また、後に続く文はit~that構文だとしたら、他動詞であるencourageの目的語はどこへ行った?という疑問より、少し変な訳かもしれません。

 According to contemporary research standards, there is a paucity of high-quality research assessing efficacy of acupuncture compared with placebo or sham acupuncture. The vast majority of papers studying acupuncture in the biomedical literature consist of case reports, case series, or intervention studies with designs inadequate to assess efficacy. 

現代の研究基準によると、プラセボや疑似鍼治療と比較して、鍼治療の有効性を評価している高い質を持った研究は不足している。生物医学的文献において、鍼治療を研究している論文の大多数は、症例報告、症例の一続き、または有効性を評価するには不適切な計画でなされた治療研究で成り立っている。

 This discussion of efficacy refers to needle acupuncture (manual or electroacupuncture) because the published research is primarily on needle acupuncture and often does not encompass the full breadth of acupuncture techniques and practices. The controlled trials usually have involved only adults and did not involve long-term (i.e., years) acupuncture treatment. 

 Efficacy of a treatment assesses the differential effect of a treatment when compared with placebo or another treatment modality using a double-blind controlled trial and a rigidly defined protocol. Papers should describe enrollment procedures, eligibility criteria, description of the clinical characteristics of the subjects, methods for diagnosis, and a description of the protocol (i.e., randomization method, specific definition of treatment, and control conditions, including length of treatment and number of acupuncture sessions). Optimal trials should also use standardized outcomes and appropriate statistical analyses. This assessment of efficacy focuses on high-quality trials comparing acupuncture with sham acupuncture or placebo. 

Response Rate.

 As with other types of interventions, some individuals are poor responders to specific acupuncture protocols. Both animal and human laboratory and clinical experience suggest that the majority of subjects respond to acupuncture, with a minority not responding. Some of the clinical research outcomes, however, suggest that a larger percentage may not respond. The reason for this paradox is unclear and may reflect the current state of the research. 

Efficacy for Specific Disorders. 

 There is clear evidence that needle acupuncture is efficacious for adult postoperative and chemotherapy nausea and vomiting and probably for the nausea of pregnancy. 

 Much of the research is on various pain problems. There is evidence of efficacy for postoperative dental pain. There are reasonable studies (although sometimes only single studies) showing relief of pain with acupuncture on diverse pain conditions such as menstrual cramps, tennis elbow, and fibromyalgia. This suggests that acupuncture may have a more general effect on pain. However, there are also studies that do not find efficacy for acupuncture in pain. 

 There is evidence that acupuncture does not demonstrate efficacy for cessation of smoking and may not be efficacious for some other conditions.

 Although many other conditions have received some attention in the literature and, in fact, the research suggests some exciting potential areas for the use of acupuncture, the quality or quantity of the research evidence is not sufficient to provide firm evidence of efficacy at this time. 

Sham Acupuncture. 

 A commonly used control group is sham acupuncture, using techniques that are not intended to stimulate known acupuncture points. However, there is disagreement on correct needle placement. Also, particularly in the studies on pain, sham acupuncture often seems to have either intermediate effects between the placebo and ‘real’ acupuncture points or effects similar to those of the ‘real’ acupuncture points. Placement of a needle in any position elicits a biological response that complicates the interpretation of studies involving sham acupuncture. Thus, there is substantial controversy over the use of sham acupuncture in control groups. This may be less of a problem in studies not involving pain.

2. What Is the Place of Acupuncture in the Treatment of Various Conditions for Which Sufficient Data Are Available, in Comparison or in Combination With Other Interventions (Including No Intervention)? 

 Assessing the usefulness of a medical intervention in practice differs from assessing formal efficacy. In conventional practice, clinicians make decisions based on the characteristics of the patient, clinical experience, potential for harm, and information from colleagues and the medical literature. In addition, when more than one treatment is possible, the clinician may make the choice taking into account the patient’s preferences. While it is often thought that there is substantial research evidence to support conventional medical practices, this is frequently not the case. This does not mean that these treatments are ineffective. The data in support of acupuncture are as strong as those for many accepted Western medical therapies. 

 One of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted medical procedures used for the same conditions. As an example, musculoskeletal conditions, such as fibromyalgia, myofascial pain, and tennis elbow, or epicondylitis, are conditions for which acupuncture may be beneficial. These painful conditions are often treated with, among other things, anti-inflammatory medications (aspirin, ibuprofen, etc.) or with steroid injections. Both medical interventions have a potential for deleterious side effects but are still widely used and are considered acceptable treatments. The evidence supporting these therapies is no better than that for acupuncture. 

 In addition, ample clinical experience, supported by some research data, suggests that acupuncture may be a reasonable option for a number of clinical conditions. Examples are postoperative pain and myofascial and low back pain. Examples of disorders for which the research evidence is less convincing but for which there are some positive clinical trials include addiction, stroke rehabilitation, carpal tunnel syndrome, osteoarthritis, and headache. Acupuncture treatment for many conditions such as asthma or addiction should be part of a comprehensive management program. 

Many other conditions have been treated by acupuncture; the World Health Organization, for example, has listed more than 40 for which the technique may be indicated. 

3. What Is Known About the Biological Effects of Acupuncture That Helps Us Understand How It Works? 

   Many studies in animals and humans have demonstrated that acupuncture can cause multiple biological responses. These responses can occur locally, i.e., at or close to the site of application, or at a distance, mediated mainly by sensory neurons to many structures within the central nervous system. This can lead to activation of pathways affecting various physiological systems in the brain as well as in the periphery. A focus of attention has been the role of endogenous opioids in acupuncture analgesia. Considerable evidence supports the claim that opioid peptides are released during acupuncture and that the analgesic effects of acupuncture are at least partially explained by their actions. That opioid antagonists such as naloxone reverse the analgesic effects of acupuncture further strengthens this hypothesis. Stimulation by acupuncture may also activate the hypothalamus and the pituitary gland, resulting in a broad spectrum of systemic effects. Alteration in the secretion of neurotransmitters and neurohormones and changes in the regulation of blood flow, both centrally and peripherally, have been documented. There is also evidence of alterations in immune functions produced by acupuncture. Which of these and other physiological changes mediate clinical effects is at present unclear. 

   Despite considerable efforts to understand the anatomy and physiology of the “acupuncture points,” the definition and characterization of these points remain controversial. Even more elusive is the scientific basis of some of the key traditional Eastern medical concepts such as the circulation of Qi, the meridian system, and other related theories, which are difficult to reconcile with contemporary biomedical information but continue to play an important role in the evaluation of patients and the formulation of treatment in acupuncture. 

   Some of the biological effects of acupuncture have also been observed when “sham” acupuncture points are stimulated, highlighting the importance of defining appropriate control groups in assessing biological changes purported to be due to acupuncture. Such findings raise questions regarding the specificity of these biological changes. In addition, similar biological alterations, including the release of endogenous opioids and changes in blood pressure, have been observed after painful stimuli, vigorous exercise, and/or relaxation training; it is at present unclear to what extent acupuncture shares similar biological mechanisms. 

   It should be noted also that for any therapeutic intervention, including acupuncture, the so-called “non-specific” effects account for a substantial proportion of its effectiveness and thus should not be casually discounted. Many factors may profoundly determine therapeutic outcome, including the quality of the relationship between the clinician and the patient, the degree of trust, the expectations of the patient, the compatibility of the backgrounds and belief systems of the clinician and the patient, as well as a myriad of factors that together define the therapeutic milieu. 

   Although much remains unknown regarding the mechanism(s) that might mediate the therapeutic effect of acupuncture, the panel is encouraged that a number of significant acupuncture-related biological changes can be identified and carefully delineated. Further research in this direction not only is important for elucidating the phenomena associated with acupuncture, but also has the potential for exploring new pathways in human physiology not previously examined in a systematic manner. 

4. What Issues Need To Be Addressed So That Acupuncture Can Be Appropriately Incorporated Into Today’s Health Care System? 

    The integration of acupuncture into today’s health care system will be facilitated by a better understanding among providers of the language and practices of both the Eastern and Western health care communities. Acupuncture focuses on a holistic, energy-based approach to the patient rather than a disease-oriented diagnostic and treatment model. 

    An important factor for the integration of acupuncture into the health care system is the training and credentialing of acupuncture practitioners by the appropriate State agencies. This is necessary to allow the public and other health practitioners to identify qualified acupuncture practitioners. The acupuncture educational community has made substantial progress in this area and is encouraged to continue along this path. Educational standards have been established for training of physician and non-physician acupuncturists. Many acupuncture educational programs are accredited by an agency that is recognized by the U.S. Department of Education. A national credentialing agency exists for nonphysician practitioners and provides examinations for entry-level competency in the field. A nationally recognized examination for physician acupuncturists has been established. 

   A majority of States provide licensure or registration for acupuncture practitioners. Because some acupuncture practitioners have limited English proficiency, credentialing and licensing examinations should be provided in languages other than English where necessary. There is variation in the titles that are conferred through these processes, and the requirements to obtain licensure vary widely. The scope of practice allowed under these State requirements varies as well. While States have the individual prerogative to set standards for licensing professions, consistency in these areas will provide greater confidence in the qualifications of acupuncture practitioners. For example, not all States recognize the same credentialing examination, thus making reciprocity difficult. 

   The occurrence of adverse events in the practice of acupuncture has been documented to be extremely low. However, these events have occurred on rare occasions, some of which are life-threatening (e.g., 
 pneumothorax). Therefore, appropriate safeguards for the protection of patients and consumers need to be in place. Patients should be fully informed of their treatment options, expected prognosis, relative risk, and safety practices to minimize these risks before their receipt of acupuncture. This information must be provided in a manner that is linguistically and culturally appropriate to the patient. Use of acupuncture needles should always follow FDA regulations, including use of sterile, single-use needles. It is noted that these practices are already being done by many acupuncture practitioners; however, these practices should be uniform. Recourse for patient grievance and professional censure are provided through credentialing and licensing procedures and are available through appropriate State jurisdictions. 

   It has been reported that more than 1 million Americans currently receive acupuncture each year. Continued access to qualified acupuncture professionals for appropriate conditions should be ensured. Because many individuals seek health care treatment from both acupuncturists and physicians, communication between these providers should be strengthened and improved. If a patient is under the care of an acupuncturist and a physician, both practitioners should be informed. Care should be taken to ensure that important medical problems are not overlooked. Patients and providers have a  responsibility to facilitate this communication. 

   There is evidence that some patients have limited access to acupuncture services because of inability to pay. Insurance companies can decrease or remove financial barriers to access depending on their willingness to provide coverage for appropriate acupuncture services. An increasing number of insurance companies are either considering this possibility or now provide coverage for acupuncture services. Where there are State health insurance plans, and for populations served by Medicare or Medicaid, expansion of coverage to include appropriate acupuncture services would also help remove financial barriers to access. 

   As acupuncture is incorporated into today’s health care system, and further research clarifies the role of acupuncture for various health conditions, it is expected that dissemination of this information to health care practitioners, insurance providers, policymakers, and the general public will lead to more informed decisions in regard to the appropriate use of acupuncture. 
  
  
  

5. What Are the Directions for Future Research? 

   The incorporation of any new clinical intervention into accepted practice faces more scrutiny now than ever before. The demands of evidence-based medicine, outcomes research, managed care systems of health care delivery, and a plethora of therapeutic choices make the acceptance of new treatments an arduous process. The difficulties are accentuated when the treatment is based on theories unfamiliar to Western medicine and its practitioners. It is important, therefore, that the evaluation of acupuncture for the treatment of specific conditions be carried out carefully, using designs that can withstand rigorous scrutiny. In order to further the evaluation of the role of acupuncture in the management of various conditions, the following general areas for future research are suggested. 
    What Are the Demographics and Patterns of Use of Acupuncture in the United States and Other Countries? 

   There is currently limited information on basic questions such as who uses acupuncture, for what indications is acupuncture most commonly sought, what variations in experience and techniques used exist among acupuncture practitioners, and are there differences in these patterns by geography or ethnic group. Descriptive epidemiologic studies can provide insight into these and other questions. This information can in turn be used to guide future research and to identify areas of greatest public health concern. 

   Can the Efficacy of Acupuncture for Various Conditions for Which It Is Used or for Which It Shows Promise Be Demonstrated? 

   Relatively few high-quality, randomized, controlled trials have been published on the effects of acupuncture. Such studies should be designed in a rigorous manner to allow evaluation of the effectiveness   of acupuncture. Such studies should include experienced acupuncture practitioners to design and deliver appropriate interventions. Emphasis should be placed on studies that examine acupuncture as used in clinical practice and that respect the theoretical basis for acupuncture therapy. 

   Although randomized controlled trials provide a strong basis for inferring causality, other study designs such as those used in clinical epidemiology or outcomes research can also provide important insights regarding the usefulness of acupuncture for various conditions. There have been few such studies in the acupuncture literature. 

   Do Different Theoretical Bases for Acupuncture Result in Different Treatment Outcomes? 

    Competing theoretical orientations (e.g., Chinese, Japanese, French) currently exist that might predict divergent therapeutic approaches (i.e., the use of different acupuncture points). Research projects should be designed to assess the relative merit of these divergent approaches and to compare these systems with treatment programs using fixed acupuncture points. 

    In order to fully assess the efficacy of acupuncture, studies should be designed to examine not only fixed acupuncture points, but also the Eastern medical systems that provide the foundation for acupuncture therapy, including the choice of points. In addition to assessing the effect of acupuncture in context, this would also provide the opportunity to determine whether Eastern medical theories predict more effective acupuncture points. 

    What Areas of Public Policy Research Can Provide Guidance for the Integration of Acupuncture Into Today’s Health Care System? 

   The incorporation of acupuncture as a treatment raises numerous questions of public policy. These include issues of access, cost-effectiveness, reimbursement by State, Federal, and private payers, and training, licensure, and accreditation. These public policy issues must be founded on quality epidemiologic and demographic data and effectiveness research. 

    Can Further Insight Into the Biological Basis for Acupuncture Be Gained? 

   Mechanisms that provide a Western scientific explanation for some of the effects of acupuncture are beginning to emerge. This is encouraging and may provide novel insights into neural, endocrine, and other physiological processes. Research should be supported to provide a better understanding of the mechanisms involved, and such research may lead to improvements in treatment. 

   Does an Organized Energetic System That Has Clinical Applications Exist in the Human Body? 

   Although biochemical and physiologic studies have provided insight into some of the biologic effects of acupuncture, acupuncture practice is based on a very different model of energy balance. This theory might or might not provide new insights to medical research, but it deserves further attention because of its potential for elucidating the basis for acupuncture. 

    How Do the Approaches and Answers to These Questions Differ Among Populations That Have Used Acupuncture as a Part of Their Healing Tradition for Centuries, Compared With Populations That Have Only Recently Begun to Incorporate Acupuncture Into  Health Care? 
  
  

        Conclusions 

   Acupuncture as a therapeutic intervention is widely practiced in the United States. There have been many studies of its potential usefulness. However, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebo and sham acupuncture groups. 

   However, promising results have emerged, for example, efficacy of acupuncture in adult post-operative and chemotherapy nausea and vomiting and in postoperative dental pain. There are other situations such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma for which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. Further research is likely to uncover additional areas where acupuncture interventions will be useful. 

   Findings from basic research have begun to elucidate the mechanisms of action of acupuncture, including the release of opioids and other peptides in the central nervous system and the periphery and changes in neuroendocrine function. Although much needs to be accomplished, the emergence of plausible mechanisms for the therapeutic effects of acupuncture is encouraging. 

   The introduction of acupuncture into the choice of treatment modalities readily available to the public is in its early stages. Issues of training, licensure, and reimbursement remain to be clarified. There is sufficient evidence, however, of its potential value to conventional medicine to encourage further studies. 

   There is sufficient evidence of acupuncture’s value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value. 

        Consensus Development Panel 

        David J. Ramsay, D.M., D. Phil. 
        Panel and Conference Chairperson 
        President 
        University of Maryland, Baltimore 
        Baltimore, Maryland 

        Marjorie A. Bowman, M.D., M.P.A. 
        Professor and Chair 
        Department of Family Practice and Community Medicine 
        University of Pennsylvania Health System 
        Philadelphia, Pennsylvania 

        Philip E. Greenman, D.O., F.A.A.O. 
        Associate Dean 
        College of Osteopathic Medicine 
        Michigan State University 
        East Lansing, Michigan 

        Stephen P. Jiang, A.C.S.W. 
        Executive Director 
        Association of Asian Pacific Community Health Organizations 
        Oakland, California 

        Lawrence H. Kushi, Sc.D. 
        Associate Professor 
        Division of Epidemiology 
        University of Minnesota School of Public Health 
        Minneapolis, Minnesota 

        Susan Leeman, Ph.D. 
        Professor 
        Department of Pharmacology 
        Boston University School of Medicine 
        Boston, Massachusetts 

        Keh-Ming Lin, M.D., M.P.H. 
        Professor of Psychiatry, UCLA 
        Director, Research Center on the Psychobiology of Ethnicity 
        Harbor-UCLA Medical Center 
        Torrance, California 

        Daniel E. Moerman, Ph.D. 
        William E. Stirton Professor of Anthropology 
        University of Michigan, Dearborn 
        Ypsilanti, Michigan 

        Sidney H. Schnoll, M.D., Ph.D. 
        Chairman 
        Division of Substance Abuse Medicine 
        Professor of Internal Medicine and Psychiatry 
        Medical College of Virginia 
        Richmond, Virginia 

        Marcellus Walker, M.D. 
        Honesdale, Pennsylvania 

        Christine Waternaux, Ph.D. 
        Associate Professor and Chief 
        Biostatistics Division 
        Columbia University and New York State Psychiatric Institute 
        New York, New York 

        Leonard A. Wisneski, M.D., F.A.C.P. 
        Medical Director, Bethesda Center 
        American WholeHealth 
        Bethesda, Maryland 
  
  
  

        Speakers 

        Abass Alavi, M.D. 
        “The Role of Physiologic Imaging in the Investigation of the Effects of Pain and Acupuncture on Regional 
        Cerebral Function” 
        Professor of Radiology 
        Chief, Division of Nuclear Medicine 
        Hospital of the University of Pennsylvania 
        Philadelphia, Pennsylvania 

        Brian M. Berman, M.D. 
        “Overview of Clinical Trials on Acupuncture for Pain” 
        Associate Professor of Family Medicine 
        Director 
        Center for Complementary Medicine 
        University of Maryland School of Medicine 
        Baltimore, Maryland 

        Stephen Birch, Lic.Ac., Ph.D. 
        “Overview of the Efficacy of Acupuncture in the Treatment of Headache and Face and Neck Pain” 
        Anglo-Dutch Institute for Oriental Medicine 
        The Netherlands 

        Hannah V. Bradford, M.Ac. 
        “Late-Breaking Data and Other News From the Clinical Research Symposium (CRS) on Acupuncture at 
        NIH” 
        Acupuncturist 
        Society for Acupuncture Research 
        Bethesda, Maryland 

        Xiaoding Cao, M.D., Ph.D. 
        “Protective Effect of Acupuncture on Immunosuppression” 
        Professor and Director 
        Institute of Acupuncture Research 
        Shanghai Medical University 
        Shanghai, China 

        Daniel C. Cherkin, Ph.D. 
        “Efficacy of Acupuncture in Treating Low Back Pain: A Systematic Review of the Literature” 
        Senior Scientific Investigator 
        Group Health Center for Health Studies 
        Seattle, Washington 

        Patricia Culliton, M.A., L.Ac. 
        “Current Utilization of Acupuncture by United States Patients” 
        Director 
        Alternative Medicine Division 
        Hennepin County Medical Center 
        Minneapolis, Minnesota 

        David L. Diehl, M.D. 
        “Gastrointestinal Indications” 
        Assistant Professor of Medicine 
        UCLA Digestive Disease Center 
        University of California, Los Angeles 
        Los Angeles, California 

        Kevin V. Ergil, L.Ac. 
        “Acupuncture Licensure, Training, and Certification in the United States” 
        Dean 
        Pacific Institute of Oriental Medicine 
        New York, New York 

        Richard Hammerschlag, Ph.D. 
        “Methodological and Ethical Issues in Acupuncture Research” 
        Academic Dean and Research Director 
        Yo San University of Traditional Chinese Medicine 
        Santa Monica, California 

        Ji-Sheng Han, M.D. 
        “Acupuncture Activates Endogenous Systems of Analgesia” 
        Professor 
        Neuroscience Research Center 
        Beijing Medical University 
        Beijing, China 

        Joseph M. Helms, M.D. 
        “Acupuncture Around the World in Modern Medical Practice 
        Founding President 
        American Academy of Medical Acupuncture 
        Berkeley, California 

        Kim A. Jobst, D.M., M.R.C.P. 
        “Respiratory Indications” 
        University Department of Medicine and Therapeutics 
        Gardiner Institute 
        Glasgow, Scotland, United Kingdom 

        Gary Kaplan, D.O. 
        “Efficacy of Acupuncture in the Treatment of Osteoarthritis and Musculoskeletal Pain” 
        President 
        Medical Acupuncture Research Foundation 
        Arlington, Virginia 

        Ted J. Kaptchuk, O.M.D. 
        “Acupuncture: History, Context, and Long-Term Perspectives” 
        Associate Director 
        Center for Alternative Medicine Research 
        Beth Israel Deaconess Medical Center 
        Boston, Massachusetts 

        Janet Konefal, Ph.D., Ed.D., M.P.H., C.A. 
        “Acupuncture and Addictions” 
        Associate Professor 
        Acupuncture Research and Training Programs 
        Department of Psychiatry and Behavioral Sciences 
        University of Miami School of Medicine 
        Miami, Florida 

        Lixing Lao, Ph.D., L.Ac. 
        “Dental and Postoperative Pain” 
        Assistant Professor of Family Medicine 
        Department of Family and Complementary Medicine 
        University of Maryland School of Medicine 
        Baltimore, Maryland 

        C. David Lytle, Ph.D. 
        “Safety and Regulation of Acupuncture Needles and Other Devices” 
        Research Biophysicist 
        Center for Devices and Radiological Health 
        U.S. Food and Drug Administration 
        Rockville, Maryland 

        Margaret A. Naeser, Ph.D., Lic.Ac., Dipl. Ac. 
        “Neurological Rehabilitation: Acupuncture and Laser Acupuncture To Treat Paralysis in Stroke and Other 
        Paralytic Conditions and Pain in Carpal Tunnel Syndrome” 
        Research Professor of Neurology 
        Neuroimaging Section 
        Boston University Aphasia Research Center 
        Veterans Affairs Medical Center 
        Boston, Massachusetts 

        Lorenz K.Y. Ng, M.D. 
        “What Is Acupuncture?” 
        Clinical Professor of Neurology 
        George Washington University School of Medicine 
        Medical Director 
        Pain Management Program 
        National Rehabilitation Hospital 
        Bethesda, Maryland 

        Andrew Parfitt, Ph.D. 
        “Nausea and Vomiting” 
        Researcher 
        Laboratory of Developmental Neurobiology 
        National Institute of Child Health and Human Development 
        National Institutes of Health 
        Bethesda, Maryland 

        Bruce Pomeranz, M.D., Ph.D. 
        “Summary of Acupuncture and Pain” 
        Professor 
        Departments of Zoology and Physiology 
        University of Toronto 
        Toronto, Ontario, Canada 

        Judith C. Shlay, M.D. 
        “Neuropathic Pain” 
        Assistant Professor in Family Medicine 
        Denver Public Health 
        Denver, Colorado 

        Alan I. Trachtenberg, M.D., M.P.H. 
        “American Acupuncture: Primary Care, Public Health, and Policy” 
        Medical Officer 
        Office of Science Policy and Communication 
        National Institute on Drug Abuse 
        National Institutes of Health 
        Rockville, Maryland 

        Jin Yu, M.D. 
        “Induction of Ovulation With Acupuncture” 
        Professor of Obstetrics and Gynecology 
        Obstetrical and Gynecological Hospital 
        Shanghai Medical University 
        Shanghai, China 
  
  
  

        Planning Committee 

        Alan I. Trachtenberg, M.D., M.P.H. 
        Planning Committee Chairperson 
        Medical Officer 
        Office of Science Policy and Communication 
        National Institute on Drug Abuse 
        National Institutes of Health 
        Rockville, Maryland 

        Brian M. Berman, M.D. 
        Associate Professor of Family Medicine 
        Director 
        Center for Complementary Medicine 
        University of Maryland School of Medicine 
        Baltimore, Maryland 

        Hannah V. Bradford, M.Ac. 
        Acupuncturist 
        Society for Acupuncture Research 
        Bethesda, Maryland 

        Elsa Bray 
        Program Analyst 
        Office of Medical Applications of Research 
        National Institutes of Health 
        Bethesda, Maryland 

        Patricia Bryant, Ph.D. 
        Director 
        Behavior, Pain, Oral Function, and Epidemiology Program 
        Division of Extramural Research 
        National Institute of Dental Research 
        National Institutes of Health 
        Bethesda, Maryland 

        Claire M. Cassidy, Ph.D. 
        Director 
        Paradigms Found Consulting 
        Bethesda, Maryland 

        Jerry Cott, Ph.D. 
        Head 
        Pharmacology Treatment Program 
        National Institute of Mental Health 
        National Institutes of Health 
        Rockville, Maryland 

        George W. Counts, M.D. 
        Director 
        Office of Research on Minority and Women’s Health 
        National Institute of Allergy and Infectious Diseases 
        National Institutes of Health 
        Bethesda, Maryland 

        Patricia D. Culliton, M.A., L.Ac. 
        Director 
        Alternative Medicine Division 
        Hennepin County Medical Center 
        Minneapolis, Minnesota 

        Jerry M. Elliott 
        Program Management and Analysis Officer 
        Office of Medical Applications of Research 
        National Institutes of Health 
        Bethesda, Maryland 

        John H. Ferguson, M.D. 
        Director 
        Office of Medical Applications of Research 
        National Institutes of Health 
        Bethesda, Maryland 

        Anita Greene, M.A. 
        Public Affairs Program Officer 
        Office of Alternative Medicine 
        National Institutes of Health 
        Bethesda, Maryland 

        Debra S. Grossman, M.A. 
        Program Officer 
        Treatment Research Branch 
        Division of Clinical and Services Research 
        National Institute on Drug Abuse 
        National Institutes of Health 
        Rockville, Maryland 

        William H. Hall 
        Director of Communications 
        Office of Medical Applications of Research 
        National Institutes of Health 
        Bethesda, Maryland 

        Richard Hammerschlag, Ph.D. 
        Academic Dean and Research Director 
        Yo San University of Traditional Chinese Medicine 
        Santa Monica, California 

        Freddie Ann Hoffman, M.D. 
        Deputy Director, Medicine Staff 
        Office of Health Affairs 
        U.S. Food and Drug Administration 
        Rockville, Maryland 

        Wayne B. Jonas, M.D. 
        Director 
        Office of Alternative Medicine 
        National Institutes of Health 
        Bethesda, Maryland 

        Gary Kaplan, D.O. 
        President 
        Medical Acupuncture Research Foundation 
        Arlington, Virginia 

        Carol Kari, R.N., L.Ac., M.Ac. 
        President 
        Maryland Acupuncture Society 
        Member, National Alliance 
        Kensington, Maryland 

        Charlotte R. Kerr, R.N., M.P.H., M.Ac. 
        Practitioner of Traditional Acupuncture 
        The Center for Traditional Acupuncture 
        Columbia, Maryland 

        Thomas J. Kiresuk, Ph.D. 
        Director 
        Center for Addiction and Alternative Medicine Research 
        Minneapolis, Minnesota 

        Cheryl Kitt, Ph.D. 
        Program Officer 
        Division of Convulsive, Infectious, and Immune Disorders 
        National Institute of Neurological Disorders and Stroke 
        National Institutes of Health 
        Bethesda, Maryland 

        Janet Konefal, Ph.D., M.P.H., L.Ac. 
        Associate Professor 
        Acupuncture Research and Training Programs 
        Department of Psychiatry and Behavioral Sciences 
        University of Miami School of Medicine 
        Miami, Florida 

        Sung J. Liao, M.D., D.P.H. 
        Clinical Professor of Surgical Sciences 
        Department of Oral and Maxillofacial Surgery 
        New York University College of Dentistry 
        Consultant 
        Rust Institute of Rehabilitation Medicine 
        New York University College of Medicine 
        Middlebury, Connecticut 

        Michael C. Lin, Ph.D. 
        Health Scientist Administrator 
        Division of Heart and Vascular Diseases 
        National Heart, Lung, and Blood Institute 
        National Institutes of Health 
        Bethesda, Maryland 

        C. David Lytle, Ph.D. 
        Research Biophysicist 
        Center for Devices and Radiological Health 
        U.S. Food and Drug Administration 
        Rockville, Maryland 

        James D. Moran, Lic.Ac., D.Ac., C.A.A.P., C.A.S. 
        President Emeritus and Doctor of Acupuncture 
        American Association of Oriental Medicine 
        The Belchertown Wellness Center 
        Belchertown, Massachusetts 

        Richard L. Nahin, Ph.D. 
        Program Officer, Extramural Affairs 
        Office of Alternative Medicine 
        National Institutes of Health 
        Bethesda, Maryland 

        Lorenz K.Y. Ng, M.D., R.Ac. 
        Clinical Professor of Neurology 
        George Washington University School of Medicine 
        Medical Director 
        Pain Management Program 
        National Rehabilitation Hospital 
        Bethesda, Maryland 

        James Panagis, M.D. 
        Director, Orthopaedics Program 
        Musculoskeletal Branch 
        National Institute of Arthritis and Musculoskeletal and Skin Diseases 
        National Institutes of Health 
        Bethesda, Maryland 

        David J. Ramsay, D.M., D.Phil. 
        Panel and Conference Chairperson 
        President 
        University of Maryland, Baltimore 
        Baltimore, Maryland 

        Charles R. Sherman, Ph.D. 
        Deputy Director 
        Office of Medical Applications of Research 
        National Institutes of Health 
        Bethesda, Maryland 

        Virginia Taggart, M.P.H. 
        Health Scientist Administrator 
        Division of Lung Diseases 
        National Heart, Lung, and Blood Institute 
        National Institutes of Health 
        Bethesda, Maryland 

        Xiao-Ming Tian, M.D., R.Ac. 
        Clinical Consultant on Acupuncture for the National Institutes of Health 
        Director 
        Academy of Acupuncture and Chinese Medicine 
        Bethesda, Maryland 

        Claudette Varricchio, D.S.N. 
        Program Director 
        Division of Cancer Prevention and Control 
        National Cancer Institute 
        National Institutes of Health 
        Rockville, Maryland 
  
  
  

        Lead Organizations 

        Office of Alternative Medicine 
        Wayne B. Jonas, M.D. 
        Director 

        Office of Medical Applications of Research 
        John H. Ferguson, M.D. 
        Director 
  
  
  

        Supporting Organizations 

        National Cancer Institute 
        Richard D. Klausner, M.D. 
        Director 

        National Heart, Lung, and Blood Institute 
        Claude Lenfant, M.D. 
        Director 

        National Institute of Allergy and Infectious Diseases 
        Anthony S. Fauci, M.D. 
        Director 

        National Institute of Arthritis and Musculoskeletal and Skin Diseases 
        Stephen I. Katz, M.D., Ph.D. 
        Director 

        National Institute of Dental Research 
        Harold C. Slavkin, D.D.S. 
        Director 

        National Institute on Drug Abuse 
        Alan I. Leshner, Ph.D. 
        Director 

        Office of Research on Women’s Health 
        Vivian W. Pinn, M.D. 
        Director 
  
  
  

        Bibliography 

        The speakers listed above identified the following key references in developing their presentations for the 
        consensus conference. A more complete bibliography prepared by the National Library of Medicine at NIH, 
        along with the references below, was provided to the consensus panel for its consideration. The full NLM 
        bibliography is available at the following Web site: http://www.nlm.nih.gov/pubs/cbm/acupuncture.html. 

        Addictions 

        Bullock MD, Umen AJ, Culliton PD, Olander RT. 
               Acupuncture treatment of alcoholic recidivism: a pilot study. Clin Exp Res 1987 ;11:292-5. 

        Bullock ML, Culliton PD, Olander RT. 
               Controlled trial of acupuncture for severe recidivist alcoholism. Lancet 1989 ;1:1435-9. 

        Clavel-Chapelon F, Paoletti C, Banhamou S. 
               Smoking cessation rates 4 years after treatment by nicotine gum and acupuncture. Prev Med 1997 
               Jan-Feb;26(1):25-8. 

        He D, Berg JE, Hostmark AT. 
               Effects of acupuncture on smoking cessation or reduction for motivated smokers. Prev Med 1997 
               ;26(2): 208-14. 

        Konefal J, Duncan R, Clemence C. 
               Comparison of three levels of auricular acupuncture in an outpatient substance abuse treatment 
               program. Altern Med J 1995 ;2(5):8-17. 

        Margolin A, Avants SK, Chang P, Kosten TR. 
               Acupuncture for the treatment of cocaine dependence in methadone-maintained patients. Am J 
               Addict 1993 ;2:194-201. 

        White AR, Rampes H. 
               Acupuncture in smoking cessation. In: Cochrane Database of Systematic Reviews [database on 
               CDROM]. Oxford: Update Software; 1997 [updated 1996 Nov 24]. [9p.]. (The Cochrane Library; 
               1997 no. 2). 

        Gastroenterology 

        Cahn AM, Carayon P, Hill C, Flamant R. 
               Acupuncture in gastroscopy. Lancet 1978 ;1(8057):182-3. 

        Chang FY, Chey WY, Ouyang A. 
               Effect of transcutaneous nerve stimulation on esophageal function in normal subjects–evidence for 
               a somatovisceral reflex. Amer J Chinese Med 1996 ;24(2):185-92. 

        Jin HO, Zhou L, Lee KY, Chang TM, Chey WY. 
               Inhibition of acid secretion by electrical acupuncture is mediated via J-endorphin and somatostatin. 
               Am J Physiol 1996 ;271(34):G524-G530. 

        Li Y, Tougas G, Chiverton SG, Hunt RH. 
               The effect of acupuncture on gastrointestinal function and disorders. Am J Gastroenterol 1992 
               ;87(10):1372-81. 

        General Pain 

        Chen XH, Han JS. 
               All three types of opioid receptors in the spinal cord are important for 2/15 Hz electroacupuncture 
               analgesia. Eur J Pharmacol 1992 ;211:203-10. 

        Patel M, Gutzwiller F, et al. 
               A meta-analysis of acupuncture for chronic pain. Int J Epidemiol 1989 ;18:900-6. 

        Portnoy RK. 
               Drug therapy for neuropathic pain. Drug Ther 1993 ; 23:41-5. 

        Shlay JC et al. 
               The efficacy of a standardized acupuncture regimen compared to placebo as a treatment of pain 
               caused by peripheral neuropathy in HIV-infected patients. CPCRA protocol 022. 1994. 

        Tang NM, Dong HW, Wang XM, Tsui ZC, Han JS. 
               Cholecystokinin antisense RNA increases the analgesic effect induced by EA or low dose 
               morphine: conversion of low responder rats into high responders. Pain 1997 ;71:71-80. 

        Ter Riet G, Kleijnen J, Knipschild P. 
               Acupuncture and chronic pain: a criteria based meta-analysis. J Clin Epidemiol 1990 ; 43:1191-9. 

        Zhu CB, Li XY, Zhu YH, Xu SF. 
               Binding sites of mu receptor increased when acupuncture analgesia was enhanced by droperidol: an 
               autoradiographic study. Acta Pharmacologica Sinica 1995 ;16(4):289-384. 

        History and Reviews 

        Helms JM. 
               Acupuncture energetics: a clinical approach for physicians. Berkeley (CA): Medical Acupuncture 
               Publishers; 1996. 

        Hoizey D, Hoizey MJ. 
               A history of Chinese medicine. Edinburgh: Edinburgh University Press; 1988. 

        Kaptchuk TJ. 
               The web that has no weaver: understanding Chinese medicine. New York: Congdon & Weed; 
               1983. 

        Lao L. 
               Acupuncture techniques and devices. J Altern Compl Med 1996a;2(1):23-5. 

        Liao SJ, Lee MHM, Ng NKY. 
               Principles and practice of contemporary acupuncture. New York: Marcel Dekker, Inc.; 1994. 

        Lu GD, Needham J. 
               Celestial lancets. A history and rationale of acupuncture and moxa. Cambridge University Press; 
               1980. 

        Lytle CD. 
               An overview of acupuncture. Center for Devices and Radiological Health, FDA, PHS, DHHS; 
               May 1993. 

        Mitchell BB. 
               Acupuncture and oriental medicine laws. Washington: National Acupuncture Foundation; 1997. 

        Porkert M. 
               The theoretical foundations of Chinese medicine. Cambridge (MA): MIT Press; 1974. 

        Stux G, Pomerantz B. 
               Basics of Acupuncture. Berlin: Springer Verlag; 1995. p. 1-250. 

        Unschuld PU. 
               Medicine in China: a history of ideas. Berkeley: University of California Press; 1985. 

        Immunology 

        Cheng XD, Wu GC, Jiang JW, Du LN, Cao XD. 
               Dynamic observation on regulation of spleen lymphocyte proliferation from the traumatized rats in 
               vitro of continued electroacupuncture. Chinese Journal of Immunology 1997 ;13:68-70. 

        Du LN, Jiang JW, Wu GC, Cao XD. 
               Effect of orphanin FQ on the immune function of traumatic rats. Chinese Journal of Immunology. 
               In press. 

        Zhang Y, Du LN, Wu GC, Cao XD. 
               Electroacupuncture (EA) induced attenuation of immunosuppression appearing after epidural or 
               intrathecal injection of morphine in patients and rats. Acupunct Electrother Res Int J 1996 ; 
               21:177-86. 

        Miscellaneous 

               Medical devices; Reclassification of acupuncture needles for the practice of acupuncture. Federal 
               Register 1996 ;61(236):64616-7. 

               NIH Technology Assessment Workshop on Alternative Medicine; Acupuncture. J Alt 
               Complement Med 1996 ;2(1). 

        Bullock ML, Pheley AM, Kiresuk TJ, Lenz SK, Culliton PD. 
               Characteristics and complaints of patients seeking therapy at a hospital-based alternative medicine 
               clinic. J Altern Compl Med 1997 ;3(1):31-7. 

        Cassidy C. 
               A survey of six acupuncture clinics: demographic and satisfaction data. Proceedings of the Third 
               Symposium of the Society for Acupuncture Research. Georgetown University Medical Center. 
               1995 September 16-17:1-27. 

        Diehl DL, Kaplan G, Coulter I, Glik D, Hurwitz EL. 
               Use of acupuncture by American physicians. J Altn Compl Med 1997 ;3(2):119-26. 

        Musculoskeletal 

        Naeser MA, Hahn KK, Lieberman B. 
               Real vs sham laser acupuncture and microamps TENS to treat carpal tunnel syndrome and worksite 
               wrist pain: pilot study. Lasers in Surgery and Medicine 1996 ;Suppl 8:7. 

        Nausea, Vomiting, and Postoperative Pain 

        Christensen PA, Noreng M, Andersen PE, Nielsen JW. 
               Electroacupuncture and postoperative pain. Br J Anaesth 1989 ;62:258-62. 

        Dundee JW, Chestnutt WN, Ghaly RG, Lynas AG. 
               Traditional Chinese acupuncture: a potentially useful antiemetic? Br Med J (Clin Res) 1986 
               ;293(6547):583-4. 

        Dundee JW, Ghaly G. 
               Local anesthesia blocks the antiemetic action of P6. Clinical Pharmacology & Therapeutics 1991 
               ;50(1): 78-80. 

        Dundee JW, Ghaly RG, Bill KM, Chestnutt WN, Fitzpatrick KT, Lynas AG. 
               Effect of stimulation of the P6 antiemetic point on postoperative nausea and vomiting. Br J 
               Anaesth 1989 ;63(5):612-18. 

        Dundee JW, Ghaly RG, Lynch GA, Fitzpatrick KT, Abram WP. 
               Acupuncture prophylaxis of cancer chemotherapy-induced sickness. J R Soc Med 1989 
               ;82(5):268-71. 

        Dundee JW, McMillan C. 
              Positive evidence for P6 acupuncture antiemesis. Postgrad Med J 1991 ;67(787):47-52. 

        Lao L, Bergman S, Langenberg P, Wong RH, Berman B. 
               Efficacy of Chinese acupuncture on postoperative oral surgery pain. Oral Surg Med Oral Pathol 
               1995 ;79(4):423-8. 

        Martelete M, Fiori AMC. 
               Comparative study of analgesic effect of transcutaneous nerve stimulation (TNS), 
               electroacupuncture (EA), and meperidine in the treatment of postoperative pain. Acupunct 
               Electrother Res 1985 ;10(3):183-93. 

        Sung YF, Kutner MH, Cerine FC, Frederickson EL. 
               Comparison of the effects of acupuncture and codeine on postoperative dental pain. Anesth Analg 
               1977 ;56(4):473-8. 

        Neurology 

        Asagai Y, Kanai H, Miura Y, Ohshiro T. 
               Application of low reactive-level laser therapy (LLLT) in the functional training of cerebral palsy 
               patients. Laser Therapy 1994 ;6:195-202. 

        Han JS, Wang Q. 
               Mobilization of specific neuropeptides by peripheral stimulation of identified frequencies. News 
               Physiol Sci 1992:176-80. 

        Han JS, Chen XH, Sun SL, Xu XJ, Yuan Y, Yan SC, et al. 
               Effect of low- and high-frequency TENS on met-enkephalin-Arg-Phe and dynorphin A 
               immunoreactivity in human lumbar CSF. Pain 1991 ;47:295-8. 

        Johansson K, Lindgren I, Widner H, Wiklung I, Johansson BB. 
               Can sensory stimulation improve the functional outcome in stroke patients? Neurology 1993 
               ;43:2189-92. 

        Naeser MA. 
               Acupuncture in the treatment of paralysis due to central nervous system damage. J Alt Comple 
               Med 1996 ;2(1):211-48. 

        Simpson DM, Wolfe DE. 
               Neuromuscular complications of HIV infection and its treatment. AIDS 1991 ;5:917-26. 

        Reproductive Medicine 

        Yang QY, Ping SM, Yu J. 
               Central opioid and dopamine activities in PCOS during induction of ovulation with 
               electro-acupuncture. J Reprod Med (in Chinese)1992 ; 1(1):6-19. 

        Yang SP, He LF, Yu J. 
               Changes in densities of hypothalamic m opioid receptor during cupric acetate induced preovulatory 
               LH surge in rabbit. Acta Physiol Sinica (in Chinese)1997 ;49(3):354-8. 

        Yang SP, Yu J, He LF. 
               Release of GnRH from the MBH induced by electroacupuncture in conscious female rabbits. 
               Acupunct Electrother Res 1994 ;19:9-27. 

        Yu J, Zheng HM, Ping SM. 
               Changes in serum FSH, LH and ovarian follicular growth during electroacupuncture for induction 
               of ovulation. Chin J Integrated Tradit Western Med 1995 ; 1(1):13-6. 

        Research Methods 

        Birch S, Hammerschlag R. 
               Acupuncture efficacy: a compendium of controlled clinical trials. Tarrytown (NY): Nat Acad Acu & 
               Oriental Med; 1996. 

        Hammerschlag R, Morris MM. 
               Clinical trials comparing acupuncture to biomedical standard care: a criteria-based evaluation. 
               Compl Ther Med. In press 1997. 

        Kaptchuk TJ. 
               Intentional ignorance: a history of blind assessment in medicine. Bull Hist Med. In press 1998. 

        Singh BB, Berman BM. 
               Research issues for clinical designs. Compl Therap Med 1997 ;5:3-7. 

        Vincent CA. 
               Credibility assessment in trials of acupuncture. Compl Med Res 1990 ;4:8-11. 

        Vincent CA, Lewith G. 
               Placebo controls for acupuncture studies. J Roy Soc Med 1995 ;88:199-202. 

        Vincent CA, Richardson PH. 
               The evaluation of therapeutic acupuncture: concepts and methods. Pain 1986 ;24:1-13. 

        Side Effects 

        Lao L. 
               Safety issues in acupuncture. J Altern Comp Med 1996 ;2:27-31. 

        Norheim AJ, F?nneb? V. 
               Acupuncture adverse effects are more than occasional case reports: results from questionnaires 
               among 1135 randomly selected doctors and 197 acupuncturists. Compl Therap Med 1996 ;4:8-13.

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