ACUPUNCTURE: REVIEW AND ANALYSIS OF REPORTS ON CONTROLLED CLINICAL TRIALS
ACUPUNCTURE: REVIEW AND ANALYSIS OF REPORTS ON CONTROLLED CLINICAL TRIALS
ii
Acknowledgements Acknowledgements The World Health Organization acknowledges its indebtedness to the experts who participated in the WHO Consultation on Acupuncture held in Cervia, Italy in 1996, at which the selection criteria for the data included in this publication were set. Special thanks are due to Dr Zhu-Fan Xie, Honorary Director of the Institute of Integrated Medicines, First Hospital of Beijing Medical University, China, who drafted, revised and updated this report. Further, Dr Xie made numerous Chinese language documents available in English. We also thank Dr Hongguang Dong, Geneva University Hospital, Switzerland for providing Appreciation is extended to the Norwegian Royal Ministry of Health and Social Affairs for providing the financial support to print this review
Acknowledgements Acknowledgements The World Health Organization acknowledges its indebtedness to the experts who participated in the WHO Consultation on Acupuncture held in Cervia, Italy in 1996, at which the selection criteria for the data included in this publication were set. Special thanks are due to Dr Zhu-Fan Xie, Honorary Director of the Institute of Integrated Medicines, First Hospital of Beijing Medical University, China, who drafted, revised and updated this report. Further, Dr Xie made numerous Chinese language documents available in English. We also thank Dr Hongguang Dong, Geneva University Hospital, Switzerland for providing additional information. Appreciation is extended to the Norwegian Royal Ministry of Health and Social Affairs for providing the financial support to print this review. iii
iv
Contents Contents Acknowledgements Introduction Background Use of the publication 1. General considerations 1.1 Definition 1.2 Need for evaluation 1.3 Evaluation methodology 1.5 Availability and practicability 1.6 Studies on therapeutic mechanisms 6 1.7 Selection of clinical trial reports 2. Review of clinical trial report 2.1 Pair 9 Head and face 9 Biliary and renal colic Traumatic or postoperative pain... Dentistry 2.2 Infections 2.3 Neurological disorders 12 2.4R 2.5 Digestive disorders 14 2. 6 Blood disorders 15 2.7 Urogenital disorders 2.8 Gynaecological and obstetric disorders
Contents Contents Acknowledgements ...............................................................................................iii Contents ........................................................................................................... v Introduction............................................................................................................ 1 Background........................................................................................................ 1 Objectives .......................................................................................................... 2 Use of the publication ........................................................................................ 2 1. General considerations .................................................................................. 3 1.1 Definition.................................................................................................. 3 1.2 Need for evaluation ................................................................................. 3 1.3 Evaluation methodology .......................................................................... 3 1.4 Safety ...................................................................................................... 5 1.5 Availability and practicability.................................................................... 5 1.6 Studies on therapeutic mechanisms........................................................ 6 1.7 Selection of clinical trial reports ............................................................... 7 2. Review of clinical trial reports............................................................................ 9 2.1 Pain ......................................................................................................... 9 Head and face.................................................................................................... 9 Locomotor system.............................................................................................. 9 Gout.................................................................................................................. 10 Biliary and renal colic ....................................................................................... 10 Traumatic or postoperative pain ...................................................................... 11 Dentistry ........................................................................................................... 11 Childbirth .......................................................................................................... 11 Surgery............................................................................................................. 11 2.2 Infections ............................................................................................... 12 2.3 Neurological disorders........................................................................... 12 2.4 Respiratory disorders............................................................................. 14 2.5 Digestive disorders ................................................................................ 14 2.6 Blood disorders...................................................................................... 15 2.7 Urogenital disorders............................................................................... 15 2.8 Gynaecological and obstetric disorders................................................. 16 v
2.9 Cardiovascular disord 2.10 Psychiatric disorders and mental disturbances 18 2.11 Paediatric disorders ..19 2. 12 Disorders of the sense organs 19 2.13 Skin diseases 2.14 Cancers 2. 15 Other reports 3. Diseases and disorders that can be treated with acupuncture 222 4. Summary table of controlled clinical trials References
2.9 Cardiovascular disorders....................................................................... 17 2.10 Psychiatric disorders and mental disturbances..................................... 18 2.11 Paediatric disorders .............................................................................. 19 2.12 Disorders of the sense organs .............................................................. 19 2.13 Skin diseases........................................................................................ 20 2.14 Cancers................................................................................................. 20 2.15 Other reports......................................................................................... 21 3. Diseases and disorders that can be treated with acupuncture........................ 23 4. Summary table of controlled clinical trials ....................................................... 27 References ......................................................................................................... 67 vi
duction Introduction Background Over its 2500 years of development, a wealth of experience has accumulated in the practice of acupuncture, attesting to the wide range of diseases and conditions that can be effectively treated with this approach. Unlike many other traditional methods of treatment, which tend to be specific to their national or cultural context, acupuncture has been used throughout the world, particularly since the 1970s. In recognition of the increasing worldwide interest in the subject, the World Health Organization(WHO)conducted a symposium on acupuncture in June 1979 in Beijing, China. Physicians practising acupuncture in different countries were invited to identify the conditions that might benefit from this therapy. The participants drew up a list of 43 suitable diseases. However, this list of indications was not based on formal clinical trials conducted in a rigorous scientific manner, and its credibility has been questioned The past two decades have seen extensive studies on acupuncture, and great efforts have been made to conduct controlled clinical trials that include the use of sham"acupuncture or placebo"acupuncture controls. Although still limited in number because of the difficulties of carrying out such trials, convincing reports, based on sound research methodology, have been published. In addition, experimental investigations on the mechanism of acupuncture have been carried out. This research, while aimed chiefly at answering how acupuncture works may also provide evidence in support of its effectivenes In 1991, a progress report on traditional medicine and modern health care was Assembly 1 The report pointed out that in countries where ourth World Health submitted by the director-General of Who to the Forty-fo acupuncture forms part of the cultural heritage, its use in an integrated approach to modern and traditional medicine presents no difficulty. However, in countries where modern Western medicine is the foundation of health care, the ethical use of acupuncture requires objective evidence of its efficacy under controlled clinical conditions In 1996, a draft report on the clinical practice of acupuncture was reviewed at the HO Consultation on Acupuncture held in Cervia, Italy. The participants recommended that WHO should revise the report, focusing on data from controlled clinical trials. This publication is the outcome of that process Traditional medicine and modern health care Progress report by the Director-General. Geneva, World Health Organization, 1991(unpublished document A44/10)
Introduction Introduction Background Over its 2500 years of development, a wealth of experience has accumulated in the practice of acupuncture, attesting to the wide range of diseases and conditions that can be effectively treated with this approach. Unlike many other traditional methods of treatment, which tend to be specific to their national or cultural context, acupuncture has been used throughout the world, particularly since the 1970s. In recognition of the increasing worldwide interest in the subject, the World Health Organization (WHO) conducted a symposium on acupuncture in June 1979 in Beijing, China. Physicians practising acupuncture in different countries were invited to identify the conditions that might benefit from this therapy. The participants drew up a list of 43 suitable diseases. However, this list of indications was not based on formal clinical trials conducted in a rigorous scientific manner, and its credibility has been questioned. The past two decades have seen extensive studies on acupuncture, and great efforts have been made to conduct controlled clinical trials that include the use of “sham” acupuncture or “placebo” acupuncture controls. Although still limited in number because of the difficulties of carrying out such trials, convincing reports, based on sound research methodology, have been published. In addition, experimental investigations on the mechanism of acupuncture have been carried out. This research, while aimed chiefly at answering how acupuncture works, may also provide evidence in support of its effectiveness. In 1991, a progress report on traditional medicine and modern health care was submitted by the Director-General of WHO to the Forty-fourth World Health Assembly.1 The report pointed out that in countries where acupuncture forms part of the cultural heritage, its use in an integrated approach to modern and traditional medicine presents no difficulty. However, in countries where modern Western medicine is the foundation of health care, the ethical use of acupuncture requires objective evidence of its efficacy under controlled clinical conditions. In 1996, a draft report on the clinical practice of acupuncture was reviewed at the WHO Consultation on Acupuncture held in Cervia, Italy. The participants recommended that WHO should revise the report, focusing on data from controlled clinical trials. This publication is the outcome of that process. 1 Traditional medicine and modern health care. Progress report by the Director-General. Geneva, World Health Organization, 1991 (unpublished document A44/10). 1
Acupuncture: review and analysis of controlled clinical trials Objectives The objective of this publication is to provide a review and analysis of controlled clinical trials of acupuncture therapy, as reported in the current literature, with a view to strengthening and promoting the appropriate use of acupuncture in health care systems throughout the world. Information on the therapeutic mechanisms of acupuncture has also been incorporated Since the methodology of clinical research on acupuncture is still under debate, it very difficult to evaluate acupuncture practice by any generally accepted measure. This review is limited to controlled clinical trials that were published up to 1998(and early 1999 for some journals), in the hope that the conclusions will prove more acceptable. Such trials have only been performed for a limited number of diseases or disorders. This should not be taken to mean however that acupuncture treatment of diseases or disorders not mentioned here is excluded Use of the publication This publication is intended to facilitate research d the evaluation and application of acupuncture. It is hoped that it will provide a useful resource for researchers, health care providers, national health authorities and the general public It must be emphasized that the list of diseases, symptoms or conditions covered here is based on collected reports of clinical trials, using the descriptions given in those reports. Only national health authorities can determine the diseases, symptoms and conditions for which acupuncture treatment can be recommended The data in the reports analysed were not always clearly recorded. We have made every effort to interpret them accurately, in some cases maintaining the original wording in the text and summary table presented here. Research on traditional medicine, including acupuncture is by no means easy. However, researchers should be encouraged to ensure the highest possible standards of study design and reporting in future research in order to improve the evidence base in this field Dr Xiaorui zhang cting Traditional Medicine(Trm) Department of Essential Drugs and Medicines Policy(EDM) World Health Organization
Acupuncture: review and analysis of controlled clinical trials Objectives The objective of this publication is to provide a review and analysis of controlled clinical trials of acupuncture therapy, as reported in the current literature, with a view to strengthening and promoting the appropriate use of acupuncture in health care systems throughout the world. Information on the therapeutic mechanisms of acupuncture has also been incorporated. Since the methodology of clinical research on acupuncture is still under debate, it is very difficult to evaluate acupuncture practice by any generally accepted measure. This review is limited to controlled clinical trials that were published up to 1998 (and early 1999 for some journals), in the hope that the conclusions will prove more acceptable. Such trials have only been performed for a limited number of diseases or disorders. This should not be taken to mean, however, that acupuncture treatment of diseases or disorders not mentioned here is excluded. Use of the publication This publication is intended to facilitate research on and the evaluation and application of acupuncture. It is hoped that it will provide a useful resource for researchers, health care providers, national health authorities and the general public. It must be emphasized that the list of diseases, symptoms or conditions covered here is based on collected reports of clinical trials, using the descriptions given in those reports. Only national health authorities can determine the diseases, symptoms and conditions for which acupuncture treatment can be recommended. The data in the reports analysed were not always clearly recorded. We have made every effort to interpret them accurately, in some cases maintaining the original wording in the text and summary table presented here. Research on traditional medicine, including acupuncture is by no means easy. However, researchers should be encouraged to ensure the highest possible standards of study design and reporting in future research in order to improve the evidence base in this field. Dr Xiaorui Zhang Acting Coordinator Traditional Medicine (TRM) Department of Essential Drugs and Medicines Policy (EDM) World Health Organization 2
1. General consideratio 1. General considerations 1.1 Definition Acupuncture literally means to puncture with a needle. However, the application of needles is often used in combination with moxibustion -the burning on or over the skin of selected herbs -and may also involve the application of other kinds of stimulation to certain points. In this publication the term "acupuncture is used in its broad sense to include traditional body needling, moxibustion, electric acupuncture (electro-acupuncture), laser acupuncture (photo- acupuncture), microsystem acupuncture such as ear(auricular), face, hand and alp acupuncture, and acupressure(the application of pressure at selected sites 1.2 Need for evaluation Acupuncture originated in China many centuries ago and soon spread to Japan, the Korean peninsula and elsewhere in Asia. Acupuncture is widely used in health care systems in the countries of this region; it is officially recognized by governments and well received by the general public Ithough acupuncture was introduced to Europe as long ago as the early seventeenth century, scepticism about its effectiveness continues to exist in countries where modern Western medicine is the foundation of health care especially in those where acupuncture has not yet been widely practised. People question whether acupuncture has a true therapeutic effect, or whether it works merely through the placebo effect, the power of suggestion, or the enthusiasm with which patients wish for a cure. There is therefore a need for scientific studies that evaluate the effectiveness of acupuncture under controlled clinical conditions This publication reviews selected studies on controlled clinical trials. Some of these studies have provided incontrovertible scientific evidence that acupuncture is more successful than placebo treatments in certain conditions. For example, the proportion of chronic pain relieved by acupuncture is generally in the range 55- 85%, which compares favourably with that of potent drugs(morphine helps in 70% of cases)and far outweighs the placebo effect(30-35%)(1-3). In addition, the mechanisms of acupuncture analgesia have been studied extensively since the ate 1970s, revealing the role of neural and humoral factors 1.3 Evaluation methodology Unlike the evaluation of a new drug, controlled clinical trials of acupuncture are extremely difficult to conduct, particularly if they have to be blind in design and the acupuncture has to be compared with a placebo. Various"sham"or placebo"acupuncture procedures have been designed, but they are not easy to
1. General considerations 1. General considerations 1.1 Definition Acupuncture literally means to puncture with a needle. However, the application of needles is often used in combination with moxibustion—the burning on or over the skin of selected herbs—and may also involve the application of other kinds of stimulation to certain points. In this publication the term “acupuncture” is used in its broad sense to include traditional body needling, moxibustion, electric acupuncture (electro-acupuncture), laser acupuncture (photoacupuncture), microsystem acupuncture such as ear (auricular), face, hand and scalp acupuncture, and acupressure (the application of pressure at selected sites). 1.2 Need for evaluation Acupuncture originated in China many centuries ago and soon spread to Japan, the Korean peninsula and elsewhere in Asia. Acupuncture is widely used in health care systems in the countries of this region; it is officially recognized by governments and well received by the general public. Although acupuncture was introduced to Europe as long ago as the early seventeenth century, scepticism about its effectiveness continues to exist in countries where modern Western medicine is the foundation of health care, especially in those where acupuncture has not yet been widely practised. People question whether acupuncture has a true therapeutic effect, or whether it works merely through the placebo effect, the power of suggestion, or the enthusiasm with which patients wish for a cure. There is therefore a need for scientific studies that evaluate the effectiveness of acupuncture under controlled clinical conditions. This publication reviews selected studies on controlled clinical trials. Some of these studies have provided incontrovertible scientific evidence that acupuncture is more successful than placebo treatments in certain conditions. For example, the proportion of chronic pain relieved by acupuncture is generally in the range 55– 85%, which compares favourably with that of potent drugs (morphine helps in 70% of cases) and far outweighs the placebo effect (30–35%) (1–3). In addition, the mechanisms of acupuncture analgesia have been studied extensively since the late 1970s, revealing the role of neural and humoral factors. 1.3 Evaluation methodology Unlike the evaluation of a new drug, controlled clinical trials of acupuncture are extremely difficult to conduct, particularly if they have to be blind in design and the acupuncture has to be compared with a placebo. Various “sham” or “placebo” acupuncture procedures have been designed, but they are not easy to 3
Acupuncture: review and analysis of controlled clinical trials perform in countries such as China where acupuncture is widely used In these countries, most patients know a great deal about acupuncture, including the special sensation that should be felt after insertion or during manipulation of the needle. Moreover, acupuncturists consider these procedures unethical because they are already convinced that acupuncture is effective. In fact, most of the placebo-controlled clinical trials have been undertaken in countries where there is scepticism about acupuncture, as well as considerable interest. A more practical way to evaluate the therapeutic effect of acupuncture is to compare it with the effect of conventional therapy through randomized controlled trials or group studies, provided that the disease conditions before treatment are comparable across the groups, with outcome studies developed for all patients Because of the difficulty of ruling out the placebo effect, a comparative study with no treatment as the control may not be convincing in the evaluation of acupuncture practice. Retrospective surveys, in which the effect of acupuncture therapy is compared with past treatments, may not be of significance either, particularly if they have not been well designed. Non-comparative studies are certainly of little significance, particularly when acupuncture is used for the treatment of a self-limited disease. However, if rapid improvement can be achieved in the treatment of a long-standing, chronic disease, or if there is definite improvement in a disease that is generally recognized as intractable to conventional treatment, the effect of acupuncture should be viewed in a more favourable light, even when a well-designed, controlled study has not been Another difficulty in evaluating acupuncture practice is that the therapeuti effect depends greatly on the proficiency of the acupuncturists-their ability and skill in selecting and locating the acupuncture points and in manipulating the needles. This may partly explain the disparities or inconsistencies in the results reported by different authors, even when their studies were carried out on equally sound methodological bases Evaluating acupuncture practice and arriving at generally accepted conclusions is no easy task, therefore. While effectiveness is doubtless of the utmost importance, other factors, including safety, cost, availability and the condition of local health services must also be considered. Given the same effectiveness these other factors may lead to different evaluations of acupuncture in different countries and areas. However, conclusions are needed that apply to worldwide use, particularly for countries and areas where proper development of acupuncture practice would bring a great deal of benefit. Evaluations should not therefore be confined to those diseases for which modern conventional treatments are inadequate or ineffective Because of the success of surgical procedures carried out under acupuncture analgesia, the treatment of pain with acupuncture has been extensively studied For other conditions often treated with acupuncture, there are fewer reports that have adequate methodology
Acupuncture: review and analysis of controlled clinical trials perform in countries such as China where acupuncture is widely used. In these countries, most patients know a great deal about acupuncture, including the special sensation that should be felt after insertion or during manipulation of the needle. Moreover, acupuncturists consider these procedures unethical because they are already convinced that acupuncture is effective. In fact, most of the placebo-controlled clinical trials have been undertaken in countries where there is scepticism about acupuncture, as well as considerable interest. A more practical way to evaluate the therapeutic effect of acupuncture is to compare it with the effect of conventional therapy through randomized controlled trials or group studies, provided that the disease conditions before treatment are comparable across the groups, with outcome studies developed for all patients. Because of the difficulty of ruling out the placebo effect, a comparative study with no treatment as the control may not be convincing in the evaluation of acupuncture practice. Retrospective surveys, in which the effect of acupuncture therapy is compared with past treatments, may not be of significance either, particularly if they have not been well designed. Non-comparative studies are certainly of little significance, particularly when acupuncture is used for the treatment of a self-limited disease. However, if rapid improvement can be achieved in the treatment of a long-standing, chronic disease, or if there is definite improvement in a disease that is generally recognized as intractable to conventional treatment, the effect of acupuncture should be viewed in a more favourable light, even when a well-designed, controlled study has not been carried out. Another difficulty in evaluating acupuncture practice is that the therapeutic effect depends greatly on the proficiency of the acupuncturists—their ability and skill in selecting and locating the acupuncture points and in manipulating the needles. This may partly explain the disparities or inconsistencies in the results reported by different authors, even when their studies were carried out on equally sound methodological bases. Evaluating acupuncture practice and arriving at generally accepted conclusions is no easy task, therefore. While effectiveness is doubtless of the utmost importance, other factors, including safety, cost, availability and the condition of local health services must also be considered. Given the same effectiveness, these other factors may lead to different evaluations of acupuncture in different countries and areas. However, conclusions are needed that apply to worldwide use, particularly for countries and areas where proper development of acupuncture practice would bring a great deal of benefit. Evaluations should not therefore be confined to those diseases for which modern conventional treatments are inadequate or ineffective. Because of the success of surgical procedures carried out under acupuncture analgesia, the treatment of pain with acupuncture has been extensively studied. For other conditions often treated with acupuncture, there are fewer reports that have adequate methodology. 4
