5 English Summary

5.1 Introduction

This chapter provides a summary of the Report on Alternative Medicine. The main emphasis is on the chapters in the report containing the Committee's evaluations, conclusions and proposals.

5.2 Committee's mandate, composition and method

Chapter 1 accounts for the Committee's mandate and composition and how the Committee approached its task. The statements from the Standing Committee on Health and Social Affairs and the Storting (the Norwegian Parliament) resolutions underlying the appointment of the Committee are also reproduced.

5.2.1 Appointment and mandate

After a unanimous request by the Storting, the Ministry of Health and Social Affairs in April 1997 appointed a Committee to report on various aspects of Alternative Medicine. The Committee has been called the Alternative Medicine Committee or Aarbakke Committee in recognition of its chairman, Professor Jarle Aarbakke. The Committee was given the following mandate:

  1. Account for the status of alternative medicine and the place alternative medicine has in Norway today The account should preferably build on available source material and should embrace, among other aspects:

    • Account of content of current and relevant new legislation and restrictions regarding the licence to provide treatment for illness

    • Survey of relevant alternative treatment methods

    • Survey of educational programs and competence of practitioners

    • Account of number and geographical dispersion of various practitioners

    • Account of how widely alternative medicine is used and characteristics of users of alternative medicine

    • Account of relevant parties' attitudes to and knowledge of various forms of alternative medicine

    • Account of where alternative medicine stands in a research context - any documented effects and side-effects of various forms of alternative medicine to be included in the account

    • Account of place and significance of various forms of alternative medicine today - including existing co-operation with the established public and private health service. The use of alternative forms of therapy by health personnel in their practice should be included in this account.

    • Account of economic aspects relating to practice of alternative medicine (for example in connection with education and fees)

    • Account of situation in other countries having relevant experience of co-operation between alternative medicine and the established public and private health service

    • Account of agreements, documents and attitudes in relevant international organisations such as the World Health Organisation (WHO), European Union (EU) and Council of Europe regarding co-operation between alternative medicine and established medicine.

  2. Account for and discuss the salient characteristics of (various forms of) alternative treatment and practice Include here also an evaluation of the distinctions between such methods and practitioners from each other and from officially recognised treatment methods and practitioners.

  3. Discuss and evaluate whether and to what extent various forms of alternative medicine should have a place in connection with the established health service

    • Describe any advantages and drawbacks of a medical, patient-related, or economic character connected with use of alternative treatment forms in relation to established treatment forms. The effects or lack of effects, and side effects should be included in the description of medical advantages and drawbacks.

    • The account should embrace grounds for and discussion of why different forms of alternative medicine should - or should not - take a place outside the established health service.

  4. Discuss and make proposals for how different forms of alternative medicine could, if desired, be co-ordinated with the public and private health service at the municipal, county and national level

  5. Discuss issues connected with registration and registers, including the purpose of a register, criteria for identifying serious practitioners in a special register, and evaluating if any registration should be voluntary

  6. Discuss key issues connected with an approval scheme and make suggestions for any approval procedures for groups of alternative medicine practitioners, including requirements for education

  7. Discuss and take a stand on legislative models for legislative regulation of the alternative medicine field. The practice of various forms of alternative medicine by publicly licensed and authorised health personnel and non-licensed or non-authorised health personnel should be discussed here. Legislative models might include:

    • Revision of Medical Quackery Act

    • Regulate professional alternative medicine practitioners' activities through relevant provisions in the Criminal Code

    • Special act regulating alternative forms of therapy (see SOU 1989:60).

  8. Discuss need for and make proposals for relevant complaints channels for users of alternative medicine

  9. Discuss consequences of the proposals made

    • Account for challenges of implementation, for instance relating to know-how, educational/ informational, and attitudinal

    • Account for economic and administrative consequences. Under the Report Instructions, one of the proposals should be based on reduced or unchanged input of resources.

  10. The evaluations and proposals should build into a recommendation and the work should be crystallised in a Committee Report, the Report to be presented to the Ministry no later than 15 December 1998

5.2.2 Committee's composition

The following persons were appointed members of the Committee:

  • Aarbakke, Jarle, Professor, Doctor of Medicine, University of Tromsø, Chairman

  • Befring, Anne Kjersti, Project Co-ordinator, Ministry of Health and Social Affairs. Now: Section Manager, Norwegian Medical Association, Oslo

  • Bjørgan, Britt Untiedt, Nurse and Zone Therapist, Bergen

  • Bjørndal, Andreas N., Acupuncturist NFKA and Homeopath MNHL, Oslo

  • Braut, Geir Sverre, County Medical Officer, Rogaland

  • Bruset, Stig, Physician, Lier

  • Christie, Vigdis Moe, Research Sociologist, University of Oslo

  • Fønnebø, Vinjar, Professor, Doctor of Medicine, University of Tromsø

  • Grini, Hanne Karin, Adviser for political interests, Joint Organisation for Disabled Persons, Oslo

  • Guttormsen, Laila, Nurse and Natural Therapist, Berlevåg

  • Halvorsen, Marit, Senior lecturer, Doctor of Law, University of Oslo

  • Ingstad, Benedicte, Professor, Doctor of Philosophy, University of Oslo

  • Mestad, Ingvild, Attorney, Kluge Advokatfirma ANS (firm of attorneys), Oslo

  • Pedersen, Tom A., Kinesiologist, Bergen

  • Risberg, Terje, Chief Physician, Regional Hospital in Tromsø. Now: Doctor of Medicine

  • Rygh, Liv H., Advisor, Doctor of Philosophy, Norwegian Medicines Control Authority (Statens legemiddelkontroll). Now: Leading Technical Officer, Norwegian Board of Health (Statens helsetilsyn)

  • Syse, Aslak, Senior Lecturer, Doctor of Law, Candidate of Medicine, University of Oslo. Now: Professor.

The Committee enjoyed the same composition throughout the entire work period, although some of the persons have, as can be seen, experienced changes in position or place of employment.

The Ministry of Health and Social Affairs looked after the Secretariat functionalities for the Committee.

The Committee Secretaries were Report Co-ordinator Kari Bente Sørlie from appointment of the Committee until April 1998, Report Co-ordinator Kirsten Been from 1 September 1997, and Report Co-ordinator Karl Skaar from 25 May 1998, the two last working until the conclusion of the Committee's work. Secretary Kari Mette Sandviken also assisted.

5.2.3 Committee's interpretation of mandate

The Committee has sought to distinguish alternative medicine with respect to conventional medicine and the established health service on the one hand, and with respect to other activities involving a treatment element on the other hand.

The distinction with respect to treatment employing psychological elements is not sharp. Treatment where these are paramount is not discussed.

The Committee's report does not cover activities normally considered ordinary religious practice. This implies activities whose main foundation is in a faith and rituals connected with the faith, such as vigils and prayers for the sick, expulsion of evil spirits, etc. But alternative medicine treatments can contain elements of ideology or worldview, or be motivated by a religious belief, which can also motivate the choice of treatment and aftercare regimes for patients. Such treatment is covered by the Report. In questions of regulation this will be important where it concerns professional treatment, which is to say treatment activities that form a line of employment, where patients must compensate for the service by payment. In evaluating whether a practice is an ordinary religious activity or a treatment activity, relevant tests will include asking what the basis is for the treatment or meeting, the strength of the faith, whether compensation is given, and if so what form and magnitude the compensation takes.

The distinctions from conventional medicine are blurred because methods and know-how used in alternative medicine are also applied in conventional medicine. Where these methods take a prominent place in alternative medicine treatment, like nutritional advice and additives, they are discussed specifically.

The Committee was, in the mandate, asked to rely on available sources. The Committee has additionally conducted an opinion poll in the autumn of 1997 to obtain up-to-date information about the use of alternative medicine in Norway.

Any direct comparison of the use of alternative medicine treatments in Norway and other countries is complicated by the different classification of alternative medicine and conventional medicine in different countries.

In the mandate the Committee is asked to examine what separates the serious from the spurious practitioner. The Committee has examined this problem and delved into certain measures that could make things clearer.

5.2.4 Work in the Committee

The Committee started its work in May 1997. The Committee has worked under a comprehensive mandate with a broad composition. In order to address the various parts of the mandate usefully the Committee established several sub-committees. The groups have held numerous meetings and there have been plenary meetings during the entire report period. The Committee's work has been characterised not least by the fact that most of the Committee members have been active in submitting drafts for specific parts of the Report.

The Committee has obtained information and received input from affected groups in Norway, including associations of practitioners of alternative medicine, educational institutions within alternative medicine, and patient organisations. Many others have also contributed information.

Study visits have been made in Norway and one study tour has been made to England, another to China and India. Certain Committee members have participated in international conferences and others have met with WHO representatives in Geneva and EU representatives in Brussels.

5.3 Discussion of concepts and the nature of science

Chapter 3 discusses to begin with the concepts of alternative medicine and conventional medicine. The Committee chose to use these two concepts in its work despite their susceptibility to criticism. The choice was made because the Committee believes that the concepts as used in Norway today provide a reasonably precise distinction of the two fields of endeavour, and at the same time they seem to be the most commonly used expressions.

The concept of illness is discussed briefly. The Committee found itself unable to foray into a deep discussion of this term. There exists no generally accepted definition of illness. The views of what constitutes illness can vary from one person to the next and not least from one culture and social stratification to another. The concept also houses legal implications. The Committee notes that an increasing range of different treatments will also affect our perception of what is considered illness at any time.

The final part of the chapter is devoted to a brief presentation of various approaches to the issue of what is science. The Committee points to the problems connected to the issue of whether science can be value-neutral. The key thing is whether perceptions of truth and knowledge can be considered objective phenomena or must always be seen in a subjective light. Also a brief summary of the possibilities of the qualitative and quantitative methods and their limitations in relation to research in alternative medicine is given.

5.4 Roots of alternative medicine

Chapter 4 provides a description of the roots of alternative medicine, including the folk medicine traditions in Norway, medical knowledge traditions outside Europe, and medical traditions in Europe in historic times.

A historical perspective and cultural comparison show how important premises for what we now know as conventional medicine and alternative medicine were laid in earlier times. These two perspectives are inseparably connected. Medical knowledge throughout history has often been created locally through human experience and the belief systems that were used to organise that experience. The knowledge was often created through a much wider global process whereunder people with different medical traditions, throughout the ages and under different social regimes, met and exchanged learning.

There is a distinction between (1) folk medicine or ethnic medicine, (2) alternative medicine, and (3) conventional medicine even if this distinction often is difficult to discern. Folk medicine is the oldest of the three. Many of its elements have retained their original conception up to the present. Both conventional medicine and alternative medicine can be said to have grown from folk medicine.

Alternative medicine in our part of the world has received much impetus from ethnic medicine in other parts of the world. For example, ideas from Asian learning traditions have been carried on by many of our modern alternative medicine treatments.

The chapter also draws up certain other lines of development towards our own century. Something is also said about possible causes of the emergence of alternative medicine.

Finally folk medicine in the world today is discussed.

5.5 Alternative medicine's models of health, disease and explanatory constructions

Chapter 5 accounts for the explanatory constructions of alternative medicine. Within alternative medicine there are a range of treatments and explanations, and not all forms of alternative medicine build on the same principles and theories. But many models are replicated in different alternative medicine therapies, even if the terminology varies somewhat. Chapter 5 emphasises the similarities rather than the differences.

Bio-energetic explanations, concepts of vital energy and of the body as an integrated whole are key elements. The holographic concept implies that the whole organism is projected in several of the parts of the body. The close connection between mind and body is also common in many alternative medicine therapies.

The body's self-healing capacity is stimulated in order to regain anatomical and functional integrity. Disease is more seen as a weakening of the body's own healing properties rather than as a colonisation by bacteria or virus. Development of disease from an acute to a chronic phase is seen as a gradual weakening of the self-healing vital power in the body.

In many forms of alternative medicine the focus is also on the natural, for example eating natural foods, and avoiding - and getting rid of - various forms of contamination in the body in the form of artificial additives, synthetic drugs, etc, which are believed to be a cause of disease.

One of the oldest models common in current alternative medicine is the division into categories and qualities, for example four or five elements, weather types or body fluids. All symptoms are categorised, unbalance is assessed, and the practitioner tries to restore a balance between the qualities. Diet, herbs or other interventions are utilised.

5.6 Selected alternative medicine treatments

Chapter 6 provides a brief summary of several alternative medicine treatments, and a closer look at some of them, with an account of their history, methodology, areas of use, and explanatory underpinnings. Also described are some alternative medicine analysis methods. These descriptions build on Norwegian alternative medicine practitioners and their organisations currently perceive their treatment method and its background. The Committee has not sought to take a critical look at the sources for this material.

5.7 Users of alternative medicine treatments

Chapter 7 accounts for the uses and users of alternative medicine based on a series of empirical surveys and interviews. One of these was performed for the Committee.

Based on the statistics available there seems to have been an increase in the use of alternative medicine in Norway over the past decades. Homeopathy, acupuncture and zone therapies are the most used forms of therapy. Women are more frequent patrons of alternative medicine practitioners than men, but there is an increasing tendency for men to make use of these services. Middle aged and younger people make more frequent use of alternative medicine than the elderly, but in recent years use among the elderly has increased most. While the use of alternative medicine used to be greatest in the towns, it is now essentially equal in town and country. The correlation between level of education and reliance on alternative medicine is fading, although persons with a high education still use alternative medicine rather more than others.

Particularly persons suffering chronic or serious illness make use of alternative medicine, but there seems to be an increasing tendency to apply it also for other ailments. Headache, migraine, and back and neck problems are the complaints that are most often brought before the alternative medicine practitioner. Many people who approach alternative therapists want guidance on diet and supplements, and assistance to bolster up their immune systems and improve their general health.

Patients mainly seek a medical doctor before consulting an alternative medicine practitioner. Increasingly, alternative medicine treatment is sought without the patient first consulting a doctor. This applies in particular if the patient has previously received help for the same type of illness from an alternative therapist.

More than two-thirds of people who have used alternative medicine stated that they recovered or improved from the treatment, whilst the others became neither better nor worse. More women than men, and more young than old, claimed to have been healed. Improvement is said to occur with greater frequency if alternative treatment is sought early in the disease process.

Two-thirds of those who have not used alternative medicine would consider doing so. The proportion is greater among younger people than among the old.

There is an increasing tendency for patients to tell their doctor that they use alternative medicine, but there are still many who feel that they cannot discuss such issues with their doctor.

Two-thirds of those questioned are positive towards a refund scheme for alternative medicine treatment and four out of five would like a licensing or authorisation scheme for alternative medicine practitioners. A majority of the users of alternative medicine believe that alternative medicine should be offered at hospitals.

The results of the surveys in other countries regarding use of alternative medicine treatment are also discussed. The use of, and public interest in, and research into alternative medicine treatments are on the up in the great majority of countries, and certainly in Europe. The proportion of the population that has visited an alternative medicine practitioner at one time or another varies between 18 and 70 per cent in the countries reported to the Committee, and between 50 and 80 per cent of the population has a positive feeling about alternative therapists.

Just like in Norway, studies in USA and many of the European countries show that women make use of alternative medicine treatment more frequently than men. In most countries for which the Committee has information, consumption of alternative medicine services is greatest in the age range 30-60 years. This use seems to be concentrated on the same types of illnesses and suffering as in Norway.

5.8 Education and organisation of alternative medicine practitioners

Section 8.2 provides a summary of educational paths for alternative medicine in Norway. The information came from responses to a questionnaire the Committee sent to known educational institutions for alternative medicine in the summer of 1997. The form was sent to 62 places of learning, and the Committee received 39 responses. The summary is therefore not exhaustive.

Education is offered in a range of treatments: acupuncture, acupressure, aroma therapy, biopathy, colour therapy, gestalt therapy, healing, holistic therapy, homeopathy, kinesiology, light therapy, osteopathy, polarity theory, zone therapy, and yoga/ breathing exercises. Some schools offer education in basic medical subjects (which are not alternative medicine, but which are included in some courses of education within alternative medicine).

The schools are mainly concentrated around the Oslo area. Most of them were established during the past 20 years. The schools are run on a private basis and are not entitled to give examinations under the Universities and Colleges Act (except for certain courses in basic medical subjects). Most of the schools are small, with between 10 and 40 students a year. Between 1971 and 1997 about 3,500 therapists qualified at the schools which returned the forms.

The duration of the education varies from brief courses to several years of full-time study. All contain a practice period. Some constitute continuing or further education for health personnel or practitioners of alternative medicine, but most study options are intended as basic education. The entrance requirements vary enormously. Some schools make no formal requirements for entrance, whilst others require completion of a health education (such as nursing or physiotherapy). Some schools vet students for suitability. Most schools offer part-time studies. The price of an education varies from 5,000 to 240,000 NKR for the full package. Annual tuition fees vary between 2,600 and 39,000 NKR. The variation is of course mostly explained by the great variation in scope of course, but variations in price per tuition hour are also significant. No educational course in alternative medicine has as yet been approved for educational grants from the State Educational Loan Fund.

Section 8.2 also accounts in more detail for the content and scope of the studies, the competence of the teaching staff, the links to research programs, co-operation between schools in Norway and schools abroad, and recruitment from foreign places of learning.

Section 8.3 provides an account of the organisation of alternative medicine practitioners. This information is gleaned from the responses to the questionnaire sent out by the Committee in the summer of 1997 to the 37 known associations of alternative medicine practitioners. The Committee received input from 25 associations. The information cannot be deemed exhaustive. Of the associations that responded to the enquiry, three had been established earlier than 1980, eight were established in that decade and 14 were established in the 1990s. The total number of active members in the associations at 1 July 1997 was 2,604. Some practitioners hold membership in several associations. The membership of the individual association varied between 7 and 385 active members. Some associations organise practitioners in several therapies. Several associations organise practitioners in a specific therapy. Some associations only organise publicly accredited health personnel who practice alternative medicine.

5.9 Health Service's attitude to and use of alternative medicine

Chapter 9 offers an account of attitudes to alternative medicine in many institutions, organisations and groups of people who make up part of what we can call the health service in the broad sense, and of attitudes expressed by certain other organisations, etc. The account includes political health authorities at the national and local level, political parties, the Norwegian Board of Health and County Medical Officers, educational institutions offering health studies, research environments, public and private health institutions, accredited and authorised health professionals, and students of health subjects. The description builds in part on responses to enquiries from the Committee and in part on other documents and investigations.

One can say that the health service's actions and expressions regarding alternative medicine can take three forms, with continuous transitions between them: dismissive, neutral, and supportive. The Committee's impression is that many people involved in the health service have generally been dismissive in recommending or even having any contact with alternative medicine environments. It seems that many have now gone over to a more neutral position where they more or less quietly accept alternative medicine as something in the patient's private domain where he or she mainly takes their own decisions. Active co-operation or referral is still relatively uncommon, even if a study shows that 65 per cent of doctors refer patients to acupuncture treatment.

The material the Committee builds on shows that female health professionals are generally more positive to alternative medicine than their male colleagues, and the young more positive than the old, and general practitioners more positive than hospital doctors (with surgeons the most dismissive). Physicians who received their education abroad are more positive than those trained in Norway. Nurses and other health professionals are far more positive toward alternative medicine treatment than doctors. Health personnel in other countries and their attitudes to alternative medicine treatment are discussed at the end of chapter 9. Their attitudes seem generally to be more supportive than in Norway. In most non-Norwegian studies known to the Committee it appears that doctors consider that alternative medicine treatments can offer methods and ideas that conventional medicine could benefit from integrating into their own practice. In many countries in Southern Europe doctors have a monopoly for the practice of certain forms of alternative therapy, such as homeopathy.

5.10 Presentation of the regulation of services and service providers in and outside of the health service

Chapter 10 discusses current Norwegian law regarding areas of significance for the Committee's deliberations. Parts of the relevant health laws are considered, in addition to affiliated legal fields with special emphasis on provisions that regulate practice and practitioners of alternative medicine.

An account of the structure of the health service, its organisation and funding, and the rules that apply to licensed and authorised health personnel are included as background information.

In addition to the rules that apply in criminal law, compensation law and consumer law, the Medical Quackery Act restricting the right for a person who is not a Norwegian doctor or dentist to treat patients, has special significance for the practice of alternative medicine therapies. Among other things the Act lays down limits for the utilisation of certain treatment methods and limits practice to certain specified conditions. Thus the use of prescription drugs, surgical intervention, injections and complete or local anaesthesia is restricted to doctors and dentists. Only doctors are permitted to treat certain contagious diseases, cancer, diabetes, dangerous anemias and goitre in harmful forms. Section 10.4 discusses these provisions in more detail. For instance it discusses the unresolved question of whether acupuncture should be deemed a surgical intervention under the Medical Quackery Act. The Committee feels that this is stretching the wording of the law rather too far, and that there are good reasons for claiming that acupuncture involving no serious risk is legal also for practitioners other than doctors and dentists. The Medical Quackery Act also regulates the use of titles, marketing of business, time spent in the realm, etc. Violations of the law are a criminal offence. Anyone treating patients without being a Norwegian doctor or dentist is also liable to prosecution if the patient's life or health is put under serious threat, either by the treatment itself or by the patient neglecting to seek expert assistance. It does not release the practitioner from culpability if he or she, due to inadequate medical knowledge, failed to understand the nature of the disease or the risk to which the patient was exposed.

In section 10.5 an account is given of the relevant patient rights, particularly the patient's right to select and reject treatment. The basic assumption is that the patient has the right to choose and that examination and treatment must be based on consent. The patient can choose whether to receive treatment if an offer for treatment is given. There also exists a requirement that the practitioner shall offer and provide treatment within a professional code of propriety. Special legal grounds must be shown in order to carry out a non-consensual examination or treatment. In practice the freedom of choice may be limited by other factors, like economy and availability.

Section 10.6 describes regulatory supervision and sanctions within and outside the health service. The Norwegian Board of Health and County Medical Officers supervises the health service and accredited and authorised health personnel and it also processes complaints under the Medical Quackery Act. Other public agencies oversee their respective fields, such as the Consumer Ombudsman and Monopolies Commission. An account is also given of professional quality controls resulting from professional moral codes and disciplinary recourse, etc. The presentation is largely based on responses to a questionnaire sent to associations for practitioners of alternative medicine in the summer 1997.

In both conventional medicine and some forms of alternative medicine substances are given for internal or external use. The Medicines and Drugs legislation and also sometimes the Foodstuffs Act regulate such substances. These two sets of legislation are very different both in their requirements for products and their rules for sale. Therefore it is vital to distinguish between the substances considered drugs which come under the Medicines Act, and other substances. An account is given of medicines and the rules that regulate them, including special rules for natural medicines. It also discusses the legal situation for natural extracts, dietary supplements and so forth where these are not drugs. For such products the Foodstuffs Act applies, but the Medicines Act also provides rules about advertising of products that are not drugs. The rules for medical equipment are discussed in section 10.8.

Section 10.9 explains the financial support schemes that apply for medical treatment, like free hospital treatment, refunds through the National Insurance scheme, basic and assistance grants and special tax deductions.

Section 10.10 looks at the regulation of alternative medicine from an international perspective.

Section 10.11 discusses proposals for new health acts, particularly the Patient Rights Act and a new Health Personnel Act, see the two law bills, Odelsting Propositions nos. 12 and 13 for 1998-99.

5.11 The views of alternative medicine practitioners regarding which place alternative medicine should have in the health service

Chapter 11 presents views regarding the place of alternative medicine in the health service received in the responses to the Committee's questionnaire in the summer of 1997. The questionnaire was sent to organisations of practitioners of alternative medicine, educational institutions for alternative medicine, and patient organisations.

The general impression the Committee received from the responses is that most people, in practitioner associations, schools and patient organisations alike, desire more co-operation between, and fuller integration of alternative medicine and the health service.

5.12 General discussion of efficacy evaluations

Chapter 12 discusses the basis for the method chosen for the efficacy evaluations in chapter 13. The Committee considers it impossible to establish general, exhaustive criteria for what constitutes effective treatment and what outcomes are necessary for a treatment to be used beyond the trial stage. Many factors have to be weighed, including a look at what alternatives exist.

The Committee has, for instance, based itself on discussions of efficacy in other public reports in recent years. These reports do not distinguish between requirements for conventional medicine and alternative medicine. It is pointed out that what should be used as the basis for evaluations of the efficacy of drugs and other treatment measures are good documentation and the potential to verify according to defined scientific criteria. Even though the goal is that the efficacy can be determined before a method is taken into use, it turns out in practice that many measures are implemented without this being done.

The Committee also discusses the placebo effect referring to several approaches that could be useful in interpreting this phenomenon. The efficacy concept in alternative medicine is often subject to a wider interpretation than in the pharmaceutical and method assessments in conventional medicine. This complicates the interpretation of an efficacy study made in alternative medicine. This chapter presents also certain difficulties and limitations connected with the generally used methods of evaluating efficacy. In conclusion the Committee cautions that many other factors, apart from pure scientific fact, will in practice influence the implementation and use of a given method in medicine. For example, patients' and patient organisations' preferences and the marketing campaigns for drugs.

5.13 Evaluation of alternative medicine treatments' efficacy and side-effects

An increasing level of research has been going on in western countries in the field of alternative medicine in the past 15-20 years. Several countries, among them Norway, have their own research program for alternative medicine. Sometimes established researchers in scientific subjects have tested alternative methods, but many alternative therapists have also wanted to take part in the scientific research. One problem has been that established researchers often have had little knowledge about treatment methods, while the alternative practitioners often suffer from inadequate training in the scientific method. There has been little development of alternative medicine research environments, and there has therefore been little development of research methods and experimental designs specifically adapted to alternative medicine.

The Committee has evaluated the quality and results of some research on alternative therapeutic forms practised in Norway. The Committee has largely relied on material submitted by organisations as well as educational institutions for alternative practitioners in connection with responses to the Committee's questionnaire in summer 1997. The Committee has therefore not evaluated treatment forms where the organisations have not submitted documentation.

In section 13.2 the Committee has accounted for the criteria that underlie the evaluation of the documentation. A discussion is made of the criteria for efficacy, what references should be used for comparison, the different levels of the documentation, and scientific criteria for evaluation of documentation.

The Committee established a scale with six steps that makes it possible to classify individual treatment methods:

  1. Documented effective: Extensive positive research results combined with good clinical experience provide a basis for considering the method's efficacy to be duly documented.

  2. Possibly effective: Some positive scientific research results and good clinical experience exist. The method's efficacy cannot be deemed to be documented until confirmed by further clinical studies.

  3. Conceivably effective: A few positive scientific research results and some good clinical experience provide a basis for further research into the method.

  4. Inadequate data: The sparse documentation makes it impossible to draw a conclusion.

  5. No effect: Extensive negative research results combined with poor clinical experience provide reason to consider the method to be proven ineffective.

  6. Hazardous: Extensive research results provide reason to consider the method dangerous.

Some members of the Committee want to replace the term «possibly effective» with «probably effective».

The Committee has reached the following conclusions regarding documentation of efficacy:

  • Acupuncture: The Committee considers acupuncture treatment to be documented effective for post-operative and chemotherapy induced nausea in adults. The method is possibly effective for nausea in pregnancy, pain following dental surgery, as an aid in detoxification regimes for drug and alcohol rehabilitation, and as an aid for stroke rehabilitation. For treatment of pain following general surgery, chronic pain conditions, asthma and in connection with nicotine withdrawal, the Committee considers acupuncture to be conceivably effective. For acupuncture for other pulmonary complaints, the Committee considers there to be inadequate data.

  • Aroma therapy: Essential oils have biological effects. There exists inadequate data to evaluate combined treatment with oil, massage and scent with respect to the specific contribution from the oil.

  • Ayurvedic medicine: Ayurvedic medicine traditions probably contain elements that might be assumed to have therapeutic effects, but the insights regarding specific effectuation mechanisms are defective. The Committee considers documentation in this field provides grounds to consider the method conceivably effective.

  • Healing: The efficacy of healing cannot be dismissed, but no effectuation mechanism is known. The method is deemed conceivably effective, but it is not possible to say anything about the effect on specific diseases or groups of diseases.

  • Homeopathy: The Committee considers homeopathic treatment in general to be possibly effective, but find it difficult to provide concrete evaluations of homeopathy in specific conditions.

  • Kinesiology: There is inadequate data to draw any certain conclusions about kinesiology as a system of therapy. There are indications that the muscle testing method has a basis and may be explained by neuromuscular effectuation mechanisms. The Committee considers the muscle testing method to be possibly effective.

  • Osteopathy: The existence of connections inside or outside the spinal cord of nerve fibres from the autonomous and somatic nervous system is accepted as documented. As a clinical treatment method for systemic illnesses the Committee considers Osteopathy to be supported by inadequate data.

  • Zone therapy: There is still inadequate data to evaluate this method's clinical efficacy.

  • Transcendental meditation: Used as a relaxation technique, transcendental meditation is considered possibly effective. In relation to dependency issues the method must be considered possibly effective. In other conditions, such as cardiovascular illness, there is inadequate data.

In general the Committee concludes that alternative treatments seem to have a potential in the treatment of a range of illnesses apart from acute medicine, but research has not come far enough or perhaps is headed in a direction that is unhelpful. The Committee in section 13.5 points to a number of problems in connection with research into alternative medicine, such as small sample size, few systematic verifications of earlier studies, difficulties of obtaining good placebo controls, bias in connection with patient inclusion, unrealistic treatment situations, poor treatment quality, and publication bias.

Research has in many cases been designed according to models from the pharmaceuticals industry. This research is characterised by the need to determine if new drugs have any biological effects whatsoever, and then to determine their clinical suitability. Following this line of research for alternative treatments might be an approach that is unsuitable for the fields in which alternative medicine is practised.

Most people who consult alternative medicine suffer from conditions where conventional medicine already recognises that there are few or no specific medications that provide a cure. For such long-term, but not life-threatening, illnesses and complaints, it is appropriate to take a holistic approach that may consist of several components. Therefore more research should be instigated of whole «treatment packages» to compare conventional medicine's care with the care given by alternative medicine practitioners. This research could, for instance, provide important clues as to which components in a therapist-patient relationship are the key ones either for improvement of a condition or acceptance of it.

5.14 Summary of relevant concerns and forms of legal regulation and other measures for alternative medicine

5.14.1 Concerns

Section 14.1 provides an account of the concerns that arise in evaluating if practice of alternative medicine should be subject to special regulation, and if so in what way this regulation should be accomplished. The concerns will tend to involve different directions. The weight the Committee puts on each concern is given in Chapter 15. The concerns that the Committee feels are relevant are, especially, the concern for an effective and good health service, which embodies predictability and safety in using treatment services, good public health, rational utilisation of the community's resources (good social economy), protection of patients and their integrity, safeguarding patients' right to self-determination, freedom of choice and treatment need, and freedom of establishment for practitioners.

5.14.2 Legal measures

Section 14.2 provides a presentation of possible forms of legal regulation of alternative medicine. Even regulatory forms that the Committee did not wish to discuss further are reviewed briefly. A distinction is made between negative and positive regulation. The first aims to limit the forms of activity that are recognised by society. Here the Committee discusses criminal law, compensation law, withdrawal of license/authorisation, registration privilege, etc, and supervision of professional activities. Positive regulations aim to recognise and encourage certain types of activity. Those mentioned include the right to register, opportunity to be accredited as a practitioner, etc, right to economic refund for patients, practitioners and businesses, and right to treatment.

The Committee proposes the repeal of the Medical Quackery Act. It also proposes that certain criminal provisions limiting the opportunity to practice treatment activities should be incorporated instead in a proposed new Health Personnel Act, see section 15.2 in this summary. The Committee does not propose changes in other criminal rules of significance for practitioners of alternative medicine, such as the Medicines Act or other, more general laws containing criminal provisions.

The Committee does not propose any revisions in compensation law. Treatment by alternative medicine practitioners is not covered by the provision in the Norwegian Patient Compensation (NPE) rules. The Committee finds that any expansion of this would have to be considered separately. In connection with a proposal for registration of practitioners of alternative medicine, see section 15.3 in this summary, the Committee proposes a requirement for liability insurance to ensure that injured patients receive economic settlement if the injury triggers compensation.

In connection with the registration scheme that the Committee proposes, the revocation or non-award of registration will represent a sanction. Similarly, revocation of license or authorisation will provide a sanction if such schemes are instituted for alternative medicine practitioners, whether under the terms of the proposed new Health Personnel Act or under a possible special licensing scheme. The question whether to institute such schemes is discussed in more detail in section 15.4, see section 15.4 in this summary.

The Committee does not suggest expanding or formalising the statutory supervision that the Norwegian Board of Health and County Medical Officers carries out to alternative medicine activities. If alternative practitioners get authorisation under the proposed new Health Personnel Act, the oversight regulations that cover health personnel will automatically apply. If special authorisation rules are established, then the Committee's opinion is that a special report is required which also should look into the issue of supervision.

Regulation in the form of right to register or licensing and authorisation is discussed in detail in sections 15.3 and 15.4, which are described in the identical section numbers in this summary.

Similarly, refund from the National Insurance is discussed in section 15.5 and described in section 15.5 in this summary. The Committee has not found grounds to propose or discuss other statutory grant schemes.

The question of whether a special provision should be introduced whereby patients shall have a right to receive treatment from alternative medicine practitioners is dealt with in section

5.14.3 Non-legal measures

Section 14.3 provides a summary of possible measures of an educational, organisational and economic nature.

Among the educational measures named are an «information bank», research efforts and dissemination of knowledge by general information and educational activities.

Among the organisational measures mentioned are local collaboration projects and projects in institutions and public health.

Economic measures might include funds for local government and county councils, for general public information, for research purposes, and for co-operative projects between the health service and alternative therapists.

The Committee's proposals for measures that should be implemented are given in section 15.6.

5.15 Committee's evaluations and proposals

5.15.1 Evaluations of principle

Section 15.1 provides an account of the views that the Committee is particularly concerned with in its proposals.

The whole Committee supports the descriptions and evaluations given in the foregoing chapters 1 through 13. The Committee members approached the common formula from different starting points, and have not always shared the same justifications for the conclusions drawn based on those chapters. However, all Committee members wish to see progress in relation to alternative medicine.

The Committee desires knowledge of alternative medicine to increase and for the patient to have an opportunity to draw benefit from this knowledge, so that the freedom of choice is more genuine and the patient's safety is enhanced. The Committee considers that the patient's best interests, including concerns of self-determination, protection of patient security and the need for treatment, are paramount.

The Committee also desires greater co-operation between alternative medicine and conventional medicine to meet patients' needs. Greater co-operation can also help render alternative medicine practitioners more visible. Some members desire a development that promotes alternative medicine as a complementary offer in addition to conventional medicine treatments, while others want to assess the development before they take a stand on this issue.

Other concerns that the Committee has highlighted are the information we have that many people consult alternative therapists and that the majority is satisfied with the treatment, and that the attitudes to alternative medicine among health personnel are in flux, from dismissive to neutral acceptance.

The range of alternative medicine analyses and treatment forms is large and varied. It is not easy for a patient to find his or her way in this market, or to know what forms of therapy might have a positive effect, and for what illnesses, and which practitioners are serious. Some members want to emphasise that some patients believe they were misled and exploited in their contact with alternative medicine.

The Committee finds that the patients' best interests are to expand the total knowledge about treatment methods. Therefore one should be open to all serious attempts to acquire systematic knowledge. The research methods must be adapted to the object and goals of the research.

The Committee believes that treatment methods to be offered by a public health authority should be adequately documented as efficacious and helpful. Most forms of alternative medicine are today inadequately documented in the Committee's judgement. There exists a research challenge to obtain further knowledge about the efficacy of alternative medicine, particularly considering that so many patients are satisfied with their treatment.

The Committee's mandate asks for an evaluation of the place that alternative medicine should have in connection with the established health service in the future. The Committee will not make proposals on a general basis for inclusion of alternative medicine within the established health service. The Committee prefers to propose measures that can help bring alternative medicine and conventional medicine closer together in a way that the people involved consider fruitful.

The Committee's proposals for measures fall into two main categories - legal measures and other measures, including organisational, educational and economic.

The Committee proposes changes in the criminal restrictions on accepting patients for treatment. It is suggested that the rules be included in the proposed new Health Personnel Act. New, more modern legal rules can spur enforcement of the rules as intended. The Committee suggests weakening the doctors' monopoly on treatment of serious illnesses and complaints, since the Committee recognises the patient's right to self-determination. The Committee further suggests a voluntary registration scheme regulated by law and a statutory vow of confidentiality for alternative medicine practitioners. For more about these proposals see sections 15.2 and 15.3. Beyond this the majority in the Committee do not wish to recommend further legal or regulatory measures for alternative medicine activities at this time.

The Committee itemises other measures that the health authorities can and should make use of to promote developments in relation to alternative medicine and increase the co-operation between alternative medicine practitioners and the established health service. In the Committee's evaluation the measures should be designed such that they reflect the varying needs, and such that a large range of good treatment offers is available. They should be flexible and suitable for researching the utility of new co-operation forms and alternative medicine treatments. They should therefore be directed at concrete projects or limited trials and be suited to local conditions, including the patient's needs and desires, available personnel resources, and willingness to work together between health personnel and alternative medicine practitioners. Therefore these measures should not be legal in nature, in the sense that alternative medicine practitioners or the health service by law or regulation are assigned obligations or rights. Instead, organisational, educational and economic measures should be used.

5.15.2 Criminal regulation

The unanimous Committee proposes in section 15.2 the repeal of the Medical Quackery Act and for criminal provisions about non-health personnel therapists to be written into a new chapter in the proposed new Health Personnel Act. This conforms to the proposal in the Ministry of Social Affairs and Health's consultative memorandum of summer 1997. The Committee finds it expedient for the Medical Quackery Act to be replaced by more modern legislation, that can be enforced in line with the presuppositions underlying the regulation.

The Committee's proposal also implies real changes both in relation to today's Medical Quackery Act, to the bill proposed in Odelsting Proposition no. 13 for 1998-99 relating to an Act for Health Personnel etc, and the consultative draft already mentioned. The Committee's proposal means that alternative medicine practitioners get an expanded access to treat patients with serious illnesses. The Committee is very concerned about the patient's right of self-determination and proposes that adults, who are competent to both grant consent and reject conventional medicine treatment, should personally be able to choose to receive alternative medicine treatment without this triggering criminal liability for the therapist. For children and others who are incompetent to give such consent and are suffering from serious disease, the Committee proposes that alternative medicine treatment can be given without prosecution if the health service has no healing or alleviating treatment to offer. In all cases the presumption must be that treatment takes place in co-operation with, or in mutual understanding with, a doctor.

The Committee proposes further that a statutory vow of confidentiality be instituted for non-health service therapists.

5.15.3 Registration scheme

A unanimous Committee suggests the establishment of a register for practitioners of alternative medicine. The register should be open to health and non-health personnel alike who wish to apply alternative medicine treatment methods. The purpose of such a register and the criteria for registration, etc, are discussed in section 15.3.

The purpose of a registration scheme is to distinguish between practitioners based on a set of criteria. In the Storting decisions that underlie the appointment of the Committee, it says, «the work to distinguish the serious practitioners of alternative medicine in a special register must be intensified». The concept «serious practitioner» and what it implies is not straightforward. The same can be said of setting up a registration scheme that distinguishes between «serious» and «spurious» practitioners.

The Committee proposes that the criteria for registration should be that the practitioner of a profession is a member of a professional organisation for practitioners of alternative medicine, that he or she has taken out liability insurance and can document his or her business for the past year with the annual report, or general business report, or declaration from an employer. The Committee proposes that the Ministry of Health and Social Affairs should accredit organisations where membership will provide grounds for registration. Among other things the association must make qualification requirements for membership, have professional ethical rules and a disciplinary system for considering complaints about members' professional conduct, with the option of exclusion, and have a minimum of 30 members. The Committee has considered if a requirement for a minimum competency level in basic medical subjects should be enforced, and perhaps also a competency level in the relevant alternative medicine treatment form, but has rejected this. The Committee's proposals regarding legal authorisation and a scheme of Regulations for Registration of Alternative Therapists are given in sections 15.3.6 and 15.3.7.

5.15.4 Licensing and authorisation scheme

The Committee discusses in section 15.4 if a scheme of licensing or authorisation should be introduced for practitioners of alternative medicine. Such schemes would imply more than registration, and would predicate greater official involvement. Requirements would be made for education and practice and there would be regulatory supervision, etc.

The Committee points out that groups of alternative medicine practitioners can apply for an authorisation scheme to be established under the proposed new Health Personnel Act. If there is a need or basis for an authorisation scheme, then the same general criteria should be brought to bear as for (other) health personnel. The Committee finds it unnecessary and rather unfruitful to suggest a special licensing scheme for alternative medicine practitioners. A special scheme would create uncertainty and confusion, and help sustain the perception that there is a sharp distinction between such practitioners and health personnel. The Committee does not decide whether, and if so which groups of, alternative medicine practitioners should be given authorisation under the proposed new Health Personnel Act. The proposal contains something about the criteria that should be highlighted in the application for an authorisation scheme for a new group.

5.15.5 Refunding from National Insurance

The question of whether to introduce a scheme of refunds from the National Insurance for alternative medicine treatment is discussed in section 15.5. The Committee majority considers that no such scheme should be introduced. They point out that other authorised health personnel do not necessarily receive a refund for treatment. For instance adult patients do not get a refund for ordinary dental treatment. One argument against introduction of a refund is also the low level of documented efficacy, see chapter 13. The fact that there exists inadequate scientific documentation of the efficacy of some conventional medicine treatment measure that qualify for refunds is not an argument to expand the refund scheme to cover other weakly-documented forms of treatment. The introduction of a refund for more types of treatment would also drive up the public expenditure on the health sector. The Committee's majority believes that, if public funds are to be used on alternative medicine, they should be channelled to other measures besides refunds. First and foremost measures should be chosen that increase the knowledge about alternative medicine and enhance co-operation between the established health service and practitioners of alternative medicine, see section 15.6. In practice the introduction of a refund scheme for alternative medicine treatment would unleash many difficult differentiation problems.

The minority suggests the introduction of a refund scheme for treatment by alternative medicine practitioners who are registered in the register proposed by the Committee, see section 15.3. One criterion for refund in that case would be that co-operation is established between a doctor and the alternative therapists and that experience shows that the alternative medicine treatment has a positive effect on the patient's health and welfare. The treatment must be of considerable significance for the patient's functional capacity.

5.15.6 Proposals for other non-legal measures

The Committee proposes using non-legal measures to enhance the knowledge about alternative medicine and promote co-operation between alternative medicine practitioners and the established health service. The committee proposes the establishment of an «information bank». This «bank» can collect and store current information about alternative medicine.

The Committee considers that measures should be initiated to upgrade the research effort in alternative medicine. One should consider if a Centre for Alternative Medicine Research should be set up at one of the universities, among other things to foster a coherent research environment. The «information bank» can be located to this research centre. The Committee considers that in connection with this Centre, one should consider opening an Information Office responsible for disseminating information about various aspects of alternative medicine research and therapy.

Health personnel education should also embrace an introduction to alternative medicine treatment forms, etc, so that health personnel are acquainted with the field.

Further, the Committee proposes that funds be appropriated for co-operative projects. These measures should be flexible, investigative and suited to local conditions. The Ministry of Health and Social Affairs on application should allocate the funds.

The Committee proposes that funds be provided for implementation of the measures mentioned. The Committee suggests the amount of 100 million NKR over a five-year period.

5.16 Economic and administrative consequences

The Committee finds that its proposals for changes in the criminal regulation of alternative medicine treatment activities will not have economic or administrative repercussions relative to present-day legislation.

The registration scheme for practitioners of alternative medicine treatment methods as proposed by the Committee will only predicate minor organisational consequences for the national registries at Brønnøysund. The Committee proposes that the expenses of establishment and operation of the register be defrayed by registration fees and an annual fee from those registered, so that the registration scheme essentially has no economic impact on public finances.

The Committee proposes appropriation of an amount of 100 million NKR over a five-year period to be used first and foremost on other (non-legal) measures. This constitutes the Committee's priority focus area for development of alternative medicine. The funds include certain minor expenditure items that currently figure in the National Budget.

5.17 Draft legislation and regulations with comments

Finally in the Report the Committee includes its proposal for legal revisions and a scheme covering Regulations for Registration of Alternative Therapists, plus comments on the various provisions in the draft.

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