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SYSTEMATIC REVIEW

Complementary and Alternative Medicine (CAM) 2007

Complementary and Alternative Medicine (CAM) A Systematic review of Intervention Research in Sweden Irene Jensen1, Chair Mats Lekander2 Carl Erik Nord3 Anders Rane4 Christin Ekenryd5

April 2007

Osher Center for Integrativ Medicin

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Professor, Dep Clin Neuroscience, Section for Personal Injury Prevention, Karolinska Institutet Associate professor, Director, Dep Clin Neuroscience, Osher Center for Integrative Medicin and Section of Psychology, Karolinska Institutet 3 Professor, Dept of Laboratory Medicine, Div of Clin Microbiology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden 4 Professor, Dept of Laboratory Medicine, Div of Clin Pharmacology, Karolinska Institutet at Karolinska University hospital, Stockholm, Sweden 5 BSc, Dep Clin Neuroscience, Section for Personal Injury Prevention, Karolinska Institutet 2

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FÖRORD I regleringsbrevet för 2006 fick FAS i uppdrag att ”redovisa vilka insatser som har gjorts för att främja forskning till stöd för en evidensbaserad utveckling av hälso- och sjukvården inom alternativ och komplementär medicin”. Uppdraget diskuterades med en forskargrupp vid Karolinska institutet under ledning av professor Irene Jensen, vilket resulterade i en avgränsning av uppdraget till en inventering av de effektstudier som gjorts avseende det som kan klassas alternativa eller komplementära medicinska insatser. Forskargruppen anlitades för att göra detta. I rapporten konstateras att användning av alternativ och komplementär medicin har en stor och växande utbredning i det svenska samhället. I Stockholm genomfördes kartläggningar 1980 och 2001 av andelen personer som använt alternativ eller komplementär medicin, och man fann då att den andelen hade ökat från 22 procent till 49 procent. Det rör sig då vanligen om massage, naturprodukter, akupunktur och naprapati. Någon riksrepresentativ svensk studie finns inte. Motsvarande siffror från studier i Danmark, Norge och USA varierar mellan 35 och 45 procent. Den omfattande användningen av alternativ och komplementär medicin motsvaras inte av någon omfattande forskning där dessa mediciner och behandlingsformer utsätts för vetenskaplig prövning. Endast 56 sådana studier kunde identifieras, de flesta av dem med inriktning på utvärdering av behandling av muskuloskeletal smärta. Forskning inom fältet bedrivs i huvudsak vid Göteborgs universitet, Karolinska institutet och Linköpings universitet. De studier som publicerats efter refereegranskning var publicerade i tidskrifter med låg ”impact” och var även förhållandevis lågt citerade. Vidare konstaterar utvärderarna att studierna ofta var gjorda på mycket små urval och ofta med enbart kvinnor i urvalen. Studier av biverkningar förkom inte heller särskilt ofta. Finansiärer av forskning om alternativ och komplementär medicin är framför allt privata stiftelser eller landsting. Ekhagastiftelsen är den främsta finansiären av denna forskning och har finansierat ungefär lika mycket som landstingen och Vetenskapsrådet tillsammans. Rapporten påtalar behovet av att bättre kartlägga användningen av alternativ och komplementär medicin, och med tanke på dess stora och sannolikt växande utbredning är behovet av kvalificerad forskning om alternativ- och komplementärmedicinens effekter stor.

Rune Åberg Huvudsekreterare Forskningsrådet för arbetsliv och socialvetenskap

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CONTENTS Introduction......................................................................................................................... 5 Definition of complementary and alternative medicine.................................................. 5 Complementary and alternative medicine in an international perspective ..................... 7 Complementary and alternative medicine in Sweden..................................................... 8 Intervention research....................................................................................................... 8 AIM................................................................................................................................. 9 Procedure .......................................................................................................................... 10 Database searches ......................................................................................................... 10 Survey to researchers .................................................................................................... 11 Survey to research funding institutions......................................................................... 11 Results............................................................................................................................... 12 Diagnoses and types of interventions used in Swedish research .................................. 12 Funding organizations................................................................................................... 14 Survey to organizations............................................................................................. 14 Grant sources identified in published papers and reported by researchers............... 18 Review of internationally published papers.................................................................. 19 Alternative Medical Systems .................................................................................... 19 Mind-body interventions........................................................................................... 26 Biologically Based Therapies ................................................................................... 30 Manipulative and Body-based Methods ................................................................... 32 Results from survey to researchers ............................................................................... 36 Summary and Discussion.................................................................................................. 38 Identifying CAM research in Sweden - limitations ...................................................... 38 Study population ........................................................................................................... 38 Cost-effectiveness ......................................................................................................... 38 Adverse events .............................................................................................................. 39 Quality of studies .......................................................................................................... 39 Research groups ............................................................................................................ 40 Research funding .......................................................................................................... 40 Conclusions................................................................................................................... 40 Implications for research................................................................................................... 41 References......................................................................................................................... 42

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INTRODUCTION Definition of complementary and alternative medicine In this review we adhere to the definition of complementary and alternative medicine (CAM) as defined by the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH), USA. The definition of CAM is: “CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. - Complementary medicine is used together with conventional medicine. An example of a complementary therapy is using aromatherapy to help lessen a patient’s discomfort following surgery. - Alternative medicine is used in place of conventional medicine. An example of an alternative therapy is using a special diet to treat cancer instead of undergoing surgery, radiation, or chemotherapy that has been recommended by a conventional doctor.“ (NCCAM, Publication No. D156, 2002).

According to the definition, it is the application and purpose of the CAM intervention that determines whether it is to be regarded as complementary or alternative medicine. Consequently, the present report is structured in accordance with the NCCAM classification of CAM therapies into five domains. These five domains are, as described by NCCAM: “1. Alternative Medical Systems Alternative medical systems are built upon complete systems of theory and practice. Often, these systems have evolved apart from and earlier than the conventional medical approach used in the United States. Examples of alternative medical systems that have developed in Western cultures include homeopathic medicine and naturopathic medicine. Examples of systems that have developed in non-Western cultures include traditional Chinese medicine and Ayurveda. 2. Mind-Body Interventions Mind-body medicine uses a variety of techniques designed to enhance the mind’s capacity to affect bodily function and symptoms. Some techniques that were considered CAM in the past have become mainstream (for example, patient support groups and cognitive-behavioral therapy). Other mind-body techniques are still considered CAM, including meditation, prayer, mental healing, and therapies that use creative outlets such as art, music, or dance. 3. Biologically Based Therapies Biologically based therapies in CAM use substances found in nature, such as herbs, foods, and vitamins. Some examples include dietary supplements, herbal products, and the use of other so-called natural but as yet scientifically unproven therapies (for example, using shark cartilage to treat cancer).

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4. Manipulative and Body-Based Methods Manipulative and body-based methods in CAM are based on manipulation and/or movement of one or more parts of the body. Some examples include chiropractic or osteopathic manipulation and massage. 5. Energy Therapies Energy therapies involve the use of energy fields. They are of two types: • Biofield therapies are intended to affect energy fields that purportedly surround and penetrate the human body. The existence of such fields has not yet been scientifically proven. Some forms of energy therapy manipulate biofields by applying pressure and/or manipulating the body by placing the hands in, or through, these fields. Examples include qi gong, Reiki, and Therapeutic Touch. • Bioelectromagnetic-based therapies involve the unconventional use of electromagnetic fields, such as pulsed fields, magnetic fields, or alternating-current or direct-current fields.”

(NCCAM, Publication No. D156, 2002)

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Complementary and alternative medicine in an international perspective Using definitions of CAM such as the one given by NCCAM, a treatment modality may be regarded as CAM in one country but not in another, depending on whether the treatment is represented in conventional health care settings or not. In parts of the world where allopathic medicine is less dominant, the term traditional medicine is therefore more usable. The prevalence of the use of traditional medicine has been estimated to be up to 80% in African countries, 70% in India, and about 40% of all health care delivered in China (WHO 2002). Several surveys in the USA indicate a high consumption of CAM (Eisenberg, Kessler et al. 1993; Eisenberg, Davis et al. 1998; Barnes, Powell-Griner et al. 2004). Based on over 31 000 interviews, a study from the National Center for Health Statistics indicated that 36% of American adults had used some form of CAM therapy (self- or practitioner-provided) during the last 12 months (Barnes, Powell-Griner et al. 2004). Eisenberg and colleagues (Eisenberg, Davis et al. 1998) reported the use of at least one of 16 CAM therapies to amount to 42% during the last year. The corresponding figure from a similar survey conducted in 1990 was 34%, indicating an increase in CAM use. However, a fourth often-cited study (Druss and Rosenheck 1999) noted substantially lower numbers. In that study 6.5% of 16 068 adults, had consultations for both unconventional therapies and conventional care, while 1.8% used only conventional services (Druss and Rosenheck 1999). One reason for the discrepant findings may be that only practitioner-based therapies were included in the latter study. Other reasons for the often discrepant findings of CAM prevalence, such as use of divergent definitions and recall bias in retrospective studies, are discussed in a recent article by Edzard Ernst (Ernst 2006). In Denmark, ever-use of CAM was reported to be 45% in a national representative sample, while the corresponding figure for Norway was 34% (Hanssen, Grimsgaard et al. 2005). However, the figures are not completely comparable as both visits to practitioners and self-provided therapies were reflected in Denmark, but only visits to practitioners in Norway. The authors concluded that the use of CAM appeared to have increased in the Scandinavian countries (including Sweden; see below) compared to earlier estimations (Hanssen, Grimsgaard et al. 2005). Also when investigating specific patient populations, CAM use appears to be considerable. For example, Richardson and Straus (Richardson and Straus 2002) discussed the challenges and opportunities of CAM use in cancer patients. In 14 investigations including different cancer populations, CAM use ranged from 20% to over 80%. Importantly, rates of non-disclosure to physicians were substantial, meaning that, to a large extent, health-related issues are not discussed with a physician. In the studies of the general population by Eisenberg and co-workers, nondisclosure rates exceeded 60% in both 1990 and 1997 (Eisenberg, Kessler et al. 1993; Eisenberg, Davis et al. 1998). As is clear from the above, surveys may be attended by considerable uncertainty in prevalence estimates of CAM use. As shown in a recent review, the vast majority of CAM prevalence surveys fail to fulfil criteria that would yield more reliable and 7

comparable estimates (Ernst 2006). The true use of CAM therapies in the populations discussed above and below is still not known. Complementary and alternative medicine in Sweden In conformity with other Western countries, the use of CAM appears to be high in Sweden. However, studies on CAM use have not been made in representative samples of the Swedish population. The only larger study conducted in more recent years is a survey of inhabitants of Stockholm (Eklöf M 2001). A random selection of 1001 Stockholmers were interviewed by telephone about their experiences of and attitudes to different aspects of health care and treatment, including CAM. Forty-nine per cent of the participants had at least once (ever use) consulted what they considered to be a CAM practitioner. The corresponding number for Stockholmers from a survey conducted in the 1980s was 22% (Alternativmedicinkommittén 1987), indicating that CAM use had more than doubled in Stockholm during the last 15 years. The most common CAM therapies (>10% ever-use) were massage, natural products, chiropractics, acupuncture and naprapathy. Less common therapies (37 gestational weeks with a spontaneous onset labour/ 100 / 100%

RCT

Pain intensity and relaxation during delivery

Kvorning N, et al. 2004

Acupuncture/no treatment

Pregnant women reporting pelvic or low-back pain/ 72 / 100%

RCT

Pain

Kvorning Ternov N, et al. 2001

Acupuncture

Lower back and pelvic pain during late pregnancy 167 / 100%

Observational Retrospective

Analgesic effect Adverse effects

Carlsson M, et al. 2004

Anthroposophic medicine/convention al care

Breast cancer 72 / 100%

NRCT

Quality of life

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Acupuncture reduced the need for epidural analgesia and gave a significantly better degree of relaxation compared to control. Pain intensity decreased significantly more over time in the acupuncture group The analgesic effect of acupuncture was reported as good or excellent in 72% of the cases. 21% of the patients reported transient dizziness or tiredness due to the treatment. No other adverse effects were reported. Anthroposophic medicine gave a small or moderate increase in quality of life/life satisfaction

BJOG /2.17/18

17,18

No

Acta Obster Gynecol Scand/ 1.55/7 Pain Med/ 2.22/3

No information

No

No information

No

Acta Oncol / 2.36/5

42,43,44, 45

No

Magnusson A-L, et al. 2004

Acupuncture/ sham acupuncture

Allergic rhinitis 40 / 63%

RCT

Symptoms of allergic rhinitis Specific IgE Scin test reaction

Arman M, et al. 2001

Complementary care/ Conventional care

Breast cancer 59 / 100 %

Observational

Change in life perspective

Gejervall AL, et al. 2005

Electro-acupuncture/ Conventional analgesia

Women undergoing IVF 160 / 100%

RCT Open

Pain intensity Well-being Time for mobilization Duration of surgery Drug consumption

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For one allergen, mugwort, greater reduction in specific IgE and skin test reaction. No differences in clinical symptoms In the patients in compl care, selfconfidence and experience of strength improved, and they regarded life as being more enriched. Changes in ideas of how to achieve well-being and health CA less pain at oocyte aspiration and after retrieval compared to EA. 60 min after surgery no difference. No diff in well-being. EA group was significantly less tired and confused after oocyte aspiration. No differences in time for surgery and costs for drug consumption were noted

Am J Chin Med / 0.74/2

No Information

No

Eur J Cancer Care (Engl) / 0.91/6

42,43,44, 45

Finland

Hum Reprod / 3.67/4

38,39,40, 41

No

Hammar M, et al. 1999

Acupuncture.

Nedstrand E, et al. 2005

Applied relaxation / electro-acupuncture

StenerVictorin E, et al. 2004

Electro-acupuncture + patient education / Hydrotherapy + patient education / patient education (control)

StenerVictorin E, et al. 1999

Electroacupuncture /intravenous alfentanil.

Söderberg E, et al. 2006

Acupuncture / relaxation training / physical training

Wyon Y, et al. 2004

Electro-acupuncture/ oral oestradiol Electro-cupuncture/ superficial needle insertion (placebo)

Vasomotor symptoms due to castration 7 / 0% Breast cancer and Vasomotor symptoms / 31 / 100% Osteoarthritis 44 / no information

Observational

Vasomotor symptoms

RCT Open

Vasomotor symptoms

RCT

Pain Quality of life

Women undergoing in-vitro fertilization (IVF) and embryo transfer 150 / 100 % Chronic tension-type headache 90 / 73%

Multicentre trial RCT

Pain Nausea

RCT Open

Headache

vasomotor symptoms 44 / 100 %

RCT

Vasomotor symptoms

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Decrease in the number of hot flushes No difference

J Urol / 3.59/32

36

No

Climacteric / 2.30/2

7, 31,20, 36

No

EA reduced pain intensity and improved QoL longer than hydrotherapy. Both EA and hydrotherapy better than patient education only No differences

Clin J Pain / 2.71/2

10

No

Hum Reprod / 3.67/26

20,37

No

Cephalgia / 4.66/n.l

32,33,34, 35

No

Climacteric

7, 20, 30,.31

No

Number of headache-free periods and headache-free days was higher in the relaxation group compared with the acupuncture group. Less effect of EA compared to oestradiol. No difference between EA and superficial needle insertion.

/ 2,30/7

Carlsson J, et al. 1990

Acupuncutre / Physiotherapy

Chronic tension headache 62 / 100%

RCT

Wenneberg et al. 2004

Qigong/standard treatment

Muscular dystrophy/36 patients/17 females

RCT Open

List T, et al. 1992

Acupuncture/ Occlusal splint therapy/ No treatment

Craniomandibular disorder 110 / 79%

RCT Open

List T, et al. 1992

Acupuncture/ Occlusal splint therapy

Craniomandibular dysfunction 61 / 72%

RCT

* n.l=not listed,

Overall function Mental wellbeing Intensity and frequency of headache Health related quality of life, coping, depresion Pain

Adverse effects

¤ See tab 4 for explanation

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Physiotherapy reduced pain, improved overall functioning and mental well-being.

Headache/ 2,46/17

67, 68, 69

No

Qigong maintained HRQoL

Disability and Rehabilita tion/ 0.99/5

16,17,18

No

Both acupuncture and occlusal splint therapy reduced symptoms compared with controls. Acupuncture gave better subjective results than occlusal splint therapy. Acupuncture led to adverse events of a more general nature, whereas, adverse events of occlusal splint therapy were locally related to the orofacial region

Swed Dent J / 0.57/30

20, 30

No

Cranio / 0.52/11

No information

No

Mind-body interventions

Mind-body medicine focuses on the interactions between the brain, mind, body and behavior and the ways in which such interactions affect health. Mind-body medicine is, in a way, a misnomer, because at least researchers in the area mostly oppose a dualistic view on the mind and body as different entities. Even though there are exceptions, the mind and body concepts refer rather to the level of observation or description and to the fact that the two levels are studied simultaneously. In this search there were 16 published papers eligible for inclusion (table 6) (Ragneskog, Brane et al. 1996; Lekander, Furst et al. 1997; Wijma, Melin et al. 1997; Palo-Bengtsson, Winblad et al. 1998; Strom, Pettersson et al. 2000; Gotell, Brown et al. 2002; Almerud and Petersson 2003; Gotell, Brown et al. 2003; Norberg, Melin et al. 2003; Wahlund 2003; Ikonomidou, Rehnstrom et al. 2004; Larsson, Carlsson et al. 2005; Lindemalm, Strang et al. 2005; Nedstrand, Wijma et al. 2005; Wikstrom 2005; Gustavsson and von Koch 2006). It should be noted that one of these publications (Larsson, Carlsson et al. 2005) was a synthesis of original data compiled from seven previously published studies of which only one (Fichtel and Larsson 2001) was retrieved in the original search. Therefore, the Larsson study (Larsson, Carlsson et al. 2005) represents 7 original studies, including the one by Fitchell et al.(Larsson and Melin 1986; Larsson, Daleflod et al. 1987; Larsson, Melin et al. 1987; Larsson, Melin et al. 1990; Larsson and Carlsson 1996; Fichtel and Larsson 2001; Fichtel and Larsson 2004). In general, the results of mind-body interventions are published in journals with a relatively low impact (mean impact = 1.85, range 0.65 – 4.97) or in journals for which impact ratings are unavailable (not listed (n.l.)=5). An exception is, to some extent, the studies that focus on relaxation, for which journals with a slightly higher impact are represented. The numbers cited according to the Science Citation Index (SCI) is, on an average 9, range 0-51 (1996-2006). Because relaxation can also occur in established medicine, the inclusion of such studies in a review of CAM research in Sweden can be questioned. In addition, cognitive-behavioral therapies were not included in the report (following NCCAM definitions of mind-body medicine (NCCAM 2007)in which relaxation or other stress-management strategies can be integrated. Due to methodological shortcomings, many studies are not conclusive, are hampered by small numbers of participants and inclusion of many study variables. One example is a study published twice in the Scandinavian Journal of Nursing Studies, 1986 (Norberg, Melin et al. 1986) and republished in 2003 (Norberg, Melin et al. 2003), in which the effects of three different manipulations (touch, music and object presentation) in the late stage of dementia were compared in a large range of outcome variables in only two patients. There is a clear predominance of women in the retrieved studies. Thus, 14 out of 16 studies are skewed towards overrepresentation of the female sex. This may be viewed in the context of findings of women’s higher consumption of CAM in Scandinavian 26

population studies (Hanssen, Grimsgaard et al. 2005), US populations (Eisenberg, Davis et al. 1998; Druss and Rosenheck 1999; Barnes, Powell-Griner et al. 2004) and in cancer patients (Richardson and Straus 2002). However, the prevalence of CAM use hardly explains the heavy skew towards representation of women in Swedish studies on mind-body interventions.

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Table 6. Description of the included published studies on mind-body interventions Author/year

Intervention/ control

Diagnosis/number of subjects/ % females

Study design

Main outcome

Main results

Journal/ Impact factor/SCI

Sponsor¤

International co operation

Ragneskog, 1996

Dinner music/control period without music

Dementia 24 / 50%

Observational Prospective

Increased food intake, decreases in irritability, fearpanic and depressed mood

Scand J Caring Sci/0.65/29

38,66

No

PaloBengtsson, 1998

Social dancing (part of regular duties)

Dementia 6 / 67%

Observational Cross-sectional and prospective

Food intake (and depressed mood, irritability and restlessness) Not clearly specified

No

Caregiver singing or background music/normal care

Dementia 10 / 80%

Observational Crossectional

Verbal communication

59,60,61,6 2,63,64

No

Götell 1 , 2003

Caregiver singing or background music/standard care Music, touch and object presentation

Dementia 10 / 80%

Observational Cross-sectional

Non-verbal communication

Journal of Psychiatric and Mental Health Nursing/ n.l./n.l Western Journal of Nursing Research/ 0.74/3 International Psychogeriatric /1.22/4

64, 65

Götell, 2002

Not disclosed

USA

Dementia 2 / 100%

Observational Prospective

Not clearly described

Social dancing supported postive feelings, communication and behaviour. Caregiver singing: increased understanding and cooperation. Background music: increased understanding Elongated posture, increased balance, physical strength and spatial awareness, especially during caregiver singing Results not consistent across the two subjects.

56,57,58

No

Lekander, 1997

Applied relaxation/no relaxation

Ovarian cancer 22/ 100%

NRCT Open Prospective

White blood cell counts

Increased lymphocyte counts after intervention

43, 55

No

Lindemalm, 2005

Multidisciplinary rehabilitation, incl. Physical exercise, relaxation and qigong Applied relaxation

Cancer 59/ 97%

Observational Prospective

Improvements in sickness, anxiety, depression and quality of life

43

No

Vasomotor symptoms 6 / 100%

Observational Prospective

Sickness symptoms, fatigue, anxiety, depression and quality of life Hot flushes

International Journal of Nursing Studies/ 0.84/ 2 Psychotherapy and Psychosomatics / 4.97/14 Supportive Care in Cancer/1.59/4

J Behav Ther & Exp. Psychiat /1.17/ 34

Not disclosed

No

Norberg, 2003

Wijma, 1997

1

Data collection appears to be identical with Götell et al. 2002.

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Decreased hot flushes

Nedstrand, 2005

Applied relaxation /oestradiol treatment

Vasomotor symptoms 30/100%

RCT Open Prospective

Hot flushes, mood

Ström, 2000

Applied relaxation implemented via the Internet/ waiting-list control

Recurrent headache 102 / 68%

RCT Open Prospective

Headache

Wahlund, 2003

Relaxation training + information or occlusal appliance + information/ information only Relaxation music pre- and postoperatively/blank CD Relaxation/ Attention control or self-monitoring of headaches Applied relaxation /treatment as usual (=physiotherapy)

Temporomandibular disorder 122 / 76%

RCT Single-blinded Prospective

Pain symptoms

Pain intensity, pain frequency and analgesic consumption significantly reduced with occlusal appliance

Laparoscopic surgery 60 / 100%

RCT Blind (single) Prospective RCT Open Prospective

Neck disorders 37 / 87%

RCT Open Prospective

Pain, nausea, well-being and vital signs Pain intensity, duration and headache-free days. Pain intensity, coping strategies

Almerud, 2003

Listening to music/ treatment as usual

NRCT Open

Blood pressure, heart rate

Wikström, 2005

Expressive arts

Adult intensive care patients in need of mechanical ventilation 20 / 60% Hospitalized children 6-9 years old 22 patients/ 45%

Observational Prospective

Not clearly described

Ikonomidou, 2004 Larsson, 2005 2

Gustavsson, 2006

2

Recurrent headache 292 / 90%

Collapsed data from seven previously published studies ¤ See table 4 for explanation.

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Decreased hot flushes in both study groups, but changes occurred faster in the estradiol group. Reductions in headache

Maturitas/2.0/2

20, 31, 36

No

Journal of Consulting and Clinical Psychology/4.0 2/51 Acta Odontol Scan/0.78/3

Not disclosed

No

11

Norway

Decreased respiratory rate preoperatively and opiod use postoperatively. Decreased headache-free days and peak headache intensity in relaxation group.

AORN Journal/ n.l/n.l.

Not disclosed

No

Headache/2.45/ 5

Not disclosed

Norway

No change in pain intensity in either group. Increased pain control in relaxation group. Some impairments in TAU group (pain medication, depressive signs, catastrophizing) Decreased systolic and diastolic blood pressure during listening to music

J Rehabil Med/1.8/n.l

8,51

No

Intensive and Critical Care Nursing/ n.l./n.1

Not disclosed

No

Pediatric Nursing/ n.l./n.l.

38

No

Children expressed fear, longing and powerlessness

Biologically Based Therapies

Biologically based therapies in complementary and alternative medicine use substances found in nature, bacteria, food and vitamins. Five publications with biologically based therapies met the criteria for this review (table 7) (Nguyen, Nguyen et al. 1996; Johansson, Andersson et al. 2001; Biorklund, van Rees et al. 2005; Klarin, Johansson et al. 2005; Sullivan and Nord 2006). The papers are published in journals with impact factors between 0.5 and 2.93 (mean 1.73) (1 not listed). The numbers cited according to the Science Citation Index (SCI) are, on an average, 2, range 0-5 (1996-2006). In two studies the effect of lactobacillus administration on bacteraemia and rectal adhesion, respectively, in patients was found to be positive. One investigation showed that oat glucan improved the lipid and glucose metabolism in patients with elevated serum cholesterol. The water bark of Choerospondias axillaries healed second degree burns in another study.

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Table 7. Description of the included published studies on biological interventions Author/year

Intervention/ control

Diagnosis /number of subjects / % females

Study design

Main outcome

Main results

Björklund M et al. 2005

Oat glucans/ Beverage

Milded elevated serum cholesterol/89/ 51%

RCT Single blind

Effect of oat

Improved lipid and glucose metabolism

Nguyen et al. 1996

Water extract of the bark of Choerospondias axillaris/ Saline guaze

Second degree burns /39 /31%

RCT Open

Convenient treatment of burns

Sullivan Å, et al. 2006

Probiotic lactobacilli

Bacteraemia /74 /unknown

Observational Single-blind

No bacteraemia

Johansson G et al. 2001

Salinum/ Salinum + chlorhexidine/ placebo (water) Lactobacillus plantarum/ Enteral formula

Sjögren’s syndrome /22 /91%

NRCT Double-blind

Mouth dryness

Critically ill patients /17 /41%

RCT Open

Effect of adhesion to mucosa

Klarin B et al. 2005

glucans

¤ See table 4 for explanation.

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The water extract of the bark of Choerospondias axillaries heals second degree burns in patients Probiotic lactobacilli do not cause bacteraemia Positive effects with Salinum and Salinum + chlorhexidine Lactobacillus plantarum adheres to the rectal mucosa in critically ill patients

Journal/ Impact factor/ SCI Eur J Clin Nutr/ 2.16/n.l Scand J Plast Reconstr Hand Surg/0.5/2

Sponsor¤

International cooperation

28

27

The Netherlan ds Vietnam

Scand J Infect Dis/1.31/1 Gerodonto logy / n.l./5

25

No

87,88

No

20,21,22,2 3,24

No

Crit Care/ 2.93/n.l

Manipulative and Body-based Methods

Manipulative and body-based methods in complementary and alternative medicine are based on manipulation and/or movement of one or more parts of the human body. Fourteen publications describing manipulative and body-based methods have been reviewed (Skargren, Carlsson et al. 1998; Leboeuf-Yde, Axen et al. 1999; Lundblad, Elert et al. 1999; Axen, Rosenbaum et al. 2002; Grunnesjo, Bogefeldt et al. 2004; Axen, Jones et al. 2005; Axen, Rosenbaum et al. 2005; Bodin, Fagevik Olsen et al. 2005; Hammer, Nilsagard et al. 2005; Leboeuf-Yde, Axen et al. 2005; Agren and Berg 2006; Fagevik Olsen, Elden et al. 2006; Heyman, Ohrvik et al. 2006; Palmgren, Sandstrom et al. 2006). The papers are published in journals with impact factors between 0.65 and 2.19, mean 1.08, (1 not listed) i.e. an impact factor lower than for the other fields reviewed in this report (table 8). The numbers cited according to the Science Citation Index (SCI) are, on an average, 6, range 0-51 (1998-2006). The majority of the articles have been studies on patients with different pain syndromes, i.e. back pain, pelvic pain and neck pain. Most trials showed an improvement in the pain syndromes after physiotherapy or chiropractic care. Two publications pertain to obstetrics: severe nausea/vomiting during pregnancy and nerve stimulation for post-partum pain. The papers demonstrated a positive effect on the symptoms. Female patients with neck-shoulder complaints had positive experiences after Feldenkrais intervention but not after physiotherapy. Cervical cord lesions in patients were not improved after applying an abdominal binder to prevent respiratory complications. Spinal manipulative therapy resulted in minor improvement in patients with non-musculoskeletal symptoms. There is a small predominance of women (57%) in the reviewed trials which may reflect the fact that manipulative and body-based methods involve both female and male patients in the same range. Most of the RCT studies reviewed suffer from small sample sizes.

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Table 8. Description of the included published studies on manipulative and body-based methods Author/year

Intervention/ control

Diagnosis/number of subjects / % females

Study design

Main outcome

Main results

Journal/ Impact factor/SCI

Sponsor¤

Lundblad et al. 1999

Feldenkrais/ physiotherapy

Neck, shoulder complaints /97 /100%

RCT Open

Decrease in complaints

Chiropractic care

Low back pain /615 /49%

Observational retrospective study

J Occup Rehabil/ 1.65/ 12 J Manipulativ e Physiol Ther/ 0.76 /4

15

Axen et al. 2002

Neck, shoulder complaint Pain relief

International cooperation No

5

Denmark

Axen et al. 2005

Chiropractic care

Low back pain /674 /41%

Observational retrospective study

Pain relief

J Manipulativ e Physiol Ther/ 0.76/ 2

5

Denmark

Palmgren et al. 2006

Chiropractic care/No treatment

Cervical pain syndrome /37 /65%

RCT Open

Pain relief

14

No

Hammer A et al. 2005

Hippotherapy/

Multiple sclerosis 11 / 82%

NRCT Single-blind Open

Positive response in patients with multiple sclerosis

J manipulative Physiol Ther/ 0.76/ n.l Physiothera py Theory and Practice/ n.l./ n.l

Research Committee 6,17

No

33

In patients with persistent low back pain it is possible to predict which patients will report improvement early on during treatment In patients with nonpersistent low back pain, it is possible to predict by the second visit which patients may report improvement at the fourth visit Chiropractic care alters chronic neck pain

Balance improvement in 10 patients

Back and neck pain /323 /No information

RCT Open

Pain

No difference

Spine/ 2.19/ 51

11,12

No

Low back pain /160 /43%

RCT Open

Pain Disability

Reduced pain and disability compared to advice

No

Low back pain /1061 /56%

Observational retrospective study

Predictive model for treatment of back pain

Low back pain nonresponding patients should be carefully monitored

5

Denmark

Leboeuf-Yde et al. 2005

Chiropractic care

Low back pain /1054 /No information

Observational retrospective study

Specific subgroups were identified in relation to past year history of low back pain

5

Denmark

Leboeuf et al. 1999

Manipulative therapy

Non-muskuloskeletal symptoms /1504 /55%

Observational retrospective study

Treatment of patients with low back pain can be predicted Nonmusculoskeletal reactions

J Manipulativ e Physiol Ther/0.76/4 J Manipulativ e Physiol Ther/ 0.76/ 1 J Manipulativ e Physiol Ther/ 0.76/ n.l

8

Axen et al. 2005

Chiropractic care/physiotherapy Manual treatment/ advice to stay active Chiropractic care

J Manipulativ e Physiol Ther/ 0.76/ 9

5,19

Denmark

Bodin et al. 2005

Abdominal binder/ No abdominal binder

Cervical cord lesion /20 /15%

RCT Open

Respiratoy complications

Spinal Cord/ 1.07/ n.l

6,7

No

Heyman et al. 2006

Stretching

Chronic pelvic pain /50 /100%

RCT Open

Pain HRQL

Acta Obstetr Gyne/ 1.55/ n.l

No informatio n

No

Skargren et al. 1998 Grunnesjo et al. 2004

34

A small number of patients reported positive nonmusculoskeletal reactions after spinal manipulative therapy General use of abdominal binder to prevent respiratory complications is questionable Reduction of pain and improvement in quality of life

Fagevik-Olsen et al. 2006

Ågren and Berg 2006

High intensity, high frequency transcutaneous electric nerve stimulation/ low intensity stimulation Tactile massage/ No control

Newly delivered women /21/100%

RCT Single-blind

Pain

Decreased postpartum pain and discomfort than after low intensity stimulation

Acta Obstet Gyn/ 1.55/ n.l

No informatio n

No

Severe nausea and vomiting during pregnancy/10/100%

RCT Open

Nausea Vomiting

Reduced severe nausea and vomiting

Scand J Caring Sci/ 0.65/ n.l

13

No

¤ See tab 4 for explanation

35

Results from survey to researchers A total of 122 researchers were contacted and asked to respond to the questionnaire. Seventy-one responded and 20 of them answered that they did not conduct CAM research. Thus 51 researchers responded positively to the question concerning whether they conducted CAM research. Seven (17/51) researchers did not use the enclosed questionnaire to answer our questions. These responses were treated in this section as non-responses because of difficulties in identifying the requested information. However, published papers listed in the survey and not found in the database search were included in the literature review. Consequently, the results presented below are based on 34 responders and should only be interpreted as data from researchers and research groups that we were able to identify from the sources used. Furthermore, the overlapping between authors of published studies identified in the database search and researchers identified as being involved in CAM intervention research was small. Only 6 of 51 researchers who responded were also found in the database search of published international studies. However, the majority of the respondents had currently ongoing and thus not yet published studies. Seven researchers were conducting intervention research but they either worked with psychiatric diagnoses or used cognitive behavioural interventions. Hence their research was not within the scope of this report. One researcher was engaged in pure preclinical research. Other researchers (7) were either mainly conducting surveys with descriptions of the use of CAM or health-promoting interventions on healthy subjects. Consequently, from the 34 respondents, 19 researchers were identified as conducting CAM intervention research on humans with a disease or illness. Several intervention studies are ongoing and have attracted research grants from different sources. The principal investigators for the CAM studies with research grants are listed in table 9. The majority of the studies pertain to musculoskeletal pain and the application of manipulative or other body-based interventions. The research was conducted mainly at the Karolinska Institute and Göteborg University. As shown in table 6, few studies are funded by national governmental grant offices. Regional councils or private organizations are the most frequent funders.

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Table 9. Results from the survey to researchers. Principal investigators for CAM studies in intervention research in Sweden Name Diagnose Type of intervention Grant source¤ Academic affiliation Alfredsson, Lars Low back pain Manual medicine 20, 71, 70, ,73; 74 Karolinska Institute 84 Billhult , Annika Breast cancer Massage 71 Göteborg University Carlsson, Jane Neck pain Qigong 32 Göteborg University Olsson, Elisabeth Neck/low back Acupuncture 71 Karolinska Institute pain Axen, Iben Low back pain Manual medicine 5 Karolinska Institute Hagberg, Henrik Hjelmstedt, Anna Falkenberg, Torkel

Wenneberg, Stig Stener-Victorin, Elisabeth Cederholm, Tommy

Pelvic pain Labour pain Back pain, headache, gastrointestinal disorders, cancer Muscle dystrophy PCOS

Hamrin, Elisabeth

Alzheimer’s diseasee Breast cancer

Bränström, Richard

Cancer

Jacobsson, Catrine Constipation Wändell, Per Type 2 diabetes ¤ See table 4 for explanation.

Acupunctur Acupressure Massage therapy, Manual medicine, Shiatsu, Acupuncture Qigong, Rosen therapy, Qigong

71 69 67,72, 75, 76

Göteborg University Karolinska Institute Karolinska Institute

16, 71

Örebro University

Electro-acupuncture

20, 71, 77, 78 79,

Göteborg University

Omega 3

80, 81 83

Uppsala University

43, 44, 45, 68, 82

Linköping University

69

Karolinska Institute

20, 67, 85, 86

Umeå University Karolinska Institute

Anthroposophic medicine Mindfulness-based meditation Tactile massage Tactile massage

37

67, 71

SUMMARY AND DISCUSSION Identifying CAM research in Sweden – limitations This review is based on three different search strategies. Firstly, we used database searches of studies published in peer-reviewed international journals. Secondly, a survey of the researchers was conducted and, thirdly, a survey of funding organizations was performed. A librarian experienced in systematic database searches was engaged. Even though the search was performed with the Mesh term and keywords used for CAM categories both in Swedish and English listed in table 1, the overlap between the database search and reports from researchers was small. Many of the published studies listed in the responses from researchers were not identified in the database search. Furthermore, we found that some of the English terms had been translated incorrectly into Swedish and thereby led to incorrect search results. These inaccuracies were reported back to the library. Lastly, the labelling of terms in the databases is biased by human errors since it is based on the perception of the person actually labelling the study with the different MeSH terms. Thus, there are probably some published research or researchers that have not been identified in this search. The conclusions drawn below are based on the research presented in this review. Study population The true use of CAM interventions in Sweden is unknown. To establish the use and cost of CAM in Sweden, well-designed national surveys are needed. However, international surveys and published surveys of Swedish population samples reveal that CAM is used more by women than by men. The present review reveals that women are slightly overrepresented in the studies, both as study subjects and in terms of the representation of the sexes in the conditions studied. Cost-effectiveness The cost of CAM interventions is believed to consist mainly of out-of-pocket expenditures for the patients both internationally and in Sweden (Herman, Craig et al. 2005). Very little is known about the cost effectiveness of CAM interventions. Only 5 (9%) of the studies reviewed included some kind of cost-effectiveness analysis. Cost and effects can be evaluated using different approaches, depending mainly on what outcome parameters are used. In cost-effectiveness and cost–benefit analyses, comparisons between treatments can be made (Hansson 2005). In our review few studies have used parameters that can be evaluated in monetary terms, such as use of health care facilities, medication, sick leave or return-to-work figures. Some studies on cost effectiveness have however been conducted internationally. In one review, the authors conclude that the reporting quality of the majority of CAM studies is poor but comparable to studies in conventional medicine (Herman, Craig et al. 2005). There is a growing body of RCT studies in CAM including cost-effect analyses. In a cost-utility analysis RCT study comparing standard care to spinal manipulation, the results revealed slightly improved effects on the health- related quality of life (Qualy score) for the manipulation alternative but at a higher cost (Williams, Edwards et al. 2004). Similar results were presented in a Finnish RCT study comparing the same types of interventions (Niemisto, Rissanen et al. 2005). In another RCT study investigating

38

acupuncture for chronic headache, the authors conclude that acupuncture improved the quality of life (Qualy score) but at a higher cost compared to conventional care (Wonderling, Vickers et al. 2004). Adverse events Negative side effects of treatments are rarely reported in studies. International studies on risk and adverse effects have revealed risks with, for instance, manipulation and acupuncture (Ernst 2002; Weiger, Smith et al. 2002; Ernst 2003; Ernst 2006). In this review 11 of the 54 studies (20%) addressed adverse effects. This can be due to a reporting bias or a true state in which no side effects are evident (Ernst 2002). Another important issue not addressed in the reviewed studies is the interaction between the CAM intervention and treatment administered simultaneously by the conventional caregiver (Weiger, Smith et al. 2002). This topic is of interest in view of the very high rates of non-disclosure found in the international studies by EInsenberg et al (Eisenberg, Kessler et al. 1993; Eisenberg, Davis et al. 1998).

Quality of studies In this review our first criterion for quality was that the study had to be published in an international peer-reviewed journal. Secondly, we used the Journal Impact Factor (ISI Web of Knowledge/Journal Citation Reports) and the Science Citation Index (ISI Web of Knowledge/Web of Science) as indicators of the quality and impact of the research. These are commonly used indicators of the performance of single researchers or research groups. There are several studies showing the association between peer judgement and bibliometric indicators in discriminating between high and low quality (Lundberg 2006). The review of published studies revealed a relatively low mean journal impact factor (IF) in each investigated area. It exceeds a mean of 2 only in alternative medical systems. The highest IF overall was for studies investigating acupuncture. The two most frequently cited studies (Skargren, Carlsson et al. 1998; Strom, Pettersson et al. 2000), according to the Science Citation Index, were cited 50 times or more. Overall, most of the studies were cited less than 30 times. However, when interpreting the number of citations one must consider the time frame. Of the studies cited 30 times or more, all but one were published before 2000. The vast majority of the studies were published during the year 2000 or later. The majority of the studies were randomized controlled (32) or other controlled studies (5) but, overall the published studies suffer from small study samples which seriously endanger the possibility of determining the true effects of an intervention. Small study samples also prohibit the application of subgroup analyses that could establish whether the results of an intervention are modified by, for instance, gender, age or the severity of the disease of the participants.

39

Research groups Results from the questionnaire sent to researchers and published studies reveal that CAM intervention research is fairly young in Sweden. Only a few researchers were identified in the survey as conducting intervention research within the field and the research is carried out mainly at the Karolinska Institute, Göteborg University and Linköping University. However number of published studies and the increase in funding reported in the present summary indicate an increase during the last years. Research funding The funding of research in complementary and alternative medicine is small in size compared to other fields of medicine. For the year 2006, the major Swedish funding organizations devoted a total of 896,000,000 SEK to research projects in medicine. No governmental funding is specifically directed to CAM research. As a comparison, the NCCAM at NIH, USA, had at its disposal 122 000 000 USD in 2006 for research in CAM. Funding for CAM research in Sweden is obtained mainly from regional authorities or private foundations. However, in 2006 a new contributor arose who provided funding for projects and PhD students. In 2005 the Karolinska Institutet received a donation for a centre named the Osher Center for Integrative Medicine devoted to integrative Medicine, a term that encloses but is broader than CAM and which focuses on the integration of evidencebased knowledge from different disciplines and traditions to complement established medicine (www.ki.se/ocim). Conclusions Based on the results from this review, we conclude that: •

The CAM intervention research in Sweden is small-scaled.



Overall, the studies are published in journals with relatively low impact factors and are fairly little cited in the research community.



Overall, the published studies have small study samples, women are overrepresented, adverse effects are rarely reported and cost-effect are rarely analysed



Only a few identified researchers are at present conducting research in this field.



The research is carried out mainly at Göteborg University, the Karolinska Institute and Linköping University.



The funding obtained are minor compared to conventional medicine and are mostly received from private organizations and regional research funds.



The number of published studies and the reporting of ongoing studies indicate an increase in research within this field during the last five years.

40

IMPLICATIONS FOR RESEARCH In order to establish safe and effective treatments, the results of this review reveal that more research should be devoted to:

• a national survey of CAM consumption in Sweden with the purpose of determining • • • •

the use of CAM therapies, the type of interventions used and conditions treated high-quality intervention studies on CAM treatments offered and used in Sweden investigation of adverse effects and risks of CAM interventions subgroup analyses of differences in effects of CAM interventions health economic evaluations of CAM alternatives compared to conventional care

and further, efforts should be made to:

• ensure that research funding is allocated to high-quality CAM intervention research • encourage that intervention trials should be registered in international databases, such as Clinicaltrials.gov, to ensure access to publication in journals that follow the initiative of the International Committee of Medical Journal Editors (ICMJE) requiring prior entry of clinical trials in a public registry as a condition for publication.

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