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Abstract Extracts of Chinese red yeast rice (RYR, a traditional dietary seasoning of Monascus purpureus) contains several active ingredients including lovastatin, and several trials of its possible lipid-lowering effects have been conducted. This meta-analysis assesses the effectiveness and safety of RYR preparations on lipid modification in primary hyperlipidemia. We included randomized controlled trials testing RYR preparation, compared with placebo, no treatment, statins, or other active lipid-lowering agents in people with hyperlipidemia through searching PubMed, CBMdisk, TCMLARS, the Cochrane Library, and AMED up to December 2004. Ninety-three randomized trials (9625 participants) were included and three RYR preparations (Cholestin, Xuezhikang and Zhibituo) were tested. The methodological quality of trial reports was generally low in terms of generation of the allocation sequence, allocation concealment, blinding, and intention-to-treat. The combined results showed significant reduction of serum total cholesterol levels (weighted mean difference -0.91 mmol/L, 95% confidence interval -1.12 to -0.71), triglycerides levels (-0.41 mmol/L, -0.6 to -0.22), and LDL-cholesterol levels (-0.73 mmol/L, -1.02 to -0.043), and increase of HDL-cholesterol levels (0.15 mmol/L, 0.09 to 0.22) by RYR treatment compared with placebo. The lipid modification effects appeared to be similar to pravastatin, simvastatin, lovastatin, atorvastatin, or fluvastatin. Compared with non-statin lipid lowering agents, RYR preparations appeared superior to nicotinate and fish oils, but equal to or less effective than fenofibrate and gemfibrozil. No significant difference in lipid profile was found between Xuezhikang and Zhibituo. RYR preparations were associated with non-serious adverse effects such as dizziness and gastrointestinal discomfort. Current evidence shows short-term beneficial effects of RYR preparations on lipid modification. More rigorous trials are needed, and long-term effects and safety should be investigated if RYR preparations are to be recommended as one of the alternative treatments for primary hyperlipidemia.

Abstract Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). Discussion The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). Summary Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform.

Byline: L. A. Ahmed (1,1), H. Schirmer (1,2), G. K. Berntsen (1), V. Fonnebo (1), R. M. Joakimsen (3) Keywords: Blood pressure; Body mass index (BMI); Diabetes mellitus; High-density lipoprotein (HDL); Metabolic syndrome; Non-vertebral fractures; Triglycerides Abstract: Introduction We wanted to examine whether the features of the metabolic syndrome carried an increased risk of non-vertebral fracture. Methods This is a population-based, 6-year follow-up of 27,159 subjects from the municipality of Tromso, followed from 1994 until 2001. Age range was 25--98 years. Non-fasting serum levels of high-density lipoprotein (HDL), triglycerides and glucose, blood pressure (BP), weight and height were measured at baseline. All non-vertebral fractures were registered by computerised search in radiographic archives. Results A total of 1,249 non-vertebral fractures were registered. Increasing number of metabolic syndrome features was associated with significantly reduced fracture risk in both men and women, p= 0.004 and p Conclusions Increasing burden of metabolic syndrome features protects against non-vertebral fractures. Reduced non-vertebral fracture risk was associated with high BP in men and increased body mass in women. Lower non-fasting serum levels of HDL protect against fractures in women and obese men. Author Affiliation: (1) Institute of Community Medicine, University of Tromso, 9037, Tromso, Norway (2) Department of Cardiology, University Hospital of Tromso, Tromso, Norway (3) Department of Internal Medicine, University Hospital of Tromso, Tromso, Norway Article History: Registration Date: 06/09/2005 Received Date: 11/03/2005 Accepted Date: 04/09/2005 Online Date: 31/12/2005 Article note: An erratum to this article can be found at http://dx.doi.org/ 10.1007/s00198-009-0847-8.

Byline: R. M. Joakimsen (1), V. Fonnebo (1), A.Johanne Sogaard (2), A. Tollan (3), J. Stormer (4), J. H. Magnus (1) Keywords: Key words:Data collection -- Epidemiologic methods -- Follow-up studies -- Fractures -- Questionnaires -- Recall Abstract: In order to compare different methods of fracture registration, we sought all nonvertebral fractures suffered during 8 years (1988--95) among 21441 persons invited to a survey in 1979/80. We registered a total of 54 hip fracture cases through three separate sources (self-report, computer linkage to the local radiographic archives, discharge register), whereas forearm fractures (a total of 291 cases) were registered through two separate sources (self-report, computer linkage to the radiographic archives). The registration of fractures at other sites (a total of 1321 cases) were from one source (computer linkage to the local radiographic archives), and we have compared three ways of obtaining data from this single source (no ascertainment, ascertainment of records coded as fracture, ascertainment of all records). Ninety-three percent of all hip fractures and 97% of all wrist fractures in the entire study population were found by computer linkage to the radiographic archives, whereas the discharge register detected 87% of all the hip fractures. Computer linkage with ascertainment gave no overreporting of fractures. Among the 11626 persons who answered a follow-up questionnaire in 1994/95, 97% (CI 84--100%) of all hip fractures and 72% (CI 66--78%) of all wrist fractures were self-reported. We conclude that a computerized search of radiographic archives is a viable method of fracture registration. Author Affiliation: (1) Institute of Community Medicine, University of Tromso, 9037 Tromso, NO (2) National Institute of Public Health, Department of Population Health Sciences, 0403 Oslo, NO (3) Department of Gynecology, Central Hospital of Hedmark, 2300 Hamar , NO (4) Department of Radiology, University Hospital of Tromso, 9038 Tromso, Norway, NO Article note: Received: 8 February 1999 / Accepted: 11 June 2001

Byline: G. K. R. Berntsen (1), A. Tollan (2), J. H. Magnus (1), A. J. Sogaard (3), T. Ringberg (4), V. Fonnebo (1) Keywords: Key words:Artifacts -- BMD -- Densitometry -- Forearm -- Movement artifacts -- Region of interest Abstract: Suboptimal performance of bone densitometer, operator and/or subject may cause artifacts of consequence both for individual patient management and research. The prevalence and effects of such artifacts are largely unknown in densitometry. A cross-sectional population-based study was carried out of artifacts in forearm bone densitometry with single X-ray Absorptiometry (SXA) of the nondominant hand (distal and ultradistal site). After the screening, all scans were reviewed for artifact detection and reanalysis. The effect on the bone mineral density (BMD) result was found by comparing artifactual scans with a reanalyzed version or with normal repeat scans. All women aged 50--74 years, all men aged 55--74 years and 5--10% samples of other age groups aged aY=25 years attending the fourth Tromso health study were invited to have bone densitometry. The response rate from the background population was 80% (n= 7948). Fourteen percent of subjects had a movement artifact at either the distal or ultradistal site. The individual BMD variation was twice as large in scans with a movement artifact (0.94%) compared with normal scans (0.58%) (p= 0.0027). The radial endplate was inaccurately detected in 74% of the scans. Reanalysis of these scans led to a mean 3.8% decrease in the BMD value and an increase in the prevalence of osteoporosis of 10%. Artifacts were thus common, and their effects were clinically relevant in forearm bone densitometry. Artifacts and their effects need to be characterized in other bone densitometry settings also. Author Affiliation: (1) Institute of Community Medicine, University of Tromso, 9037 Tromso, Norway, NO (2) Department of Gynaecology, Central Hospital of Hedmark, Hamar, Norway, NO (3) Department of Population Health, National Institute of Public Health, Torshov, Oslo, Norway , NO (4) Hospital of Aabenraa, Aabenraa, Denmark, DK Article note: Received: 25 February 1999 / Accepted: 3 May 1999

Byline: R. M. Joakimsen (1), V. Fonnebo (1), J. H. Magnus (2), A. Tollan (3), A. Johanne Sogaard (4) Keywords: Key words:Anthropometry -- Body mass index -- Fractures -- Stature Abstract: Tall persons suffer more hip fractures than shorter persons, and high body mass index is associated with fewer hip and forearm fractures. We have studied the association between body height, body mass index and all non-vertebral fractures in a large, prospective, population-based study. The middle-aged population of Tromso, Norway, was invited to surveys in 1979/80, 1986/87 and 1994/95 (The Tromso Study). Of 16 676 invited to the first two surveys, 12 270 attended both times (74%). Height and weight were measured without shoes at the surveys, and all non-vertebral fractures in the period 1988--1995 were registered (922 persons with fractures) and verified by radiography. The risk of a low-energy fracture was found to be positively associated with increasing body height and with decreasing body mass index. Furthermore, men who had gained weight had a lower risk of hip fractures, and women who had gained weight had a lower risk of fractures in the lower extremities. High body height is thus a risk factor for fractures, and 1 in 4 low-energy fractures among women today might be ascribed to the increase in average stature since the turn of the century. Low body mass index is associated with a higher risk of fractures, but the association is probably too weak to have any clinical relevance in this age category. Author Affiliation: (1) Institute of Community Medicine, University of Tromso, Tromso, NO (2) Department of Rheumatology, University of Tromso, Tromso, NO (3) Department of Gynaecology and Obstetrics, University of Tromso, Tromso, NO (4) National Institute of Public Health, Department of Population Health Sciences, Norway, NO Article note: Received: 22 July 1997 / Accepted: 9 February 1998

Design: In 1992 and 1996, all medical students in Tromso, Norway, completed a questionnaire regarding their attitudes toward acupuncture. Objectives: To study possible changes in medical students' attitudes toward acupuncture as a therapeutic tool during four years in medical school. Also examined was the students levels of interest in acquiring more knowledge about acupuncture. Findings: After four additional years in medical school a higher proportion of students would not consider acupuncture if they had complaints or diseases where acupuncture could be an alternative, and a higher proportion would actively advise their future migraine patients against acupuncture treatment. Fewer students were planning to acquire knowledge about acupuncture in order to consider using the method in their future practice as doctors. Although the proportion of students who were highly negative were in the minority for each class, the changes from the first to the follow-up testing were found to be significant and in a consistently negative direction. Conclusions: We conclude that the main explanation for our findings is that the medical school role models and the educational process have a direct negative effect on the students' attitudes towards acupuncture. [ABSTRACT FROM AUTHOR]

1466 Norwegian working doctors under 71 y of age were surveyed in February 1994 on their attitudes to acupuncture and experience as acupuncture patients. 1135 doctors responded (response rate: 77%). More than 8% had undergone acupuncture treatment and 38% of these reported benefit from the treatment. Over 53% would realistically consider acupuncture if they got problems or diseases where acupuncture treatment could be an alternative. More than 38% recommend acupuncture treatment to their migraine patients. More than four out of five doctors would not try to interfere with a patient's wish to try acupuncture treatment for cancer. 81% said that acupuncture is, or should be integrated in the national health care system. More general practitioners held this view than other doctors (p < 0.001). Positive attitudes were strongest among doctors who either had already undergone acupuncture treatment or intended to do so. If this development continues, acupuncture could be an integrated part of the national Norwegian health care system in the near future. [ABSTRACT FROM AUTHOR]

A fund-raising TV show was broadcast on one Sunday in Autumn 1992 by the Norwegian Broadcasting Cooperation, one of two TV channels covering the whole country. The 6 h show consisted of information on mental health problems and prevention intermingled with entertainment and reports of fund-raising activities. Newspapers, radio and TV had covered the forthcoming TV show extensively. The campaign is evaluated as a nationwide mass-media-based mental health campaign using a stratified random sample of 613 persons. Almost 94% were aware of the campaign, two-thirds had watched the pre-campaign TV programs and 62% followed the campaign day TV show. Nearly 70% had read about psychiatric disorders in connection with the campaign and 45% had discussed the campaign topic with others. Two-thirds made a financial contribution to the campaign, while 10% expressed some concern. The wide penetration of this campaign conveying that psychological problems are a normal part of living and that solutions can be found has put mental health issues on the cultural agenda, and perhaps contributed to a breakdown of taboos and stigma associated with mental health problems. [ABSTRACT FROM AUTHOR]

Abstract Background Although use of complementary and alternative medicine (CAM) among cancer patients has been described previously, prevalence of use has not commonly been compared to other disease groups in a true population sample where CAM use or cancer is not the main focus. The aims of the present study are to (1) examine how CAM use in cancer patients differs from people with a previous CHD diagnosis and people with no cancer or CHD diagnosis in an unselected general population and (2), investigate the use of a CAM provider among individuals with a previous cancer diagnosis. Methods A total of 8040 men and women aged 29 to 87 in the city of Tromsø, Norway filled in a questionnaire developed specifically for the Tromsø V study with questions on life style and health issues. Visits to a CAM provider within the last 12 months and information on cancer, heart attack and angina pectoris (heart cramp) were among the questions. 1449 respondents were excluded from the analyses. Results Among the 6591 analysed respondents 331 had a prior cancer diagnosis, of whom 7.9% reported to have seen a CAM provider within the last 12 months. This did not differ significantly from neither the CHD group (6.4%, p = 0.402) nor the no cancer/CHD group (9.5%, p = 0.325). Conclusion According to this study, the proportion of cancer patients seeing a CAM provider was not statistically significantly different from patients with CHD or individuals without cancer or CHD.

Abstract Background Several studies have found that a high proportion of the population in western countries use complementary and alternative medicine (CAM). However, little is known about whether CAM is offered in hospitals. The aim of this study was to describe to what extent CAM is offered in Norwegian and Danish hospitals and investigate possible changes in Norway since 2001. Methods A one-page questionnaire was sent to all included hospitals in both countries. The questionnaire was sent to the person responsible for the clinical activity, typically the medical director. 99 hospitals in the authority (85%) in Norway and 126 in Denmark (97%) responded. Given contact persons were interviewed. Results CAM is presently offered in about 50% of Norwegian hospitals and one-third of Danish hospitals. In Norway CAM was offered in 50 hospitals, 40 of which involved acupuncture. 19 hospitals gave other alternative therapies like biofeedback, hypnosis, cupping, ear-acupuncture, herbal medicine, art therapy, homeopathy, reflexology, thought field therapy, gestalt therapy, aromatherapy, tai chi, acupressure, yoga, pilates and other. 9 hospitals offered more than one therapy form. In Denmark 38 hospitals offered acupuncture and one Eye Movement Desensitization and Reprocessing Light Therapy. The most commonly reported reason for offering CAM was scientific evidence in Denmark. In Norway it was the interest of a hospital employee, except for acupuncture where the introduction is more often initiated by the leadership and is more based on scientific evidence of effect. All persons (except one) responsible for the alternative treatment had a medical or allied health professional background and their education/training in CAM treatment varied substantially. Conclusions The extent of CAM being offered has increased substantially in Norway during the first decade of the 21st century. This might indicate a shift in attitude regarding CAM within the conventional health care system.

Abstract Background To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities. Discussion There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This "gap" might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited. Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic "agents" before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated 'whole system' of care, without careful consideration of the safety issue. We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise: 1. Context, paradigms, philosophical understanding and utilization 2. Safety status 3. Comparative effectiveness. 4. Component efficacy 5. Biological mechanisms. Summary Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.

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Background: Due to limitations of conventional medicine for atopic eczema (AE), complementary and alternative medicine (CAM) is widely used as an alternative, maintaining, or simultaneous treatment for AE. We aimed to evaluate the beneficial and harmful effects of CAM for children with AE under 14 years old., Methods: We searched for randomized trials on CAM in 12 Chinese and English databases from their inception to May 2018. We included children (< 14 years) diagnosed with AE, who received CAM therapy alone or combined with conventional medicine. We extracted data, and used the Cochrane "Risk of bias" tool to assess methodological quality. Effect was presented as relative risk (RR) or mean difference (MD) with 95% confidence interval (CI) using RevMan 5.3., Results: Twenty-four randomized controlled trials involving 2233 children with AE were included. Methodological quality was of unclear or high risk of bias in general. The trials tested 5 different types of CAM therapies, including probiotics, diet, biofilm, borage oil, and swimming. Compared to placebo, probiotics showed improved effect for the SCORAD index (MD 9.01, 95% CI 7.12-10.90; n = 5). For symptoms and signs such as itching, skin lesions, CAM combined with usual care was more effective for symptom relief ≥95% (RR 1.47, 95% CI 1.30-1.68; n = 8), and for ≥50% symptoms improvement (RR 1.34, 1.25-1.45; n = 9) compared to usual care. There was no statistic significant difference between CAM and usual care on ≥95% improvement or ≥ 50% improvement of symptoms. However, swimming, diet and biofilm showed improvement of clinical symptoms compared with usual care. At follow-up of 8 weeks to 3 years, CAM alone or combined with usual care showed lower relapse rate (RR 0.38, 0.28-0.51, n = 2; RR 0.31, 0.24-0.40, n = 7; respectively) compared to usual care. Twelve out of 24 trials reported no occurrence of severe adverse events., Conclusions: Low evidence demonstrates that some CAM modalities may improve symptoms of childhood AE and reduce relapse rate. Safety remains unclear due to insufficient reporting. Further well-designed randomized trials are needed to confirm the potential beneficial effect and to establish safety use.