Now showing items 1-10 of 10
| 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. |
| URI: | http://hdl.handle.net/10037/1094 |
| 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 metaanalyses 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. |
| URI: | http://hdl.handle.net/10037/1111 |
| Abstract: | Background: The extent to which a health care intervention causes or facilitates health-related
change is a key question in research. The need to quantify such change has led to the development
of an increasing number of change indicators, to measure what have come to be known as
'outcomes'. In the context of medical research into the efficacy or effectiveness of an intervention
the term 'outcomes' has often been interpreted to mean single endpoints with a linear cause and
effect link to an external intervention.
Discussion: In this paper we present a critical analysis of the nature and interpretation of the 'outcomes' concept and of the assumptions that underpin it. Drawing on our own work and that of others, we analyse the problems that arise when the concept is applied to complex interventions and discuss the use of other models, such as programme theory, as a basis for alternative conceptualisations for indicators of change. Our analysis demonstrates that the interpretation of 'outcomes' that may be appropriate for clinical trials of pharmaceutical products, is problematic when used in evaluations of complex interventions in areas such as complementary medicine, palliative care, rehabilitation, and health promotion. The 'outcomes' concept may impose inappropriate patterns of thought and meaning. We present alternative models, such as those based on programme theory, which conceptualise health-related change as resulting from the interaction between intervention, process and context over time. In this framework both the intervention and the patient are defined as causal factors, because the result of the treatment is dependent on the resources of the patient – such as the body's ability to heal itself – and the impact of the patient's situation. Summary: Evaluations based on a model such as programme theory will encompass a wide range of health-related changes that include aspects of process, such as new meanings and understanding, as well as longer term changes in health, wellbeing and health-related competences and behaviours. |
| URI: | http://hdl.handle.net/10037/2186 |
| Abstract: | Background: Green tea is one of the most popular beverages worldwide. This review summarizes
the beneficial effects of green tea on cancer prevention.
Methods: Electronic databases, including PubMed (1966–2008), the Cochrane Library (Issue 1, 2008) and Chinese Biomedical Database (1978–2008) with supplement of relevant websites, were searched. There was no language restriction. The searches ended at March 2008. We included randomized and non-randomized clinical trials, epidemiological studies (cohort and case-control) and a meta-analysis. We excluded case series, case reports, in vitro and animal studies. Outcomes were measured with estimation of relative risk, hazard or odd ratios, with 95% confidence interval. Results: Forty-three epidemiological studies, four randomized trials and one meta-analysis were identified. The overall quality of these studies was evaluated as good or moderate. While some evidence suggests that green tea has beneficial effects on gastrointestinal cancers, the findings are not consistent. Conclusion: Green tea may have beneficial effects on cancer prevention. Further studies such as large and long term cohort studies and clinical trials are warranted. |
| URI: | http://hdl.handle.net/10037/2138 |
| Abstract: | Background: Moxibustion, acupuncture and other acupoint stimulations are commonly used for
the correction of breech presentation. This systematic review aims to evaluate the efficacy and
safety of moxibustion and other acupoint stimulations to treat breech presentation.
Methods: We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on moxibustion, acupuncture or any other acupoint stimulating methods for breech presentation in pregnant women. All searches in PubMed, the Cochrane Library (2008 Issue 2), China National Knowledge Information (CNKI), Chinese Scientific Journal Database (VIP) and WanFang Database ended in July 2008. Two authors extracted and analyzed the data independently. Results: Ten RCTs involving 2090 participants and seven CCTs involving 1409 participants were included in the present study. Meta-analysis showed significant differences between moxibustion and no treatment (RR 1.35, 95% CI 1.20 to 1.51; 3 RCTs). Comparison between moxibustion and knee-chest position did not show significant differences (RR 1.30, 95% CI 0.95 to 1.79; 3 RCTs). Moxibustion plus other therapeutic methods showed significant beneficial effects (RR 1.36, 95% CI 1.21 to 1.54; 2 RCTs). Laser stimulation was more effective than assuming the knee-chest position plus pelvis rotating. Moxibustion was more effective than no treatment (RR 1.29, 95% CI 1.17 to 1.42; 2 CCTs) but was not more effective than the knee-chest position treatment (RR 1.22, 95% CI 1.11 to 1.34; 2 CCTs). Laser stimulation at Zhiyin (BL67) was more effective than the knee-chest position treatment (RR 1.30, 95% CI 1.10 to 1.54; 2 CCTs,). Conclusion: Moxibustion, acupuncture and laser acupoint stimulation tend to be effective in the correction of breech presentation. |
| URI: | http://hdl.handle.net/10037/2187 |
| Abstract: | Sosial og helsedirektoratet arbeider med retningslinjer for pasientbehandling ved mistanke om helseskade fra amalgamfyllinger. Som bakgrunn for dette arbeid fikk Nasjonalt Forskningssenter innen Komplementær og Alternativ Medisin (NAFKAM) ved Universitetet i Tromsø i oppdrag å beskrive hvordan befolkningen opplever sammenhengen mellom amalgam og helse. Kvantitative og kvalitative metoder har vært brukt for å belyse ulike sider av amalgamproblematikken. Resultatene viser at 7,7% i den norske befolkning mener amalgam i tannfyllinger har påvirket egen helsetilstand. De fleste av disse beskriver vedvarende/kronisk og/eller stadig tilbakevendende helseplager. Nesten hver femte person som skifter ut sine amalgamfyllinger har en helsemessig årsak til utskiftning. En bedring av helsetilstanden etter utskiftning er vanligst dersom alle fyllinger byttes ut. Pasienter med dårligst helse angir størst bedring ved amalgamutskiftning. Personene rapporterer en diffus sykehistorie som kan være vanskelig å skille fra andre uspesifikke lidelser. Helsevesenet oppleves som kunnskapsløst og uten interesse/empati i forhold til problemstillingen. Svært mange personer har søkt forklaring, hjelp og støtte innen alternativ medisin. Resultatene viser at store deler av befolkningen har et annet syn på sammenhengen mellom amalgamfyllinger og helseskader enn de fleste medisinske undersøkelser hittil har vist. |
| URI: | http://hdl.handle.net/10037/353 |
| Abstract: | Denne rapport giver en introduction til kvalitative forskningsmetoder, der er velegnede til forskning i komplementær og alternativ behandling. Kvalitative og kvantitative metoder producerer meget forskellige former for kundskaber, som er rettet mod forskellige brugssammenhænge og formål. Vi starter med at forholde os til evidens-baseret viden og beskriver epistemologiske baggrunde for at vælge kvalitative metoder.Vi fortsætter med at give svar på følgende spørgsmål: Hvilke aspekter inden for komplementær og alternativ behandling er mest velegnede at udforske med kvalitative metoder? Derefter beskriver vi det prominente forskningsdesign til gennemførelse af kvalitativ forskning; forskningsprocessen og udvalgte forskningsmetoder: det kvalitative forskningsinterview, fokusgruppe interview og deltagerobservation. Afsluttende giver vi en kort beskrivelse af forskellige kombinationer af kvalitative og kvantitative metoder |
| Description: | The report is a revised version of: Launsø, L. and Rieper, O. (2006) Qualitative research methods in complementary and alternative treatment In: Jianping, L. (ed.) Clinical reseach methodology for evidencebased chinese medicine. Beijing, People's Medical Publishing House in China, pp 171-193 (The book in in chinese) |
| URI: | http://hdl.handle.net/10037/1184 |
| Abstract: | Objective: The previously published ACUFLASH study compared the effectiveness of
individualized acupuncture treatment plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women. This paper reports on the
observational follow-up results at six and 12 months.
Methods: The ACUFLASH study was a pragmatic, multicenter, randomized, controlled trial with two parallel arms, conducted in 2006-2007. The 267 participants were postmenopausal women experiencing, on average, 12.6 hot flashes per 24 hours. The acupuncture group received 10 individualized acupuncture treatments during 12 weeks and advice on self-care, and the control group received advice on self-care only. Hot flash frequency and intensity (0-10 scale) and hours of sleep per night were registered in a diary. Health-related quality of life was assessed by the Women‟s Health Questionnaire. Results: From baseline to six months, the mean reduction in hot flash frequency per 24 hours was 5.3 in the acupuncture group and 5.0 in the control group, a non-significant difference of 0.3. At 12 months, the mean reduction in frequency was 6.0 in the acupuncture group and 5.8 in the control group, a non-significant difference of 0.2. Differences in quality of life scores were not statistically significant at six and 12 months. Conclusion: The statistically significant differences between the study groups found at Week 12 were no longer present at six and 12 months. Acupuncture can contribute to a more rapid reduction of vasomotor symptoms and increase in health-related quality of life in postmenopausal women, but probably has no long-term effects. |
| Description: | This article is part of Einar Kristian Borud's PhD thesis, which is available in Munin: http://hdl.handle.net/10037/2449 |
| URI: | http://hdl.handle.net/10037/2974 |
| Abstract: | Background: After menopause, 10–20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints.
Methods/Design: The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments. Discussion: The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway. |
| Description: | This article is part of Einar Kristian Borud's PhD thesis, which is available in Munin: http://hdl.handle.net/10037/2449 |
| URI: | http://hdl.handle.net/10037/2235 |
| Abstract: | Internasjonalt og nasjonalt bruker stadig flere mennesker alternativ behandling i forbindelse med sykdom og helseplager. I økende grad trekkes alternativ behandling inn på sykehus, også i Norge. Helsepersonell ønsker mer kunnskap om alternativ behandling og ønsker å se hva alternativ behandling kan bidra med for deres pasienter. Flere helsepersonell ved ulike avdelinger ved norske sykehus har derfor tatt initiativ til å inndra alternativ behandling innenfor sin sykehusavdeling. Denne rapporten presenterer resultater fra et forskningsprosjekt hvor vi har ønsket å fremskaffe kunnskaper om hvilke erfaringer alternative behandlere og helsepersonell har fått med å utprøve alternative behandlinger på offentlige sykehus. Vår hensikt er at de utprøvninger som er under planlegging, kan dra nytte av disse erfaringer. Problemstillingene som har vært utforsket i prosjektet, er knyttet til helsepersonells motivasjon for utprøving av alternativ behandling på sykehus. Hva som kjennetegner forsøkene som utprøves, hvilke erfaringer helsepersonell og alternative behandlere har fått ved å samarbeide og hvilke former for samarbeid som har blitt etablert. Vi har også hatt fokus på hva helsepersonell har opplevd som hemmende og fremmende i forsøk på å etablere samarbeid med alternative behandlere. Forskningsdesignet som er valgt er et case-studie design. Det er i prosjektet anvendt flere datakilder: helsepersonell, alternative behandlere og initiativtakere samt flere datainnsamlingsmetoder: det kvalitative forskningsintervju, spørreskjema, dokumentarisk materiale og observasjon. I prosjektet inngår avdelinger fra UNN, Nordlandssykehuset Vesterålen, Sykehus Østfold i Moss og Fredrikstad, og NU-Sjukvården ved sykehusene i Uddevalla og Trollhättan. Avdelingene har selv kontaktet NAFKAM for å være med i studien. Hovedfunnet fra denne studien er at utprøvning av alternativ behandling og samarbeid mellom alternative behandlere og helsepersonell på norske sykehus er betinget av helsepersonells erfaringsbaserte kunnskaper om de behandlingsresultater alternative behandlere kan oppnå i behandlingen av pasienter. I det omfang helsepersonell erfarer at alternative behandlere kan tilføre pasientene positive behandlingsresultater, blir de motiverte til å utvikle et samarbeid med alternative behandlere. Det er således ikke evidens basert på metananalyser som er avgjørende for helsepersonalets motivasjon for å utprøve alternativ behandling på deres avdelinger, men helt klart deres erfaringsbaserte kunnskaper som guider dem. I utprøvningene er det anvendt både kombinasjoner av etablert og alternativ behandling og enkeltintervensjoner som akupunktur og musikkterapi. Målgruppene har vært pasienter på sykehus med et bredt spekter av diagnoser. Utøvere har vært både helsepersonell og alternative behandlere. Intensjonene har variert fra å teste spesifikke behandlingsmetoder til å utvikle behandlingssamarbeid og forbedre behandlingsresultatene for pasientene. 62 Samarbeidsformene i praksis har vært parallell behandling med eller uten kjennskap til hverandres behandlingsmodeller. Støttende ledelse, åpen og nysgjerrig avdelingskultur, press fra pasientorganisasjoner, motivert helsepersonell, prosjekt initiert nedenfra og helsepersonells egne erfaringer med positive behandlingsresultater er fremmende faktorer for utprøvning av alternativ behandling og for utvikling av samarbeid mellom alternative og helsepersonell på sykehus. Hemmende faktorer har vært interne barrierer, manglende kunnskaper om og skepsis til alternativ behandling og behandlingsresultater, begrensede ressurser og for kort innleggelsestid. Vi kan konkludere med at de utprøvninger vi har studert har gitt mulighet for ny læring og et forbedret samarbeidsklima på sykehusavdelinger. Samtidig erfarer helsepersonell at alternative behandlinger kan gi positive behandlingsresultater for deres pasienter. På bakgrunn av den stigende etterspørselen både fra pasient- og behandlerside etter samarbeid mellom helsepersonell og alternative behandlere, er det behov for at myndighetene bevilger midler til etablering av samarbeid mellom alternative behandlere og helsepersonell og til forskningsbaserte evalueringer av utvikling av forskjellige samarbeidsformer og av behandlingsresultatene som disse samarbeidsformene kan skape for pasientene. |
| URI: | http://hdl.handle.net/10037/1402 |
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