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Biomedical subjects

Edzard Ernst

Publications and source records attributed to Edzard Ernst.

At least 145 records · Page 8Linked to original sources

Cimicifuga racemosa: a systematic review of its clinical efficacy.

BACKGROUND: Cimicifuga racemosa has long been advocated as an alternative to hormone-replacement therapy. However, recent experimental studies and a clinical trial have raised some questions on its utility. The aim of this systematic review is principally to summarise the trial evidence regarding the efficacy of C. racemosa in the treatment of menopausal symptoms. In addition, we also explore the evidence relating to the mechanism of action of this herbal medicine. METHODS: Searches of seven computerised databases were performed to identify all randomised clinical trials (RCTs) on C. racemosa as well as animal and in vitro experiments. No language restrictions were imposed. Data were extracted by both authors according to predefined criteria and are summarised in narrative form. RESULTS: Four RCTs of C. racemosa as a treatment of menopausal symptoms were included. They yielded no compelling evidence for the efficacy of C. racemosa on menopausal symptoms. The small beneficial effects observed in some studies could be explained by a central activity, and an oestrogenic activity cannot be completely excluded. CONCLUSIONS: In spite of plausible mechanisms of action of C. racemosa, its clinical efficacy for the treatment of menopausal symptoms has not been convincingly demonstrated through rigorous clinical trials. Additional rigorous RCTs and biochemical and chemical investigations are warranted.

Animals↗

Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995-2001.

OBJECTIVE: To summarise recent evidence from case reports (published January 1995-September 2001) of adverse events after cervical spine manipulation. DATA SOURCES: Five computerised literature searches (MEDLINE-Pubmed; EMBASE, the Cochrane Library, AMED [Allied and Complementary Medicine Database], and CISCOM [Centralised Information Service for Complementary Medicine] were performed. No language restrictions were applied. STUDY SELECTION: All case reports containing original data of adverse events after cervical spine manipulation were included. DATA EXTRACTION: All articles were evaluated and key data extracted according to pre-defined criteria: patient's age, sex and diagnosis; type of therapist; type of treatment; nature of adverse event; method of diagnosis; and clinical outcome. DATA SYNTHESIS: Thirty-one case reports (42 individual cases) were found. The patients were equally distributed between the sexes (21 male, 20 female, one unknown) and mostly middle-aged (range, 3 months to 87 years). Most were treated by chiropractors. Arterial dissection causing stroke was reported in at least 18 cases. CONCLUSIONS: Serious adverse events after cervical spine manipulation continue to be reported. As the incidence of these events is unknown, large and rigorous prospective studies of cervical spine manipulation are needed to accurately define the risks.

Adult↗

The risk-benefit profile of commonly used herbal therapies: Ginkgo, St. John's Wort, Ginseng, Echinacea, Saw Palmetto, and Kava.

Because use of herbal remedies is increasing, a risk-benefit profile of commonly used herbs is needed. This article provides a clinically oriented overview of the efficacy and safety of ginkgo, St. John's wort, ginseng, echinacea, saw palmetto, and kava. Wherever possible, assessments are based on systematic reviews of randomized clinical trials. Encouraging data support the efficacy of some of these popular herbal medicinal products, and the potential for doing good seems greater than that for doing harm. The published evidence suggests that ginkgo is of questionable use for memory loss and tinnitus but has some effect on dementia and intermittent claudication. St. John's wort is efficacious for mild to moderate depression, but serious concerns exist about its interactions with several conventional drugs. Well-conducted clinical trials do not support the efficacy of ginseng to treat any condition. Echinacea may be helpful in the treatment or prevention of upper respiratory tract infections, but trial data are not fully convincing. Saw palmetto has been shown in short-term trials to be efficacious in reducing the symptoms of benign prostatic hyperplasia. Kava is an efficacious short-term treatment for anxiety. None of these herbal medicines is free of adverse effects. Because the evidence is incomplete, risk-benefit assessments are not completely reliable, and much knowledge is still lacking.

Anxiety↗

Risks associated with spinal manipulation.

The aim of this systematic review was to summarize the evidence about the risks of spinal manipulation. Articles were located through searching three electronic databases (MEDLINE, EMBASE, Cochrane Library), contacting experts (n =9), scanning reference lists of relevant articles, and searching departmental files. Reports in any language containing data relating to risks associated with spinal manipulation were included, irrespective of the profession of the therapist. Where available, systematic reviews were used as the basis of this article. All papers were evaluated independently by the authors. Data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

Cerebrovascular Disorders↗

Toxic heavy metals and undeclared drugs in Asian herbal medicines.

Asian herbal medicines are currently used by large sections of the population. Because they are not regulated as medicines and are freely available to everyone, serious safety concerns might be associated with these herbal medicines. In this article, evidence suggesting that some Asian herbal medicines contain toxic heavy metals or undeclared prescription drugs is reviewed. In particular, Indian and Chinese preparations have been implicated. Although adulteration with drugs is by definition fraudulent, the inclusion of heavy metals could be either intentional for alleged medicinal purposes or accidental. Evidence from various countries implies that toxic heavy metals and undeclared prescription drugs in Asian herbal medicines might constitute a serious health problem. However, the majority of the data is anecdotal and insufficient to define prevalence figures. Ways ought to be found to maximize consumer safety.

Consumer Product Safety↗

Complementary and alternative medicine in neurology: hype, hope and hazards.

More and more neurological patients use some form of complementary and alternative medicine. Contrary to what many sceptics believe, not all of these approaches are useless. Contrary to what many proponents think, not all treatments are harmless. Neurologists should know more about complementary and alternative medicine and should advise their patients responsibly.

Complementary Therapies↗

Randomised controlled trial of reflexology for menopausal symptoms.

OBJECTIVE: Clinical experience suggests that reflexology may have beneficial effects on the symptoms occurring in menopausal women, particularly psychological symptoms. This study aims to examine that effect rigorously. DESIGN: Randomised controlled trial with two parallel arms. SETTING: School of Complementary Health in Exeter, Devon, UK. SAMPLE: Seventy-six women, aged between 45 and 60 years, reporting menopausal symptoms. METHODS: Women were randomised to receive nine sessions of either reflexology or nonspecific foot massage (control) by four qualified reflexologists given over a period of 19 weeks. MAIN OUTCOME MEASURES: The Women's Health Questionnaire (WHQ), the primary measures being the subscores for anxiety and depression. Severity (visual analogue scale, VAS) and frequency of flushes and night sweats. RESULTS: Mean (SD) scores for anxiety fell from 0.43 (0.29) to 0.22 (0.25) in the reflexology group and from 0.37 (0.27) to 0.27 (0.29) in the control group over the course of treatment. Mean (SD) scores for depression fell from 0.37 (0.25) to 0.20 (0.24) in the reflexology group and from 0.36 (0.23) to 0.20 (0.21) in the control (foot massage) group over the same period. For both scores there was strong evidence of a time effect (P < 0.001) but no evidence of a time-group interaction (P > 0.2). Similar changes were found for severity of hot flushes and night sweats. In the control group, 14/37 believed they had not received true reflexology. CONCLUSION: Foot reflexology was not shown to be more effective than non-specific foot massage in the treatment of psychological symptoms occurring during the menopause.

Aged↗

Validating a new non-penetrating sham acupuncture device: two randomised controlled trials.

For clinical trials of acupuncture, it would be desirable to have a sham procedure that is indistinguishable from the real treatment, yet inactive. A sham needle has been designed which telescopes instead of penetrating the skin. The Park Sham Device involves an improved method of supporting the sham needle and requires validation. The objective of these studies was to test whether the sham procedure using the new device was 1) indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and 2) inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. The studies were designed as subject and assessor blind, randomised controlled trials. Study 1) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke. Study 2) included 63 healthy, acupuncture naïve, adult volunteers. The interventions used were real or sham acupuncture using the Park Sham Device. Study 1) was set in a district general hospital, and study 2) in a university laboratory. The outcome measure in study 1) was the form of treatment that patients believed they had received. In study 2) the outcome measure was experience of de qi, as judged by three acupuncture experts. No patient in either group(study 1) believed he or she had been treated with the sham needle. In 40 volunteers (study 2) for whom experts achieved consensus, the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 (95% CI 2.26 to 104.86). The inter-rater reliability of all 13 experts (study 2), calculated from their judgements on 10 subjects selected by randomisation, was 0.52 (95% CI 0.19 to 0.61). In conclusion, the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and is inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de qi, a major concept underlying traditional Chinese acupuncture.

Acupuncture Points↗

A systematic review of the safety of kava extract in the treatment of anxiety.

This paper systematically reviews the clinical evidence relating to the safety of extracts of the herbal anxiolytic kava (Piper methysticum). Literature searches were conducted in four electronic databases and the reference lists of all papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting schemes of the WHO and national drug safety bodies and ten manufacturers of kava preparations were contacted. Data from short-term post-marketing surveillance studies and clinical trials suggest that adverse events are, in general, rare, mild and reversible. However, published case reports indicate that serious adverse events are possible including dermatological reactions, neurological complications and, of greatest concern, liver damage. Spontaneous reporting schemes also suggest that the most common adverse events are mild, but that serious ones occur. Controlled trials suggest that kava extracts do not impair cognitive performance and vigilance or potentiate the effects of central nervous system depressants. However, a possible interaction with benzodiazepines has been reported. It is concluded that when taken as a short-term monotherapy at recommended doses, kava extracts appear to be well tolerated by most users. Serious adverse events have been reported and further research is required to determine the nature and frequency of such events.

Anti-Anxiety Agents↗

Panax ginseng: a systematic review of adverse effects and drug interactions.

Panax ginseng C. A. Meyer is a perennial herb native to Korea and China and has been used as an herbal remedy in eastern Asia for thousands of years. Modern therapeutic claims refer to vitality, immune function, cancer, cardiovascular diseases, improvement of cognitive and physical performance and sexual function. A recent systematic review of randomised controlled trials found that the efficacy of ginseng root extract could not be established beyond doubt for any of these indications. In order to obtain a balanced assessment of the therapeutic value of P. ginseng it is also necessary to consider the safety profile. In view of the extremely widespread use of P. ginseng it seems important to ask whether this herbal medicine involves health risks for the consumer. This review was conducted as a systematic attempt to document and evaluate all the available safety data on P. ginseng root extracts. Systematic searches were performed in five electronic databases and the reference lists of all papers located were checked for further relevant publications. All articles containing original data on adverse events and drug interactions with P. ginseng were included. Information was also requested from 12 manufacturers of ginseng preparations, the spontaneous reporting schemes of the WHO and national drug safety bodies. No language restrictions were imposed. Data from clinical trials suggest that the incidence of adverse events with ginseng monopreparations is similar to that with placebo. The most commonly experienced adverse events are headache, sleep and gastrointestinal disorders. The possibility of more serious adverse events is indicated in isolated case reports and data from spontaneous reporting schemes; however, causality is often difficult to determine from the evidence provided. Combination products containing ginseng as one of several constituents have been associated with serious adverse events and even fatalities. Interpretation of these cases is difficult as ingredients other than P. ginseng may have caused the problems. Possible drug interactions have been reported between P. ginseng and warfarin, phenelzine and alcohol. Collectively, these data suggest that P. ginseng monopreparations are rarely associated with adverse events or drug interactions. The ones that are documented are usually mild and transient. Combined preparations are more often associated with such events but causal attribution is usually not possible.

Clinical Trials as Topic↗

Complementary/alternative medicine in dermatology: evidence-assessed efficacy of two diseases and two treatments.

The objective of this article is to provide a brief, but critical, overview of the evidence related to complementary/alternative medicine (CAM) use, and to offer valid and useful information for dermatologists in clinical practice. Systematic literature searches were conducted on these databases: Medline, EMBASE, The Cochrane Library, CISCOM and AMED (until October 2000). Where appropriate, the evaluation of the published literature was based on systematic reviews and randomized controlled trials. After scanning the literature it was decided to focus on a selection of two conditions (atopic dermatitis and chronic venous insufficiency) and two treatment modalities (aloe vera gel and tea tree oil). Data for the life-time prevalence of CAM use by patients with dermatological disease ranges between 35 to 69%. The most popular modalities include herablism and (other) dietary supplements, while atopic dermatitis is one of the conditions most frequently treated with CAM. For patients with atopic dermatitis the evidence relates to autogenic training, hypnotherapy, diet, herbal medicine, and dietary supplements. Compelling evidence of effectiveness exists for none of these therapies. However, some promising data have been reported for those with a psychological component: autogenic training, biofeedback and hypnotherapy. For chronic venous insufficiency there is relatively convincing evidence for the effectiveness of oral horse chestnut seed extract. The data for aloe vera gel and tea tree oil indicate that for neither is there compelling evidence of effectiveness. The use of CAM treatments is not free of risk; direct and indirect risks associated with CAM must be considered.

Chronic Disease↗