Complementary/Alternative medicine: medico-legal issues.
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Biomedical subjects
Publications and source records attributed to Edzard Ernst.
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Crataegus spp. (hawthorn) monopreparations are predominantly used for treating congestive heart failure. The effectiveness of hawthorn preparations (flowers with leaves; berries) is documented in a number of clinical studies, reviews and meta-analyses. The aim of this article is to assess the safety data of all available human studies on hawthorn monopreparations. Systematic searches were conducted on MEDLINE, EMBASE, AMED, The Cochrane Library, the UK National Research Register and the US ClinicalTrials.gov (up to January 2005). Data were requested from the spontaneous reporting scheme of the WHO. Hand searches were also conducted in a sample of relevant medical journals, conference proceedings, reference lists of identified articles and our own files. Eight manufacturers of hawthorn-containing preparations were contacted and asked to supply any information on adverse events or drug interactions. Data from all clinical studies and reports were assessed. Only human studies on monopreparations were included. Data from hawthorn-containing combination preparations and homeopathic preparations were excluded. All studies were read and evaluated by one reviewer and independently verified by at least one additional reviewer.Twenty-nine clinical studies were identified, of which 24 met our inclusion criteria. A total of 7311 patients were enrolled, and data from 5,577 patients were available for analysis. The daily dose and duration of treatment with hawthorn monopreparations ranged from 160 to 1,800 mg and from 3 to 24 weeks, respectively. The extracts most used in the clinical trials were WS 1,442 (extract of hawthorn standardised to 18.75% oligomeric procyanidins) and LI 132 (extract of hawthorn standardised to 2.25% flavonoids). Overall, 166 adverse events were reported. Most of these adverse events were, in general, mild to moderate; eight severe adverse events have been reported with the LI 132 extract. The most frequent adverse events were dizziness/vertigo (n = 15), gastrointestinal complaints (n = 24), headache (n = 9), migraine (n = 8) and palpitation (n = 11). The WHO spontaneous reporting scheme received 18 case reports. In the identified trials, the most frequent adverse events were dizziness (n = 6), nausea (n = 5), fall (n = 2), gastrointestinal haemorrhage (n = 2), circulation failure (n = 2) and erythematous rash (n = 2). There were no reports of drug interactions. In conclusion, all data reviewed in this article seem to indicate that hawthorn is well tolerated even if some severe adverse events were reported; this suggests that further studies are needed to better assess the safety of hawthorn-containing preparations. Moreover, the unsupervised use of this drug can be associated with problems, especially if given with concomitant medications.
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The efficacy of Traditional Chinese Medicine (TCM) is less well-established than many believe and needs to be more firmly established through clinical trials. Such studies should adhere to the currently accepted standards. When planning and conducting clinical trials, one encounters numerous logistical and methodological problems. The most important logistical obstacle is a lack of funds while the most important methodological issue is to transparently minimise bias. Despite these formidable problems, clinical trials of TCM are usually feasible and certainly necessary for testing the efficacy of TCM.
OBJECTIVE: To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover. DATA SOURCES: Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted. STUDY SELECTION AND DATA EXTRACTION: All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality. RESULTS: Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from B officinalis, and a yeast based preparation. CONCLUSION: No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.
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BACKGROUND: Nutritional supplements, such as Seatone, which contain freeze-dried tissue from the New Zealand green-lipped mussel Perna canaliculus, are sold in many countries to relieve arthritic symptoms and to aid in the regeneration of arthritic and injured joints. METHODS: Searches for all published controlled trials on the clinical effectiveness of green-lipped mussel, as a nutritional supplement with potential health benefits for arthritis, were carried out from four independent databases. No language restrictions were imposed, and the review was undertaken from extracted data and was assessed critically according to predefined criteria by the authors. RESULTS: Reports of clinical studies, using freeze-dried mussel powder, show mixed outcome measures and are not conclusive, with only two of five randomized controlled trials attesting benefits for rheumatoid and osteoarthritis patients. Similarly, animal studies have likewise yielded mixed findings. In both these cases possibly due to the lack of stabilization of the omega-3 polyunsaturated fatty acids, now known to be the basis of anti-inflammatory activity. CONCLUSION: There is little consistent and compelling evidence, to date, in the therapeutic use of freeze-dried green-lipped mussel powder products for rheumatoid or osteoarthritis treatment, particularly in comparison to other cheaper alternative nutriceutical supplements of proven efficacy. However, further investigations are necessary to determine whether green-lipped mussel supplements, such as Seatone, are therapeutic options in the management of arthritis.
BACKGROUND: Any adjunctive therapy that may reduce persistent disability after stroke should be considered. Acupuncture is used for this purpose, but there is conflicting evidence on its effectiveness. METHODS: Patients with a recent (<4 weeks) episode of stroke were randomized to receive 12 sessions of either real or sham acupuncture during 2 weeks. The primary outcome was the change in Barthel activities of daily living score at the end of treatment. Secondary outcome measures included National Institutes of Health Stroke Scale score, motoricity index, and quality of life (EQ-5D [ EuroQoL-5 Dimensional form] and EQ-VAS [EuroQoL-Visual Analog Scale]). Assessments were carried out by blinded physicians. RESULTS: A total of 116 patients (56 in the real acupuncture group and 60 in the sham group) were randomized, and 98 (real, 48; sham, 50) completed treatment and the 2-week assessment. Patient blinding by means of the sham acupuncture device was successful. Acupuncture was well tolerated except for 1 seizure during a real acupuncture session. The improvements in the Barthel scores were 4 points (interquartile range [IQR], 0-8) vs 3 points (IQR, 0-7) in the real and sham acupuncture groups, respectively (P = .38). The secondary outcome measures also essentially showed no significant effect of acupuncture. Post hoc analysis by baseline severity showed a greater improvement in leg function in the subgroup with baseline Barthel score less than the median (median score, 6): 22 points (IQR, 0-37) vs 0 [corrected] points (IQR, 0-4) in the acupuncture and sham control groups, respectively (P = .02). CONCLUSIONS: Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients.
Homeopathy is a popular but implausible form of medicine. Contrary to many claims by homeopaths, there is no conclusive evidence that highly dilute homeopathic remedies are different from placebos. The benefits that many patients experience after homeopathic treatment are therefore most probably due to nonspecific treatment effects. Contrary to widespread belief, homeopathy is not entirely devoid of risk. Thus, the proven benefits of highly dilute homeopathic remedies, beyond the beneficial effects of placebos, do not outweigh the potential for harm that this approach can cause.
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BACKGROUND: Low back pain limits activity and is the second most frequent reason for physician visits. Previous research shows widespread use of acupuncture for low back pain. PURPOSE: To assess acupuncture's effectiveness for treating low back pain. DATA SOURCES: Randomized, controlled trials were identified through searches of MEDLINE, Cochrane Central, EMBASE, AMED, CINAHL, CISCOM, and GERA databases through August 2004. Additional data sources included previous reviews and personal contacts with colleagues. STUDY SELECTION: Randomized, controlled trials comparing needle acupuncture with sham acupuncture, other sham treatments, no additional treatment, or another active treatment for patients with low back pain. DATA EXTRACTION: Data were dually extracted for the outcomes of pain, functional status, overall improvement, return to work, and analgesic consumption. In addition, study quality was assessed. DATA SYNTHESIS: The 33 randomized, controlled trials that met inclusion criteria were subgrouped according to acute or chronic pain, style of acupuncture, and type of control group used. The principal [correction] measure of effect size was the standardized mean difference, since the trials assessed the same outcome but measured it in various ways. For the primary outcome of short-term relief of chronic pain, the meta-analyses showed that acupuncture is significantly more effective than sham treatment (standardized mean difference, 0.54 [95% CI, 0.35 to 0.73]; 7 trials) and no additional treatment (standardized mean difference, 0.69 [CI, 0.40 to 0.98]; 8 trials). For patients with acute low back pain, data are sparse and inconclusive. Data are also insufficient for drawing conclusions about acupuncture's short-term effectiveness compared with most other therapies. LIMITATIONS: The quantity and quality of the included trials varied. CONCLUSIONS: Acupuncture effectively relieves chronic low back pain. No evidence suggests that acupuncture is more effective than other active therapies.
While peripheral arterial disease (PAD) affects a considerable proportion of patients in the primary care setting, there is a high level of use of complementary treatment options. The aim was to assess the effectiveness of any type of complementary therapy for peripheral arterial disease. A systematic review was performed. Literature searches were conducted on Medline, Embase, Amed, and the Cochrane Library until December 2004. Hand-searches of medical journals and bibliographies were conducted. There were no restrictions regarding the language of publication. The screening of studies, selection, data extraction, the assessment of methodologic quality and validation were performed independently by the two reviewers. Data from randomized controlled trials, and systematic reviews and meta-analyses, which based their findings on the results of randomized controlled trials were included. Seven systematic reviews and meta-analyses and three additional randomized controlled trials met the inclusion criteria and were reviewed. The evidence relates to acupuncture, biofeedback, chelation therapy, CO(2)-applications and the dietary supplements Allium sativum (garlic), Ginkgo biloba (ginkgo), omega-3 fatty acids, padma 28 and Vitamin E. Most studies included only patients with peripheral arterial disease in Fontaine stage II (intermittent claudication). The reviewed RCTs, systematic reviews and meta-analyses which based their findings on the results of RCTs suggest that G. biloba is effective compared with placebo for patients with intermittent claudication. Evidence also suggests that padma 28 is effective for intermittent claudication, although more data are required to confirm these findings. For all other complementary treatment options there is no evidence beyond reasonable doubt to suggest effectiveness for patients with peripheral arterial disease.
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