Herbal medicines for children.
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Biomedical subjects
Publications and source records attributed to E Ernst.
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Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.
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Complementary medicine is fast becoming an integral part of palliative cancer care. There is considerable debate as to whether such treatments require proof of effectiveness through randomized clinical trials or whether it may suffice that patients adopt them with apparent appreciation. We attempt to raise some of the arguments on both sides. The arguments include the logistical problems of conducting research in palliative care, ethical problems of placebo controls, methodological difficulties of standardizing treatments or quantifying subtle effects and the, often considerable, costs of clinical trials. We feel that neither those who argue against nor those who argue in favour of rigorous clinical trials are entirely wrong or entirely right. However, our final verdict is that an absence of rigorous science will critically hinder progress. This, in turn, would be to the detriment of future patients. Through discussing the strengths and weaknesses of both sets of arguments, both sides might learn valuable lessons.
OBJECTIVE: A pilot study to assess multiple crossover n = 1 trials with verum/placebo discrimination as the outcome measure as a means of identifying responders and non-responders to the acute nootropic effect of Ginkgo biloba (G. biloba) among healthy volunteers. METHOD: Multiple double-blind, placebo-controlled n = 1 trials with 8 treatments in randomized order and separated by minimum washout periods of 7 days. Treatments were acute 120 mg doses of G. biloba extract (GK501) or undistinguishable placebo. The frequency distribution of correct scores for verum-placebo discrimination was compared with the binomial distribution to identify putative responders, who were then tested for consistency of performance over a further 8 treatments. RESULTS: The frequency distribution of scores (n = 11) was bimodal and a discontinuity defined 3 putative responders and 2 putative negative responders for re-test. Two of the putative responders again performed at above chance level and the probability of achieving their scores or better by chance was 0.013 and 0.052. CONCLUSIONS: n = 1 trials with verum/placebo discrimination as outcome are a promising method for exploring response heterogeneity to treatments with a subjective effect. Preliminary evidence suggests that there are responders and non-responders to an acute G. biloba treatment among healthy subjects.
Herbal medicines are popular but health care professionals often feel uncertain about their risks. This article summarizes recent evidence regarding the serious or potentially serious cardiovascular adverse effects of herbal medicines. Five electronic literature databases were searched. The evidence found was mostly anecdotal. Case reports and case series indicate that life-threatening adverse effects of herbal medicines occur. Potentially serious adverse effects are arrhythmias, arteritis, cardiac glycosides overdose, chest pain, congestive heart failure, hypertension, hypotension, myocardial infarction, over-anticoagulation, pericarditis and death. The problems relate to toxic herbal ingredients, adulteration and contamination of herbal medicinal products, and herb-drug interactions. Herbal medicines that have been implicated repeatedly include aconite, ephedra and licorice. Because of the anecdotal nature of the evidence, it is impossible to estimate the incidence of adverse effects. In conclusion, herbal medicinal products are regularly associated with serious cardiovascular adverse events but the size of this problem cannot be estimated at present. Vigilance and research seem to be the best way forward.
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HYPOTHESIS: St John's wort is one of the most popular herbal medicines, and health care professionals often are unaware that their patients take such supplements. St John's wort causes a decrease in cyclosporine levels, thus endangering the success of organ transplantations. DESIGN: Systematic review. METHODS: Five independent computerized literature searches were conducted to identify all reports of such interactions. Data were extracted and are summarized in narrative form. RESULTS: Eleven case reports and 2 case series were located. In most instances, causality between St John's wort and the clinical or biochemical result is well established. The mechanism of interaction between St John's wort and cyclosporine has been recently elucidated and involves both P-glycoprotein and cytochrome P 450 3A4 expression. Collectively these data leave little doubt that St John's wort interacts with cyclosporine, causing a decrease of cyclosporine blood levels and leading in several cases to transplant rejection. CONCLUSIONS: St John's wort can endanger the success of organ transplantations. Adequate information may be the best way to avoid future incidences.
BACKGROUND: Conservative therapy of chronic venous insufficiency (CVI) consists largely of compression treatment. However, this often causes discomfort and has been associated with poor compliance, which renders oral drug treatment an attractive option. OBJECTIVES: To review the evidence from rigorous clinical trials assessing the efficacy and safety of oral horse chestnut seed extract (HCSE) versus placebo, or reference therapy for the treatment of CVI. SEARCH STRATEGY: Publications describing randomised controlled trials (RCTs) of HCSE for chronic venous insufficiency were sought through EMBASE, MEDLINE, Amed, and Phytobase (from inception to January 2001), The Cochrane Controlled Trials Register (Issue 1, 2001) and the Specialised Trials Register of the Cochrane Peripheral Vascular Diseases Group (April 2001). Manufacturers of HCSE preparations and experts on the subject were contacted and asked to contribute published and unpublished material. There were no restrictions on the language of publication. SELECTION CRITERIA: Randomised controlled trials of oral HCSE mono-preparations for patients with CVI were included. Trials comparing HCSE with placebo or reference medications were included. Trials assessing HCSE as one of several active components in a combination preparation or as a part of a combination treatment were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted systematically and methodological quality was evaluated using a standard scoring system. The screening of studies, selection, data extraction and the assessment of methodological quality were performed independently by two reviewers. Disagreements concerning evaluation of individual trials were resolved through discussion. MAIN RESULTS: Overall, the included placebo controlled trials suggest an improvement in CVI related signs and symptoms. Leg pain was assessed in six placebo-controlled trials that reported a significant reduction of leg pain in the HCSE groups compared with the placebo groups. One trial, which reported adequate data suggested a weighted mean difference (WMD) of 42.4 mm [95% confidence interval (CI) 34.9-49.9] measured on a 100 mm visual analogue scale. Leg volume was assessed in five placebo-controlled trials. Meta-analysis of four trials (n = 239) reporting adequate data suggested a significant reduction in favour of HCSE compared with placebo (WMD 58.6 ml [95% CI 24.9-92.2]). One trial indicated that HCSE may be as effective as treatment with compression stockings. Adverse effects are usually mild and infrequent. REVIEWER'S CONCLUSIONS: The evidence presented implies that HCSE is an efficacious and safe short-term treatment for CVI. However several caveats exist and more rigorous RCTs are required to assess the efficacy of this treatment option.
BACKGROUND: Hypercholesterolaemia is directly associated with an increased risk for coronary heart disease and other sequelae of atherosclerosis. Artichoke leaf extract (ALE), which is available as an over-the-counter remedy, has been implicated in lowering cholesterol levels. Whether ALE is truly efficacious for this indication, however, is still a matter of debate. OBJECTIVES: To assess the evidence of ALE versus placebo or reference medication for treating hypercholesterolaemia defined as mean total cholesterol levels of at least 5.17 mmol/L (200 mg /dL). SEARCH STRATEGY: We searched MEDLINE, Embase, Amed, Cinahl, CISCOM and the Cochrane Controlled Trial Register. All databases were searched from their respective inception until June 2001. Reference lists of articles were also searched for relevant material. Manufacturers of preparations containing artichoke extract and experts on the subject were contacted and asked to contribute published and unpublished material. SELECTION CRITERIA: Randomized controlled trials of ALE mono-preparations compared with placebo or reference medication for patients with hypercholesterolaemia were included. Trials assessing ALE as one of several active components in a combination preparation or as a part of a combination treatment were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted systematically and methodological quality was evaluated using a standard scoring system. The screening of studies, selection, data extraction and the assessment of methodological quality were performed independently by two reviewers. Disagreements in the evaluation of individual trials were resolved through discussion. MAIN RESULTS: Two randomised trials including 167 participants met all inclusion criteria. In one trial ALE reduced total cholesterol levels from 7.74 mmol/l to 6.31 mmol/l after 42 +/- 3 days of treatment whereas the placebo reduced cholesterol from 7.69 mmol/l to 7.03 mmol/l (p=0.00001). Another trial did state that ALE significantly (p<0.05) reduced blood cholesterol compared with placebo in a sub-group of patients with baseline total cholesterol levels of more than 230 mg/dl. Trial reports and post-marketing surveillance studies indicate mild, transient and infrequent adverse events. REVIEWER'S CONCLUSIONS: Few data from rigorous clinical trials assessing ALE for treating hypercholesterolaemia exist. Beneficial effects are reported, the evidence however is not compelling. The limited data on safety suggest only mild, transient and infrequent adverse events with the short term use of ALE. More rigorous clinical trials assessing larger patient samples over longer intervention periods are needed to establish whether ALE is an effective and safe treatment option for patients with hypercholesterolaemia.
The growing popularity of traditional Indian remedies necessitates a critical evaluation of risks associated with their use. This systematic review aims at summarising all available data relating to the heavy metal content in such remedies. Computerised literature searches were carried out to identify all articles with original data on this subject. Fifteen case reports and six case series were found. Their collective results suggest that heavy metals, particularly lead, have been a regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to patients taking such remedies. The incidence of heavy metal contamination is not known, but one study shows that 64% of samples collected in India contained significant amounts of lead (64% mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of heavy metal content in traditional Indian remedies and motivate us to consider means of protecting consumers from such risks.
BACKGROUND: Acupuncture is commonly used to treat back pain. A meta-analysis of clinical trials of acupuncture for this condition came to a positive conclusion whilst a qualitative review was negative. AIM: To compare our meta-analysis of trials of acupuncture for the treatment of back pain with a qualitative review and the most recent studies on the subject. METHODS: A systematic literature search was conducted to retrieve all randomised controlled trials of any form of acupuncture for any type of back pain in humans. The adequacy of the acupuncture was assessed by consulting six experienced acupuncturists. The main outcome measure for the meta-analysis was numbers of subjects who where improved at the end of treatment. These data are discussed in relation to the qualitative review and the most recent studies. RESULTS: Twelve studies were included of which nine presented data suitable for meta-analysis. The odds ratio of improvement with acupuncture compared with control intervention was 2.30 (95% confidence interval 1.28 to 4.13). For sham-controlled, evaluator-blinded studies, the odds ratio was 1.37 (95% confidence interval, 0.84-2.25). The results from the majority of the most recent studies also support the effectiveness of acupuncture in the treatment of back pain. CONCLUSIONS: Collectively, these data imply that acupuncture is superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo.
Generalized statements about herbal medicines are nonsensical, and each remedy has to be evaluated on its own merits. Some herbal treatments can be shown to have a favorable risk-benefit profile, but for most herbal medicines the data are insufficient to determine whether they do more good than harm. The research required to fill the gaps in present knowledge should have a high priority.
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