Obstacles to research in complementary and alternative medicine.
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Biomedical subjects
Publications and source records attributed to Edzard Ernst.
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The aim of this meta-analysis was to assess the evidence from rigorous clinical trials of the use of hawthorn extract to treat patients with chronic heart failure. We searched the literature using MEDLINE, EMBASE, the Cochrane Library, CINAHL, CISCOM, and AMED. Experts on and manufacturers of commercial preparations containing hawthorn extract were asked to contribute published and unpublished studies. There were no restrictions about the language of publication. Two reviewers independently performed the screening of studies, selection, validation, data extraction, and the assessment of methodological quality. To be included, studies were required to state that they were randomized, double-blind, and placebo controlled, and used hawthorn extract monopreparations. Thirteen trials met all inclusion criteria. In most of the studies, hawthorn was used as an adjunct to conventional treatment. Eight trials including 632 patients with chronic heart failure (New York Heart Association classes I to III) provided data that were suitable for meta-analysis. For the physiologic outcome of maximal workload, treatment with hawthorn extract was more beneficial than placebo (weighted mean difference, 7 Watt; 95% confidence interval [CI]: 3 to 11 Watt; P < 0.01; n = 310 patients). The pressure-heart rate product also showed a beneficial decrease (weighted mean difference, -20; 95% CI: -32 to -8; n = 264 patients) with hawthorn treatment. Symptoms such as dyspnea and fatigue improved significantly with hawthorn treatment as compared with placebo. Reported adverse events were infrequent, mild, and transient; they included nausea, dizziness, and cardiac and gastrointestinal complaints. In conclusion, these results suggest that there is a significant benefit from hawthorn extract as an adjunctive treatment for chronic heart failure.
AIM: To update our published systematic review of clinical trials of distant healing. DESIGN: Systematic review. DATA SOURCES: Medline, Embase, Cochrane Library and personal files. STUDY SELECTION: Any type of clinical study of any type of distant healing published between 2000 and December 2002. DATA EXTRACTION: For each included study, essential data were extracted and summarised in narrative form. RESULTS: 8 non-randomised and 9 randomised clinical trials were located. The majority of the rigorous trials do not to support the hypothesis that distant healing has specific therapeutic effects. The results of two studies furthermore suggest that distant healing can be associated with adverse effects. CONCLUSION: Since the publication of our previous systematic review in 2000, several rigorous new studies have emerged. Collectively they shift the weight of the evidence against the notion that distant healing is more than a placebo.
We wanted to investigate what advice UK homeopaths, chiropractors and general practitioners give on measles, mumps and rubella vaccination programme (MMR) vaccination via the Internet. Online referral directories listing e-mail addresses of UK homeopaths, chiropractors and general practitioners and private websites were visited. All addresses thus located received a letter of a (fictitious) patient asking for advice about the MMR vaccination. After sending a follow-up letter explaining the nature and aim of this project and offering the option of withdrawal, 26% of all respondents withdrew their answers. Homeopaths yielded a final response rate (53%, n = 77) compared to chiropractors (32%, n = 16). GPs unanimously refused to give advice over the Internet. No homeopath and only one chiropractor advised in favour of the MMR vaccination. Two homeopaths and three chiropractors indirectly advised in favour of MMR. More chiropractors than homeopaths displayed a positive attitude towards the MMR vaccination. Some complementary and alternative medicine (CAM) providers have a negative attitude towards immunisation and means of changing this should be considered.
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OBJECTIVES: Many hundreds of plant extracts have been tested for in vitro antibacterial activity. This review is a critical evaluation of controlled clinical trials of herbal medicines with antibacterial activity. METHODS: Four electronic databases were searched for controlled clinical trials of antibacterial herbal medicines. Data were extracted and validated in a standardized fashion, according to predefined criteria, by two independent reviewers. RESULTS: Seven clinical trials met our inclusion criteria. Four of these studies were randomized. Three trials of garlic and cinnamon treatments for Helicobacter pylori infections reported no significant effect. Bacterial infections of skin were treated in four trials. Positive results were reported for an ointment containing tea leaf extract in impetigo contagiosa infections. Two trials of tea tree oil preparations used for acne and methicillin-resistant Staphylococcus aureus, and one trial of Ocimum gratissimum oil for acne, reported results equivalent to conventional treatments. CONCLUSIONS: Few controlled clinical trials have been published and most are methodologically weak. The clinical efficacy of none of the herbal medicines has so far been demonstrated beyond doubt. This area seems to merit further study through rigorous clinical trials.
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BACKGROUND AND AIMS: Many antiviral compounds presently in clinical use have a narrow spectrum of activity, limited therapeutic usefulness and variable toxicity. There is also an emerging problem of resistant viral strains. This study was undertaken to examine the published literature on herbs and plants with antiviral activity, their laboratory evaluation in vitro and in vivo, and evidence of human clinical efficacy. METHODS: Independent literature searches were performed on MEDLINE, EMBASE, CISCOM, AMED and Cochrane Library for information on plants and herbs with antiviral activity. There was no restriction on the language of publication. Data from clinical trials of single herb preparations used to treat uncomplicated viral infections were extracted in a standardized, predefined manner. RESULTS: Many hundreds of herbal preparations with antiviral activity were identified and the results of one search presented as an example. Yet extracts from only 11 species met the inclusion criteria of this review and have been tested in clinical trials. They have been used in a total of 33 randomized, and a further eight nonrandomized, clinical trials. Fourteen of these trials described the use of Phyllanthus spp. for treatment of hepatitis B, seven reporting positive and seven reporting negative results. The other 10 herbal medicines had each been tested in between one and nine clinical trials. Only four of these 26 trials reported no benefit from the herbal product. CONCLUSIONS: Though most of the clinical trials located reported some benefits from use of antiviral herbal medicines, negative trials may not be published at all. There remains a need for larger, stringently designed, randomized clinical trials to provide conclusive evidence of their efficacy.
OBJECTIVES: To systematically review the clinical evidence for herbal medicinal products in the treatment of hypercholesterolemia. STUDY DESIGN: A systematic review of randomized clinical trials of herbal medicinal products used to lower serum cholesterol. Systematic literature searches were conducted in 6 electronic data-bases. The reference lists of all papers and our files were searched for more relevant publications. Experts in the field and manufacturers of identified herbal medicinal products were contacted for published and unpublished data. No language restrictions were imposed. OUTCOMES MEASURED: All randomized clinical trials of serum cholesterol reduction, in which mono-preparations of herbal medicinal products were administered as supplements to human subjects, were included. RESULTS: Twenty-five randomized clinical trials involving 11 herbal medicinal products were identified. Guggul (Commiphora mukul), fenugreek (Trigonella foenum-graecum), red yeast rice, and artichoke (Cynara scolymus) have been most extensively studied and have demonstrated reductions in total serum cholesterol levels of between10% and 33%. The methodological quality as assessed by the Jadad score was less than 3 (maximum, 5) for 13 of the 25 trials. CONCLUSIONS: Many herbal medicinal products have potential hypocholesterolemic activity and encouraging safety profiles. However, only a limited amount of clinical research exists to support their efficacy. Further research is warranted to establish the value of these extracts in the treatment of hypercholesterolemia.
Herbal medicines have been submitted to systematic reviews more frequently than any other complementary therapy, and it is here where the most positive evidence can be found. There is not much research into potential serious risks of complementary medicine. Possible risks range from the toxicity of herbs to vertebral artery dissection or nerve damage after chiropractic manipulation. Currently the Cochrane Library contains 34 systematic reviews of complementary medicine: 20 of herbal medicines, 7 of acupuncture, 3 of homeopathy, 2 of manual therapies, and 2 of other forms.
BACKGROUND: Flower remedies (also called "Bach" flower remedies) are used by an increasing number of individuals, and many health claims have been made for them. No systematic review of flower remedies has so far been published. AIM: The aim of this systematic review is to summarise and critically analyse the data from all available controlled clinical trials of flower remedies. METHODS: Six databases were searched to identify all controlled clinical trials of flower remedies in humans for any medical condition. No language restrictions were applied. Key data were validated and extracted into table format according to pre-defined criteria. Statistical pooling was not possible, and results were evaluated in narrative form. RESULTS: Four studies met the inclusion/exclusion criteria. Two trials suggested a positive outcome. Those studies that controlled for placebo-effects and minimised selection bias through randomisation failed to demonstrate effects beyond a placebo response. CONCLUSION: The hypothesis that flower remedies are associated with effects beyond a placebo response is not supported by data from rigorous clinical trials.
Unconventional therapies have become popular in paediatric and adolescent populations. It is therefore important to define their risks. The aim of this systematic review was to summarise the recent evidence. Computerised literature searches were carried out in five databases to identify all recent reports of adverse events associated with unconventional therapies in children. The reports were summarised in narrative and tabular form. The results show that numerous case reports and several case series have been published since 1990. Investigations of a more systematic nature are, however, rare. Most of the adverse events were associated with herbal medications. Inadequately regulated herbal medicines may contain toxic plant material, be contaminated with heavy metals, or be adulterated with synthetic drugs. The adverse events included bradycardia, brain damage, cardiogenic shock, diabetic coma, encephalopathy, heart rupture, intravascular haemolysis, liver failure, respiratory failure, toxic hepatitis and death. A high degree of uncertainty regarding a causal relationship between therapy and adverse event was frequently noted. The size of the problem and its importance relative to the well-documented risks of conventional treatments are presently unknown. Several unconventional therapies may constitute a risk to the health of children and adolescents. At present, it is impossible to provide reliable incidence figures. It seems important to be vigilant and investigate this area more systematically.
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