[Meta-analysis of randomized clinical studies. Hawthorn extract for treatment of chronic cardiac insufficiency].
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Publications and source records attributed to Edzard Ernst.
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AIM: The aim of this paper is to summarise and critically evaluate the evidence available from controlled clinical trials regarding the use of guided imagery as a sole adjuvant therapy for cancer patients. METHODS: Electronic searches for controlled clinical trials were carried out in eight databases and two clinical trial registers. Trials that featured guided imagery as a sole adjuvant therapy were included. No language restrictions were imposed. Data were extracted and validated independently by two researchers. RESULTS: Six randomised clinical trials were included. Detailed results were available for four studies only. Poor reporting and heterogeneous populations, interventions and outcome measures across trials precluded statistical pooling of results. The methodological quality was on average low. Three studies reported significant differences in measures of anxiety, comfort or emotional response to chemotherapy for patients who received guided imagery over the control groups. Two studies showed no differences between guided imagery and other interventions in any of the outcome measures. CONCLUSION: Guided imagery, as a sole adjuvant cancer therapy may be psycho-supportive and increase comfort. There is no compelling evidence to suggest positive effects on physical symptoms such as nausea and vomiting. The data seem sufficiently encouraging for the use of guided imagery as an adjuvant cancer therapy to merit further research.
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The effectiveness of spinal manipulation as a treatment for back pain remains uncertain and controversial. This is because of methodological weakness in many of the published clinical trials and also because of markedly opposing interpretations of the primary data by different reviewers. We have systematically assessed a representative sample of recent reviews on this topic. Reviews were included in the analysis if they were published between 1993 and March 2004, were listed in PubMed with an abstract and categorised as a review or meta-analysis, and were written in English. They were also required to present the evidence from at least two referenced clinical trials of spinal manipulation for back pain and to reach a conclusion about the effectiveness of the intervention. Each review was evaluated for methodological quality. Twenty-nine reviews met the inclusion criteria. Sixteen reached an overall positive conclusion, 7 a negative conclusion and 6 a neutral conclusion regarding therapeutic effectiveness. There were statistically significant pairwise correlations between each of the three factors: direction of conclusion, methodological quality and authorship by osteopaths or chiropracters. This indicates an association between authorship by osteopaths or chiropractors and low methodological quality and positive conclusion. We conclude that the outcomes of reviews of this subject are strongly influenced by both scientific rigour and profession of authors. The effectiveness of spinal manipulation for back pain is less certain than many reviews suggest; most high quality reviews reach negative conclusions.
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Many hypertensive patients try complementary/alternative medicine for blood pressure control. Based on extensive electronic literature searches, the evidence from clinical trials is summarised. Numerous herbal remedies, non-herbal remedies and other approaches have been tested and some seem to have antihypertensive effects. The effect size is usually modest, and independent replications are frequently missing. The most encouraging data pertain to garlic, autogenic training, biofeedback and yoga. More research is required before firm recommendations can be offered.
Use of herbal medicines among patients under cardiovascular pharmacotherapy is widespread. In this paper, we have reviewed the literature to determine the possible interactions between herbal medicines and cardiovascular drugs. The Medline database was searched for clinical articles published between January 1996 and February 2003. Forty-three case reports and eight clinical trials were identified. Warfarin was the most common cardiovascular drug involved. It was found to interact with boldo, curbicin, fenugreek, garlic, danshen, devil's claw, don quai, ginkgo, papaya, lycium, mango, PC-SPES (resulting in over-anticoagulation) and with ginseng, green tea, soy and St. John's wort (causing decreased anticoagulant effect). Gum guar, St. John's wort, Siberian ginseng and wheat bran were found to decrease plasma digoxin concentration; aspirin interactions include spontaneous hyphema when associated with ginkgo and increased bioavailability if combined with tamarind. Decreased plasma concentration of simvastatin or lovastatin was observed after co-administration with St. John's wort and wheat bran, respectively. Other adverse events include hypertension after co-administration of ginkgo and a diuretic thiazide, hypokalemia after liquorice and antihypertensives and anticoagulation after phenprocoumon and St. John's wort. Interaction between herbal medicine and cardiovascular drugs is a potentially important safety issue. Patients taking anticoagulants are at the highest risk.
The aim of this systematic review is to assess the effectiveness of acupuncture as an adjunctive analgesic method to standard anaesthetic procedures for surgery and to determine whether acupuncture has any analgesic-sparing effect. Electronic literature searches for randomised clinical trials (RCTs) of acupuncture during surgery were performed in seven electronic databases. No language restrictions were imposed. All included studies were rated according to their methodological quality and validity. As the studies were clinically heterogeneous, no meta-analyses were performed. The evidence was classified according to four levels: strong, moderate, limited, or inconclusive. Nineteen RCTs were identified. Seven of them suggested that acupuncture is efficacious. Of nine high-quality RCTs, two studies had positive outcomes. There was no significant association between study quality and direction of outcome. One of eight high-validity trials reported a positive outcome and there was a significant relationship between validity and direction of outcome. The evidence that acupuncture is more effective than no acupuncture as an adjunct to standard anaesthetic procedures is therefore inconclusive. Strong evidence exists that real acupuncture is not significantly different from placebo acupuncture. For an analgesic-sparing effect of acupuncture, evidence remains inconclusive. In conclusion, this review does not support the use of acupuncture as an adjunct to standard anaesthetic procedures during surgery.
OBJECTIVE: To systematically review all randomized controlled trials (RCTs) on the effectiveness of Ayurvedic medicine for rheumatoid arthritis (RA). METHODS: Computerized literature searches for all RCTs of Ayurvedic medicine for RA in the following databases: Medline (March 1969 to March 2003), Embase (February 1985 to February 2003), AMED (March 1980 to March 2003), Cochrane Controlled Trial Register (October 1997 to March 2003), and the abstract service of Central Council for Research in Ayurveda and Siddha (CCRAS; 1976 to March 2003). Hand searches were performed in 1 Sri Lankan and 3 Indian journals and the authors' personal files. Key data of included studies were extracted and reviewed. The methodological quality of all studies was evaluated with the Jadad scale. RESULTS: Seven studies met our inclusion criteria. Trials tested either Ayurvedic medicine against placebo or other Ayurvedic medicines. In general, patient and physician global assessments on the severity of pain, and morning stiffness were used as endpoints. Of 3 placebo-controlled RCTs, 1 high-quality trial did not show benefit of the active treatment against placebo, while another incompletely reported study indicated beneficial effects of an Ayurvedic medicine. A further incompletely reported study showed no significant difference. The remaining 4 trials were difficult to interpret because they tested an Ayurvedic medicine against other Ayurvedic medicines whose effects were not proven. CONCLUSION: There is a paucity of RCTs of Ayurvedic medicines for RA. The existing RCTs fail to show convincingly that such treatments are effective therapeutic options for RA.
Consumption of herbal medicines is widespread and increasing. Harvesting from the wild, the main source of raw material, is causing loss of genetic diversity and habitat destruction. Domestic cultivation is a viable alternative and offers the opportunity to overcome the problems that are inherent in herbal extracts: misidentification, genetic and phenotypic variability, extract variability and instability, toxic components and contaminants. The use of controlled environments can overcome cultivation difficulties and could be a means to manipulate phenotypic variation in bioactive compounds and toxins. Conventional plant-breeding methods can improve both agronomic and medicinal traits, and molecular marker assisted selection will be used increasingly. There has been significant progress in the use of tissue culture and genetic transformation to alter pathways for the biosynthesis of target metabolites. Obstacles to bringing medicinal plants into successful commercial cultivation include the difficulty of predicting which extracts will remain marketable and the likely market preference for what is seen as naturally sourced extracts.
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Herbal medicine has become a popular form of healthcare. Even though several differences exist between herbal and conventional pharmacological treatments, herbal medicine can be tested for efficacy using conventional trial methodology. Several specific herbal extracts have been demonstrated to be efficacious for specific conditions. Even though the public is often misled to believe that all natural treatments are inherently safe, herbal medicines do carry risks. Ultimately, we need to know which herbal remedies do more harm than good for which condition. Because of the current popularity of herbal medicine, research in this area should be intensified.
OBJECTIVE: Upper spinal manipulation (USM) is frequently used by chiropractors and other health care professionals to treat minor complaints. This systematic review aimed to summarize ophthalmological adverse effects of USM recently reported in the medical literature. METHODS: Five electronic databases were searched for all case reports of ophthalmological adverse effects after USM published between January 1995 and April 2003. No language restrictions were applied. Key data from the primary publications thus located were extracted and critically evaluated. RESULTS: Fourteen case reports were found. Clinical symptoms and signs were diverse and included loss of vision, ophthalmoplegia, diplopia and Horner's syndrome. The underlying mechanism was arterial wall dissection in most cases. The eventual outcome varied and often included permanent deficits. Causality was frequently deemed likely or certain. CONCLUSION: Upper spinal manipulation is associated with ophthalmological adverse effects of unknown frequency. Ophthalmologists should be aware of its risks. Rigorous investigations must be conducted to establish reliable incidence figures.
OBJECTIVE: To summarise the existing evidence on acupuncture as a therapy for depression. METHODS: RCTs were included, in which either manual acupuncture or electroacupuncture was compared with any control procedure in subjects with depression. Data were extracted independently by two authors. The methodological quality was assessed. Pre and post means and SDs for depression specific measures were extracted, when available, for meta-analysis. RESULTS: Seven randomised comparative trials involving 509 patients were included. The evidence is inconsistent on whether manual acupuncture is superior to sham, and suggests that acupuncture was not superior to waiting list. Evidence suggests that the effect of electroacupuncture may not be significantly different from antidepressant medication, weighted mean difference -0.43(95% CI -5.61 to 4.76). There is inconclusive evidence on whether acupuncture has an additive effect when given as an adjunct to antidepressant drugs. CONCLUSION: The evidence from controlled trials is insufficient to conclude whether acupuncture is an effective treatment for depression, but justifies further trials of electroacupuncture.
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The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM's popularity, the paucity of clinical trials and their low methodological quality are concerning.
This systematic review discusses the proposed uses, dosing parameters, adverse effects, toxicology, interactions and mechanism of action of kava. The widespread concern regarding the potential hepatotoxicity of kava is discussed. A recommendation is made to consolidate and analyse available reports and to continue postmarket surveillance in an international repository to prevent duplicates and promote collection of thorough details at the time of each report so that any association with kava is clearly defined.
Vitex agnus castus L. (VAC) [Verbenaceae] is a deciduous shrub that is native to Mediterranean Europe and Central Asia. Traditionally, VAC fruit extract has been used in the treatment of many female conditions, including menstrual disorders (amenorrhoea, dysmenorrhoea), premenstrual syndrome (PMS), corpus luteum insufficiency, hyperprolactinaemia, infertility, acne, menopause and disrupted lactation. The German Commission E has approved the use of VAC for irregularities of the menstrual cycle, premenstrual disturbances and mastodynia. Clinical reviews are available for the efficacy of VAC in PMS, cycle disorders, hyperprolactinaemia and mastalgia, but so far no systematic review has been published on adverse events or drug interactions associated with VAC. Therefore, this review was conducted to evaluate all the available human safety data of VAC monopreparations. Literature searches were conducted in six electronic databases, in references lists of all identified papers and in departmental files. Data from spontaneous reporting schemes of the WHO and national drug safety bodies were also included. Twelve manufacturers of VAC-containing preparations and five herbalist organisations were contacted for additional information. No language restrictions were imposed. Combination preparations including VAC or homeopathic preparations of VAC were excluded. Data extraction of key data from all articles reporting adverse events or interactions was performed independently by at least two reviewers, regardless of study design. Data from clinical trials, postmarketing surveillance studies, surveys, spontaneous reporting schemes, manufacturers and herbalist organisations indicate that the adverse events following VAC treatment are mild and reversible. The most frequent adverse events are nausea, headache, gastrointestinal disturbances, menstrual disorders, acne, pruritus and erythematous rash. No drug interactions were reported. Use of VAC should be avoided during pregnancy or lactation. Theoretically, VAC might also interfere with dopaminergic antagonists. Although further rigorous studies are needed to assess the safety of VAC, the data available seem to indicate that VAC is a safe herbal medicine.