A systematic review of randomised clinical trials of individualised herbal medicine in any indication.

AIM: To summarise and critically evaluate the evidence from randomised clinical trials for the effectiveness of individualised herbal medicine in any indication. METHODS: Search of electronic databases and approaches to experts in the field to identify randomised, controlled clinical trials of individualised herbal medicine in any indication. Independent data extraction and assessment of methodological quality by two authors and best evidence synthesis. RESULTS: Three randomised clinical trials of individualised herbal medicine were identified. Statistically non-significant trends favouring active over placebo treatment in osteoarthritis of the knee probably result from large baseline differences and regression to the mean. Individualised treatment was superior to placebo in four of five outcome measures in the treatment of irritable bowel syndrome, but was inferior to standardised herbal treatment in all outcomes. Individualised herbal treatment was no better than placebo in the prevention of chemotherapy-induced toxicity. CONCLUSIONS: There is a sparsity of evidence regarding the effectiveness of individualised herbal medicine and no convincing evidence to support the use of individualised herbal medicine in any indication.

The antioxidant vitamins A, C, E and selenium in the treatment of arthritis: a systematic review of randomized clinical trials.

OBJECTIVE: To systematically review the evidence from randomized clinical trials (RCTs) for the effectiveness of the antioxidant vitamins A, C, E or selenium or their combination in the treatment of arthritis. METHODSL: A systematic search of computerized databases from inception to September 2006 for relevant RCTs, application of pre-defined inclusion/exclusion criteria and independent data extraction by two authors. Methodological quality was assessed using the Jadad scale. RESULTS: The searches identified 20 unique RCTs meeting the inclusion criteria: 11 in inflammatory arthritis and 9 in osteoarthritis (OA). The studies included are generally of poor quality. They fall into three main clusters: selenium for rheumatoid arthritis (n = 5); vitamin E for inflammatory arthritis (n = 5) and vitamin E for OA (n = 7). One RCT suggests superiority of vitamin E over placebo and three RCTs suggest equivalence between vitamin E and diclofenac in the treatment of inflammatory arthritis. In OA, four RCTs compared vitamin E with placebo. Two shorter-term studies were positive and two longer-term studies were negative. Two further RCTs suggest equivalence between vitamin E and diclofenac in the treatment of OA. Findings for selenium, vitamin A and a combination product in inflammatory arthritis and for vitamin A, and a combination product in OA were negative. An isolated positive result for vitamin C in OA is of doubtful clinical significance. CONCLUSIONS: Clinical trials testing the efficacy of vitamin E in the treatment of OA and inflammatory arthritis have been methodologically weak and have produced contradictory findings. There is presently no convincing evidence that selenium, vitamin A, vitamin C or the combination product selenium ACE is effective in the treatment of any type of arthritis.

Ginkgo biloba is not a smart drug: an updated systematic review of randomised clinical trials testing the nootropic effects of G. biloba extracts in healthy people.

Here, we update our earlier systematic review of 2001, which critically evaluated the data from clinical trials to determine whether Ginkgo biloba enhances cognitive function in healthy subjects. Literatures searches of six computerised databases, updated to January 2007, were made for randomised, placebo-controlled, double-blind clinical trials of the effects of standardised Ginkgo biloba (G. biloba) extracts on cognitive function in healthy subjects under the age of 60 years. Trials published in any language were included, and data were extracted independently by the two authors following a standardised protocol. We include 15 randomised clinical trials of which 7 are single-dose studies and 8 are longer term studies with treatment periods ranging from 2 days to 13 weeks. Three single dose studies and 4 longer term studies are newly included. Several of the studies have methodological flaws. A number of the acute studies used multiple outcomes and report positive effects on one or more of these at particular time points with particular doses but these findings are either not replicated, or are directly contradicted by other studies. The evidence from longer term studies is largely negative. Of those studies which measured subjective effects, only one of five acute studies and one of six longer term studies reported any significant positive results. Overall, and in line with our previous conclusions, we have found no convincing evidence from randomised clinical trials for a robust positive effect of G. biloba ingestion upon any aspect of cognitive function in healthy young people, after either acute or longer term administration.

Johrei family healing: a pilot study.

Johrei is a form of spiritual healing comprising "energy channelling" and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot trial lasting 12 months. Parents were trained in Johrei healing and then practised at home with their family. Participants kept diaries and provided questionnaire data at baseline, 3,6 and 12 months. Eczema symptoms were scored at the same intervals. Scepticism about Johrei is presently an obstacle to recruitment and retention of a representative sample in a clinical trial, and to its potential use in general practice. The frequency and quality of practise at home by families may be insufficient to bring about the putative health benefits. Initial improvements in eczema symptoms and diary recorded illness, could not be separated from seasonal factors and other potential confounders. There were no improvements on other outcomes measuring general health and psychological wellbeing of family members.

A systematic review of systematic reviews of spinal manipulation.

OBJECTIVES: To systematically collate and evaluate the evidence from recent systematic reviews of clinical trials of spinal manipulation. DESIGN: Literature searches were carried out in four electronic databases for all systematic reviews of the effectiveness of spinal manipulation in any indication, published between 2000 and May 2005. Reviews were defined as systematic if they included an explicit and repeatable inclusion and exclusion criteria for studies. RESULTS: Sixteen papers were included relating to the following conditions: back pain (n=3), neck pain (n=2), lower back pain and neck pain (n=1), headache (n=3), non-spinal pain (n=1), primary and secondary dysmenorrhoea (n=1), infantile colic (n=1), asthma (n=1), allergy (n=1), cervicogenic dizziness (n=1), and any medical problem (n=1). The conclusions of these reviews were largely negative, except for back pain where spinal manipulation was considered superior to sham manipulation but not better than conventional treatments. CONCLUSIONS: Collectively these data do not demonstrate that spinal manipulation is an effective intervention for any condition. Given the possibility of adverse effects, this review does not suggest that spinal manipulation is a recommendable treatment.

A systematic review of randomised clinical trials of Tripterygium wilfordii for rheumatoid arthritis.

Tripterygium wilfordii is a Chinese herb with immunosuppressive effects and an established history of use in the treatment of rheumatoid arthritis (RA). We have carried out a systematic review of randomised clinical trials (RCTs) which assess the effectiveness of T. wilfordii in this indication. We included only randomised and controlled studies which tested the effectiveness of T. wilfordii monopreparations in the treatment of RA. Studies in any language were included. A search of five electronic databases from inception to February 2005 identified 18 articles which could potentially meet our inclusion criteria. Only 16 of these could be retrieved from the scientific literature and after reading these in full, only two unique RCTs meeting our inclusion criteria were identified. Both indicated that T. wilfordii has beneficial effects on the symptoms of RA. However, the literature indicates that T. wilfordii is associated with serious adverse events which make the risk-benefit analysis for this herb unfavourable. Therefore, we cannot recommend its use.

Research into complementary and alternative medicine across Europe and the United States.

BACKGROUND: There has been an increase in complementary/ alternative medicine (CAM) research with a wide range of perspectives. OBJECTIVE: To capture and analyse the diversity of CAM research across 7 European countries (Germany, United Kingdom, Italy, France, Spain, Netherlands, Belgium) and the US. We were predominantly interested in finding out how CAM research differs between countries. STUDY DESIGN: A systematic review of CAM literature published in 2002 and included in Medline, Embase, International Bibliography of the Social Sciences (IBBS) and PsycLit. OUTCOME CRITERIA: Data were extracted regarding country of origin, type of methodology, type of research question, CAM modality, direction of conclusion, setting and type of journal. RESULTS: In total 652 abstracts of articles were assessed (Germany: 137, UK: 183, Italy: 39, France: 47, Spain: 24, Netherlands: 17, Belgium: 22, US: 183). The vast majority of CAM research was of a medical nature and published in medical journals. The majority of articles were nonsystematic reviews and comments, analytical studies and surveys. The UK carried out more surveys than any of the other countries and also published the largest number of systematic reviews. Germany, the UK and the US covered the widest range of interests across various CAM modalities and investigated the safety of CAM. CONCLUSION: Our data suggest that important national differences exist in terms of the nature of CAM research. This raises important questions regarding the reasons for such differences.

Multiple n = 1 trials in the identification of responders and non-responders to the cognitive effects of Ginkgo biloba.

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.

The Alexander technique: a systematic review of controlled clinical trials.

AIM: Alexander technique (AT), a process of psychophysical re-education, is being promoted for a range of medical conditions. This systematic review is aimed at critically evaluating the evidence for or against the effectiveness of AT. METHODS: Computerized literature searches were performed in five databases to locate all controlled clinical trials of AT in any human condition. Data were extracted independently by two reviewers according to pre-defined criteria. The information was summarized in tabular and narrative form. The methodological quality of the primary studies was assessed using the Jadad score. RESULTS: Four clinical trials met our inclusion/exclusion criteria. Only two of these trials were methodologically sound and clinically relevant. Their results are promising and imply that AT is effective in reducing the disability of patients suffering from Parkinson's disease and in improving pain behaviour and disability in patients with back pain. CONCLUSION: The few controlled clinical trials of AT yield encouraging albeit not convincing evidence. AT deserves to be studied in more detail.