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Biomedical subjects

M H Pittler

Publications and source records attributed to M H Pittler.

At least 19 recordsLinked to original sources

Complementary/alternative medicine for supportive cancer care: development of the evidence-base.

AIM: The aim of this article is to compare the evidence relating to the effectiveness of complementary/alternative medicine (CAM) in palliative cancer care as it existed in 2000 and 2005. METHODS: Our comparison is based on systematic reviews using the same methodology at these two points in time. RESULTS: The results reveal a buoyant research activity in this sector. Consequently, new evidence for 19 CAM modalities has emerged between 2000 and 2005. For some treatments, the evidence is encouraging but for very few, it is as yet fully convincing. CONCLUSION: It follows that further research is warranted, particularly in areas where the data already looks encouraging.

Complementary Therapies↗

Complementary therapies for back pain: is the evidence getting stronger?

Back pain is the most common reason for using complementary therapies. This analysis of the trial evidence is aimed at determining whether the evidence base for or against complementary therapies for back pain is getting stronger. Two series of systematic reviews conducted with the same methodology 5 years apart were compared. The results suggest that the weight of the evidence has increased between 2000 and 2005 for a number of interventions. The direction of the evidence, however, remained unchanged for all but one therapy. We conclude that the value of complementary therapies in the management of back pain remains encouraging but not fully convincing.

Back Pain↗

Acupuncture for peripheral joint osteoarthritis: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the evidence for the effectiveness of acupuncture in peripheral joint osteoarthritis (OA). METHODS: Systematic searches were conducted on Medline, Embase, AMED, Cochrane Library, CINAHL, British Nursing Index, PsychINFO and CAMPAIN until July 2005. Hand-searches included conference proceedings and our own files. There were no restrictions regarding the language of publication. All randomized controlled trials (RCTs) of acupuncture for patients with peripheral joint OA were considered for inclusion. Trials assessing needle acupuncture with or without electrical stimulation were considered if sham- or placebo-controlled or controlled against a comparator intervention. Trials testing other forms of acupuncture were excluded. Methodological quality was assessed and, where possible, meta-analyses were performed. RESULTS: Thirty-one possibly relevant studies were identified and 18 RCTs were included. Ten trials tested manual acupuncture and eight trials tested electro-acupuncture. Overall, ten studies demonstrated greater pain reduction in acupuncture groups compared with controls. The meta-analysis of homogeneous data showed a significant effect of manual acupuncture compared with sham acupuncture (standardized mean difference 0.24, 95% confidence interval 0.01-0.47, P = 0.04, n = 329), which is supported by data for knee OA. The extent of heterogeneity in trials of electro-acupuncture prevented a meaningful meta-analysis. CONCLUSIONS: Sham-controlled RCTs suggest specific effects of acupuncture for pain control in patients with peripheral joint OA. Considering its favourable safety profile acupuncture seems an option worthy of consideration particularly for knee OA. Further studies are required particularly for manual or electro-acupuncture in hip OA.

Acupuncture Analgesia↗

Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials.

OBJECTIVES: Low back pain is a major public health concern and complementary treatments are frequently used for this condition. The objective of this systematic review and meta-analysis was to assess the evidence for or against the effectiveness of spa therapy and balneotherapy for treating low back pain. METHODS: Systematic searches were conducted on Medline, Embase, Amed Cochrane Central, the UK National Research Register and ClincalTrials.gov (all until July 2005). Hand searches were performed and experts contacted. Methodological quality was assessed using a standard scale. RESULTS: Five randomized clinical trials met all inclusion criteria. Quantitative data synthesis was performed. The data for spa therapy, assessed on a 100 mm visual analogue scale (VAS), suggest significant beneficial effects compared with waiting list control groups (weighted mean difference 26.6 mm, 95% confidence interval 20.4-32.8, n=442) for patients with chronic low back pain. For balneotherapy the data, assessed on a 100 mm VAS, also suggest beneficial effects compared with control groups (weighted mean difference 18.8 mm, 95% confidence interval 10.3-27.3, n=138). CONCLUSIONS: Even though the data are scarce, there is encouraging evidence suggesting that spa therapy and balneotherapy may be effective for treating patients with low back pain. These data are not compelling but warrant rigorous large-scale trials.

Adult↗

Horse chestnut seed extract for chronic venous insufficiency.

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. Therefore, oral drug treatment is an attractive option. OBJECTIVES: To review the efficacy and safety of oral horse chestnut seed extract (HCSE) versus placebo, or reference therapy, for the treatment of CVI. SEARCH STRATEGY: We searched the Cochrane Peripheral Vascular Diseases Review Group's Specialised Register (October 2005), the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 3, 2005, MEDLINE (January 1966 to October 2005), EMBASE (January 1980 to October 2005), Allied and Complementary Medicine (AMED) (inception to July 2005) and Phytobase (inception to January 2001) for randomised controlled trials (RCTs) of HCSE for chronic venous insufficiency. Manufacturers of HCSE preparations and experts on the subject were contacted for published and unpublished material. There were no restrictions on language. SELECTION CRITERIA: RCTs were included if they compared oral HCSE mono-preparations with placebo, or reference therapy, in people with CVI. 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: Both authors independently selected the studies and, using a standard scoring system, assessed methodological quality and extracted data. Disagreements concerning evaluation of individual trials were resolved through discussion. MAIN RESULTS: Overall, there appeared to be an improvement in CVI related signs and symptoms with HCSE compared with placebo. Leg pain was assessed in seven placebo-controlled trials. Six reported a significant reduction of leg pain in the HCSE groups compared with the placebo groups, while another reported a statistically significant improvement compared with baseline. One trial suggested a weighted mean difference (WMD) of 42.4 mm (95% confidence interval (CI) 34.9 to 49.9) measured on a 100 mm visual analogue scale. Leg volume was assessed in seven placebo-controlled trials. Meta-analysis of six trials (n = 502) suggested a WMD of 32.1ml (95% CI 13.49 to 50.72) in favour of HCSE compared with placebo. One trial indicated that HCSE may be as effective as treatment with compression stockings. Adverse events were usually mild and infrequent. AUTHORS' 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 confirm the efficacy of this treatment option.

Aesculus↗

Herbal medicines for the treatment of COPD: a systematic review.

The aim of the current study was to systematically assess the effectiveness of herbal medicines in treating chronic obstructive pulmonary disease (COPD). Randomised clinical trials (RCTs) testing herbal medicines against any type of control intervention in patients with COPD and assessing clinically relevant outcomes were included. The selection of studies, data extraction and validation were performed independently by at least two reviewers. Methodological quality was evaluated using the Jadad score. Effect sizes and their 95% confidence intervals were calculated. Fourteen eligible RCTs, testing 14 different herbal medicines, were located. Herbal medicines were compared against placebo or no treatment in six trials. Significant intergroup differences for one or more outcome were reported for several herbal medicines including Panax ginseng and Salvia miltiorrhiza. In seven RCTs, which compared herbal medicines with other herbal medicines, the results were mixed. A single trial compared a herbal medicine (Hedera helix leaf extract) with a conventional treatment (ambroxol tablet) and reported no significant difference between groups. Due to the heterogeneity of the data, statistical pooling was not performed. The median methodological quality score was 2 out of a possible maximum 5. The effectiveness of herbal medicines for treating chronic obstructive pulmonary disease is not established beyond reasonable doubt. Currently, the evidence from randomised clinical trials is scarce and often methodologically weak. Considering the popularity of herbal medicine among chronic obstructive pulmonary disease patients, rigorously designed studies seem warranted.

Humans↗

Zingiberis rhizoma: a comprehensive review on the ginger effect and efficacy profiles.

Zingiberis rhizoma is used as a broadspectrum antiemetic. We, therefore, conducted a comprehensive review of the literature to summarize the pharmacological and clinical effects of this popular plant material. Although clinical and experimental studies suggest that ginger has some antiemetic properties, clinical evidence beyond doubt is only available for pregnancy-related nausea and vomiting. Meta-analyses could not demonstrate the postoperative antiemetic effectiveness, and effect in motion sickness or nausea/vomiting of other ethiology. It also remains to be confirmed that proprietary ginger preparations are clinically useful to alleviate osteoarthritic or other pain, although there is no doubt that ginger constituents interfere with the inflammatory cascade and the vanilloid nociceptor. Ginger exerts in vitro antioxidative, antitumorigenic and immunomodulatory effects and is an effective antimicrobial and antiviral agent. Animal studies demonstrate effects on the gastrointestinal tract, the cardiovascular system, on experimental pain and fever, antioxidative, antilipidemic and antitumor effects, as well as central and other effects. The most relevant human pharmacological studies require a confirmatory study to exclude interaction of ginger preparations with platelet aggregation. Pharmacokinetic data are only available for [6]-gingerol and zingiberene. Preclinical safety data do not rule out potential toxicity, which should be monitored especially following ginger consumption over longer periods.

Antiemetics↗

Complementary therapies for reducing body weight: a systematic review.

The prevalence of obesity is increasing at an alarming rate and a plethora of complementary therapies are on offer claiming effectiveness for reducing body weight. The aim of this systematic review is to critically assess the evidence from randomized controlled trials (RCTs) and systematic reviews of complementary therapies for reducing body weight. Literature searches were conducted on Medline, Embase, Amed, and the Cochrane Library until January 2004. Hand-searches of relevant medical journals and bibliographies of identified articles were conducted. There were no restrictions regarding the language of publication. Trial selection, quality assessment and data abstraction were performed systematically and independently by two authors. Data from RCTs and systematic reviews, which based their findings on the results of RCTs, were included. Six systematic reviews and 25 additional RCTs met our inclusion criteria and were reviewed. The evidence related to acupuncture, acupressure, dietary supplements, homeopathy and hypnotherapy. Except for hypnotherapy, Ephedra sinica and other ephedrine-containing dietary supplements the weight of the evidence is not convincing enough to suggest effectiveness. For these interventions, small effects compared with placebo were identified. In conclusion, our findings suggest that for most complementary therapies, the weight of the evidence for reducing body is not convincing. Hypnotherapy, E. sinica and other ephedrine-containing dietary supplements may lead to small reductions in body weight. However, the intake of E. sinica and ephedrine is associated with an increased risk of adverse events. Interventions suggesting positive effects in single RCTs require independent replication.

Acupuncture Therapy↗

Adverse events of herbal food supplements for body weight reduction: systematic review.

Herbal weight-loss supplements are marketed with claims of effectiveness. Our earlier systematic review identified data from double-blind, randomized controlled trials for a number of herbal supplements. The aim of this systematic review was to assess all clinical evidence of adverse events of herbal food supplements for body weight reduction for which effectiveness data from rigorous clinical trials exist. We assessed Ephedra sinica, Garcinia cambogia, Paullinia cupana, guar gum, Plantago psyllium, Ilex paraguariensis and Pausinystalia yohimbe. Literature searches were conducted on Medline, Embase, Amed and The Cochrane Library. Data were also requested from the spontaneous reporting scheme of the World Health Organization. We hand-searched relevant medical journals and our own files. There were no restrictions regarding the language of publication. The results show that adverse events including hepatic injury and death have been reported with the use of some herbal food supplements. For herbal ephedra and ephedrine-containing food supplements an increased risk of psychiatric, autonomic or gastrointestinal adverse events and heart palpitations has been reported. In conclusion, adverse events are reported for a number of herbal food supplements, which are used for reducing body weight. Although the quality of the data does not justify definitive attribution of causality in most cases, the reported risks are sufficient to shift the risk-benefit balance against the use of most of the reviewed herbal weight-loss supplements. Exceptions are Garcinia cambogia and yerba mate, which merit further investigation.

Anti-Obesity Agents↗

Feverfew for preventing migraine.

BACKGROUND: Feverfew (Tanacetum parthenium L.) extract is a herbal remedy used for preventing attacks of migraine. OBJECTIVES: To systematically review the evidence from double-blind randomised controlled trials (RCTs) assessing the clinical efficacy and safety of feverfew versus placebo for preventing migraine. SEARCH STRATEGY: Publications describing (or which might describe) double-blind RCTs of feverfew extract for migraine were sought through the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2003); PREMEDLINE/MEDLINE (1966 to July 2003); EMBASE (1974 to July 2003); the trials register of the Cochrane Pain, Palliative and Supportive care group (July 2003); and AMED (1985 to July 2003). Manufacturers of feverfew were contacted and the bibliographies of identified articles checked for further trials. SELECTION CRITERIA: Randomised, placebo-controlled, double-blind trials assessing the efficacy of feverfew for preventing migraine were included. Trials using clinical outcome measures were included. Trials focusing exclusively on physiological parameters were excluded. There were no restrictions regarding the language of publication. DATA COLLECTION AND ANALYSIS: Data on patients, interventions, methods, outcome measures, results and adverse events were extracted systematically. Methodological quality was evaluated using the scoring system developed by Jadad and colleagues. Two reviewers independently selected studies, assessed methodological quality and extracted data. Disagreements concerning evaluation of individual trials were resolved through discussion. MAIN RESULTS: Five trials (343 patients) met the inclusion criteria. Results from these trials were mixed and did not convincingly establish that feverfew is efficacious for preventing migraine. Only mild and transient adverse events were reported in the included trials. REVIEWER'S CONCLUSIONS: There is insufficient evidence from randomised, double-blind trials to suggest an effect of feverfew over and above placebo for preventing migraine. It appears from the data reviewed that feverfew presents no major safety problems.

Humans↗

Horse chestnut seed extract for chronic venous insufficiency.

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. Therefore, oral drug treatment is an attractive alternative. OBJECTIVES: To review the evidence from rigorous clinical trials assessing the efficacy and safety of oral horse chestnut seed extract (HCSE) versus placebo, or other treatments for CVI. SEARCH STRATEGY: Randomised controlled trials (RCTs) of HCSE for chronic venous insufficiency were sought through EMBASE (inception to December 2001), MEDLINE and AMED (from inception to February 2004), The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2004), the Specialised Trials Register of the Cochrane Peripheral Vascular Diseases Group (last searched February 2004), and Phytobase (from inception to January 2001, no longer operational). Manufacturers of HCSE preparations and experts on the subject were contacted for published and unpublished material. There were no restrictions on language. SELECTION CRITERIA: RCTs were included if they compared oral HCSE mono-preparations with placebo, or other treatments, in patients with CVI. 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: Two reviewers independently selected and assessed methodological quality of the studies using a standardised scoring system, and extracted data. Disagreements concerning evaluation of individual trials were resolved through discussion. MAIN RESULTS: Overall, there appeared to be an improvement in CVI related signs and symptoms with HCSE compared with placebo. Leg pain was assessed in seven placebo-controlled trials. Six reported a significant reduction of leg pain in the HCSE groups compared with the placebo groups, while another reported a statistically significant improvement compared with baseline. One trial suggested a weighted mean difference (WMD) of 42.4 mm [95% confidence interval (CI) 34.9 to 49.9] measured on a 100 mm visual analogue scale. Leg volume was assessed in six placebo-controlled trials. Meta-analysis of five trials (n = 289) suggested a significant reduction in favour of HCSE compared with placebo (WMD 56.3 ml [95% CI 24.1 to 88.5]). One trial indicated that HCSE may be as effective as compression stockings at reducing leg volume. Adverse events were usually mild and infrequent. REVIEWERS' 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.

Aesculus↗

Systematic review: hepatotoxic events associated with herbal medicinal products.

BACKGROUND: Large proportions of patients use herbal medicinal products, and encouraging data in terms of effectiveness exist for some of these. One aspect, however, which is still largely under-investigated is the question of potential harm. AIM: To review the recent evidence on hepatotoxic events associated with the use of herbal medicinal products. METHODS: Systematic literature searches were performed on Medline, Embase, The Cochrane Library, Amed and Ciscom. To identify additional data, searches were conducted by hand in relevant medical journals and in our own files. The screening and selection of articles and the extraction of data were performed independently by the two authors. There were no restrictions regarding the language of publication. In order to be included articles were required to report data on hepatotoxic events associated with the therapeutic use of herbal medicinal products. RESULTS: Single medicinal herbs and combination preparations are associated with hepatotoxic events. Clinically, the spectrum ranges from transient elevations of liver enzyme levels to fulminant liver failure and death. In most instances hepatotoxic herbal constituents are believed to be the cause, while others may be due to herb-drug interactions, contamination and/or adulteration. CONCLUSIONS: A number of herbal medicinal products are associated with serious hepatotoxic events. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risk.

Chemical and Drug Induced Liver Injury↗

Chromium picolinate for reducing body weight: meta-analysis of randomized trials.

The aim of this meta-analysis was to assess the evidence of chromium picolinate for reducing body weight. Literature searches were conducted on Medline, Embase, The Cochrane Library, Amed and Ciscom. Nine experts and four manufacturers of commercial preparations containing chromium picolinate were asked to contribute published and unpublished studies. There were no restrictions regarding the language of publication. The screening of studies, selection, data extraction, validation and the assessment of methodological quality were performed independently by two reviewers. To be included, studies were required to state that they were randomized, double-blind and placebo-controlled, and report on body weight. Ten trials met all inclusion criteria and provided data, which were suitable for statistical pooling. For body weight a significant differential effect was found in favour of chromium picolinate (weighted mean difference: -1.1 kg; 95% confidence interval (CI): -1.8 to -0.4 kg, n=489). Sensitivity analysis suggests that this effect is largely dependent on the results of a single trial (weighted mean difference: -0.9 kg; 95% CI: -2.0 to 0.2 kg, n=335). Three of the reviewed trials reported on adverse events, indicating their absence in the treatment groups. In conclusion, our meta-analysis suggests a relatively small effect of chromium picolinate compared with placebo for reducing body weight. The clinical relevance of the effect is debatable and the lack of robustness means that the result has to be interpreted with caution.

Dietary Supplements↗

Randomized, double-blind, placebo-controlled trial of autologous blood therapy for atopic dermatitis.

BACKGROUND: Autologous blood therapy (ABT) is used for treating atopic dermatitis (AD) in some European countries and is promoted on internet sites for this condition. However, there is little evidence from rigorous clinical trials to suggest that it is effective. OBJECTIVES: To test the effectiveness of ABT for the symptomatic treatment of patients with AD. METHODS: Fifty subjects responded to press advertisements, and 31 were randomized within strata of severity at recruitment. Patients were included into a double-blind, placebo-controlled trial and received ABT or placebo once weekly for 5 weeks. Assessments were performed at baseline, at weekly intervals and after a 5-week follow up. The Six Area, Six Sign AD (SASSAD) severity index was predefined as the primary outcome measure. The Dermatology Life Quality Index and patient ratings of pruritus, quality of sleep and skin appearance on 100-mm visual analogue scales were defined as secondary outcome measures. Success of patient blinding and adverse events were assessed. RESULTS: Data were analysed on an intention-to-treat basis. Analysis of covariance suggested a significant differential change of the SASSAD score between baseline and the end of the follow-up period in favour of ABT. The mean reduction in SASSAD score was 13.5 points (95% confidence interval, CI 6.6-20.4, P < 0.001) over and above placebo; the corresponding value at the end of treatment was 9.6 (95% CI 4.2-14.9, P = 0.001). No clear significant intergroup differences in any of the secondary outcome measures were found. Six patients in the ABT group and seven in the placebo group reported minor and transient adverse events. CONCLUSIONS: These data suggest that, according to the SASSAD score, ABT has beneficial effects in the treatment of AD, although this was not confirmed by the patient-rated assessments. The improvement in observer-rated skin condition suggested by this study needs confirmation in larger trials.

Adult↗