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PubMed2003

Bile acids for primary sclerosing cholangitis.

BACKGROUND: Bile acids have been used for treating primary sclerosing cholangitis, but their beneficial and harmful effects remain unclear. OBJECTIVES: To assess the beneficial and harmful effects of bile acids for patients with primary sclerosing cholangitis. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group's Trials Register, The Cochrane Library, MEDLINE, EMBASE, and The Chinese Biomedical Database generally from inception through to May 2002. SELECTION CRITERIA: Randomised clinical trials comparing any dose or duration of bile acids versus placebo, no intervention, or another intervention were included. Trials were included irrespective of blinding, language, or publication status. DATA COLLECTION AND ANALYSIS: Two reviewers extracted the data. The methodological quality of the trials was evaluated with respect to the generation of the allocation sequence, allocation concealment, double blinding, and follow-up. The results were reported by intention-to-treat analysis. The outcomes were presented as relative risks (RR) or weighted mean differences (WMD), both with 95% confidence intervals (CI). MAIN RESULTS: We identified six randomised clinical trials, all with low methodological quality. Patients were treated for three months to six years (median two years). Five trials (183 patients) compared ursodeoxycholic acid versus placebo, and one trial (40 patients) compared ursodeoxycholic acid versus no treatment. Ursodeoxycholic acid did not significantly reduce the risk of death (RR 0.86; 95% CI 0.27 to 2.73); treatment failure including liver transplantation, varices, ascites, and encephalopathy (RR 0.94; 95% CI 0.63 to 1.42); liver histological deterioration (RR 0.89; 95% CI 0.45 to 1.74); or liver cholangiographic deterioration (RR 0.43; 95% CI 0.18 to 1.02). Ursodeoxycholic acid significantly improved serum bilirubin (WMD -14.6 micro mol/litre; 95% CI -18.7 to -10.6), alkaline phosphatases (WMD -506 IU/litre; 95% CI -583 to -430), aspartate aminotransferase (WMD -46 IU/litre; 95% CI -77 to -16), and gamma-glutamyltranspeptidase (WMD -260 IU/litre; 95% CI -315 to -205), but not albumin (WMD -0.20 g/litre; 95% CI -1.91 to 1.50). Ursodeoxycholic acid was well tolerated. REVIEWER'S CONCLUSIONS: Ursodeoxycholic acid leads to a significant improvement in liver biochemistry, but there is insufficient evidence to either support or refute its clinical effects in patients with primary sclerosing cholangitis. Large scale, high-quality randomised clinical trials are needed.

Cholagogues and Choleretics↗
PubMed2005

Ribavirin monotherapy for chronic hepatitis C.

BACKGROUND: Hepatitis C is a major cause of liver-related morbidity and mortality. The disease progresses without symptoms for several decades. Ribavirin monotherapy may represent a treatment for some patients. OBJECTIVES: To assess the beneficial and harmful effect of ribavirin monotherapy for patients with chronic hepatitis C. SEARCH STRATEGY: We identified trials through electronic databases, manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies until May 2005. SELECTION CRITERIA: We included all randomised trials irrespective of blinding, language, or publication status comparing ribavirin versus no intervention, placebo, or interferon for chronic hepatitis C. DATA COLLECTION AND ANALYSIS: The primary outcome measures were the six months sustained loss of hepatitis C virus RNA in blood after end of treatment and liver-related morbidity plus all-cause mortality. Secondary outcome measures were end of treatment virological response, biochemical response, histological response, and adverse events. Random- and fixed-effects meta-analyses with 95% confidence intervals (CI) were performed for all outcomes. We used Peto odds ratios (OR) for analysis of morbidity plus mortality and relative risks (RR) for the remaining outcomes. MAIN RESULTS: We identified 13 randomised trials including 594 patients with chronic hepatitis C. Most trials had low methodological quality. Compared with placebo/no intervention, ribavirin had no significant effect on sustained (RR 1.01, 95% CI 0.96 to 1.07, five trials) or end of treatment virological response (RR 1.00, 95% CI 0.94 to 1.07, ten trials). Ribavirin had no significant effect on liver-related morbidity plus mortality (Peto OR 1.96, 95% CI 0.20 to 19.0, eleven trials). Ribavirin significantly improved end of treatment biochemical and histological response but not sustained biochemical response. Further, ribavirin significantly increased the risk of anaemia. Ribavirin was significantly inferior to interferon regarding virological and biochemical response (four trials). AUTHORS' CONCLUSIONS: We found that ribavirin versus placebo/no intervention had no significant beneficial effect on virological response and liver morbidity, but may improve biochemical and histological response transiently. Ribavirin increased the risk of anaemia. Therefore, we cannot recommend ribavirin monotherapy for patients with chronic hepatitis C outside randomised trials.

Antiviral Agents↗
PubMed2003

[The practice of systematic reviews. XI. The Cochrane Library].

Systematic reviews of the literature provide a summary of the current status of medical scientific research. They are important for the solution of medical questions by doctors active in clinical practice, may serve to support practice guidelines, and are used in health care to take policy decisions and to determine the research agenda. The Cochrane Library is the most important source of information on the efficacy of interventions in health care and comprises eight databases. The most relevant for doctors active in clinical practice are the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, and the Cochrane Central Register of Controlled Trials. At present, the first two databases contain over 5000 systematic reviews of the literature. The third database listed above is the largest database in the world with references to (randomised) controlled studies.

Databases, Bibliographic↗
PubMed2002

Polyunsaturated fatty acids. Is there a role in postmenopausal osteoporosis prevention?

OBJECTIVE: To review the effect of a diet supplemented with polyunsaturated fatty acids (PUFA) on prevention or treatment of osteoporosis. METHODS: MEDLINE (1966-April 2001), Allied Complementary Medicine (1985-2001), Cochrane Library and Database of Systematic Reviews (1st Quarter 2001) was searched. Five reviews and no systematic reviews were found on this topic in the Cochrane Library. Eleven relevant in-vivo studies were identified on the effect of these compounds on bone. Eight were animal studies and three were randomised control trials (RCT) in human. RESULTS: There are two classes of PUFA designated as n-3 and n-6 with alpha-linolenic acid (ALA). These two different types of PUFA differently influence prostaglandin formation and hence modulate bone metabolism differently. These are several in vitro and animal data suggesting that diet with a low n-6/n-3 ratio may have beneficial effects on bone mineral density. Only three, short-term, small studies have been performed in human so far. Two studies, one performed with bone markers and one with bone density showed a positive effect of PUFA on bone. While a third study showed no effect. CONCLUSIONS: Preliminary, data have suggested that a diet with a low n-6/n-3 ratio may have beneficial effects on bone mineral density. Further studies are, however, required to fully assess the dose and type of PUFA to be used for optimum bone effects. This may be useful particularly for the prevention of disease in the elderly, since a diet rich in n-3 PUFA has been shown to have additional benefit on the cardiovascular, central nervous system and joints.

Animals↗
PubMed2005

Obtaining an evidence-base for clinical dentistry through clinical trials.

Ideally, all clinical practice should be based on the best available evidence; however, in general dental practice even a very routine issue, such as the appropriate management of the carious primary dentition, is hampered by the lack of a sound evidence-base from high quality clinical trials run in general dental practices. Furthermore, the use of the evidence that is available may be confounded by inadequate reporting. This paper reviews the difficulties reported in successfully completing such clinical trials, and reports on the authors' own experiences. Suggestions are made for overcoming the challenge of patient recruitment in randomised controlled clinical trials in primary dental care. These include: regular contact with a principal investigator, who is viewed as a peer; ensuring the relevance of the research topic to the dentists' daily practice; appropriate remuneration; acknowledgement of the contribution made and recognition of the contribution of research activity to continuing professional development. Use of the CONSORT statement to improve planning and reporting of clinical trials is recommended.

Attitude of Health Personnel↗
PubMed2005

Risperidone versus olanzapine for schizophrenia.

BACKGROUND: Antipsychotic medication is a mainstay of treatment for schizophrenia and risperidone and olanzapine are the most popular treatment choice of the new generation drugs. OBJECTIVES: To determine the clinical effects, safety and cost effectiveness of risperidone compared with olanzapine for treating schizophrenia. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (June 2004) which is based on regular searches of, amongst others, BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. References of all identified studies were inspected for further trials. We also contacted relevant pharmaceutical companies for additional information. SELECTION CRITERIA: We included all clinical randomised trials comparing risperidone with olanzapine for schizophrenia and schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: We extracted data independently. For homogenous dichotomous data we calculated random effects, relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat/harm (NNT/H) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). MAIN RESULTS: We found no difference for the outcome of unchanged or worse in the short term (n=548, 2 RCTs, RR 1.00 CI 0.88 to 1.15). One study, sponsored by the manufactures of olanzapine, favoured this drug for the outcome of relapse/rehospitalisation by 12 months (n=279, RR 2.16 CI 1.31 to 3.54, NNT 7 CI 4 to 25). Most mental state data showed the two drugs to as effective as each other (n=552, 2 RCTs, RR 'no <20% decrease PANSS by eight weeks' 1.01 CI 0.87 to 1.16). At least two thirds of people given risperidone or olanzapine experienced an adverse event (n=300, 2 RCTs, RR 1.16 CI 0.70 to 1.94). About 20% had anticholinergic symptoms (n=719, 3 RCTs, RR 1.12 CI 0.77 to 1.63) and 20% of both groups experienced insomnia (n=594, 3 RCTs, RR 1.33 CI 0.95 to 1.85) and approximately 33% sleepiness (n=719, 4 RCTs, 0.99 CI 0.79 to 1.23). One third of people given either drug experienced some extrapyramidal symptoms (n=893, 3 RCTs, RR 1.18 CI 0.75 to 1.88) but 25% of people using risperidone require medication to alleviate extrapyramidal adverse effects (n=419, 2 RCTs, RR 1.76 CI 1.25 to 2.48, NNH 8 CI 4 to 25). People allocated to risperidone were less likely to gain weight compared with those given olanzapine and the weight gain resulting from olanzapine can be considerable and of rapid onset (n=377, 1 RCT, RR gain more than 7% of their baseline weight 0.40 CI 0.23 to 0.70, NNT 8 CI 6 to 17). Risperidone may cause more sexual dysfunction than olanzapine (n=370, 2 RCTs, RR abnormal ejaculation 4.36 CI 1.38 to 13.76, NNH 20 CI 6 to 176; n=31, 1 RCT, RR impotence 2.43 CI 0.24 to 24.07). Within trials both drugs are associated with equal attrition (n=1217, 7 RCTs, RR leaving the study early 1.17 CI 0.92 to 1.49). AUTHORS' CONCLUSIONS: Data regarding quality of life and economic outcomes are difficult to interpret, and for both these highly marketed new drugs we know very little from evaluative studies regarding service outcomes, general functioning and behaviour, engagement with services and treatment satisfaction. There is little to differentiate between risperidone and olanzapine except on the issue of adverse effects and both these drugs have unpleasant adverse effects. Risperidone is particularly associated with movement disorders and sexual dysfunction. Olanzapine can cause considerable rapid weight gain.This review highlights the need for large, independent, well designed, conducted and reported pragmatic randomised studies.

Antipsychotic Agents↗