Radiofrequency thermal ablation versus other interventions for hepatocellular carcinoma.

BACKGROUND: Hepatocellular carcinoma is one of the most common malignant diseases worldwide. A potential curative option is surgical resection. Due to impaired liver function and/or anatomical reasons only few patients can be treated surgically. For the majority of patients, several interventions have been developed. Among these, local radiofrequency inducing heat production has been used to coagulate the cancer. OBJECTIVES: To evaluate the effects of radiofrequency thermal ablation in hepatocellular carcinoma patients with respect to clinically relevant outcomes (mortality, rate of recurrences, adverse events, quality of life, and duration of hospital stay) versus sham intervention, no intervention, or other interventions. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, EMBASE, CancerLit, and Current Contents until October 2003. Handsearches were also conducted. Reference lists of the identified articles were checked for further trials. SELECTION CRITERIA: All randomised trials investigating radiofrequency thermal ablation versus placebo, no intervention, or any other therapeutic approach were considered for inclusion, regardless of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. MAIN RESULTS: Only two randomised clinical trials were identified. One trial including 102 patients compared radiofrequency thermal ablation versus percutaneous ethanol injection for small hepatocellular carcinoma. Radiofrequency thermal ablation significantly increased recurrence-free survival (hazard ratio 0.48, 95% confidence interval (CI) 0.27 to 0.85) but did not significantly influence overall survival (hazard ratio 0.20, 95% CI 0.02 to 1.69). The rate of complications and side effects did not differ significantly between the two groups. Another trial with methodological flaws compared radiofrequency thermal ablation versus percutaneous microwave coagulation for 72 patients with 94 hepatocellular carcinoma lesions. The main outcome criterion was the rate of recurrences in both groups; no significant difference was detected. The rate of side effects did not differ significantly, but significantly more treatment sessions were needed with percutaneous microwave coagulation to achieve complete tumour ablation. REVIEWERS' CONCLUSIONS: Radiofrequency thermal ablation seems a potentially promising technique for the treatment of small hepatocellular carcinoma. However, more randomised clinical trials are needed.

[Diet therapy in chronic inflammatory bowel disease: results from meta-analysis and randomized controlled trials]. / Diättherapie chronisch entzündlicher Darmerkrankungen: Resultate aus Meta-Analysen und randomisierten klinischen Studien.

BACKGROUND: Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases of unknown etiology. Unspecific immunosuppressive therapy represents current standard treatment and is often associated with severe side effects. Several treatment regimens have been evaluated to identify alternative therapeutic options. Among these different diet therapies were investigated. Objective of this paper is to review the results of diet therapy in chronic inflammatory bowel disease on the basis of randomised controlled trials and meta-analysis of randomised controlled trials. METHODS: Medline and Cochrane Library were searched for meta-analysis and randomised controlled trials investigating this question. Additionally reference lists of identified articles and text books were checked for further trials. RESULTS: Four meta-analyses investigated the treatment of acute Crohn's disease with elemental-, semi-elemental-, and polymeric diets in comparison to corticosteroids or to another form of enteral diet. All meta-analyses show a superiority of corticosteroids and no difference in the effect of the compared enteral diets. Randomised controlled trials investigating diet therapy in ulcerative colitis have not been summarised in a meta-analysis yet. Eleven randomised trials were identified which evaluated diets in ulcerative colitis patients: Dietary supplementation with n-3-fatty acids (6 trials), elemental diet [2], dietary supplementation with dietary fiber [1], elimination diet [1], and dietary supplementation with olestra [1]. Only for the elimination diet a significant positive effect on the course of disease was found in one trial which investigated only 18 patients. CONCLUSIONS: Enteral nutritional therapy of acute Crohn's disease is less effective than treatment with corticosteroids. In case of severe steroid induced side effects diet treatment can present a promising alternative. Superiority of one of the investigated different formulations was not found. Meta-analyses of randomised trials provide a clear and easy to understand presentation of the effect of this intervention. Eleven published trials investigating the effect of diets in ulcerative colitis show only for elimination diet a positive treatment effect. The trials do find a positive effect of one of the other interventions but the trials are very small and cannot exclude a treatment effect. Meta-analysis of these trials would be helpful for a better presentation and understanding of these results.

[Nonsurgical therapy of hepatocellular carcinoma]. / Nicht-chirurgische Therapie des hepatozellulären Karzinoms.

Several non-surgical local ablation methods for the treatment of hepatocellular carcinoma (HCC) have been developed. Among them, percutaneous ethanol injection is worldwide an accepted alternative to surgery in patients with small HCCs. Other local minimal-invasive treatment options, like one time radio-frequency thermal ablation seem to result in more effective tumor control. Randomized controlled trials showed no survival benefit after transarterial chemoembolization and its variants for the treatment of local advanced HCCs. Combined therapeutic strategies may play an increasing role in future in these cases. Effective chemotherapy is not available for metastasized or advanced HCCs. The role of novel techniques for the treatment of HCC has to be carefully determined in large controlled clinical studies.

Ursodeoxycholic acid and/or antibiotics for prevention of biliary stent occlusion.

BACKGROUND: Malignant biliary obstruction, which requires endoscopic stenting as palliative therapy, is often complicated by clogging of the stent with subsequent jaundice and/or cholangitis. Stent clogging may be caused by microbiological adhesion and biliary stasis. Therefore, antibiotics and choleretic agents like ursodeoxycholic acid (UDCA) have been investigated to see whether they prolong stent patency. OBJECTIVES: To evaluate if UDCA and/or antibiotics may prolong stent patency and survival in patients with strictures of the biliary tract and endoscopically inserted stents. SEARCH STRATEGY: The Trials Register of The Cochrane Hepato-Biliary Group, The Cochrane Library, MEDLINE, Current Contents, EMBASE, and CancerLit were searched until June 2001. Reference lists of the identified articles were checked for further trials. SELECTION CRITERIA: All randomised or quasi-randomised clinical trials investigating UDCA and/or antibiotics in patients with biliary stents were considered for inclusion, regardless of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. Survival data were combined by using hazard ratios (with 95% confidence interval (95% CI)). MAIN RESULTS: Five non-blinded randomised trials with 258 patients with malignant strictures treated with polyethylene stents were included. Three trials, including 152 patients, investigated a combination of UDCA and antibiotics versus no treatment. The meta-analysis of these three trials does not show a significant treatment effect on the duration of stent patency (hazard ratio (random effects model) 0.58, 95% CI 0.22 to 1.54) or mortality (hazard ratio (fixed effect model) 0.99, 95% CI 0.68 to 1.43). Two trials with 106 patients compared antibiotics with no treatment, one of these trials used a combination of antibiotics and rowachol (an 'alternative' drug of the 'mint' family). The pooled results of these two trials do not show significant effects of antibiotics on the duration of stent patency (hazard ratio (fixed effect model) 0.69 (95% CI 0.37 to 1.30)) or mortality (hazard ratio (fixed effect model) 1.23 (95% CI 0.72 to 2.08). Data concerning duration of hospital stay, frequency of cholangitis, and rate of infectious complications due to selection of antibiotic resistant bacteria strains were not available. REVIEWER'S CONCLUSIONS: Treatment with UDCA and/or antibiotics to prevent clogging of biliary stents in patients with malignant stricture of the biliary tract cannot be recommended routinely on the basis of the existing randomised clinical trials. Further trials are needed with rigorous methodology and sufficient statistical power.

Radiofrequency thermal ablation versus other interventions for hepatocellular carcinoma.

BACKGROUND: Hepatocellular carcinoma (HCC) is one of the most common malignant diseases worldwide. The only possibly curative therapeutic option is surgical resection. Due to impaired liver function and/or anatomical reasons only a low percentage of patients can be treated surgically. For the remainder, several non-surgical treatment approaches have been developed. In addition to percutaneous ethanol injection, transarterial interventions, and several medical interventions, radiofrequency thermal ablation has been investigated in coagulating HCC lesions. OBJECTIVES: To evaluate the effects of radiofrequency thermal ablation in HCC patients with respect to clinically relevant outcomes (mortality, rate of recurrences, adverse events, quality of life, and duration of hospital stay). SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, Current Contents, EMBASE, and CancerLit until June 2001 and further handsearch was conducted. Reference lists of the identified articles were checked for further trials. SELECTION CRITERIA: All randomised or quasi-randomised clinical trials investigating radiofrequency thermal ablation versus placebo, no intervention, or any other therapeutic approach were considered for inclusion, regardless of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. MAIN RESULTS: One randomised trial which is still ongoing and only published as an interim analysis was identified. This trial compared radiofrequency thermal ablation versus percutaneous ethanol injection in 102 patients with small HCC. With respect to mortality the trial showed no significant difference between the two treatments (relative risk = 0.19, 95% confidence interval 0.02 to 1.59). Concerning the recurrence free survival the trial demonstrated no significant superiority of radiofrequency thermal ablation versus percutaneous ethanol injection (relative risk = 0.70, 95% confidence interval 0.46 -1.04). REVIEWER'S CONCLUSIONS: At present, radiofrequency thermal ablation is an insufficiently studied intervention for HCC.

Radiofrequency thermal ablation of hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is one of the major malignancies worldwide. Due to advanced or decompensated liver cirrhosis, comorbidity and multicentricity of the tumor lesions, 70-80% of HCC patients are inoperable at the time of diagnosis. Radiofrequency thermal ablation (RFTA) is a new minimally invasive and sage technique for the nonsurgical treatment of HCCs. Similar to other ablation techniques, the treatment strategy depends on several factors, including the patient's clinical status, the stage of liver cirrhosis and of the HCC. RFTA can be performed percutaneously, laparoscopically or after laparotomy. Advanced RFTA equipment, refined techniques of modifying tumor tissue response to RFTA, and combined treatment strategies should lead to better response rates even in larger HCCs.

What is evidence-based medicine?

INTRODUCTION: Three challenges that physicians and decision makers in the health care systems have to meet are a remarkable proportion of medical decisions without a sufficient base of scientific evidence, a slow and opaque process of integrating scientific knowledge into medical practice and a steadily decreasing half-life period of the medical knowledge. DISCUSSION: During the last two decades, a number of projects have faced these problems and forced the development of evidence-based medicine (EBM). This concept claims the explicit conscientious use of current evidence from clinical research combined with the personal expertise in the process of medical decision making. The following article explains the main steps of practising and teaching EBM illustrated by a clinical example.