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Bicyclol for chronic hepatitis C

  • Review
  • Intervention

Authors


Abstract

Background

Bicyclol is a novel synthetic 'anti-hepatitis' drug, used in China for chronic hepatitis C. Until now, systematic reviews on bicyclol therapy have not been performed.

Objectives

To study the benefits and harms of bicyclol for patients with chronic hepatitis C.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2005), the Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2005), MEDLINE (1994 to July 2005), EMBASE (1994 to July 2005), Science Citation Index Expanded (1994 to July 2005), The Chinese Biomedical Database (1994 to August 2005), Chinese Journals Full-article Database (1994 to August 2005), VIP Chinese Science and Technique Journals Database (1994 to August 2005), and China National Infrastructure (CNKI) (1994 to August 2005). We also contacted manufacturers and researchers in the field.

Selection criteria

Randomised clinical trials on bicyclol versus no intervention, placebo, or other interventions in patients with chronic hepatitis C were included, irrespective of blinding, publication status, or language.

Data collection and analysis

The primary outcome measures were total and liver-related mortality and liver-related morbidity (eg, cirrhosis and carcinoma). Secondary outcome measures were viral response and liver histology.

Main results

The search identified one randomised clinical trial comparing bicyclol with placebo for 39 patients with chronic hepatitis C. The follow-up was three months. In the trial, there was no evidence that bicyclol was superior to placebo for clearance of HCV RNA (RR 3.80, 95% CI 0.47 to 31.0) and anti-HCV antibodies, but bicyclol was associated with statistically significant decrease in alanine aminotransferase activity at 12-th week after treatment (WMD -69 IU/L, 95% CI -115 to -24).

Authors' conclusions

Only one randomised clinical trial has examined bicyclol for patients with chronic hepatitis C. This small, short-term trial found no evidence to support or refute its use. Large, randomised, double-blind clinical trials with long-term follow-up are needed to examine the possible benefits and harms associated with bicyclol. Bicyclol can only be recommended for use in randomised trials.

摘要

背景

Bicyclol治療C型肝炎

Bicyclol是一種新型人工合成的抗肝炎藥物,在中國用於治療慢性C型肝炎. 到現在為止,還沒有對Bicyclol療法的系統性回顧。

目標

研究bicyclol對慢性C型肝炎患者的利弊

搜尋策略

我們搜索 Cochrane HepatoBiliary Group Controlled Trials Register(2005年7月),Cochrane Central Register of Controlled Trials in The Cochrane Library(第2期,2005年期),MEDLINE(1994年至2005年7月),EMBASE(1994年至2005年7月),Science Citation Index Expanded(1994年至2005年7月),The Chinese Biomedical Database(1994年至2005年8月),Chinese Journals Fullarticle Database(1994年至2005年8月),VIP Chinese Science and Technique Journals Database(1994年至2005年8月),以及China National Infrastructure(CNKI)(1994年至2005年8月)。我們還聯絡這領域的廠商和研究人員。

選擇標準

bicyclol與不治療,安慰劑或其他措施治療慢性C型肝炎患者的隨機臨床試驗,不限盲法、出版狀況或語言。

資料收集與分析

主要結果評量為總死亡率與肝相關死亡率和肝有關罹病率(如肝硬化和肝癌)。次要結果包括病毒反應和肝組織學。

主要結論

找到一個比較bicyclol與安慰劑的隨機臨床試驗(39例慢性C型肝炎患者)。 共追蹤了3個月。在試驗中,沒有任何證據支持bicyclol清除C型肝炎病毒RNA(RR 3.80,95%CI 0.47至31.0)和抗 HCV抗體優於安慰劑,但bicyclol使用12周後, 在降低谷丙轉氨?活性有統計上的意義(WMD −69 IU/L, 95% CI −115 至−24).

作者結論

只有一個隨機的臨床試驗研究bicyclol對於慢性C型肝炎病人的效用。這個小型短期的試驗發現沒有證據支持或駁斥其使用。需要一個大型、隨機、雙盲臨床試驗加上長期追蹤研究bicyclol可能帶來的好處和危害.。在隨機試驗確定後,才能推薦Bicyclol的使用。

翻譯人

本摘要由臺中榮民總醫院薛榮華翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

沒有發現決定bicyclol治療慢性C型肝炎利弊證據。 Bicyclol是一種新型人工合成的抗肝炎藥物,在中國用於治療慢性C型肝炎。只有找到一個小型短期隨機臨床試驗評估bicyclol治療慢性C型肝炎的療效。臨床使用應注意bicyclol的使用是缺乏證據的。

Plain language summary

Evidence on beneficial or harmful effects of bicyclol for chronic hepatitis C is not found

Bicyclol is a novel synthetic 'anti-hepatitis' drug, used primarily in China for patients with chronic hepatitis C. Only one small, short-term randomised clinical trial was found evaluating the efficacy of bicyclol for patients with chronic hepatitis C. Clinicians should be aware of the lack of evidence for bicyclol.

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