In-Depth: Liver Protection Drug Market Grows to 10 Billion Yuan (AI Translation)

【周刊提前读】深度：保肝药市场达百亿 滥用风险为何挥之不去？

Summary

Liver-protective medications, or hepatoprotective drugs, are widely prescribed in China, despite limited high-quality evidence for their efficacy in many clinical contexts. Commonly, they are used whenever liver enzyme levels—particularly ALT and AST—increase, as seen in the case of Li Yun, who was treated with such drugs after abnormal liver function tests, and Liu Xin, who recovered liver health after stopping potentially harmful traditional Chinese medicine but also received multiple hepatoprotective drugs [para. 1]. Clinical practice in China often focuses on rapidly lowering liver enzyme levels as a proxy for improved liver health, making hepatoprotective drug use widespread [para. 3].

These drugs encompass various active ingredients, like glycyrrhizin, bicyclol, silymarin, polyene phosphatidylcholine, and glutathione, among others. Many are derived from natural animal or plant sources. They claim to offer diverse benefits: decreasing liver inflammation, promoting cell regeneration, improving detoxification, and lowering enzyme levels. However, most existing studies in China to support these claims are small in scale, short in duration, and carry low evidence quality, with robust randomized controlled trials (RCTs) being rare [para. 4][para. 5].

Internationally, mainstream medical guidelines, including those from the World Health Organization (WHO), do not recommend hepatoprotective drugs due to insufficient clinical evidence [para. 6]. The ambiguity surrounding their benefits leads to significant debate among Chinese doctors, with some considering them largely ineffective, while others offer cautious support. Despite skepticism, sales remain strong. In 2023, annual hospital sales for major hepatoprotective drugs neared 10 billion yuan [para. 8].

Prescribing habits have led to “main courses” of treatment, like antiviral drugs for hepatitis B, being cheap—5 yuan per month for essential antivirals like entecavir—while “side dishes” such as hepatoprotective drugs impose far higher monthly out-of-pocket costs, often hundreds of yuan [para. 9][para. 13]. This paradox contributes to a considerable burden on China’s health insurance system, with one study uncovering over 8.64 million hepatoprotective prescriptions issued to 3.19 million patients at notable cost increases between 2016 and 2023 [para. 10].

For hepatitis B, global consensus and Chinese guidelines agree that effective antiviral treatment is paramount, with hepatoprotective drugs playing, at best, an auxiliary—and not always necessary—role [para. 17][para. 19]. Nevertheless, legacy issues from periods preceding available antivirals have entrenched the widespread use of liver-protecting drugs [para. 22]. Even as the price of antivirals dropped by over 90% due to national drug procurement programs, many patients like Li Ping spend far more on poorly substantiated hepatoprotective drugs, further straining their finances [para. 28][para. 29][para. 32].

Similar patterns are seen for other liver conditions such as fatty liver disease, where lifestyle modifications should be first-line intervention, yet clinicians often resort to prescribing hepatoprotective drugs. International and Chinese guidelines do not recommend these drugs for nonalcoholic fatty liver disease (NAFLD), citing lack of evidence for genuine histological benefit [para. 53][para. 55][para. 57].

One area where hepatoprotective drugs may have more clinical justification is drug-induced liver injury (DILI), especially in China where causes often include traditional medicines. Magnesium isoglycyrrhizinate and bicyclol have received approval for treating acute DILI, supported by randomized controlled trials showing enzyme-lowering effects, but broader efficacy and long-term impact remain insufficiently evidenced [para. 70][para. 73].

Multiple factors explain the entrenched use of these drugs: patient expectations, non-specialist doctors’ overreliance on quick marker improvements, and financial incentives including past examples of kickback schemes to boost prescription volumes [para. 91][para. 103]. Regulatory and insurance mechanisms have not yet curbed their overuse, though there are calls to support large-scale, high-quality clinical trials and to tighten evidence requirements for continued approval and reimbursement [para. 119][para. 121][para. 127].

In summary, hepatoprotective drugs are ubiquitous and lucrative within China’s healthcare system, but lack robust evidence for most chronic liver disease indications. Their overuse represents both a clinical and financial challenge, requiring reform in public health policy, professional education, and drug approval standards [para. 130][para. 135].