Autoimmune hepatitis (AIH) is characterized by acute or chronic liver inflammation, which is considered to be associated with autoimmune response in liver cells. Previous studies [
1] have proved that AIH can easily progress to cirrhosis or liver failure, and even some patients need for liver transplantation finally. It is reported that 40% of untreated severe AIH patients might die within 6 months, and those surviving commonly develop cirrhosis and subsequent complications of portal hypertension [
2]. Moreover, it accounts for 2.6% of the transplantations in Europe [
3] and 5.9% in the United States [
4]. Due to this poor prognosis and the increasing detection rate, more and more studies focus on the management of AIH recently. It is well known that low dose prednisone plus azathioprine is the standard therapy for AIH, with alleviation of symptoms achieved in 60 to 80% of cases [
5]. However, it must be noted that 50 to 86% of patients witness a recurrence of the disease after stopping medications, while 13% of patients stop the treatment too early due to the severity of the side effects and 9% of patients’ situation will deteriorate, even though they are administered medications according to guidelines [
6]. Due to the high recurrence rate and the common side effects of corticosteroids, more and more AIH patients seek for traditional Chinese medicine (TCM) to manage their symptoms and reduce the side effects of corticosteroids in China.
In recent years, more and more researchers try to explore the efficacy and safety of combination treatment of steroids and Chinese herbal medicine in AIH patients. Fortunately, a number of clinical studies have proved the positive efficacy of TCM in Chinese AIH patients [
7‐
9], such as alleviating liver inflammation; reducing side effects of corticosteroids and improving TCM signs and symptoms. But most of these studies were case reports or expert experience, or did not report strict inclusion and exclusion criteria, or had small sample size. Moreover, even the formulation of TCM was in the form of capsule or injection in some of these trials. Thus, current studies do not provide sufficient evidence to support the effectiveness of TCM in the treatment of AIH. So we have made a further research on the issue to explore whether the combination treatment of TCM and steroid standard therapy could improve the clinical management of AIH. Shu-Gan-Jian-Pi (SGJP) Decoction, made by famous traditional Chinese medicine doctor Chi Xiao-ling, is a popular used Chinese herbal formula in Guangdong province of China, which has demonstrated the effect of improving efficacy and reducing side effects of corticosteroids in AIH patients. This recipe, coming from the Golden mirror of medicine (a famous textbook of TCM), is widely used in treating chronic liver disease patients with pattern of live stagnation and spleen deficiency for more than 30 years. The results of previous clinical studies and animal experiments [
10,
11] of SGJP Decoction provide the evidence that it has the effects of immunomodulatory and anti-liver-inflammation. However, previous clinical studies were retrospective study or focus on the patients with autoimmune diseases combined with hepatitis B, not on the AIH itself. Therefore, we conduct a prospective study to evaluate the efficacy and safety of SGJP Decoction combined with steroid standard therapy in AIH patients.