2. Efficacy Statistics

Among the 429 cases, the treatment group had 289 cases, with 101 recent cures, accounting for 34.94%; 152 improvements, accounting for 52.59%; and 36 no effects, accounting for 12.47%; total effective rate 87.53%. HBsAg negative conversion rate 39.9%, e-antigen negative conversion rate 68.57%. The control group had 12 recent cures, accounting for 8.57%; 52 improvements, accounting for 37.14%; and 76 no effects, accounting for 54.28%. The treatment group's cure rate and improvement rate were both higher than the control group. Statistical analysis showed P<0.01, indicating a highly significant difference.

Recovery of Symptoms and Signs: Before treatment, there was no significant statistical difference between the two groups in terms of symptoms and signs (P>0.05); after treatment, except for susceptibility to colds and jaundice, where P<0.05, all other items (fatigue, poor appetite, abdominal distension, liver pain, nausea, aversion to oil, bitter taste in the mouth, low-grade fever, gingival bleeding, hepatomegaly, splenomegaly) showed highly significant differences between the two groups (P<0.01), with overall combined processing showing P<0.01.

Improvement of Liver Function: Before treatment, there was no significant statistical difference between the two groups (P<0.05); after treatment, except for TFT, where P<0.05, all other items—SGPT (King’s unit), TTT, ZnTT, gamma-globulin—showed highly significant differences between the two groups (P<0.01), with overall combined processing showing P<0.01.

Improvement of Three Systems: Before treatment, there was no significant statistical difference between the two groups (P>0.05); after treatment, the two groups showed highly significant differences (P<0.01).

Relationship Between Efficacy and Syndrome Type: See Table 1.

Relationship Between Efficacy and Disease Course: See Table 2.

Relationship Between Efficacy and Treatment Cycle: See Table 3.

IV. Discussion

This paper’s comparative observation of TCM syndrome differentiation treatment for 289 cases of chronic active hepatitis B demonstrates that TCM syndrome differentiation treatment is more effective than Western medicine Ganbifu. Statistical analysis shows significant or highly significant differences in all test indicators. TCM syndrome differentiation not only has obvious effects in eliminating hepatitis B symptoms and improving liver function (total effective rate reaching 87.53%); moreover, it plays a more prominent role in HBsAg negative conversion (conversion rate 39.9%), e-antigen negative conversion (conversion rate 68.57%), and HBV-DNA-P negative conversion (conversion rate 56.43%). This indicates that TCM syndrome differentiation treatment for chronic active hepatitis B is not merely symptomatic therapy; rather, it fundamentally treats hepatitis B at its root, fully embodying the TCM academic principle of “internal factors manifest externally” and the TCM spirit of “treating disease by addressing its root.” Chronic active hepatitis B is diagnosed based on microscopic test indicators combined with hepatosplenomegaly and disease severity, whereas TCM syndrome differentiation mainly approaches it from another angle—the patient’s subjective symptoms, pulse condition, and tongue color—macroscopic aspects. Even for the same chronic active hepatitis B, there are different presentations: Qi-Yin initial deficiency, Shaoyang pathogen invasion, Qi stagnation and blood stasis, and Yang deficiency with water overflow. Patients with Qi-Yin initial deficiency usually have good compensatory function and mild subjective symptoms, so their formula Type 1 focuses on tonifying qi and nourishing yin, clearing heat and detoxifying; patients with Shaoyang pathogen invasion often show recent aggravation or recurrence, so their main formula Type 2 focuses on soothing the liver and resolving stagnation, clearing heat and detoxifying; patients with Qi stagnation and blood stasis mostly have significant hepatosplenomegaly, obvious liver pain, and severe liver function impairment, so their main formula Type 3 focuses on promoting qi circulation, activating blood, nourishing yin and softening the liver, clearing heat and detoxifying; patients with Yang deficiency and water overflow are mostly already in cirrhosis or early cirrhosis, with obvious physical weakness and clear portal hypertension signs, so their main formula Type 4 focuses on tonifying the middle jiao, warming yang and promoting diuresis. Clearing heat and detoxifying is an important principle in treating chronic active hepatitis B; herbs like Polygonum cuspidatum, wild chrysanthemum, Artemisia capillaris, Isatis indigotica, and Solanum nigrum are used for patients positive for hepatitis B antigens (surface antigen and e-antigen), which can reduce or even turn negative the surface antigen ratio while improving symptoms, and e-antigen often turns negative as well; when SGPT is elevated and hepatitis B antigens are positive, it’s considered pathogenic toxin, judged by the heat manifestation of acute hepatitis B, so this toxin should be treated with clearing heat and detoxifying. Abnormalities like albumin reduction, such as musk turbidity and musk flocculation, fall under the category of deficiency syndrome. The Inner Canon says “deficiency should be supplemented,” so the approach is to tonify qi and nourish yin. Clearing heat and detoxifying complement and reinforce each other, thus enhancing their effectiveness.

(Chinese Journal of Medicine, 1989.4)

Clinical Report on TCM Syndrome Differentiation Treatment for 100 Cases of Hepatitis B

Pei Zhengxue, Cheng Jiechen, Peng Xiang, Zhong Xu

Hepatitis B is an infectious immune disease caused by the hepatitis B virus (HBV). Due to its high infectivity, long incubation period, and tendency to become chronic, with a higher risk of developing cirrhosis and liver cancer than other viral hepatitis, research and treatment of this disease have recently attracted widespread attention in the medical community. The author has treated 100 cases of this disease using TCM syndrome differentiation treatment, achieving satisfactory results, as reported below.

I. Case Selection

All 100 cases were clinically confirmed patients with hepatitis B (according to the 1978 Hangzhou Conference diagnostic criteria). Among them, 52 were male and 48 female. Nine were under 15, 36 were aged 15–30, 32 were aged 31–45, 20 were aged 46–60, and 3 were over 60. Disease course within 3 months in 18 cases, 3–6 months in 35 cases, 6 months to 1 year in 28 cases, and more than 1 year in 19 cases. Clinically diagnosed as acute in 53 cases, prolonged in 43 cases, and chronic in 4 cases (including cirrhosis). All cases tested positive for HBsAg (reverse passive hemagglutination method) upon admission (with 86 cases also positive for anti-HBC).

II. TCM Classification and Treatment Methods

The 100 cases were classified into four types based on TCM syndrome differentiation: 3 cases of Qi-Yin initial deficiency, 53 cases of Shaoyang pathogen invasion, 40 cases of Qi stagnation and blood stasis, and 4 cases of Yang deficiency with water overflow. ① Qi-Yin initial deficiency: Symptoms include fatigue, poor appetite, tidal heat, restlessness, a deep and thin pulse, a red tongue body, and a light coating. The prescribed formula is Shengshan Baige Decoction: 6g of Cimicifuga, 10g of Chinese yam, 10g of Kudzu root, 10g of Ligustrum lucidum, 10g of Goji berry, 10g of Platycladus orientalis, 10g of Trichosanthes kirilowii, 4 pieces of Prunus mume, 10g of Polygonum cuspidatum, 10g of wild chrysanthemum, and 6g of Cicada exuviae, decocted in water and taken once daily. ② Shaoyang pathogen invasion: Symptoms include bitter taste in the mouth, dry throat, flank pain, abdominal distension, irritability, a wiry and rapid pulse, a red tongue body, and a slightly yellowish greasy coating. The prescribed formula is Compound Chaihu Decoction: 10g of Bupleurum, 6g of Scutellaria baicalensis, 6g of Pinellia ternata, 10g of Codonopsis pilosula, 6g of Glycyrrhiza uralensis, 10g of Salvia miltiorrhiza, 3g of Aucklandia lappa, 3g of Amomum villosum, 10g of Polygonum cuspidatum, 10g of Isatis indigotica, 15g of Artemisia capillaris, 6g of late silkworm excrement, 10g of Papaya, 6g of Cyperus rotundus, and 6g of Agastache rugosa, decocted in water and taken once daily. ③ Qi stagnation and blood stasis: Symptoms include a rapid pulse, a red tongue body with blood stasis spots, and a scant coating. The prescribed formula is Compound Yi Yin Jian: 10g of Achyranthes bidentata, 10g of Salvia miltiorrhiza, 10g of Rehmannia glutinosa, 10g of Paeonia lactiflora, 10g of Angelica sinensis, 6g of Chuanxiong, 6g of Atractylodes, 15g of Solanum nigrum, 15g of Polygonum cuspidatum, 6g of Curcuma longa, 30g of orange leaves, 6g of Yuanhu, 6g of Chuanlianzǐ, decocted in water and taken once daily. ④ Yang deficiency with water overflow: Symptoms include fatigue, exhaustion, abdominal distension, ascites, lower limb edema, aversion to cold with spontaneous sweating, a deep, thin, and slippery pulse, a plump tongue body, and a light coating. The prescribed formula is Compound Liu Junzi Decoction: 10g of Codonopsis pilosula, 10g of Atractylodes, 12g of Poria cocos, 6g of Glycyrrhiza uralensis, 6g of Pinellia ternata, 6g of Citrus reticulata, 6g of Atractylodes, 6g of Houpu, 10g of Zhu Ling, 10g of Ze Xie, 10g of Gui Zhi, 6g of Dry ginger, 6g of Fuzi, decocted in water and taken once daily.

All cases were treated with traditional Chinese medicine, with every 20 doses constituting one treatment cycle, and other medications were discontinued during treatment.

III. Treatment Results