Table 8 Clinical research

1

Shuganning injection

Yinchen, Ganoderma lucidum, Gardenia, Radix Isatidis, Scutellaria

60 patients (31 men and 29 women) with anti-tuberculous

Randomized, Controlled study

250 mL 10% glucose solution or 250 mL 0.9% NaCl with 6 mL Shuganing injection, 1 times/day

3 weeks

AST, ALT and TBIL and adverse reactions were lowered by treat group compared to control group. Effective rate was higher than control group

Ib

[192]

2

Sini Shugan decoction

Bupleurum, Tangerine Peel, Codonopsis, Cyperus rotundus, Red White Peony, Licorice, Poria, Rehmannia, Angelica, Atractylodes, Citrus aurantium

66 People (33 men and 33 women)

Randomized, Controlled study

Magnesium Isoglycyrrhizinate Injection (150 mg/times, 3 times per day) or Compound Glycyrrhizin Tablets (50 mg/times, 3 times/day)

/

AST, ALT, TBIL are significantly lower than before treatment

Ib

[193]

3

Sunflower hugan tablets

Bupleurum, Yinchen, Radix Isatidis, Schisandra, Pork Gallbladder Powder, Mung Bean

97 People (57 men and 40 women)

Randomized, Controlled study

Bicyclol (1 tablets /times, 3 times/day)

Sunflower hugan tablets (4 tablets /times, 3 times/day)

4 weeks

Significantly reduce the incidence of adverse reactions, and the economy is better

Ib

[194]

4

Jiangmeiling capsule

Schisandrae Chinensis Fructus

63 People (42 men and 21 women)

/

Jiangmeiling capsule (3 tablets /times, 3 times/day) Inosine Tabletes (3 tablets /times, 3 times/day)

4 weeks

Liver function indexes returned to normal after switching to medical liver protection treatment

Ib

[195]

5

Shuganning

Yinchen, Ganoderma lucidum, Gardenia, Radix Isatidis, Scutellaria

164 People (101 men and 63 women)

Randomized, Controlled study

250 mL 10% glucose solution or 250 mL 0.9% NaCl with 6 mL Shuganing injection, 1 times/day

3 weeks

ALT, AST, TBiL are significantly lower than before treatment

Ib

[196]

6

Baidan Shugan prescription

Bupleurum, Cyperus rotundus, White Peony, Angelica, Dan Ginseng, Turmeric, Yinchen, Rhubarb, Whole Cucumber, Magnolia, Hawthorn, Gallus gallus, Astragalus, Atractylodes, Lily, Adenophora, Gentiana

196 People (102 men and 94 women)

Randomized, Controlled study

C: Diammonium glycyrrhizinate enteric-coated capsules (150 mg, 3 times/ day);

T: Baidan Shugan prescription

4 weeks

The total effective rate of the test group were better than control group, ALT, AST, and TBiL significant improvement

Ib

[197]

7

Hugan Jiedu recipe

Bupleurum, Atractylodes macrocephala, Yinchen, Coptis chinensis, Guang turmeric, Weeping pot grass, Ginseng leaves

85 People (35 men and 50 women)

Randomized, Controlled study

Polyene Phosphatidyl choline (2 tablets /times, 3 times/day)

Hugan Jiedu recipe (250 mL/times, 2 times/day)

6 weeks

ALT, AST, TNF-α, IL-6 values before and after treatment in the treatment group were statistically ignificant. The cure rate of the treatment group was significantly different than that of the control group

Ib

[198]

8

Yinlan Yigan Granule

Yinchen, forsythia, turmeric, isatis root, salvia, dangshen, angelica

69 People (43 men and 26 women)

Randomized, Controlled study

C: Silybin methylamine tablets (100 mg, 3 times/day)

T: Yilanyigan Granules (9 g/times, 3 times/day)

2 months

The treatment effect of the observation group was significantly higher than that of the control

Ib

[199]

9

Liuwei Wuling tablets

Schisandra, Ligustrum lucidum, Forsythia, Zedoary turmeric, Cocory, Ganoderma lucidum spore powder

65 People (50 men and 15 women)

Randomized, Controlled study

C: Ganlixin capsule (100 mg /times, 3 times/day);

T: Liuwei Wuling tablets (1.5 g/times, 3 times/day)

2 weeks

Total effective rate and TBIL of the treatment and control group were significant differences

Ib

[200]

10

Shuganning injection

Yinchen, Ganoderma lucidum, Gardenia, Radix Isatidis, Scutellaria

46 People (29 men and 17 women)

Randomized, Controlled study

C: Hepatic glycosides, vitamin C

T: 250 mL 5% glucose solution with 20 mL Shuganing injection, 1 times/day

10 days

The serum level of ALT in treatment group was obviously lower than that of control group,

Ib

[201]

11

Compound Glycyrrhizin tablets

Glycyrrhiza

100 People (54 men and 46 women)

Randomized, Controlled study

T: Compound Glycyrrhizin tablets (50 mg/times, 3 times/day)

2 month

Compound Glycyrrhizin tablets can better improve the levels of ALT, AST, TBIL andγ-GT in patients with elevated transaminase induced by antipsychotic drugs than Glucurolactone tablets

Ib

[202]

12

Silibinin

Milk Thistle

568 patients were included with 277 in experiment group and 291 in control group

Prospective, multi-center, randomized, open-label and controlled trial

T: 2HREZ (S)/4HR and Silibinin, include isoniazid (H), 0.3 g/time, once a day; rifampin, 600 mg/time for patients weighted 50 kg, or 450 mg/time for patients weighted < 50 kg, once a day,; pyrazinamide (Z), 0.5 g/time, 3 times/day, ethambutol (E), 1.0 g/time for patients weighted 50 kg, or 0.75 g/ time for patients weighted < 50 kg, once a day; streptomycin (S), intramuscular injection of 0.75 g, once a day. Silibinin phospholipid complex capsules (35 mg/capsule,) were orally administered two capsules (70 mg) a time, with three times daily (210 mg/ day)

C: 2HREZ (S)/4HR

8 weeks

ALT, AST, AKP, TBiL and DBiL. Liver injury symptoms included fatigue, anorexia, nausea, vomiting and abdominal distension; Other clinical outcomes were assessed based on improvement of clinical symptoms, acteriological results of sputum culture after 8 weeks of treatment and imaging analysis result

Ia

[203]

13

Silymarin

Silybum marianum (L.) Gaertn

55 People (22 men and 33 women)

Randomized, double-blinded, Controlled study

One tablet of silymarin (140 mg) or placebo was taken three times a day along with antituberculosis drugs. Study subjects were emphasized to make records when taking anti-tuberculosis and the study drugs

4 weeks

ALT, SOD, MDA and AOE; adverse events (i.e., decreased appetite, fatigue, confusion etc.) were reviewed from direct questioning and self-recording on the follow-up days

Ia

[204]

14

Silymarin

Silybum marianum

70 cases (37 men and 33 women)

Randomized Double blind

Group one was received Silymarin three times per day for two weeks. Each 140 tablet contains dried extract of Sylibum arianum equivalent to 140 mg Silymarin. The second group was received placebo with the same shape, size and dose intervals manufactured by the same company. Drugs and placebo were encoded

2 weeks

Liver function was being evaluated at the beginning of treatment and three times per week for 2 weeks by measurement of serum aspartate AST, ALT and TBIL. The patients were strictly monitored for drug induced adverse effects including nausea, vomiting, diarrhea, vertigo, exanthema and other allergic phenomenon

Ia

[205]

15

S. marianum capsule

S. marianum

370 cases (274 men and 96 women)

Randomized, Controlled trial

T: Received the standard anti-tuberculosis therapy plus the S. marianum capsule (oral, 200 mg, twice a day)

C: Received the standard anti-tuberculosis therapy plus a vitamin C tablet

8 weeks

ATLI, the peak AST/ALT ratio, and the maximum altered ALP or GGT value. Secondary outcome measures included the occurrence of adverse drug reactions, prolonged treatment duration, taking second-line drugs, and the clearance of tuberculosis bacteria from the sputum after 2 months of treatment

Ia

[206]

16

Silymarin

Silybum marianum

103 cases (68 men and 35 women)

Double-blinded randomized controlled trial

Silymarin or placebo (with similar appearance with the study drug) were assigned to the study patient on the first day of anti-TB treatment. One tablet of silymarin (140 mg) or placebo was taken twice a day along with anti-TB drugs. The remaining tablets were counted on the days of follow-up to check patient’s compliance and adherence

8 weeks

The primary outcome of the study was to compare the development of anti-TB treatment related DILI defined by serum AST or ALT > 3 × upper normal limit (UNL) or TBil (TB) > 2 × UNL

Ia

[207]