Copyright
©The Author(s) 2022.
World J Gastroenterol. Sep 7, 2022; 28(33): 4890-4908
Published online Sep 7, 2022. doi: 10.3748/wjg.v28.i33.4890
Published online Sep 7, 2022. doi: 10.3748/wjg.v28.i33.4890
Table 1 Search strategy
Number | Search terms |
1 | Mesh descriptor (Medicine, Traditional) explode all trees |
2 | (Medicine, Chinese Traditional*): ti,ab,kw |
3 | Mesh descriptor(Drugs, Chinese Herbal) explode all trees, |
4 | ((Chinese Drugs, Plant*) or (Chinese Herbal Drugs*) or (Herbal Drugs, Chinese*) or (Plant Extracts, Chinese*) or (Chinese Plant Extracts*) or(Extracts, Chinese Plant*)): ti,ab,kw |
5 | Mesh descriptor (shen-ling-bai-zhu) explode all trees |
6 | ((shen-ling-bai-zhu powder*) or (shen-ling-bai-zhu formula*) or (shen-ling-bai-zhu decoction*) or (shen-ling-bai-zhu decoction*) or (Shen-ling-bai-zhu powder*) or (Shen-ling-bai-zhu formula*) or (Shen-ling-bai-zhu formula*)): ti,ab,kw |
7 | Or 1-6 |
8 | Mesh descriptor: (Chronic gastritis) explode all trees |
9 | ((Chronic gastritis*) or (Digestive System Diseases*) or (Gastrointestinal Diseases*) or (Gastroenteritis*) or (Gastritis*) or (Chronic, gastritis*)): ti, ab, kw |
10 | Or 8-9 |
11 | Mesh descriptor: (randomized controlled trials) explode all trees |
12 | (random*) or (randomly*) or (allocation*) or (random allocation*) or (placebo*) or (double blind*) or (clinical trials*) or (randomized control trial*) or (RCT*) or (controlled clinical trials*): ti, ab, kw |
13 | Or: 11-12 |
14 | 7 and 10 and 13 |
Table 2 Excluded 11 studies after reading the full text
Reason | Ref. (n = 11) |
Intervention combined with other decoction (n = 3) | Li GS. Observation on the curative effect of Shenling Baizhu Powder and Taohong Siwu Decoction in treating chronic gastritis. Zhongyi Linchuang Zazhi 2007; 19 (10): 260-261 |
Yang Y. Shenlingbaizhu san and zhaqupingwei powder combined with western medicine in the treatment of chronic gastritis randomized paraller controlled study. Shiyong Zhongyi Neike Zazhi 2013; 27 (10): 40-41 | |
Yang SX. Clinical study on the treatment of Chronic functional diarrhea with Shenling Baizhu Powder and Lizhong Decoction. Yatai Chuantong Yixue 2017; 30 (13): 145-146 | |
Intervention combined with other decoction, no diagnostic criteria (n = 2) | Jin JZ. Shenling Baizhu Powder and Zuojin pill to treat chronic gastritis. Shiyong Zhongyi Neike Zazhi 2011; 27 (11): 752 |
Gao CZ, Yang SM. Observation on curative effect of cefaclor combined with Shenlingbaizhu granule and Muxiang Shunqi pill in treating chronic gastritis. Zhonghua Yixue Chuangxin Zazhi 2012; 9 (22): 127-128 | |
No diagnostic criteria (n = 1) | Shi ZR. Clinical observation on 8 cases of chronic gastritis treated by Shenling Baizhu Powder. Neimenggu Zhongyi Zazhi 2014 [DOI: 10.16040/j.cnki.cn15-1101.2014.07.024] |
Not CG(n = 1) | Zhang WW. Clinical observation on 96 cases of spleen deficiency and stomachache treated with Shenling Baizhu Powder. Zhongguo Minzuyixue Yu Minzuyaoxue 2013; 9 (12): 80 |
Intervention combined with acupuncture (n = 3) | Yang FX. Acupuncture combined with Shenling Baizhu Powder to treat chronic gastritis with spleen deficiency and dampness. Kouqiang Yixue Dianzi Zazhi 2015; 6 (13): 140-143 |
Wu XR. 30 cases of chronic gastritis with spleen deficiency and dampness treated by acupuncture combined with Shenling Baizhu Powder. Guangming Zhongyi 2015; 30 (5): 1018-1020 | |
Wu CY. Analysis of curative effect of acupuncture combined with Shenling Baizhu Powder on chronic gastritis with spleen deficiency and dampness. Jixu Yixue Jiaoyu Zazhi 2019; 33 (10): 161-162 | |
Intervention combined with other decoction, WM are inconsistent in two groups (n = 1) | Yan Z. Clinical study of cefaclor combined with Shenling Baizhu granule and Muxiang Shunqi pill in treating chronic gastritis. Yatai Chuantong Yixue 2015; 11 (18): 106-107 |
Table 3 Characteristics of included studies
Ref. | Study design | Sample size (E/C) | Gender (E/C) and age (yr) | Duration | Interventions | Period | Outcome measure | Balance report of baseline | |
Control group | Experimental group | ||||||||
Yun[27], 2014 | RCT | 48 (24/24) | (13/11) (10/14); (34.96 ± 11. 39)/(34.08 ± 12.82) | Not mentioned | Rabeprazole enteric-coated capsule | Rabeprazole enteric-coated capsule + SLBZD | 4 wk | Effective rate | P > 0.05 |
Chen et al[28], 2014 | RCT | 79 (40/39) | (24/16) (23/16); (42.6 ± 13.1)/43.5 ± 13.4 | 6-17 mo/6-19 mo | Triple therapy (clarithromycin sustained-release tablets + rabeprazole sodium capsule + metronidazole tablets) | Triple therapy + SLBZD | 4 wk | Effective rate | P > 0.05 |
Chen et al[29], 2018 | RCT | 60 (30/30) | (14/16) (15/15); (55.45 ± 6.55)/(55.46 ± 6.44) | 3-12 mo | Quadruple therapy (rabeprazole sodium capsule + amoxicillin + clarithromycin sustained-release tablets + biskalcitrate) | Quadruple therapy + SLBZD | 8 wk | Effective rate; H. Pylori eradication; adverse event | P > 0.05 |
Du[30], 2017 | RCT | 48 (26/22) | (14/12) (12/10); (40.7 ± 6.1)/(41.2 ± 6.6) | 7 mo-9 years/6 mo-8 years | Quadruple therapy (amoxicillin clavulanic potassium chewable tablets + metronidazole + omeprazole + compound bismuth aluminate capsule) | SLBZD | 5 wk | Effective rate | P > 0.05 |
Gu[31], 2017 | RCT | 98 (49/49) | Not mentioned; 19-58 | Not mentioned | Triple therapy (omeprazole + clarithromycin + amoxicillin) | Triple therapy + SLBZD | 4 wk | Effective rate; H. Pylori eradication rate; adverse event | P > 0.05 |
Li et al[32], 2020 | RCT | 66 (33/33) | (19/14) (18/15); (58.54 ± 4.65)/(58.62 ± 4.57) | 4-17 years/4-18 years | Triple therapy (mosapride tablet + polyzyme tablets + lansoprazole tablets) | Triple therapy + SLBZD | 12 wk | Effective rate | P > 0.05 |
Tang[33], 2014 | RCT | 60 (30/30) | (16/14) (17/13); (22-46)/(23-52) | Not mentioned | Omeprazole enteric-coated capsules | Omeprazole Enteric-coated Capsules + SLBZD | 8 wk | Effective rate | P > 0.05 |
Xia[34], 2015 | RCT | 300 (150/150) | Not mentioned; 18-85 | Not mentioned | Omeprazole enteric-coated capsules | SLBZD | 8 wk | Effective rate; recurrence rate; adverse event | P > 0.05 |
Xu et al[35], 2018 | RCT | 60 (30/30) | (17/13) (16/14); (55.6 ± 16.4)/(56.8 ± 14.9) | 4-20 years/4-19 years | Triple therapy (mosapride tablet + polyzyme tablets + lansoprazole tablets) | Triple therapy+SLBZD | 12 wk | Effective rate | P > 0.05 |
Zhang et al[36], 2020 | RCT | 68 (34/34) | (15/19) (17/17); (44.8 ± 5.0)/(45.2 ± 5.4) | 1-12 years/2-14 years | Combination therapy (omeprazole + compound bismuth aluminate granules) | Combination therapy + SLBZD | 8 wk | Effective rate; adverse events | P > 0.05 |
Zhao and Lin[37], 2010 | RCT | 80 (40/40) | (37/3) (38/2); (46.2 ± 6.7)/(44.2 ± 5.7) | 2-7 years/2-8 years | No alcohol, famotidine | No alcohol, famotidine + SLBZD | 4 wk | Effective rate; | P > 0.05 |
Zheng[38], 2014 | RCT | 92 (46/46) | (28/18) (30/16); ( 34 ± 5.34)/( 33 ± 5.76) | 5 mo-6 years/7 mo-6 years | Triple therapy (amoxicillin dispersion tablet + omeprazole enteric-coated capsules + clarithromycin tablet) | SLBZD | 4 wk | Effective rate; adverse events; recurrence rate | P > 0.05 |
Zhuang et al[39], 2019 | RCT | 106 (53/53) | (65/41); (46.20 ± 8.75) | 1-11 years | Triple therapy (omeprazole enteric-coated tablets + clarithromycin dispersible tablets+amoxil capsule) | Triple therapy + SLBZD | 4 wk | Effective rate; H. Pylori’s negative conversion rate | P > 0.05 |
Zou[40], 2015 | RCT | 170 (85/85) | (86/84); (40.9 ± 11.1) | Not mentioned | Triple therapy (amoxicillin + clarithromycin + omeprazole) | Triple therapy + SLBZD | 8 wk | Effective rate; H. Pylori’s negative conversion rate; recurrence rate | P > 0.05 |
Table 4 Methodological quality details of all included studies
Ref. | Baseline | Randomization | Allocation concealment | Blind method | Withdrawal or dropped-out | Follow up | Protocol and registration | Ethics committee approved |
Yun[27], 2014 | Comparability | Random | NR | NR | NR | NR | NR | NR |
Chen et al[28], 2014 | Comparability | Random number table | NR | NR | NR | NR | NR | NR |
Chen et al[29], 2018 | Comparability | Random | NR | NR | NR | NR | NR | NR |
Du[30], 2017 | Comparability | Random | NR | NR | NR | NR | NR | NR |
Gu[31], 2017 | Comparability | Random | NR | NR | No cases withdrawal and dropped-out | NR | NR | Approved |
Li et al[32], 2020 | Comparability | Random | NR | NR | NR | NR | NR | Approved |
Tang[33], 2014 | Comparability | Random | NR | NR | NR | NR | NR | NR |
Xia[34], 2015 | Comparability | Random | NR | NR | No cases withdrawal and dropped-out | Recurrence rate | NR | Approved |
Xu et al[35], 2018 | Comparability | Random | NR | NR | NR | NR | NR | NR |
Zhang et al[36], 2020 | Comparability | Random | NR | NR | NR | NR | NR | NR |
Zhao and Lin[37], 2010 | Comparability | Random | NR | NR | NR | NR | NR | NR |
Zheng[38], 2014 | Comparability | Random | NR | NR | NR | Recurrence rate | NR | NR |
Zhuang et al[39], 2019 | Comparability | Random number table | NR | NR | NR | NR | NR | NR |
Zou[40], 2015 | Comparability | Random number table | NR | NR | NR | Recurrence rate | NR | NR |
Table 5 Subgroup analysis of total effectiveness
Subgroup method (total effective rate) | Items | Number of comparisons | Results (risk ratio, 95%CI) | P value for overall effect | I2 | P value for subgroup difference |
Course of treatment | All comparisons | 14 | 1.29 (1.22,1.37) | < 0.00001 | 0% | |
Supplementary Table 1 | 4 wk | 5 | 1.27 (1.17,1.37) | < 0.00001 | 0% | |
5 wk | 1 | 1.45 (1.04, 2.03) | 0.03 | NA | 0.58 | |
8 wk | 5 | 1.28 (1.16, 1.40) | 0.02 | 0% | ||
12 wk | 2 | 1.44 (1.19, 1.74) | 0.0002 | 0% | ||
Comparison type | All comparisons | 14 | 1.23 (1.14, 1.32) | < 0.00001 | 47% | |
Supplementary Table 2 | SLBZS vs CM | 3 | 1.23 (1.10, 1.38) | 0.0003 | 0% | 0.93 |
SLBZS + CM vs CM | 11 | 1.23 (1.11, 1.35) | < 0.0001 | 57% | ||
Intervention method | All comparisons | 14 | 1.29 (1.22, 1.37) | < 0.0001 | 0% | |
Supplementary Table 3 | Monotherapy | 4 | 1.25 (1.12, 1.40) | < 0.0001 | 5% | |
Combined therapy | 1 | 1.41 (1.08, 1.84) | 0.01 | NA | 0.82 | |
Triple therapy | 7 | 1.30 (1.21,1.40) | < 0.0001 | 0% | ||
Quadruple therapy | 2 | 1.35 (1.11, 1.64) | 0.003 | 0% |
Table 6 Adverse events
Study | Experiment group | Control group |
Zhang, 2020 | Diarrhea (2/34) | Dizziness (2/34) and dry mouth (1/34) |
Chen, 2018 | Headache (1/30), diarrhea (1/30), nausea (1/30) | Headache (2/30), diarrhea (1/30), nausea (2/30), constipation (1/30), rash (1/30) |
Zheng, 2014 | None | Headache and rash (17.39%) |
Table 7 GRADE evidence for the effect of Shen-ling-bai-zhu san
Quality assessment | Summary of findings | Importance | ||||||||||
No of patients | Effect | Quality | ||||||||||
No of studies | Design | Limitations | Inconsistency | Indirectness | Imprecision | Other considerations | RQLQ | Control | Relative (95%CI) | Absolute | ||
Effective rate | ||||||||||||
14 | Randomized trials | Serious1 | Serious2 | Serious3 | No serious imprecision4 | None | 595/670 (88.8%) | 459/665 (69%) | RR 1.45 (1.22 to 1.37) | 200 more per 1000 (from 152 more to 255 fewer) | Very low | Critical |
0.676 | 196 more per 1000 (from 149 fewer to 250 more) | |||||||||||
Recurrence rate | ||||||||||||
3 | Randomized trials | Serious1 | Serious2 | Serious3 | No serious imprecision4 | None | 7/281 (2.5%) | 31/281 (11%) | RR 0.24 (0.11 to 0.55) | 84 fewer per 1000 (from 50 fewer to 98 fewer) | Very low | Important |
0.177 | 135 fewer per 1000 (from 58 fewer to 158 fewer) | |||||||||||
HP negative conversion rate | ||||||||||||
4 | Randomized trials | No serious limitations1 | Very serious2 | No serious indirections3 | No serious imprecision4 | None | 207/217 (95.4%) | 170/270 (78.3%) | RR 1.2 (1.11 to 1.3) | 157 more per 1000 (from 86 more to 135 more) | Moderate | Important |
0.815 | 163 more per 1000 (from 90 more to 244 more) |
- Citation: Jin W, Zhong J, Song Y, Li MF, Song SY, Li CR, Hou WW, Li QJ. Chinese herbal formula shen-ling-bai-zhu-san to treat chronic gastritis: Clinical evidence and potential mechanisms. World J Gastroenterol 2022; 28(33): 4890-4908
- URL: https://www.wjgnet.com/1007-9327/full/v28/i33/4890.htm
- DOI: https://dx.doi.org/10.3748/wjg.v28.i33.4890