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The efficacy of Shugan Jianpi Zhixie therapy for diarrhea-predominant irritable bowel syndrome: a meta-analysis of randomized, double-blind, placebo-controlled trials.

Xiao Y, Liu Y, Huang S, Sun X, Tang Y, Cheng J, Wang T, Li F, Kuang Y, Luo R, Zhao X - PLoS ONE (2015)

Bottom Line: SJZT was significantly more likely to reduce overall BSS score (SMD -0.67; 95% CI -0.94, -0.40; P < 0.00001) and improve abdominal pain (RR 4.34; 95% CI 2.64, 7.14; P < 0.00001) than placebo.The adverse events of SJZT were no different from those of placebo.This meta-analysis suggests that SJZT is an effective and safe therapy option for patients with IBS-D.

View Article: PubMed Central - PubMed

Affiliation: Department of Traditional Chinese Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China; School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, Guangdong, 510515, China.

ABSTRACT

Background: Shugan Jianpi Zhixie therapy (SJZT) has been widely used to treat diarrhea-predominant irritable bowel syndrome (IBS-D), but the results are still controversial. A meta-analysis of randomized, double-blind, placebo-controlled trials was performed to assess the efficacy and tolerability of SJZT for IBS-D.

Methods: The MEDLINE, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, the Chinese Biomedical Literature database and the Wanfang database were searched up to June 2014 with no language restrictions. Summary estimates, including 95% confidence intervals (CI), were calculated for global symptom improvement, abdominal pain improvement, and Symptom Severity Scale (BSS) score.

Results: Seven trials (N=954) were included. The overall risk of bias assessment was low. SJZT showed significant improvement for global symptom compared to placebo (RR 1.61; 95% CI 1.24, 2.10; P =0.0004; therapeutic gain = 33.0%; number needed to treat (NNT) = 3.0). SJZT was significantly more likely to reduce overall BSS score (SMD -0.67; 95% CI -0.94, -0.40; P < 0.00001) and improve abdominal pain (RR 4.34; 95% CI 2.64, 7.14; P < 0.00001) than placebo. The adverse events of SJZT were no different from those of placebo.

Conclusions: This meta-analysis suggests that SJZT is an effective and safe therapy option for patients with IBS-D. However, due to the high clinical heterogeneity and small sample size of the included trials, further standardized preparation, large-scale and rigorously designed trials are needed.

No MeSH data available.


Related in: MedlinePlus

Funnel plot analysis of global symptom improvement (Begg’s test, P = 0.707).RR, relative risk.
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pone.0122397.g004: Funnel plot analysis of global symptom improvement (Begg’s test, P = 0.707).RR, relative risk.

Mentions: Among the included studies, six evaluated global symptom improvement [12,15,16–18,20]: of 917 patients, 570 were assigned to the treatment groups, whereas 347 were assigned to the placebo groups. The number of participants included in this meta-analysis was slightly larger than the calculated OIS (917 vs. 794 patients). SJZT showed significant improvement in global symptoms compared to placebo (RR 1.61; 95% CI 1.24, 2.10; P = 0.0004) (Fig 3a). 76.8% of SJZT patients had global improvement over 43.8% of placebo patients (therapeutic gain = 33.0% with NNT = 3.0) (Table 3). The heterogeneity was significant (P = 0.005, I2 = 70.0%). We performed a sensitivity analysis to investigate potential sources of heterogeneity and found that the Leung et al. study may be the main origin of heterogeneity in the meta-analysis [12]. The heterogeneity was small after exclusion of the Leung et al. study (P = 0.25, I2 = 26%). However, the corresponding pooled RR was not conspicuously altered without the Leung et al. study (RR 1.79 95% CI 1.51, 2.12) (Fig 3b). The findings supported the robustness of the analysis. No evidence of asymmetry was identified by funnel plot analysis (Begg’s test P = 0.707) (Fig 4).


The efficacy of Shugan Jianpi Zhixie therapy for diarrhea-predominant irritable bowel syndrome: a meta-analysis of randomized, double-blind, placebo-controlled trials.

Xiao Y, Liu Y, Huang S, Sun X, Tang Y, Cheng J, Wang T, Li F, Kuang Y, Luo R, Zhao X - PLoS ONE (2015)

Funnel plot analysis of global symptom improvement (Begg’s test, P = 0.707).RR, relative risk.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4390216&req=5

pone.0122397.g004: Funnel plot analysis of global symptom improvement (Begg’s test, P = 0.707).RR, relative risk.
Mentions: Among the included studies, six evaluated global symptom improvement [12,15,16–18,20]: of 917 patients, 570 were assigned to the treatment groups, whereas 347 were assigned to the placebo groups. The number of participants included in this meta-analysis was slightly larger than the calculated OIS (917 vs. 794 patients). SJZT showed significant improvement in global symptoms compared to placebo (RR 1.61; 95% CI 1.24, 2.10; P = 0.0004) (Fig 3a). 76.8% of SJZT patients had global improvement over 43.8% of placebo patients (therapeutic gain = 33.0% with NNT = 3.0) (Table 3). The heterogeneity was significant (P = 0.005, I2 = 70.0%). We performed a sensitivity analysis to investigate potential sources of heterogeneity and found that the Leung et al. study may be the main origin of heterogeneity in the meta-analysis [12]. The heterogeneity was small after exclusion of the Leung et al. study (P = 0.25, I2 = 26%). However, the corresponding pooled RR was not conspicuously altered without the Leung et al. study (RR 1.79 95% CI 1.51, 2.12) (Fig 3b). The findings supported the robustness of the analysis. No evidence of asymmetry was identified by funnel plot analysis (Begg’s test P = 0.707) (Fig 4).

Bottom Line: SJZT was significantly more likely to reduce overall BSS score (SMD -0.67; 95% CI -0.94, -0.40; P < 0.00001) and improve abdominal pain (RR 4.34; 95% CI 2.64, 7.14; P < 0.00001) than placebo.The adverse events of SJZT were no different from those of placebo.This meta-analysis suggests that SJZT is an effective and safe therapy option for patients with IBS-D.

View Article: PubMed Central - PubMed

Affiliation: Department of Traditional Chinese Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China; School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, Guangdong, 510515, China.

ABSTRACT

Background: Shugan Jianpi Zhixie therapy (SJZT) has been widely used to treat diarrhea-predominant irritable bowel syndrome (IBS-D), but the results are still controversial. A meta-analysis of randomized, double-blind, placebo-controlled trials was performed to assess the efficacy and tolerability of SJZT for IBS-D.

Methods: The MEDLINE, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, the Chinese Biomedical Literature database and the Wanfang database were searched up to June 2014 with no language restrictions. Summary estimates, including 95% confidence intervals (CI), were calculated for global symptom improvement, abdominal pain improvement, and Symptom Severity Scale (BSS) score.

Results: Seven trials (N=954) were included. The overall risk of bias assessment was low. SJZT showed significant improvement for global symptom compared to placebo (RR 1.61; 95% CI 1.24, 2.10; P =0.0004; therapeutic gain = 33.0%; number needed to treat (NNT) = 3.0). SJZT was significantly more likely to reduce overall BSS score (SMD -0.67; 95% CI -0.94, -0.40; P < 0.00001) and improve abdominal pain (RR 4.34; 95% CI 2.64, 7.14; P < 0.00001) than placebo. The adverse events of SJZT were no different from those of placebo.

Conclusions: This meta-analysis suggests that SJZT is an effective and safe therapy option for patients with IBS-D. However, due to the high clinical heterogeneity and small sample size of the included trials, further standardized preparation, large-scale and rigorously designed trials are needed.

No MeSH data available.


Related in: MedlinePlus