Is Chinese herbal medicine effective in treating functional dyspepsia of spleen (Pi) and stomach (Wei) deficiency-cold syndrome, as compared to placebo?
Date of publication of the randomized controlled trial: July 2013
Design
Randomized controlled trial (RCT).
Participants
162 patients with functional dyspepsia of spleen (Pi) and stomach (Wei) deficiency-cold syndrome (mean age: 35.87 years in treatment group, 37.50 years in control group; 34% male). Patients were assessed according to the Rome III criteria and the Principle for Clinical Research on New Drugs of Traditional Chinese Medicine.
Intervention
150mL(50°C) granules of Chinese herbal extracts Gastrosis No.1 Compound (dissolved in 300ml boiled water cooled to 70°C) consumed twice daily for 4 weeks, followed by a 4-week follow-up period.
Comparator
Comparison 1: Gastrosis No.1 Compound extracts (150mL, 50°C) versus placebo with an identical appearance.
Major Outcomes
Outcome 1: Functional dyspepsia symptoms scores as measured by total dyspepsia symptom (TDS) scale after 4 weeks of treatment;
Outcome 2: Functional dyspepsia symptoms scores as measured by single dyspepsia symptom (SDS) scale after 4 weeks of treatment;
Outcome 3: Traditional Chinese medicine syndromes (CMS) score after 4 weeks of treatment.
Settings
This study was performed in an outpatient setting.
Comparison    Gastrosis No.1 Compound extract (150mL, 50°C) versus placebo
Main Results
Compared to placebo, Gastrosis No.1 Compound extract showed significant effect in reducing both the scores of TDS (mean difference (MD): -1.40, 95% CI: not reported) and SDS (MD for epigastric pain: -0.73, 95% CI: not reported), (MD for postprandial fullness and bloating: -1.16, 95% CI: not reported), (MD for early satiety: -1.11, 95% CI: not reported). Besides, Gastrosis No.1 Compound extract showed significant effect in in reducing the syndromes of CMS score (MD: -4.64, 95% CI: not reported).
Comparison: Gastrosis No.1 Compound extract versus placebo among functional dyspepsia patients
Outcomes No. of studies (Total no. of participants) Mean score (SD)/ No. of participants Heterogeneity test (I2) MD (95% CI) p value Overall quality of evidence*
Intervention Comparator
1 1 (162) 1.62 (1.85)/108 3.02 (2.38)/54 Not applicable as there is only 1 study. -1.40 (not reported) <0.01 Low
2a) Epigastric pain 1 (162) 0.90 (1.62)/108 1.63 (1.92)/54 Not applicable as there is only 1 study. -0.73 (not reported) <0.01 Low
2b) Postprandial fullness and bloating 1 (162) 1.26 (1.82)/108 2.42 (2.09)/54 Not applicable as there is only 1 study. -1.16 (not reported) <0.01 Low
2c) Early satiety 1 (162) 0.46 (1.11)/108 1.57 (1.83)/54 Not applicable as there is only 1 study. -1.11 (not reported) <0.01 Low
3 1 (162) 5.10 (5.46)/108 9.74 (7.84)/54 Not applicable as there is only 1 study. -4.64 (not reported) <0.01 Low
Keys: SD = standard deviation, MD = mean difference; CI = confidence interval.
Comparison    Gastrosis No.1 Compound extract (150mL, 50°C) versus placebo
Main Results
Compared to placebo, Gastrosis No.1 Compound extract showed significant effect in reducing both the scores of TDS (mean difference (MD): -1.40, 95% CI: not reported) and SDS (MD for epigastric pain: -0.73, 95% CI: not reported), (MD for postprandial fullness and bloating: -1.16, 95% CI: not reported), (MD for early satiety: -1.11, 95% CI: not reported). Besides, Gastrosis No.1 Compound extract showed significant effect in in reducing the syndromes of CMS score (MD: -4.64, 95% CI: not reported).
Comparison: Gastrosis No.1 Compound extract versus placebo among functional dyspepsia patients
Outcomes 1 2a) Epigastric pain 2b) Postprandial fullness and bloating 2c) Early satiety 3
No. of studies (Total no. of participants) 1 (162) 1 (162) 1 (162) 1 (162) 1 (162)
Mean score (SD)/ No. of participants Intervention 1.62 (1.85)/108 0.90 (1.62)/108 1.26 (1.82)/108 0.46 (1.11)/108 5.10 (5.46)/108
Comparator 3.02 (2.38)/54 1.63 (1.92)/54 2.42 (2.09)/54 1.57 (1.83)/54 9.74 (7.84)/54
MD (95% CI) -1.40 (not reported) -0.73 (not reported) -1.16 (not reported) -1.11 (not reported) -4.64 (not reported)
p value <0.01 <0.01 <0.01 <0.01 <0.01
Overall quality of evidence* Low Low Low Low Low
Keys: SD = standard deviation, MD = mean difference; CI = confidence interval.
Conclusion
Benefits
Compared to placebo, Gastrosis No.1 Compound extract showed significant improvement in the dyspepsia symptom score by reducing the scores of TDS and SDS. Besides, it showed significant improvement in the CMS score. For all outcomes, the overall quality of evidence is low. Further research is likely to have an important impact on our confidence in this estimate of effect.
Harms
No adverse effects were reported in this trial.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/23818201
The synopsis is based on the following article:
Zhang S, Zhao L, Wang H, Wu B, Wang CJ, Huang SP, et al. Efficacy of Gastrosis No. 1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: a multi-center, double-blind, placebo-controlled clinical trial. Chinese Journal of Integrative Medicine. 2013 Jul; 19: 498-504.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.