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To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential comparative trial

Identifieur interne : 000D72 ( Ncbi/Checkpoint ); précédent : 000D71; suivant : 000D73

To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential comparative trial

Source :

BMC Gastroenterology [ 1471-230X ] ; 2011.

RBID : PMC:3160401

English descriptors

KwdEn :
- Adult, Citrus, Citrus sinensis, Double-Blind Method, Drugs, Chinese Herbal (therapeutic use), Dyspepsia (drug therapy), Dyspepsia (pathology), Female, Humans, Male, Middle Aged, Phytotherapy, Qi, Splenic Diseases (drug therapy), Splenic Diseases (pathology), Syndrome, Tablets, Treatment Outcome.
MESH :
- chemical , therapeutic use : Drugs, Chinese Herbal.
- drug therapy : Dyspepsia, Splenic Diseases.
- pathology : Dyspepsia, Splenic Diseases.
- Adult, Citrus, Citrus sinensis, Double-Blind Method, Female, Humans, Male, Middle Aged, Phytotherapy, Qi, Syndrome, Tablets, Treatment Outcome.

Abstract

Background

In Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine ---- two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.

Methods

A randomized, group sequential, double-blinded, multicenter trial was conducted in patients with FD of spleen-deficiency and qi-stagnation syndrome at 3 hospitals in Beijing between June 2003 and May 2005. Participants were randomly allocated into two groups (IFCA group and IFCS group) in a 1:1 ratio, and respectively took one of the two kinds of Zhizhu pills orally, 6 g each time, 3 times a day, for 4 weeks. Statistical analysis was performed with use of a group sequential method, the triangular test (TT).

Results

A total of 163 patients were randomized, and 3 patients were excluded from analysis because of early dropouts, leaving 160 patients (IFCA group: n = 82; IFCS group: n = 78) for statistical analysis. Three interim analyses were done after 62, 116, and 160 patients had completed their 4-week treatment, respectively. At the third interim analysis, the sample path crossed the upper boundary and the trial was stopped, the cure-markedly effective rates were 45% for IFCS group and 67% for IFCA group, respectively, the one-sided p-value was 0.0036, the median unbiased estimate of the odds ratio (OR) for the benefit of IFCA relative to IFCS was 2.91 with 95%CI: 1.40 to 6.06.

No adverse events were observed in the two groups.

Conclusions

Zhizhu pills containing IFCA was superior to Zhizhu pills containing IFCS in the treatment of FD of spleen-deficiency and qi-stagnation syndrome. The application of group sequential analysis in clinical trials of TCM may offer some financial and ethical benefits.

Trial Registration

Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-00000485

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160401

DOI: 10.1186/1471-230X-11-81
PubMed: 21762493
PubMed Central: 3160401

Affiliations:

Links to Exploration step

PMC:3160401

Le document en format XML

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<term>Humans</term>
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<term>Middle Aged</term>
<term>Phytotherapy</term>
<term>Qi</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>In Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine ---- two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.</p>
</sec>
<sec><title>Methods</title>
<p>A randomized, group sequential, double-blinded, multicenter trial was conducted in patients with FD of spleen-deficiency and qi-stagnation syndrome at 3 hospitals in Beijing between June 2003 and May 2005. Participants were randomly allocated into two groups (IFCA group and IFCS group) in a 1:1 ratio, and respectively took one of the two kinds of Zhizhu pills orally, 6 g each time, 3 times a day, for 4 weeks. Statistical analysis was performed with use of a group sequential method, the triangular test (TT).</p>
</sec>
<sec><title>Results</title>
<p>A total of 163 patients were randomized, and 3 patients were excluded from analysis because of early dropouts, leaving 160 patients (IFCA group: n = 82; IFCS group: n = 78) for statistical analysis. Three interim analyses were done after 62, 116, and 160 patients had completed their 4-week treatment, respectively. At the third interim analysis, the sample path crossed the upper boundary and the trial was stopped, the cure-markedly effective rates were 45% for IFCS group and 67% for IFCA group, respectively, the one-sided <italic>p</italic>
-value was 0.0036, the median unbiased estimate of the odds ratio (OR) for the benefit of IFCA relative to IFCS was 2.91 with 95%CI: 1.40 to 6.06.</p>
<p>No adverse events were observed in the two groups.</p>
</sec>
<sec><title>Conclusions</title>
<p>Zhizhu pills containing IFCA was superior to Zhizhu pills containing IFCS in the treatment of FD of spleen-deficiency and qi-stagnation syndrome. The application of group sequential analysis in clinical trials of TCM may offer some financial and ethical benefits.</p>
</sec>
<sec><title>Trial Registration</title>
<p>Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-00000485</p>
</sec>
</div>
</front>
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<author><name sortKey="Stanghellini, V" uniqKey="Stanghellini V">V Stanghellini</name>
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<author><name sortKey="Heading, Rc" uniqKey="Heading R">RC Heading</name>
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<biblStruct><analytic><author><name sortKey="Malfertheiner, P" uniqKey="Malfertheiner P">P Malfertheiner</name>
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<author><name sortKey="Liu, Z" uniqKey="Liu Z">Z Liu</name>
</author>
<author><name sortKey="Xie, B" uniqKey="Xie B">B Xie</name>
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</analytic>
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<biblStruct><analytic><author><name sortKey="Zheng, Xy" uniqKey="Zheng X">XY Zheng</name>
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<name sortKey="Wang, Xinyue" sort="Wang, Xinyue" uniqKey="Wang X" first="Xinyue" last="Wang">Xinyue Wang</name>
<name sortKey="Wang, Yongyan" sort="Wang, Yongyan" uniqKey="Wang Y" first="Yongyan" last="Wang">Yongyan Wang</name>
<name sortKey="Wang, Zhong" sort="Wang, Zhong" uniqKey="Wang Z" first="Zhong" last="Wang">Zhong Wang</name>
<name sortKey="Yu, Yanan" sort="Yu, Yanan" uniqKey="Yu Y" first="Yanan" last="Yu">Yanan Yu</name>
<name sortKey="Yu, Youhua" sort="Yu, Youhua" uniqKey="Yu Y" first="Youhua" last="Yu">Youhua Yu</name>
<name sortKey="Zhang, Shengsheng" sort="Zhang, Shengsheng" uniqKey="Zhang S" first="Shengsheng" last="Zhang">Shengsheng Zhang</name>
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To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential comparative trial

To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential comparative trial

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