Full
Outline
To evaluate the safety and efficacy of Simo Decoction Oral Liquid（四磨汤口服液）for post-prandial distress syndrome（PDS）of functional dyspepsia（FD）.
Randomized，controlled and placebo-controlled parallel trial design was adopted，the observation was conducted in 12 parallel centers，and 240 cases were randomly divided into trial group and control group，with 120 cases in each group. The trial group was administered with Simo Decoction Oral Liquid，while the control group was given Simo Decoction Oral Liquid simulation agent. The treatment course was 4 weeks. The PDSsymptom improvement rate，other individual symptom scores of FD，overall treatment evaluation scale（OTE），hospital anxiety and scale（HAD），functional dyspepsia quality of live（FDDQL）and safety were compared. Full analysis set（FAS）and per protocol set（PPS）were used for effectiveness analysis，while safety set（SS）was used for safety analysis.
There were 237 cases in the FAS（with 118 in the trial group and 119 in the control group），220 cases in the PPS（with 112 in the trial group and 108 in the control group），and 239 cases in the SS（with 120 in the trial group and 119 in the control group）. FASand PPSanalyses showed that after treatment，postprandial distress syndrome，postprandial fullness and discomfort and early satiety in the trial group were higher；the decrease of postprandial discomfort symptoms and postprandial fullness and discomfort VAS scores were larger and the symptom improvement rates of OTEwere higher than those in the control group（P<0.05）. FASanalyses showed that after treatment，the response rates of stomach burning sensation，acid reflux and poor bowel movement in the trial group were higher；the decrease of stomach burning sensation VASscore was larger than those in the control group（P<0.05）. PPS analyses showed that after treatment，the response rates of stomach burning sensation and poor bowel movement in the trial group were higher；the decrease of stomachache，stomach burning sensation and poor bowel movement VAS scores were larger than those in the control group（P<0.05）. There was 1 adverse event occurred in the trial group，and 2 adverse events occurred in the control group，and there were no statistical difference between groups（P>0.05）.
Simo Decoction Oral Liquid is effective and safe in treating post-prandial distress syndrome of functional dyspepsia.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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