A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia.

BACKGROUND: Functional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD. METHODS: The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared. RESULTS: (1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo. CONCLUSION: Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo. TRIAL REGISTRATION: https://clinicaltrials.gov/, NCT02460601.

[Effects of the diet ratio of polyunsaturated fatty acids ω-3/ω-6 on experimental colitis in mice].

OBJECTIVE: To investigate the effect of changed ratio of polyunsaturated fatty acids (PUFA) on dextran sulfate sodium (DSS)-induced colitis in mice. METHODS: Thirty-two male BALB/c mice were randomly divided into two groups: control group and PUFA group, PUFA group was continuously divided into 3 sub-groups: PUFA ω-3/ω-6 1:3 group, PUFA ω-3/ω-6 1:15 group and PUFA ω-3/ω-6 1:30 group. According to the difference in the sub-groups, PUFA group mice were fed with the corresponding modified diet. The control group was fed with the common diet, whose ratio of PUFA ω-3/ω-6 was 1:15. After eight weeks of different diets, experimental colitis in the three sub-groups of PUFA group was induced by DSS exposure. The mice were placed on three five-day cycles of 30 g/L DSS with ten days of recovery after each cycle, then were sacrificed after the final ten-day period. Overall symptomatic score and histopathological score were evaluated. And levels of mucosal prostaglandin E2 (PGE2) in the proximal and distal colon were measured respectively by enzyme immunoassay. RESULTS: The changed ratio of PUFA ω-3/ω-6 had no effect on the weight gain of the growing mice. Although there were no significant differences among the PUFA groups from the three separate aspects: weight gain, stool character and blood in the stool, there were significant differences among the three groups in overall symptomatic scores. A further comparison showed the overall symptomatic score of 1:3 group was significantly lower than that of the 1:30 group (P<0.05). There were significant differences among the PUFA groups in the histopathological score. The following comparison between the sub-groups showed the histopathological score of the 1:3 group was significantly lower than that of the 1:30 group (P<0.05). One mouse in the 1:30 group died of severe hemorrhage and one mouse also in this group had a huge dysplastic adenomatous polyp. The mucosal PGE2 which could reflect the level of intestinal inflammation showed that in the distal colon, the inflammations were obvious, and the levels of mucosal PGE2 of the distal colon in the 1:15 group [(153.0 ± 49.4) ng/g tissue] and the 1:30 group [(192.4 ± 94.0) ng/g tissue] were significantly higher than that of the control group [(43.2 ± 13.4) ng/g tissue, P<0.05], but there was no significant difference between the 1:3 group [(43.4 ± 8.2) ng/g tissue] and the control group. Although the mucosa damages were sparing in proximal colon, the level of mucosal PGE2 of the proximal colon in 1:30 group [(97.4 ± 64.8) ng/g tissue] markedly increased as compared with the control group [(21.6 ± 16.0) ng/g tissue, P<0.01], there were no differences among the 1:3 group [(36.6 ± 4.6) ng/g tissue], the 1:15 group [(18.8 ± 6.4) ng/g tissue] and the control group. CONCLUSION: The colonic inflammatory severity and the level of mucosal PGE2 in the experimental colitis mice were affected by the changed ratio of PUFA ω-3/ω-6 in the feed. Increased ratio of PUFA ω-3/ω-6 in the feed had a protective effect on the intestinal mucosa in the experimental colitis mice, otherwise had hazards. Before the inflammation happened, changed ratio of PUFA ω-3/ω-6 firstly altered the local inflammatory factors, such as PGE2, and then affected the inflammatory severity.

[Efficacies of lactulose plus live combined Bacillus subtilis and Enterococcus faecium capsules in the treatment of functional constipation: a multicenter, randomized, double blind, controlled trial].

OBJECTIVE: To explore the efficacies of live combined Bacillus subtilis (B. subtilis) and Enterococcus faecium (E. faecium) capsules plus lactulose in the treatment of functional constipation. METHODS: A total of 216 patients fulfilling the diagnostic criteria of functional constipation (slow transit pattern) were randomly enrolled from 9 participating hospitals and allocated into treatment group and control group. The patients of treatment group received lactulose plus live combined B. subtilis and E. faecium capsules for 14 days and only took the latter during the following 14 days. The patients of control group received lactulose plus placebo for 2 weeks and then only took placebo continually for the following 2 weeks. RESULTS: A total of 216 patients were analyzed (treatment group n = 104, control group n = 112). The effective rates of 7-day treatment were 88.46% (n = 92) and 84.82% (n = 95) for treatment and control groups respectively. And those of 28-day treatment were 87.50% (n = 91) and 81.25% (n = 91)respectively. And the inter-group differences were not statistically significant (all P > 0.05). Fecal form, frequency, difficulty, urgency, distension, abdominal pain and expelling rates of barium enema were not statistically significant (all P > 0.05). Comparing the effective rates of 28-day with that of 14-day, differences were not statistically significant in A group (S = 0.5, P = 0.4795), but in B group the effective rates of 28-day were lower than that of 14-day statistically(S = 11, P = 0.0009). CONCLUSION: The regiment of live combined B. subtilis and E. faecium capsules plus lactulose offers better efficacies in the treatment of functional constipation.

Treatment of non-alcoholic fatty liver disease by Qianggan Capsule.

OBJECTIVE: To observe the therapeutic effect and safety of Qianggan Capsule (QGC) in treating non-alcoholic fatty liver disease (NAFLD), using polyene phosphatidylcholine capsule (PPC) as a reference. METHODS: Eighty-eight patients with NAFLD were randomly assigned to two groups, 45 in the treatment group treated with QGC and 43 in the control group treated with PPC. The course of treatment lasted for 6 months. Changes in liver function, blood lipids, and iconographic indexes before and after treatment were observed, and clinical efficacy was evaluated. RESULTS: In the treatment group, alanine aminotransferase (ALT) was lowered significantly from 56.02 + or - 32.59 IU/L before treatment to 38.27 + or - 22.68 IU/L after treatment, and CT liver/spleen ratio significantly increased from 0.69 + or - 0.18 to 0.91 + or - 0.25, showing statistical significance (P<0.05); in contrast, the corresponding changes of the two indexes in the control group were 56.56 + or - 26.33 IU/L to 49.67 + or - 26.22 IU/L, and 0.66 + or - 0.20 to 0.75 + or - 0.24, respectively, the pre-post treatment difference showing insignificant difference (P>0.05). No severe adverse reactions occurred during the whole treatment course. CONCLUSION: QGC is an effective and safe remedy for the treatment of NAFLD.