Objective To evaluate the efficacy and safety of Huo Xiang Zhengqi dropping pill in treating wind cold and dampness stagnation pattern of common cold. Methods A multicenter, randomlyized, double blind, double dummy, controlled trial was conducted. A total of 480 patients with common cold were randomly divided into two groups: a trial group (360 patients) were treated with Huo Xiang Zhengqi Dropping Pill and Huo Xiang Summer-heat Eliminating Soft Capsule analogue, while a control group (120 patients) were treated with Huo Xiang Summer-heat Eliminating Soft Capsule and Huo Xiang Zhengqi Dropping Pill analogue. The therapeutic course of both groups was 3 days. Results The therapeutic effectiveness of diarrhea as the main symptom: the marked effective rate and total effective rate of the trial group were 86.1% and 96.1%, respectively, while those of the control group were 69.2% and 84.6%, respectively; the therapeutic effectiveness of traditional Chinese medicine (TCM) pattern: the marked effective rate and total effective rate of the trial group were 87.5% and 98.5%, respectively, while those of the control group were 69.2% and 91.5%, respectively. There were significant differences between the two groups in terms of the above two indicators (Plt;0.05), which indicated Huo Xiang Zhengqi Dropping Pill was superior to Huo Xiang Summer-heat Eliminating Soft Capsule in treating wind cold and dampness stagnation pattern of common cold. No adverse effects were found in the trial group. Conclusion Huo Xiang Zhengqi Dropping Pill is effective and safe in treating wind cold and dampness stagnation pattern of common cold.
ObjectivesTo investigate the efficacy and safety of Hou Gu Mi Xi (HGMX) in patients with nonorganic gastrointestinal disorders (NOGD) from the aspect of dietary therapy.MethodsA randomized, double-blind, parallel, placebo-controlled trial was performed. Patients with NOGD and spleen qi deficiency (SQD) syndrome were randomly assigned into HGMX or placebo group. Each received 30 g/day HGMX or placebo for one year. The outcomes included SQD scores, body weight, body mass index (BMI), gastrin-17, and adverse events (AEs) between HGMX and placebo groups, or subgroups divided by NOGD type or helicobacter pylori (Hp) infection, at the 0th, 2nd, 4th, 8th, 26th, or 52nd weeks’ follow-up.ResultsThe reduction of SQD scale score was found in the HGMX group compared with the placebo group at 4th week (MD=−9.40, 95%CI −18.53 to −0.27, P=0.044), 8th week (MD=−10.07, 95%CI −19.66 to −0.48, P=0.04), 26th week (MD=−12.45, 95%CI −22.31 to −2.59, P=0.014) and 52th week (MD=−17.25, 95%CI −28.53 to −5.97, P=0.003), respectively. In the subgroup analyses, HGMX showed significant efficacy in Hp-negative patients with the detailed reduction of SQD scale score being (MD=−15.20, 95%CI −28.16 to −2.24, P=0.022), (MD=−17.91, 95%CI −31.22 to −4.59, P=0.009) and (MD=−20.38, 95%CI −35.43 to −5.32, P=0.008) at the 8th, 26th and 52nd week, respectively, and in patients with chronic nonatrophic gastritis with the detailed reduction being (MD=−13.02, 95%CI −24.75 to −1.29, P=0.03), (MD=−12.43, 95%CI −24.36 to −0.5, P=0.041) and (MD=−15.90, 95%CI −30.72 to −1.08, P=0.036) at the 2nd, 26th and 52nd week, respectively, and in patients with functional gastrointestinal disease with the reduction being (MD=−18.22, 95%CI −35.75 to −0.69, P=0.042) at the 52nd week. However, no significant efficacy was found in Hp-positive patient at any time. HGMX was not associated with changes in weight, BMI, or gastrin-17. No AEs were reported in the HGMX group.ConclusionsHGMX improves SQD symptoms in patients with NOGD, especially Hp-negative patients, and has a good safety profile.