Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China.
Chin J Integr Med. 2013 Jul;19(7):498-504. doi: 10.1007/s11655-013-1503-x. Epub 2013 Jul 2.
To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen (Pi) and Stomach (Wei) deficiency-cold syndrome.
A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia (FD) of Spleen-deficiency and qi-stagnation syndrome (162 cases) were randomly assigned to groups given Chinese herbal medicine (CHM) Gastrosis No.1 compound or placebo in a 2:1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores (measured by total dyspepsia symptom scale and single dyspepsia symptom scale) and syndromes of traditional Chinese medicine score (measured by traditional Chinese medicine syndrome scale). The outcomes were noted at weeks 0, 4 and 8.
Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators (P <0.01), and also showed improvement in syndromes of traditional Chinese medicine score (P <0.01). No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values.
CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome.
评价胃舒 1 号复方治疗脾胃虚寒型功能性消化不良的疗效和安全性。
采用随机、双盲、安慰剂对照的多中心临床试验方法，选择脾胃虚寒证功能性消化不良患者 162 例，按 2∶1 随机分为中药组（胃舒 1 号复方）和安慰剂组，疗程 4 周，随访 4 周。观察两组患者治疗前后的中医证候疗效、中医证候积分、总体消化不良症状积分和单项消化不良症状积分的变化。
与安慰剂组比较，中药组患者的中医证候疗效、中医证候积分、总体消化不良症状积分和单项消化不良症状积分改善更为明显（P＜0.01），且未见明显不良反应。
胃舒 1 号复方治疗脾胃虚寒型功能性消化不良疗效确切，安全性良好。
