Romero-Cerecero Ofelia, Islas-Garduño Ana Laura, Zamilpa Alejandro, Pérez-García Ma Dolores, Tortoriello Jaime
Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Morelos, Mexico.
Evid Based Complement Alternat Med. 2018 Sep 27;2018:1716939. doi: 10.1155/2018/1716939. eCollection 2018.
Social anxiety is one of the most common disorders found in the population attending the first level of health care. has been used for many years in Mexican traditional medicine to treat "nervous disorders". A standardized extract of this species has been evaluated in clinical studies that have proven its efficacy and safety in patients with generalized anxiety disorder. In this work, a double-blind clinical trial was carried out, using sertraline as a control. Patients from both sexes (18 to 35 years old) with moderate or severe social anxiety were included. Experimental group was treated daily (orally), for 10 weeks, with an extract from containing 0.374 mg/dose of Galphimine-B (G-B, active compound). Patients in the control group were given sertraline (50 mg) in the same conditions. All patients were evaluated every two weeks. Another assessment was done one month after the end of the administration period. A total of 34 patients was included, 17 in each group. Women were predominant, and the mean age was 25 ± 4.7 years. In patients who received the standardized extract, a significant reduction in anxiety was observed, with a value (in the Brief Social Phobia Scale) of 41.1±10.3 points at the start and 11.2±5.6 points at the end of treatment, while patients treated with sertraline had a value of 37.7±7.3 points at the beginning and 11.1±5.2 points at the end. No significant difference was observed between the treated groups. In a similar way, the health scale showed a gradual and continuous improvement in each of the five evaluations. In conclusion, the 10-week oral administration of standardized extract showed efficacy and safety in patients with social anxiety disorder, without showing a significant difference from patients treated with sertraline.
社交焦虑是在初级卫生保健机构就诊人群中最常见的疾病之一。多年来,它一直被用于墨西哥传统医学治疗“神经紊乱”。该物种的标准化提取物已在临床研究中进行评估,这些研究证明了其在广泛性焦虑症患者中的疗效和安全性。在这项工作中,进行了一项双盲临床试验,使用舍曲林作为对照。纳入了年龄在18至35岁之间、患有中度或重度社交焦虑的男女患者。实验组每天(口服)接受含有0.374毫克/剂量的加菲明-B(G-B,活性化合物)的提取物治疗,为期10周。对照组患者在相同条件下服用舍曲林(50毫克)。所有患者每两周接受一次评估。在给药期结束后一个月进行了另一项评估。共纳入34名患者,每组17名。女性占主导,平均年龄为25±4.7岁。接受标准化提取物治疗的患者焦虑显著降低,治疗开始时(在简短社交恐惧症量表中的)值为41.1±10.3分,治疗结束时为11.2±5.6分,而接受舍曲林治疗的患者开始时的值为37.7±7.3分,结束时为11.1±5.2分。治疗组之间未观察到显著差异。同样,健康量表在五次评估中的每一次都显示出逐渐且持续的改善。总之,对社交焦虑症患者口服标准化提取物10周显示出疗效和安全性,与接受舍曲林治疗的患者相比未显示出显著差异。