Dexa Laboratories of Biomolecular Sciences.
Int J Gen Med. 2011;4:465-76. doi: 10.2147/IJGM.S21053. Epub 2011 Jun 16.
DLBS1442, a proprietary and standardized semipolar bioactive extract of the fruit Phaleria macrocarpa, is preclinically proven to have anti-inflammatory properties. The current clinical study evaluated the efficacy and safety of DLBS1442 in alleviating symptoms of premenstrual syndrome and primary dysmenorrhea.
This was an open study over four menstrual cycles (with two control cycles, followed by two treatment cycles). Women with premenstrual syndrome and/or primary dysmenorrhea, 18-40 years of age, and with a regular menstrual cycle were included in the study. In the treatment cycles, DLBS1442 extract was given as a 100 mg capsule two or three times daily (for those with mild and moderate-to-severe baseline abdominal pain, respectively), for an average of six days, ie, three days before until the end of the first three days of the menstrual period. Throughout all four study cycles, daily self-assessment of symptoms related to premenstrual syndrome was made by each subject using a visual analog scale (VAS). Data were descriptively analyzed and profiled in curves of VAS score versus time point evaluation starting from day 5 before menstruation to day 5 of menstruation.
Twenty-three subjects of mean age 27.35 ± 5.73 years were evaluable for the intention to treat analysis. Most subjects experienced the primary efficacy variable (abdominal pain), peaking on days 1-2 of the menstrual phase, with a mean VAS score of 36.8 ± 24.3 mm and 30.0 ± 29.6 mm, respectively, during control cycles. DLBS1442 markedly reduced VAS scores by 13.76 ± 28.27 mm (37.46%) and 13.28 ± 29.06 mm (44.28%), respectively. Other symptoms of premenstrual syndrome were also markedly alleviated by DLBS1442. Some mild adverse events were observed and resolved by the end of the study.
This preliminary study indicates the effectiveness of DLBS1442 in alleviating primary dysmenorrhea and abdominal pain, as well as other symptoms related to premenstrual syndrome. DLBS1442 was safe and well tolerated in women with premenstrual syndrome and/or dysmenorrhea.
DLBS1442 是一种专有的标准化半极性生物活性提取物，来自 Phaleria macrocarpa 的果实，已在临床前研究中证明具有抗炎特性。目前的临床研究评估了 DLBS1442 缓解经前期综合征和原发性痛经症状的疗效和安全性。
这是一项为期四个月经周期（两个对照周期，随后两个治疗周期）的开放研究。年龄在 18-40 岁之间、月经周期规律的经前期综合征和/或原发性痛经女性纳入本研究。在治疗周期中，DLBS1442 提取物以 100mg 胶囊的形式每天服用两次或三次（分别用于轻度和中度至重度基线腹痛的患者），平均服用六天，即在月经前三天开始直到月经周期的前三天结束。在所有四个研究周期中，每位受试者均使用视觉模拟量表（VAS）每天自行评估与经前期综合征相关的症状。对数据进行描述性分析，并以从月经前五天到月经第五天的 VAS 评分与时间点评估曲线的形式进行分析。
23 名平均年龄为 27.35 ± 5.73 岁的受试者可进行意向治疗分析。大多数受试者经历了主要疗效变量（腹痛），在月经周期的第 1-2 天达到高峰，在对照周期中的平均 VAS 评分为 36.8 ± 24.3mm 和 30.0 ± 29.6mm。DLBS1442 可显著降低 VAS 评分 13.76 ± 28.27mm（37.46%）和 13.28 ± 29.06mm（44.28%）。DLBS1442 还明显缓解了经前期综合征的其他症状。观察到一些轻微的不良反应，并在研究结束时得到解决。
这项初步研究表明，DLBS1442 可有效缓解原发性痛经和腹痛以及与经前期综合征相关的其他症状。DLBS1442 在患有经前期综合征和/或痛经的女性中安全且耐受良好。
