Symptomatic treatment of premenstrual syndrome and/or primary dysmenorrhea with DLBS1442, a bioactive extract of Phaleria macrocarpa

Abstract

Background: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.Methods: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.Results: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.Conclusion: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.

Phytochemistry and medicinal properties of Phaleria macrocarpa (Scheff.) Boerl. extracts

“…[7] The bark and fruits are rich in saponins, alkaloids, polyphenolics, phenols, flavanoids, lignans and tannins. [8910] Isolated constituents of fruit include Icariside C3, magniferin, and gallic acid. [1111213] Phalerin was first isolated from leaves of P. macrocarpa as a benzophenone glycoside (3,4,5, trihydroxy-4-methoxy-benzophenone-3-O-β-D-glucoside) by Hartati et al .…”

“…[43] P. macrocarpa is also found to treat primary dysmenorrhea in which the production of leukotrienes and prostaglandins F2-α and E2 is enhanced at a large level and may cause increased uterine smooth muscles tone and contractions causing abdominal cramps. [10] The pericarp and mesocarp extract of fruit have shown moderate anti-inflammatory activity while seed extract has shown weak activity. [2] Cytokines by binding with macrophages up-regulate nitric oxide synthase enzyme which forms NO (nitric oxide) from l-arginine.…”

Review on Phaleria macrocarpa Pharmacological and Phytochemical Properties

“…Research had been done on in-vivo and in-vitro hypercholesterolemia model to determine the effects of Phaleria macrocarpa fruit extracts on blood lipid profile (total cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein) as well as LDL receptor, PCSK9 protein, and mRNA expression [12]. Meanwhile, the work performed on DLBS1245, a Phaleria macrocarpa standardized extract of fresh fruit, revealed the anticancer activities of this plant [13]. Likewise, Phaleria macrocarpa fruits and seeds had shown the existence of important biological activities of the extract in term of anti-microbial, anti-inflammatory and its antioxidant activity [14].…”

1-(2,6-Dihydroxy-4-methoxyphenyl)-2-(4-hydroxyphenyl) Ethanone-Induced Cell Cycle Arrest in G1/G0 in HT-29 Cells Human Colon Adenocarcinoma Cells

“…A compound (referred to as DLBS 1442) from the P. macrocarpa fruit has been shown to be effective in assuaging the effects of primary dysmenorrhoea in addition to abdominal pain and other symptoms related to premenstrual syndrome [8]. …”