Efficacy and Safety of Plook-fai-tat Formula to Increase Milk Volume in Post-partum Women with Lactation Insufficiency

Abstract

Plook-fai-tat is a Thai traditional herbal medicine formula in Mahachotirat scripture, Thai Traditional Medicine Textbook for Obstetrics and Gynecology diseases, used for augmenting breastmilk production. Plook-fai-tat has been officially included in the National List of Essential Medicines since 2012. The objective of this study was to determine efficacy, safety and patient satisfaction of Plook-fai-tat formula in increasing milk volume in postpartum mothers who have lactation insufficiency. Forty-nine subjects who had normal spontaneous vaginal delivery at term in Sung-noen and Si-kiew Hospitals voluntarily participated in the study. The participants were randomly assigned to receive Plook-fai-tat formula (3 g/day in 4 divided doses, n = 24) or placebo (n = 25). It was found that mean breastmilk volumes increased significantly in both groups within 3 days after start taking the prescribed products (p < 0.001). Mean breastmilk volumes were 51.01 ± 54.97 ml in the Plook-fai-tat formula group and 43.12 ± 40.08 ml in the placebo group: however, these increases were not statistically significant different (p = 0.567). Nevertheless, it was worth noting that in the Plook-fai-tat formula group, there were 6 persons (25%) who had an increased mean breastmilk volume of 110 ml or more, which was significantly higher than that of the placebo group which only 1 person (4%) was found (p < 0.05). No adverse reaction was detected among both groups. The result indicates that the galactogenic effect of Plook-fai-tat formula was not significantly different from that of placebo; however, the proportion of nursing mothers who had an increased breastmilk volume of 110 ml and higher in Plook-fai-tat group was significantly higher than that in the placebo group. This herbal formula is safe as no adverse drug reaction was observed.