Tuesday, 12 December 2017

Re: Effects of Tri-Sura-Phon Supplement on Lipid Profile, Body Mass Index, and Fasting Blood Sugar

Agarwood (Aquilaria crassna, Thymelaeaceae) Martaban Camphor (Cinnamomum parthenoxylon, Lauraceae) Cinnamomum bejolghota, Lauraceae Lipid Profile Date: 11-30-2017 HC# 051756-581 Kuamsub S, Singthong P, Chanthasri W, et al. Improved lipid profile associated with daily consumption of Tri-Sura-Phon in healthy overweight volunteers: An open-label, randomized controlled trial. Evid Based Complement Alternat Med. 2017;2017:2687173. doi: 10.1155/2017/2687173. Tri-Sura-Phon (TSP) is a Thai formulation of powdered, dried wood derived from agarwood (Aquilaria crassna, Thymelaeaceae) wood, Martaban camphor (Cinnamomum parthenoxylon, Lauraceae) wood, and C. bejolghota bark. In traditional Thai medicine, TSP is used as a rejuvenating agent and blood tonic. According to the authors, this is the first clinical study evaluating TSP. The purpose of this single-center, open-label, randomized, placebo-controlled study was to evaluate the effects of TSP tea on fasting blood glucose (FBG), insulin levels, lipid profiles, and liver function. Healthy, overweight men and women (n = 70, aged 20-55 years) participated in this study conducted from July 2013 to March 2014 at the Traditional Thai Medicine Hospital, Prince of Songkla University; Hat Yai, Songkhla, Thailand. Subjects who lived < 5 km from the university were recruited via letter. Included subjects had a body mass index (BMI) of 23-29.9 kg/m2, were in good health, and were willing to fill out the study questionnaires. Excluded subjects met the following criteria: were taking medication or supplements that might affect metabolism or appetite; used weight control therapy or antioxidant products within the last 3 months; had a history of allergic reactions to medications or food; had severe health problems (i.e., hypertension, cardiovascular disease, dyslipidemia, clinical depression, diabetes mellitus, and thyroid diseases); and/or were pregnant and/or lactating. Subjects were randomly assigned to consume TSP or placebo (corn [Zea mays, Poaceae] starch) 2x/day, 20 min before breakfast and dinner, for 8 weeks. TSP was made according to specifications in the Thai Pharmaceutical Textbook. The wood and bark were obtained from Triburi Orsot (Songkla, Thailand), a licensed traditional medical drug store. The wood and bark were powdered and mixed in equal proportions (1:1:1). The plant materials were standardized to their total phenolic and flavonoid contents. A total of 1.25 g of TSP powder was put into teabags. Subjects were instructed to infuse the teabag in 100 mL boiling water for 3 min. No sugar or other sweeteners were permitted. Subjects also received advice on diet, exercise, and lifestyle modification. Compliance was monitored via a daily compliance chart. At baseline, 4 weeks, and 8 weeks, the following were measured: insulin levels, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, albumin, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and gamma-glutamyl transpeptidase (GGT). Subjects recorded in diaries the incidence and severity of symptoms and any adverse effects. Prior to the clinical trial, TSP was evaluated to determine the optimal infusion time. There were no significant differences in color, aroma, taste, and overall acceptability among TSP teas brewed for 1, 3, and 5 min. Since the TSP tea brewed for 3 min yielded significantly higher free radical scavenging activity (P < 0.05) and had slightly higher scores for color and aroma, it was chosen for further study. A total of 61 subjects completed the trial; 9 subjects were excluded for abnormal liver function tests (n = 1) or being lost to follow-up (n = 8). The baseline parameters did not significantly differ between groups (P ≥ 0.05). In the TSP group, triglycerides, total cholesterol, and LDL significantly decreased at week 8 compared with baseline (P = 0.001, P = 0.013, and P = 0.017, respectively) and placebo (P = 0.005 for all). In the TSP group, HDL significantly increased at week 8 compared with baseline (P = 0.005) and placebo (P = 0.005). In contrast, in the placebo group, there were no significant differences compared to baseline in total cholesterol, LDL, or HDL levels, but the triglyceride levels significantly decreased at week 4 only (P = 0.002). Neither group had significant changes in BMI or insulin levels; however, both groups had a significant increase in FBG levels compared to baseline (P value not reported). No adverse events were reported. There were no significant changes in direct bilirubin, AST, ALP, or GGT. The TSP group had significant decreases in albumin and ALP at week 8 compared with baseline (P < 0.001 for both). [Note: The authors state that ALP had no significant changes and then apparently contradict themselves by saying that TSP significantly decreased ALP. It is possible that the authors were referring to ALT showing a significant decrease instead.] The placebo group had significant decreases in albumin and total bilirubin over the course of the study (P < 0.05 for all). The authors conclude TSP tea, 2 cups per day, for 8 weeks safely and effectively improved serum lipid profiles in overweight or obese subjects. The authors hypothesize that the benefits were due to the antioxidant activity of TSP, which is high in flavonoids and polyphenols, represented by favorable changes in study subjects' lipid profiles. More specifically, pro-atherosclerotic LDL-C levels dropped while plaque-inhibiting HDL-C levels increased. Limitations of the study are the small sample size and that the placebo treatment differed from TSP in the appearance of color, odor, and taste. The authors acknowledge that another limitation is the lack of information on diet, exercise, and energy and nutrient intake. Another limitation of the study is that the authors say that it was open-label and placebo-controlled; however, this statement seems to contradict the study's title, as this statement means that subjects could pick if they wanted TSP or placebo. Perhaps a mistake was made in titling the paper "open-label." According to the article, the authors are continuing their research with a long-term study. One of the authors (Chanthasri) was funded by a Natural Product Research Center of Excellence Postgraduate Scholarship; Prince of Songkla University. The research was funded by Grants for a General Researcher, the Annual Income Budget of Prince of Songkla University, and TRF Senior Research Scholar, the Thailand Research Fund (Bangkok, Thailand). —Heather S. Oliff, PhD