Worldwide increase in numbers of obese women among all populations and age groups has resulted in a significant increase risk in cardiovascular related mortality and morbidity. Obesity in women is associated with elevated risk of hypertension, metabolic syndrome, dyslipidemia, polycystic ovarian and systematic inflammation. Obesity has been introduced as the cause of many female cancers such as endometrial, postmenopausal breast cancer, also colon and kidney cancer. Female obesity occurs as result of many biological, hormonal and behavioral patterns (Kornstein & Clayton, 2010). Apparently, the endocrine system plays major role in obesity, as fat oxidation in women appears to be promoted by estrogen (D’Eon et al., 2015). Decrease in estrogen has been linked to changes in fat redistribution pattern as well as to insulin and leptin resistance (Azarbad & Gonder-Frederick, 2010). Reduced estrogen also contributes to dyslipidemia, elevated blood pressure, endothelial dysfunction, and vascular inflammation (Kornstein & Clayton, 2010). All these effects jointly cause in increased risk of obesity and cardiovascular disease. Obesity is associated with hyperlipidemia and characterized by decreased levels of HDL, increased levels of LDL, hypertriglyceridemia, and hypercholesterol (Jung & Choi, 2014). Currently, the use of available drugs in the market is costly and not devoid of side effects. The need for the replacement of current drugs, has turned sufferers’ attention to natural product as a potential source for a more effective and safer anti-obesity drugs alternative.
Labisia pumila var. alata (LPva) (Primulaceae) is a plant commonly found in Southeast Asia and known as ‘kacip fatimah’. It has been used traditionally for maintenance of general health and vitality of female reproductive system. It has been a remedy for regulating menstrual disorders, postpartum complications, pre and post-menopausal symptoms as well as weight management (Chua, Lee, Abdullah, & Sarmidi, 2012; Karimi, Jaafar, & Ghasemzadeh, 2016; Manda et al., 2014; Nurdiana et al., 2016; Samad 2018). LPva has been shown to exhibit pharmacological properties such as anti-photoaging(Choi et al., 2010), antioxidant(Fadlina Chany Saputri, 2011; Ibrahim & Jaafar, 2011; Karimi et al., 2016; Norhaiza, Maziah, & Hakiman, 2009), anti-cancer(Karimi et al., 2016), anti-inflammatory (Sanusi, Ab Shukor, & Sulaiman, 2013), antimicrobial and antifungal (Fazliana et al., 2011; Ibrahim, Jaafar, Karimi, & Ghasemzadeh, 2012; Karimi, Jaafar, & Ahmad, 2011), cardioprotective (Al-Wahaibi, Wan Nazaimoon, Norsyam, Farihah, & Azian, 2008; Dianita, Jantan, Amran, & Jalil, 2015), upregulation T helper1 cells (Pandey, Bani, Sangwan, & Koul, 2010), selective inhibition of CYP2C isoforms (Pan et al., 2012), anti-stress with adaptogenic potential (Kour et al., 2010). LPva regulates metabolism via regulation of insulin sensitivity and lipid profile by estrogenic effect, evidenced by increased uterus weight (Mannerås et al., 2010). Another study confirmed such an effect showing improved serum lipid profiles and modulation of serum antioxidants (Dianita, Jantan, Jalil, & Amran, 2016). The extract and its isolated active compound, Gallic acid, showed suppressed formation of fat droplets and triglyceride accumulation. In the study, gallic acids induced anti-obesity effect via inhibition of leptin secretion, triglyceride, LDL, VLDL, and promotion of HDL(Pandey, 2014). LPva extract consumption improved lipid profiles of pre- and postmenopausal women by regulation of total cholesterol as well as attenuating the effects of oxidative stress and inflammation. The consumption of the extract is assumed to be safe for postmenopausal women (Annie, Dale, Azreena, & Malkanthi, 2014).
There is still very little information or clinical data on the safety of LPva for human consumption and medical applications. In a recent animal safety study, no treatment related and mortality was reported in response to sub-acute oral toxicity aqueous extract of LPva (50, 250, 500, and 1000 mg/kg), however there was some toxicological concerns, evidenced by histopathological changes. These findings may suggest that aqueous extracts of LPva up to 1000 mg/kg/day statistically did not show any significant teratogenic effects in rats however it did dose-dependently affect the maternal body weight. However, the corrected maternal body weights were slightly higher in animals receiving low dose extracts (2 mg/kg/day) (Fuad, Sulaiman, & Islam, 2005). Another study reported aqueous extract of LPva posed no significant toxic effect, when tested on the estrous cycle, reproductive performance, post-natal growth and offspring survival of rats (Ezumi, Siti Amrah, Suhaimi, & Mohsin, 2007). Subcutaneous administration of petroleum-ether extract of LPva (0.025, 0.05, and 0.1 mg/ml) induced organ toxicity evidenced by degeneration in sinusoid area in liver and glomerulonephritis and nephrosis of the kidney (Effendy, Siti- Nurtahirah, & Hussin, 2006). Leaves extract of LPva contain flavonoids such as quercetin, myricetin, kaempferol, naringin, rutin, apigenin, anthocyanins, catechin, epigallocatechin and anthocyanins (Jaafar, Ibrahim, & Karimi, 2012; Karimi & Jaafar, 2011; Karimi et al., 2011; Norhaiza et al., 2009; Suan Chua et al., 2011), phenolic acids, salicylic acid, syringic acid, vanillic acid, protocatechin acid, gallic acid, coumaric acid, caffeic acid, chlorogenic acid, and pyrogallol, ascorbic acid and ß-carotene (Karimi et al., 2011; Norhaiza et al., 2009),(Karimi & Jaafar, 2011; Suan Chua et al., 2011) saponins (Karimi et al., 2011),(Avula, Wang, Ali, Smillie, & Khan, 2011), and fatty acid (Karimi, Ze Jaafar, Ghasemzadeh, & Ebrahimi, 2015).
The present study assessed the responses of a single female subject to 40 days intake of Labeesity® 125mg, Labisia pumila standardized extract. The specific goals were to evaluate the safety and effect of test sample on weight management and fatigue. Patients’ testimonies provided by the manufacturer indicate that the consumption of the standardized extracts in capsule form was associated with reports of general wellbeing, body weight and fat loss. Nevertheless, caution on interpreting the results should be exercised, as randomized, placebo-controlled clinical trials have not been carried out. There were also no records of any safety data such as blood test results measuring effects on liver function and renal function.