Baseline symptom severity and efficacy of Silexan in patients with anxiety disorders: A symptom-based, patient-level analysis of randomized, placebo-controlled trials.

The influence of baseline severity on the efficacy of Silexan, a proprietary essential oil from Lavandula angustifolia, in anxiety disorders has not been investigated in a pooled dataset. We report on an individual patient data analysis of all five double-blind, randomized, placebo-controlled trials with Silexan in anxiety disorders. Eligible participants received Silexan 80 mg/d or placebo for 10 weeks. Analyses were based on the Hamilton Anxiety Rating Scale (HAMA), its psychic and somatic anxiety subscores, and the Clinical Global Impressions (CGI) scale. To correlate baseline severity with outcome, patients were segregated into mild, moderate, and severe cases. Altogether 1,172 patients (Silexan, n = 587; placebo, n = 585) were analyzed. For the HAMA total score, we found a significant association between the score at baseline and the treatment effect of Silexan versus placebo at week 10 (p < 0.001). HAMA items from the somatic domain scored lower at baseline and showed less improvement than items from the psychic domain, particularly in patients with mild or moderate baseline symptoms. For CGI item 2 (global improvement), significant efficacy favoring Silexan were observed in mild, moderate, and severe baseline symptom severity. Although significant improvements were found for all subsets, the more severe the initial symptoms, the greater the treatment effects documented by the HAMA. Overall this analysis confirms that Silexan is an effective treatment option in early or mild stages of anxiety disorder. Given its favorable safety profile, Silexan can thus fill a therapeutic gap in the treatment of (subsyndromal) anxiety disorders.

Benefits and Harms of Edible Vegetable Oils and Fats Fortified with Vitamins A and D as a Public Health Intervention in the General Population: A Systematic Review of Interventions.

This systematic review aims to assess whether edible vegetable oils and fats fortified with vitamin A and/or D are effective and safe in improving vitamin intake and ameliorating deficiency states in the general population. In November 2022, we systematically searched MEDLINE, Cochrane CENTRAL, Scopus, Global Index Medicus, ClinicalTrials.gov, and WHO ICTRP (International Clinical Trials Registry Platform) for randomized controlled trials (RCT) and non-randomized studies of interventions (NRSI) investigating the fortification of edible vegetable oils and fats with either vitamin A or vitamin D or both as compared to the same vegetable oils and/or fats without vitamin A and D fortification or no interventions, in the general population, without age restriction. We assessed the methodological quality of included RCTs using Cochrane's risk of bias tool 2.0 and of NRSIs using ROBINS-I tool. We performed random-effects meta-analysis and assessed certainty of evidence using GRADE. We included eight studies. Available evidence showed no significant effect of fortification with vitamin A on serum retinol levels (RCTs: MD 0.35 µmol/L, 95% CI -0.43 to 1.12; two trials; 514 participants; low-certainty evidence; CCTs: MD 0.31 µmol/L, 95% CI -0.18 to 0.80; two trials; 205 participants; very low-certainty evidence) and on subclinical vitamin A deficiency. Low-certainty evidence showed no effect of vitamin D fortification on serum 25-hydroxy vitamin D concentration (MD 6.59 nmol/L, 95% CI -6.89 to 20.07; one trial; 62 participants). In conclusion, vitamin A-fortified vegetable oils and fats may result in little to no difference in serum retinol levels in general populations. The dose of vitamin A used in the trials may be safe but may not be sufficient to reduce subclinical vitamin A deficiency. Further, the evidence suggests that vitamin D fortification results in little to no difference in serum 25-hydroxy vitamin D concentration. Several aspects of providing fortified oils and fats to the general population as a public health intervention should be further investigated, including optimal fortification dose, effects on vitamin D deficiency and its clinical symptoms and potential adverse effects.

Coconut Oil and Cardiovascular Disease Risk.

PURPOSE OF REVIEW: This narrative review summarizes the current peer-reviewed literature and mechanisms surrounding the cardiovascular health impact of coconut oil. RECENT FINDINGS: No randomized controlled trials (RCTs) and/or prospective cohort studies have investigated the effect or association of coconut oil with cardiovascular disease. Evidence from RCTs indicated that coconut oil seems to have less detrimental effects on total and LDL-cholesterol compared to butter, but not compared to cis-unsaturated vegetable oils, such as safflower, sunflower, or canola oil. The isocaloric replacement (by 1% of energy intake) of carbohydrates with lauric acid (the predominant fatty acid in coconut oil) increased total cholesterol by 0.029 mmol/L (95% CI: 0.014; 0.045), LDL-cholesterol by 0.017 mmol/L (0.003; 0.031), and HDL-cholesterol by 0.019 mmol/L (0.016; 0.023). The current evidence from shorter term RCTs suggests that replacement of coconut oil with cis-unsaturated oils lowers total and LDL-cholesterol, whereas for the association between coconut oil intake and cardiovascular disease, less evidence is available.

An unexpected allergic skin reaction to peppermint oil capsules.

Peppermint oil capsules are prescribed to manage abdominal colic and distension, a common complaint in postcaesarean section patients. Arachis (peanut) oil is contained within one frequently prescribed peppermint formulation: Colpermin. This ingredient is contraindicated in patients with peanut and soya allergy; however, this is not stated in the side effects or contraindications section of the British National Formulary, or present on the medication packaging. A postpartum woman in her early 30s had an unexpected allergic reaction to the capsules, in the form of a generalised body rash, fortunately with no anaphylactic features. The patient reported the same reaction to soya in the past. After review of the patient's clinical and medication history, Colpermin capsules were thought to be responsible for the patient's symptoms. This case highlights the necessity for clearer documentation in prescribing formularies and on medication packaging to ensure patient safety.

Chemical characterization, anti-nociceptive and anti-inflammatory activities of Plukenetia conophora seed oil in experimental rodent models.

ETHNOPHARMACOLOGICAL RELEVANCE: The seed of the African walnut, Plukenetia conophora Mull.-Arg is well-known for its nutritional and medicinal values. The seed oil is widely used in massages to relieve pain, as nerve tonic and to enhance sexual performance. OBJECTIVE: The study aimed at investigating the chemical profile, antinociceptive and anti-inflammatory activities of P. conophora oil (PCO). METHODS: Seed oil of P. conophora was characterized using Gas-Liquid Chromatographic method (GC-MS) and oral acute toxicity evaluated at 2000 mg/kg. Antinociceptive effects were evaluated in hot plate, acetic acid and formalin-induced paw licking tests. The anti-inflammatory effects were investigated in egg albumin and carrageenan-, formalin and complete Freund adjuvant (CFA)-induced paw oedema models. The levels of pro-inflammatory cytokines in the fluid exudates were also evaluated in carrageenan air pouch model. RESULTS: PCO exhibited high content of alpha linolenic acid (ALA). No toxicity was observed at 2000 mg/kg of PCO. PCO (50-200 mg/kg) demonstrated significant anti-nociceptive activity in pain models. PCO exhibited anti-inflammatory activity against oedema formation by phlogistic agents. The increased inflammatory oedema and oxidative stress in CFA-treated rats were also attenuated by PCO. The PCO (100 and 200 mg/kg) significantly reduced the levels of TNF-α (59.3% and 85.2%) and IL-6 (27.5% and 72.5%) in carrageenan-induced air pouch model. CONCLUSION: The results of this study suggest that ALA-rich seed oil of Plukenetia conophora demonstrated anti-nociceptive and anti-inflammatory activities via inhibition of pro-inflammatory cytokines and oxidative stress, lending supportive evidences for its use in painful inflammatory conditions.

Hospital change to mixed lipid emulsion from soybean oil-based lipid emulsion for parenteral nutrition in hospitalized and critically ill adults improves outcomes: a pre-post-comparative study.

INTRODUCTION: Early data suggest use of a mixed lipid emulsion (LE) with a soybean oil reduction strategy in parenteral nutrition (PN) may improve clinical outcomes. Duke University Hospital made a full switch to a Soybean oil/MCT/Olive/Fish Oil lipid (4-OLE) from pure soybean oil-based LE (Intralipid, Baxter Inc) in May 2017. Since 4-OLE has limited evidence related to its effects on clinical outcome parameters in US hospitals, evidence for clinical benefits of switching to 4-OLE is needed. Therefore, we examined the clinical utility of a hospital-wide switch to 4-OLE and its effect on patient outcomes. METHODS: We conducted a single-center retrospective cohort study among adult patients (> 18 years) requiring PN from 2016 to 2019. Our primary exposure was treatment period (1-year pre-4-OLE switch versus 2-year post). We used multivariable regression models to examine our primary outcomes, the association of treatment period with hospital length of stay (LOS), and secondary outcomes liver function, infections, and ICU LOS. Analyses were stratified into critically ill and entire adult cohort. RESULTS: We identified 1200 adults hospitalized patients. 28% of PN patients (n = 341) were treated pre-4-OLE switch and 72% post-4-OLE (n = 859). In the adult cohort, 4-OLE was associated with shorter hospital LOS (IRR 0.97, 95% CI 0.95-0.99, p = 0.039). The ICU cohort included 447 subjects, of which 25% (n = 110) were treated pre-4-OLE switch and 75% (n = 337) were post-switch. ICU patients receiving 4-OLE were associated with shorter hospital LOS (IRR 0.91, 95% CI 0.87-0.93, p < 0.0001), as well as a shorter ICU LOS (IRR 0.90, 95% CI 0.82-0.99, p = 0.036). 4-OLE ICU patients also had a significantly lower delta total bilirubin (- 1.6, 95% CI - 2.8 to - 0.2, p = 0.021) and reduced urinary tract infection (UTI) rates (OR 0.50, 95% CI 0.26-0.96, p = 0.038). There were no associations in AST, ALT, or total bilirubin in ICU and all adult patients. CONCLUSION: 4-OLE was successfully implemented and reduced soybean oil LE exposure in a large academic hospital setting. The introduction of 4-OLE was associated with reduced LOS, UTI rates, and mitigated hepatic dysfunction in critically ill patients. Overall, these findings prove a switch to a soybean oil-LE sparing strategy using 4-OLE is feasible and safe and is associated with improved clinical outcomes in adult PN patients.

Positive association between dietary exposure to polybrominated diphenyl ethers and breast cancer risk in the French E3N cohort: The role of vegetable oil consumption.

Exposure to endocrine-disrupting chemicals, like Polybrominated diphenyl ethers (PBDEs), is suspected of playing a role in the occurrence of breast cancer. Moreover, there is growing evidence that food chemical contaminants, especially lipophilic ones such as PBDEs, could interact with different components of the diet. The objective of the present study was to assess the association between dietary intake of PBDEs and breast cancer risk in the French E3N cohort study, and to investigate the potential modification of this association by vegetable oil consumption. The study included 67879 women. Intakes of eight PBDEs were estimated using food consumption data from a validated semi-quantitative food frequency questionnaire, and food contamination levels measured by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES). Cox proportional hazards models were used to estimate Hazard Ratios (HR) and 95% Confidence Intervals (CI) for the association between total PBDEs dietary intake and breast cancer risk. Interaction measures for vegetable oil consumption were estimated on both additive and multiplicative scales. The women were followed for a maximum of 21.4 years, and 5 686 developed an incident breast cancer. A positive linear trend was highlighted between dietary intake of PBDEs in quintile groups and breast cancer risk, borderline with statistical significance (p-trend = 0.06, HRQ5vsQ1 and 95% CI: 1.09 [0.99;1.20]). Interaction measures for vegetable oil consumption were significant in both additive and multiplicative scales. Higher effect sizes of the association were highlighted in high consumers of vegetable oil, i.e. ≥4.6 g/day (HRQ5vsQ1 and 95% CI: 1.23 [1.08; 1.40]), and almost no effect were found in low consumers (HRQ5vsQ1 and 95% CI: 0.97 [0.86; 1.10]). Highlighting such interactions between nutrients and chemicals is crucial to develop efficient dietary recommendations to limit the negative health effects associated with exposure to food chemical contaminants.

Coconut, Castor, and Argan Oil for Hair in Skin of Color Patients: A Systematic Review.

Coconut, castor, and argan oils are popular commercial hair oils culturally rooted in current and historical Indian and African heritages. Dermatologists treating hair and scalp conditions often face challenging patient questions of whether over-the-counter hair oils should be used. This is particularly challenging given the deeply rooted cultural practices of some skin of color patients. As a result, many dermatologists recommend patients to continue using hair oils not based on clinical efficacy but rather lack of foreseeable side effects. We analyzed the literature to investigate claims to substantiate whether these hair oils can improve hair growth, hair quality, and treat infestation clinically. Based on 22 articles that met inclusion criteria, coconut oil has been shown to treat both brittle hair and hair infestation clinically, with limited evidence regarding its impact on hair growth. There is weaker evidence for castor oil improving hair quality by increasing hair luster, and no strong evidence supporting its use for hair growth or treatment of infestation. Argan oil does not have any significant evidence supporting its use to improve hair growth, quality, or treatment of infestation. J Drugs Dermatol. 2022;21(7):751-757. doi:10.36849/JDD.6972.

Misinformation in nutrition through the case of coconut oil: An online before-and-after study.

BACKGROUND AND AIMS: Despite recent scientific evidence indicating absence of cardiometabolic benefit resulting from coconut oil intake, its consumption has increased in recent years, which can be attributed to a promotion of its use on social networks. We evaluated the patterns, reasons and beliefs related to coconut oil consumption and its perceived benefits in an online survey of a population in southern Brazil. METHODS AND RESULTS: We conducted a before-and-after study using an 11-item online questionnaire that evaluated coconut oil consumption. In the same survey, participants who consumed coconut oil received an intervention to increase literacy about the health effects of coconut oil intake. We obtained 3160 valid responses. Among participants who consumed coconut oil (59.1%), 82.5% considered it healthy and 65.4% used it at least once a month. 81.2% coconut oil consumers did not observe any health improvements. After being exposed to the conclusions of a meta-analysis showing that coconut oil does not show superior health benefits when compared to other oils and fats, 73.5% of those who considered coconut oil healthy did not change their opinion. Among individuals who did not consume coconut oil, 47.6% considered it expensive and 11.6% deemed it unhealthy. CONCLUSIONS: Coconut oil consumption is motivated by the responders' own beliefs in its supposed health benefits, despite what scientific research demonstrates. This highlights the difficulty in deconstructing inappropriate concepts of healthy diets that are disseminated in society.

Association of Early Pubertal Onset in Female Rats With Inhalation of Lavender Oil.

BACKGROUND: Central precocious puberty (CPP) is caused by early activation of the hypothalamic-pituitary-gonadal axis but its major cause remains unclear. Studies have indicated an association between chronic environmental exposure to endocrine-disrupting chemicals and pubertal onset. Essential oil is widely used in homes worldwide for relief of respiratory symptoms, stress, and/or sleep disturbance. METHODS: To evaluate this association, we compared the hormone levels and timing of vaginal opening (VO) in female rats exposed to lavender oil (LO) through different routes (study groups: control, LO nasal spray [LS], and indoor exposure to LO [LE]) during the prepubertal period. The body weights of the animals were also compared every 3 days until the day of VO, at which time gonadotropin levels and internal organ weights were assessed. RESULTS: The LS group showed early VO at 33.8 ± 1.8 days compared with the control (38.4 ± 2.9 days) and LE (36.6 ± 1.5 days) groups. Additionally, luteinizing hormone levels were significantly higher in the LE and LS groups than those in the control group. Body weights did not differ significantly among the groups. CONCLUSION: Inhalation exposure to an exogenic simulant during the prepubertal period might trigger early pubertal onset in female rats. Further evaluation of exposure to other endocrine-disrupting chemicals capable of inducing CPP through the skin, orally, and/or nasally is warranted.

African oils in dermatology.

Plant and seed oils have been used for centuries and possibly millennia in Nigeria and Africa for the maintenance of healthy skin and the traditional treatment of skin disorders. In recent times, some of these oils have regained popularity due to their availability and affordability coupled with concerns about the side effects of commercially processed skin care products. This is to assess the chemical properties, current knowledge, source of procurement, indications for topical use, benefits, and possible adverse effects of six plant oils and one animal fat commonly used in Nigeria. This is a literature review and interview with traditional healers and alternative health practitioners to document the traditional, medical, cosmetics, and other usage of oils for skin and scalp care in the African context. Literature review was done on the biochemical and pharmacological properties of each of the seven oils. Searches were made from PubMed, African Journal online, Medline, and Google scholar. Medical subject heading terms used in the search include shea butter, coconut oil, palm kernel oil, palm oil, soy oil, Baobab oil, and python oil. Plant and seed oils used locally in Nigeria and other African countries for skin care and treatment have several benefits due to the constituents of the plant oils (free fatty acids, triglycerides, ceramides, phospholipids, vitamins and antioxidants) which have been shown to promote healthy skin barrier function, wound healing and have anti-inflammatory and antimicrobial effects. They are however not without adverse effects, which may be mainly due to processing and storage hygiene. Further studies are required on these oils in view of their potential in the development of novel skincare products and dermatological therapies.

Pumpkin seed oil (Cucurbita pepo) versus tamsulosin for benign prostatic hyperplasia symptom relief: a single-blind randomized clinical trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is very common in aging men. We aimed to compare the effects of tamsulosin and pumpkin (Cucurbita pepo) seed oil on BPH symptoms. METHODS: This single-blind randomized clinical trial included patients with BPH aged ≥ 50 years referred to the Urology Clinic of Shahid Beheshti Hospital, Hamadan, Iran, from August 23, 2019 to February 19, 2020. Patients were randomized into two groups. One group received 0.4 mg tamsulosin every night at bedtime and the other received 360 mg pumpkin seed oil twice a day. Patients' age, weight, height, and body mass index (BMI) were recorded. The International Prostate Symptom Score (IPSS) was filled out by the patients at baseline and then 1 month and 3 months after the initiation of treatment. The BPH-associated quality of life (QoL), serum prostate-specific antigen, prostate and postvoid residual volume, and maximum urine flow were also assessed at baseline and 3 months later. Drug side effects were also noted. RESULTS: Of the 73 patients included in this study with a mean age of 63.59 ± 7.04 years, 34 were in the tamsulosin group and 39 in the pupkin seed oil group. Patients were comparable with respect to age, weight, height, BMI, and baseline principal variables in both groups. Also, there was no significant difference between groups in terms of principal variables at any time point. However, there was a significant decrease in IPSS and a significant improvement in QoL in both groups. Although the decrease in IPSS from baseline to 1 month and 3 months was significantly higher in the tamsulosin group compared to the pumpkin group (P = 0.048 and P = 0.020, respectively), the decrease in IPSS from 1 to 3 months was similar (P = 0.728). None of the patients in the pumpkin group experienced drug side effects, while dizziness (5.9%), headache (2.9%), retrograde ejaculation (2.9%), and erythema with pruritus occurred in the tamsulosin group. CONCLUSIONS: Pumpkin (Cucurbita pepo) seed oil relieved BPH symptoms with no side effects, but was not as effective as tamsulosin. Further studies are required to confirm the role of pumpkin seed oil as an option for the treatment of BPH symptoms. Trial registration Iranian Registry of Clinical Trials, IRCT20120215009014N340. Registered 19.02.2020. Retrospectively registered, https://en.irct.ir/trial/45335 .

Effects of Some Insecticides (Deltamethrin and Malathion) and Lemongrass Oil on Fruit Fly (Drosophila melanogaster).

<b>Background and Objective:</b> The continuous use of pesticides in the ecosystem is of great concern, as some of them are highly stable and impact non-target organisms. The effect was tested of different concentrations of insecticides such as (Deltamethrin and Malathion) and natural products, Including, lemongrass oil on Fruit Fly (<i>Drosophila melanogaster</i>), to calculate the concentration at which the highest mortality occurred and death half the number of individuals after 96 hrs, as well as calculating the half-lethal time for individuals. <b>Materials and Methods:</b> This study, which evaluated the toxicity of five different concentrations (0.75, 1.00, 1.25, 1.50 and 1.75 mg L¹) of Malathion, (0.05, 0.10, 0.21, 0.53 and 1.48 mg L¹) of Deltamethrin and lemongrass oil (0.25, 0.50, 0.75, 1.00 and 1.50 mg L¹) on the insect of <i>Drosophila melanogaster</i> after 96 hrs of treatment. <b>Results:</b> From the results of this study, the concentration (LC₅₀= 2.938 mg L¹) of Malathion leads to kills half of the individuals, compared to Deltamethrin a higher concentration (LC₅₀= 4.8673 mg L¹) that leads to killing half of the individuals. While lemongrass oil the concentration (LC₅₀= 9.7478 mg L¹) leads to kills half of individuals. Also, when used Deltamethrin it takes (LT₅₀= 660.277) hours to kill half of the individuals compared to Malathion, which takes approximately (LT₅₀ = 321.862) hours to death half of the individuals. But lemongrass oil (LT₅₀= 819.745) hours to kill half of the individuals. <b>Conclusion:</b> In conclusion, the lemon plant and its components have excellent potential for being used in the control of <i>Drosophila melanogaster</i>, which had an effective role in biological control.

Oral gel loaded with penciclovir-lavender oil nanoemulsion to enhance bioavailability and alleviate pain associated with herpes labialis.

Herpes labialis, caused by herpes simplex virus type 1, is usually characterized by painful skin or mucosal lesions. Penciclovir (PV) tablets are found to be effective against herpes labialis but suffer from poor oral bioavailability. This study aimed to combine the benefits of PV and lavender oil (LO), which exhibits anesthetic activity, in the form of a self-nanoemulsifying drug delivery system (SNEDDS) for the treatment of herpes labialis. Toward this purpose, LO (oil), Labrasol:Labrafil M1944 CS in the ratio of 6:4 (surfactant mixture), and Lauroglycol-FCC (co-surfactant, selected based on the solubility of PV) were evaluated as the independent factors using a distance quadratic mixture design. The formulation was optimized for the minimum globule size and maximum stability index and was determined to contain 14% LO, 40.5% Labrasol:Labrafil 1944 (6:4), and 45.5% Lauroglycol-FCC. The optimized PV-LO-SNEDDS was embedded in chitosan hydrogel and the resulting formulations coded by (O3) were prepared and evaluated. The rheological studies demonstrated a combined pseudoplastic and thixotropic behavior with the highest flux of PV permeation across sheep buccal mucosa. Compared to a marketed 1% PV cream, the O3 formulation exhibited a significantly higher and sustained PV release, nearly twice the PV permeability, and a relative bioavailability of 180%. Overall, results confirm that the O3 formulation can provide an efficient delivery system for PV to reach oral mucosa and subsequent prolonged PV release. Thus, the PV-LO-SNEDDS embedded oral gel is promising and can be further evaluated in clinical settings to establish its therapeutic use in herpes labialis.