NICEVIVA
MONOGRAPH SPEC LATEST 2024

Evening Primrose Oil (PMS)

WOMEN HEALTH · Evidence Monograph

Evening Primrose Oil (PMS) is an evidence-graded women health monograph evaluated across 19 peer-reviewed PubMed studies (1 meta-analyses, 3 systematic reviews, and 6 randomized controlled trials, encompassing n = 1,086 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 19 Studies
Meta-Analyses · Reviews 1 Meta · 3 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (9 Double-Blind)
Cumulative Participants n = 1,086
Reported Trial Dosages 400 mg · 600 mg · 351 mg
Trial Duration Range 2 weeks · 8 weeks · 12 weeks
Reading Time ~10 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 19 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (400 mg · 600 mg · 351 mg) over a structured 2 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
With Breakfast or Lunch
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary women health clinical efficacy (19 PubMed studies)
Quantitative biomarker & outcome analysis (13 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 9 double-blind)
Systematic review & meta-analysis synthesis (1 meta-analyses · 3 reviews)
01

What Is Evening Primrose Oil (PMS) & Why Does Form Matter?

Evening Primrose Oil (PMS) is classified under WOMEN HEALTH and has been investigated across 19 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (400 mg, 600 mg, 351 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Evening Primrose Oil (PMS) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Evening Primrose Oil (PMS) acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Evening Primrose Oil (PMS) an overall evidence rating of GRADE High (4.0 / 4.0) based on 19 PubMed studies: 1 meta-analyses, 3 systematic reviews, and 6 randomized controlled trials (9 double-blind, n = 1,086 total participants).

Representative peer-reviewed findings include: • PMID:21171936 (2011) — "Herbal treatments for alleviating premenstrual symptoms: a systematic review." (None of the herbs was associated with major health risks, although the reduced number of tested patients does not allow definitive conclusions on safety.) • PMID:19923637 (2009) — "Herbs, vitamins and minerals in the treatment of premenstrual syndrome: a systematic review." (CONCLUSION: Only calcium had good quality evidence to support its use in PMS.) • PMID:19454075 (2007) — "Premenstrual syndrome." (CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, alprazolam, bright light therapy, buspirone, chiropractic manipulation, clomipramine, cognitive behavioural therapy, danazol, endome)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 400 mg · 600 mg · 351 mg · 510 mg/day over 2 weeks · 8 weeks · 12 weeks · 9 months. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Evening Primrose Oil (PMS), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (400 mg · 600 mg · 351 mg) and re-evaluate efficacy after 2 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (19 Studies) · 13 Quantitative Analyses

01
SYSTEMATIC REVIEW Journal of psychosomatic obstetrics and gynaecology (2011) PMID: 21171936 ↗
Herbal treatments for alleviating premenstrual symptoms: a systematic review.
Clinical Trial Synthesis 2011 Meta-Analysis published in Journal of psychosomatic obstetrics and gynaecology involving n = 500 participants. Key conclusion: None of the herbs was associated with major health risks, although the reduced number of tested patients does not allow definitive conclusions on safety.
View Original PubMed Abstract ↓

Premenstrual syndrome (PMS) is a condition of cyclical and recurrent physical and psychological discomfort occurring 1 to 2 weeks before menstrual period. More severe psychological symptoms have been described for the premenstrual dysphoric disorder (PMDD). No single treatment is universally recognised as effective and many patients often turn to therapeutic approaches outside of conventional medicine. This systematic review is aimed at analysing the effects of herb remedies in the above conditions. Systematic literature searches were performed in electronic databases, covering the period January 1980 to September 2010. Randomised controlled clinical trials (RCTs) were included. Papers quality was evaluated with the Jadad' scale. A further evaluation of PMS/PMDD diagnostic criteria was also done. Of 102 articles identified, 17 RCTs were eligible and 10 of them were included. The heterogeneity of population included, study design and outcome presentation refrained from a meta-analysis. Vitex agnus castus was the more investigated remedy (four trials, about 500 women), and it was reported to consistently ameliorate PMS better than placebo. Single trials also support the use of either Gingko biloba or Crocus sativus. On the contrary, neither evening primrose oil nor St. John's Wort show an effect different than placebo. None of the herbs was associated with major health risks, although the reduced number of tested patients does not allow definitive conclusions on safety. Some herb remedies seem useful for the treatment of PMS. However, more RCTs are required to account for the heterogeneity of the syndrome.

02
SYSTEMATIC REVIEW The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique (2009) PMID: 19923637 ↗
Herbs, vitamins and minerals in the treatment of premenstrual syndrome: a systematic review.
Clinical Trial Synthesis 2009 Meta-Analysis published in The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique. Key conclusion: CONCLUSION: Only calcium had good quality evidence to support its use in PMS.
View Original PubMed Abstract ↓

BACKGROUND: As many women experiencing symptoms of premenstrual syndrome (PMS) seek relief from natural products (NP), health care providers should have quality information available to aid women in making evidence-based decisions regarding use of these products. OBJECTIVE: To identify herbs, vitamins and minerals advocated for the treatment of PMS and/or PMDD and to systematically review evidence from randomized controlled trials (RCTs) to determine their efficacy in reducing severity of PMS/PMDD symptoms. METHODS: Searches were conducted from inception to April 2008 in Clinical Evidence, The Cochrane Library, Embase, IBID, IPA, Mayoclinic, Medscape, MEDLINE Plus, Natural Medicines Comprehensive Database and the Internet to identify RCTs of herbs, vitamins or minerals advocated for PMS. Bibliographies of articles were also examined. Included studies were published in English or French. Studies were excluded if patient satisfaction was the sole outcome measure or if the comparator was not placebo or recognized therapy. RESULTS: Sixty-two herbs, vitamins and minerals were identified for which claims of benefit for PMS were made, with RCT evidence found for only 10. Heterogeneity of length of trials, specific products and doses, and outcome measures precluded meta-analysis for any NP. Data supports the use of calcium for PMS, and suggests that chasteberry and vitamin B6 may be effective. Preliminary data shows some benefit with ginkgo, magnesium pyrrolidone, saffron, St. John's Wort, soy and vitamin E. No evidence of benefit with evening primrose oil or magnesium oxide was found. CONCLUSION: Only calcium had good quality evidence to support its use in PMS. Further research is needed, using RCTs of adequate length, sufficient sample size, well-characterized products and measuring the effect on severity of individual PMS symptoms.

03
CLINICAL STUDY BMJ clinical evidence (2007) PMID: 19454075 ↗
Premenstrual syndrome.
Clinical Trial Synthesis 2007 Systematic Review published in BMJ clinical evidence. Key conclusion: CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, alprazolam, bright light therapy, buspirone, chiropractic manipulation, clomipramine, cognitive behavioural therapy, danazol, endome
View Original PubMed Abstract ↓

INTRODUCTION: Premenstrual symptoms occur in 95% of women of reproductive age. Severe, debilitating symptoms (PMS) occur in about 5% of those women. There is no consensus on how symptom severity should be assessed, which has led to a wide variety of symptoms scales, making it difficult to synthesise data on treatment efficacy. The cyclical nature of the condition also makes it difficult to conduct RCTs. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of drug treatments; hormonal treatments; psychological interventions; physical therapies; dietary supplements; and surgical treatments in women with premenstrual syndrome? We searched: Medline, Embase, The Cochrane Library and other important databases up to November 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 52 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, alprazolam, bright light therapy, buspirone, chiropractic manipulation, clomipramine, cognitive behavioural therapy, danazol, endometrial ablation, evening primrose oil, exercise, gonadorelin analogues, hysterectomy, laparoscopic bilateral oophorectomy, magnesium supplements, metolazone, non-steroidal anti-inflammatory drugs, oestrogens, oral contraceptives, progesterone, progestogens, pyridoxine, reflexology, relaxation, selective serotonin reuptake inhibitors, spironolactone, tibolone.

04
SYSTEMATIC REVIEW Menopause (New York, N.Y.) (2003) PMID: 14501609 ↗
A systematic review of herbal medicinal products for the treatment of menopausal symptoms.
Clinical Trial Synthesis 2003 Systematic Review published in Menopause (New York, N.Y.). Key conclusion: CONCLUSIONS: There is no convincing evidence for any herbal medical product in the treatment of menopausal symptoms.
View Original PubMed Abstract ↓

OBJECTIVE: Many women have turned to complementary and alternative medicines for relief from their menopausal symptoms. The prevalence of herbal medicinal product use among menopausal women highlights the need for investigation into these interventions. The aim of this study was to evaluate the benefit of herbal medicinal products for the treatment of menopausal symptoms by performing a systematic review of randomized clinical trials. DESIGN: Literature searches of four computerized databases were done to identify randomized clinical trials of herbal medicinal products for the treatment of menopausal symptoms. Manufacturers of herbal products were contacted, and our own files were also searched. There were no restrictions on the language of publication. Trials were considered if the outcome measures related to the physical or psychological impact of menopause, whether by compendium scores, questionnaires, or women's symptom diaries, excluding studies describing artificially induced menopause. This review was not concerned with biochemical or pathological data. RESULTS: Eighteen randomized clinical trials that fit our criteria were identified. These studies investigated black cohosh (n = 4), red clover (n = 4), kava (n = 3), dong quai (n = 1), evening primrose oil (n = 1), ginseng (n = 1), and combination products (n = 4). Trial quality was generally good, with 16 of 18 studies scoring 3 or more (maximum 5) on the Jadad Scale. CONCLUSIONS: There is no convincing evidence for any herbal medical product in the treatment of menopausal symptoms. However, the evidence for black cohosh is promising, albeit limited by the poor methodology of the trials. The studies involving red clover suggest it may be of benefit for more severe menopausal symptoms. There is some evidence for the use of kava, but safety concerns mean this herbal product is not a therapeutic option at present. The evidence is inconclusive for the other herbal medicinal products reviewed.

05
META-ANALYSIS Allergy (2024) PMID: 38783644 ↗
A systematic review and meta-analysis of nutritional and dietary interventions in randomized controlled trials for skin symptoms in children with atopic dermatitis and without food allergy: An EAACI task force report.
Clinical Trial Synthesis 2024 Meta-Analysis published in Allergy. Key conclusion: A meta-analysis of 20 RCTs assessing probiotics, alone or combined with prebiotics, revealed a significant reduction in SCORAD scores, suggesting a consistent trend in alleviating AD symptoms in children without food allergies.
View Original PubMed Abstract ↓

This systematic review and meta-analysis aimed to consolidate evidence on dietary interventions for atopic eczema/dermatitis (AD) skin symptoms in children without food allergies, following PRISMA 2020 guidelines. Systematic review updates were conducted in May 2022 and June 2023, focusing on randomized placebo-controlled trials (RCTs) involving children with AD but without food allergies. Specific diets or supplements, such as vitamins, minerals, probiotics, prebiotics, symbiotics, or postbiotics, were explored in these trials. Exclusions comprised descriptive studies, systematic reviews, meta-analyses, letters, case reports, studies involving elimination diets, and those reporting on food allergens in children and adolescents. Additionally, studies assessing exacerbation of AD due to food allergy/sensitization and those evaluating elimination diets' effects on AD were excluded. Nutritional supplementation studies were eligible regardless of sensitization profile. Evaluation of their impact on AD clinical expression was performed using SCORAD scores, and a meta-analysis of SCORAD outcomes was conducted using random-effect models (CRD42022328702). The review encompassed 27 RCTs examining prebiotics, Vitamin D, evening primrose oil, and substituting cow's milk formula with partially hydrolyzed whey milk formula. A meta-analysis of 20 RCTs assessing probiotics, alone or combined with prebiotics, revealed a significant reduction in SCORAD scores, suggesting a consistent trend in alleviating AD symptoms in children without food allergies. Nonetheless, evidence for other dietary interventions remains limited, underscoring the necessity for well-designed intervention studies targeting multiple factors to understand etiological interactions and propose reliable manipulation strategies. © 2024 The Author(s). Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

06
RANDOMIZED TRIAL (RCT) Iranian journal of nursing and midwifery research (2023) PMID: 37694196 ↗
Comparison of the Effect of Fennel and Evening Primrose Oil on Menopausal Problems and Hormonal Levels: A Randomized Controlled Trial.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Iranian journal of nursing and midwifery research involving n = 125 participants; statistical significance reported at p = 0.001. Key conclusion: CONCLUSIONS: Consumption of fennel and EPO can significantly change FSH, estradiol, and psychological menopausal symptoms in postmenopausal women.
View Original PubMed Abstract ↓

BACKGROUND: Using natural oral supplements is one of the methods of complementary medicine that has been widely welcomed in the last decade Since studies have reported contradictory results for effectiveness of herbal medicines during menopause and no other more effective herbal medicine has been suggested yet, the researchers of this study decided to compare the fennel and Evening Primrose Oil (EPO) and their effect on menopause problems and sex hormones. MATERIALS AND METHODS: The present study was a triple-blinded, controlled clinical trial with 125 participants randomly assigned to. An intervention group received fennel, another intervention group received evening primrose oil, and the placebo group received placebo twice daily for 8 weeks. Pre-intervention and post-intervention results were obtained using hormonal assay and the Menopause Rating Scale (MRS). RESULTS: In this study, the mean follicle-stimulating hormone (FSH) and estradiol levels changed significantly in the fennel and EPO groups compared to placebo (p < 0.001). The difference in the mean FSH score between the fennel group and EPO group was not significant (p = 0.304), but the difference in the mean estradiol level between these groups was significant (p = 0.043). Moreover, there was a significant difference in the mean MRS score between the intervention groups before the intervention (p < 0.05). However, the difference in the mean MRS score between the fennel and EPO groups was not significant after the intervention (p = 0.322). CONCLUSIONS: Consumption of fennel and EPO can significantly change FSH, estradiol, and psychological menopausal symptoms in postmenopausal women. Copyright: © 2023 Iranian Journal of Nursing and Midwifery Research.

07
RANDOMIZED TRIAL (RCT) Scientific reports (2023) PMID: 37081029 ↗
Anti-inflammatory effect of combining fish oil and evening primrose oil supplementation on breast cancer patients undergoing chemotherapy: a randomized placebo-controlled trial.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Scientific reports involving n = 16 participants. Key conclusion: Consequently, this treatment may help reduce cancer complications resulting from impaired lipid metabolism and inflammation.
View Original PubMed Abstract ↓

Breast cancer is the most common malignant tumor and one of the leading causes of cancer-related death in women throughout the world. This study is a parallel, randomized, double-blind, controlled, 12-week supplementation trial, investigating the anti-inflammatory effects of dietary intake of fish oil and evening primrose oil (EPO), in patients with breast cancer undergoing chemotherapy. The primary outcomes were changes in the nutritional status and inflammatory cytokines of patients during the study. The secondary outcomes were changes in hematological and biochemical parameters and fatty acid profile. Of the 32 eligible patients, half of them is randomly assigned to a treatment arm with fish oil and EPO (n = 16), or a control arm (n = 16) with mineral oil as a placebo. The intervention group was taking 2 gel capsules of fish oil and 3 gel capsules of EPO (400 mg eicosapentaenoic acid, 600 mg docosahexaenoic acid, and 351 mg gamma-linolenic acid) fish oil and evening primrose oil for 12 weeks, during their chemotherapy. The control/placebo group was taking 5 gel capsules of 1g of mineral oil. One of the patients dropped out due to discontinuation of the treatment (in the placebo group) and two did not show up at the post-treatment measurements (in the intervention group), thus, 29 women completed the study. The results showed an increase in plasma levels of docosapentaenoic acid (22:5n-3), docosahexaenoic acid (22:6n-3), total n-3PUFA, vaccenic acid (18:1n-7), and a decrease in n-6/n-3 PUFA ratio in the intervention group. An increase in the plasma level of dihomo-gamma-linolenic acid (20:3n-6) was observed in the placebo group. There was no difference in plasma levels of interleukin (IL) IL-8, IL-10, and tumor necrosis factor-alpha, while the level of IL-6 decreased in both groups and was significantly lower in the intervention group at the end of the study. In conclusion, this supplementation improved the PUFA status and decreased the level of IL-6 in breast cancer patients undergoing chemotherapy. Consequently, this treatment may help reduce cancer complications resulting from impaired lipid metabolism and inflammation. ClinicalTrials.gov Identifier: NCT035

08
RANDOMIZED TRIAL (RCT) Nutrients (2022) PMID: 35889936 ↗
Effect of Evening Primrose Oil Supplementation on Selected Parameters of Skin Condition in a Group of Patients Treated with Isotretinoin-A Randomized Double-Blind Trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Nutrients involving n = 25 participants; statistical significance reported at p = 0.015. Key conclusion: Conclusions: During isotretinoin treatment, supplementation with evening primrose oil increased skin hydration.
View Original PubMed Abstract ↓

Background: Retinoids, which include isotretinoin, reduce sebum levels, the degree of epidermal wetness (CORN) and cause an increase in transepidermal water loss (TEWL). Weight gain has also been observed in isotretinoin-treated patients. An agent that can reduce the severity of isotretinoin side effects is evening primrose oil (Oenothera paradoxa). The purpose of this study was to evaluate the effect of evening primrose oil supplementation in patients with acne vulgaris treated with isotretinoin on skin hydration status (CORN), transepidermal water loss (TEWL), skin oiliness (sebum) and changes in body weight and BMI. Methods: Patients diagnosed with acne were assigned to the isotretinoin-treated group (n = 25) or the isotretinoin and evening primrose oil-treated group (n = 25). The intervention lasted 9 months. CORN (with a corneometer), TEWL (with a tewameter) and sebum (with a sebumeter) were assessed twice, as well as body weight and BMI (Tanita MC-780). Results: The isotretinoin-treated group showed statistically significant reductions in CORN (p = 0.015), TEWL (p = 0.004) and sebum (p < 0.001) after the intervention. In the group treated with isotretinoin and evening primrose oil, TEWL and sebum levels also decreased significantly (p < 0.05), while CORN levels increased from 42.0 ± 9.70 to 50.9 ± 10.4 (p = 0.017). A significant decrease in body weight (p < 0.001) and BMI (p < 0.001) was observed in both groups after 9 months of intervention. Conclusions: During isotretinoin treatment, supplementation with evening primrose oil increased skin hydration. However, there were no differences between groups in transepidermal water loss, skin oiliness, weight loss and BMI.

09
CLINICAL STUDY Clinical and translational science (2022) PMID: 35791734 ↗
Supplementation with omega-3 or omega-6 fatty acids attenuates platelet reactivity in postmenopausal women.
Clinical Trial Synthesis 2022 Clinical Study published in Clinical and translational science. Key conclusion: Hence, this study supports the beneficial effects of fish oil or primrose oil supplementation as a therapeutic intervention to reduce the risk of thrombotic events in postmenopausal women.
View Original PubMed Abstract ↓

Postmenopausal women are at increased risk for a cardiovascular event due to platelet hyperactivity. There is evidence suggesting that ω-3 polyunsaturated fatty acids (PUFAs) and ω-6 PUFAs have cardioprotective effects in these women. However, a mechanistic understanding of how these fatty acids regulate platelet function is unknown. In this study, we supplemented postmenopausal women with fish oil (ω-3 fatty acids) or evening primrose oil (ω-6 fatty acids) and investigated the effects on their platelet activity. The effects of fatty acid supplementation on platelet aggregation, dense granule secretion, and activation of integrin αIIbβ3 at basal levels and in response to agonist were tested in postmenopausal women following a supplementation and washout period. Supplementation with fish oil or primrose oil attenuated the thrombin receptor PAR4-induced platelet aggregation. Supplementation with ω-3 or ω-6 fatty acids decreased platelet dense granule secretion and attenuated basal levels of integrin αIIbβ3 activation. Interestingly, after the washout period following supplementation with primrose oil, platelet aggregation was similarly attenuated. Additionally, for either treatment, the observed protective effects post-supplementation on platelet dense granule secretion and basal levels of integrin activation were sustained after the washout period, suggesting a long-term shift in platelet reactivity due to fatty acid supplementation. These findings begin to elucidate the underlying mechanistic effects of ω-3 and ω-6 fatty acids on platelet reactivity in postmenopausal women. Hence, this study supports the beneficial effects of fish oil or primrose oil supplementation as a therapeutic intervention to reduce the risk of thrombotic events in postmenopausal women. https://clinicaltrials.gov/ct2/show/NCT02629497. © 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

10
RANDOMIZED TRIAL (RCT) Nutrients (2022) PMID: 35405955 ↗
Effect of Evening Primrose Oil Supplementation on Biochemical Parameters and Nutrition of Patients Treated with Isotretinoin for Acne Vulgaris: A Randomized Double-Blind Trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Nutrients involving n = 25 participants; statistical significance reported at p = 0.001. Key conclusion: The evening primrose oil treatment group also showed a reduction in dietary energy due to a reduction in dietary protein and carbohydrates.
View Original PubMed Abstract ↓

Background: Acne vulgaris is one of the most common skin diseases. One of the therapeutic options recommended for severe acne or acne that has not responded to previous therapies is isotretinoin. However, its use may lead to adverse changes in the serum lipid profile and increased levels of transaminases. In this study, we evaluated the effect of supplementation with evening primrose oil in acne vulgaris patients treated with isotretinoin on blood lipid parameters and transaminase activity. Methods: Study participants were randomly assigned to two treatments: conventional with isotretinoin (25 patients) and novel with isotretinoin combined with evening primrose oil (4 × 510 mg/day; 25 patients) for 9 months. Results: Compared to isotretinoin treatment, isotretinoin treatment combined with evening primrose oil had a positive effect on TCH concentrations (mean: 198 vs. 161, p < 0.001), LDL (95.9 vs. 60.2, p < 0.001), HDL (51.0 vs. 48.0, p < 0.001), TG (114 vs. 95.0, p < 0.001), ALT (24.0 vs. 22.0, p < 0.001), and AST (28.0 vs. 22.0, p < 0.001), but had no effect on the energy and ingredient content of the diets (p > 0.05) after treatment. Conclusion: Evening primrose oil was found to have beneficial effects on lipid profiles and transaminase activity during isotretinoin treatment. However, longer studies are needed to make more reliable decisions regarding the use of evening primrose oil and its safety in clinical practice. The evening primrose oil treatment group also showed a reduction in dietary energy due to a reduction in dietary protein and carbohydrates.

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