NICEVIVA
MONOGRAPH SPEC LATEST 2026

Tea Tree Oil (Internal)

BOTANICALS · Evidence Monograph

Tea Tree Oil (Internal) is an evidence-graded botanicals monograph evaluated across 27 peer-reviewed PubMed studies (5 meta-analyses, 0 systematic reviews, and 9 randomized controlled trials, encompassing n = 3,762 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 27 Studies
Meta-Analyses · Reviews 5 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 9 RCTs (5 Double-Blind)
Cumulative Participants n = 3,762
Reported Trial Dosages 0.01 g
Trial Duration Range 35 days · 42 days · 7 days
Reading Time ~14 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 27 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (0.01 g) over a structured 35 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (27 PubMed studies)
Quantitative biomarker & outcome analysis (19 studies with effect-size/sample data)
Randomized controlled trial verification (9 RCTs · 5 double-blind)
Systematic review & meta-analysis synthesis (5 meta-analyses · 0 reviews)
01

What Is Tea Tree Oil (Internal) & Why Does Form Matter?

Tea Tree Oil (Internal) is classified under BOTANICALS and has been investigated across 27 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

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 (0.01 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Tea Tree Oil (Internal) 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 (9 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Tea Tree Oil (Internal) acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Tea Tree Oil (Internal) an overall evidence rating of GRADE High (4.0 / 4.0) based on 27 PubMed studies: 5 meta-analyses, 0 systematic reviews, and 9 randomized controlled trials (5 double-blind, n = 3,762 total participants).

Representative peer-reviewed findings include: • PMID:34365060 (2021) — "Advantages of using toothpaste containing propolis and plant oils for gingivitis prevention and oral cavity hygiene in cleft lip/palate patients." (These results may be clinically useful for improving preventative oral care and for control of oral infectious diseases during orthodontic treatment in patients with oral cleft.) • PMID:21477403 (2011) — "MRSA colonisation (eradicating colonisation in people without active/invasive infection)." (CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: antiseptic body washes, chlorhexidine-neomycin nasal cream, mupirocin nasal ointment, systemic antimicrobials, tea tree oil preparations, and oth) • PMID:40095592 (2025) — "Evaluation of the Effectiveness of a Mouthwash Containing Spilanthol and Cannabidiol on Improving Oral Health in Patients with Gingivitis-Clinical Trial." (Secondly, the combination of TTO with spilanthol and CBD in the rinse was shown to result in a more significant reduction in selected oral health parameters (BOP and API) and anti-inflammatory effects when compared to a rinse with TTO alone.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 0.01 g over 35 days · 42 days · 7 days · 12 weeks. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Tea Tree Oil (Internal), 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 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (0.01 g) and re-evaluate efficacy after 35 days.
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 (27 Studies) · 19 Quantitative Analyses

01
CLINICAL STUDY Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie (2021) PMID: 34365060 ↗
Advantages of using toothpaste containing propolis and plant oils for gingivitis prevention and oral cavity hygiene in cleft lip/palate patients.
Clinical Trial Synthesis 2021 Clinical Study published in Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie involving n = 50 participants; statistical significance reported at p = 0.011. Key conclusion: These results may be clinically useful for improving preventative oral care and for control of oral infectious diseases during orthodontic treatment in patients with oral cleft.
View Original PubMed Abstract ↓

BACKGROUND: The anti-inflammatory and antibacterial action of preparations used during oral hygiene procedures is particularly important in patients with oral cleft. Few reports have been published assessing the influence of natural products on the state of the oral cavity in patients with oral cleft. The aim of this study was to assess the effect of toothpaste containing Polish propolis and plant oils on oral cavity health in patients with oral cleft treated orthodontically. MATERIALS AND METHODS: A total of 50 patients aged 9-16 years old (20 females, 23 males) were selected and randomly assigned into two groups. Group (A) received toothpaste with Polish propolis, tea tree oil, menthol, and rosemary oil. Group (B) received toothpaste without active ingredients (placebo). A baseline assessment was followed by an oral hygiene index (OHI, debris OHI-D, and calculus OHI-C component) and gingival bleeding index (GBI) after 35 days. The methodology of the oral condition assessment included the presence of cleft malformation as a dysmorphic of the anterior maxilla segment. RESULTS: In group A, improvement in oral cavity hygiene assessed for incisors and molars was found (OHI-T p = 0.011). For the gingival condition, a decrease in the gingival bleeding index - total (GBI-T p = 0.002), as well as for the incisors (GBI-I p = 0.007) and molars (GBI-M p = 0.017) was found. CONCLUSIONS: This research confirms the biological effectiveness of toothpaste with Polish propolis and plant oils. These results may be clinically useful for improving preventative oral care and for control of oral infectious diseases during orthodontic treatment in patients with oral cleft.

02
CLINICAL STUDY BMJ clinical evidence (2011) PMID: 21477403 ↗
MRSA colonisation (eradicating colonisation in people without active/invasive infection).
Clinical Trial Synthesis 2011 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: antiseptic body washes, chlorhexidine-neomycin nasal cream, mupirocin nasal ointment, systemic antimicrobials, tea tree oil preparations, and oth
View Original PubMed Abstract ↓

INTRODUCTION: Methicillin-resistant Staphylococcus aureus (MRSA) has a gene that makes it resistant to methicillin as well as to other beta-lactam antibiotics, including flucloxacillin, beta-lactam/beta-lactamase inhibitor combinations, cephalosporins, and carbapenems. MRSA can be part of the normal body flora (colonisation), especially in the nose, but it can cause infection. Until recently, MRSA has primarily been a problem associated with exposure to the healthcare system, especially in people with prolonged hospital admissions, with underlying disease, or after antibiotic use. In many countries worldwide, a preponderance of S aureus bloodstream isolates are resistant to methicillin. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatment for MRSA nasal or extra-nasal colonisation? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2010 (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 9 systematic reviews, RCTs, or observational studies that met our inclusion criteria. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: antiseptic body washes, chlorhexidine-neomycin nasal cream, mupirocin nasal ointment, systemic antimicrobials, tea tree oil preparations, and other topical antimicrobials.

03
CLINICAL STUDY Journal of clinical medicine (2025) PMID: 40095592 ↗
Evaluation of the Effectiveness of a Mouthwash Containing Spilanthol and Cannabidiol on Improving Oral Health in Patients with Gingivitis-Clinical Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of clinical medicine involving n = 40 participants; statistical significance reported at p = 0.005062. Key conclusion: Secondly, the combination of TTO with spilanthol and CBD in the rinse was shown to result in a more significant reduction in selected oral health parameters (BOP and API) and anti-inflammatory effects when compared to a rinse with TTO alone.
View Original PubMed Abstract ↓

Background/Objectives: Plaque-associated gingivitis is widely regarded as a local inflammatory condition initiated by the accumulation of a non-specific dental biofilm in the interaction with the host immune system. The initial symptom noticed by the patient is bleeding gums. The use of mouthwash can serve to supplement mechanotherapy. However, there is an increasing interest in mouthwashes comprising natural ingredients, including cannabidiol (CBD) and spilanthol. The objective of this study was to evaluate the effect of an oral rinse containing spilanthol and CBD oil compared to a rinse containing tea tree oil on the oral microbiota and the values of selected oral status indicators in patients with gingivitis. Methods: The study included 40 patients treated with a rinse containing tea tree oil (TTO)/TTO + spilanthol + CBD for a period of 42 days. Patients rinsed their mouth twice daily for 30 s. The patients' oral microbiome was assessed before and after treatment, and bleeding on probing (BOP) and approximal plaque index (API) were assessed. The study was double-blind. Results: API and BOP were reduced in all groups, both the test and control. The most significant decrease in baseline BOP-1 scores was observed in test groups A and D (p = 0.005062 and p = 0.005062, respectively). A significant difference in API improvement was observed between the initial and final visits in the test (A, D) and control (B, C) groups (p = 0.012516, p = 0.005062, p = 0.004028, p = 0.003172, respectively). Conclusions: Firstly, the use of a mouthwash containing cannabidiol (CBD) and spilanthol was demonstrated to be efficacious in the maintenance of oral microbiota homeostasis. Secondly, the combination of TTO with spilanthol and CBD in the rinse was shown to result in a more significant reduction in selected oral health parameters (BOP and API) and anti-inflammatory effects when compared to a rinse with TTO alone. It should be noted that this is a pilot study and will continue.

04
CLINICAL STUDY Seminars in cutaneous medicine and surgery (2016) PMID: 27416314 ↗
Over-the-counter treatments for acne and rosacea.
Clinical Trial Synthesis 2016 Clinical Study published in Seminars in cutaneous medicine and surgery. Key conclusion: ©2016 Frontline Medical Communications.
View Original PubMed Abstract ↓

Acne and rosacea are common inflammatory processes historically classified in the same disease category, but evolving understanding of their disparate pathophysiology and exacerbating factors have generated an enormous armamentarium of therapeutic possibilities. Patients seek over-the-counter therapies first when managing cutaneous disease; therefore, this review defines ingredients considered to be effective over-the-counter acne and rosacea products, their mechanisms, and safe formulations, including botanical components, oral supplements, and other anecdotal options in this vast skin care domain. ©2016 Frontline Medical Communications.

05
CLINICAL STUDY Journal of strength and conditioning research (2012) PMID: 21921823 ↗
Effects of 2-nitrooxy ethyl 2-amino 3-methylbutanoate gel on resistance exercise performance and blood nitrate/nitrite in resistance trained men.
Clinical Trial Synthesis 2012 Clinical Study published in Journal of strength and conditioning research; statistical significance reported at p = 0.05. Key conclusion: These findings indicate that 2-nitrooxy ethyl 2-amino 3-methylbutanoate gel has a modest (6.2%), nonstatistically significant effect on exercise performance, in particular when using a load of 50% 1RM-with greater benefit noted in selected individuals.
View Original PubMed Abstract ↓

Nitric oxide dietary supplements are popular within the sport community. Our recent work involving the oral intake of 2-nitrooxy ethyl 2-amino 3-methylbutanoate demonstrated an approximately 6.7% increase in circulating nitrate/nitrite. However, no measures of exercise performance were obtained. The present study used a topical form of this molecule to determine the impact on exercise performance and blood nitrate/nitrite. Fourteen resistance trained men (24 ± 1 years old) reported to the laboratory on 2 occasions to undergo exercise testing, which consisted of arm curl isometric force and muscular endurance (3 sets to fatigue using 80, 65, and 50% of 1 repetition maximum [1RM]: total of 9 sets). The gel (2-nitrooxy ethyl 2-amino 3-methylbutanoate; mixed in tea tree oil) or placebo (tea tree oil) was applied topically by the subjects for 7 days before each test day, with 7-10 days separating the randomly ordered conditions. Blood samples, arm circumference, and perceived "muscle pump" were taken before and immediately after exercise on both test days. The heart rate and perceived exertion were measured after each set. No statistically significant differences were noted between conditions for performance variables (p > 0.05). However, when using a load of 50% of 1RM, 6.2% more repetitions were performed when using the gel as compared with when using the placebo; 19.9% more repetitions were performed by 8 subjects noted to be "responders" to gel treatment. Blood lactate and muscle pump significantly increased with exercise (p < 0.0001) but were not different between conditions (p > 0.05). Minimal change was noted in nitrate/nitrite, and the heart rate and perceived exertion were nearly identical between conditions (p > 0.05). These findings indicate that 2-nitrooxy ethyl 2-amino 3-methylbutanoate gel has a modest (6.2%), nonstatistically significant effect on exercise performance, in particular when using a load of 50% 1RM-with greater benefit noted in selected individuals. Studies inclusive of a larger sample size are needed to extend these initial findings.

06
CLINICAL STUDY American journal of clinical dermatology (2010) PMID: 20509719 ↗
Botanicals in dermatology: an evidence-based review.
Clinical Trial Synthesis 2010 Clinical Study published in American journal of clinical dermatology. Key conclusion: Botanical extracts and single compounds are increasingly used in cosmetics but also in over-the-counter drugs and food supplements.
View Original PubMed Abstract ↓

Botanical extracts and single compounds are increasingly used in cosmetics but also in over-the-counter drugs and food supplements. The focus of the present review is on controlled clinical trials with botanicals in the treatment of acne, inflammatory skin diseases, skin infections, UV-induced skin damage, skin cancer, alopecia, vitiligo, and wounds. Studies with botanical cosmetics and drugs are discussed, as well as studies with botanical food supplements. Experimental research on botanicals was considered to a limited extent when it seemed promising for clinical use in the near future. In acne therapy, Mahonia, tea tree oil, and Saccharomyces may have the potential to become standard treatments. Mahonia, Hypericum, Glycyrrhiza and some traditional Chinese medicines appear promising for atopic dermatitis. Some plant-derived substances like dithranol and methoxsalen (8-methoxypsoralen) [in combination with UVA] are already accepted as standard treatments in psoriasis; Mahonia and Capsicum (capsaicin) are the next candidates suggested by present evidence. Oral administration and topical application of antioxidant plant extracts (green and black tea, carotenoids, coffee, and many flavonoids from fruits and vegetables) can protect skin from UV-induced erythema, early aging, and irradiation-induced cancer. Hair loss and vitiligo are also traditional fields of application for botanicals. According to the number and quality of clinical trials with botanicals, the best evidence exists for the treatment of inflammatory skin diseases, i.e. atopic dermatitis and psoriasis. However, many more controlled clinical studies are needed to determine the efficacy and risks of plant-derived products in dermatology. Safety aspects, especially related to sensitization and photodermatitis, have to be taken into account. Therefore, clinicians should not only be informed of the beneficial effects but also the specific adverse effects of botanicals used for dermatologic disorders and cosmetic purposes.

07
CLINICAL STUDY American journal of clinical dermatology (2002) PMID: 12069640 ↗
Complementary/alternative medicine in dermatology: evidence-assessed efficacy of two diseases and two treatments.
Clinical Trial Synthesis 2002 Systematic Review published in American journal of clinical dermatology. Key conclusion: The use of CAM treatments is not free of risk; direct and indirect risks associated with CAM must be considered.
View Original PubMed Abstract ↓

The objective of this article is to provide a brief, but critical, overview of the evidence related to complementary/alternative medicine (CAM) use, and to offer valid and useful information for dermatologists in clinical practice. Systematic literature searches were conducted on these databases: Medline, EMBASE, The Cochrane Library, CISCOM and AMED (until October 2000). Where appropriate, the evaluation of the published literature was based on systematic reviews and randomized controlled trials. After scanning the literature it was decided to focus on a selection of two conditions (atopic dermatitis and chronic venous insufficiency) and two treatment modalities (aloe vera gel and tea tree oil). Data for the life-time prevalence of CAM use by patients with dermatological disease ranges between 35 to 69%. The most popular modalities include herablism and (other) dietary supplements, while atopic dermatitis is one of the conditions most frequently treated with CAM. For patients with atopic dermatitis the evidence relates to autogenic training, hypnotherapy, diet, herbal medicine, and dietary supplements. Compelling evidence of effectiveness exists for none of these therapies. However, some promising data have been reported for those with a psychological component: autogenic training, biofeedback and hypnotherapy. For chronic venous insufficiency there is relatively convincing evidence for the effectiveness of oral horse chestnut seed extract. The data for aloe vera gel and tea tree oil indicate that for neither is there compelling evidence of effectiveness. The use of CAM treatments is not free of risk; direct and indirect risks associated with CAM must be considered.

08
META-ANALYSIS Oral health & preventive dentistry (2024) PMID: 38864380 ↗
The Effect of Local Application of Tea Tree Oil Adjunctive to Daily Oral Maintenance and Nonsurgical Periodontal Treatment: A Systematic Review and Meta-Analysis of Randomised Controlled Studies.
Clinical Trial Synthesis 2024 Meta-Analysis published in Oral health & preventive dentistry. Key conclusion: CONCLUSION: There is a lack of strong evidence to support the beneficial effects of TTO.
View Original PubMed Abstract ↓

PURPOSE: To evaluate the efficacy of the adjunctive use of tea tree oil (TTO) for dental plaque control and nonsurgical periodontal treatment (NSPT). MATERIALS AND METHODS: Three electronic databases were searched from 2003. The reference lists of the included articles and relevant reviews were also manually searched. Randomised controlled trials reporting the clinical outcomes of the topical use of TTO as an adjunct to daily oral hygiene or scaling and root planing (SRP) were included. Regarding the use of TTO as an adjunctive to daily oral hygiene, the primary outcome was plaque index (PI) reduction. Regarding the use of TTO as an adjunctive to SRP, probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain were the primary outcomes. The secondary outcomes were adverse events. RESULTS: Eleven studies were included for qualitative analysis, 9 studies were included for quantitative analysis, and 6 studies were included to examine the application of TTO mouthwash as an adjunctive to daily oral hygiene. In addition, three studies were included to analyse the subgingival use of TTO adjunctive to SRP at selected sites. The results indicated a nonsignificant improvement in PI reduction in the TTO mouthwash group compared with placebo. The incidence of adverse events was statistically significantly greater in the CHX group than in the TTO group. For subgingival use of TTO adjunctive to SRP, beneficial effects were observed in the TTO group compared with SRP alone in terms of PPD and CAL at both three and six months post-treatment. However, an unpleasant taste was reported in three out of four studies. CONCLUSION: There is a lack of strong evidence to support the beneficial effects of TTO. Studies with larger sample sizes and standardised evaluation criteria are needed to further demonstrate the clinical relevance of TTO.

09
META-ANALYSIS American journal of ophthalmology (2024) PMID: 38513948 ↗
Efficacy and Safety of Lotilaner Ophthalmic Solution (0.25%) for the Treatment of Demodex Blepharitis: A GRADE Assessed Systematic Review and Meta-Analysis of Observational & Experimental Studies.
Clinical Trial Synthesis 2024 Meta-Analysis published in American journal of ophthalmology; statistical significance reported at p = 0.00001. Key conclusion: CONCLUSIONS: Our results indicated that lotilaner is an effective, well-tolerated, and promising drug in treating patients with Demodex blepharitis.
View Original PubMed Abstract ↓

PURPOSE: Several treatments have been in use for Demodex blepharitis, before the discovery of lotilaner, like tea tree oil and antibiotics; however, they either have irritable effects or systemic adverse effects, respectively. Lotilaner, a novel ectoparasiticide, has been proposed as a treatment for patients grappling with Demodex blepharitis. This review aims to assess the safety and efficacy of lotilaner in the treatment of Demodex blepharitis. DESIGN: Systematic review and meta-analysis. METHODS: An extensive search was conducted on PubMed, Cochrane Library, Scopus, and Google Scholar to find relevant literature till July 31, 2023 following the PRISMA guidelines. A total of 143 articles were retrieved by database searching, out of which 6 studies met the inclusion criteria and were included in the review. Four randomized controlled trials were included in the meta-analysis of mite eradication incidence. The review is registered with PROSPERO: CRD42023459997. RESULTS: Lotilaner is effective in eradicating Demodex mites in individuals suffering from Demodex blepharitis according to RR for the intervention versus the control group of 3.55 (95% confidence interval [CI]: 2.87-4.40, P < .00001, I2 = 0%). The meta-analysis of clinically meaningful collarette score revealed the summary RR for the intervention versus the control group was 3.15 (95% CI: 2.56-3.89, P < 0.00001, I2 = 27%). In conclusion, the results of the included studies were comparable and consistent. CONCLUSIONS: Our results indicated that lotilaner is an effective, well-tolerated, and promising drug in treating patients with Demodex blepharitis. Lotilaner administration and cost-effectiveness should now be contemplated for the study population as these constituents have a vital impact on its treatment success.

10
CLINICAL STUDY The Cochrane database of systematic reviews (2020) PMID: 32589270 ↗
Tea tree oil for Demodex blepharitis.
Clinical Trial Synthesis 2020 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 562 participants. Key conclusion: BACKGROUND: Demodex blepharitis is a chronic condition commonly associated with recalcitrant dry eye symptoms though many people with Demodex mites are asymptomatic.
View Original PubMed Abstract ↓

BACKGROUND: Demodex blepharitis is a chronic condition commonly associated with recalcitrant dry eye symptoms though many people with Demodex mites are asymptomatic. The primary cause of this condition in humans is two types of Demodex mites: Demodex folliculorum and Demodex brevis. There are varying reports of the prevalence of Demodex blepharitis among adults, and it affects both men and women equally. While Demodex mites are commonly treated with tea tree oil, the effectiveness of tea tree oil for treating Demodex blepharitis is not well documented. OBJECTIVES: To evaluate the effects of tea tree oil on ocular Demodex infestation in people with Demodex blepharitis. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); Ovid MEDLINE; Embase.com; PubMed; LILACS; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no date or language restrictions in the electronic search for trials. We last searched the databases on 18 June 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared treatment with tea tree oil (or its components) versus another treatment or no treatment for people with Demodex blepharitis. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the titles and abstracts and then full text of records to determine their eligibility. The review authors independently extracted data and assessed risk of bias using Covidence. A third review author resolved any conflicts at all stages. MAIN RESULTS: We included six RCTs (1124 eyes of 562 participants; 17 to 281 participants per study) from the US, Korea, China, Australia, Ireland, and Turkey. The RCTs compared some formulation of tea tree oil to another treatment or no treatment. Included participants were both men and women, ranging from 39 to 55 years of age. All RCTs were assessed at unclear or high risk of bias in one or more domains. We also identified two RCTs that are ongoing or awaiting publications. Data from three RCTs that reported a short-term mean change in the number of Demodex mites per eight eyelashes contributed

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