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Radiodermatitis in Patients With Cancer: Systematic Review and Meta-Analysis.

1. Oncol Nurs Forum. 2020 Nov 1;47(6):E225-E236. doi: 10.1188/20.ONF.E225-E236. Radiodermatitis in Patients With Cancer: Systematic Review and Meta-Analysis. Ginex PK(1), Backler C(1), Croson E(2), Horrell LN(3), Moriarty KA(1), Maloney C, Vrabel M(1), Morgan RL(4). Author information: (1)Oncolo

Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer.

1. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Roberts KE(1)(2), Adsett IT(3), Rickett K(4), Conroy SM(5), Chatfield MD(6), Woodward NE(2)(7). Author information: (1)Department of Medical Oncology, Princess Alexandra Hospital, Woolloongabba, Australia. (2)School of Clinical Medicine, Mater Clinical Unit, Mater Hospital, University of Queensland, South Brisbane, Australia. (3)Ipswich Hospital, Queensland Health, Ipswich, Australia. (4)The University of Queensland Library, UQ/Mater McAuley Library, Brisbane, Australia. (5)Medical Oncology, Mater Health, Brisbane, Australia. (6)Centre for Health Services Research, The University of Queensland, Woolloongabba, Australia. (7)Department of Medical Oncology, Mater Misericordiae Ltd, South Brisbane, Australia. Update of doi: 10.1002/14651858.CD013167. BACKGROUND: Adjuvant aromatase inhibitors (AI) improve survival compared to tamoxifen in postmenopausal women with hormone receptor-positive stage I to III breast cancer. In approximately half of these women, AI are associated with aromatase inhibitor-induced musculoskeletal symptoms (AIMSS), often described as symmetrical pain and soreness in the joints, musculoskeletal pain and joint stiffness. AIMSS may have significant and prolonged impact on women's quality of life. AIMSS reduces adherence to AI therapy in up to a half of women, potentially compromising breast cancer outcomes. Differing systemic therapies have been investigated for the prevention and treatment of AIMSS, but the effectiveness of these therapies remains unclear. OBJECTIVES: To assess the effects of systemic therapies on the prevention or management of AIMSS in women with stage I to III hormone receptor-positive breast cancer. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, WHO International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov registries to September 2020 and the Cochrane Breast Cancer Group (CBCG) Specialised Register to March 2021.  SELECTION CRITERIA: We included all randomised controlled trials that compared systemic therapies to a comparator arm. Systemic therapy interventions included all pharmacological therapies, dietary supplements, and complementary and alternative medicines (CAM). All comparator arms were allowed including placebo or standard of care (or both) with analgesia alone. Published and non-peer-reviewed studies were eligible. DATA COLLECTION AND ANALYSIS: Two review authors independently screened studies, extracted data, and assessed risk of bias and certainty of the evidence using the GRADE approach. Outcomes assessed were pain, stiffness, grip strength, safety data, discontinuation of AI, health-related quality of life (HRQoL), breast cancer-specific quality of life (BCS-QoL), incidence of AIMSS, breast cancer-specific survival (BCSS) and overall survival (OS). For continuous outcomes, we used vote-counting by reporting how many studies reported a clinically significant benefit within the confidence intervals (CI) of the mean difference (MD) between treatment arms, as determined by the minimal clinically importance difference (MCID) for that outcome scale. For dichotomous outcomes, we reported outcomes as a risk ratio (RR) with 95% CI. MAIN RESULTS: We included 17 studies with 2034 randomised participants. Four studies assessed systemic therapies for the prevention of AIMSS and 13 studies investigated treatment of AIMSS. Due to the variation in systemic therapy studies, including pharmacological, and CAM, or unavailable data, meta-analysis was limited, and only two trials were combined for meta-analysis. The certainty of evidence for all outcomes was either low or very low certainty. Prevention studies The evidence is very uncertain about the effect of systemic therapies on pain (from baseline to the end of the intervention; 2 studies, 183 women). The two studies, investigating vitamin D and omega-3 fatty acids, showed a treatment effect with 95% CIs that did not include an MCID for pain. Systemic therapies may have little to no effect on grip strength (RR 1.08, 95% CI 0.37 to 3.17; 1 study, 137 women) or on women continuing to take their AI (RR 0.16, 95% 0.01 to 2.99; 1 study, 147 women). The evidence suggests little to no effect on HRQoL and BCS-QoL from baseline to the end of intervention (the same single study; 44 women, both quality of life outcomes showed a treatment effect with 95% CIs that did include an MCID). The evidence is very uncertain for outcomes assessing incidence of AIMSS (RR 0.82, 95% CI 0.63 to 1.06; 2 studies, 240 women) and the safety of systemic therapies (4 studies, 344 women; very low-certainty evidence). One study had a US Food and Drug Administration alert issued for the intervention (cyclo-oxygenase-2 inhibitor) during the study, but there were no serious adverse events in this or any study. There were no data on stiffness, BCSS or OS. Treatment studies The evidence is very uncertain about the effect of systemic therapies on pain from baseline to the end of intervention in the treatment of AIMSS (10 studies, 1099 women). Four studies showed an MCID in pain scores which fell within the 95% CI of the measured effect (vitamin D, bionic tiger bone, Yi Shen Jian Gu granules, calcitonin). Six studies showed a treatment effect with 95% CI that did not include an MCID (vitamin D, testosterone, omega-3 fatty acids, duloxetine, emu oil, cat's claw).  The evidence was very uncertain for the outcomes of change in stiffness (4 studies, 295 women), HRQoL (3 studies, 208 women) and BCS-QoL (2 studies, 147 women) from baseline to the end of intervention. The evidence suggests systemic therapies may have little to no effect on grip strength (1 study, 107 women). The evidence is very uncertain about the safety of systemic therapies (10 studies, 1250 women). There were no grade four/five adverse events reported in any of the studies. The study of duloxetine reported more all-grade adverse events in this treatment group than comparator group. There were no data on the incidence of AIMSS, the number of women continuing to take AI, BCCS or OS from the treatment studies. AUTHORS' CONCLUSIONS: AIMSS are chronic and complex symptoms with a significant impact on women with early breast cancer taking AI. To date, evidence for safe and effective systemic therapies for prevention or treatment of AIMSS has been minimal. Although this review identified 17 studies with 2034 randomised participants, the review was challenging due to the heterogeneous systemic therapy interventions and study methodologies, and the unavailability of certain trial data. Meta-analysis was thus limited and findings of the review were inconclusive. Further research is recommended into systemic therapy for AIMSS, including high-quality adequately powered RCT, comprehensive descriptions of the intervention/placebo, and robust definitions of the condition and the outcomes being studied. Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DOI: 10.1002/14651858.CD013167.pub2 PMCID: PMC8743877 PMID: 35005781 [Indexed for MEDLINE] Conflict of interest statement: KER: travel/accommodation/meeting expenses by Roche, Amgen, Pfizer; advisory board Amgen; conference registration by Novartis.  IA: none.  KR: none. SC: none. MC: none. NW: consultancy fees by Roche and Novartis; grant for department trials from Medivation; expert panel review for Roche; stock in CSL, travel/accommodation/meeting expenses by Roche and Novartis.

Transdermal application of H100 gel to the penile shaft in patients with Peyronie's disease infiltrates the tunica albuginea.

2. Int J Impot Res. 2024 Apr;36(2):107-109. doi: 10.1038/s41443-023-00819-w. Epub 2024 Jan 13. Transdermal application of H100 gel to the penile shaft in patients with Peyronie's disease infiltrates the tunica albuginea. Twidwell J(1), Mahon J(2), Tortorelis D(2), Levine L(3). Author information: (1)Minnesota Urology, Minneapolis, MN, USA. jtwidwell@HybridMedical.org. (2)Minnesota Urology, Minneapolis, MN, USA. (3)Rush Medical College, Chicago, IL, USA. Treatment options for Peyronie's disease (PD) remain limited. Topical H100 gel, (Hybrid Medical, Edina, USA), which contains nicardipine, super oxide dismutase and emu oil showed safety and efficacy in a previous small double-blind placebo-controlled pilot study. The present study evaluates if topically applied H100 gel applied to the penile shaft infiltrates the tunica albuginea. Nicardipine is a key active ingredient in H100 and serves as a surrogate marker. Three men already scheduled to undergo a planned surgical procedure for PD applied commercially available H100 gel twice daily to the penile shaft for up to 30 days prior to the procedure. Tunica albuginea samples were obtained at surgery. Nicardipine evaluation was performed using isotope dilution technique via liquid-chromatograph-mass spectrometry (LCMS). All three patients tolerated H100 gel application without side effects. All three tunica albuginea specimens showed detectable nicardipine in the tunical tissue. Transdermal application of commercially available H100 gel is able to penetrate the tunica albuginea tissue and is detectable in men with acute and chronic PD. This finding may support the encouraging results found in the prior H100 pilot study. © 2024. The Author(s), under exclusive licence to Springer Nature Limited. DOI: 10.1038/s41443-023-00819-w PMID: 38218956 [Indexed for MEDLINE]

The Effectiveness of Topical Cannabidiol Oil in Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities.

3. Curr Pharm Biotechnol. 2020;21(5):390-402. doi: 10.2174/1389201020666191202111534. The Effectiveness of Topical Cannabidiol Oil in Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities. Xu DH(1), Cullen BD(2)(3)(4), Tang M(5), Fang Y(5)(6). Author information: (1)PGY-2, Department of Podiatric Medicine and Surgery, Scripps Mercy Hospital, San Diego, CA 92103, United States. (2)Podiatric Surgery Section Chief, Scripps Mercy Hospital, 4077 Fifth Ave, MER35, San Diego, CA, 92103, United States. (3)Department of Podiatric Medicine and Surgery, Scripps Mercy Hospital, San Diego, CA 92103, United States. (4)Private Practice, San Diego Podiatry Group, San Diego, CA, 92108, United States. (5)Department of Microbiology, Immunology & Pathology, Des Moines University, Des Moines, IA, 50312, United States. (6)Department of Surgery, University of Missouri School of Medicine, Columbia, MO, 65212, United States. BACKGROUND: Peripheral neuropathy can significantly impact the quality of life for those who are affected, as therapies from the current treatment algorithm often fail to deliver adequate symptom relief. There has, however, been an increasing body of evidence for the use of cannabinoids in the treatment of chronic, noncancer pain. The efficacy of a topically delivered cannabidiol (CBD) oil in the management of neuropathic pain was examined in this four-week, randomized and placebocontrolled trial. METHODS: In total, 29 patients with symptomatic peripheral neuropathy were recruited and enrolled. 15 patients were randomized to the CBD group with the treatment product containing 250 mg CBD/3 fl. oz, and 14 patients were randomized to the placebo group. After four weeks, the placebo group was allowed to crossover into the treatment group. The Neuropathic Pain Scale (NPS) was administered biweekly to assess the mean change from baseline to the end of the treatment period. RESULTS: The study population included 62.1% males and 37.9% females with a mean age of 68 years. There was a statistically significant reduction in intense pain, sharp pain, cold and itchy sensations in the CBD group when compared to the placebo group. No adverse events were reported in this study. CONCLUSION: Our findings demonstrate that the transdermal application of CBD oil can achieve significant improvement in pain and other disturbing sensations in patients with peripheral neuropathy. The treatment product was well tolerated and may provide a more effective alternative compared to other current therapies in the treatment of peripheral neuropathy. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net. DOI: 10.2174/1389201020666191202111534 PMID: 31793418 [Indexed for MEDLINE]

Randomized phase II placebo-controlled study to evaluate the efficacy of topical pure emu oil for joint pain related to adjuvant aromatase inhibitor use in postmenopausal women with early breast cancer: JUST (Joints Under Study).

4. Support Care Cancer. 2017 Dec;25(12):3785-3791. doi: 10.1007/s00520-017-3810-9. Epub 2017 Jul 9. Randomized phase II placebo-controlled study to evaluate the efficacy of topical pure emu oil for joint pain related to adjuvant aromatase inhibitor use in postmenopausal women with early breast cancer: JUST (Joints Under Study). Chan A(1), De Boer R(2), Gan A(2), Willsher P(2), Martin R(2), Zissiadis Y(2), Miller K(2), Bauwens A(2), Hastrich D(2). Author information: (1)Breast Cancer Research Centre-WA, Perth, Western Australia, 6000, Australia. arlenechan@me.com. (2)Breast Cancer Research Centre-WA, Perth, Western Australia, 6000, Australia. PURPOSE: Aromatase inhibitors are standard of care in women with hormone receptor-positive early breast cancer. Published evidence demonstrates that adverse effects may have an impact on drug compliance, with arthralgias being one of the most commonly reported adverse effects. METHODS: Eligible patients were postmenopausal women who had experienced arthralgia following initiation of an aromatase inhibitor. Patients who experienced arthralgias following a minimum of a 3-month treatment on the aromatase inhibitor were randomized to emu oil or placebo oil. The primary endpoint was to assess for a reduction in pain as measured by a visual analogue score after 8 weeks of treatment. RESULTS: Seventy-three patients comprised the intent-to-treat population, and there was no statistically significant benefit with use of EO. However, there was a statistically significant improvement in pain (visual analogue score was -1.28; p < 0.001) and Brief Pain Inventory severity score -0.88 (p < 0.001), as well as functional interference (Brief Pain Inventory interference -1.10 (p < 0.001) for the entire population following an 8-week administration of EO or placebo oil. CONCLUSIONS: Arthralgias, as a result of aromatase inhibitor use, may be ameliorated by the use of topical oil massaged onto the joint. Further research into interventions for this common side effect is needed. DOI: 10.1007/s00520-017-3810-9 PMID: 28691132 [Indexed for MEDLINE]

Topical treatment for acute phase Peyronie's disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study.

5. Int J Impot Res. 2016 Mar-Apr;28(2):41-5. doi: 10.1038/ijir.2015.22. Epub 2015 Dec 24. Topical treatment for acute phase Peyronie's disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study. Twidwell J(1), Levine L(2). Author information: (1)Urology Associates, Robbinsdale, MN, USA. (2)Rush Medical College, Chicago, IL, USA. Erratum in Int J Impot Res. 2021 Sep;33(6):665. doi: 10.1038/s41443-020-0303-z. Comment in J Urol. 2016 May;195(5):1562-1564. doi: 10.1016/j.juro.2016.02.053. Safety and efficacy of topically applied gel H-100 composed of Nicardipine, superoxide dismutase and emu oil for treatment of acute phase Peyronie's disease (PD) was evaluated. Twenty-two patients (PD <12 months duration) were studied in a prospective, randomized, double-blind, placebo-controlled study. Eleven patients received H-100 and 11 patients received placebo for 3 months. All 22 patients then received H-100 for the final 3 months. Flaccid-stretched penile length, degree of penile curvature, pain level and side effects were assessed monthly. H-100 showed significant improvement in all PD parameters at 6 months: mean stretched penile length increase (22.6%, P=0.0002), mean curvature reduction (40.8%, P=0.0014), and mean pain level reduction (85.7%, P=0.004). Placebo group showed no significant improvement except for mean stretched penile length increase (6.8%, P=0.009). Crossover patients from placebo to H-100 showed significant improvement in all parameters: mean stretched penile length increase (17.5%, P=0.000007), mean curvature reduction (37.1%, P=0.006), and mean pain level reduction (40%, P=0.17). Treatment was well tolerated. A self-limited rash was the only side effect in three patients. Statistically significant improvements in flaccid-stretched penile length, curvature and pain suggest that H-100 is a safe and possibly effective non-invasive, topically applied treatment for acute phase Peyronie's Disease. DOI: 10.1038/ijir.2015.22 PMID: 26700214 [Indexed for MEDLINE]

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis.

6. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):650-8. doi: 10.1016/j.ijrobp.2015.02.028. Epub 2015 Apr 28. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis. Rollmann DC(1), Novotny PJ(2), Petersen IA(1), Garces YI(1), Bauer HJ(1), Yan ES(1), Wahner-Roedler D(3), Vincent A(3), Sloan JA(2), Issa Laack NN(4). Author information: (1)Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota. (2)Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota. (3)Department of General Internal Medicine, Mayo Clinic, Rochester, Minnesota. (4)Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota. Electronic address: laack.nadia@mayo.edu. PURPOSE: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. METHODS AND MATERIALS: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). RESULTS: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. CONCLUSIONS: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation. Copyright © 2015 Elsevier Inc. All rights reserved. DOI: 10.1016/j.ijrobp.2015.02.028 PMID: 25936812 [Indexed for MEDLINE]