Azin Ayatollahi, Alireza Firooz, Safoura Shakoei, Reza M. Robati, Nima Aramipour, Setayesh Sadeghi, Fateme Tavakoli-Far, Mohammad Reza Niavand, Mohammad Saber, Mahsa Fattahi, Arash Sadri, Naser-Aldin Lashgari
{"title":"Phoenix dactylifera L. 叶提取物（WartOver®）治疗皮肤疣的有效性和安全性：随机、双盲、安慰剂对照试验","authors":"Azin Ayatollahi, Alireza Firooz, Safoura Shakoei, Reza M. Robati, Nima Aramipour, Setayesh Sadeghi, Fateme Tavakoli-Far, Mohammad Reza Niavand, Mohammad Saber, Mahsa Fattahi, Arash Sadri, Naser-Aldin Lashgari","doi":"10.1155/2024/8814508","DOIUrl":null,"url":null,"abstract":"<p><i>Background</i>. Cutaneous warts are caused by the human papillomavirus that can affect a patient’s quality of life. Current treatments have high cost, low efficacy, adverse effects, and recurrence. Therefore, novel therapeutic approaches are needed. Complementary and Alternative Medicines (CAMs) are gaining popularity as a therapeutic approach. <i>Phoenix dactylifera</i> L. (date palm) is used in folk medicine to treat warts. Antiviral effects of <i>P. dactylifera</i> L. have been demonstrated due to its polyphenolic compounds, especially gallic acid and tannins in various studies. So, this trial evaluates the efficacy and safety of <i>P. dactylifera</i> L. leaf extract (formulated as WartOver®) as a novel treatment for cutaneous warts. <i>Study Design</i>. Based on the results of our previously published pilot clinical trial and the CONSORT guideline, this randomized, double-blind, and placebo-controlled study was performed on 70 eligible patients divided into intervention and placebo groups (<i>N</i> = 35/per group). Every 2 weeks, patients were examined to assess the rate of complete clearance, duration of treatment, patient satisfaction (measured using a Likert scale), and occurrence of any adverse effects and recurrence in a maximum of 12 weeks of treatment and at the 6-month follow-up. <i>Results</i>. Based on the intention-to-treat (ITT) analysis approach, complete clearance was achieved in 24 patients in the intervention group (68.57%; confidence interval 95% = 0.51–0.81), which was significantly higher than that in the placebo group (8.57%; CI 95% = 0.02–0.23, <i>p</i> < 0.0001). The time to complete clearance was 7.6 weeks (mean ± SD: 53.30 ± 17.17 days). The treatment was very satisfactory (Likert score of 4.24 ± 1.15 (mean ± SD)) with no recurrence or adverse effects. <i>Conclusion</i>. WartOver® is a novel efficacious treatment for cutaneous warts with minimal risk for adverse events or recurrence. Due to the rising popularity of CAM approaches in medicine, including herbal medicines, WartOver® can be a valuable choice for clinicians against cutaneous warts. This trial is registered with IRCT20200509047352N2.</p>","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"2024 1","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Phoenix dactylifera L. Leaf Extract (WartOver®) in the Treatment of Cutaneous Warts: A Randomized, Double-Blind, Placebo-Controlled Trial\",\"authors\":\"Azin Ayatollahi, Alireza Firooz, Safoura Shakoei, Reza M. Robati, Nima Aramipour, Setayesh Sadeghi, Fateme Tavakoli-Far, Mohammad Reza Niavand, Mohammad Saber, Mahsa Fattahi, Arash Sadri, Naser-Aldin Lashgari\",\"doi\":\"10.1155/2024/8814508\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><i>Background</i>. Cutaneous warts are caused by the human papillomavirus that can affect a patient’s quality of life. Current treatments have high cost, low efficacy, adverse effects, and recurrence. Therefore, novel therapeutic approaches are needed. Complementary and Alternative Medicines (CAMs) are gaining popularity as a therapeutic approach. <i>Phoenix dactylifera</i> L. (date palm) is used in folk medicine to treat warts. Antiviral effects of <i>P. dactylifera</i> L. have been demonstrated due to its polyphenolic compounds, especially gallic acid and tannins in various studies. So, this trial evaluates the efficacy and safety of <i>P. dactylifera</i> L. leaf extract (formulated as WartOver®) as a novel treatment for cutaneous warts. <i>Study Design</i>. Based on the results of our previously published pilot clinical trial and the CONSORT guideline, this randomized, double-blind, and placebo-controlled study was performed on 70 eligible patients divided into intervention and placebo groups (<i>N</i> = 35/per group). Every 2 weeks, patients were examined to assess the rate of complete clearance, duration of treatment, patient satisfaction (measured using a Likert scale), and occurrence of any adverse effects and recurrence in a maximum of 12 weeks of treatment and at the 6-month follow-up. <i>Results</i>. Based on the intention-to-treat (ITT) analysis approach, complete clearance was achieved in 24 patients in the intervention group (68.57%; confidence interval 95% = 0.51–0.81), which was significantly higher than that in the placebo group (8.57%; CI 95% = 0.02–0.23, <i>p</i> < 0.0001). The time to complete clearance was 7.6 weeks (mean ± SD: 53.30 ± 17.17 days). The treatment was very satisfactory (Likert score of 4.24 ± 1.15 (mean ± SD)) with no recurrence or adverse effects. <i>Conclusion</i>. WartOver® is a novel efficacious treatment for cutaneous warts with minimal risk for adverse events or recurrence. Due to the rising popularity of CAM approaches in medicine, including herbal medicines, WartOver® can be a valuable choice for clinicians against cutaneous warts. This trial is registered with IRCT20200509047352N2.</p>\",\"PeriodicalId\":11045,\"journal\":{\"name\":\"Dermatologic Therapy\",\"volume\":\"2024 1\",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-04-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatologic Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1155/2024/8814508\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatologic Therapy","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1155/2024/8814508","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Efficacy and Safety of Phoenix dactylifera L. Leaf Extract (WartOver®) in the Treatment of Cutaneous Warts: A Randomized, Double-Blind, Placebo-Controlled Trial
Background. Cutaneous warts are caused by the human papillomavirus that can affect a patient’s quality of life. Current treatments have high cost, low efficacy, adverse effects, and recurrence. Therefore, novel therapeutic approaches are needed. Complementary and Alternative Medicines (CAMs) are gaining popularity as a therapeutic approach. Phoenix dactylifera L. (date palm) is used in folk medicine to treat warts. Antiviral effects of P. dactylifera L. have been demonstrated due to its polyphenolic compounds, especially gallic acid and tannins in various studies. So, this trial evaluates the efficacy and safety of P. dactylifera L. leaf extract (formulated as WartOver®) as a novel treatment for cutaneous warts. Study Design. Based on the results of our previously published pilot clinical trial and the CONSORT guideline, this randomized, double-blind, and placebo-controlled study was performed on 70 eligible patients divided into intervention and placebo groups (N = 35/per group). Every 2 weeks, patients were examined to assess the rate of complete clearance, duration of treatment, patient satisfaction (measured using a Likert scale), and occurrence of any adverse effects and recurrence in a maximum of 12 weeks of treatment and at the 6-month follow-up. Results. Based on the intention-to-treat (ITT) analysis approach, complete clearance was achieved in 24 patients in the intervention group (68.57%; confidence interval 95% = 0.51–0.81), which was significantly higher than that in the placebo group (8.57%; CI 95% = 0.02–0.23, p < 0.0001). The time to complete clearance was 7.6 weeks (mean ± SD: 53.30 ± 17.17 days). The treatment was very satisfactory (Likert score of 4.24 ± 1.15 (mean ± SD)) with no recurrence or adverse effects. Conclusion. WartOver® is a novel efficacious treatment for cutaneous warts with minimal risk for adverse events or recurrence. Due to the rising popularity of CAM approaches in medicine, including herbal medicines, WartOver® can be a valuable choice for clinicians against cutaneous warts. This trial is registered with IRCT20200509047352N2.
期刊介绍：
Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.
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