{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:56:20Z","timestamp":1782845780135,"version":"3.54.5"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T00:00:00Z","timestamp":1724803200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100012166","name":"National Key Research and Development Program of China","doi-asserted-by":"publisher","award":["2022YFC3602203"],"award-info":[{"award-number":["2022YFC3602203"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012166","name":"National Key Research and Development Program of China","doi-asserted-by":"publisher","award":["2022YFC3602200"],"award-info":[{"award-number":["2022YFC3602200"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012166","name":"National Key Research and Development Program of China","doi-asserted-by":"publisher","award":["2022YFC3602202"],"award-info":[{"award-number":["2022YFC3602202"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2024,11]]},"abstract":"Abstract<\/jats:title>\n \n Objective<\/jats:title>\n To explore the efficacy and safety of 5% lidocaine\u2010medicated plaster (LMP) in patients with trigeminal neuralgia (TN).<\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n TN is an excruciatingly painful type of neuropathic facial pain. Anti\u2010epileptics are the first\u2010line treatment for TN; however, these oral drugs alone sometimes fail to achieve satisfactory analgesic effects. Two retrospective studies have shown that LMP can be an effective and safe treatment option for some patients with TN. No other high\u2010quality clinical studies have explored the effect and safety of LMP in patients with TN.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n The PATCH trial is an enriched enrollment with randomized withdrawal, double\u2010blind, vehicle\u2010controlled, parallel\u2010group trial performed at five study centers. Eligible patients with TN received LMP during a 3\u2010week initial open\u2010label phase. Patients who met the response criteria entered the double\u2010blind treatment phase and were randomly assigned for treatment with either LMP (LMP group) or vehicle patches (control group) at a 1:1 ratio. Patients who met the criteria for treatment failure were withdrawn from the double\u2010blind treatment phase, and treatment was continued in the remaining patients for up to 28\u2009days. The primary outcome was the number of treatment failures. The secondary endpoints were the time to loss of therapeutic response (LTR) in the double\u2010blind phase and the weekly mean pain severity in both the open\u2010label phase and the double\u2010blind phase of the study.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The first patient was enrolled in this study on May 1, 2021, and the enrollment of the last patient was completed on August 26, 2022. A total of 307 patients were initially screened, 226 (74.0%) of whom entered the open\u2010label phase. Of the 226 respondents, 124 (55.0%) were randomized to the double\u2010blind phase. In the double\u2010blind phase, 62 patients were assigned to the LMP group, and 62 were assigned to the control group. For the primary endpoint, 16 (26.0%) patients with LMP and 36 (58.0%) patients with vehicle patches met the treatment failure criteria during the double\u2010blind phase (relative risk, 0.48; 95% confidence interval [CI], 0.31 to 0.75;\n p<\/jats:italic>\n \u2009<\u20090.001). The survival curve of the LTR showed that the LTR of LMP was significantly longer than that of the vehicle patches (hazard ratio, 0.275; 95% CI, 0.15 to 0.50; log\u2010rank\n p<\/jats:italic>\n \u2009<\u20090.001). LMP also significantly reduced the weekly mean pain severity in the double\u2010blind phase of the study (\n p<\/jats:italic>\n \u2009=\u20090.007).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n LMP produced partial relief of pain symptoms in some patients with TN. For responders, LMP may be used as an add\u2010on therapy in a multidrug treatment protocol.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/head.14814","type":"journal-article","created":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T06:04:34Z","timestamp":1724825074000},"page":"1318-1328","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["The\n PATCH<\/scp>\n trial: 5% lidocaine\u2010medicated plaster for trigeminal neuralgia\u2014Results of a multicentric, enriched enrollment, randomized withdrawal, double\u2010blind, vehicle\u2010controlled, parallel\u2010group study"],"prefix":"10.1111","volume":"64","author":[{"given":"Chunmei","family":"Zhao","sequence":"first","affiliation":[{"name":"Department of Pain Management, Beijing Tiantan Hospital Capital Medical University Beijing 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