{"title":"一项疗效和安全性的随机安慰剂对照试验:含有超可变形磷脂囊泡(TDT 064)的无药凝胶治疗骨关节炎膝关节。","authors":"Varah Yuenyongviwat, Khanin Iamthanaporn, Pakjai Tuntarattanapong, Theerawit Hongnaparak, Boonsin Tangtrakulwanich","doi":"10.1177/11795441211031338","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>There are a number of topical agents that are used for treatment of knee osteoarthritis. Drug-free gels, containing ultra-deformable phospholipid vesicles (TDT 064) are one such topical therapy, which have been stated to act as a bio lubricant. However, the evidence of TDT 064 in treatment of knee osteoarthritis is limited. Hence, the aim of this study was to evaluate the efficacy of pain control as a primary outcome and safety of TDT 064 compared with a topical placebo.</p><p><strong>Methods: </strong>Sixty-four patients with primary osteoarthritis, with radiographic showing Kellgren and Lawrence classification grade II to III, were randomized into 2 groups. In the first group of 32 patients TDT 064 was used as topical agent, whilst in the second group of 32 patients a placebo identical in appearance was used instead. The verbal numerical rating scale (VNRS) was used for recording pain levels, Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) as well as amounts of rescue medication were also recorded. The data were recorded at the start of the study, and then at follow-up appointments of 14 days, 6 weeks, and 3 months.</p><p><strong>Results: </strong>The mean VNRS for pain in both groups were significantly improved, when compared to the start of treatment (<i>P</i> < .0001); however, there were no differences between groups at any follow up visit. KOOS in all subscales were not significantly different between both groups at baseline and at the end of treatment. However, the average amount of NSAIDs in the TDT 064 group was 26.39 ± 22.11 tabs, which was significantly lower than the control group; which used an average 37.03 ± 19.22 tabs in 3 months (<i>P</i> = .047).</p><p><strong>Conclusions: </strong>There were no differences in the VNRS for pain and KOOS scores between the active and placebo groups. Although, TDT 064 could decrease usage of rescue medication the difference with use of a placebo was minimal. Further, larger trials would also be beneficial to demonstrate any differences between TDT 064 and a placebo.</p><p><strong>Trial registration: </strong>TCTR, TCTR 20190302001. Registered 1 March, 2019: http://www.clinicaltrials.in.th.</p>","PeriodicalId":10443,"journal":{"name":"Clinical Medicine Insights. Arthritis and Musculoskeletal Disorders","volume":"14 ","pages":"11795441211031338"},"PeriodicalIF":1.9000,"publicationDate":"2021-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/11795441211031338","citationCount":"0","resultStr":"{\"title\":\"A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees.\",\"authors\":\"Varah Yuenyongviwat, Khanin Iamthanaporn, Pakjai Tuntarattanapong, Theerawit Hongnaparak, Boonsin Tangtrakulwanich\",\"doi\":\"10.1177/11795441211031338\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>There are a number of topical agents that are used for treatment of knee osteoarthritis. Drug-free gels, containing ultra-deformable phospholipid vesicles (TDT 064) are one such topical therapy, which have been stated to act as a bio lubricant. However, the evidence of TDT 064 in treatment of knee osteoarthritis is limited. Hence, the aim of this study was to evaluate the efficacy of pain control as a primary outcome and safety of TDT 064 compared with a topical placebo.</p><p><strong>Methods: </strong>Sixty-four patients with primary osteoarthritis, with radiographic showing Kellgren and Lawrence classification grade II to III, were randomized into 2 groups. In the first group of 32 patients TDT 064 was used as topical agent, whilst in the second group of 32 patients a placebo identical in appearance was used instead. The verbal numerical rating scale (VNRS) was used for recording pain levels, Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) as well as amounts of rescue medication were also recorded. The data were recorded at the start of the study, and then at follow-up appointments of 14 days, 6 weeks, and 3 months.</p><p><strong>Results: </strong>The mean VNRS for pain in both groups were significantly improved, when compared to the start of treatment (<i>P</i> < .0001); however, there were no differences between groups at any follow up visit. KOOS in all subscales were not significantly different between both groups at baseline and at the end of treatment. However, the average amount of NSAIDs in the TDT 064 group was 26.39 ± 22.11 tabs, which was significantly lower than the control group; which used an average 37.03 ± 19.22 tabs in 3 months (<i>P</i> = .047).</p><p><strong>Conclusions: </strong>There were no differences in the VNRS for pain and KOOS scores between the active and placebo groups. Although, TDT 064 could decrease usage of rescue medication the difference with use of a placebo was minimal. Further, larger trials would also be beneficial to demonstrate any differences between TDT 064 and a placebo.</p><p><strong>Trial registration: </strong>TCTR, TCTR 20190302001. Registered 1 March, 2019: http://www.clinicaltrials.in.th.</p>\",\"PeriodicalId\":10443,\"journal\":{\"name\":\"Clinical Medicine Insights. Arthritis and Musculoskeletal Disorders\",\"volume\":\"14 \",\"pages\":\"11795441211031338\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2021-07-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1177/11795441211031338\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Medicine Insights. Arthritis and Musculoskeletal Disorders\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/11795441211031338\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Medicine Insights. Arthritis and Musculoskeletal Disorders","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/11795441211031338","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees.
Background: There are a number of topical agents that are used for treatment of knee osteoarthritis. Drug-free gels, containing ultra-deformable phospholipid vesicles (TDT 064) are one such topical therapy, which have been stated to act as a bio lubricant. However, the evidence of TDT 064 in treatment of knee osteoarthritis is limited. Hence, the aim of this study was to evaluate the efficacy of pain control as a primary outcome and safety of TDT 064 compared with a topical placebo.
Methods: Sixty-four patients with primary osteoarthritis, with radiographic showing Kellgren and Lawrence classification grade II to III, were randomized into 2 groups. In the first group of 32 patients TDT 064 was used as topical agent, whilst in the second group of 32 patients a placebo identical in appearance was used instead. The verbal numerical rating scale (VNRS) was used for recording pain levels, Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) as well as amounts of rescue medication were also recorded. The data were recorded at the start of the study, and then at follow-up appointments of 14 days, 6 weeks, and 3 months.
Results: The mean VNRS for pain in both groups were significantly improved, when compared to the start of treatment (P < .0001); however, there were no differences between groups at any follow up visit. KOOS in all subscales were not significantly different between both groups at baseline and at the end of treatment. However, the average amount of NSAIDs in the TDT 064 group was 26.39 ± 22.11 tabs, which was significantly lower than the control group; which used an average 37.03 ± 19.22 tabs in 3 months (P = .047).
Conclusions: There were no differences in the VNRS for pain and KOOS scores between the active and placebo groups. Although, TDT 064 could decrease usage of rescue medication the difference with use of a placebo was minimal. Further, larger trials would also be beneficial to demonstrate any differences between TDT 064 and a placebo.
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