Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial
Abstract Background Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. Accordingly, we assessed the efficacy and safety of DS for the treatmen...
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| Format: | Article |
| Language: | English |
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BMC
2021-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05135-6 |
| _version_ | 1818911920997007360 |
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| author | Jae-Hong Kim Cham-Kyul Lee Eun-Yong Lee Myoung-Rae Cho Young-Su Lee Jeong-Soon Lee |
| author_facet | Jae-Hong Kim Cham-Kyul Lee Eun-Yong Lee Myoung-Rae Cho Young-Su Lee Jeong-Soon Lee |
| author_sort | Jae-Hong Kim |
| collection | DOAJ |
| description | Abstract Background Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. Accordingly, we assessed the efficacy and safety of DS for the treatment of acute lateral ankle sprain (ALAS). Methods This study was a multicenter (two Korean hospitals), randomized, double-blind, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio that included a per-protocol analysis and sub-analysis based on symptom severity. Forty-eight participants (n = 28 at Semyung University Korean Medicine Hospital in Chungju; n = 20 at DongShin University Gwangju Korean Medicine Hospital) with grade I or II ALAS that occurred within 72 h before enrollment were randomized to a DS (n = 24) or placebo (n = 24) group. Both groups received acupuncture treatment once daily for 5 consecutive days and the trial medication (DS/placebo capsule) three times a day for 7 consecutive days. Primary (visual analog scale [VAS] scores for pain) and secondary (Foot and Ankle Outcome Scores [FAOS], edema, and European Quality of Life Five-Dimension-Five-Level Scale [EQ-5D-5L] scores) outcome measures were recorded at baseline (week 0), the end of the intervention (week 1), and 4 weeks after treatment completion (week 5). Results Forty-six participants completed the trial (n = 23 each). Changes in VAS scores, FAOS Symptom/Rigidity, and FAOS Ache from week 1 to week 5 showed significant differences between the two groups. Sub-analyses showed significant differences in changes of FAOS Ache (week 0 to week 5) and VAS scores, total FAOS, and EQ-5D-5L scores (week 1 to week 5) between the two subgroups (grade II). There were no adverse events and significant negative changes in clinical laboratory parameters in both groups. Conclusions Overall, the results of this study are in favor of DS combined with acupuncture and suggest that DS combined with acupuncture is a safe treatment with positive long-term effects in terms of pain reduction and symptom alleviation in patients with grade I or II ALAS. Trial registration Clinical Research Information Service KCT0002374 . Registered on July 11, 2017; retrospectively registered. |
| first_indexed | 2024-12-19T23:06:22Z |
| format | Article |
| id | doaj.art-cc32cfa5a7c94d518181ee14196413b9 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T23:06:22Z |
| publishDate | 2021-03-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-cc32cfa5a7c94d518181ee14196413b92022-12-21T20:02:22ZengBMCTrials1745-62152021-03-0122111210.1186/s13063-021-05135-6Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trialJae-Hong Kim0Cham-Kyul Lee1Eun-Yong Lee2Myoung-Rae Cho3Young-Su Lee4Jeong-Soon Lee5Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, DongShin UniversityDepartment of Acupuncture and Moxibustion Medicine, Semyung University Korean Medicine Hospital in ChungjuDepartment of Acupuncture and Moxibustion Medicine, Semyung University Korean Medicine Hospital in ChungjuDepartment of Acupuncture and Moxibustion Medicine, College of Korean Medicine, DongShin UniversityDepartment of Korean Internal Medicine, DongShin University Gwangju Korean Medicine HospitalDepartment of Nursing, Christian College of NursingAbstract Background Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. Accordingly, we assessed the efficacy and safety of DS for the treatment of acute lateral ankle sprain (ALAS). Methods This study was a multicenter (two Korean hospitals), randomized, double-blind, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio that included a per-protocol analysis and sub-analysis based on symptom severity. Forty-eight participants (n = 28 at Semyung University Korean Medicine Hospital in Chungju; n = 20 at DongShin University Gwangju Korean Medicine Hospital) with grade I or II ALAS that occurred within 72 h before enrollment were randomized to a DS (n = 24) or placebo (n = 24) group. Both groups received acupuncture treatment once daily for 5 consecutive days and the trial medication (DS/placebo capsule) three times a day for 7 consecutive days. Primary (visual analog scale [VAS] scores for pain) and secondary (Foot and Ankle Outcome Scores [FAOS], edema, and European Quality of Life Five-Dimension-Five-Level Scale [EQ-5D-5L] scores) outcome measures were recorded at baseline (week 0), the end of the intervention (week 1), and 4 weeks after treatment completion (week 5). Results Forty-six participants completed the trial (n = 23 each). Changes in VAS scores, FAOS Symptom/Rigidity, and FAOS Ache from week 1 to week 5 showed significant differences between the two groups. Sub-analyses showed significant differences in changes of FAOS Ache (week 0 to week 5) and VAS scores, total FAOS, and EQ-5D-5L scores (week 1 to week 5) between the two subgroups (grade II). There were no adverse events and significant negative changes in clinical laboratory parameters in both groups. Conclusions Overall, the results of this study are in favor of DS combined with acupuncture and suggest that DS combined with acupuncture is a safe treatment with positive long-term effects in terms of pain reduction and symptom alleviation in patients with grade I or II ALAS. Trial registration Clinical Research Information Service KCT0002374 . Registered on July 11, 2017; retrospectively registered.https://doi.org/10.1186/s13063-021-05135-6Ankle sprainDangguixu-sanHerbal medicineRandomized controlled trial |
| spellingShingle | Jae-Hong Kim Cham-Kyul Lee Eun-Yong Lee Myoung-Rae Cho Young-Su Lee Jeong-Soon Lee Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial Trials Ankle sprain Dangguixu-san Herbal medicine Randomized controlled trial |
| title | Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial |
| title_full | Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial |
| title_fullStr | Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial |
| title_full_unstemmed | Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial |
| title_short | Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial |
| title_sort | effects of dangguixu san in patients with acute lateral ankle sprain a randomized controlled trial |
| topic | Ankle sprain Dangguixu-san Herbal medicine Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-021-05135-6 |
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