Abstract
BackgroundDangguixu-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).MethodsThis 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).ResultsForty-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.ConclusionsOverall, 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 registrationClinical Research Information Service KCT0002374. Registered on July 11, 2017; retrospectively registered.
Highlights
Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain
Lateral ankle sprains are one of the most common injuries experienced during athletic or recreational activities [1], and they are more serious than commonly believed because, in addition to causing immediate-onset pain, swelling, and loss of joint motion, they progress to chronic ankle instability (CAI) in a third of patients [2,3,4]
Dangguixu-san (DS), which is composed of Angelicaegigantis Radix, PaeoniaeRadix, Linderae Radix, Cyperi Rhizoma, Sappan Lignum, Carthami Flos, Persicae Semen, Cinnamomi Cortex, and Glycyrrhizae Radix et Rhizoma, promotes blood circulation and relieves blood stasis; it is most frequently used for the treatment of traumatic ecchymosis and pain [18, 19] and is recommended for the treatment of ankle sprain [11]
Summary
Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. Lateral ankle sprains are one of the most common injuries experienced during athletic or recreational activities [1], and they are more serious than commonly believed because, in addition to causing immediate-onset pain, swelling, and loss of joint motion, they progress to chronic ankle instability (CAI) in a third of patients [2,3,4]. CAI is characterized by residual symptoms, including a feeling of “giving way” and instability, recurrent ankle sprains, and functional loss after acute ankle sprains [5]. It reduces physical activity (because of persistent ankle pain, stiffness, weakness, and instability) and leads to the development of posttraumatic ankle osteoarthritis [6, 7]. In addition to conventional treatments, complementary and alternative therapies such as acupuncture, herbs, cupping therapy, taping, and chuna have been used for the treatment of ankle sprains [11]
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