Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial.

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.

Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial.

BACKGROUND: Ankle sprain is a common musculoskeletal injury. In Korean medicine, blood stasis is thought to be the main cause of pain and swelling in patients with ankle sprain. Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine for the treatment of traumatic ecchymosis and pain by promoting blood circulation and relieving blood stasis. However, the effects of DS on ankle sprain have not been evaluated in a randomized clinical trial. Here, we describe the protocol for a randomized controlled trial that will evaluate the efficacy and safety of DS for the treatment of ankle sprain. METHODS/DESIGN: In this randomized, double-blinded, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio, participants (n = 48) with acute lateral ankle sprain (ALAS) that occurred within 72 h before enrollment will be randomly assigned to a DS (n = 24) or a placebo (n = 24) group. Both groups will receive acupuncture treatment once a day for 5 days a week (excluding Saturday and Sunday) and the trial medication (DS/placebo capsule) three times a day for seven consecutive days. The primary outcome measure will be pain relief evaluated using a Visual Analog Scale (VAS). Secondary outcome measures will include Foot and Ankle Outcome Scores (FAOS), edema, European Quality of Life Five-Dimension-Five-Level Scale (EQ-5D-5 L) scores, and the number of recurrent ankle sprains. VAS, FAOS, edema, and EQ-5D-5 L scores will be recorded before, at the end of, and at 4 weeks after treatment completion. EQ-5D-5 L scores will be additionally recorded at 26 weeks after treatment completion. The number of recurrent ankle sprains will be recorded at 4, 8, 12, and 26 weeks after treatment completion. DISCUSSION: This study is expected to provide evidence regarding the efficacy, safety, and usefulness of DS for the treatment of ALAS. TRIAL REGISTRATION: cris.nih.go.kr, registration number: KCT 0002374 . Registered on 11 July, 2017 and approved by the Ministry of Food and Drug Safety (registration number, 31244).

A Retrospective Analysis of Patients' Conditions Using Acupuncture in a Traditional Korean Medicine Hospital.

Objective. The aim of this study was to identify the patient demographics, health issues, and type of acupuncture treatments who visited a traditional Korean medical hospital for acupuncture treatment. Methods. We retrospectively analysed the data using the electronic medical records (EMRs) of patients treated with at least one treatment of acupuncture from 1 January 2010 to December 2012 in the Chung-Ju Korean hospital at Semyung University. Results. The total number of identified patients was 1189 inpatients and 10138 outpatients. The 50-59 age group received acupuncture treatment in the hospital the most, followed by the 40-49 age group. Among the patients undergoing acupuncture treatment because of a diagnosis of pain, 82.74% were outpatients and 72.85% were inpatients. Additionally, all patients with a spine condition received acupuncture treatment. The most common musculoskeletal conditions of patients at the traditional Korean medicine (TKM) hospital were associated with spine conditions, such as low back pain and neck pain. Various treatments have been performed at the hospital in conjunction with acupuncture. The study results show a high prevalence of acupuncture treatment for diagnosed diseases. Conclusion. Our study suggests the need to investigate additional TKM hospitals to analyse characteristics of patients who received specific treatments. Analysis of the characteristics of patients treated with Korean acupuncture at the TKM hospital in this study will help future researchers who want to implement strong clinical evidence. However, we cannot completely discount all symptoms because of the retrospective nature of this study, and only one hospital was used, which limits the generalisation of our findings.

Effects of Salviae Miltiorrhizae Radix Hot Aqueous Extract on Nitric Oxide and Prostaglandin E2 Production and on 1,1-diphenyl-2-picryl hydrazyl Radical Scavenging in Macrophages.

OBJECTIVES: The objective of this study is to investigate the effects of Salviae Miltiorrhizae Radix hot aqueous extract on nitric oxide (NO) and prostaglandin E2 (PGE2 ) production and on 1,1-diphenyl-2-picryl hydrazyl (DPPH) free-radical scavenging in macrophages. METHODS: Salviae Miltiorrhizae Radix(300 g) was heated at 100℃ with distilled water (2 L) for 4 hours. The extract was filtered and concentrated to 100 mL by using a rotary evaporator, was frozen at -80℃, and was then freeze-dried by using a freezing-drying system. The RAW 264.7 macrophage was subcultured by using 10-㎍/mL lipopolysaccharide (LPS). In order to evaluate cytotoxicity, we performed (3-(4,5-dimrthylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) (MTT) assays and measured the cell viability. The NO production was measured by using Griess assays, and the PGE2 production was measured by using enzyme immunoassays. The antioxidant activity, the DPPH free-radical scavenging capability, was measured by using the DPPH method. RESULTS: Cell viability with the 1-, 5-, 25-, 125- and 625-㎍/mL Salviae Miltiorrhizae Radix hot aqueous extract was not significantly decreased compared to the cell viability without the extract. When 125 and 625 ㎍/mL of Salviae Miltiorrhizae Radix hot aqueous extract were used, NO production in LPS-stimulated RAW 264.7 macrophages was significantly inhibited compared to that in the control group. When 25, 125, and 625 ㎍/mL of Salviae Miltiorrhizae Radix hot aqueous extract were used, PGE2 production in LPS-stimulated RAW 264.7 macrophages was significantly inhibited compared to that in the control group. The 125- and 625-㎍/mL Salviae Miltiorrhizae Radix hot aqueous extracts had high DPPH free-radical scavenging capabilities in RAW 264.7 macrophages. CONCLUSION: This study indicates that Salviae Miltiorrhizae Radix hot aqueous extract suppresses NO and PGE2 production and improves DPPH free-radical scavenging capability. Thus, it seems that Salviae Miltiorrhizae Radix hot aqueous extract may have an anti-inflammation effect and antioxidant activity.