Exploring the efficacy and safety of topical Jaungo application in patients with atopic dermatitis: A pilot randomized, double-blind, placebo-controlled study.

BACKGROUND: Atopic dermatitis (AD) is a chronic relapsing eczematous skin disease with an increasing prevalence. In Korea, Jaungo is a traditional medicinal ointment, which is commonly used for treating skin wounds. OBJECTIVE: Thus, we aim to explore the basic clinical efficacy and safety data for Jaungo in patients with AD. METHODS: This study was a pilot randomized, double-blind, placebo-controlled, single-center trial with three groups. The participants in treatment group 1 applied Jaungo to the lesion twice a day for 3 weeks. Those in treatment group 2 applied Jaungo and placebo ointments to the lesion once a day for 3 weeks. Those in the placebo group applied placebo ointments to the lesion twice a day for 3 weeks. The Eczema Area and Severity Index and SCORing Atopic Dermatitis scores, transepidermal water loss value, and Dermatology Life Quality Index score were assessed. The outcomes used to evaluate safety were the Draize score, blood test results, and expert opinion. RESULTS: In total, 28 patients (82.4%) completed the study. During the study, significant decline of EASI scores in treatment group 2 and placebo group was observed (p < 0.05). And there was significant decline of SCORAD scores in treatment group1 and placebo group (p < 0.05). Patients in all groups showed decreased TEWL and DLQI scores with no significant difference. There was significant decline of IL-17 in all groups (p < 0.05). No serious adverse event was observed. CONCLUSION: This is the first study that has explored the potential therapeutic effect of Jaungo as a complementary therapy for AD. However, further large study with adjusting placebo ingredients is needed to confirm the effectiveness of Jaungo in patients with chronic-phase AD.

Three Cases of Cutaneous Warts Treated With Moxibustion.

Moxibustion is a treatment that uses thermal stimulation generated when herbal materials are burned, indirectly or directly, on the affected area or acupoint. Three cases are presented to report the efficacy of direct moxibustion on cutaneous warts. Three patients with chronic cutaneous warts received direct moxibustion made of Artemisia argyi (Dongbang Inc., Chungnam, Korea). Moxa burning was performed using moxa cones. Approximately 80% of a cone was burned, until patients reported feeling a burning sensation, at which time the cone was removed and another one burned. As part of this approach, patients underwent 5-19 moxibustion procedures during and after wart removal. After warts were completely eliminated, moxa burning was performed on each patient until approximately 60% of a cone was burned or the patient felt heat sensitization but no pain. In these cases, moxibustion seemed to have an effect on cutaneous warts. A possible mechanism is that direct moxibustion likely induces tissue damage from burning and, subsequently, a wound healing effect at a different temperature level. Our reports suggest that it would be worthwhile to conduct further studies on the safety and efficacy of moxibustion on warts or to develop a medical device that uses modified moxibustion.

Autonomic conditions in tinnitus and implications for korean medicine.

Tinnitus patients suffer from not only auditory sensations but also physical, mental, and social difficulties. Even though tinnitus is believed to be associated with the autonomic nervous system, changes in autonomic conditions in tinnitus patients are not receiving much research attention. The aims of this study were to investigate the autonomic condition of tinnitus patients and to consider Korean medicine in the treatment of tinnitus with an evidence-based approach. We performed a retrospective chart review and compared the heart rate variability (HRV) parameters of 40 tinnitus patients (19 acute and 21 chronic) and 40 healthy controls. In tinnitus patients, the power of the high frequency component and total power of the HRV significantly decreased (P < 0.05), and the low frequency to high frequency ratio significantly increased (P < 0.05). There was no significant difference between the acute and chronic patients. When comparing each group with the controls, there was a tendency that the longer the duration of tinnitus was, the larger the observed HRV change was. In conclusion, tinnitus patients have vagal withdrawal and sympathetic overactivity, and chronic tinnitus more strongly affects autonomic conditions than acute tinnitus. This study provides evidence for Korean medical treatments of tinnitus, such as acupuncture and Qi-training, that cause modulation of cardiac autonomic function.

Three cases of atopic dermatitis in pregnant women successfully treated with Korean medicine.

BACKGROUND: Korean medicine (KM) is used in many patients with atopic dermatitis (AD), which is commonly aggravated during pregnancy. However, to date, no previous studies have reported the safety and efficacy of complementary and alternative medicine (CAM) therapy for pregnant patients with AD and their fetus in clinical practice. SUBJECTS: Three pregnant women were suffering from AD that first appeared or was aggravated during pregnancy. They would not have received conventional treatments for AD during their pregnancy. INTERVENTIONS AND OUTCOME MEASURES: They were treated with KM, including acupuncture, herbal medicine, and herbal wet dressing. The severity of AD was assessed with the SCORAD (Severity Scoring Atopic Dermatitis) index. Liver and renal function tests were performed. We noted adverse events on maternity, fetus or neonate and evaluated the side effects of KM therapy. RESULTS: AD symptoms improved after treatment. There was no hepatic or renal toxicity, nor were there any adverse maternal, fetal or neonatal effects. CONCLUSIONS: This study is meaningful as the first case series of AD in pregnant women successfully treated with KM therapy including herbal medicine, acupuncture, and herbal wet dressings.

Detoxification combining fasting with fluid therapy for refractory cases of severe atopic dermatitis.

To introduce and determine the clinical benefits of a detoxification program that combines fasting with fluid therapy for refractory cases of severe atopic dermatitis (AD), we performed a retrospective chart review of inpatients with AD from March 2010 to February 2012 at the Department of Ophthalmology, Otorhinolaryngology and Dermatology of Korean Medicine in the Kyung Hee Medical Center. Patients were treated with the detoxification program, which combined fasting with fluid therapy, and herbal medicine, herbal wet wrap dressings, or acupuncture treatment when clinically necessary. The primary outcome was the SCORAD total index. The secondary outcome was the pruritus visual analogue scale (VAS) score in SCORAD as evaluated by a trained dermatology specialist. Among the 130 inpatients that have done detoxification, 7 patients met the inclusion criteria. The mean total SCORAD scores significantly decreased from 64.67 ± 11.72 to 26.26 ± 11.01 (P = 0.018) after the detoxification program. There was also a significant decrease in VAS score for pruritus from 8.00 ± 1.16 to 2.57 ± 0.98 (P = 0.016) between admission and discharge. We suggest that fasting with fluid therapy as a complementary and alternative treatment method may provide some benefits for patients with refractory cases of severe atopic dermatitis.

Long-term effect of acupuncture for treatment of tinnitus: a randomized, patient- and assessor-blind, sham-acupuncture-controlled, pilot trial.

OBJECTIVE: The aim of this study was to investigate the long-term effect of acupuncture for treatment of tinnitus. STUDY DESIGN: This study is a randomized, patient- and assessor-blind, sham-acupuncture-controlled, pilot trial. SUBJECTS: Participants were adults (18-60 years old) with chronic (≥6 months), unilateral tinnitus, and without moderate or severe hearing loss. INTERVENTIONS: Thirty-three (33) participants were randomized to one of two treatment groups: real acupuncture and sham-acupuncture (nonmeridian; no specific response, de qi). Participants received 10 sessions of acupuncture treatment (twice a week for 5 weeks), and usual patient care education. OUTCOME MEASURES: The subjective outcome was the score of Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) from baseline to 3 months after. Pure Tone Average (PTA) and Speech Discrimination (SD) from baseline to 3 months after were assessed as objective outcomes. RESULTS: A significant interaction between time and group in VAS (p=0.017) was evident, but not in THI, PTA, and SD scores. THI showed significant improvement at the end of treatment and 3 months after, compared to baseline, in real acupuncture (p=0.004). In SD, a significant long-term effect of real acupuncture was observed until 3 months after (p=0.011). However, the effect of real acupuncture in PTA was not maintained until 3 months after the end of treatment. No significant difference in the sham-acupuncture treatment group was evident. No statistical difference in any outcome was observed between real and sham acupuncture. Only in the mean percent change of VAS, real acupuncture showed statistical significance, compared with sham-acupuncture from baseline to 3 months after (p=0.019). CONCLUSIONS: Through evaluation of subjective (THI and VAS) and objective outcomes (PTA and SD), this study demonstrates the long-term effect of real acupuncture.

Anti-inflammatory effect of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: a randomized controlled pilot trial.

OBJECTIVES: The objectives of this study were to evaluate the efficacy and interaction of Keigai-rengyo-to extract (KRTE) and acupuncture in male patients with acne and the feasibility of a large clinical trial. DESIGN: A randomized, assessor single-blinded, 2×2 factorial trial was conducted. The trial is registered with the Clinical Research Information Service, Republic of Korea: KCT0000071. SUBJECTS: Forty-four (44) participants with acne vulgaris were randomized into one of four groups: waiting list group (WL), KRTE only group (KO), acupuncture only group (AO), and KRTE and acupuncture combined treatment group (KA). INTERVENTION: After randomization, patients in the AO and KA groups underwent eight sessions of acupuncture treatment, twice per week. Patients in the KO and KA groups were prescribed KRTE 3 times daily, 7.4 g each dose, after meals, for 4 weeks. OUTCOME MEASURES: The following outcome measurements were used in examination of subjects: mean percentage change and the count change of inflammatory and noninflammatory acne lesions, Skindex 29, investigator global assessment from baseline to end of trial, and proportion of dropouts and compliance with KRTE. RESULTS: A significant interaction of KRTE and acupuncture was evident according to mean percent change of inflammatory acne lesions, but not of noninflammatory acne lesions from baseline to the end of the study. Statistically significant differences were observed in the primary effect on mean percent change of noninflammatory acne lesions, not by acupuncture, but by KRTE. Adjusted Skindex 29 score changes indicated no statistically significant reduction within groups and between groups. The improvement rate in patients with KRTE and acupuncture treatment was not significant, compared to patients with no KRTE and acupuncture treatment. The proportion of dropouts was 22.7% and rate of compliance with KRTE was 92.3%. CONCLUSIONS: For treatment of acne vulgaris, use of KRTE combined with acupuncture is recommended for inflammatory lesions and KRTE only is recommended for noninflammatory lesions. Further large-scale trials assuming a higher dropout rate and aimed at confirming the ability of KRTE and acupuncture to improve inflammatory and noninflammatory lesions in patients with acne are needed.

Clinical effect of pricking blood at neiyingxiang (ExHN 9) on non-allergic rhinopathy: study protocol for a randomized controlled trial.

BACKGROUND: Non-allergic rhinopathy (NAR), formerly known as vasomotor rhinitis, is a non-allergic and non-infectious chronic disease that is accompanied by nasal hyperemia, rhinorrhea, and no increase in the number of eosinophils. Although the medications for NAR, including intranasal corticosteroids and intranasal antihistamine, have been used in clinical practice, given the relative paucity of effective therapy with available medications, alternative non-pharmacologic treatments could play an important role in treating NAR. Acupuncture treatment is representative potential alternative therapy for the treatment of various diseases, including rhinitis. Therefore, the objective of this study was to evaluate the efficacy of pricking blood at Neiyingxiang (ExHN 9) relative to acupuncture treatment at Waiyingxiang (LI 20) in patients with NAR. METHODS/DESIGN: A randomized, parallel-group, controlled, assessor single-blinded, trial will be conducted. Fifty participants with NAR will be randomized into one of two groups: either the control group with acpuncture treatment at LI 20 or the experimental group with pricking blood at ExHN 9. After randomization, a total of three sessions of treatment will be performed once a week in both groups. The total nasal symptom score (TNSS) and the Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire (MiniRQLQ) at baseline and the end of the trial will be used to evaluate the efficacy of each treatment. DISCUSSION: This study will be the first randomized trial to evaluate the efficacy of pricking blood for the treatment of NAR. The results of this study will help establish an alternative approach for treating patients with NAR that do not respond to Western medication.

Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: a study protocol for a randomized controlled pilot trial.

BACKGROUND: In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering these methodological flaws, this study was designed to assess the interaction and efficacy of an available herbal medicine, Keigai-rengyo-to extract (KRTE), and acupuncture for treatment of acne using the 2 × 2 factorial design and the feasibility of a large clinical trial. METHODS/DESIGN: A randomized, assessor single blinded, 2 × 2 factorial pilot trial will be conducted. Forty four participants with acne vulgaris will be randomized into one of four groups: waiting list group (WL), KRTE only group (KO), acupuncture only group (AO), and KRTE and acupuncture combined treatment group (KA). After randomization, a total of 8 sessions of acupuncture treatment will be performed twice a week in the AO- and KA groups, respectively. Patients in the KO- and KA groups will be prescribed KRTE 3 times a day at a dose of 7.4 g after meals for 4 weeks. The following outcome measurements will be used in examination of subjects: the mean percentage change and the count change of inflammatory and non-inflammatory acne lesions, the Skindex 29, visual analogue scale (VAS) and investigator global assessment (IGA) from baseline to the end of the trial. TRIAL REGISTRATION: The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0000071.

Enhanced hypothalamic leptin signaling in mice lacking dopamine D2 receptors.

The dopamine D(2) receptor (D2R) plays a critical role in diverse neurophysiological functions. D2R knock-out mice (D2R(-/-)) show reduced food intake and body weight while displaying an increased basal energy expenditure level, compared with their wild type littermates. Thus, these mice show a lean phenotype. D2R(-/-) mice displayed increased leptin sensitivity, and leptin injection induced increased phosphorylation of the hypothalamic signal transducer and activator of transcription 3 (STAT3) in D2R(-/-) mice relative to wild type littermates. Using double immunofluorescence histochemistry, we have demonstrated that D2Rs are present in leptin-sensitive STAT3-positive cells in the arcuate nucleus of the hypothalamus and that leptin injection induces STAT3 phosphorylation in hypothalamic neurons expressing D2Rs. Stimulation of D2R by the D2R agonist quinpirole suppressed the leptin-induced STAT3 phosphorylation and nuclear trans-localization of phospho-STAT3 in the hypothalamus of wild type mice. However, this regulation was not detected in the D2R(-/-) mice. Treatment of D2R agonist and antagonist could modulate the leptin-induced food intake and body weight changes in wild type mice but not in D2R(-/-) mice. Together, our findings suggest that the interaction between the dopaminergic system and leptin signaling in hypothalamus is important in control of energy homeostasis.