[show abstract][hide abstract] ABSTRACT: Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture.Methods/designs: This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit.
This pilot multicentre randomised controlled trial will explore the feasibility of further auricular acupuncture research and provide important clinical evidence for the effect and safety of auricular acupuncture on blood pressure in patients with prehypertension and stage 1 hypertension compared with usual care.Trial registration: Clinical Research Information Service: KCT0000169.
[show abstract][hide abstract] ABSTRACT: Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN.Methods/design: This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient's global impression of change and adverse events. Safety will be assessed at each visit.
The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA.Trial registration: Clinical Research Information Service: KCT0000506http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=2757.
[show abstract][hide abstract] ABSTRACT: The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research.Methods/designThis study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a >= six month history of PDN and a mean weekly pain score of >= 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit.
The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN.Trial registrationClinical Research information Service. Unique identifier: KCT0000466.
[show abstract][hide abstract] ABSTRACT: Abstract Blood-letting therapy is one of the most important treatments in traditional Mongolian medicine (TMM). To observe the practice of Mongolian traditional-style blood-letting therapy (MTSBLT), two TMM clinics in Mongolia were visited in 2012 and two practitioners and a patient were interviewed. The interviews provided information on several characteristic features of MTSBLT, including its three stages: preparation, blood-letting, and recuperation. In the preparation stage, an herbal decoction, such as Braivu sumtan, is given for 3-5 days, during which time massage, cupping, and moxibustion can be applied. In the blood-letting stage, specific points, which differ from acupuncture points, are selected according to the patient's symptoms, and the targeted vein is incised just once. At this time, about 10 mL of blood is drained. In the recuperation stage, the patient needs to be cautious about diet and refrain from excessive physical exercise to prevent adverse effects. The patient interviewed had a favorable attitude toward blood-letting, believing that MTSLBT was an effective treatment for his symptoms.
Journal of alternative and complementary medicine (New York, N.Y.) 07/2013; · 1.69 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: Even though chronic fatigue syndrome and idiopathic chronic fatigue are quite common, there are no clearly known causes. Most treatments are therefore symptomatic in nature, and chronic fatigue syndrome and idiopathic chronic fatigue patients are highly interested in using oriental medicine or complementary and alternative medicine treatment. Acupuncture, one of the major treatments used in oriental medicine, is effective in treating various diseases. This study will attempt to analyze the effectiveness and safety of acupuncture in the treatment of chronic fatigue by comparing the two treatment groups (body acupuncture, Sa-am acupuncture) and the control group (usual care).Methods/design: This study consists of a four-center, three-arm, randomized, controlled, and open-label trial. One hundred and fifty participants are randomly divided into treatment groups A and B and a control group. The treatment groups will receive acupuncture treatments either two or three times per week for a total of 10 sessions over a period of 4 weeks. The control group will not receive acupuncture treatments and will continue their usual care during this period. The primary outcome variable is the Fatigue Severity Scale, which will be utilized 5 weeks after randomization. Secondary outcome variables are the Fatigue Severity Scale at 13 weeks, a short form of the Stress Response Inventory, the Beck Depression Inventory, the Numeric Rating Scale, and the EuroQol-5 Dimension at 5 and 13 weeks after randomization. DISCUSSION: This study will provide evidence with high external validity on the effectiveness and safety of acupuncture as a treatment for chronic fatigue syndrome and idiopathic chronic fatigue.Trial registration: Clinical Research Information Service KCT0000508.
[show abstract][hide abstract] ABSTRACT: BACKGROUND: The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care.Methods/designs: This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach. DISCUSSION: This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis.Trial registration: Clinical Research information Service: KCT0000130 http://cris.nih.go.kr/cris/en/.
BMC Complementary and Alternative Medicine 03/2013; 13(1):59. · 2.08 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVES: De qi is a sensation experienced by a patient or an acupuncturist during acupuncture treatment. Although de qi is considered to be important in acupuncture treatment, there are not many studies about de qi and its character. The purpose of this study is to review de qi questionnaires and evaluate the relationship between de qi and acupuncture points, stimulation and treatment effects. METHODS: A search was conducted using three English-language databases (PubMed, Cochrane and ScienceDirect) and seven Korean databases with the keywords 'de qi' and 'needle sensation'. The included studies were then categorised as following: (1) de qi measurement tools, (2) the relationship between de qi and acupuncture points, (3) the relationship between de qi and stimulation, (4) the relationship between de qi and treatment effects and (5) attitudes and opinions toward de qi. RESULTS: Several questionnaires have been developed to evaluate de qi, and the most frequent sensation in those questionnaires was 'heavy' and 'numb'. Although a few studies showed specificity to acupuncture points, information is still lacking to be able to draw a clear conclusion about the relationship between de qi and acupuncture points. Also, greater de qi was elicited in real acupuncture than placebo acupuncture in many studies. The relationship between de qi and treatment effects was controversial. CONCLUSIONS: It seems that real acupuncture induced greater de qi than sham acupuncture, and the relationship between de qi, acupuncture points and treatment effects was controversial. However, the current literature evaluating de qi is not sufficient to derive clear conclusions. Further studies with more objective indices and rigorous methodologies are needed.
Acupuncture in Medicine 03/2013; · 1.05 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVE: To explore and understand how patients with knee osteoarthritis (OA) experience moxibustion. METHOD: This qualitative research was conducted as part of a larger clinical trial of the effectiveness of moxibustion for the treatment of knee OA by qualitative content analysis. Sixteen patients with mild knee OA who participated in a 12-week moxibustion treatment as part of the trial were interviewed using open-ended questions. RESULTS: The participants recognised knee OA as a normal ageing process that caused physical and emotional discomfort in daily life. Regardless of any adverse effects of moxibustion, most of the participants were interested in continuous moxibustion treatment as a long-term management strategy and for general health. CONCLUSIONS: This study suggests that moxibustion can be helpful in managing symptoms related to knee OA. Patients' attitudes towards moxibustion can affect the treatment result and those who prefer it want to continue the treatment for a long time because they understand that knee OA is a chronic condition which needs continuous care. However, practitioners need to pay more attention to those who are very enthusiastic because they tend to endure treatment-related adverse events in their desire for better effects.
Acupuncture in Medicine 01/2013; · 1.05 Impact Factor
[show abstract][hide abstract] ABSTRACT: Background
The objectives of this study were to compare the efficacy of acupuncture among different types and to evaluate point-selective pain relief effects between selected adjacent or distant points in participants with temporomandibular joint disorders (TMDs).Methods
Forty-two participants were randomly allocated to three groups: an adjacent point selection group (Trt, n = 14), a distant point selection group (Con1, n = 14), or a combination group (Con2, n = 14). All three groups received a total of six acupuncture sessions (twice a week for 3 weeks), the outcomes being assessed pain intensity using a 10-cm visual analogue scale, and the palpation index of the muscle and temporomandibular joint every week of treatment and 4 weeks after the end of treatment.ResultsThe pain intensity was reduced in the Trt (34%), Con1 (31%), and Con2 (36%) groups after 3 weeks compared with each group's baseline, with no significant difference among the three groups (p = 0.5867). Similarly, the palpation index was decreased by 52% (Trt), 62% (Con1), and 50% (Con2) after 3 weeks of treatment, but no significant differences between groups were shown (p = 0.3289).Conclusion
Our results suggest that point-selective effects among adjacent, distal, or a combination of acupoints are hardly associated with pain intensity or palpation index in participants with TMDs. Larger sample size trials are required to overcome the shortcomings of the study.
Integrative Medicine Research. 12/2012; 1(1):36–40.
[show abstract][hide abstract] ABSTRACT: BACKGROUND: Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have adverse side effects and poor adherence. The purpose of this study is to evaluate the effects of moxibustion on blood pressure in individuals with pre- or stage I hypertension.Methods/designForty-five subjects with pre- or stage I hypertension will be randomized into three groups: treatment group A (2 times/week), treatment group B (3 times/week), and the control group (non-treated group). The inclusion criteria will be as follows: (1) aged between 19 and 65 years; (2) prehypertension or stage I hypertension (JNC 7, Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure); (3) the participants are volunteers and written consent obtained.The participants in the treatment group A will undergo indirect moxibustion 2 times per week for 4 weeks, and the participants in the treatment group B will undergo indirect moxibustion 3 times per week for 4 weeks. The participants in the control group (non-treated group) will maintain their current lifestyle, including diet and exercise. The use of antihypertensive medication is not permitted. The primary endpoint will be a change in patient blood pressure. The secondary endpoints will be the body mass index, lipid profile, EuroQol and Heart Rate Variability. The data will be analyzed with the Student's t-test and analysis of variance (ANOVA) (p < 0.05). DISCUSSION: The results of this study will help to establish the optimal approach for the care of adults with pre- or stage I hypertension.Trial registrationClinical Research Information Service KCT0000469.
[show abstract][hide abstract] ABSTRACT: Objectives: This was a randomized controlled pilot trial to evaluate the effectiveness of cupping therapy for neck pain in video display terminal (VDT) workers. Methods: Forty VDT workers with moderate to severe neck pain were recruited from May, 2011 to February, 2012. Participants were randomly allocated into one of the two interventions: 6 sessions of wet and dry cupping or heating pad application. The participants were offered an exercise program to perform during the participation period. A 0 to 100 numeric rating scale (NRS) for neck pain, measure yourself medical outcome profile 2 score (MYMOP2 score), cervical spine range of motion (C-spine ROM), neck disability index (NDI), the EuroQol health index (EQ-5D), short form stress response inventory (SRI-SF) and fatigue severity scale (FSS) were assessed at several points during a 7-week period. Results: Compared with a heating pad, cupping was more effective in improving pain (adjusted NRS difference: -1.29 [95% CI -1.61, -0.97] at 3 wk (p=0.025) and -1.16 [-1.48, -0.84] at 7 wk (p=0.005)), neck function (adjusted NDI difference: -0.79 [-1.11, -0.47] at 3 (p=0.0039) and 7 wk (p< 0.0001)) and discomfort (adjusted MYMOP2 difference score: -0.72 [-1.04 to -0.40] at 3 wk and -0.92 [-1.24, -0.60] at 7 wk). Significant improvement in EQ-5D was observed at 7 wk (1.0 [0.88, 1.0] with cupping and 0.91 [0.86, 0.91] with heating pad treatment, p=0.0054). Four participants reported mild adverse events of cupping. Conclusion: Two weeks of cupping therapy and an exercise program may be effective in reducing pain and improving neck function in VDT workers.
Journal of Occupational Health 09/2012; · 1.63 Impact Factor
[show abstract][hide abstract] ABSTRACT: To evaluate the effects of acupuncture compared to a control group using artificial tears.
Setting & design: multicenter randomised controlled trial (three local research hospitals of South Korea). Study Population: 150 patients with moderate to severe dry eye. Intervention: Participants were randomly allocated into four weeks of acupuncture treatment (bilateral BL2, GB14, TE 23, Ex1, ST1, GB20, LI4, LI11 and single GV23) or to the artificial tears group (sodium carboxymethylcellulose). Main Outcome Measure(s): The ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer Ι test, visual analogue scale (VAS) for self-assessment of ocular discomfort, general assessment (by both acupuncture practitioners and participants) and quality of life (QOL) through the Measure Yourself Medical Outcome Profile-2 (MYMOP-2).
There was no statistically significant difference between two groups for the improvement of dry eye symptoms as measured by OSDI (MD -16.11, 95% CI [-20.91, -11.32] with acupuncture and -15.37, 95% CI [-19.57, -11.16] with artificial tears; P = 0.419), VAS (acupuncture: -23.84 [-29.59, -18.09]; artificial tears: -22.2 [-27.24, -17.16], P = 0.530) or quality of life (acupuncture: -1.32 [-1.65, -0.99]; artificial tears: -0.96 [-1.32, -0.6], P = 0.42) immediately after treatment. However, compared with artificial tears group, the OSDI (acupuncture: -16.15 [-21.38, -10.92]; artificial tears: -10.76 [-15.25, -6.27], P = 0.030) and VAS (acupuncture: -23.88 [-30.9, -16.86]; artificial tears: -14.71 [-20.86, -8.55], P = 0.018) were significantly improved in the acupuncture group at 8 weeks after the end of acupuncture treatment. TFBUT measurements increased significantly in the acupuncture group after treatment.
Acupuncture may have benefits on the mid-term outcomes related to dry eye syndrome compared with artificial tears.
PLoS ONE 01/2012; 7(5):e36638. · 3.73 Impact Factor
[show abstract][hide abstract] ABSTRACT: Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have side effects and poor adherence. Qigong has been studied as an alternative therapy for hypertension; however, the types of qigong used in those studies were diverse, and there have not been many well-designed randomized controlled trials.Our objectives are the following: 1) To evaluate the effects of qigong on blood pressure, health status and hormone levels for pre- or mild hypertension. 2) To test the methodological appropriateness of this clinical trial and calculate a sample size for future randomized trials.
Forty subjects with pre- or mild hypertension will be randomized to either the qigong exercise group or the non-treated group. Participants in the qigong group will conduct qigong exercises 5 times per week for 8 weeks, and participants in the non-treated group will maintain their current lifestyle, including diet and exercise. The use of antihypertensive medication is not permitted. The primary endpoint is a change in patient blood pressure. Secondary endpoints are patient health status (as measured by the SF-36 and the MYMOP2 questionnaires) and changes in hormone levels, including norepinephrine, epinephrine, and cortisol.
This study will be the first randomized trial to investigate the effectiveness of qigong exercises for the treatment of pre- and mild hypertension. The results of this study will help to establish the optimal approach for the care of adults with pre- or mild hypertension.
Clinical Research Information Service KCT0000140.
[show abstract][hide abstract] ABSTRACT: Persistent non-specific low back pain (PNSLBP) is one of the most frequently experienced types of back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping treatment for PNSLBP.
We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group) who had been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in both groups. Separate assessors participated in the outcome assessment. We used the 0 to 100 numerical rating scale (NRS) for pain, the McGill Pain Questionnaire for pain intensity (PPI) and the Oswestry Disability Questionnaire (ODQ), and we assessed acetaminophen use and safety issues.
The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping group and -9.1 [-18.1 to -0.1] in the waiting-list group), but there was no statistical difference between the groups (p = 0.52). However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p < 0.01). In addition, less acetaminophen was used in the wet-cupping group during 4 weeks (p = 0.09). The ODQ score did not show significant differences between the two groups (-5.60 [-8.90 to -2.30] in the wet-cupping group and -1.8 [-5.8 to 2.2] in the waiting-list group, p = 0.14). There was no report of adverse events due to wet-cupping.
This pilot study may provide preliminary data on the effectiveness and safety of wet-cupping treatments for PNSLBP. Future full-scale randomised controlled trials will be needed to provide firm evidence of the effectiveness of this intervention.
[show abstract][hide abstract] ABSTRACT: A pathophysiologic relationship between allergic rhinitis and rhinosinusitis and asthma has long been suggested. However, few clinical studies of acupuncture have been conducted on these comorbid conditions. A 48-year-old male suffering from persistent allergic rhinitis with comorbid chronic rhinosinusitis and asthma since the age of 18 years was studied. He complained of nasal obstruction, sneezing, cough, rhinorrhea and moderate dyspnea. He occasionally visited local ear-nose-throat clinics for his nasal symptoms, but gained only periodic symptom relief. The patient was treated with acupuncture, infrared radiation to the face and electro-acupuncture. Needles were inserted at bilateral LI20, GV23, LI4 and EX-1 sites with De-qi. Electro-acupuncture was performed simultaneously at both LI20 sites and additional traditional Korean acupuncture treatments were performed. Each session lasted for 10 min and the sessions were carried out twice a week for 5 weeks. The patient's Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire score decreased from 38, at the beginning of treatment, to 23, 3 weeks after the last treatment. The Total Nasal Symptom Score was reduced from six (baseline) to five, 3 weeks after the last treatment. There was significant clinical improvement in the forced expiratory volume in 1 s-from 3.01 to 3.50 l-with discontinuation of the inhaled corticosteroid, and no asthma-related complaints were reported. Further clinical studies investigating the effectiveness of acupuncture for the patients suffering from allergic rhinitis and/or rhinosinusitis with comorbid asthma are needed.
Evidence-based Complementary and Alternative Medicine 01/2011; 2011:798081. · 1.72 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: Previous studies of acupuncture show favourable results for both subjective and objective outcomes of dry eye. However, firm conclusions could not be drawn from these studies because the quality of the trials was too low to establish concrete evidence. Therefore, this study was designed both to avoid the flaws of the existing trials and to assess the effectiveness, cost-effectiveness and qualitative characteristics of acupuncture treatment for dry eye. METHODS/DESIGN: One hundred fifty participants with dry eye will be recruited into three independent hospitals from different areas: Korea Institute of Oriental Medicine, DongGuk University Ilsan Oriental Hospital and Dongshin University Gwangju Oriental Hospital. The number of participants required was calculated from the data of a previous, relevant study. These patients will be randomly allocated into acupuncture treatment or artificial tear groups. Either 17 acupuncture points (bilateral BL2, GB14, TE 23, Ex1, ST1, GB20, LI4, LI11 and single GV23) will be used 3 times a week or disposable artificial tear drops (Refresh Plus®, ALLERGAN) will be provided for use at least once a day for 4 weeks. The ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer I test, visual analogue scale (VAS) for self-assessment of ocular discomfort, general assessment (by both acupuncture practitioners and participants) and quality of life (QOL) through the Measure Yourself Medical Outcome Profile-2 (MYMOP-2) will be assessed for approximately 3-months for each study participant. In addition, qualitative study and cost-effectiveness of acupuncture treatment will be conducted. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01105221).
[show abstract][hide abstract] ABSTRACT: To evaluate the efficacy and safety of acupuncture for ocular symptoms, tear film stability and tear secretion in dry eye patients.
This is a randomized, patient-assessor blinded, sham acupuncture controlled trial. Forty-two participants with defined moderate to severe dry eye underwent acupuncture treatment three times a week for 3 weeks. Seventeen standard points (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8 on the left for men and right for women) with 'de qi' manipulation for the verum acupuncture group and seventeen sham points of shallow penetration without other manipulation for the sham group were applied during the acupuncture treatment. Differences were measured using the ocular surface disease index (OSDI), the visual analogue scale (VAS) of ocular discomfort, the tear film break-up time (BUT) and the Schimer I test with anaesthesia. In addition, adverse events were recorded.
There were no statistically significant differences between results on the OSDI, VAS, BUT or Schimer I tests from baseline between the verum and sham acupuncture groups. However, results from the within-group analysis showed that the OSDI and VAS in both groups and the BUT in the verum acupuncture group were significantly improved after 3 weeks of treatment. No adverse events were reported during this trial.
Both types of acupuncture improved signs and symptoms in dry-eye patients after a 4-week treatment. However, verum acupuncture did not result in better outcomes than sham acupuncture.
[show abstract][hide abstract] ABSTRACT: Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control.
This study consists of a multi-centre (two centres in Korea and two centres in China), randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group). The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group.
This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching) from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping). The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure.
Current Controlled Trials ISRCTN90807007.