Efficacy of intraorbital electroacupuncture for diabetic abducens nerve palsy： study protocol for a prospective single-center randomized controlled trial

Abducens nerve palsy（ANP） is commonly seen in patients with diabetes mellitus. The validity of acupuncture as a traditional Chinese medicine method in peripheral nerve repair is well established. However, its efficacy in randomized controlled trials remains unclear. Herein, we designed a protocol for a prospective, single-center, randomized controlled trial to investigate the effect of intraorbital electroacupuncture on diabetic ANP. We plan to recruit 60 patients with diabetic ANP, and randomly divide them into treatment and control groups. Patients in both groups will continue their glucose-lowering therapy. A neural nutrition drug will be given to both groups for six weeks. The treatment group will also receive intraorbital electroacupuncture therapy. We will assess efficacy of treatment, eyeball movement, diplopia deviation and the levels of fasting blood-glucose and glycosylated hemoglobin before treatment at 2, 4, and 6 weeks after treatment. The efficacy and recurrence will be investigated during follow-up（1 month after intervention）. This protocol was registered at Chinese Clinical Trial Registry on 16 January 2015（Chi CTR-IPR-15005836）. This study was approved by the Ethics Committee of First Affiliated Hospital of Harbin Medical University of China（approval number： 201452）. All protocols will be in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be provided by participants. We envisage that the results of this clinical trial will provide evidence for promoting clinical use of this new therapy for management of ANP.

Current State of Clinical Studies on Diagnosis and Treatment of Sudden Deafness in China

Objective To evaluate the current status of clinical studies on diagnosis and treatment of sudden deafness (SD) in China by retrospective reviewing articles on SD published in Chinese journals in the past 5 years. Special attention is given to whether the diagnosis and treatment standards established in 1996 by the otolaryngology branch of Chinese Medical Association (the'1996 standard') were followed. Methods The terms of 'Sudden deafness' and 'treatment' were used as the keywords in searching articles published between 2000 and 2004 in the Chinese biomedicine literature database and Chinese journal network. Principles of evidence-based medicine were applied in reviewing the articles. Results Two hundreds and thirty- four articles were identified, including 176 between 2000 and 2002 and 58 between 2003 and 2004. Among the 176 articles published between 2000 and 2002, effects of medications were studies in 126 articles, of which only 26 (20.6%) followed the'1996 standards'. Eighty-nine (70.6%) were reported based on controlled clinical trials (CCT) and 36 (28.5%) met the criteria of randomized controlled trails (RCT). Of the 58 articles published between 2003 and 2004, drug effects were evaluated in 25 articles, which were all based on the '1996 standards'. However, there lacked placebo control, follow-up data or statistical analysis in these papers. Only 6 articles reported side-effects from pharmacological treatment. Conclusions While a significant number of articles on SD were published in the past 5 years, the '1996 standards' were followed only in a small number of them. The standards may not be appropriate in guiding research and need to be modified for improved guidance to SD management. Multi-center, RCTs should be a crucial part in studies on SD.

Effect of ultrasound-guided acupotomy vs electro-acupuncture on knee osteoarthritis:a randomized controlled study

OBJECTIVE:To investigate the effect of acupotomy on knee osteoarthritis(KOA),compared to electro-acupuncture(EA).METHODS:Sixty KOA patients were randomly divided into 2 groups:ultrasound-guided acupotomy group and EA group;each had 3 weeks' therapy.After the treatment,by contrast before and after therapy,by comparing curative effects among groups,we looked into disease improvement degree through activities of daily living score(ADL),hospital for special surgery index(HSS),visual analogue scales score(VAS) and knee joint's infrared thermal imaging detection.RESULTS:Graded by ADL,the excellent rate in acupotomy group was much higher than EA group;both acupotomy group and EA group had obviouschanges in HSS index before and after the therapy(P < 0.01).And there was remarkable difference in HSS index variation between the groups(P < 0.01).Acupotomy group and EA group showed big difference in pain index before and after treatment(P <0.01).Apparent difference also existed in the comparison among groups(P < 0.01).Both acupotomy group and EA group had apparent changes in infrared thermal imaging detection before and after the treatment(P < 0.01).CONCLUSION:Acupotomy and EA both have significant effects in KOA treatment;the former is better than the latter in relieving pain and improving knee functions.

Curative effect of Dingqi analgesic patch on cancer pain:a single-blind randomized controlled trail

OBJECTIVE:To observe the curative effect of an acupoint application with a Dingqi analgesic patch on moderate to severe pain caused by liver cancer.METHODS:Forty patients with moderate to severe pain caused by liver cancer were randomly divided intoatreatmentgroup(TG)andacontrolgroup(CG).Patients with moderate pain were given 100 mg qd of a sustainably released tablet of tramadol hydrochloride;patientswithseverepainweregiven4.2mg q3d of the fentanyl transdermal system.The ashi points Ganshu(BL 18),Danshu(BL 19) and Qimen(LR 14) were chosen for the acupoint application intervention.CG patients were given a sham patch and TG patients were given a Dingqi analgesic patch.A visual analogue scale(VAS) was used before treatment and after 1,3,6,9 and 12 days of treatment.The Karnofsky score was measured before treatment and after 12 days of treatment.Any main adverse reactions(e.g.nausea,constipation,dizziness and headache) were recorded after 6 and 12 days of treatment.Any skin side effects(i.e.skin irritation and allergic reactions) were recorded.RESULTS:The VAS in TG was significantly lower than that in CG after 3,6,9 and 12 days of treatment(P<0.05).There was no significant difference in the Karnofsky score before treatment and after 12 days of treatment between CG and TG.There were also no significant differences in the main adverse reactions or skin side effects after 6 and 12 days of treatment between CG andTG(P>0.05).CONCLUSION:The Dingqi analgesic patch can enhance the analgesic effect of tramadol and fentanyl.

Effectiveness and clinical benefit of a therapy of combined non-pharmaceutical Traditional Chinese Medicine for knee osteoarthritis: a randomized controlled study

OBJECTIVE: To compare the efficacy of honey mouthwash 12.5% and chlorhexidine solution 0.2% to reduce the rate of oropharyngeal bacterial colonization in mechanically-ventilated patients.METHODS: This study was a randomized, single blind, phase Ⅲ controlled clinical trial. Sixty patients newly admitted to internal and trauma Intensive Care Units of the two educational hospitals of Sanandaj city affiliated with Kurdistan University of Medical Sciences were selected by convenience sampling and allocated to two groups of 30 patients using random blocks design. In each group,the mouthwash was applied twice a day for four consecutive days. Swab samples were taken from the mouth and throat of all patients three times a day(pre-intervention, two days, and four days after the intervention) and then the samples were transferred onto the blood agar and eosin methylene blue(EMB) culture plates and investigated for bacterial growth and colonization after 24-48 h.RESULTS: The findings showed that oropharyngeal colonization was not significantly different between the two groups, pre-intervention, two days,and four days after the intervention(P > 0.05). Rinsing with honey mouthwash 12.5% led to the inhibition of Staphylococcus aureus and Pseudomonas aeruginosa on the fourth day of the intervention in all samples.CONCLUSION: None of the studied solutions contributed to the reduction of oropharyngeal bacterial colonization. It seems that the growth inhibition of Staphylococcus aureus and Pseudomonas aeruginosa by the honey 12.5% mouthwash in mechanically-ventilated patients need further investigation.

Effect of Qingxue Dan on obesity and metabolic biomarker: a double-blind randomized-controlled pilot study

OBJECTIVE: To investigate the clinical effect of Qingxue Dan(QXD) on obesity and metabolic biomarker related to obesity.METHODS: A randomized, double blinded, placebo-controlled trial with a paralleled study design was conducted. Twenty-six obese volunteers aged between 30 and 60 with obesity and more than 2 metabolic risk factors were recruited at the department of oriental rehabilitation medicine, Kyunghee university oriental medical hospital, Seoul, Korea. Subjects were randomly assigned to an intervention(QXD) group or a placebo group, and treated with 900 mg/d of QXD or placebo medicine for 8 weeks. Primary endpoint was the change of body mass index(BMI) at 8 week from baseline. Secondary outcomes included the change of body composition, abdominal fat mass measured with Dual energy X-ray absorptiometry(DXA), blood pressure,lipid profiles and the homeostasis model assessment for insulin resistance(HOMA-IR).RESULTS: BMI was decreased in the QXD group sig-nificantly. Total body fat, abdominal fat mass measured with DXA Region of Interest and waist circumference(WC) showed a trend toward decreasing in the QXD group, but fat free mass was decreased in all groups. Triglyceride(TG) was decreased in QXD group significantly, but WC, total cholesterol and high-density lipoprotein cholesterol were increased in both group. BP didn't change during the study period. HOMA-IR is decreased in both groups without group effect.CONCLUSION: 8-weeks of oral administrations of QXD(900 mg/d) reduces BMI, with a tendency of lose of total body fat mass, especially abdominal fat. It also significantly reduced serum TG level.These results suggest QXD could be used to treat obesity and metabolic risk factors. Further study is needed to confirm our pilot findings.

Immediate analgesic effect of needling acupoints(bilateral De Qi vs unilateral De Qi)on primary dysmenorrhea:a multi-center,randomized,controlled trail

OBJECTIVE: To analyze the effect of needling acupoints(bilateral vs unilateral) with De Qi using data collected from 501 primary dysmenorrhea(PD) patients participating in multi-center, randomized,controlled trail.METHODS: De Qi was defined as at least one of the feelings in soreness, numbness, fullness or heaviness at the acupoints when stimulated with needles. The 501 patients were grouped in 3 groups in terms of De Qi or not De Qi in one side(unilateral)or both sides(bilateral) of the body: bilateral De Qi group, unilateral De Qi group, and non-De Qi group. The abdominal pains were measured using visual analog scale(VAS).RESULTS: In 501 patients, 472 acquired De Qi at unilateral acupoints, 24 De Qi at bilateral acupoint,and 5 had no De Qi at any acupoint. The data of non-De Qi group was excluded as the sample was less than 5% of that in the bilateral De Qi group.There was significant difference in the VAS before and after treatment between unilateral and bilateral De Qi group(P < 0.01). After stratified by acupoints, for the patients needled at Sanyinjiao(SP 6)and Xuanzhong(GB 39), VAS scores in the bilateral De Qi group were larger than those in the unilateral De Qi group(P < 0.05).CONCLUSION: Bilateral De Qi was possibly superior to unilateral De Qi in enhancing the immediate analgesic effect of needling the acupoints, but no statistical significance was observed on the pa-tients of needling at non acupoint, which preliminarily suggested this immediate analgesic effect was perhaps along meridians.

Safety and efficacy of Tongkuaixiao ointment in reliving cancer-induced pain: a multicenter double-blind placebo-controlled randomized trial

OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia were randomly divided into a TKXO group and a control group.The patients were treated with either TKXO applied externally or placebo, with opioid analgesics orally at the same time. Observation parameters were included numerical rating scale(NRS) scores,analgesic efficacy, initiation effective time, persistent analgesic time, equivalent morphine dose,National Comprehensive Cancer Network(NCCN)grade in Impact of Pain Measurement Scores, and safety and satisfaction extent investigation.RESULTS: NRS scores and NCCN grade in Impact of Pain Measurement Scores decreased significantly after 5-days' treatment in the two groups(P <0.0001). Compared to the control group, initiation effective time was significantly shorter(P < 0.05)and persistent analgesic time was significantly longer(P < 0.01), equivalent oral morphine doses of the first day and the whole treatment course were significantly decreased in the TKXO treatment group(P < 0.01 or P < 0.05). No obvious adverse effects were found in the TKXO group.CONCLUSION: TKXO combined with opioid analgesics possesses the advantages of high efficacy,fast action, long persistent action, safety and convenience in use, and it can reduce the dose of opioid.