Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial.

BACKGROUND: Cold hands sensation is a common disorder within the Korean population. Many Korean family physicians believe that it is a mild early manifestation of Raynaud's phenomenon (RP), or may be related to RP. RP is characterized by reversible digital vasospasm provoked by cold temperatures and/or emotional stress, and doctors often prescribe medications that are used in treatment of RP for subjects with cold hands. However, this has not shown a clear benefit, and these medications can cause unwanted side effects. It is also reported that traditional Korean medicine, including acupuncture, is widely used to treat cold hands, although the current level of evidence for this approach is also poor and to date, there have been no published randomized controlled clinical trials (RCTs) evaluating the efficacy and safety of acupuncture for cold hands. We have therefore designed a pilot RCT to obtain information for the design of a further full-scale trial. METHODS/DESIGN: The proposed study is a five-week pilot RCT. A total of 14 subjects will be recruited and randomly allocated to two groups: an acupuncture plus medication group (experimental group) and a medication-only group (control group). All subjects will take nifedipine (5 mg once daily) and beraprost (20 mg three times daily) for three weeks. The experimental group will receive additional treatment with three acupuncture sessions per week for three weeks (nine sessions total). The primary outcome will be measured using a visual analogue scale. Secondary outcomes will be measured by blood perfusion in laser Doppler perfusion imaging of the hands, frequency and duration of episodes of cold hands, and heart rate variability. Assessments will be made at baseline and at one, three, and five weeks thereafter. DISCUSSION: This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial. TRIAL REGISTRATION: This study was registered at Korean Clinical Research Information Service (CRIS) registry on 5 August 2013 with the registration number #KCT0000817.

Retrospective study of sintered porous-surfaced dental implants placed in the augmented sinus.

The purpose of this study was to analyze clinical and radiographic outcomes of sintered porous-surfaced dental implants placed in partially edentulous posterior maxillae. The study group consisted of 42 partially edentulous patients who received sinus augmentation using the lateral window technique or crestal approach at Catholic University Hospital of Daegu and one private clinic. The 42 patients received a total of 92 sintered porous-surfaced dental implants in the edentulous posterior maxillae. All implants were restored with fixed prostheses. Of the 92 implants, 17 implants were restored with individual (nonsplinted) crowns, while 75 implants were splinted to other implants. Panoramic views and periapical radiographs using the standardized long-cone paralleling technique were taken at the first visit, postoperatively, at the time of prosthesis seating, and at a follow-up visit. Survival rates of implants in relation to location, length, diameter, crown-to-implant (C/I) ratio, and type of prosthesis were investigated. Statistical data were analyzed using software with the chi-square test. Of the 92 implants, 8 (8.7%) were removed, and the cumulative survival rate was 91.3% after a maximum 9-year functional period (mean: 72.8 months; range: 11 to 107 months). There were no statistical differences in relation to the location of implants, C/I ratio, or type of prosthesis. However, there were statistical differences in relation to the length and diameter of implants. Average crestal bone loss was 0.68 mm at 1-year follow-up and 1.13 mm at final examination. All implants were inserted in the augmented maxillary sites. The cumulative survival rate of sintered porous-surfaced implants in posterior maxillae was 91.3%. Sintered porous-surfaced implants showed satisfactory results in the edentulous posterior maxillae.

Effect of acupuncture on diabetic peripheral neuropathy: an uncontrolled preliminary study from Korea.

BACKGROUND: Diabetic neuropathic pain can severely influence quality of life, and patients may be dissatisfied with treatment. OBJECTIVE: To carry out an observational study of the effects of acupuncture for the treatment of diabetic neuropathic pain, in preparation for a full study. METHODS: Nine patients with diabetic neuropathic pain were recruited from a Korean diabetic clinic and given 12 sessions of acupuncture over 4 weeks. Their symptoms were evaluated using the Total Symptom Score (TSS) and Michigan Neuropathy Screening Instrument (MNSI) at baseline and 4 weeks after the last treatment. RESULTS: Mean TSS scores reduced from 7.99 (SD 3.55) at baseline to 4.95 (SD 4.41), at the 8-week follow-up-a statistically non-significant change (p=0.057). The MNSI scores improved from 6.33 (SD 1.31) before treatment to 4.33 (SD 3.00) after acupuncture treatment-a significant improvement (p=0.010). One participant experienced an exacerbation of diabetic neuropathy symptoms, but two patients gained complete relief of their diabetic peripheral neuropathy (DPN) symptoms. CONCLUSIONS: The results of this study justify further investigations into the effects of acupuncture on DPN.

Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial.

BACKGROUND: Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis. METHODS/DESIGN: The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation). DISCUSSION: This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis. TRIAL REGISTRATION: This trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.

Gastric cancer detection using gastric juice pepsinogen and melanoma-associated gene RNA.

OBJECTIVES: To develop a new method for gastric cancer detection with gastric juice using melanoma-associated gene (MAGE) RNA and pepsinogen (PG). METHODS: In total, 183 gastric juice and paired serum specimens were obtained from 134 patients with gastric cancer and 49 healthy individuals. The gastric juice specimens were analyzed with MAGE A1 to A6 nested reverse transcription-polymerase chain reaction. The serum and gastric juice PG were measured with a PG I and II immunoassay. RESULTS: The gastric juice PG I and PG I/II ratios were more accurate than those of serum. The combination test using the gastric PG I/II ratio and MAGE was the most accurate, with a sensitivity of 77.6% and a specificity of 87.8%. The sensitivity was 78.8% for stage I gastric cancer and not influenced by cancer location or pathologic type. CONCLUSIONS: The combination test is potentially an additional tool for gastric cancer detection.

Acupuncture for chronic low back pain: a multicenter, randomized, patient-assessor blind, sham-controlled clinical trial.

STUDY DESIGN: Multicenter, randomized, patient-assessor blind, sham-controlled clinical trial. OBJECTIVE: To investigate the efficacy of acupuncture treatment with individualized setting for reduction of bothersomeness in participants with chronic low back pain (cLBP). SUMMARY OF BACKGROUND DATA: Low back pain is one of the main reasons of disability among adults of working age. Acupuncture is known as an effective treatment of cLBP, but it remains unclear whether acupuncture is superior to placebo. METHODS: One hundred thirty adults aged 18 to 65 years with nonspecific LBP lasting for at least last 3 months prior to the trial participated in the study from 3 Korean medical hospitals. Participants received individualized real acupuncture treatments or sham acupuncture treatments for more than 6 weeks (twice a week) from Korean Medicine doctors. Primary outcome was change of visual analogue scale (VAS) score for bothersomeness of cLBP. Secondary outcomes included VAS score for pain intensity and questionnaires including Oswestry Disability Index, general health status (Short Form-36), and Beck Depression Inventory (BDI). RESULTS: There were no baseline differences observed between the 2 groups, except in the Oswestry Disability Index. One hundred sixteen participants finished the treatments and 3- and 6-month follow-ups, with 14 subjects dropping out. Significant difference in VAS score for bothersomeness and pain intensity score of cLBP has been found between the 2 groups (P < 0.05) at the primary end point (8 wk). In addition, those 2 scores improved continuously until 3-month follow-up (P = 0.011, P = 0.005, respectively). Oswestry Disability Index, the Beck Depression Inventory, and Short Form-36 scores were also improved in both groups without group difference. CONCLUSION: This randomized sham-controlled trial suggests that acupuncture treatment shows better effect on the reduction of the bothersomeness and pain intensity than sham control in participants with cLBP.

Clinico-pathologic Parameters for Prediction of Microsatellite Instability in Colorectal Cancer.

PURPOSE: Although the incidence of microsatellite instability (MSI) accounts for 10-15% of cases of colorectal cancer, its clinical application for all colorectal cancers has widened. We attempted to identify clinical and pathological parameters that may be helpful in selection of patients with MSI-high (MSI-H). MATERIALS AND METHODS: A total of 120 resected colorectal cancers were enrolled retrospectively for this MSI study. Polymerase chain reaction (PCR) and denaturing high performance liquid chromatography and/or real time PCR methods with five markers and immunohistochemistry (IHC) for MLH1 and MSH2 were performed for analysis of cancer and blood specimens. Clinico-pathologic parameters, including IHC, were investigated in order to determine their usefulness as predictive factors of MSI. RESULTS: Among 120 cases of colorectal cancer, MSI was observed in 15 cases (12.5%), including 11 cases of MSI-H and four cases of MSI-low. Patients with MSI were younger, less than 50 years old, had a family history of cancer, Rt. sided colon cancer and/or synchronous multiple colorectal cancer, mucinous histologic type, and serum carcinoembryonic antigen group in the normal range. Results of multivariate analysis showed Bethesda guidelines, Rt. sided and/or synchronous multiple colorectal cancer, and negative expression of IHC for MLH1, which was consistently associated with MSI-H. MSI-H colorectal tumors have met at least one of these three parameters and their sensitivity and specificity were 100% and 72.5%, respectively. CONCLUSION: Bethesda guidelines, tumor location, and negative expression of MLH1 protein are important parameters for selection of patients with colorectal cancers for MSI testing. MSI testing is recommended for patients showing any of these three parameters.

γδ T cells are increased in the peripheral blood of patients with gastric cancer.

BACKGROUND: γδ T cells are implicated in immunoregulation. However, little is known about the characteristics of γδ T cells in gastric cancer. In this study, we assessed the incidence of γδ T cells and lymphocyte subsets in the peripheral blood of gastric cancer patients. METHODS: We enrolled 48 patients and 49 healthy controls. The γδ T cells, lymphocyte subsets were analyzed with flow cytometry. RESULTS: The mean percentage of γδ T cells in patients with gastric cancer was 5.0±3.4% and for controls 2.3±1.6%. Twenty (41.7%) of the 48 patients with gastric cancer had a high percentage (more than 5%) of peripheral blood γδ T cells, while 4 (8.2%) of the 49 controls did. The percentage of CD3⁺ T cells were elevated in gastric cancer compared to controls (P=0.007). The CD4/CD8 ratio increased in gastric cancer (P=0.311). The percentage of CD3⁺CD4⁻CD8⁻ T cells increased in gastric cancer compared to controls (P=0.004). CONCLUSION: The proportion of γδ T cells in the peripheral blood of gastric cancer patients was significantly higher in comparison to that in the healthy controls. Our findings suggest that increased proportion of peripheral γδ T cells may explain anti-tumor immunity against gastric cancer partly.

VEGFA and VEGFR2 genetic polymorphisms and survival in patients with diffuse large B cell lymphoma.

We evaluated the impact of functional polymorphisms in the vascular endothelial growth factor A (VEGFA) and vascular endothelial growth factor 2 (VEGFR2) genes on the survival of patients with diffuse large B cell lymphoma (DLBCL). Five potentially functional polymorphisms in the VEGFA (rs699947, rs2010963 and rs3025039) and VEGFR2 (rs1870377 and rs2305948) genes were assessed in 494 DLBCL patients treated with rituximab plus CHOP chemotherapy. The associations of genotype and haplotype with overall survival (OS) and progression-free survival (PFS) were analyzed. Of the five polymorphisms, VEGFR2 rs1870377T>A was significantly associated with both OS and PFS; in the dominant model, patients with the AA + TA genotypes had significantly better OS (P = 0.002) and PFS (P = 0.004) than those with the TT genotype. The association between significantly better OS and the AA + TA genotypes was observed separately in patients with low (0-2; P = 0.035) and high (3-5; P = 0.043) International Prognostic Index scores. Multivariate analysis showed that, relative to the AA + TA genotypes, the TT genotype was an independent prognostic factor for poor OS (HR, 1.71; 95% CI, 1.21-2.43; P = 0.002) and PFS (HR, 1.57; 1.13-2.17; P = 0.004). Other independent significant predictors of survival in patients with DLBCL were International Prognostic Index score, age > 60 years, lactate dehydrogenase concentration >normal, extranodal disease >1 and presence of B symptoms. The VEGFR2 rs1870377 polymorphism might affect survival in patients with DLBCL, suggesting that angiogenesis might be related to poor survival in these patients.

MAGE A1-A6 RT-PCR and MAGE A3 and p16 methylation analysis in induced sputum from patients with lung cancer and non-malignant lung diseases.

The melanoma antigen gene (MAGE) A1-A6 RT-PCR system was developed for the detection of lung cancer cells in the sputum. However, we identified MAGE expression in some patients with non-malignant lung diseases. To understand these patterns of MAGE expression, we performed MAGE A3 methylation-specific PCR (MSP) and p16 MSP. We collected 24 biopsy specimens of lung cancer tissue and performed MAGE A1-A6 RT-PCR, MAGE A3 MSP and p16 MSP. RNA and DNA were simultaneously extracted from induced sputum specimens of 133 patients with lung diseases and 30 random sputum specimens of healthy individuals and the 3 molecular analyses were performed. The patients were diagnosed as 65 cases of lung cancer and 68 of benign lung diseases. Positive rates of MAGE A1-A6 RT-PCR, MAGE A3 MSP and p16 MSP were as follows: in lung cancer tissue, 87.5, 58.3 and 70.8%; in the sputum of lung cancer patients, 50.8, 46.2 and 63.1%; benign lung diseases, 10.3, 30.9 and 39.7%; and healthy individuals, 3.3, 6.7 and 3.3%. Of the 40 MAGE-positive cases, 33 were diagnosed with lung cancer and 7 as having benign lung diseases. From the 7 cases of MAGE-positive benign lung diseases, 6 cases showed methylation abnormalities. The MAGE-positive group revealed significantly higher rates of methylation abnormalities. Of the 40 MAGE-positive cases, 39 cases were found to be lung cancer or benign lung diseases with abnormal methylation. Thus, MAGE expression in the sputum suggests the presence of lung cancer cells or pre-cancerous cells.