Acupuncture for hot flashes in hormone receptor-positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.

BACKGROUND: Hot flashes are a common side effect of endocrine therapy (ET) that contribute to poor quality of life and decreased treatment adherence. METHODS: Patients with breast cancer wo were receiving ET and experiencing hot flashes were enrolled through three parallel, randomized trials conducted in the United States, China, and South Korea. Participants were randomized to either immediate acupuncture (IA) or delayed acupuncture control (DAC). IA participants received 20 acupuncture sessions over 10 weeks, whereas DAC participants received usual care, then crossed over to acupuncture with a reduced intensity. The primary end point was a change in score on the endocrine symptom subscale of the Functional Assessment of Cancer Therapy (FACT)-Endocrine Symptoms between baseline and week 10. Secondary end points included the hot flash score and the FACT-Breast score. A planned pooled analysis of individual patient data was performed using longitudinal mixed models. RESULTS: In total, 158 women with stage 0-III breast cancer were randomized (United States, n = 78; China, n = 40; South Korea, n = 40). At week 10, IA participants reported statistically significant improvements in the endocrine symptom subscale score (mean change ± standard error: 5.1 ± 0.9 vs. 0.2 ± 1.0; p = .0003), the hot flash score (-5.3 ± 0.9 vs. -1.4 ± 0.9; p < .003), and the FACT-Breast total score (8.0 ± 1.6 vs. -0.01 ± 1.6; p = .0005) compared with DAC participants. The effect of the acupuncture intervention differed by site (p = .005). CONCLUSIONS: Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer-specific quality of life in women undergoing ET for breast cancer in the United States, China, and South Korea.

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating long-term side effects in breast cancer survivors. We conducted a randomized controlled pilot trial to assess the feasibility, safety, and effects of an acupuncture intervention on CIPN in this population. PATIENTS AND METHODS: Women with stage I-III breast cancer with grade 1 or higher CIPN after taxane-containing adjuvant chemotherapy were randomized 1:1 to an immediate acupuncture (IA) arm or to a waitlist control group (CG). Participants in the IA arm received 18 sessions of acupuncture over 8 weeks, then received no additional acupuncture. Patients in the CG arm received usual care over 8 weeks, followed by nine sessions of acupuncture over 8 weeks. Measures including Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF) were collected at baseline and at 4, 8, and 16 weeks after enrollment. RESULTS: Forty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92). At 8 weeks, participants in the IA arm experienced significant improvements in PNQ sensory score (-1.0 ± 0.9 vs. -0.3 ± 0.6; p = .01), FACT-NTX summary score (8.7 ± 8.9 vs. 1.2 ± 5.4; p = .002), and BPI-SF pain severity score (-1.1 ± 1.7 vs. 0.3 ± 1.5; p = .03), compared with those in the CG arm. No serious side effects were observed. CONCLUSION: Women with CIPN after adjuvant taxane therapy for breast cancer experienced significant improvements in neuropathic symptoms from an 8-week acupuncture treatment regimen. Additional larger studies are needed to confirm these findings. IMPLICATIONS FOR PRACTICE: Chemotherapy-induced peripheral neuropathy (CIPN) is a toxicity that often persists for months to years after the completion of adjuvant chemotherapy for early breast cancer. In a randomized pilot trial of 40 breast cancer survivors with CIPN, an 8-week acupuncture intervention (vs. usual care) led to a statistically and clinically significant improvement in subjective sensory symptoms including neuropathic pain and paresthesia. Given the lack of effective therapies and established safety profile of acupuncture, clinicians may consider acupuncture as a treatment option for mild to moderate CIPN in practice.

The Risk Factors and Pregnancy Outcomes of 48 Cases of Heterotopic Pregnancy from a Single Center.

The purpose of this study was to investigate risk factors that are associated with heterotopic pregnancy (HP) following in vitro fertilization (IVF)-embryo transfer (ET) and to demonstrate the outcomes of HP after the surgical treatment of ectopic pregnancies. Forty-eight patients from a single center, who were diagnosed with HP between 1998 and 2012 were included. All of the patients had received infertility treatments, such as Clomid with timed coitus (n = 1, 2.1%), superovulation with intrauterine insemination (n = 7, 14.6%), fresh non-donor IVF-ET (n = 33, 68.8%), and frozen-thawed cycles (n = 7, 14.6%). Eighty-four additional patients were randomly selected as controls from the IVF registry database. HP was diagnosed at 7.5 ± 1.2 weeks (range 5.4-10.3) gestational age. In six cases (12.5%), the diagnosis was made three weeks after the patients underwent treatment for abortion. There were significant differences in the history of ectopic pregnancy (22.5% vs. 3.6%, P = 0.002). There were no significant differences in either group between the rates of first trimester intrauterine fetal loss (15.0% vs. 13.1%) or live birth (80.0% vs. 84.1%) after the surgical treatment for ectopic pregnancy. The risk factors for HP include a history of ectopic pregnancy (OR 7.191 [1.591-32.513], P = 0.010), abortion (OR 3.948 [1.574-9.902], P = 0.003), and ovarian hyperstimulation syndrome (OHSS) (OR 10.773 [2.415-48.060], P = 0.002). In patients undergoing IVF-ET, history of ectopic pregnancy, abortion, and OHSS may be risk factors for HP as compared to the control group of other IVF patients. The surgical treatment of HP does not appear to affect the rates of first trimester fetal loss or live birth.

Comparison of experience curves between two 3-dimensional intraoral scanners.

STATEMENT OF PROBLEM: Conventional impression-making methods are being replaced by intraoral digital scanning. How long dental professionals take to master the new technologies is unknown. PURPOSE: The purpose of this human subject study was to compare the experience curves of 2 intraoral scanners among dental hygienists and determine whether repeated scanning experience could change the scan time (ST). MATERIAL AND METHODS: A total of 29 dental hygienists with more than 3 years of working experience were recruited (group 1: 3-5 years; group 2: >6 years of clinical experience) to learn the iTero and Trios systems. All learners scanned the oral cavities of 4 human participants (participants A, B, C, and D) 10 times (T1-T10) throughout the learning sessions and the experimental dentoform model twice at the beginning and end of the 10 sessions. ST was measured, and changes in ST were compared between the 2 devices. RESULTS: The average ST for 10 sessions was greater with iTero than with Trios, but the decrease in the measured ST was greater for iTero than for Trios. Baseline and postexperience STs with iTero showed statistically significant differences, with a decrease in time related to the clinical experience levels of the dental hygienists (group 1: T2 and T4, P<.01; group 2: T2 and T5, P<.01). The experience curve with iTero was not influenced by the human participant's intraoral characteristics, and greater ST was shown for participants B and C than for participants A and D with Trios. CONCLUSIONS: Although the learning rate of iTero was rapid, the average ST for iTero was longer than Trios, and clinical experience levels influenced the operator's ability to manipulate the device. In contrast, the learning rate of Trios was slow, and measured ST was shorter than iTero, and was not influenced by clinical experience.

Efficacy of saam acupuncture treatment on improvement of immune cell numbers in cancer patients: a pilot study.

OBJECTIVE: To collect preliminary data on the effects of Saam acupuncture with regard to the immunity in cancer patients. METHODS: Ten cancer patients were analyzed for improvements in immunity. Acupuncture was applied at the 5 acupuncture points, Jingqu (LU 8), Zutonggu (BL 66), Yanggu (SI 5), Yangchi (TE 4), and Zhongwan (CV 12) for 2 weeks with 4 sessions. We assessed the effect of Korean Saam acupuncture on the immune system in cancer patients by measuring particular blood cell subsets, including CD3+, CD4+, CD8+, CD19+, and CD56+ cells, as well as total white blood cell count, absolute neutrophil count, and fatigue score. The measurement was performed before and after acupuncture and at a 2-week follow-up. RESULTS: There was a statistically significant increase in the number of CD3+ (P = 0.023) and CD8+ cells (P < 0.001) and T-cell subsets, as well as a decrease in the fatigue severity scale (FSS) score (P = 0.001) after Saam acupuncture using the 5 acupoints. CONCLUSION: Acupuncture may improve the immune system by increasing the counts of a few immune cells and relieve fatigue in cancer patients by decreasing FSS scores. Although this was a non-controlled study, it constitutes preliminary research investigating the potential effects of Saam acupuncture in increasing the counts of several immune cells in cancer patients.

Anterior Choroidal Artery Aneurysm Clipping: Angiographic Diagnostics and Surgical Tactics Focused on Visualizing the Anterior Choroidal Artery Behind the Aneurysm.

OBJECTIVE: This study describes our experiences with anterior choroidal artery (AChA) aneurysm clipping with a focus on visualizing the AChA just behind the aneurysm to identify the risk factors for adhesion of the AChA or its branches to the posterior wall of the AChA aneurysm. METHODS: The initial segment of the AChA just behind the aneurysm was evaluated preoperatively using three-dimensional (3D) rotational angiography, and its course was designated as posteromedial, posterior, or posterolateral. The posterior aspect of the AChA aneurysm was inspected intraoperatively using an endoscope or micromirror. RESULTS: Based on 3D rotational angiography, the main trunk of the AChA showed a posteromedial (n = 47, 57.3%), posterior (n = 18, 22.0%), or posterolateral (n = 17, 20.7%) course just behind the aneurysm. Intraoperatively, 14.6% (12 of 82) of the clipped AChA aneurysms revealed an AChA branch adhered to the posterior wall of the aneurysm. A multivariate analysis revealed that the posterior or posterolateral course of the initial segment of the AChA was a statistically significant risk factor for adhesion of an AChA branch to the posterior wall of the aneurysm (odds ratio [OR] 21.083, 95% confidence interval [CI] 2.567-173.166, P = 0.005). CONCLUSIONS: The initial course of the AChA just behind an AChA aneurysm can be evaluated using 3D rotational angiography. In contrast to a posteromedial course, a posterior or posterolateral course of the AChA just behind an AChA aneurysm can be a significant risk factor for adhesion of an AChA branch to the posterior wall of an AChA aneurysm.

Efficacy of a metallic stent covered with a paclitaxel-incorporated membrane versus a covered metal stent for malignant biliary obstruction: a prospective comparative study.

BACKGROUND: The placement of a self-expandable metallic stent (SEMS) is a widely used nonsurgical treatment method in patients with unresectable malignant biliary obstructions but SEMS is susceptible to occlusion by tumor ingrowth or overgrowth. AIM: The efficacy and safety of a metallic stent covered with a paclitaxel-incorporated membrane (MSCPM) in which paclitaxel provided an antitumoral effect was compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. METHODS: Patients with unresectable distal malignant biliary obstructions (n = 106) were prospectively enrolled in this study at multiple treatment centers. A MSCPM was inserted endoscopically in 60 patients, and a CMS was inserted in 46 patients. Patients underwent systemic chemotherapy regimens alternatively according to disease characteristics. RESULTS: The two groups did not differ significantly in mean age, male to female ratio, or mean follow-up period. Stent occlusion due to tumor ingrowth occurred in 12 patients who received MSCPMs and in eight patients who received CMSs. Stent patency and survival time did not differ significantly between the two groups (p = 0.116, 0.981). Chemotherapy had no influence on stent patency, but gemcitabine-based chemotherapy was a significant prognostic factor for survival time (p = 0.012). Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. CONCLUSIONS: Although the use of a MSCPM produced no significant differences in stent patency or patient survival in patients with malignant biliary obstructions compared with the use of a CMS, this study demonstrated that MSCPM can be used safely in humans.

Impact of Acupuncture on Hot Flashes in Breast Cancer Patients Receiving Adjuvant Antiestrogen Therapy with Tamoxifen: A Randomized Controlled Trial.

Objectives: The aim of this study was to evaluate the impact of acupuncture on hot flashes in breast cancer patients taking tamoxifen as an adjuvant antiestrogen therapy in Korea. Design: This trial was a randomized, no-treatment-controlled, single-blind, multi-center trial. Participants were randomized 1:1 into the acupuncture group or into the no-treatment control group. Location: This trial was conducted at Daegu Catholic University Hospital and Daegu Haany University Korean Medicine Hospital in Daegu, Republic of Korea. Participants: Patients with moderate to severe symptoms of hot flashes while receiving adjuvant antiestrogen therapy using tamoxifen after surgery for breast cancer were included. Interventions: In the acupuncture group, acupuncture was performed three times a week for 4 consecutive weeks at five predetermined points. The control group received no treatment during the study period. Study Outcome Measures: As a primary outcome, the severity of hot flashes was measured on the visual analogue scale (VAS) and total hot flash score. In addition, the quality of life (QoL) of participants was assessed as a secondary outcome. Results: A total of 30 patients were included in this study, 15 each in the acupuncture group and the control group. The participants in the acupuncture group significantly decreased the severity of hot flashes evaluated with both VAS and total hot flash scores compared with participants in the control group. Also, the acupuncture group showed improved score of a global health status/QoL scale and functional scales assessed with the European Organisation for Research and Treatment of Cancer QoL questionnaire-core questionnaire, compared with those in the control group. This trend was maintained 4 weeks after acupuncture treatment. No adverse events have been reported in this study. Conclusions: Acupuncture was effective and safe in improving hot flashes in Korean breast cancer patients receiving adjuvant antiestrogen therapy with tamoxifen, and it improved the QoL. Clinical Trial Registration: KCT0007829.

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.

True Posterior Communicating Artery Aneurysms with High Risk of Rupture despite Very Small Diameter.

OBJECTIVE: This retrospective study investigated the clinical and angiographic characteristics of ruptured true posterior communicating artery (PCoA) aneurysms in comparison with junctional PCoA aneurysms presenting with a subarachnoid hemorrhage. METHODS: The medical records and radiological data of 93 consecutive patients who underwent three-dimensional rotational angiography and surgical or endovascular treatment for a ruptured junctional or true PCoA aneurysm over an 8-year period were examined. RESULTS: The maximum diameter of the ruptured true PCoA aneurysm (n=13, 14.0%) was significantly smaller than that of the ruptured junctional PCoA aneurysms (n=80, 4.45±1.44 vs. 7.68±3.36 mm, p=0.001). In particular, the incidence of very small aneurysms <4 mm was 46.2% (six of 13 patients) in the ruptured true PCoA aneurysm group, yet only 2.5% (two of 80 patients) in the ruptured junctional PCoA aneurysm group. Meanwhile, the diameter of the PCoA was significantly larger in the true PCoA aneurysm group than that in the junctional PCoA aneurysm group (1.90±0.57 vs. 1.15±0.49 mm, p<0.001). In addition, the ipsilateral PCoA/P1 ratio was significantly larger in the true PCoA aneurysm group than that in the group of a junctional PCoA aneurysm (mean PCoA/P1 ratio±standard deviation, 2.67±1.22 vs. 1.14±0.88; p<0.001). No between-group difference was identified for the modified Fisher grade, clinical grade at admission, and 3-month modified Rankin Scale score. CONCLUSION: A true PCoA aneurysm was found to be associated with a larger PCoA and ruptured at a smaller diameter than a junctional PCoA aneurysm. In particular, the incidence of a ruptured aneurysm with a very small diameter <4 mm was significantly higher among the patients with a true PCoA aneurysm.

Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial.

BACKGROUND: In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation. METHODS: The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks. RESULTS: Over the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings. CONCLUSIONS: Site study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03783546 (21/12/2018).

Auricular Acupuncture During Chemotherapy Infusion in Breast Cancer Patients: A Feasibility Study.

Introduction: Breast cancer patients undergoing chemotherapy experience multiple distressing symptoms. The authors investigated the feasibility and potential benefits of auricular acupuncture during chemotherapy infusion in this population. Materials and Methods: Women with stage I-III breast cancer undergoing chemotherapy were enrolled and followed for three chemotherapy cycles. During the first cycle of chemotherapy that participants received after study enrollment, they were provided with educational materials. During the second and third cycles of chemotherapy after enrollment, they received auricular acupuncture. The primary outcome was feasibility, assessed by recruitment, retention, and completion of assessments. Secondary outcomes included symptom burden (Edmonton Symptom Assessment System-Revised Version) and anxiety (State-Trait Anxiety Inventory-State), assessed at four timepoints for each cycle: day 1, pre-education/acupuncture (T1); day 1, post-education/acupuncture (T2); day 2 (T3); and day 5 (T4). Nausea and vomiting (Multinational Association of Supportive Care in Cancer [MASCC] Antiemesis Tool) were assessed on days 2 and 5. Paired t test was used to compare patient-reported outcomes during cycle 1 (education) versus an average of outcomes during cycles 2 and 3 (acupuncture). Results: Twenty-six patients were enrolled, of which 24 completed all acupuncture sessions and 22 completed all outcome assessments. In cycles 2 and 3 versus cycle 1, participants experienced significant reductions in symptom burden (change from T1 to T4: -7.9 ± 13.6, p = 0.02), anxiety (change from T1 to T2: -3.3 ± 6.5, p = 0.02), and nausea severity on day 2 (-1.3 ± 2.6, p = 0.04). Conclusions: The delivery of auricular acupuncture during chemotherapy infusion was feasible and associated with reduction of symptom burden, anxiety, and nausea in breast cancer patients. Larger-scale clinical studies are needed to confirm these findings. Clinical Trial Registration number: NCT03170648.

Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol.

BACKGROUND: Acupuncture has been reported to reduce hot flashes in patients with breast cancer undergoing adjuvant hormonal therapy. Although hot flashes are common, the prevalence varies among cultures, races, and ethnicities; the efficacy of acupuncture across cultures has not been investigated. METHODS: This is a coordinated multinational study, including three parallel randomized trials with a planned analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients on adjuvant endocrine therapy. Using a standardized acupuncture protocol (total across all three studies of n = 80) versus usual care (total n = 80), symptoms are assessed using changes in the Endocrine Symptom Subscale of Functional Assessment of Cancer Therapy-Endocrine Symptoms. Secondary outcomes include hot flash severity, quality of life, and sleep quality. Differences in response to acupuncture between participants in the three countries will also be explored. DISCUSSION: Here we describe the design of a protocol for a coordinated multinational study, with attention to the complex considerations in developing a multinational research effort testing a non-pharmacologic intervention. This protocol and approach provide guidance for future efforts to evaluate and test non-pharmacologic interventions across multinational populations. TRIAL REGISTRATION: clinicaltrials.gov (Identifier: NCT00797732, registered on December 21, 2018), Chinese Clinical Trial Registry (ChiCTR2100045888), and The Clinical Research Information Service (CRIS) of Korea (Registration number: KCT0003618).

Retrospective multicenter evaluation of tapered implant with a sandblasted and acid-etched surface at 1 to 4 years of function.

PURPOSE: The aim of this retrospective study was to evaluate the cumulative survival rate of tapered implant with a sandblasted and acid-etched surface placed in edentulous patients. MATERIALS AND METHODS: A retrospective study was performed by evaluating MIS seven implants consecutively placed from December 2004 to January 2008. Patient records were reviewed to determine gender, age at implant placement, implant location, prosthesis type, marginal bone loss according to treatment procedure, number of implants, and number of failed implants. The survival rate of the implants was analyzed, and radiographic evaluation was performed. RESULTS: A total of 294 implants were placed in 92 patients at the 3 centers. The observation period after implantation ranged from 22 to 59 months, with a mean of 38 months. The cumulative survival rate of MIS seven implants was 97.3%. After 1 year of functional loading, the mean marginal bone loss was 0.33 mm. CONCLUSION: This retrospective, multicenter study demonstrates that this dental implant system gives clinically reliable results.

Sanhuang Decoction Controls Tumor Microenvironment by Ameliorating Chronic Stress in Breast Cancer: A Report of Ninety Cases.

Long-term endocrine treatment which results in estrogen deprivation causes chronic stress associated with a series of uncomfortable symptoms leading not only to a decrease in quality of life but also to cancer recurrence, which may be mediated primarily through the enhanced expression of angiogenic factors, as well as a series of inflammatory microenvironmental changes that favor tumor progression. In this study, we designed a clinical trial and aimed to explore the effects of Sanhuang Decoction (SHD) treatment on chronic stress, inflammatory factors, and breast cancer recovery. A total of 90 patients with breast cancer who met the inclusion/exclusion criteria were randomly allocated to a treatment or control group. The treatment group received the standard endocrine treatment and the traditional Chinese medicine decoction known as SHD. The control group received the standard endocrine treatment only. The treatment period was 6 months. The modified Kupperman Menopausal Index, the self-rating anxiety scale, and the self-rating depression scale were evaluated once per month. The body microenvironment plasma indices related to chronic stress, such as oxidative and antioxidative stress markers, inflammatory factors, hemorheology, coagulation, lipid and D-dimer, immunologic functions, tumor biomarkers, and angiogenic factors of the vascular endothelial growth factor (VEGF) were measured before and after 6 months of treatment. After treatment for 5 months, the scores in the treatment group decreased to nearly normal levels and the control group showed no significant improvement. After treatment for 6 months, all indices related to the body microenvironment, as well as the tumor biomarkers and carcinoembryonic antigen, carbohydrate antigen 153, and angiogenic factor VEGF levels improved significantly to normal levels in the treatment group. Our primary research showed that treatment with SHD effectively improved the quality of life of breast cancer patients by facilitating a change in the body microenvironment that controlled tumor growth and prevented drug resistance. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, identifier ChiCTR-IIR-2000041413. Date of registration: 2017-06-07 (retrospective registration).

Prognostic significance of MAGE in peritoneal washes in gastric carcinoma patients without peritoneal metastasis: results of a 5-year follow-up study.

GOALS: The RT-PCR assay of peritoneal washes has been used to predict peritoneal metastasis of gastric carcinoma. We used melanoma associated gene (MAGE) RT-PCR to detect peritoneal metastasis of gastric carcinoma after curative surgery and evaluated its clinical significance. METHOD: Eighty-four peritoneal washes and 23 tumor and normal tissues were obtained from 84 gastric carcinoma patients. MAGE A1-A6 RT-PCR was carried out, and the results were evaluated according to their clinicopathologic characteristics. Five-year follow-up clinical studies were carried out periodically, and overall survival rates were retrospectively investigated using medical records. RESULTS: For the paired tumor and normal tissues, MAGE expression rates were 65.2% and 4.3%, respectively. In peritoneal fluids, 11 cases (13.1%) revealed MAGE expression, and higher MAGE expression rates were observed with young age, deeper invasion, and advanced stages of tumor groups. MAGE-positive cases had much higher recurrence rates than MAGE-negative cases (45.5% vs. 9.6%, P<0.002). Among T-stage, N-stage, and MAGE expression; MAGE expression was determined to be the most important prognostic factor for overall survival rate by Cox proportional hazard model analysis. CONCLUSION: MAGE RT-PCR results for peritoneal fluid disclosed significant associations with peritoneal recurrence of gastric carcinoma and proved to be the most important factor for overall survival rate in gastric carcinoma patients who had undergone radical resection.

Comparison of two piezoelectric cutting inserts for lateral bony window osteotomy: a retrospective study of 127 consecutive sites.

PURPOSE: The aim of the present retrospective clinical study was to compare the efficacy of two piezoelectric cutting inserts for the incidence, size, and types of sinus membrane perforations, and to evaluate their various advantages for lateral window osteotomy. MATERIALS AND METHODS: The study consisted of 127 maxillary sinus augmentation procedures performed at two centers. A bony window was made on the lateral wall of the maxillary sinus with either the piezoelectric saw or the round diamond insert and repositioned over the bone graft as a homologous bony barrier. The rate of membrane perforation during sinus augmentation between the two groups was compared and analyzed statistically by the chi-square test and the two-sample t test. RESULTS: Seven perforations were seen in the 127 maxillary sinus procedures in this study (5.51%). Six perforations in 84 cases (7.14%) occurred with the piezoelectric saw and one perforation in 43 sites (2.32%) occurred while using the round insert. No statistically significant difference was found between the rates of membrane perforation between the two inserts. CONCLUSION: The lateral bony window was created effectively with either of the two kinds of piezoelectric inserts. The membrane perforation rate was not significantly affected by the type of piezoelectric insert. The piezoelectric saw insert was more advantageous than the round diamond due to its greater precision and easier repositioning of the lateral bony window as a barrier.

Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial.

BACKGROUND: Use of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-controlled trial to treat chronic low back pain. Our goal is to verify the effect of acupuncture on chronic low back pain. METHODS/DESIGN: This study is a multi-center randomized sham-controlled trial with 2 parallel arms. Participants included in the study met the following criteria: 1) low back pain lasting for at least the last 3 months, 2) a documented >or= 5 points on a 10 cm visual analog scale for bothersomeness of low back pain at the time of screening and 3) between 18 and 65 years of age. Participants were blinded to the real and sham acupuncture treatments. The real acupuncture treatment group received real acupuncture 2 times a week, during a total of 12 sessions over 6 weeks. The control group received sham acupuncture during the same period. In order to assess the primary and secondary outcome measures, the participants were asked to fill out a questionnaire at the baseline and 6, 8, 12 and 24 weeks after starting the treatments. The primary outcome was measured using the visual analog scale for bothersomeness of low back pain at 8 weeks after the initiation of treatments. DISCUSSION: The result of this trial (which will be available in 2010) will demonstrate the efficacy of using acupuncture to treat chronic low back pain. TRIAL REGISTRATION: This study is registered with the U.S. National Institutes of Health Clinical Trials registry: NCT00815529.

Three-dimensional osseous micro-architecture of the distal humerus: implications for internal fixation of osteoporotic fracture.

BACKGROUND: The purpose of this study is to analyze 3-dimensional structural parameters of cortical and trabecular bone in the distal humerus using quantitative CT and to find regional variations and differences according to age. METHODS: We collected 14 cadaveric distal humeri with an average age of 58.4 years. The specimens were examined at 3 different levels: 1) distal trans-epicondylar section, 2) mid trans-olecranon fossa section, and 3) proximal supra-olecranon fossa section. RESULTS: In the distal section, bone volume was the greatest in the anterior part of the lateral condyle and the least in the posterior part of the lateral condyle. Cortical thickness in the distal section was the thickest in the posterior medial and the thinnest in the anterior aspect followed by lateral aspect. The changes in cortical thickness with aging were obvious in the posterior side and trabecular bone on the medial condyle. CONCLUSION: This study evaluated the differences in cortical and trabecular bone parameters in each different region of the distal humerus. We found a potential weakness of plate fixation in the posterolateral aspect of the distal condyle because of relative insufficient osseous micro-architecture, which may affect the treatment of osteoporotic distal humerus fractures especially in elderly patients.

A retrospective study of sintered porous-surfaced dental implants in restoring the edentulous posterior mandible: up to 9 years of functioning.

PURPOSE: The aim of this retrospective study was to evaluate the survival rate of sintered porous-surfaced implants placed in the edentulous posterior mandibles, in relation to implant length and diameter, crown-to-implant ratio, and types of prostheses, for a maximum of 9 years of functioning (mean: 55.8 months; range: 5-108 months). MATERIALS: The study group consisted of 43 partially edentulous patients who visited Catholic University Hospital of Daegu and 1 private dental clinic. A total of 122 sintered porous-surfaced implants--Endopore (Innova Life Sciences, Toronto, Ontario, Canada)--were placed in the edentulous posterior mandibles. Two diameter sizes (4.1 and 5.0 mm) and 4 lengths (5.0, 7.0, 9.0, and 12.0 mm) were used. All implants were restored with fixed prostheses. One hundred three implants were splinted and 21 implants were nonsplinted. Panoramic views and periapical radiographs were taken at the time of the first, postoperative, crown placement, and following checkup visits. The survival rates of the implants in relation to length, diameter, crown-to-implant ratio, and types of prostheses were investigated. Statistical data were analyzed using SPSS Win.Ver 14.0 software with the χ² test. RESULTS: The survival rate of the 4.1-mm-diameter implants was 100% and 91.2% for the 5.0-mm-diameter implants. The survival rates of the implants of differing diameters were found to be statistically different (P = 0.005). The survival rates of both the 5.0-mm and 7.0-mm-length implants were 100%. The survival rate of the 9.0-mm-length implants was 97.9% and for the 12.0-mm-length implants was 95.1%. There was no statistical difference in survival rates for the differing lengths of implants. Of the 103 prostheses that were splinted, the survival rate was 98.0%. The survival rate of splinted prostheses was higher than that of the nonsplinted prostheses but was found to be not statistically different. There were no failed cases when the crown-to-implant ratio was <1.0. When the crown-to-implant ratio was between 1.0 and 1.4, the failure rate of the implants was 6.7%. No failure was recorded with the ratio range of 1.5 to 2.0. Relative to the crown-to-implant ratio of 1.0, the failure rates were statistically different (P = 0.048). CONCLUSION: The cumulative survival rate of the porous-surfaced implants placed in the edentulous posterior mandibles was 97.5%. Short porous-surfaced implants showed satisfactory results after a maximum of 9 years of functioning in the edentulous posterior mandibles.