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.

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.

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).

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.

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).

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.

Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial.

OBJECTIVES: Some chemotherapy drugs can damage the nerves and cause peripheral neuropathy which is accompanied by severe neuropathic pain or gait impairment. The purpose of this study was to assess the feasibility and the safety of acupuncture for the treatment of peripheral neuropathy following chemotherapy in Korean breast cancer patients. DESIGN: This study was a prospective single-arm observational study using before and after measurements in breast cancer patients presenting with taxane-induced peripheral neuropathy. SETTINGS/LOCATION: This study was performed at East-West Medical Center at Daegu Catholic University Hospital, Daegu, South Korea. INTERVENTIONS: Acupuncture was administered 3 times a week for 4 consecutive weeks, for 25 ± 5 minutes at each session. OUTCOME MEASURES: The primary outcome measure was severity of CIPN using the Neuropathic Pain Symptom Inventory (NPSI) assessed by a self-administered questionnaire and Nerve Conduction Study (NCS) of extremities. The secondary outcome measure was quality of life (QoL) assessed by a self-administered questionnaire using the 36-Item Short From Health Survey (SF-36). RESULTS: Acupuncture significantly reduced the severity of CIPN assessed by NPSI score. Four weeks after the last treatment, the symptoms were not aggravated. According to NCS, 42.9% of participants showed improvement of sensory neuropathy. At the end of the treatment, SF-36 scores were significantly increased for variables including physical functioning, role limitations due to physical health problems, social functioning, and general health perceptions compared to those of baseline measurement. CONCLUSIONS: Acupuncture improved symptoms of CIPN and QoL in Korean women suffering from peripheral neuropathy after chemotherapy using taxane for breast cancer. The effects of acupuncture lasted for at least 1 month after the treatment.

Returning aggregate results of clinical trials: Empirical data of patient preferences.

INTRODUCTION: The purpose of this research was to understand the preferences of patients receiving integrative medicine services for return of aggregate study results. METHODS: A brief online survey (survey 1) was sent to 341 cancer patients receiving integrative medicine interventions; subsequently, a minimally revised survey (survey 2) was sent to 812 individuals with various medical conditions who had been either research participants in integrative medicine studies (n = 446) or patients (n = 346) of mind-body medicine. RESULTS: Feedback to a model plain language summary was elicited from survey 1 and survey 2 respondents. Seventy-seven survey recipients (23%) responded to survey 1, and 134 survey recipients (17%) responded to survey 2. The majority of respondents to the surveys were female and 51-70 years of age. Ninety percent of responders to survey 1 and 89% of responders to survey 2 indicated that researchers should share overall results of a study with participants. In terms of the means of result distribution, 37%-47% preferred email, while 22%-27% indicated that, as long as the results are shared, it did not matter how this occurred. Of 38 survey 1 respondents who had previously participated in a clinical trial, 37% had received the results of their study. In survey 2, 63 individuals indicated that they previously participated in clinical trials, but only 16% recalled receiving results. CONCLUSIONS: These results confirm that the majority (89%-90%) of integrative medicine patients are interested in receiving the results of clinical trials. The majority (82%-94%) of respondents felt the model plain language summary of results provided was helpful.

Intraoperative premature rupture of middle cerebral artery aneurysms: risk factors and sphenoid ridge proximation sign.

OBJECTIVE This study was an investigation of surgical cases of a ruptured middle cerebral artery (MCA) aneurysm that was conducted to identify the risk factors of an intraoperative premature rupture. METHODS Among 927 patients with a ruptured intracranial aneurysm who were treated over an 8-year period, the medical records of 182 consecutive patients with a ruptured MCA aneurysm were examined for cases of a premature rupture, and the risk factors were then investigated. The risk factors considered for an intraoperative premature rupture of an MCA aneurysm included the following: patient age; sex; World Federation of Neurosurgical Societies clinical grade; modified Fisher grade; presence of an intracerebral hemorrhage (ICH); location of the ICH (frontal or temporal); volume of the ICH; maximum diameter of the ruptured MCA aneurysm; length of the preaneurysmal M1 segment between the carotid bifurcation and the MCA aneurysm; and a sign of sphenoid ridge proximation. The sphenoid ridge proximation sign was defined as a spatial proximation < 4 mm between the sphenoid ridge and the rupture point of the MCA aneurysm, such as a daughter sac, irregularity, or dome of the aneurysm, based on the axial source images of the brain CT angiography sequences. RESULTS A total of 11 patients (6.0%) suffered a premature rupture of the MCA aneurysm during surgery. The premature rupture occurrences were classified according to the stage of the surgery, as follows: 1) craniotomy and dural opening (n = 1); 2) aspiration or removal of the ICH (n = 1); 3) retraction of the frontal lobe (n = 1); 4) dissection of the sphenoid segment of the sylvian fissure to access the proximal vessel (n = 4); and 5) perianeurysmal dissection (n = 4). The multivariate analysis with a binary logistic regression revealed that presence of a sphenoid ridge proximation sign (p < 0.001), presence of a frontal ICH associated with the ruptured MCA aneurysm (p = 0.019), and a short preaneurysmal M1 segment (p = 0.043) were all statistically significant risk factors for a premature rupture. Plus, a receiver operating characteristic curve analysis revealed that a preaneurysmal M1 segment length ≤ 13.3 mm was the best cutoff value for predicting the occurrence of a premature rupture (area under curve 0.747; sensitivity 63.64%; specificity 81.66%). CONCLUSIONS Patients exhibiting a sphenoid ridge proximation sign, the presence of a frontal ICH, and/or a short preaneurysmal M1 segment are at high risk for an intraoperative premature rupture of a MCA aneurysm. Such high-risk MCA aneurysms have a superficial location close to the arachnoid in the sphenoidal compartment of the sylvian fissure and have a rupture point directed anteriorly.

Height of aneurysm neck and estimated extent of brain retraction: powerful predictors of olfactory dysfunction after surgery for unruptured anterior communicating artery aneurysms.

OBJECTIVE: The highest incidence of olfactory dysfunction following a pterional approach and its modifications for an intracranial aneurysm has been reported in cases of anterior communicating artery (ACoA) aneurysms. The radiological characteristics of unruptured ACoA aneurysms affecting the extent of retraction of the frontal lobe and olfactory nerve were investigated as risk factors for postoperative olfactory dysfunction. METHODS: A total of 102 patients who underwent a pterional or superciliary keyhole approach to clip an unruptured ACoA aneurysm from 2006 to 2013 were included in this study. Those patients who complained of permanent olfactory dysfunction after their aneurysm surgery, during a postoperative office visit or a telephone interview, were invited to undergo an olfactory test, the Korean version of the Sniffin' Sticks test. In addition, the angiographic characteristics of ACoA aneurysms, including the maximum diameter, the projecting direction of the aneurysm, and the height of the neck of the aneurysm, were all recorded based on digital subtraction angiography and sagittal brain images reconstructed using CT angiography. Furthermore, the extent of the brain retraction was estimated based on the height of the ACoA aneurysm neck. RESULTS: Eleven patients (10.8%) exhibited objective olfactory dysfunction in the Sniffin' Sticks test, among whom 9 were anosmic and 2 were hyposmic. Univariate and multivariate analyses revealed that the direction of the ACoA aneurysm, ACoA aneurysm neck height, and estimated extent of brain retraction were statistically significant risk factors for postoperative olfactory dysfunction. Based on a receiver operating characteristic (ROC) analysis, an ACoA aneurysm neck height > 9 mm and estimated brain retraction > 12 mm were chosen as the optimal cutoff values for differentiating anosmic/hyposmic from normosmic patients. The values for the area under the ROC curves were 0.939 and 0.961, respectively. CONCLUSIONS: In cases of unruptured ACoA aneurysm surgery, the height of the aneurysm neck and the estimated extent of brain retraction were both found to be powerful predictors of the occurrence of postoperative olfactory dysfunction.

Postoperative subdural hygroma and chronic subdural hematoma after unruptured aneurysm surgery: age, sex, and aneurysm location as independent risk factors.

OBJECTIVE: This study investigated the incidence and risk factors for the postoperative occurrence of subdural complications, such as a subdural hygroma and resultant chronic subdural hematoma (CSDH), following surgical clipping of an unruptured aneurysm. The critical age affecting such occurrences and follow-up results were also examined. METHODS: The case series included 364 consecutive patients who underwent aneurysm clipping via a pterional or superciliary keyhole approach for an unruptured saccular aneurysm in the anterior cerebral circulation between 2007 and 2013. The subdural hygromas were identified based on CT scans 6-9 weeks after surgery, and the volumes were measured using volumetry studies. Until their complete resolution, all the subdural hygromas were followed using CT scans every 1-2 months. Meanwhile, the CSDHs were classified as nonoperative or operative lesions that were treated by bur-hole drainage. The age and sex of the patients, aneurysm location, history of a subarachnoid hemorrhage (SAH), and surgical approach (pterional vs superciliary) were all analyzed regarding the postoperative occurrence of a subdural hygroma or CSDH. The follow-up results of the subdural complications were also investigated. RESULTS: Seventy patients (19.2%) developed a subdural hygroma or CSDH. The results of a multivariate analysis showed that advanced age (p = 0.003), male sex (p < 0.001), middle cerebral artery (MCA) aneurysm (p = 0.045), and multiple concomitant aneurysms at the MCA and anterior communicating artery (ACoA) (p < 0.001) were all significant risk factors of a subdural hygroma and CSDH. In addition, a receiver operating characteristic (ROC) curve analysis revealed a cut-off age of > 60 years, which achieved a 70% sensitivity and 69% specificity with regard to predicting such subdural complications. The female patients ≤ 60 years of age showed a negligible incidence of subdural complications for all aneurysm groups, whereas the male patients > 60 years of age showed the highest incidence of subdural complications at 50%-100%, according to the aneurysm location. The subdural hygromas detected 6-9 weeks postoperatively showed different follow-up results, according to the severity. The subdural hygromas that converted to a CSDH were larger in volume than the subdural hygromas that resolved spontaneously (28.4 ± 16.8 ml vs 59.6 ± 38.4 ml, p = 0.003). Conversion to a CSDH was observed in 31.3% (5 of 16), 64.3% (9 of 14), and 83.3% (5 of 6) of the patients with mild, moderate, and severe subdural hygromas, respectively. CONCLUSIONS: Advanced age, male sex, and an aneurysm location requiring extensive arachnoid dissection (MCA aneurysms and multiple concomitant aneurysms at the MCA and ACoA) are all correlated with the occurrence of a subdural hygroma and CSDH after unruptured aneurysm surgery. The critical age affecting such an occurrence is 60 years.

Treatment of Lymphedema with Saam Acupuncture in Patients with Breast Cancer: A Pilot Study.

Background: Lymphedema is a troublesome complication affecting quality of life (QoL) in many women after breast-cancer treatment. Recent studies have suggested that acupuncture can reduce symptoms of lymphedema in breast-cancer survivors. Objectives: This was a pilot study. It was designed to assess the feasibility and the safety of acupuncture with the Saam acupuncture method for treating lymphedema in Korean patients after surgical therapy for breast cancer. Materials and Methods: This was a prospective, single-arm, observational pilot study using before and after measurements. The study was conducted at the East-West Medical Center at the Daegu Catholic University Medical Center, in Daegu, Korea. The subjects were 9 patients with breast cancer who presented with lymphedema of the upper limb ipsilateral to surgery. Saam acupuncture was administered 3 times per week for 6 consecutive weeks, for 30±5 minutes at each session.The primary outcome measure was severity of lymphedema as assessed by stages of lymphedema, a visual analogue scale (VAS), and by circumferential measurements of the upper extremity. The secondary outcome measure was QoL, which was assessed by a self-administered questionnaire using the Short Form-36 questionnaire. Results: Acupuncture reduced severity of lymphedema significantly, as assessed by the VAS (P<0.001) as well as by circumferential measurements of the upper extremity. Four weeks after the final treatment, symptoms were not aggravated. SF-36 scores remained significant for health status at the end of treatment. Conclusions: The Saam acupuncture method appeared to provide reduction of lymphedema among women after they had undergone surgery for breast cancer. A randomized, controlled prospective study with a larger sample size is required to clarify the role of acupuncture for managing lymphedema in patients with breast cancer.

Clinical analysis of risk factors contributing to recurrence of pterygium after excision and graft surgery.

AIM: To find the risk factors related to the reproliferation of the pterygial tissue after excision and graft surgery. METHODS: Charts of 130 eyes of 130 patients who had pterygial excision from March 2006 to April 2011 were reviewed. Preoperative pterygium morphology, surgical methods, and adjunctive treatments were statistically analyzed for their relationship with recurrence. RESULTS: During the follow-up period, recurrence was observed in 20 eyes (15.4%). None of the preoperative morphologic features were affected the rate of the recurrence. However, an age < 40y [P =0.085, odds ratio (OR) 3.609, 95% confidence interval (CI) 0.838-15.540] and amniotic membrane graft instead of conjunctival autograft (P =0.002, OR 9.093, 95% CI 2.316-35.698) were statistically significant risk factors for recurrence. Multivariate analysis revealed that intraoperative mitomycin C (MMC) (P=0.072, OR 0.298, 95% CI 0.080-1.115) decreased the rate of recurrence. CONCLUSION: Younger age is a risk factor for reproliferation of pterygial tissue after excision and amniotic membrane transplantation (AMT) are less effective in preventing recurrence of pterygium after excision based on the comparison between conjunctival autograft and AMT. Intraoperative MMC application and conjunctival autograft reduce recurrence.

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.

A survey of the satisfaction of patients who have undergone implant surgery with and without employing a computer-guided implant surgical template.

PURPOSE: This study aims to investigate the degree of subjective pain and the satisfaction of patients who have undergone an implant treatment using a computer-guided template. MATERIALS AND METHODS: A survey was conducted for 135 patients who have undergone implant surgery with and without the use of the computer-guided template during the period of 2012 and 2013 in university hospitals, dental hospitals and dental clinics that practiced implant surgery using the computer-guided template. Likert scale and VAS score were used in the survey questions, and the independent t-test and One-Way ANOVA were performed (α=.05). RESULTS: The route that the subjects were introduced to the computer-guided implant surgery using a surgical template was mostly advices by dentists, and the most common reason for which they chose to undergo such surgery was that it was accurate and safe. Most of them gave an answer that they were willing to recommend it to others. The patients who have undergone the computer-guided implant surgery felt less pain during the operation and showed higher satisfaction than those who have undergone conventional implant surgery. Among the patients who have undergone computer-guided implant surgery, those who also had prior experience of surgery without a computer-guided template expressed higher satisfaction with the former (P<.05). CONCLUSION: In this study, it could be seen that the patients who have undergone computer-guided implant surgery employing a surgical template felt less pain and had higher satisfaction than those with the conventional one, and the dentist's description could provide the confidence about the safety of surgery.

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 the treatment of hot flashes in patients with breast cancer receiving antiestrogen therapy: a pilot study in Korean women.

OBJECTIVES: Antiestrogen therapy can cause vasomotor symptoms similar to those occurring during menopause, including hot flashes. Recent studies suggest that acupuncture is effective in reducing vasomotor symptoms in patients with breast cancer receiving tamoxifen. The purpose of this study was to assess the feasibility and safety of acupuncture for treatment of hot flashes in Korean patients with breast cancer receiving antiestrogen therapy. DESIGN: This was a prospective single-arm observational study using before and after measurements. SETTINGS/LOCATION: The study was located at the East-West Medical Center at Daegu Catholic University Medical Center, Daegu, Korea. SUBJECTS: The subjects were 10 patients with breast cancer who were undergoing antiestrogen therapy with tamoxifen or anastrozole and who were suffering from hot flashes. INTERVENTIONS: Acupuncture was administered 3 times a week for 4 consecutive weeks, for 20±5 minutes at each session. OUTCOME MEASURES: The outcome measure was severity of hot flashes assessed by visual analogue scale (VAS) and total hot flash score. RESULTS: During treatment, severity of hot flashes was reduced by 70%-95% in all patients. Acupuncture significantly alleviated severity of hot flashes assessed by a visual analogue scale (F=30.261; p<0.001) as well as the total hot flash score (F=21.698; p=0.006). Four (4) weeks after the final treatment, symptoms were not aggravated. CONCLUSIONS: Acupuncture appeared to provide effective relief from hot flashes among Korean women receiving antiestrogen therapy after surgery for breast cancer, and the effects lasted for at least 1 month after termination of treatment. A randomized controlled prospective study with a larger sample size is required to clarify the role of acupuncture in the management of hot flashes in Korean patients with breast cancer.

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.

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.