Effect of laser acupuncture on pain and density of bone in osteoporotic postmenopausal women: a randomized controlled trial.

OBJECTIVE: This study aimed to evaluate the value of laser acupuncture (LA) on forearm bone mineral density (BMD) and wrist pain in osteoporotic postmenopausal women. METHODS: Sixty-eight postmenopausal women diagnosed with osteoporosis were randomly allocated equally to one of two sets. The drug-only group received calcium and vitamin D 3 supplement containing fluoride daily for 12 weeks, whereas the drug/LA group received LA therapy for 20 minutes per session, three sessions weekly, in addition to the same supplementation. The primary outcome parameter was assessment of BMD of the nondominant arm. Other outcomes included wrist pain. RESULTS: There was a highly significant improvement in the T-score of forearm BMD in both groups (-2.844 ± 0.476 to -2.597 ± 0.478 and -2.944 ± 0.486 to -1.652 ± 0.728 in the drug-only and drug/LA groups, respectively; P < 0.0001) and visual analog scale score (7.50 ± 0.79 to 4.24 ± 1.07 and 7.24 ± 0.82 to 3.09 ± 0.75 in the drug-only and drug/LA group, respectively; P < 0.0001). The improvement of both BMD and pain score was significantly higher in the drug/LA group (-1.303 and 4.15) compared with the drug-only group (-0.247 and 3.26; P < 0.0001). CONCLUSIONS: LA in combination with calcium and vitamin D supplementation containing fluoride is an effective modality in improving forearm BMD and reducing pain in osteoporotic postmenopausal women.

Whole-body vibration versus supervised aerobic exercise on hormonal parameters and inflammatory status in women with premenstrual syndrome: A randomized controlled trial.

OBJECTIVES: To compare the effects of whole-body vibration (WBV) and aerobic exercise on the hormonal profile and inflammatory status in women with premenstrual syndrome (PMS). METHODS: A prospective, randomized, pre-post-test, single-blind, controlled trial was conducted in 105 women diagnosed with PMS. They were randomized into three equal groups. All women received magnesium and vitamin B complex supplementation once daily. WBV training was added three times per week to the WBV group. The aerobic exercise group added aerobic exercise three times per week, while the control group received no additional intervention. The Premenstrual Syndrome Questionnaire (PMSQ) was used to assess PMS symptoms. Blood analysis was performed to measure hormone assays (estradiol, progesterone, prolactin, and cortisol) and high-sensitivity C-reactive protein at the start and after the end of the treatment program. RESULTS: There was no statistically significant difference between WBV and aerobic exercise according to PMSQ and high-sensitivity C-reactive protein (P = 0.99 and P = 0.98, respectively), but there was a statistically significant difference between both groups in cortisol, progesterone, prolactin, and estradiol (P = 0.001), with more favor given to the WBV group. CONCLUSION: WBV and aerobic exercise have positive effects on women with PMS, with more favor given to WBV.

Is music intervention effective in reducing anxiety and pain during breast biopsy procedure? A systematic review and meta-analysis of randomized controlled trials.

PURPOSE: To evaluate the evidence from randomized clinical trials (RCTs) about the effect of music intervention in reducing patients' anxiety during breast biopsy. METHODS: Electronic databases including PubMed, Cochrane Library, Scopus, and Web of Science were searched using the relevant MeSH terms. The inclusion criteria were all RCTs assessing the effect of music therapy versus no music in reducing anxiety during breast biopsy. The extracted outcomes were anxiety and pain during breast biopsy. They were pooled as mean difference (MD) with a 95% confidence interval (CI) in a fixed-effects model, using Review Manager 5.3 software for windows. The quality of included studies was assessed with the Cochrane risk of bias assessment tool (RoB 1.0). Then, the outcomes of our meta-analyses were independently evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to know the grade of their evidence. RESULTS: The final analysis included five RCTs. We found a positive effect of music therapy in reducing anxiety levels compared with control group (MD = - 2.11; 95% CI (- 4.16 to - 0.06); p = 0.04). No difference between music and control groups regarding pain associated with breast biopsy (MD = 0.22; 95% CI (- 0.81 to 1.25); p = 0.68). The GRADE rating of our outcomes was low for anxiety levels and very low for pain during the biopsy. CONCLUSIONS: Music therapy could be an effective, simple, non-pharmacological option in relieving anxiety during breast biopsy; however, it had no effect on procedure-associated pain. More large and high-quality studies are needed to confirm our results.

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials.

PURPOSE: Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute-designated comprehensive cancer center. METHODS: Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. RESULTS: Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. CONCLUSION: Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non-patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers.

Periconceptional risk factors of spina bifida among Egyptian population: a case-control study.

OBJECTIVE: To study the preconceptual & early conceptional risk factors predisposing to the development of spina bifida (SB) among Egyptian population. STUDY DESIGN: The study involved 197 pregnant women undergoing fetal anatomy scan; 97 women proved to have fetal SB and 100 women with normal fetuses as a control group. The control group was recruited randomly in the same period from patients undergoing anatomical scan. Risk factors that might lead to SB were investigated including maternal age, gravidity, parity, residence, history of diabetes mellitus or drug intake, smoking, infections, exposure to X-ray, history of congenital anomalies in other offspring, parental consanguinity, positive family history, and folate supplementations. RESULTS: SB affected the lumbo-sacral region in the majority of cases (89.7%). It was associated with hydrocephalus in 66 cases (68%), polyhydramnios in 12 cases (12.4%). The SB group showed significantly higher parity (p = 0.005), more frequent history of drug intake (p < 0.001), higher frequency of infection with CMV (p = 0.004), and HSV (p = 0.013) and less proportion of folate supplementation (p < 0.001). CONCLUSION: The rate of SB in the tested group was five per 1000. Risk factors were lack of folate supplementation and history of antiepileptic drugs intake.

Efficacy and toxicity of sunitinib for non clear cell renal cell carcinoma (RCC): a systematic review of the literature.

BACKGROUND: The randomized phase III trial of sunitinib versus interferon Alfa provided level-A evidence for the use of sunitinib in advanced clear cell renal cell carcinoma (RCC). This systematic literature review aims at the evaluation of the level of evidence for the use of sunitinib monotherapy for advanced non clear cell RCC in terms of efficacy and toxicity parameters. METHODS: Eligible studies were identified using MEDLINE, Google scholar, ASCO, ESMO and the Cochrane databases. Searches were last updated on 1 June 2014. Eligible studies reported survival and/or response data for patients with non clear cell RCC receiving sunitinib monotherapy. RESULTS: four hundred and five results were obtained from the searches in MEDLINE (n=319 studies) and other databases (n=86). Twelve studies (involving 980 patients) were considered eligible and were included in the final analysis: six phase II clinical trials, one expanded access prospective trial and five retrospective analyses. Median PFS was reported in 11 studies ranging from 1.6 to 8.9 months. Median OS was reported in 9 studies ranging from 12 months to 22 months. The disease control rate (DCR) was reported in 10 studies, and it ranged from 35% to 91%. The overall response rate (ORR) was reported in 10 studies and it ranged from 0% to 36%. Frequently reported Grade 3/4 toxicities were gastrointestinal toxicities, mucocutaneous toxicities and hematologic toxicities. CONCLUSION: There is insufficient evidence (level C) to recommend sunitinib monotherapy in advanced non clear cell RCC and the available data suggests it appears less efficacious than that in advanced clear cell RCC. Further prospective and randomized studies are needed to explore alternative therapies in this setting.

Five National Cancer Institute-designated cancer centers' data collection on racial/ethnic minority participation in therapeutic trials: a current view and opportunities for improvement.

BACKGROUND: To ensure that National Institutes of Health-funded research is relevant to the population's needs, specific emphasis on proportional representation of minority/sex groups into National Cancer Institute (NCI) cancer centers' clinical research programs is reported to the NCI. METHODS: EMPaCT investigators at 5 regionally diverse comprehensive cancer centers compared data reported to the NCI for their most recent Cancer Center Support Grant competitive renewal to assess and compare the centers' catchment area designations, data definitions, data elements, collection processes, reporting, and performance regarding proportional representation of race/ethnicity and sex subsets. RESULTS: Cancer centers' catchment area definitions differed widely in terms of their cancer patient versus general population specificity, levels of specificity, and geographic coverage. Racial/ethnic categories were similar, yet were defined differently, across institutions. Patients' socioeconomic status and insurance status were inconsistently captured across the 5 centers. CONCLUSIONS: Catchment area definitions and the collection of patient-level demographic factors varied widely across the 5 comprehensive cancer centers. This challenged the assessment of success by cancer centers in accruing representative populations into the cancer research enterprise. Accrual of minorities was less than desired for at least 1 racial/ethnic subcategory at 4 of the 5 centers. Institutions should clearly and consistently declare their primary catchment area and the rationale and should report how race/ethnicity and sex are defined, determined, collected, and reported. More standardized, frequent, consistent collection, reporting, and review of these data are recommended, as is a commitment to collecting socioeconomic data, given that socioeconomic status is a primary driver of cancer disparities in the United States.

Sorafenib-based combination as a first line treatment for advanced hepatocellular carcinoma: a systematic review of the literature.

BACKGROUND: Hepatocellular carcinoma is the fifth most common cancer worldwide and the third most common cause of cancer mortality. Advanced HCC is a distinct disease entity with limited approved treatment options and grave prognosis. So, we will explore in this systematic review the value of using sorafenib-based combination in this poor prognosis subset of HCC. METHODS: PubMed, Medline, the Cochrane Library, trip database and Google Scholar were searched using the terms "Hepatocellular carcinoma" OR "Hepatoma" or "Liver cancer" AND "systemic anticancer therapy" AND "Sorafenib" and specifying only English literature. Outcomes of interest included progression free survival and overall survival (PFS and OS), tumor response, and toxicities. RESULTS: A total of 17 potentially relevant trials was identified, of which 9 studies were excluded. Hence, eight trials involving 272 patients were included. Median PFS was reported in 6 out of the 8 trials ranging from 3.7 to 7.5 months. Median OS was reported in 6 out of the 8 studies ranging from 7.4 to 40.1 months. The DCR was reported in the 8 studies, ranging from 48.7% to 76%. Frequently reported Grade 3/4 toxicities were increased AST/ALT, fatigue, hypertension, hand foot skin reaction and diarrhea. However, some chemotherapy-specific side effects were noted in some studies. CONCLUSIONS: The current evidence from the available clinical trials suggests that sorafenib-based combination with some anticancer agents (especially mTOR inhibitors) could be a more effective and tolerable treatment for advanced HCC in the future. However, such sorafenib-based combination cannot be recommended outside the setting of clinical trials.

Spiritual health locus of control and health behaviors in African Americans.

OBJECTIVE: To examine relationships between spiritual health locus of control beliefs and various health behaviors. METHODS: A cross-sectional survey of a national sample of African Americans assessed spiritual beliefs, fruit and vegetable consumption, physical activity, and alcohol consumption. RESULTS: Active spiritual beliefs were positively associated with fruit consumption and negatively associated with alcohol consumption. Passive spiritual beliefs were associated with lower vegetable and increased alcohol consumption. Among male participants, passive spiritual beliefs were associated with higher alcohol consumption. CONCLUSIONS: Findings suggest that dimensions of spiritual health locus of control beliefs have complex and varying relationships with health behaviors.

Your body is the temple: impact of a spiritually based colorectal cancer educational intervention delivered through community health advisors.

Colorectal cancer (CRC) is third in cancer incidence and mortality, due in part to lack of awareness and low rates of screening. The purpose of the present study was to evaluate the efficacy of a spiritually based CRC educational intervention delivered by trained Community Health Advisors, in Alabama churches. The aim of the intervention was to increase knowledge and awareness of CRC and early detection, and to eventually increase CRC screening rates. Participants age-eligible for screening (N = 122) completed baseline, 6-month, and 12-month surveys by telephone. Increases in CRC knowledge, perceived benefits of CRC screening, and awareness of the screening modalities and decreases in perceived barriers to screening suggested that this type of intervention may be promising for CRC control and should be examined further.

Predictors of colorectal cancer knowledge and screening among church-attending African Americans and Whites in the Deep South.

This study examined colorectal cancer (CRC) knowledge and the relationship between knowledge, risk factors and screening behaviors among African Americans and Whites in the Deep South. One hundred and twenty three African Americans and Whites age-eligible for CRC screening were interviewed by telephone survey as part of a church-based CRC educational intervention. CRC knowledge was lower among those with less education, unemployed, Medicaid, Medicare, and less family income. Generally, participants who had more CRC knowledge were more likely to have engaged in screening behaviors. Participants who had a family history of CRC were more likely to have had a fecal occult blood test (OR = 2.55, 0.99-6.60) or barium enema (OR = 3.84, 1.44-10.24) than those without. Whites were more likely to have had a flexible sigmoidoscopy (OR = 4.17, 1.09-16.67), colonoscopy (OR = 7.14, 1.72-25) or barium enema (OR = 6.25, 1.67-25) than African Americans. Church-based CRC screening intervention programs should target African Americans, those with no family history of CRC, and those with less education.

Receipt of standard breast cancer treatment by African American and White women.

OBJECTIVES: Breast cancer mortality is higher among African Americans than for Whites, though their breast cancer incidence is lower. This study examines whether this disparity may be due to differential receipt of treatment defined as "standard of care" or "addition to standard of care" by the National Comprehensive Cancer Network (NCCN). DESIGN: Incident, female breast cancer cases, 2,203 African American and 7,518 White, diagnosed during 1996-2002 were identified from the Alabama Statewide Cancer Registry. Breast cancer treatment was characterized as whether or not a woman received standard of care as defined by the NCCN. For cases characterized as receiving standard of care, addition to standard of care was also evaluated, defined as receiving at least one additional treatment modality according to NCCN guidelines. Logistic models were used to evaluate racial differences in standard and addition to standard of care and to adjust for age, stage at diagnosis, year of diagnosis and area of residence. RESULTS: No racial differences were found for standard (Prevalence Ratio (PR)=1.00) or for addition to standard of care (PR=1.00) after adjustment for confounders. When the adjusted models were examined separately by age, stage, and area of residence, overall no racial differences were found. CONCLUSION: No racial differences in standard of care and addition to standard of care for breast cancer treatment were found. Therefore, both African Americans and Whites received comparable treatment according to NCCN guidelines.