Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)-a randomized phase II trial of the AIO pancreatic cancer group.

BACKGROUND: Data on perioperative chemotherapy in resectable pancreatic ductal adenocarcinoma (rPDAC) are limited. NEONAX examined perioperative or adjuvant chemotherapy with gemcitabine plus nab-paclitaxel in rPDAC (National Comprehensive Cancer Network criteria). PATIENTS AND METHODS: NEONAX is a prospective, randomized phase II trial with two independent experimental arms. One hundred twenty-seven rPDAC patients in 22 German centers were randomized 1 : 1 to perioperative (two pre-operative and four post-operative cycles, arm A) or adjuvant (six cycles, arm B) gemcitabine (1000 mg/m2) and nab-paclitaxel (125 mg/m2) on days 1, 8 and 15 of a 28-day cycle. RESULTS: The primary endpoint was disease-free survival (DFS) at 18 months in the modified intention-to-treat (ITT) population [R0/R1-resected patients who started neoadjuvant chemotherapy (CTX) (A) or adjuvant CTX (B)]. The pre-defined DFS rate of 55% at 18 months was not reached in both arms [A: 33.3% (95% confidence interval [CI] 18.5% to 48.1%), B: 41.4% (95% CI 20.7% to 62.0%)]. Ninety percent of patients in arm A completed neoadjuvant treatment, and 42% of patients in arm B started adjuvant chemotherapy. R0 resection rate was 88% (arm A) and 67% (arm B), respectively. Median overall survival (mOS) (ITT population) as a secondary endpoint was 25.5 months (95% CI 19.7-29.7 months) in arm A and 16.7 months (95% CI 11.6-22.2 months) in the upfront surgery arm. This difference corresponds to a median DFS (mDFS) (ITT) of 11.5 months (95% CI 8.8-14.5 months) in arm A and 5.9 months (95% CI 3.6-11.5 months) in arm B. Treatment was safe and well tolerable in both arms. CONCLUSIONS: The primary endpoint, DFS rate of 55% at 18 months (mITT population), was not reached in either arm of the trial and numerically favored the upfront surgery arm B. mOS (ITT population), a secondary endpoint, numerically favored the neoadjuvant arm A [25.5 months (95% CI 19.7-29.7months); arm B 16.7 months (95% CI 11.6-22.2 months)]. There was a difference in chemotherapy exposure with 90% of patients in arm A completing pre-operative chemotherapy and 58% of patients starting adjuvant chemotherapy in arm B. Neoadjuvant/perioperative treatment is a novel option for patients with resectable PDAC. However, the optimal treatment regimen has yet to be defined. The trial is registered with ClinicalTrials.gov (NCT02047513) and the European Clinical Trials Database (EudraCT 2013-005559-34).

[Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain - range of motion analysis]. / Randomisierte Studie zur Akupunktur im Vergleich mit konventioneller Massage und Schein-Laserakupunktur in der Behandlung chronischer HWS-Beschwerden - Bewegungsanalyse.

AIM: The aim of this study was to compare the effects of acupuncture on active motion of the cervical spine in patients with chronic neck pain with those of "sham" laser acupuncture and massage. MATERIAL AND METHODS: 177 patients with chronic neck pain were included in this prospective, randomized, placebo-controlled study. The patients were allocated by external randomization to five treatments over three weeks with acupuncture, massage and "sham" laser acupuncture. The range of active motion was measured by means of a 3D ultrasound real time motion analyzer. RESULTS: The analysis of cervical motion in three directions showed the largest increase in range of motion 14 days after acupuncture. Compared to massage, a significant improvement in total range of motion was seen in those patients treated by acupuncture immediately (p = 0,03) and one week (p = 0,03) weeks after therapy. There was no significant difference in those patients treated by sham laser acupuncture. CONCLUSION: The results of the study indicate that acupuncture is superior to conventional massage for improving active range of motion in patients with chronic neck pain. Because of its positive effects, its acceptance among patients and the lack of severe side effects, acupuncture can be recommended for the treatment of chronic neck pain, although there was no significant difference in results between "sham" laser acupuncture and acupuncture.

Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain.

OBJECTIVES: To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain. DESIGN: Prospective, randomised, placebo controlled trial. SETTING: Three outpatient departments in Germany. PARTICIPANTS: 177 patients aged 18-85 years with chronic neck pain. INTERVENTIONS: Patients were randomly allocated to five treatments over three weeks with acupuncture (56), massage (60), or "sham" laser acupuncture (61). PRIMARY OUTCOME MEASURE: maximum pain related to motion (visual analogue scale) irrespective of direction of movement one week after treatment. SECONDARY OUTCOME MEASURES: range of motion (3D ultrasound real time motion analyser), pain related to movement in six directions (visual analogue scale), pressure pain threshold (pressure algometer), changes of spontaneous pain, motion related pain, global complaints (seven point scale), and quality of life (SF-36). Assessments were performed before, during, and one week and three months after treatment. Patients' beliefs in treatment were assessed. RESULTS: One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage (difference 24.22 (95% confidence interval 16.5 to 31.9), P=0.0052) but not compared with sham laser (17.28 (10.0 to 24.6), P=0.327). Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years (n=75) and in patients with myofascial pain syndrome (n=129). The acupuncture group had the best results in most secondary outcome measures. There were no differences in patients' beliefs in treatment. CONCLUSIONS: Acupuncture is an effective short term treatment for patients with chronic neck pain, but there is only limited evidence for long term effects after five treatments.

Hepatitis A virus: a test method for virucidal activity.

Hepatitis A virus (HAV) is closely related to the genus enterovirus. HAV is very stable and resistant to acid pH and elevated temperature, as well as to chemicals and environmental influences. Human poliovirus is still one of the model viruses for testing disinfectants but there are discussions about changing to hepatitis A virus. The purpose of this study was to develop a method for using adapted hepatitis A virus to test hand disinfectants. Using HAV strains HM175/24a and FRhK-4 cytopathic effects were visible rarely, and not before 14 days. To verify virus growth in cells a RT-PCR was developed. Two disinfectants tested did not show the required virucidal activity to satisfy current German guidelines.

Mig, GRO alpha and RANTES messenger RNA expression in lining layer, infiltrates and different leucocyte populations of synovial tissue from patients with rheumatoid arthritis, psoriatic arthritis and osteoarthritis.

To investigate lymphocyte and monocyte recruitment-specific chemokine expression in synovial tissues from patients with rheumatoid arthritis (RA), psoriatic arthritis (PA) and osteoarthritis (OA), synovial membranes and cytocentrifuge preparations of 7 RA, 8 PA and 10 OA patients were examined by in situ hybridisation with antisense probes of Mig, GRO alpha and RANTES and by immunohistochemistry. Patients' local disease activity (swelling and tenderness) in order to was graded and histological evaluation was performed compare these data with their chemokine expression profiles. Mig and RANTES hybridisation signals were detected in the synovial lining layer and in cellular infiltrates, whereas GRO alpha expression was localised exclusively in the lining layer of PA and RA. Cytological analysis revealed Mig and GRO alpha mRNA mainly in monocytic cells expressing KIM6, while RANTES mRNA was demonstrated predominantly in lymphocytic cells expressing CD3. In OA synovial membranes, significantly fewer hybridisation signals were present than in RA and PA synovial membranes. Patients with PA and RA had mild to severe local disease activity, whereas OA patients showed only mild disease activity. Histologically, PA and RA inflammatory scores ranged from 1 to 5, while OA synovium was consistently graded 1. Therefore, we conclude that the differential expression of Mig, GRO alpha and RANTES in resident and in inflammatory cells has an important role in regulating leucocyte traffic in inflammatory arthropathies. The diverse leucocyte specificity of Mig, GRO alpha and RANTES may thus regulate the recruitment of different leucocyte populations, as detected in PA and RA. Therefore, the pattern of cellular infiltration in human synovitis and the corresponding clinical signs of inflammation basically reflect the localisation and expression intensity of chemokines, which may be an important target for future disease modulation.

Prevalence of goitre and hypothyroidism in Southern Tanzania: effect of iodised oil on thyroid hormone deficiency.

In the Southern Highlands of Tanzania the prevalence of endemic goitre due to iodine deficiency is in the range of 90% and hypothyroidism in the range of 50% of schoolchildren. The present study confirms these data and documents the beneficial effect of Lipiodol injections on thyroid function in children around the age of puberty compared with untreated children from the same villages. On the other hand, a decrease in the prevalence of goitre could not be shown. A beneficial effect is shown for infants of mothers who received iodine during pregnancy. It seems that this form of supplementation is sufficient for breast fed children for more than three years, even when a second child has been delivered in the meantime. In contrast, older siblings of these babies may become hypothyroid when breast feeding is stopped. The determination of thyroid autoantibodies in iodine treated and untreated children and in young adults showed no increasing prevalence of positive findings thus excluding iodine induced chronic thyroiditis at least in the young target population.