Effects of ginger and expectations on symptoms of nausea in a balanced placebo design.

OBJECTIVE: Ginger effects on (experimental) nausea have been described, but also strong placebo effects and sex differences when nausea is involved. The "balanced placebo design" has been proposed to allow better separation of drug and placebo effects. METHODS: Sixty-four healthy participants (32 women) were randomly assigned to receive an antiemetic ginger preparation or placebo, and half of each group was told to have received drug or placebo. They were exposed to 5×2 min body rotations to induce nausea. Subjective symptoms and behavioral (rotation tolerance, head movements) and physiological measures (electrogastrogram, cortisol) were recorded. Groups were balanced for sex of participants and experimenters. RESULTS: Ginger and the information given did not affect any outcome measure, and previous sex differences could not be confirmed. Adding the experimenters revealed a significant four-factorial interaction on behavioral but not on subjective or physiological measures Men who received placebo responded to placebo information when provided by the male experimenter, and to ginger information when provided by the female experimenter. This effect was not significant in women. CONCLUSION: The effects of an antiemetic drug and provided information interact with psychosocial variables of participants and experimenters in reports of nausea

Effects of Ginger and Expectations on Symptoms of Nausea in a Balanced Placebo Design

OBJECTIVE: Ginger effects on (experimental) nausea have been described, but also strong placebo effects and sex differences when nausea is involved. The "balanced placebo design" has been proposed to allow better separation of drug and placebo effects. METHODS: Sixty-four healthy participants (32 women) were randomly assigned to receive an antiemetic ginger preparation or placebo, and half of each group was told to have received drug or placebo. They were exposed to 5×2 min body rotations to induce nausea. Subjective symptoms and behavioral (rotation tolerance, head movements) and physiological measures (electrogastrogram, cortisol) were recorded. Groups were balanced for sex of participants and experimenters. RESULTS: Ginger and the information given did not affect any outcome measure, and previous sex differences could not be confirmed. Adding the experimenters revealed a significant four-factorial interaction on behavioral but not on subjective or physiological measures Men who received placebo responded to placebo information when provided by the male experimenter, and to ginger information when provided by the female experimenter. This effect was not significant in women. CONCLUSION: The effects of an antiemetic drug and provided information interact with psychosocial variables of participants and experimenters in reports of nausea

High Antitumor Activity of the Dual Topoisomerase Inhibitor P8-D6 in Breast Cancer

Breast cancer constitutes the leading cause of cancer deaths among females. However, numerous shortcomings, including low bioavailability, resistance and significant side effects, are responsible for insufficient treatment. The ultimate goal, therefore, is to improve the success rates and, thus, the range available treatment options for breast cancer. Consequently, the identification, development and evaluation of potential novel drugs such as P8-D6 with seminal antitumor capacities have a high clinical need. P8-D6 effectively induces apoptosis by acting as a dual topoisomerase I/II inhibitor. This study provides an overview of the effectiveness of P8-D6 in breast cancer with both 2D monolayers and 3D spheroids compared to standard therapeutic agents. For this drug effectiveness review, cell lines and ex vivo primary cells were used and cytotoxicity, apoptosis rates and membrane integrity were examined. This study provides evidence for a significant P8-D6-induced increase in apoptosis and cytotoxicity in breast cancer cells compared to the efficacy of standard therapeutic drugs. To sum up, P8-D6 is a fast and powerful inductor of apoptosis and might become a new and suitable therapeutic option for breast cancer in the future

ADAM17—A Potential Blood-Based Biomarker for Detection of Early-Stage Ovarian Cancer

Ovarian cancer has the highest mortality rate among gynecological tumors. This is based on late diagnosis and the lack of early symptoms. To improve early detection, it is essential to find reliable biomarkers. The metalloprotease ADAM17 could be a potential marker, as it is highly expressed in many solid tumors, including ovarian and breast cancer. The aim of this work is to evaluate the relevance of ADAM17 as a potential diagnostic blood-based biomarker in ovarian cancer. Ovarian cancer cell lines IGROV-1 and A2780, as well as primary patient-derived tumor cells obtained from tumor tissue and ascitic fluid, were cultured to analyze ADAM17 abundance in the culture supernatant. In a translational approach, a cohort of 117 well-characterized ovarian cancer patients was assembled and ADAM17 levels in serum and corresponding ascitic fluid were determined at primary diagnosis. ADAM17 was quantified by enzyme-linked immunosorbent assay (ELISA). In the present study, ADAM17 was detected in the culture supernatant of ovarian cancer cell lines and primary cells. In addition, ADAM17 was found in serum and ascites of ovarian cancer patients. ADAM17 level was significantly increased in ovarian cancer patients compared to an age-matched control group (p < 0.0001). Importantly early FIGO I/II stages, which would not have been detected by CA-125, were associated with higher ADAM17 concentrations (p = 0.007). This is the first study proposing ADAM17 as a serum tumor marker in the setting of a gynecological tumor disease. Usage of ADAM17 in combination with CA-125 and other markers could help detect early stages of ovarian cancer

Nectin-4 as Blood-Based Biomarker Enables Detection of Early Ovarian Cancer Stages

Ovarian cancer is the third most common gynecological malignancy and has the highest mortality rate. Owing to unspecific symptoms, ovarian cancer is not detected until an advanced stage in about two-thirds of cases. Therefore, it is crucial to establish reliable biomarkers for the early stages to improve the patients’ prognosis. The aim of this study is to investigate whether the ADAM17 substrates Nectin-4, Heparin-binding EGF-like growth factor (HB-EGF) and Amphiregulin (AREG) could function as potential tumor markers for ovarian cancer. In this study a set of 231 sera consisting of 131 ovarian cancer patients and 100 healthy age-matched controls were assembled. Nectin-4, HB-EGF and AREG levels of preoperatively collected sera were determined by enzyme-linked immunosorbent assay (ELISA). Our analysis revealed that Nectin-4 and HB-EGF were significantly increased compared to the age-matched control group (p < 0.0001, p = 0.016). Strikingly, significantly higher Nectin-4 and HB-EGF levels were detected in early-stage FIGO I/II (p <0.001; p = 0.025) compared to healthy controls. Eighty-four percent (16/19) of patients with low Ca-125 levels showed increased Nectin-4 levels. Our study proposes Nectin-4 and HB-EGF as promising blood-based biomarkers for the detection of early stages of ovarian cancer patients that would not have been detected by Ca-125

The balanced placebo design.

<p>The balanced placebo design.</p

Electrogastrogram (EGG) in participants that received ginger or placebo.

<p>EGG was evaluated as the ratio between normal activity (2.5 to 3.75 cycles per minute, cpm) and activity in the tachygastria band (4 to 9.75 cpm), and with increasing nausea the ratio usually falls below 1. Data segments were recorded at baseline, twice after drug application, and after rotation. The constant fall of the ratio from baseline to post rotation is interrupted in the ginger group but ginger was not able to prevent nausea to occur with rotation.</p

Baseline data prior to interventions in experimental groups.

1<p>Motion Sickness Susceptibility Questionnaire score;</p>2<p>Expectancy of susceptibility to rotation stimuli (VAS);</p>3<p>Ginger expectancy value (VAS) prior to rotations;</p>4<p>in the morning upon arrival in the lab;</p>5<p>immediately prior to rotation;</p>6<p>Symptom rating before rotations;</p>7<p>EGG a: available data at baseline (n = 63);</p>8<p>percentage of normal gastric activity;</p>9<p>percentage of tachygastria;</p>10<p>ratio between normal activity and tachygastria;</p>11<p>EGG b: data of cases with all 4 measures (n = 52).</p

Electrogastrogram (EGG) in male and female participants that received ginger or placebo.

<p>EGG was evaluated as the ratio between normal activity (2.5 to 3.75 cycles per minute, cpm) and activity in the tachygastria band (4 to 9.75 cpm), and with increasing nausea the ratio usually falls below 1. Data segments were recorded at baseline, twice after drug application, and after rotation. The constant fall of the ratio from baseline to post rotation was not different between men and women.</p

Number of head movements in male and female participants (HM; means +/− SD).

<p>Male (Panel A) and female (Panel B) participants received either ginger or placebo in a double-blinded design and (immediately prior to rotation) were informed to have received ginger or placebo in a balanced placebo-design, i.e. half of the participants of each group were correctly informed while the other half received false information. When the four groups were compared by effects of drug and information on symptom rating (SR), rotation tolerance (RT), and head movements (HM), MANOVA results were only significant when sex of participants and the experimenters were added as between factors to the analysis (F = 4.307, p = .009).</p