Cannabis use among adults undergoing cancer treatment.

BACKGROUND: Little is known about the risks and benefits of cannabis use in the context of cancer care. This study characterized the prevalence, reasons for use, and perceived benefits of cannabis and compared symptoms and perceived risks between those who reported past 30-day cannabis use and those who did not. METHODS: Adults undergoing cancer treatment at a National Cancer Institute-designated cancer center completed measures of sociodemographic characteristics, cannabis use, use modalities, reasons for use, perceived harms/benefits of use, physical and psychological symptoms, and other substance/medication use. Analyses compared patients who used or did not use cannabis in the past 30 days. RESULTS: Participants (N = 267) were 58 years old on average, primarily female (70%), and predominantly White (88%). Over a quarter of respondents (26%) reported past 30-day cannabis use, and among those, 4.5% screened positive for cannabis use disorder. Participants who used cannabis most often used edibles (65%) or smoked cannabis (51%), and they were younger and more likely to be male, Black, and disabled, and to have lower income and Medicaid insurance than participants who did not use cannabis. Those who used cannabis reported more severe symptoms and perceived cannabis as less harmful than those who did not use cannabis. The most common medical reasons for cannabis use were pain, cancer, sleep problems, anxiety, nausea/vomiting, and poor appetite. Participants reported the greatest cannabis-related symptom relief from sleep problems, nausea/vomiting, headaches, pain, muscle spasms, and anxiety. CONCLUSIONS: Patients with cancer who used cannabis perceived benefits for many symptoms, although they showed worse overall symptomatology. PLAIN LANGUAGE SUMMARY: Among adults undergoing cancer treatment, 26% reported cannabis use in the past 30 days. Those who used cannabis were more likely to be male and disabled and to have lower income and Medicaid insurance than those who did not use cannabis. Participants most commonly reported using cannabis for pain, cancer, sleep, anxiety, and nausea/vomiting and reported the greatest perceived benefits for sleep, nausea/vomiting, headaches, pain, muscle spasms, and anxiety, yet participants who used cannabis also reported feeling worse physically and psychologically compared to those who did not use cannabis. Participants who used cannabis were more likely to report that cannabis was less risky to their health than alcohol, smoking, and opioids than those who did not use cannabis.

Comparing the Effect of Incentive Spirometry and Deep Breathing Exercises on the Level of Shoulder Pain and Nausea Following Laparoscopic Cholecystectomy Surgery: A Clinical Trial Study.

Cholecystitis treated by laparoscopy results in patients experiencing shoulder pain and nausea. Thus, the aim of the present study was to compare the effect of incentive spirometry and deep breathing exercises on the level of shoulder pain and nausea following laparoscopy. In this clinical trial, 105 patients were enrolled into three groups: use of incentive spirometry, deep breathing exercises, and control. Data were collected using a checklist and a visual analog scale and analyzed through the χ2, the Kruskal-Wallis, the Friedman, and the paired t test by SPSS Version 25. In the deep breathing exercise, incentive spirometry, and control groups, mean pain scores immediately after surgery but within 24 hours following the intervention were 3.8, 2.6, and 4.4, respectively. The mean score of severity of nausea for patients in the deep breathing exercise and incentive spirometry groups showed a significant difference immediately after the procedure, as well as at 12 and 24 hours post-intervention. Breathing exercises and incentive spirometry can be effective in reducing pain and nausea in patients undergoing cholecystectomy through laparoscopy. Because of the effectiveness of the two methods, nurses can use incentive spirometery and deep breathing exercises to diminish patients' pain post-cholecystectomy.

Effectors of Pregorexia and Emesis among Pregnant Women: A Pilot Study.

During pregnancy, women tend to improve their lifestyle habits and refine their dietary intake. Quite often, however, these dietary improvements take an unhealthy turn, with orthorexia nervosa (ON) practices being apparent. The aim of the present pilot cross-sectional study was to assess the prevalence of ON tendencies and the incidence of pica and record diet practices in a sample of pregnant women. A total of 157 pregnant women were recruited through private practice gynecologists during the first months of 2021. Nutrition-related practices were recorded, orthorexic tendencies were assessed using the translated and culturally adapted Greek version of the ORTO-15 questionnaire, pica practices were evaluated with a binary question and nausea and emesis during pregnancy (NVP) was evaluated using the translated modified Pregnancy-Unique Quantification of Emesis and Nausea (mPUQE). Only two women reported pica tendencies, with ice and snow being the consumed items. The majority (61.1%) of women reported improving their diet since conception was achieved. Folic acid and iron oral nutrient supplements (ONS) were reportedly consumed by the majority of participants (87.9% and 72.6%, respectively) and 9.6% reported using herbal medicine products. The ORTO-15 score was reduced with tertiary education attainment, ART conception, being in the third trimester of pregnancy, consumption of folic acid and MV supplements and was only increased among women who were at their first pregnancy. The majority of participants experienced severe NVP and the remaining experienced moderate NVP. NVP was associated with lower hemoglobin levels, lack of supplementary iron intake, avoidance of gluten-containing foods, as well as with increased gestational weight gain. The results highlight the need to screen pregnant women for disturbed eating behaviors and nutrition-related problems, in order to ensure a healthy pregnancy outcome.

A Coala-T-Cannabis Survey Study of breast cancer patients' use of cannabis before, during, and after treatment.

BACKGROUND: The goal of this study was to characterize cannabis use among patients with breast cancer, including their reasons for and timing of use, their sources of cannabis information and products, their satisfaction with the information found, their perceptions of its safety, and their dialogue about cannabis with their physicians. METHODS: United States-based members of the Breastcancer.org and Healthline.com communities with a self-reported diagnosis of breast cancer within 5 years (age ≥ 18 years) were invited to participate in an anonymous online survey. After informed consent was obtained, nonidentifiable data were collected and analyzed. RESULTS: Of all participants (n = 612), 42% (n = 257) reported using cannabis for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%). Furthermore, 49% of cannabis users believed that medical cannabis could be used to treat cancer itself. Of those taking cannabis, 79% had used it during treatment, which included systemic therapies, radiation, and surgery. At the same time, few (39%) had discussed it with any of their physicians. CONCLUSIONS: A significant percentage of survey participants (42%) used cannabis to address symptoms; approximately half of these participants believed that cannabis could treat cancer itself. Most participants used cannabis during active cancer treatment despite the potential for an adverse event during this vulnerable time. Furthermore, most participants believed that cannabis was safe and were unaware that product quality varied widely and depended on the source. This study reviews the research on medicinal cannabis in the setting of these findings to help physicians to recognize its risks and benefits for patients with cancer. LAY SUMMARY: Almost half of patients with breast cancer use cannabis, most commonly during active treatment to manage common symptoms and side effects: pain, anxiety, insomnia, and nausea. However, most patients do not discuss cannabis use with their physicians. Instead, the internet and family/friends are the most common sources of cannabis information. Furthermore, most participants believe that cannabis products are safe and are unaware that the safety of many products is untested.

Haloperidol Use in the Emergency Department for Gastrointestinal Symptoms: Nausea, Vomiting, and Abdominal Pain.

INTRODUCTION: Haloperidol (HL) has successfully been used for nausea and abdominal pain in emergency departments (EDs). This study examines outcomes and predictive factors for clinical improvement of patients presenting to an ED with gastrointestinal (GI) symptoms (nausea, vomiting, and abdominal pain) who received HL. METHODS: Review of patients' records who presented to our ED between August 2016 and March 2019 with GI symptoms and received HL. International Classification of Diseases, Tenth Revision codes were used to identify patients. RESULTS: In all, 281 patients (410 encounters) presented to the ED with GI symptoms and received HL for their symptoms: 66% were women, 32% had diabetes, 68% used marijuana, and 27% used chronic opioids. Patients received HL 1.1 ± 0.3 times with dose 2.5 ± 3.0 mg, mostly intravenously (84.6%). Total ED length of stay was 7.5 ± 3.9 hours (3.2 ± 2.1 hours before HL and 4.4 ± 3.4 hours after). Approximately 4.4% of patients developed side effects to HL, including 2 patients with dystonia which improved with medication before discharge. Most patients (56.6%) were discharged home while 43.2% were admitted to hospital mostly because of refractory nausea or vomiting (70.1%). Receiving HL as the only medication in the ED led to lower hospital admission (odds ratio = 0.25, P < 0.05). Diabetes, cannabinoid use, anxiety, male sex, and longer ED stay were associated with increased hospital admissions. DISCUSSION: Most patients treated in our ED with HL for GI symptoms, particularly nausea, vomiting, and/or abdominal pain, were successfully treated and discharged home. HL use seemed relatively safe and, when used as the only medication, led to less frequent hospital admissions.

Sex and Adverse Events of Adjuvant Chemotherapy in Colon Cancer: An Analysis of 34 640 Patients in the ACCENT Database.

BACKGROUND: Adjuvant chemotherapy is a standard treatment option for patients with stage III and high-risk stage II colon cancer. Sex is one of several factors responsible for the wide inter-patient variability in drug responses. Amalgamated data on the effect of sex on the toxicity of current standard adjuvant treatment for colorectal cancer are missing. METHODS: The objective of our study was to compare incidence and severity of major toxicities of fluoropyrimidine- (5FU or capecitabine) based adjuvant chemotherapy, with or without oxaliplatin, between male and female patients after curative surgery for colon cancer. Adult patients enrolled in 27 relevant randomized trials included in the ACCENT (Adjuvant Colon Cancer End Points) database, a large, multi-group, international data repository containing individual patient data, were included. Comparisons were conducted using logistic regression models (stratified by study and treatment arm) within each type of adjuvant chemotherapy (5FU, FOLFOX, capecitabine, CAPOX, and FOLFIRI). The following major toxicities were compared (grade III or IV and grade I-IV, according to National Cancer Institute Common Terminology Criteria [NCI-CTC] criteria, regardless of attribution): nausea, vomiting, nausea or vomiting, stomatitis, diarrhea, leukopenia, neutropenia, thrombocytopenia, anemia, and neuropathy (in patients treated with oxaliplatin). RESULTS: Data from 34 640 patients were analyzed. Statistically significant and clinically relevant differences in the occurrence of grade III or IV nonhematological {especially nausea (5FU: odds ratio [OR] = 2.33, 95% confidence interval [CI] = 1.90 to 2.87, P < .001; FOLFOX: OR = 2.34, 95% CI = 1.76 to 3.11, P < .001), vomiting (5FU: OR = 2.38, 95% CI = 1.86 to 3.04, P < .001; FOLFOX: OR = 2.00, 95% CI = 1.50 to 2.66, P < .001; CAPOX: OR = 2.32, 95% CI = 1.55 to 3.46, P < .001), and diarrhea (5FU: OR = 1.35, 95% CI = 1.21 to 1.51, P < .001; FOLFOX: OR = 1.60, 95% CI = 1.35 to 1.90, P < .001; FOLFIRI: OR = 1.57, 95% CI = 1.25 to 1.97, P < .001)} as well as hematological toxicities (neutropenia [5FU: OR = 1.55, 95% CI = 1.37 to 1.76, P < .001; FOLFOX: OR = 1.96, 95% CI = 1.71 to 2.25, P < .001; FOLFIRI: OR = 2.01, 95% CI = 1.66 to 2.43, P < .001; capecitabine: OR = 4.07, 95% CI = 1.84 to 8.99, P < .001] and leukopenia [5FU: OR = 1.74, 95% CI = 1.40 to 2.17, P < .001; FOLFIRI: OR = 1.75, 95% CI = 1.28 to 2.40, P < .001]) were observed, with women being consistently at increased risk. CONCLUSIONS: Our analysis confirms that women with colon cancer receiving adjuvant fluoropyrimidine-based chemotherapy are at increased risk of toxicity. Given the known sex differences in fluoropyrimidine pharmacokinetics, sex-specific dosing of fluoropyrimidines warrants further investigation.

Polyethylene glycol versus split high-dose senna for bowel preparation: A comparative prospective randomized study.

BACKGROUND AND AIM: The aim of this study was to compare the quality and tolerability of bowel preparation using split high-doses of sennosides versus split-dose polyethylene glycol (PEG). METHODS: In this prospective, randomized, and endoscopist-blinded study, 474 outpatients were included and randomly assigned to two groups: Group 1 was comprised of 237 patients receiving split high-dose (1000 mg) sennoside solutions, and group 2 included 237 patients receiving 4 L of PEG. The efficacy of the preparations was evaluated on the Boston Bowel Preparation Scale (BBPS), and compliance and adverse effects were recorded. RESULTS: The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score ≥ 6) in 89.9% of patients taking senna, and 73.8% in the PEG group (P = 0.001). The rates of vomiting in the senna and PEG groups were 12.7% and 29.5%, nausea rates were 28.7% and 43.9%, and abdominal pain rates were 70.9% and 43%, respectively (P < 0.001). Cecal intubation rates in the senna and PEG groups were 95.4% and 86.1% (P = 0.001), and the cecal intubation times were 6.73 ± 2.84 and 5.34 ± 5.98 min, respectively (P = 0.001). CONCLUSIONS: Split high-dose senna is more effective than split-dose PEG in terms of bowel preparation quality and patient compliance. The patients who received senna had significantly less vomiting and nausea but significantly more abdominal pain. Thus, senna may be used as an alternative to PEG for bowel preparation.

Efficacy of transcutaneous electrical acupoint stimulation combined with general anesthesia for sedation and postoperative analgesia in minimally invasive lung cancer surgery: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Multimodal opioid-sparing analgesia is a key component of an enhanced recovery pathway after surgery that aims to improve postoperative recovery. Transcutaneous electrical acupoint stimulation (TEAS) is assumed to alleviate pain and anxiety and to modify the autonomic nervous system. This study aimed to determine the efficacy of TEAS for sedation and postoperative analgesia in lung cancer patients undergoing thoracoscopic pulmonary resection. METHODS: A total of 80 patients were randomized into two groups: the TEAS group and the sham TEAS combined with general anesthesia group. Postoperative pain levels at six, 24, 48 hours, and one month after surgery were measured using the visual analogue scale (VAS). Bispectral index (BIS) score during the TEAS prior to anesthetic induction, Observer's Assessment of Alertness/Sedation (OAAS) score, sufentanil consumption during postoperative patient-controlled intravenous analgesia (PCIA), number of total and effective attempts of PCIA pump use, and incidence of postoperative nausea and vomiting were recorded and analyzed statistically. RESULTS: Patients in the TEAS group had significantly lower VAS scores at six, 24, and 48 hours after surgery (P < 0.01); lower BIS scores at 10, 20, and 30 minutes before induction (P < 0.01); lower levels of postoperative sufentanil consumption; lower number of PCIA attempts and effective rates (P < 0.01); lower incidences of nausea at 0, six, 24, and 48 hours; and lower incidence of vomiting at 24 hours after surgery (P < 0.05). The postoperative OAAS scores were similar between the groups. CONCLUSIONS: TEAS could be a feasible approach for sedation and postoperative analgesia in thoracoscopic pulmonary resection.

A randomized trial of nurse-administered behavioral interventions to manage anticipatory nausea and vomiting in chemotherapy.

PURPOSE: Chemotherapy side effects diminish quality of life and can lead to treatment delay. Nausea and vomiting can occur prior to chemotherapy because of classical conditioning. We studied the effects of 20-minute behavioral interventions, administered by oncology nurses, of higher intensity (mindfulness relaxation-MR) or lower intensity (relaxing music-RM), on anticipatory nausea and vomiting (ANV). PATIENTS AND METHODS: Patients undergoing chemotherapy for solid tumors were randomized to MR (N = 160), RM (N = 159), or standard care SC (N = 155). Subjects were mostly female (91.8%) and white (86.1%) with breast cancer (85%). Most patients had early stage disease (Stage I: 26%; II: 52.9%; III: 19%; IV: 0.1%). Anticipatory nausea and vomiting were assessed at the midpoint and end of the chemotherapy course using the Morrow Assessment of Nausea and Emesis (MANE). RESULTS: Compared to SC, there was reduced anticipatory nausea at the midpoint of chemotherapy in those receiving MR (OR 0.44, 95% CI 0.20-0.93) and RM (OR 0.40, 95% CI 0.20-0.93), controlling for age, sex, cancer stage, and emetogenic level of chemotherapy. There was no difference between treatment groups in anticipatory nausea at the end of chemotherapy or in anticipatory vomiting and postchemotherapy nausea and vomiting at either time point. CONCLUSION: A brief nurse-delivered behavioral intervention can reduce midpoint ANV associated with chemotherapy.

The effect of aquapuncture at Pericardium 6 (PC-6) on dexmedetomidine-induced nausea and vomiting in cats.

OBJECTIVE: To determine the effect of aquapuncture at acupuncture point Pericardium 6 (PC-6) on the incidence of dexmedetomidine-induced vomiting and nausea in cats. STUDY DESIGN: Randomized, prospective, crossover study. ANIMALS: A group of 22 cats, 14 females and eight males, aged 1-12 years and weighing 3.8-5.9 kg. METHODS: Each cat was administered treatments in random order at ≥1 week intervals. For treatment (DEX-A), cats were administered PC-6 stimulation by aquapuncture (0.25 mL/250 µg vitamin B12 injection subcutaneously at PC-6). After 30 minutes, dexmedetomidine (10 µg kg-1) was administered intramuscularly (IM). For control treatment (DEX), cats were administered only dexmedetomidine (10 µg kg-1) IM. Incidence of vomiting, number of vomiting episodes and time to first vomiting were recorded by an observer unaware of treatment allocation. At 30 minutes after dexmedetomidine administration, atipamezole (0.1 mg kg-1) was injected IM. Behavior was video recorded and later scored by two observers for clinical signs of nausea. A regression model (analysis of covariance) was used to detect the influence of aquapuncture on vomiting and nausea. Significance was set at p < 0.05. RESULTS: Of 21 cats, 18 (85%) and 16 cats (76%) vomited in DEX-A and DEX, respectively. There was no significant difference in the incidence of vomiting (p = 0.55), number of vomiting episodes (p = 0.55), mean time to vomit (p = 0.88) or nausea score (p = 0.51) between DEX-A and DEX. CONCLUSIONS AND CLINICAL RELEVANCE: PC-6 aquapuncture did not reduce the incidence of dexmedetomidine-induced vomiting or severity of nausea in cats.

Incidence of Side-effects After Weekly Iron and Folic Acid Consumption Among School-going Indian Adolescents.

OBJECTIVE: To estimate incidence of side effects after weekly iron and folic acid supplementation (WIFS) in Delhi and Haryana. METHODS: In this cross-sectional school-based study, data were collected from 4,183 adolescents on WIFS consumption and side effects experienced first time of receipt of WIFS (week 1), and in last two consecutive weeks (week 2,3). Week 3 was 48 hours preceding the survey. RESULTS: WIFS consumption in week 1, 2 and 3 was 85%, 63% and 52%, respectively. Side effects reported were highest in first week (25%) and reduced to 7% (week 2) and 5% (week 3). Side effects most reported were abdominal pain (80%) and nausea (10%). Adolescents (45%) who faced a side-effect in week 1 did not consume WIFS in subsequent week. CONCLUSIONS: Incidence of side effects was low, but it affected compliance. Positive reinforcement to students who face side effects requires strengthening by teachers.

Risk factors for chemotherapy-induced nausea in pediatric patients receiving highly emetogenic chemotherapy.

BACKGROUND: Little is known regarding risk factors for chemotherapy-induced nausea (CIN) in pediatric patients. PROCEDURE: A secondary analysis was conducted of a previously published multicenter, prospective, randomized, single-blind, sham-controlled trial assessing the efficacy of acupressure in preventing CIN in pediatric patients receiving highly emetogenic chemotherapy. The primary outcome was nausea severity, self-reported using the Pediatric Nausea Assessment Tool. The relationships between acute and delayed nausea severity and patient- (sex, race, age, and cancer diagnosis) and treatment-related (chemotherapy, antiemetic prophylaxis, CIN, and vomiting control) factors were analyzed by a proportional odds generalized estimating equation approach. The acute phase started with administration of the first and continued for 24 hours after the last chemotherapy dose. The delayed phase started at the end of the acute phase and continued until the next chemotherapy block (maximum seven days). RESULTS: In the acute and delayed phases, 165 and 144 patients provided data for analysis, respectively. Nonwhite race was significantly associated with higher acute phase nausea severity (OR, 1.7; 95% CI, 1.1-2.6). Poor CIN control in the acute phase (OR, 16; 95% CI, 4.0-64.6), diagnosis of a cancer other than a central nervous system (CNS) tumor (OR, 2.5; 95% CI, 1.2-5.3), and cisplatin administration (OR, 3.7; 95% CI, 2.1-6.0) were significantly associated with higher delayed phase nausea severity. CONCLUSION: Acute phase CIN was associated with nonwhite race. Delayed phase CIN was associated with poor acute phase CIN control, diagnosis of non-CNS cancer, and receipt of cisplatin. These findings will inform future antiemetic trial design.

The vitamin epidemic: what is the evidence for harm or value?

Complementary medicines are a multibillion-dollar industry of which vitamin supplements are an important component. Most of the claims of benefit are not evidenced-based, and vitamin supplements may be associated with severe adverse reactions that are uncommon but can occur with high doses of some vitamins. There is no case for vitamin supplementation in normal, healthy, non-pregnant or lactating adults who are receiving the recommended daily intake of nutrients.

[Effects of Serum Sodium Concentrations on Nausea and Vomiting after Moderately Emetogenic Chemotherapy].

Chemotherapy-induced nausea and vomiting (CINV) is the most unbearable adverse effect of chemotherapy. The antiemesis guidelines of the National Comprehensive Cancer Network indicate that hyponatremia is a risk factor for CINV, although the relationship between the incidence of CINV and hyponatremia has not been sufficiently studied. This two-center prospective observational study evaluated whether low serum sodium concentrations were a risk factor for CINV. The study included 34 patients who were scheduled to receive first-line carboplatin- or oxaliplatin-based chemotherapy for gynecological or colorectal cancers. Patient diaries were used to record the daily incidences of CINV events during a 5-day period. The patients were divided based on the median serum sodium concentration into a low Na+ group (<141 mEq/L) and a high Na+ group (≥141 mEq/L). The incidences of delayed nausea were 27.8% in the high Na+ group and 62.5% in the low Na+ group (p=0.042), with complete control rates (no vomiting, rescue medication, or grade 2 nausea) of 77.8% and 43.8%, respectively (p=0.042). The time to complete control failure in each group was analyzed using the Kaplan-Meier method, which revealed a significantly shorter time in the low Na+ group (p=0.03). Therefore, these results indicate that low serum sodium concentrations may increase the risk of CINV.

Retrospective Evaluation of Clinical Experience With Intravenous Ascorbic Acid in Patients With Cancer.

BACKGROUND: Intravenous ascorbic acid (IV AA) has been used extensively in cancer patients throughout the United States. Currently, there are limited data on the safety and clinical effects of IV AA. The purpose of this study was to expand the current literature using a retrospective analysis of adverse events and symptomatic changes of IV AA in a large sample of cancer patients. METHODS: We conducted a retrospective chart review of all patients receiving IV AA for cancer at the Thomas Jefferson University Hospital over a 7-year period. We assessed all reports of adverse events, laboratory findings, and hospital or emergency department admissions. We also reviewed quality-of-life data, including fatigue, nausea, pain, appetite, and mood. RESULTS: There were 86 patients who received a total of 3034 doses of IV AA ranging from 50 to 150g. In all, 32 patients received only ascorbic acid as part of their cancer management (1197 doses), whereas 54 patients received ascorbic acid in conjunction with chemotherapy (1837 doses). The most common adverse events related to ascorbic acid were temporary nausea and discomfort at the injection site. All events reported in the ascorbic acid alone group were associated with less than 3% of the total number of infusions. Patients, overall, reported improvements in fatigue, pain, and mood while receiving ascorbic acid. CONCLUSIONS: The results of this retrospective analysis support the growing evidence that IV AA is generally safe and well tolerated in patients with cancer, and may be useful in symptom management and improving quality of life.

Ten-day high-dose proton pump inhibitor triple therapy versus sequential therapy for Helicobacter pylori eradication.

BACKGROUND AND AIM: Eradication rates of Helicobacter pylori following standard triple therapy are declining worldwide, but high-dose proton pump inhibitor-based triple therapy (HD-PPI-TT) and sequential therapy (ST) have demonstrated higher cure rates. We aimed to compare the efficacy and tolerability of HD-PPI-TT and ST in H. pylori-associated functional dyspepsia (FD). METHODS: One hundred and twenty H. pylori-associated functional dyspepsia patients were randomized to receive 10-day HD-PPI-TT (60 mg lansoprazole/500 mg clarithromycin/1 g amoxicillin, each administered twice daily for 10 days) or 10-day ST (30 mg lansoprazole/1 g amoxicillin, each administered twice daily for 5 days followed by 30 mg lansoprazole/500 mg clarithromycin/400 mg metronidazole, each administered twice daily for 5 days). H. pylori status was determined in post-treatment week 4 by 14 C-urea breath test. Eradication and antibiotic resistance rates, dyspeptic symptoms, drug compliance, and adverse effects were compared. RESULTS: Intention-to-treat eradication rates were similar in the ST and HD-PPI-TT groups (85% vs. 80%; P = 0.47). However, the eradication rate was significantly higher following ST compared with HD-PPI-TT in per protocol analysis (94.4% vs. 81.4%; P = 0.035). ST achieved higher cure rates than HD-PPI-TT in clarithromycin-resistant H. pylori strains (100% vs. 33.3%; P = 0.02). Treatment compliance was similar in the HD-PPI-TT and ST groups, although nausea and dizziness were more common in the ST group. CONCLUSIONS: Sequential therapy achieved better H. pylori eradication than HD-PPI-TT in patients with FD. However, the eradication rate for ST fell from 94.4% in per protocol to 85% in intention-to-treat analysis. Adverse effects might result in poorer compliance and compromise actual ST efficacy (ClinicalTrials.gov: NCT01888237).

Medical use of cannabis: Italian and European legislation.

This review illustrates some brief considerations of the medical use of cannabis recently issued in Italy. History and uses of cannabis throughout centuries and different countries are illustrated together with a description of botany and active phytocannabinoids. Then, medical use of cannabis anti-pain treatment for patients resistant to conventional therapies is described in case of chronic neuropathic pain, spasticity, for anticinetosic and antiemetic effect in nausea and vomiting caused by chemotherapy, for appetite stimulating effect in cachexia, anorexia, loss of appetite in cancer patients or patients with AIDS and in anorexia nervosa, hypotensive effect in glaucoma resistant to conventional therapies and for reduction of involuntary body and facial movements in Gilles de la Tourette syndrome. Italian most recent legislation on medical cannabis is detailed with some law proposals, also showing the inconsistent legislation within European Union. Some final considerations of future studies are also reported.

Development of MK-8353, an orally administered ERK1/2 inhibitor, in patients with advanced solid tumors.

BACKGROUND: Constitutive activation of ERK1/2 occurs in various cancers, and its reactivation is a well-described resistance mechanism to MAPK inhibitors. ERK inhibitors may overcome the limitations of MAPK inhibitor blockade. The dual mechanism inhibitor SCH772984 has shown promising preclinical activity across various BRAFV600/RAS-mutant cancer cell lines and human cancer xenografts. METHODS: We have developed an orally bioavailable ERK inhibitor, MK-8353; conducted preclinical studies to demonstrate activity, pharmacodynamic endpoints, dosing, and schedule; completed a study in healthy volunteers (P07652); and subsequently performed a phase I clinical trial in patients with advanced solid tumors (MK-8353-001). In the P07652 study, MK-8353 was administered as a single dose in 10- to 400-mg dose cohorts, whereas in the MK-8353-001 study, MK-8353 was administered in 100- to 800-mg dose cohorts orally twice daily. Safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity were analyzed. RESULTS: MK-8353 exhibited comparable potency with SCH772984 across various preclinical cancer models. Forty-eight patients were enrolled in the P07652 study, and twenty-six patients were enrolled in the MK-8353-001 study. Adverse events included diarrhea (44%), fatigue (40%), nausea (32%), and rash (28%). Dose-limiting toxicity was observed in the 400-mg and 800-mg dose cohorts. Sufficient exposure to MK-8353 was noted that correlated with biological activity in preclinical data. Three of fifteen patients evaluable for treatment response in the MK-8353-001 study had partial response, all with BRAFV600-mutant melanomas. CONCLUSION: MK-8353 was well tolerated up to 400 mg twice daily and exhibited antitumor activity in patients with BRAFV600-mutant melanoma. However, antitumor activity was not particularly correlated with pharmacodynamic parameters. TRIAL REGISTRATION: ClinicalTrials.gov NCT01358331. FUNDING: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., and NIH (P01 CA168585 and R35 CA197633).

Association between severe nausea and vomiting in early pregnancy and the risk of neural tube defects in Northern China.

BACKGROUND: This study assessed the association between severe NVP and the risk of NTD in offspring compared with a population and a malformed control group. We also assessed whether folic acid supplements modified this association. STUDY DESIGN AND SETTING: A case-control study was conducted with subjects enrolled from June 19, 2002, to November 18, 2014, from a population-based birth defects surveillance system that monitors major external structural birth defects through active case ascertainment in Shanxi Province, China. The main comparison was between women with NTD-affected offspring who experienced NVP in early pregnancy versus those who did not. A multivariable logistic regression model was used to examine the associations between severe NVP and the risk of NTD while adjusting for potential confounding factors. The risk was estimated by calculating the odds ratio (OR) and 95% confidence intervals (CIs). RESULTS: The adjusted OR (AOR) of severe NVP for NTDs was 3.25 (95%CI 2.56, 4.12) compared with the population control, and 1.65 (95%CI 1.00, 2.72) compared with the malformed controls. When stratified by intake of folic acid supplements, the AOR for severe NVP was 3.40 (95%CI 2.61, 4.42) in the non-intake of folic acid supplements stratum and 2.51 (95%CI 1.42, 4.43) in the intake of folic acid supplements stratum. CONCLUSION: We conclude that severe NVP is associated with NTDs, and that severe NVP may be a consequence, rather than a cause, of NTDs.

French family physician experience concerning the outpatient care for women suffering from nausea and vomiting in pregnancy.

OBJECTIVE: To explore thoughts and attitudes among French family physicians on the outpatient care for women suffering from nausea and vomiting in pregnancy (NVP). DESIGN AND SETTING: A retrospective study was conducted among family physicians who had taken care of pregnant women who gave birth in our hospital in 1 year. PATIENTS AND METHODS: Fifty-nine French family physicians responded to a questionnaire assessing their experience about outpatient care for women suffering from NVP. Analysis were done according to the physicians' age, as the annual demographics data analysis from the French Medical Council. RESULTS: More than 89% of family physicians asked systematically the question concerning NVP (53/59), which were estimated as a frequent symptom (n=44, 74.6%). The intensity of NVP was assessed as mild in 28.8% (n=17), moderate in 62.7% (n=37), severe in 6.8% (n=4) and unbearable in 1.7% (n=1). Physicians younger than 40 years questionned less frequently about NVP compared to those older than 40 or older than 60 years (66.7% vs. 90.5% vs. 95.5%, respectively; P=0.04). Severe and unbearable NVP were significantly estimated more frequent among younger physicians (33.3% vs. 6.8%; P=0.03). Treatments (sick leave, diet, drugs, homeopathy, acupuncture or psychotherapy) did not differ between groups. DISCUSSION AND CONCLUSION: Outpatient care for women suffering from NVP may vary according to the physician. French family physicians played a key role in NVP. Younger family physician considered NVP as a frequent symptom which needed active management in severe forms.