Paolo Mazzotta

A Risk-Benefit Assessment of Pharmacological and Nonpharmacological Treatments for Nausea and Vomiting of Pregnancy

Despite evidence of fetal safety, most antiemetics are contraindicated in pregnancy. We summarise a risk-benefit analysis of the literature on safety and effectiveness of pharmacotherapy and nontraditional therapy for nausea and vomiting of pregnancy (NVP) to provide evidence-based guidelines on the management of NVP.The medical literature was scanned for controlled studies on the human teratogenicity and effect of various antiemetics in pregnant women. Data were pooled based on drug/therapy class and summarised to determine relative risk with 95% confidence interval (for malformations and failure rates for NVP) and homogeneity (chi-square test).Evidence from controlled trials has demonstrated the safety and efficacy of the following drugs for the treatment of varying degrees of NVP: doxylamine/pyridoxine±dicycloverine (dicyclomine), antihistamine H1 receptor antagonists, and phenothiazines (as a group). However, pooled data for doxylamine/ pyridoxine±dicycloverine, H1 antagonists and phenothiazines were not homogeneous. Other therapies, such as pyridoxine alone, metoclopramide, ondansetron and the corticosteroids may be beneficial in managing NVP. However, limited efficacy studies and the paucity of well-controlled safety studies may limit the use of some of these agents among patients not responsive to first-line agents. Well-controlled safety and effectiveness trials in patients with NVP are lacking for nonpharmacological treatments (e.g. acupressure).NVP can be managed safely and effectively. Further trials must be conducted in order to determine the true effectiveness of certain agents in patients with NVP.

Treating allergic rhinitis in pregnancy. Safety considerations.

Allergic rhinitis affects approximately one-third of women of childbearing age. As a result, symptoms ranging from sneezing and itching to severe nasal obstruction may require pharmacotherapy. However, product labels state that medications for allergic rhinitis should be avoided during pregnancy due to lack of fetal safety data, even though the majority of the agents have human data which refute these notions. We present a systematic and critical review of the medical literature on the use of pharmacotherapy for the management of allergic rhinitis during pregnancy. Electronic databases and other literature sources were searched to identify observational controlled studies focusing on the rate of fetal malformations in pregnant women exposed to agents used to treat allergic rhinitis and related diseases compared with controls.Immunotherapy and intranasal sodium cromoglycate (Cromolyn) and beclomethasone would be considered as first-line therapy, both because of their lack of association with congenital abnormalities and their superior efficacy to other agents. First-generation (e.g. chlorpheniramine) and second-generation (e.g. cetirizine) antihistamines have not been incriminated as human teratogens. However, first-generation antihistamines are favoured over their second generation counterparts based on their longevity, leading to more conclusive evidence of safety. There are no controlled trials with loratadine and fexofenadine in human pregnancy.Oral, intranasal and ophthalmic decongestants (e.g. pseudoephedrine, phenylephrine and oxymetazoline, respectively) should be considered as second-line therapy, although further studies are needed to clarify their fetal safety. No human reproductive studies have been reported with the ophthalmic antihistamines ketorolac and levocabastine, although preliminary data reported suggest no association between pheniramine and congenital malformations. There are no documented epidemiological studies with intranasal corticosteroids (e.g. budesonide, fluticasone propionate, mometasone) during pregnancy; however, inhaled corticosteroids (e.g. beclomethasone) have not been incriminated as teratogens and are commonly used by pregnant women who have asthma.In summary, women with allergic rhinitis during pregnancy can be treated with a number of pharmacological agents without concern of untoward effects on their unborn child. Although the choice of agents in part should be based on evidence of fetal safety, issue of efficacy needs to be addressed in order to optimally manage this condition.

Factors associated with elective termination of pregnancy among Canadian and American women with nausea and vomiting of pregnancy

Case reports have associated severe nausea and vomiting of pregnancy (NVP) with elective termination of pregnancy. Therefore, our objective was to explore the determinants of consideration of termination and actual termination of pregnancy among women with NVP. From 1996 to 1997, callers to an advertised NVP Healthline underwent a semi-structured interview. From callers who retrospectively reported on NVP in a previous pregnancy, a nested unmatched case-control study was performed. Callers were divided into three groups: those who reported having electively terminated their pregnancy due to NVP, those who considered termination due to NVP and those who never considered termination. The severity of nausea and vomiting, and frequency of psychosocial morbidity, were compared between cases and controls, and multivariate logistic regression analysis was used to determine factors independently associated with termination and/or consideration of termination of pregnancy due to NVP. Of 3201 callers with NVP, 413 women reported having considered termination of pregnancy for NVP, 108 reported termination due to NVP and 2609 reported never having considered termination for NVP. The following factors were independently associated with a womans consideration of termination of pregnancy due to NVP: unplanned pregnancy (p=0.002), multiparity (p=0.0001), more severe vomiting (p=0.003), feelings of depression (p < 0.0001) and reported adverse effects of NVP on both her partners daily life (p - 0.04) and her relationship with her partner (p=0.0003). The following factors were independently associated with actual termination of pregnancy due to NVP: unplanned pregnancy (p < 0.0001), multiparity (p=0.03) and feelings of depression (p=0.001). There were no significant interactions between factors. Consideration of termination, or actual termination of pregnancy, due to NVP are associated with psychosocial circumstances, which should be taken into consideration when managing these women.

Fetal safety of drugs used in the treatment of allergic rhinitis: a critical review.

Allergic rhinitis is the most common allergic disease. Pharmacological interventions are often not used in pregnancy because of alarming information in drug labels and patient information, even when evidence for safety exists.Low-risk therapies could include immunotherapy, intranasal sodium cromoglycate (cromolyn sodium), beclometasone, budesonide and first-generation antihistamines. In a meta-analysis examining the safety of first-generation antihistamines in pregnancy, 200 000 first trimester exposures failed to show increased teratogenic risk. Loratadine is the most studied second-generation antihistamine (with a total patient cohort of 2147 women who were exposed) and does not appear to increase the risk of major congenital malformations; however, it has not been as well studied as the earlier antihistamines. Since desloratadine is the principal metabolite of loratadine, it can be assumed that a similar safety profile would fit for desloratadine as was described for loratadine although no direct human studies have been done.Decongestants have not been conclusively proven to affect the fetal outcome and may be used for short-term relief when no other safer alternatives are available.Intranasal corticosteroids have not been associated with an increase in congenital malformations in humans. Based on efficacy and the fact that there would be little systemic absorption, they can be considered a first-line treatment over oral antihistamines, decongestants and mast cell stabilisers; however, the number of controlled trials in pregnancy is limited. Intranasal corticosteroids are associated with minimal systemic effects in adults and are the most effective therapy for allergic rhinitis. Benefit-risk considerations must, therefore, be done but favour their first-line use during pregnancy.Because fetal safety is paramount, recommendations should be based both on the safety of the drugs during pregnancy and the comparative efficacy of the agent in the treatment of the underlying condition. This review exemplifies the fact that there are many safe treatment options for the clinician when dealing with allergic rhinitis during pregnancy.

Nature and Impact of Grief Over Patient Loss on Oncologists' Personal and Professional Lives

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Anorexia-Cachexia Syndrome: A Systematic Review of the Role of Dietary Polyunsaturated Fatty Acids in the Management of Symptoms, Survival, and Quality of Life

To provide a systematic review on the clinical utility of anti-inflammatory polyunsaturated fatty acids (PUFAs) in cancer-associated anorexia-cachexia syndrome (ACS), clinical trials involving eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for the management of ACS were identified in the medical literature using MEDLINE (1966 to October 2006) and EMBASE (1980 to October 2006). Review Manager 4.1 was used to compare trials based on outcome measures of interest, including weight change, lean muscle mass change, survival, and quality of life (QoL). Seven randomized controlled trials (RCTs) were identified. Various outcome measures were used in each study. Variability in study populations, dose of EPA and DHA, and standardized scales did not allow for analysis using Review Manager 4.1. Therefore, trials were summarized based on their individual outcomes. Except for one trial showing a positive effect on weight, none of the trials found a clinically or statistically significant difference in outcome measures reviewed. EPA and DHA alone have not shown significant clinical effect in altering weight, lean muscle mass, survival, or QoL in patients with ACS associated with cancer.

Oncologists’ Protocol and Coping Strategies in Dealing with Patient Loss

To identify what protocol and coping strategies oncologists turn to cope with patient loss, the authors interviewed 20 oncologists at 3 hospitals. Using the grounded theory method, findings revealed that their protocol may include meeting with families, participating in bereavement rituals, making a phone call, or sending a condolence card. Coping strategies included social support, activity-oriented coping, turning to faith, compartmentalization, and withdrawing from patients and families. The authors conclude by offering implications from this research on how to address oncologists’ grief over patient loss in institutional settings in order to improve bereavement care for families and enhance oncologists’ quality of life.

What do oncologists want

PurposeThe purpose of the study was to explore what institutional support(s) oncologists want to help them cope with patient loss.MethodsThe grounded theory method was used. Twenty oncologists were recruited and interviewed between November 2010 and July 2011 from three adult oncology centers in Ontario. Data collection and analysis took place concurrently. Analysis involved line-by-line coding, and was inductive, with codes and categories emerging from participants’ narratives.ResultsOncologists suggested institutional supports that fit under four categories that included: (1) training, information and education including fellowship training, grand rounds and the availability of fact sheets; (2) acknowledgment and validation of grief including normalizing grief, having forums to share experiences, supportive mentorship and group debriefing sessions; (3) institutional psychosocial support including access to professional help and the nursing care model; and (4) vacations and sabbaticals.ConclusionsInstitutions such as medical schools and hospitals have both the opportunity and the obligation to support oncologists with this difficult aspect of their work. In addition to offering ongoing education and forums to share experiences, medical institutions can also provide supportive mentorship models to junior oncologists on how to cope with patient loss.

Enhancing communication in end-of-life care: a clinical tool translating between the Clinical Frailty Scale and the Palliative Performance Scale.

To create a clinical tool to translate between the Clinical Frailty Scale (CFS), which geriatrics teams use, and Palliative Performance Scale (PPS), which palliative care teams use, to create a common language and help improve communication between geriatric and palliative care teams.

Choice of breastfeeding and physicians' advice: A cohort study of women receiving propylthiouracil

Clinical Pharmacology & Therapeutics (1999) 65, 200–200; doi: