Adherence and Persistence With Therapy Among Newly Prescribed Fibromyalgia Patients in Israel

Background: Fibromyalgia is a chronic debilitating disorder affecting over 4% and ~1.5% of the female and male adult population worldwide, respectively. The study aimed to assess 1-year persistence and adherence with therapy among newly prescribed fibromyalgia patients and to identify factors associated with therapy discontinuation. Methods: Included were adult members of Maccabi Healthcare Services, a 2 million-member health maintenance organization in Israel, diagnosed with fibromyalgia between 2008 and 2011. Persistence and adherence with anticonvulsants and antidepressants were analyzed among newly prescribed fibromyalgia patients by comparing those with ≥ 2 medication dispenses versus 1 or none and by examining time to treatment discontinuation (≥ 120 days) and proportion of days covered (PDC) with medication during the year following first dispense. Logistic regression models were constructed for multivariable analyses. Results: The majority of 3,932 eligible fibromyalgia patients were female (90%), and 41.2% were already prescribed fibromyalgia medications prior to diagnosis. Of the remaining 2,312 patients, 56.1% were issued a prescription, 45.0% had at least one medication dispensed in the year following diagnosis and only 28.8% had at least one additional dispense within a year from the first dispense. One-year treatment discontinuation was highest for tricyclic antidepressants (91.0%) and lowest for SSRI/SNRI antidepressants (73.7%). In multivariate analysis, having ≥ 2 dispensed fibromyalgia medications versus 1 or none was associated with baseline anxiety and depression (odds ratio: 1.86, 95% confidence interval [CI]: 1.33–2.60, P \u3c 0.001) and with migraines (odds ratio: 1.34, 95% CI: 1.03–1.73). Half of the patients (50.9%) had \u3c 20% of days covered by any medication during the year, and only 11.6% were adherent (PDC ≥ 80%). Socioeconomic status (SES) was the only factor associated with having PDC ≥ 80%: 7.1% vs 14.4% were adherent in the lowest and highest SES quintiles, respectively (P for trend = 0.017). Conclusion: Among newly prescribed fibromyalgia patients, use of fibromyalgia medications is remarkably low, possibly related to high cost, low effectiveness and/or intolerability. Additional research is required to investigate whether these patients utilize nonpharmacological therapies and to what extent they are effective. Nonetheless, it is important to endorse adherence intervention initiatives in order to lower the burden and costs for patients and providers alike and to improve the quality of life of the patients

Adherence and Persistence With Therapy Among Newly Prescribed Fibromyalgia Patients in Israel

Background: Fibromyalgia is a chronic debilitating disorder affecting over 4% and ~1.5% of the female and male adult population worldwide, respectively. The study aimed to assess 1-year persistence and adherence with therapy among newly prescribed fibromyalgia patients and to identify factors associated with therapy discontinuation. Methods: Included were adult members of Maccabi Healthcare Services, a 2 million-member health maintenance organization in Israel, diagnosed with fibromyalgia between 2008 and 2011. Persistence and adherence with anticonvulsants and antidepressants were analyzed among newly prescribed fibromyalgia patients by comparing those with ≥ 2 medication dispenses versus 1 or none and by examining time to treatment discontinuation (≥ 120 days) and proportion of days covered (PDC) with medication during the year following first dispense. Logistic regression models were constructed for multivariable analyses. Results: The majority of 3,932 eligible fibromyalgia patients were female (90%), and 41.2% were already prescribed fibromyalgia medications prior to diagnosis. Of the remaining 2,312 patients, 56.1% were issued a prescription, 45.0% had at least one medication dispensed in the year following diagnosis and only 28.8% had at least one additional dispense within a year from the first dispense. One-year treatment discontinuation was highest for tricyclic antidepressants (91.0%) and lowest for SSRI/SNRI antidepressants (73.7%). In multivariate analysis, having ≥ 2 dispensed fibromyalgia medications versus 1 or none was associated with baseline anxiety and depression (odds ratio: 1.86, 95% confidence interval [CI]: 1.33–2.60, P \u3c 0.001) and with migraines (odds ratio: 1.34, 95% CI: 1.03–1.73). Half of the patients (50.9%) had \u3c 20% of days covered by any medication during the year, and only 11.6% were adherent (PDC ≥ 80%). Socioeconomic status (SES) was the only factor associated with having PDC ≥ 80%: 7.1% vs 14.4% were adherent in the lowest and highest SES quintiles, respectively (P for trend = 0.017). Conclusion: Among newly prescribed fibromyalgia patients, use of fibromyalgia medications is remarkably low, possibly related to high cost, low effectiveness and/or intolerability. Additional research is required to investigate whether these patients utilize nonpharmacological therapies and to what extent they are effective. Nonetheless, it is important to endorse adherence intervention initiatives in order to lower the burden and costs for patients and providers alike and to improve the quality of life of the patients

The Cytotoxic Effect of Isolated Cannabinoid Extracts on Polypoid Colorectal Tissue

Purified cannabinoids have been shown to prevent proliferation and induce apoptosis in colorectal carcinoma cell lines. To assess the cytotoxic effect of cannabinoid extracts and purified cannabinoids on both colorectal polyps and normal colonic cells, as well as their synergistic interaction. Various blends were tested to identify the optimal synergistic effect. Methods: Biopsies from polyps and healthy colonic tissue were obtained from 22 patients undergoing colonic polypectomies. The toxicity of a variety of cannabinoid extracts and purified cannabinoids at different concentrations was evaluated. The synergistic effect of cannabinoids was calculated based on the cells’ survival. Isolated cannabinoids illustrated different toxic effects on the viability of cells derived from colorectal polyps. THC-d8 and THC-d9 were the most toxic and exhibited persistent toxicity in all the polyps tested. CBD was more toxic to polypoid cells in comparison to normal colonic cells at a concentration of 15 µM. The combinations of the cannabinoids CBDV, THCV, CBDVA, CBCA, and CBGA exhibited a synergistic inhibitory effect on the viability of cells derived from colon polyps of patients. Isolated cannabinoid compounds interacted synergistically against colonic polyps, and some also possessed a differential toxic effect on polyp and adjacent colonic tissue, suggesting possible future therapeutic value

Esophagogastroduodenal Findings in Patients with Intraductal Papillary Mucinous Neoplasms

The association between intraductal papillary mucinous neoplasms (IPMNs) and extra-pancreatic malignancies is controversial. This cross-sectional study compared esophagogastroduodenal findings in 340 IPMN patients to those of age- and gender-matched controls without known IPMNs who underwent esophagogastroduodenoscopies (EGDs) for similar clinical reasons. The presence of gastric and esophageal cancer, Barrett’s esophagus, neuroendocrine tumors (NETs), gastrointestinal stromal tumors (GISTs), gastric adenomas, and ampullary tumors was assessed. The results showed that 4/340 (1.2%) of the IPMN patients had gastric cancer and 1/340 (0.3%) had esophageal cancer. The matched control group had a similar incidence of gastric cancer (5/340) (1.5%), with no esophageal cancer cases (p > 0.999). The overall incidence of other esophagogastroduodenal conditions did not significantly differ between the IPMN patients and the controls. However, the incidence of gastric cancer in the IPMN patients was higher than expected based on national cancer registry data (standardized incidence ratio of 31.39; p < 0.001; CI 8.38–78.76). In conclusion, IPMN patients have a significantly higher incidence of gastric cancer compared to the general population. However, the incidence of esophagogastroduodenal findings, including gastric and esophageal cancer, is similar between IPMN patients and those who undergo an EGD for similar clinical indications. Further research is needed to determine optimal surveillance strategies for IPMN patients regarding their risk of developing gastric cancer

Helminths-based bi-functional molecule, tuftsin-phosphorylcholine (TPC), ameliorates an established murine arthritis.

A novel small molecule named tuftsin-phosphorylcholine (TPC), which is linked to the biological activity of helminths, was constructed. The current study address the effect of TPC treatment in established collagen-induced arthritis (CIA) mice and propose TPC bi-functional activity. TPC treatment was initiated when clinical score was 2 to 4. Arthritis scores in TPC treated mice were lower compared to mice treated with vehicle (P < 0.001). Joint staining showed normal joint structure in TPC-treated mice compared to control groups treated with phosphate buffered saline (PBS), phosphorylcholine, or tuftsin, which exhibited severely inflamed joints. TPC enhanced anti-inflammatory response due to increased IL-10 secretion, and reduced pro-inflammatory cytokine secretion (IL-1-β, IL-6, TNF-αP < 0.001). Furthermore, TPC therapy increased expansion of CD4+CD25+FOXP3+T regulatory cells and IL-10+CD5+CD1d+B regulatory cells. We propose that the immunomodulatory activity of TPC can be a result of a bi-specific activity of TPC: (a) The tuftsin part of the TPC shifts RAW macrophage cells from pro-inflammatory macrophages M1 to anti-inflammatory M2-secreting IL-10 (P < 0.001) through neuropilin-1 and (b) TPC significantly reduce mouse TLR4 expression via NFkB pathway by HEKTM cells (P < 0.02) via the phosphorylcholine site of the molecule. Our results indicate that TPC, significantly ameliorated established CIA by its immunomodulatory activity. These data could lead to a novel self bi-functional small molecule for treating patients with progressive RA

An infodemiological investigation of the so-called "Fluad effect" during the 2014/2015 influenza vaccination campaign in Italy: ethical and historical implications

Influenza vaccines represent a major tool to contain the clinical and epidemiological burden generated by influenza. However, in spite of their effectiveness, vaccines are victims of prejudices and false myths, which contribute to the increasing phenomenon of vaccine hesitancy and loss of confidence. Media and, mainly, new media, and information and communication technologies play a major role in disseminating health-related information. While, on the one hand, they can be extremely promising in promoting disease prevention, on the other hand, they can also have a negative impact on population's health attitudes and behaviors when delivering information not based on scientific evidences. The "Fluad-case" is an excellent example of the crucial role of an adequate information campaign. Following the cluster of deaths allegedly related to the administration of the adjuvanted influenza vaccine "Fluad" during the 2014-2015 influenza campaign, the Italian health authorities and regulatory bodies decided the withdrawal of two potentially contaminated Fluad batches. This fostered a huge media coverage, with resulted in negatively impacting on influenza vaccination coverage. Monitoring and tracking the Fluad-related web searches, we showed that Liguria resulted the Italian region with the highest number of Fluad-related website searches and that, interestingly, Fluad was searched also in Regions in which this vaccine was not distributed. A positive moderate correlation between accessing Fluad-related websites and overall influenza vaccination coverage was found (r = 0.66 ([95%CI 0.29-0.86], p = 0.0026). Considering subjects 6565&nbsp;years, who are the subjects for which the Fluad vaccination is recommended, the correlation resulted r = 0.49 ([95%CI 0.03-0.78], p = 0.0397). As such, health authorities and decision-makers should promote high-quality communication campaigns in order to raise awareness of vaccination practices

Gluten sensitivity in multiple sclerosis: Experimental myth or clinical truth

Patients with neurological disease of unknown etiology sometimes present with antigliadin and antitissue transglutaminase antibodies. The association between these antibodies and multiple sclerosis has been previously suggested. The purpose of this study was to determine the prevalence of these antibodies in multiple sclerosis patients. We determined the level of serum immunoglobulin A and immunoglobulin G antigliadin and antitissue transglutaminase antibodies in 98 patients with multiple sclerosis. We found a highly significant increase in titers of immunoglobulin G antibodies against gliadin and tissue transglutaminase in the multiple sclerosis patients. Seven patients had a positive IgG AGA, whereas only 2 controls presented positive titers (P = 0.03). Four patients had positive IgG anti-tTG while all the controls tested negative (P = 0.02). However, immunoglobulin A antibodies against gliadin and tissue transglutaminase were not statistically higher in the multiple sclerosis group in comparison to the control group. Our findings support the associations between antibodies against gliadin and tissue transglutaminase to multiple sclerosis. The specific role of these antibodies in the pathogenesis of multiple sclerosis remains uncertain and requires additional research. A gluten free diet should be considered in specific cases of patients who present with gluten antibodies. © 2009 New York Academy of Sciences