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BACKGROUND: There has been a rapid increase in vulnerable subpopulations of very old with co-morbidity, dementia, frailty, and limited life expectancy. Being treated by many specialists has led to an epidemic of inappropriate medication use and polypharmacy (IMUP) with negative medical and economic consequences. For most medications there are no evidence-based studies in older people and treatments are based on guidelines proven in much younger/healthier populations. OBJECTIVES: To evaluate whether the benefits of reducing IMUP by poly-de-prescribing (PDP) outweighs the negative outcomes in older people with polypharmacy. METHODS: The Garfinkel method and algorithm were used in older people with polypharmacy (≥ 6 prescription drugs). RESULTS: We found that in nursing departments, of 331 drugs de-prescribed only 32 (10%) had to be re-administered. Annual mortality and severe complications requiring referral to acute care facility were significantly reduced in PDP (P < 0.002). In community dwelling older people, successful de-prescribing was achieved in 81% with no increase in adverse events or deaths. Those who de-prescribed ≥ 3 prescription drugs showed significantly more improvement in functional and cognitive status, sleep quality, appetite, serious complications, quality of life, and general satisfaction compared to controls who stopped ≤ 2 medications (P < 0.002). Rates of hospitalization and mortality were comparable. Clinical improvement by polydeprescribing was usually evident within 3 months and persisted for several years. The main barrier to polydeprescribing was physician's unwillingness to deprescribe (P < 0.0001). CONCLUSIONS: Applying the Garfinkel method of PDP may improve the lives of older people and save money.
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Polimedicação , Medicamentos sob Prescrição , Idoso , Humanos , Doença Iatrogênica/epidemiologia , Doença Iatrogênica/prevenção & controle , Prescrição Inadequada/prevenção & controle , Medicamentos sob Prescrição/efeitos adversos , Qualidade de VidaRESUMO
INTRODUCTION: Improved medical technology is associated with rapidly growing sub-populations suffering from incurable co-morbidities for prolonged periods of time before death. Although there is no evidence based medicine (EBM) proving positive benefit/risk ratios for most medications in these sub-populations, it is evident that they are attended by an increased number of specialists, each of whom add medications based on "their" guidelines. Eventually, more people suffer from inappropriate medication use and polypharmacy (IMUP); IMUP's negative medical, economic and social consequences represent the 21st-century iatrogenic pandemic. Many barriers interfere with attempts to de-prescribe: The myth "drugs=health" is a deep-rooted value; de-prescribing is automatically perceived negatively; physicians are not trained to de-prescribe; and discussing de-prescribing with the patient/family is time consuming. In an era of defensive medicine, physicians have fears of lawsuits, of patient/family's reactions, fears of not following all guideline recommendations, despite the age-related decrease in their benefit/risk ratio. Like other pandemics, combined international efforts are required in order to manage IMUP effectively. The International Group for Reducing Inappropriate Medication Use & Polypharmacy (IGRIMUP) was established and has begun sowing the seeds of global collaboration. Partnership with patients/families in decision-making is essential in geriatric-palliative ethical approaches, to overcome barriers to de-prescribing. Borrowing the language of epidemics, several approaches of "curing the infected" (reducing polypharmacy) were suggested; Israeli studies have proven improved functional, mental and cognitive status and patient/family satisfaction, following massive de-prescribing, compared with those who adhered to standard recommendations. "Immunization" (prevention), should concentrate on early education of professionals and laymen about IMUP and de-prescribing. Rational de-prescribing represents "a triple-win-win game"- improves life quality in the last years of life and has huge economic benefits.
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Doença Iatrogênica , Prescrição Inadequada , Polimedicação , Idoso , Comorbidade , Epidemias , HumanosRESUMO
BACKGROUND: Elderly patients are exposed to increased number of medications, often with no proof of a positive benefit/risk ratio. Unfortunately, this trend does not spare those with limited life expectancy, including end-stage cancer patients who require only palliative treatment. For many medications in this subpopulation, the risk of adverse drug events outweighs the possible benefits and yet, many are still poly-medicated during their last year of life. AIM: To describe the extent of polypharmacy among end-stage cancer patients, at the time of admission to homecare hospice. METHODS: A retrospective chart review of 202 patients admitted to Homecare Hospice of the Israel Cancer Association and died before January 2015. RESULTS: Average lifespan from admission until death was 39.2 ± 5.4 days. 63% died within the first month, 89% within 3 months. Excluding oncological treatments, 181 (90%) and 46 (23%) patients were treated with ≥ 6 and ≥ 12 drugs for chronic diseases, respectively. Two months before death, 32 (16%) patients were treated with ≥ 3 blood pressure lowering drugs, 62 (31%) with statins and 48 (23%) with aspirin. CONCLUSION: Though not representative of the whole end-stage cancer patient population, our study demonstrates that these patients are exposed to extensive polypharmacy. Most of these medications could have probably been safely de-prescribed much earlier in the course of the malignant disease. Considering the prolonged trust-based relationship with their patients, the family physicians are those who should be encouraged to implement the palliative approach and reduce polypharmacy much before reaching hospice settings.
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Doença Crônica/tratamento farmacológico , Cuidados Paliativos na Terminalidade da Vida , Neoplasias , Papel do Médico , Polimedicação , Padrões de Prática Médica , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/uso terapêutico , Aspirina/uso terapêutico , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Masculino , Neoplasias/complicações , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Retrospectivos , Medição de RiscoRESUMO
Objectives: To evaluate polypharmacy in older people to determine whether the number of medications de-prescribed correlates with the extent of improvement in quality of life (QoL) and clinical outcomes. Design: A prospective longitudinal cohort study of polypharmacy in people living in a community in Israel. Setting: Participants aged 65 years or older who took at least six prescription drugs followed up for at least 3 years (range 3-10 years) after poly-de-prescription (PDP) recommendations. Interventions: PDP recommended at first home visit using the Garfinkel algorithm. Annual follow-up and end-of-study questionnaires used to assess clinical outcomes, QoL, and satisfaction from de-prescribing. All medications taken, complications, hospitalizations, and mortality recorded. In total, 307 participants met the inclusion criteria; 25 incomplete end-of-study questionnaires meant 282 participants for subjective analysis. Participants divided into two subgroups: (i) those who discontinued more than 50% of the drugs (PDP group) or (ii) those who discontinued less than 50% of the drugs (non-responders, NR). Main outcome measures: Objective: 3-year survival rate and hospitalizations. Subjective: general satisfaction from de-prescribing; change in functional, mental, and cognitive status; improved sleep quality, appetite, and continence; and decreased pain. Results: Mean age: 83 years (range 65-99 years). Mean number of drugs at baseline visit: 9.8 (range 6-20); 6.7 ± 2.0 de-prescribed in the PDP group (n = 146) and 2.2 ± 2.1 in the NR group (n = 161) (p < 0.001).No statistical difference between the groups in the 3-year survival rate and hospitalizations, but a significant improvement in functional and cognitive status and, in general, satisfaction from the intervention in the PDP group compared to the NR group. Improvement usually evident within the first 3 months and persists for several years. Conclusion: Poly-de-prescribing in the older population has beneficial effects on several clinical outcomes with no detrimental effect on the rate of hospitalization and survival. The extent of improvement correlates with the extent of de-prescribing. Applying the Garfinkel algorithm globally may improve QoL in millions of patients, a clinical and economic win-win situation.
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PURPOSE: To provide an overview of the current deprescribing attitudes, practices, and approaches of geriatricians and geriatricians-in-training across Europe. METHODS: An online survey was disseminated among European geriatricians and geriatricians-in-training. The survey comprised Likert scale and multiple-choice questions on deprescribing approaches and practices, deprescribing education and knowledge, and facilitators/barriers of deprescribing. Responses to the survey questions and participant characteristics were quantified and differences evaluated between geriatricians and geriatricians-in-training and between European regions. RESULTS: The 964 respondents (median age 42 years old; 64% female; 21% geriatricians-in-training) were generally willing to deprescribe (98%) and felt confident about deprescribing (85%). Despite differences across European regions, the most commonly reported reasons for deprescribing were functional impairment and occurrence of adverse drug reactions. The most important barriers for deprescribing were patients' unwillingness, fear of negative consequences, lack of time, and poor communication between multiple prescribers. Perceived risk of adverse drug reactions was highest for psychotropic drugs, nonsteroidal anti-inflammatory drugs, cardiovascular drugs, and opioid analgesics. Only one in four respondents (23% of geriatricians and 37% of geriatricians-in-training) think education in medical school had sufficiently prepared them for deprescribing in clinical practice. They reported that their future deprescribing activities would probably increase with improved information sharing between various prescribers, deprescribing recommendations in guidelines, and increased education and training. Approximately 90% think that a paradigm shift is required for prescribers and patients, increasing focus on the possible benefits of deprescribing (potentially) inappropriate medications. CONCLUSIONS: Based on the outcomes of this survey, we recommend investing in improved inter-professional communication, better education and evidence-based recommendations to improve future patient-centered deprescribing practices.
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Desprescrições , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Feminino , Masculino , Geriatras , Inquéritos e Questionários , Hábitos , InternetRESUMO
One of the common symptoms of dementia is delusions. Due to a biological conceptualization of the behaviors represented as delusions, these are classified as psychotic symptoms. This is a qualitative and quantitative study aiming to describe the delusions experienced by older persons with dementia and the context of occurrence, and to elucidate their etiology. Participants were 74 nursing home residents aged 65 and over, diagnosed with dementia, from nine nursing homes in Israel. Participants with delusions were found to have significantly more difficulties in performing ADLs, and poorer vision and hearing. Based on assessment using the BEHAVE-AD, six categories of delusions were examined: 1. One's house is not one's home, 2. Theft, 3. Danger, 4. Abandonment, 5. Misidentification, and 6. Other non-paranoid. Common themes appeared across delusions including reality, disorientation, re-experience of past events, loneliness and insecurity, boredom, and trigger. Current results suggest that delusions may not represent psychotic symptoms for most participants, because they sometimes represented reality, or were neither firm nor incontrovertible. Thus, utilizing the term delusion relegates the person's behavior to the domain of severe psychiatric phenomena and precludes understanding its true meaning.
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Delusões/diagnóstico , Delusões/psicologia , Demência/diagnóstico , Demência/psicologia , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Tédio , Confusão , Delusões/epidemiologia , Demência/epidemiologia , Feminino , Humanos , Israel , Solidão/psicologia , Masculino , Casas de Saúde , Escalas de Graduação Psiquiátrica , Teste de Realidade , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: Explicit screening tools and implicit evaluation methods have been developed to assist healthcare professionals in the management of pharmacotherapy in older adults. As prescribing habits and locally available medications vary considerably between countries, guides tailored to the needs of specific regions may be required. We aimed to report the results of the international Delphi validation study for the Turkish Inappropriate Medication use in the Elderly (TIME) criteria set, which aims to detect inappropriate prescribing in older adults in Eastern Europe. METHODS: The study was conducted between June 2019 and March 2020. Delphi rounds were conducted by the TIME international working group, which included 11 internationally recognized experts in geriatric pharmacotherapy as Delphi panelists. They were asked to indicate to what extent they agreed or disagreed with each TIME criterion, taking into account both the available evidence and their own experience. We used a five-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) and an online software program (SurveyMonkey®) to grade the level of agreement. Criteria with a median value of 1 or 2 and a 75th centile value of 1 or 2 were accepted, and criteria with a median value > 2 were rejected. Those with a median value of 1 or 2 but a 75th centile value > 2 were retained, to be assessed in the following round. The initial list of Delphi criteria comprised 153 TIME items. RESULTS: After three Delphi rounds, 134 criteria were accepted and seven criteria were rejected, while 12 criteria did not achieve consensus, and so were not included in the final validated set of TIME criteria. CONCLUSION: We developed the internationally validated TIME criteria set based on a Delphi process involving international experts. The validation study suggests that the TIME criteria set can be applied in both central and Eastern European settings. Further studies are needed to assess the utility and benefit of the TIME criteria in reducing inappropriate drug use and improving clinical outcomes.
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Prescrição Inadequada , Idoso , Consenso , Técnica Delphi , Humanos , Prescrição Inadequada/prevenção & controleRESUMO
Scant attention has been paid to the decision-making process of caregivers in disclosing bad news to patients. The purpose of this study was to describe factors influencing this process and to ascertain whether physicians and nurses behave differently, based on Ajzen and Fishbein's (1980) theory of reasoned action (TRA). In this correlational quantitative research study, a validated anonymous questionnaire was administered to a convenience sample comprising 100 physicians and 200 nurses employed in several Israeli hospitals. The results indicate that only around 30% of physicians always disclosed bad news in the past, and that future decisions would be made on an individual basis. In contrast, more than 76% of nurses said that they would disclose bad news to their patients in the future. Caregivers find it difficult to disclose terminal status information to all types of patients, although most find it relatively easier in the elderly. TRA may help to predict disclosure of bad news by physicians and nurses. Behavioural beliefs, subjective attitudes and prior clinical experience with disclosure of bad news were the main factors influencing caregivers' disclosure. The main predictors among nurses were behavioural beliefs and prior experience, and among physicians were subjective norms and prior experience.
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Atitude do Pessoal de Saúde , Enfermeiras e Enfermeiros/psicologia , Médicos/psicologia , Relações Profissional-Paciente , Doente Terminal , Revelação da Verdade , Humanos , IsraelRESUMO
BACKGROUND: In complex older patients, inappropriate medication use and polypharmacy (IMUP) are commonplace and increasing exponentially. Reducing IMUP is a challenge in multiple clinical contexts, including acute admission and family practice, due to several key barriers. In the global effort against this epidemic, educational programs geared toward changing physicians' prescribing patterns represent an important means of promoting deprescribing. METHODS: This is a nonrandomized, controlled interventional study investigating polypharmacy outcomes and prescribing patterns in patients whose physicians were trained in the Good Palliative-Geriatric Practice (GPGP) method, an algorithm for the reduction of polypharmacy, with patients whose physicians were not. Training involved a one-time, full-day workshop led by a senior geriatrician. Two separate settings were examined. In the inpatient setting, one internal medicine ward was trained and compared with another ward which was not trained. In the family practice setting, 28 physicians were trained and compared with practices of 15 physicians not trained. Patients were above the age of 70, representative of the general geriatric population, and not terminally ill. RESULTS: In the inpatient arm, the intervention group (n = 100) experienced a decrease in medications prescribed from admission to discharge of 18.5%, compared with a decrease of 1.9% in the control group (n = 100, difference between groups p < 0.0001). In the outpatient arm, the intervention group (n = 100) experienced a decrease in medication number of 6.1% compared with 0.07% in the control group (n = 100, difference between groups p = 0.001) over a 6-month period. Preferential decreases in specific drug classes were observed in both groups, including benzodiazepines, psychotropics, and antihypertensives. CONCLUSIONS: A one-time educational intervention based on GPGP can change prescribing patterns in both outpatient and inpatient settings leading to a moderate reduction in polypharmacy. Future work should focus on longitudinal interventions, and longer-term clinical outcomes such as morbidity, mortality, and quality of life.
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BACKGROUND: The aim of this study was to evaluate efficacy and safety of poly-de-prescribing (PDP) based on the Garfinkel method in older people with polypharmacy. METHODS: A longitudinal, prospective, nonrandomized study in Israel was carried out between 2009 and 2016. Comprehensive geriatric assessments were performed at home in people age ⩾66 years consuming ⩾6 prescription drugs. Exclusion criteria were life expectancy <6 months and a seeming unwillingness to cooperate (poor compliance). PDP of ⩾3 prescription drugs was recommended. Follow up was at ⩾3 years. Between April 2015 and April 2016 Likert scale questionnaires were filled by all participants/families to evaluate overall satisfaction and clinical outcomes. The outcome measures were change in functional, mental and cognitive status, sleep quality, appetite, continence; major complication, hospitalizations, mortality, and family doctor's cooperation. RESULTS: Poly-de-prescribing of ⩾3 drugs was eventually achieved by 122 participants (PDP group); ⩽2 drugs stopped by 55 'nonresponders' (NR group). The average age was 83.4 ± 5.3 in the PDP group, and 80.8 ± 6.3 in the NR group (p = 0.0045). Follow up was 43.6 ± 14 months (PDP) and 39.5 ± 16.6 months (NR) (p = 0.09). The prevalence of most diseases/symptoms was comparable except for a higher prevalence for dementia, incontinence and functional decline in the PDP group. The main barrier to de-prescribing was the family doctor's unwillingness to adopt PDP recommendations (p < 0.0001). The baseline median number of medications taken by both groups was 10 (IQR 8 to 12) (p = 0.55). On the last follow up, the drug count was 11 (IQR 8 to 12) in the NR group and 4 (IQR 2 to 5) in the PDP group (p =0.0001). The PDP group showed significantly less deterioration (sometimes improvement) in general satisfaction, functional, mental and cognitive status, sleep quality, appetite, sphincter control, and the number of major complications was significantly reduced (p < 0.002 in all). The rate of hospitalizations and mortality was comparable. Health improvement occurred within 3 months after de-prescribing in 83%, and persisted for ⩾2 years in 68%. CONCLUSIONS: This self-selected sample longitudinal research strongly suggests that the negative, usually invisible effects of polypharmacy are reversible. PDP is well tolerated and associated with improved clinical outcomes, in comparison with outcomes of older people who adhere to all clinical guidelines and take all medications conventionally. Future double-blind studies will probably prove beneficial economic outcomes as well.
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Globally, the number of drug prescriptions is increasing causing more adverse drug events, which is now a significant cause of mortality, morbidity, and disability that has reached epidemic proportions. The risk of adverse drug events is correlated to very old age, multiple co-morbidities, dementia, frailty, and limited life expectancy, with the major contributor being polypharmacy. Each characteristic alters the risk-benefit balance of medications, typically reducing anticipated benefits and amplifying risk. Current clinical guidelines are based on evidence proven in younger/healthier adult populations using a single disease model and their application to older adults with multimorbidity, in whom testing has not been conducted, yields a different risk-benefit prospect and makes inappropriate medication use and polypharmacy inevitable. Applying inappropriate clinical practice guidelines to older adults is antithetical to good healthcare, is likely to increase health inequity, and is associated with substantial negative clinical, economic, and social implications for health systems. The casualties are on the scale of a war or epidemic, yet are usually invisible in measures of healthcare quality and formal recommendations. Radical and rapid action is required to achieve a better quality of life for older populations and to remain true to the principles of medical professionalism and evidence-based medicine that place patients' interests and autonomy at the fore. This first International Group for Reducing Inappropriate Medication Use & Polypharmacy position statement briefly details the causes, consequences, and extent of inappropriate medication use and polypharmacy. This article outlines current strategies to reduce inappropriate medication use, provides evidence for their effect, and then proposes recommendations for moving forward with 10 recommendations for action and 12 recommendations for research. We conclude that an urgent integrated effort to reduce inappropriate medication use and polypharmacy should be a leading global target of the highest priority. The cornerstone of this position statement from the International Group for Reducing Inappropriate Medication Use & Polypharmacy is the understanding that without evidence of definite relevant benefit, when it comes to prescribing, for many older patients 'less is more'. This approach differs from most other current recommendations and guidance in medical care, as the focus is on what, when, and how to stop, rather than on when to start medications/interventions. Disrupting the framework that indiscriminately applies standard guidelines to older adults requires a new approach that better serves patients with multimorbidity. This transition requires a shift in medical education, research, and diagnostic frameworks, and re-examination of the measures used as quality indicators. In achieving this objective, we promote a return to some of the original concepts of evidence-based medicine: which considers scientific data (where it exists), clinical judgment, patient/family preference, and context. A shift is needed: from the current model that focuses on single conditions to one that simultaneously considers multiple conditions and patient priorities. This approach reframes the clinician's role as a professional providing care, rather than a disease technician.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Prescrição Inadequada/prevenção & controle , Polimedicação , Qualidade de Vida , Idoso , Comorbidade , Prescrições de Medicamentos/normas , HumanosRESUMO
BACKGROUND: The extent of medical and financial problems of polypharmacy in the elderly is disturbing, particularly in nursing homes and nursing departments. OBJECTIVES: To improve drug therapy and minimize drug intake in nursing departments. METHODS: We introduced a geriatric-palliative approach and methodology to combat the problem of polypharmacy. The study group comprised 119 disabled patients in six geriatric nursing departments; the control group included 71 patients of comparable age, gender and co-morbidities in the same wards. After 12 months, we assessed whether any change in medications affected the death rate, referrals to acute care facility, and costs. RESULTS: A total of 332 different drugs were discontinued in 119 patients (average of 2.8 drugs per patient) and was not associated with significant adverse effects. The overall rate of drug discontinuation failure was 18% of all patients and 10% of all drugs. The 1 year mortality rate was 45% in the control group but only 21% in the study group (P < 0.001, chi-square test). The patients' annual referral rate to acute care facilities was 30% in the control group but only 11.8% in the study group (P < 0.002). The intervention was associated with a substantial decrease in the cost of drugs. CONCLUSIONS: Application of the geriatric-palliative methodology in the disabled elderly enables simultaneous discontinuation of several medications and yields a number of benefits: reduction in mortality rates and referrals to acute care facilities, lower costs, and improved quality of living.
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Uso de Medicamentos/estatística & dados numéricos , Idoso Fragilizado , Serviços de Saúde para Idosos/normas , Casas de Saúde/normas , Polimedicação , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Custos de Medicamentos , Monitoramento de Medicamentos , Uso de Medicamentos/tendências , Feminino , Hospitais/estatística & dados numéricos , Humanos , Israel/epidemiologia , Masculino , Mortalidade , Casas de Saúde/economia , Cuidados Paliativos , Qualidade de VidaRESUMO
The vicious circle of age-related diseases, many experts and guidelines/drugs fuels the 21st century iatrogenic epidemic of inappropriate medication use and polypharmacy. There are no evidence-based medicine (EBM) 'guidelines' for treating older people, and knowledge gaps regarding dosage requirements. For all drugs, the positive benefit/risk ratio is decreasing/inverted in correlation to very old age, comorbidity, dementia, frailty and limited life-expectancy (VOCODFLEX). Main obstacles to routine deprescribing are emotional/psychological myths; patient-doctor interactions are expected to be transformed into prescription; doctors are perceived as expert prescribers who wisely choose the right medication/s to treat all diseases. Although most 'guidelines' were not proven in older people, particularly VOCODFLEX, doctors are afraid of lawsuits and of the patient/family reaction if they do not follow all experts' recommendations. Doctors are frustrated facing uncertainty regarding the effectiveness of strategies to reduce polypharmacy and the lack of EBM indicating when to de-prescribe. When explicit criteria and 'drugs to avoid' are used alone, we may disregard undiagnosed harms imposed by the remaining drug groups and interactions. The best approaches are implicit tools that take into consideration EBM data, clinical circumstances and medical judgement. The Garfinkel Good Palliative-Geriatric Practice method recommends deprescribing of as many drugs as possible simultaneously, giving high priority to patient/family preferences. It was proven highly effective and safe in nursing departments and in community-dwelling elders, having significant economic benefits as well.
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INTRODUCTION: The objective of this pilot study was to evaluate the efficacy and safety of a novel method using an autologous whole blood clot formed with the RedDress Wound Care System (RD1, RedDress Ltd, Israel), a provisional whole blood clot matrix used in the treatment of chronic wounds of various etiologies. METHODS AND MATERIALS: Patients were treated at the bedside with the whole blood clot matrix. Blood was withdrawn from each patient using citrate, mixed with a calcium gluconate/kaolin suspension, and injected into an RD1 clotting tray. Within 10 minutes, a clot was formed, placed upon the wound, and fixed with primary and secondary dressings. Wounds were redressed weekly with a whole blood clot matrix. Treatment was terminated when complete healing was achieved, or when the clinician determined that the wound could not further improve without additional invasive procedures. RESULTS: Seven patients with multiple and serious comorbidities and 9 chronic wounds were treated with 35 clot matrices. Complete healing was achieved in 7 of 9 wounds (78%). In 1 venous ulcer with a nonhealing fistula, 77% healing was achieved. Treatment was terminated in 1 pressure ulcer at 82% closure, because an unexpected mechanical trauma resulted in deterioration; this was the only adverse event reported, unrelated to the product. No systemic adverse events occurred. CONCLUSIONS: This pilot study demonstrates the in vitro autologous whole blood clot matrix is effective and safe for treating patients with chronic wounds of different etiologies. A larger clinical trial is needed to assess the relative success rate of the matrix in different types of wounds in a diverse population with comorbidities.
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Curativos Biológicos , Doença Crônica/terapia , Cicatrização/fisiologia , Ferimentos e Lesões/terapia , Idoso de 80 Anos ou mais , Coagulação Sanguínea/fisiologia , Feminino , Humanos , Israel , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Plasma Rico em Plaquetas/fisiologia , Estudos Prospectivos , Resultado do TratamentoAssuntos
Prescrição Inadequada , Polimedicação , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , HumanosRESUMO
The positive benefit-risk ratio of most drugs is decreasing in correlation to very old age, the extent of comorbidity, dementia, frailty and limited life expectancy (VOCODFLEX). First, we review the extent of inappropriate medication use and polypharmacy (IMUP) globally and highlight its negative medical, nursing, social and economic consequences. Second, we expose the main clinical/practical and perceptual obstacles that combine to create the negative vicious circle that eventually makes us feel frustrated and hopeless in treating VOCODFLEX in general, and in our 'war against IMUP' in particular. Third, we summarize the main international approaches/methods suggested and tried in different countries in an attempt to improve the ominous clinical and economic outcomes of IMUP; these include a variety of clinical, pharmacological, computer-assisted and educational programs. Lastly, we suggest a new comprehensive perception for providing good medical practice to VOCODFLEX in the 21st century. This includes new principles for research, education and clinical practice guidelines completely different from the 'single disease model' research and clinical rules we were raised upon and somehow 'fanatically' adopted in the 20th century. This new perception, based on palliative, geriatric and ethical principle, may provide fresh tools for treating VOCODFLEX in general and reducing IMUP in particular.
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BACKGROUND: Diabetes is a major comorbidity in insomnia patients. The efficacy and safety of prolonged-release melatonin 2 mg in the treatment of glucose, lipid metabolism, and sleep was studied in 36 type 2 diabetic patients with insomnia (11 men, 25 women, age 46-77 years). METHODS: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks (period 1) with prolonged-release melatonin or placebo, followed by a one-week washout period, and then crossed over for another 3 weeks (period 2) of treatment with the other preparation. All tablets were taken 2 hours before bedtime for a period of 3 weeks. In an extension period of 5 months, prolonged-release melatonin was given nightly to all patients in an open-label design. Sleep was objectively monitored in a subgroup of 22 patients using wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, and some antioxidants, as well as glycosylated hemoglobin (HbA1c) levels were measured at baseline and at the end of the study. All concomitant medications were continued throughout the study. RESULTS: No significant changes in serum glucose, fructosamine, insulin, C-peptide, antioxidant levels or blood chemistry were observed after 3 weeks of prolonged-release melatonin treatment. Sleep efficiency, wake time after sleep onset, and number of awakenings improved significantly with prolonged-release melatonin as compared with placebo. Following 5 months of prolonged-release melatonin treatment, mean HbA1c (±standard deviation) was significantly lower than at baseline (9.13% ± 1.55% versus 8.47% ± 1.67%, respectively, P = 0.005). CONCLUSION: Short-term use of prolonged-release melatonin improves sleep maintenance in type 2 diabetic patients with insomnia without affecting glucose and lipid metabolism. Long-term prolonged-release melatonin administration has a beneficial effect on HbA1c, suggesting improved glycemic control.
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BACKGROUND: Prolonged-release melatonin (PRM) 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18-80 and lack of withdrawal and rebound symptoms upon discontinuation. OBJECTIVE: To investigate the efficacy, safety, and withdrawal phenomena associated with 6-12 months PRM treatment. METHODS: Data from a prospective 6-12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM. Patients received PRM nightly, followed by a 2-week withdrawal period. Main outcome measures were patient-reported sleep quality ratings (diary), adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]). Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM. RESULTS: Of the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment. The mean number of nights by which patients reported sleep quality as "good" or "very good" was significantly higher during PRM than before treatment. There was no evidence of tolerance to PRM. Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed. PRM was well tolerated, and there was no suppression of endogenous melatonin production. CONCLUSION: Results support the efficacy and safety of PRM in primary insomnia patients aged 20-80 throughout 6-12 months of continuous therapy. PRM discontinuation even after 12 months was not associated with adverse events, withdrawal symptoms, or suppression of endogenous melatonin production.