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Sleep medicine is a relatively new specialty in the medical community. The practice of sleep medicine in Saudi Arabia (KSA) began in the mid to late nineties. Since its inception, the specialty has grown, and the number of specialists has increased. Nevertheless, sleep medicine is still underdeveloped in the KSA, particularly in the areas of clinical service, education, training and research. Based on available data, it appears that sleep disorders are prevalent among Saudis, and the demand for sleep medicine service is expected to rise significantly in the near future. A number of obstacles have been defined that hinder the progress of the specialty, including a lack of trained technicians, specialists and funding. Awareness about sleep disorders and their serious consequences is low among health care workers, health care authorities, insurance companies and the general public. A major challenge for the future is penetrating the educational system at all levels to demonstrate the high prevalence and serious consequences of sleep disorders. To attain adequate numbers of staff and facilities, the education and training of health care professionals at the level of sleep medicine specialists and sleep technologists is another important challenge that faces the specialty. This review discusses the current position of sleep medicine as a specialty in the KSA and the expected challenges of the future. In addition, it will guide clinicians interested in setting up new sleep medicine services in the KSA or other developing countries through the potential obstacles that may face them in this endeavor.

Synopsis

Complimentary and alternative medicines (CAM) are frequently used for the treatment of sleep disorders, but in many cases, patients do not discuss these therapies directly with their health care provider. There is a growing body of well-designed clinical trials using CAM that have shown the following: 1) Melatonin is an effective agent for the treatment of circadian phase disorders that affect sleep, however, the role of melatonin in the treatment of primary or secondary insomnia is less well established. 2) Valerian has shown a benefit in some, but not all clinical trials. 3) Several other modalities, such as Tai Chi, acupuncture, acupressure, yoga and meditation have improved sleep parameters in a limited number of early trials. Future work examining CAM has the potential to significantly add to our treatment options for sleep disorders in older adults.

The professional content of sleep medicine has grown significantly over the past few decades, warranting the recognition of sleep medicine as an independent specialty. Because the practice of sleep medicine has expanded in Saudi Arabia over the past few years, a national regulation system to license and ascertain the competence of sleep medicine physicians and technologists has become essential. Recently, the Saudi Commission for Health Specialties formed the National Committee for the Accreditation of Sleep Medicine Practice and developed national accreditation criteria. This paper presents the newly approved Saudi accreditation criteria for sleep medicine physicians and technologists.

This paper provides a bird’s-eye perspective of the general principles of stem-cell therapy and tissue engineering; it relates comparative knowledge in this area to the current and future status of equine regenerative medicine.

The understanding of equine stem cell biology, biofactors, and scaffolds, and their potential therapeutic use in horses are rudimentary at present. Mesenchymal stem cell isolation has been proclaimed from several equine tissues in the past few years. Based on the criteria of the International Society for Cellular Therapy, most of these cells are more correctly referred to as multipotent mesenchymal stromal cells, unless there is proof that they exhibit the fundamental in vivo characteristics of pluripotency and the ability to self-renew. That said, these cells from various tissues hold great promise for therapeutic use in horses. The 3 components of tissue engineering — cells, biological factors, and biomaterials — are increasingly being applied in equine medicine, fuelled by better scaffolds and increased understanding of individual biofactors and cell sources.

The effectiveness of stem cell-based therapies and most tissue engineering concepts has not been demonstrated sufficiently in controlled clinical trials in equine patients to be regarded as evidence-based medicine. In the meantime, the medical mantra “do no harm” should prevail, and the application of stem cell-based therapies in the horse should be done critically and cautiously, and treatment outcomes (good and bad) should be recorded and reported.

Stem cell and tissue engineering research in the horse has exciting comparative and equine specific perspectives that most likely will benefit the health of horses and humans. Controlled, well-designed studies are needed to move this new equine research field forward.

Aim

To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges.

Methods

Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency’s database and analyzed by descriptive statistics.

Results

The number of issued medicine authorizations rose from 240 in 2004 to 580 in 2008. The greatest number of new chemical and biological entities was approved in 2005. The greatest number of regular quality controls (n = 5833) and special quality controls was performed in 2008 (n = 589), while the greatest number of off-shelf quality controls (n = 132) was performed in 2007. The greatest number of medicine labeling irregularities was found in 2007 (n = 19) and of quality irregularities in 2004 (n = 9). The greatest number of adverse reactions was reported in 2008 (n = 1393). The number of registered medical devices rose from 213 in 2004 to 565 in 2008.

Conclusion

Over its 5 years of existence, the Agency has successfully coped with the constant increase in workload. In the future, as Croatia enters the European Union, the Agency will have to face the challenge of joining the integrated European regulatory framework.

The Japanese traditional herbal medicine, Kampo, has gradually reemerged and 148 different formulations (mainly herbal extracts) can be prescribed within the national health insurance system. The objective of this article is to introduce Kampo and to present information from previous clinical studies that tested Kampo formulae. In addition, suggestions on the design of future research will be stated. The literature search was based on a summary, up until January 2009, by the Japanese Society of Oriental Medicine and included only those trials which were also available in either Pubmed or ICHUSHI (Japan Medical Abstracts Society). We included 135 studies, half of these studies (n = 68) used a standard control and 28 a placebo control. Thirty-seven trials were published in English [all randomized controlled trials (RCTs)] and the remaining articles were in Japanese only. The sample size for most studies was small (two-third of the studies included less than 100 patients) and the overall methodological quality appeared to be low. None of the studies used Kampo diagnosis as the basis for the treatment. In order to evaluate Kampo as a whole treatment system, certain aspects should be taken into account while designing studies. RCTs are the appropriate study design to test efficacy or effectiveness; however, within the trial the treatment could be individualized according to the Kampo diagnosis. Kampo is a complex and individualized treatment with a long tradition, and it would be appropriate for further research on Kampo medicine to take this into account.

In a previous study, women with posttraumatic stress disorder (PTSD) had greater objective sleep disturbance than those without. In a separate previous study, women with PTSD were also found to have lower baroreceptor sensitivity (BRS), an index of blood pressure regulation. In the present study, we concurrently assessed BRS and objective sleep by diagnostic status. Comparison of 32 women with PTSD to 21 women without PTSD revealed an interaction between BRS and sleep efficiency, Wake after Sleep Onset percentage, and sleep fragmentation. Lower BRS was associated with poorer sleep in women with PTSD, but not in those without. Future research should investigate causal relationships between sleep and blood pressure regulation in those with PTSD.

Objective This manuscript provides an evidence-based psychometric review of parent and child-report pediatric sleep measures using criteria developed by the American Psychological Association (APA) Division 54 Evidence-Based Assessment (EBA) Task Force. Methods Twenty-one measures were reviewed: four measures of daytime sleepiness, four measures of sleep habits/hygiene, two measures assessing sleep-related attitudes/cognitions, five measures of sleep initiation/maintenance, and six multidimensional sleep measures. Results Six of the 21 measures met “well-established” evidence-based assessment criteria. An additional eight measures were rated as “approaching well-established” and seven were rated as “promising.” Conclusions Overall, the multidimensional sleep measures received the highest ratings. Strengths and weaknesses of the measures are described. Recommendations for future pediatric sleep assessment are presented including further validation of measures, use of multiple informants, and stability of sleep measures over time.

Sleep Medicine has only recently been recognized as a specialty of medicine. Its development is based on an increasing amount of knowledge concerning the physiology of sleep, circadian biology and the pathophysiology of sleep disorders. This review chronicles the major advances in sleep science over the past 70 years and the development of the primary organizations responsible for the emergence of Sleep Medicine as a specialty, sleep disorders as a public health concern and sleep science as an important area of research.

A growing number of studies have identified chronic sleep restriction as a potential risk factor for obesity. This could have important implications for how obesity is prevented and managed, but current understanding of the processes linking chronic sleep restriction to obesity is incomplete. In this paper, we examined some of the pathways that could underlie the relationship between chronic sleep restriction and obesity. This involved exploring some of the potential environmental, health, behavioral, and sociodemographic determinants of chronic sleep restriction, which require further investigation in this context. Three pathways that could potentially link chronic sleep restriction to obesity were then examined: (1) altered neuroendocrine and metabolic function, (2) impaired glucose regulation, and (3) waking behavior. The selected pathways linking chronic sleep restriction to obesity reviewed in this paper are presented in a schematic representation; this may be used to guide future research in this area. This area of research is important because it may lead to more effective interventions and strategies to combat the present obesity epidemic.

The aim of this article is to highlight the importance of the sleep–wake cycle in children, adolescents, and adults with bipolar disorder. After reviewing the evidence that has accrued to date on the nature and severity of the sleep disturbance experienced, we document the importance of sleep for quality of life, risk for relapse, affective functioning, cognitive functioning, health (sleep disturbance is implicated in obesity, poor diet, and inadequate exercise), impulsivity, and risk taking. We argue that sleep may be critically important in the complex multifactorial cause of interepisode dysfunction, adverse health outcomes, and relapse. An agenda for future research is presented that includes improving the quality of sleep measures and controlling for the impact of bipolar medications.

Background

Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies.

Discussion

Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine.

Summary

This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized decision-making, a comparison of current and future applications of clinical decision support to enable individualized medical treatment plans is presented. If clinical decision support tools are to impact outcomes in a clear and positive manner, their development and deployment must therefore consider the needs of the providers, including specific practice needs, information workflow, and practice environment.

Women can and should make a difference in how medical care is given in the future. The increased number of women physicians presents an opportunity to make a significant impact on the quality of medical care. Data is provided on the number of women applicants to medical school, matriculants and graduates, specialty choices, the status of women in academic medicine, and the income of women physicians. Four aspects of the environment that portend important changes for medicine in the future are identified: scientific developments, alternative delivery systems and the corporate practice of medicine, the aging population and other demographic changes, and the expanding number of physicians. Some of these changes suggest opportunities for making a difference in the traditional specialties of medicine, in providing care to underserved populations, in research careers, in the shortage areas of preventive medicine and public health, occupational medicine, child psychiatry, and physical medicine and rehabilitation, and in new areas such as community pediatrics, behavioral pediatrics, and adolescent medicine. There are many choices and many decisions to be made, and each individual can choose to make a difference.

PROBLEM BEING ADDRESSED: Family medicine residents frequently interact with pharmaceutical sales representatives (PSRs) during their medical training; the literature indicates that these meetings affect future prescribing habits. We needed to develop a structured approach to PSR visits because our program did not provide residents with a consistent experience in dealing with PSRs. OBJECTIVE OF PROGRAM: To develop a structured approach to PSR visits that would permit residents to better understand the role of PSRs and to gain more from their interactions with PSRs in the future. MAIN COMPONENTS OF PROGRAM: First-year family medicine residents at an academic teaching unit in Edmonton were surveyed on their knowledge and attitude to PSRs and then given a 1-hour educational seminar and five structured visits from PSRs. Following each PSR presentation, residents completed an evaluation form and discussed the interaction with their preceptors. CONCLUSIONS: We believe that a structured educational program is better than a written policy restricting interactions between PSRs and residents for providing residents with an understanding of the role of PSRs and making them better prepared for future contact.

Although the physiological and biochemical changes that occur during the acute stress response have been well-characterized, the contrasting changes that underlie the relaxation response evoked by various mind-body techniques are less understood. To help guide future mind-body research, we present a conceptual model that integrates patterns of change at the physiological and molecular levels. In addition, we point to future research opportunities and discuss how repeated elicitation of these responses could influence the health of patients.

Background

Sleepiness is a significant problem among residents due to chronic sleep deprivation. Recent studies have highlighted medical errors due to resident sleep deprivation. We hypothesized residents routinely use pharmacologic sleep aids to manage their sleep deprivation and reduce sleepiness.

Methods

A web-based survey of US allopathic Emergency Medicine (EM) residents was conducted during September 2004. All EM residency program directors were asked to invite their residents to participate. E-mail with reminders was used to solicit participation. Direct questions about use of alcohol and medications to facilitate sleep, and questions requesting details of sleep aids were included.

Results

Of 3,971 EM residents, 602 (16%) replied to the survey. Respondents were 71% male, 78% white, and mean (SD) age was 30 (4) years, which is similar to the entire EM resident population reported by the ACGME. There were 32% 1st year, 32% 2nd year, 28% 3rd year, and 8% 4th year residents. The Epworth Sleepiness Scale (ESS) showed 38% of residents were excessively sleepy (ESS 11–16) and 7% were severely sleepy (ESS>16). 46% (95 CI 42%–50%) regularly used alcohol, antihistamines, sleep adjuncts, benzodiazepines, or muscle relaxants to help them fall or stay asleep. Study limitations include low response and self-report.

Conclusion

Even with a low response rate, sleep aid use among EM residents may be common. How this affects performance, well-being, and health remains unknown.

The field of sleep medicine is in a welcome stage of rapid advance, but at a pace that leads to a sometimes overwhelming overload of knowledge for both clinicians and researchers. The nine papers in this issue are designed to give the reader an organized overview of current thinking and background in Basic Science, Clinical Science and Therapeutic Measures, the major divisions of this special issue.

An important trend is the increasing development of basic science knowledge relevant to understanding and treating the clinical features of sleep disorders.

The therapeutic advances section covers both the treatment of narcolepsy and the role of non‐invasive ventilation. The recent neurobiologic knowledge that narcolepsy‐cataplexy results from a deficiency of the hypothalamic neuropeptide hypocretin (orexin) has opened has opened the exciting possibility of using novel therapies. Despite this new knowledge, traditional stimulants and anticataplectic agents including modafinil, a novel wake‐promoting agent and selective serotonergic, adrenergic and dopaminergic reuptake inhibitors and recently introduced sodium oxybate remain the mainstay of treatment for this condition.

To whet the reader’s appetite and to offer a road map for possible reading, we briefly summarize the content of the papers.

Sleep problems are associated with mood and function disturbances in caregivers of persons with Alzheimer's disease (AD). However, the factors associated with the onset and maintenance of sleep disturbances in caregivers of persons with dementia are unknown, and little attention has been paid to treatments to improve sleep in caregivers. Here we review some of the evidence for the association between caregiver sleep problems, and caregiver and care-recipient demographic, health, and psychosocial variables. We present data from a longitudinal study that examined factors associated with self-reported sleep problems in dementia caregivers and care-recipients over a 5-year follow-up period, and describe the existing caregiver insomnia treatment literature. We conclude with recommendations for future research.

Evidence indicates acute sleep deprivation affects negative mood states. The present study experimentally tested the effects of acute sleep deprivation on self-reported symptoms of state anxiety and depression as well as general distress among 88 physically and psychologically healthy adults. As hypothesized, the effects of acute sleep deprivation increased state anxiety and depression, as well as general distress, relative to a normal night of sleep control condition. Based on the tripartite model of anxiety and depression, these findings replicate and extend prior research by suggesting sleep deprivation among individuals without current Axis I disorders increases both state symptoms of anxiety and depression specifically, and general distress more broadly. Extending this work to clinical samples and prospectively testing mechanisms underlying these effects are important future directions in this area of research.

The emergence of alternative medicines for AIDS in Asia and Africa was discussed at a satellite symposium and the parallel session on alternative and traditional treatments of the AIDSImpact meeting, held in Marseille, in July 2007. These medicines are heterogeneous, both in their presentation and in their geographic and cultural origin. The sessions focused on the role of these medications in selected resource poor settings in Africa and Asia now that access to anti-retroviral therapy is increasing. The aims of the sessions were to (1) identify the actors involved in the diffusion of these alternative medicines for HIV/AIDS, (2) explore uses and forms, and the way these medicines are given legitimacy, (3) reflect on underlying processes of globalisation and cultural differentiation, and (4) define priority questions for future research in this area. This article presents the insights generated at the meeting, illustrated with some findings from the case studies (Uganda, Senegal, Benin, Burkina Faso, China and Indonesia) that were presented. These case studies reveal the wide range of actors who are involved in the marketing and supply of alternative medicines. Regulatory mechanisms are weak. The efficacy claims of alternative medicines often reinforce a biomedical paradigm for HIV/AIDS, and fit with a healthy living ideology promoted by AIDS care programs and support groups. The AIDSImpact session concluded that more interdisciplinary research is needed on the experience of people living with HIV/AIDS with these alternative medicines, and on the ways in which these products interact (or not) with anti-retroviral therapy at pharmacological as well as psychosocial levels.

Medicine has developed sophisticated technologies based on an extensive knowledge base but it has met with serious application obstacles. Where prevention data is available, implementation of preventive measures faces great difficulty. Where compliance with treatment is found to improve outcome, ways to improve compliance have to be found. Although behavioral medicine has produced efficient learning based strategies for helping people modify their potentially noxious habits and even their environment, it cannot influence motivation to change. Information raises motivation and informing is the task of health education. The present paper presents three applications of SIC**, a microcomputer based patient teaching aid developed in response to the need for an unobtrusive, cost-efficient and flexible vehicle for transmitting clinically relevant information to target populations in a programmerless environment. Examples in mental health and psychosomatic medicine are presented and implication for future research is discussed.

Purpose

Blacks experience a number of health disparities. Sleep disturbances contribute to poor health. This preliminary study explores whether a disparity exists for sleep disturbance in Blacks compared to Whites and Others.

Methods

A cross-sectional study was conducted in a sample (N=92) of urban, primary care patients (52% Black, 46% White, and 2% Other) from a university-based, family medicine practice. Mean (sd) age was 51.9 (8.9) years. Participants completed the Pittsburgh Sleep Quality Index, the Center for Epidemiologic Studies Depression Scale -Revised, and a checklist of chronic health-conditions.

Results

The rate of clinically meaningful sleep disturbance was 71%. In bivariate logistic regressions, Black race was associated with sleep disturbance (OR: 3.00; 95% CI: 1.17–7.69). Controlling for income attenuated that association by about 11% (race OR = 2.71; 95% CI 1.04–7.06). Education explained about 35% (race OR = 2.39; 95% CI .89–6.42). Adjustment for depression, chronic illness, and education simultaneously resulted in an estimate for race of OR = 2.44; 95% CI = .85–7.01.

Conclusions

Being Black is associated with having a sleep disturbance that is only partially accounted for by depression, socioeconomic status and disease burden. Black primary care patients may benefit from additional screening and monitoring of sleep difficulties.

The basic treatment goals of pharmacological therapies in sleep medicine are to improve waking function by either improving sleep or by increasing energy during wakefulness. Stimulants to improve waking function include amphetamine derivatives, modafinil, and caffeine. Sleep aids encompass several classes, from benzodiazepine hypnotics to over-the-counter antihistamines. Other medications used in sleep medicine include those initially used in other disorders, such as epilepsy, Parkinson's disease, and psychiatric disorders. As these medications are prescribed or encountered by providers in diverse fields of medicine, it is important to recognize the distribution of adverse effects, drug interaction profiles, metabolism, and cytochrome substrate activity. In this paper, we review the pharmacological armamentarium in the field of sleep medicine to provide a framework for risk-benefit considerations in clinical practice.

Using the technique of nuclear magnetic resonance (NMR, MR, MRI), the first images displaying pathology in humans were published in 1980.1 Since then, there has been a rapid extension in the use of the technique, with an estimated 225 machines in use in the USA at the end of 1985.2 Considerable enthusiasm has been expressed for this new imaging technique,3 although awareness of its high cost in the present economic climate has led to reservations being expressed in other quarters.2 The aim of this article is to give an outline of the present state of NMR, and indicate some possible future developments.

Images

Caring for children with developmental disabilities and their families requires the close monitoring and management of a multitude of complex medical and psychosocial issues. The need for an interdisciplinary team approach to address these concerns presents special logistical problems on how to organize and present the information obtained during a clinic visit, and how to expedite the dissemination of this information to the team members. I am currently utilizing a computerized medical record database in the Developmental Disabilities Clinic at Children's Hospital-Columbus, Ohio and at The Nisonger Center a university affiliated program (UAP). The hardware required for the operation of this system includes a Macintosh PowerBook 170 and FilemakerPro software by Claris. The flexibility of use and the potential future applications of this program provides a practical clinical approach to caring for children with developmental disabilities.