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Guermazi · used methods to determine the sever- in the context of epidemiological F buy alendronate 70 mg line. Genant (✉) ity of such fractures in clinical re- studies and clinical drug trials; how- Osteoporosis and search are the semiquantitative as- ever order 70 mg alendronate mastercard, the studies would be flawed if Arthritis Research Group generic alendronate 35mg on line, Department of Radiology, sessment of vertebral deformities, quantitative morphometry were to be University of California San Francisco, which is based on visual evaluation, performed in isolation without addi- 350 Parnassus Avenue, and the quantitative approach, which tional adjudication by a trained and San Francisco, CA 94117, USA is based on different morphometric highly experienced radiologist or Tel. Therefore the evaluation of spinal radiographs for prevalent and inci- Osteoporosis is a serious public health problem. The inci- dent vertebral fractures is important in both clinical and dence of osteoporotic fractures increases with age. Fewer population, the financial and human costs associated with than 1% of back pain episodes are related to vertebral osteoporotic fractures will multiply exponentially. Therefore vertebral fractures are often not cording to the International Osteoporosis Foundation, more suspected in patients reporting back pain, unless associ- than 40% of middle-aged women in Europe will suffer ated with trauma. Trauma-related fractures, however, are one or more osteoporotic fracture during their remaining not considered as classical osteoporotic fractures. Some Vertebral fractures are the hallmark of osteoporosis height loss is expected with aging due to compression of and occur with a higher incidence earlier in life than any the intervertebral discs and postural changes. However, other type of osteoporotic fractures, including hip frac- height loss could also be due to multiple fractures, which tures. The importance of fragility fractures, of which represent significant and irreparable damage. Therefore it vertebral fractures are the most common, was acknowl- has been concluded that height loss is an unreliable indi- edged by the World Health Organization classification cri- cator of fracture status until it exceeds 4 cm. The criterion of the vertebral fractures are often not being considered in clini- World Health Organization defines severe osteoporosis cal patient evaluation, and it is relatively uncommon for as low bone mass (T score below –2. Improvements in detecting and report- The definition of osteoporosis is centered on the level ing vertebral fractures in patients with osteoporosis would of bone mass, which is measured as bone mineral density increase the potential of therapeutic intervention to pre- (BMD). In Radiographic assessment of vertebral fractures addition, many other risk factors have been identified, some of which are known to add to the risk independently of Radiographic diagnosis is considered to be the best way to BMD measurements. The combination of BMD with such identify and confirm the presence of osteoporotic verte- risk factors increases the gradient of risk/standard devia- bral fractures in clinical practice. Several clinical tional lateral radiographs of the thoracolumbar spine have trials have demonstrated that a substantial improvement in been visually evaluated by radiologists or clinicians to the assessment of the risk for future fractures can be ac- identify vertebral fractures. However, there is still no in- complished by the assessment of prevalent vertebral frac- ternationally agreed definition for vertebral fracture. One tures in combination with BMD measurements [2, 5, 15, global prospective study (the IMPACT study) compared 27, 31, 36, 39, 41]. Nonetheless, it remains a common the results of local radiographic reports from five conti- clinical practice to consider low BMD to be a risk fac- nents with that of subsequent central readings in more tor irrespective of the presence of vertebral fractures. This study demonstrated that vertebral fractures were frequently underdiagnosed radiologically worldwide, with false-neg- Clinical identification of vertebral fractures ative rates as high as 30% despite a strict radiographic protocol that provided an unambiguous vertebral fracture It has been shown that both symptomatic and asympto- definition and minimized the influence of inadequate film matic vertebral fractures are associated with increased quality. It was concluded that the failure was a global morbidity and mortality [8, 22, 35]. Morbidity associ- problem attributable to either lack of radiographic detec- ated with these fractures includes decreased physical func- tion or use of ambiguous terminology in reports. Large-scale prospec- the diagnosis of osteoporosis and to assess the severity or tive studies demonstrate that only about one of four verte- progression of the disease as well as to rule out nonfrac- bral fractures becomes clinically recognized. They introduced a classification of ver- and there would have to be changes in vertebral shape in tebral deformities as diagnosed from lateral thoracolum- order to account for incident vertebral fractures on follow- bar radiographs for the purpose of diagnosing the severity up radiographs. This method grades only the most se- fractures consist of a combination of wedge and endplate verely deformed vertebra on the radiograph. From a radiological prospective, there are vertebral bodies T3 (or T7) to L4 are evaluated. This grading reflected at its best in the semiquantitative fracture assess- scheme is based on the reduction in the anterior, middle, ment method proposed by Genant et al. In addition to height reductions, ical change, and vertebral fractures are differentiated from careful attention is given to alterations in the shape and other, nonfracture deformities. These features add severity grade based upon the visually apparent degree of a strong qualitative aspect to the interpretation. Unlike the other approaches the type ple, vertebral deformities due to degenerative changes of the deformity (wedge, biconcavity, or compression) is should be ruled out, whereas an endplate vertebral frac- no longer linked to the grading of a fracture in this ap- ture can be identified without a 20% reduction in the ver- proach.

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Green  2004 John Wiley & Sons buy cheap alendronate 35 mg on line, Ltd ISBN: 0-471-98787-5 20 C ontraception ∗ GILDA PIAGGIO Department of Reproductive Health and Research cheap alendronate 70 mg, World Health Organisation purchase alendronate 35 mg otc, Geneva, Switzerland ∗The views expressed in this paper are solely those of the author and do not necessarily reflect the views of the World Health Organization. INTRODUCTION very safe so that it does not offset the benefits obtained from their use, and this emphasizes the Contraception deals with the prevention of preg- importance of addressing the safety concerns. The basic pillar of family planning is Both contraceptive efficacy and risks should be a wide spectrum of contraceptive methods that well defined to enable the user and the prescriber enables men and women to make informed to make the best choice of a contraceptive method. Effec- tive and safe methods should be available such The development of effective and safe methods that they fit the needs of women and men in of contraception poses special challenges. First, very diverse social and cultural settings world- to achieve an understanding of the complex phys- wide. Second, the effectiveness tect against sexually transmitted infections, can be of many methods depends on a successful inter- controlled by women, can be used by adolescents action between men and women. The choice of a have to be used by the man or the couple but contraceptive method involves personal decisions failure (pregnancy) is always observed in the and depends on the stage of life, family situation woman. Third, for some methods, behavioural or civil status, age, preferences and health profile and social factors are critical, determining com- of individuals and couples. Hormonal methods used by women include knowledge about method safety and effectiveness. They need to be post-coital oral pills (visiting pills and emergency Textbook of Clinical Trials. Green  2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5 316 TEXTBOOK OF CLINICAL TRIALS contraceptive (EC) pills). Non-hormonal meth- Modern low-dose COCs contain a combination ods used by women include intrauterine devices of oestrogen and a progestin (20 to 35 mcg of (IUDs), barrier methods (diaphragm and female oestrogen and 150 mcg or less of levonorgestrel, condom), spermicides, natural methods (calendar or 200 to 300 mcg of norgestrel or 400 to and lactational amenorrhoea) and sterilisation, 1000 mcg of norethindrone or the equivalent of as well as immunocontraceptives, that are being another progestin). Hormonal male methods consist of lations, with constant daily doses of oestrogen injectable preparations and implants, still under and progestin, biphasic ones, in which the dose development. Non-hormonal ones comprise con- of progestin changes in each of two periods and doms, withdrawal and sterilisation (vasectomy triphasic ones, in which the dosages change in and vas occlusion), while immunocontraceptives each of the three seven-day periods of pill intake or vaccines are under development. These broad classes of contraceptive methods COCs prevent conception through the suppres- differ in the length of the acting period, in the sion of ovulation via hypothalamic and pituitary mechanism of action, in the interval and way of effects and progestin-mediated alterations in the administration or insertion, in the possibility of consistency and properties of cervical mucus. It control by the woman, in their effectiveness and is still unconfirmed if the mechanism of action in their possible effects on health and indications also includes alterations in the endometrial lining for their use. They prevent conception through CONTRACEPTION METHODS: a combination of mechanisms including suppres- AN OVERVIEW sion of ovulation, alteration of cervical mucus, of the endometrium and of the fallopian tubes. Exten- progestins were first produced in the early sive and detailed descriptions of old and new 2,3 1950s. In this decade the first generation pro- contraceptive methods are available. Acom- gestins, like ethynodiol and lynesterol were prehensive review of the literature on contracep- 4 developed. OCs became available in the United tive efficacy was done by Trussell and Kost. A major breakthrough in the HORMONAL CONTRACEPTIVES development of OCs was the finding that the FOR WOMEN oestrogen and progestin acted synergistically to inhibit the pituitary. This allowed the transi- Hormonal methods prevent conception by inhibit- tion from high-dose to low-dose, of both the ing ovulation or preventing implantation or oestrogen and the progestin. Low-dose oestro- changing the quality of cervical mucus and thus gen COCs have less frequent complaints about preventing sperm access to the cervix. Infor- ods exert their action if administered within a mation on efficacy and common side-effects cycle, while injectable preparations, implants and was obtained from randomised clinical trials hormone-releasing devices are long-acting. Contraceptive methods available, their characteristics, typical failure and discontinuation rates and safety concerns Typical one year Perfect one year pregnancy pregnancy Duration of rate per 100 rate per 100 Type Method action woman-years woman-years Safety concerns Hormonal for women OCs COCs Daily 6–8 0. Side-effects of COCs are nausea, headaches, The effect of low-dose OCs on these physiologi- dizziness, spotting, weight gain, breast tenderness cal functions has been shown to be non-existent and chloasma. Some studies have reported that the use of The association between OCs and cardiovas- hormonal contraceptives is protective of cancer cular diseases, namely venous thrombosis (VTE), 318 TEXTBOOK OF CLINICAL TRIALS ischaemic heart disease and cerebrovascular dis- mucus and the endometrium. A multicentre trial mated that 60 to 80 million women are OC users was important to decide between the 100 mg worldwide.

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Initial drug doses should be approximately half of the and adolescent hypertension than in adult disease purchase alendronate 35mg with amex. Although all clients with primary hypertension need reg- should be smaller and spaced at longer intervals quality alendronate 70 mg. Blood pressure should be reduced slowly to facilitate adequate blood flow through arteriosclerotic vessels generic 35mg alendronate amex. Use in Older Adults Rapid lowering of blood pressure may produce cere- bral insufficiency (syncope, transient ischemic at- Most principles of managing hypertension in other popula- tacks, stroke). A further incentive for successful management of lowing factors require consideration: hypertension in older clients is the benefit of reduc- 1. There are basically two types of hypertension in older ing the incidence of dementia with antihypertensives. If blood pressure control is achieved and maintained blood pressure is above 160 mm Hg, but diastolic for approximately 6 to 12 months, drug dosage should pressure is below 95 mm Hg or normal. Both types increase cardiovascular morbidity and Use in Renal Impairment mortality, especially heart failure and stroke, and should be treated. Nonpharmacologic management should be tried alone with renal impairment ranging from mild insufficiency to or with drug therapy. A temporary decrease in renal function and moderate sodium restriction may be the initial may occur in these clients when the blood pressure is initially management of choice if the client is hypertensive and lowered. If antihypertensive drug therapy is required, drugs used diabetic nephropathy, drug therapy may slow progres- for younger adults may be used alone or in combina- sion of renal impairment. Diuretics are usually required because sodium retention older adults and may be effective alone. Some ACE inhibitors ever, metolazone, a thiazide-related drug, may be used (eg, lisinopril, ramipril, quinapril, moexipril) or their and relatively large doses may be required. Loop di- active metabolites produce higher plasma concentra- uretics, such as furosemide, are more often used, and tions in older adults than in younger ones. Additional guidelines include: effective in clients with renal impairment, but responses a. The goal of drug therapy for systolic-diastolic may vary and the following factors should be considered. When a client with renal impairment is started on an 140 mm Hg and a diastolic below 90 mm Hg in ACE inhibitor, careful monitoring is required, espe- clients with no other complications. For those with cially during the first few weeks of therapy, to pre- diabetes or renal failure, the goal is a systolic pres- vent irreversible renal failure. For some clients, it sure below 130 mm Hg and a diastolic below 85 mm may not be possible to normalize blood pressure and Hg. However, the latter goal may be difficult for most maintain adequate renal perfusion. In clients with severe atherosclerosis, especially those during blood pressure reduction in most clients; and with unilateral or bilateral stenosis of renal arteries, they are mainly eliminated by hepatic metabolism. ACE inhibitors can impair renal blood flow and However, cautious use is still recommended because worsen renal impairment (ie, increase blood urea ni- several agents produce active metabolites that are trogen [BUN] and serum creatinine). This may re- excreted by the kidneys (see section on Use in Renal quire stopping the drug. Although these are usually minor and transient, the drug may Use in Hepatic Impairment need to be discontinued or reduced in dosage. Approximately 25% of clients taking an ACE in- Little information is available about the use of antihyperten- hibitor for heart failure experience an increase in sive drugs in clients with impaired hepatic function. These clients usu- many of the drugs are metabolized in the liver and hepatic im- ally do not require drug discontinuation unless they pairment can increase and prolong plasma concentrations. Angiotensin-converting enzyme inhibitors have occa- with severe heart failure, whose renal function may sionally been associated with a syndrome that started depend on the activity of the renin–angiotensin– with cholestatic jaundice and progressed to hepatic aldosterone system, management with an ACE in- necrosis and sometimes death. The mechanisms are unclear, but ACE inhibitors also ACE inhibitor should have the drug discontinued.

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PNE Despite numerous studies on PNE discount alendronate 35mg, its etiology remains elusive to modern Western medicine buy discount alendronate 35 mg on line. The pathophysiology of enuresis 12 Treating Pediatric Bed-wetting with Acupuncture & Chinese Medicine appears to be multifactorial cheap alendronate 35 mg amex. Therefore, modern Western medicine has difficulty determining the etiology. This lack of clarity around the etiology ultimately complicates the therapeutic approach. In other words, all other organic causes of bed-wetting must first be ruled out before a diagnosis of PNE is made. However, NE does not have an identifiable organic etiology in 97-99% of the cases. SNE As defined above, SNE occurs in those who were previously able to achieve night-time bladder control, but, due to some change in their lives, they are now unable to control their night-time urina- tion. In addition, SNE may also be caused by pyschologi- cal stress and situational changes. Psychological stress As mentioned above, SNE may be caused by psychological stress but PNE is not. This psychological stress may be due to such things as divorce, a move, the death of a family member or friend, a new school, a new baby in the family, or school deadlines. In an older person, it may also include things such as job-related stress, a romantic break-up, or difficult room-mates. It is extremely impor- tant for the parent and the individual to realize that the sufferer is no more at fault than an adult with a headache or some other symptom caused by stress. Structural and physical problems Very few children (only 1-3%) have a physical disorder causing their bedwetting. Such disorders include: urinary tract infections, anatomical abnormalities of the urinary tract, abnormal nerve con- trol of the bladder, i. Some of the possible conditions and causes of enuresis are The Western Medical Causes of Enuresis 13 explained in more detail below including: antidiuretic hormone defi- ciency, low bladder capacity, nocturnal polyuria, urge syndrome/ dysfunctional voiding, neurogenic bladder, ectopic ureter, cystitis, constipation, seizure disorder, urethral obstruction, diabetes melli- tus, diabetes insipidus, heart block, and hyperthyroidism. The above conditions are divided into two groups: a bladder dysfunction group and a group of medical conditions that affect the bladder. Bladder dysfunction i) Developmental delay According to modern Western medicine, the most commonly accepted cause of nocturnal enuresis but also the most difficult to prove is the delayed functional maturation of the central nerv- ous system. Thus, the central cortical control over the urinary sphincter contraction does not occur. The failure of the arousal mechanism may also contribute to the inability to inhibit micturition. This slower physical development theory is proven by the spontaneous cure rates and animal studies. This form of incontinence fades away as the blad- der grows and the natural alarms become operational. The reason for this is thought to be a night-time surge of a hormone called antidiuret- ic hormone (ADH). The levels of ADH found in the blood are high- er beginning in the evening. One study looking at ADH levels in those with enuresis compared to controls found that there was a constant low level of ADH in those suffering from this disease. However, the fullness of the bladder may influence nocturnal secretion of ADH. Other studies report that ADH secretion can be influenced by bladder distention 14 Treating Pediatric Bed-wetting with Acupuncture & Chinese Medicine (increased) and emptying (decreased). Therefore, if ADH secretion decreases when the bladder is empty, the observed low nocturnal blood levels of ADH may be a result of enuresis instead of the cause of nocturnal enuresis. Sometime in middle childhood, most individuals make the transition from urinating around the clock to only urinating during waking hours. According to modern Western medicine, there are three reasons why individuals continue to need to urinate at night. For example, the muscle that contracts to squeeze the urine out is stronger at moments than the sphincter muscle that holds the urine in.

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