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PubMed1990

Women's attitudes to screening after participation in the National Breast Screening Study. A questionnaire survey.

A self-administered questionnaire study exploring women's attitudes to breast screening after participation in the Canadian National Breast Screening Study (NBSS) achieved an 82% response rate. Of active respondents (AR) attending two to five screening examinations, 1582 had received annual mammography (MA) and physical examination (PE) of the breasts and 548 received annual PE alone. Of 139 dropouts after the first screening, 105 received MA and PE and 34 received PE alone. Dropout respondents (DR) were significantly less likely than AR to report receiving very prompt (46% versus 66%), very courteous (73% versus 92%), or very competent examinations (74% versus 95%). Although 35% of those allocated to PE expressed disappointment with PE allocation compared with 9% of those allocated to MA, fewer of those allocated PE were prepared to accept MA in the future than those allocated MA (59% versus 73%). Of those who had MA, 36% reported moderate and 9% extreme discomfort from mammography. Almost half of each subgroup--MA allocations, PE allocations, and DR--preferred mammography every 2 to 3 years and 30% preferred mammography restricted to diagnostic purposes. Only 5% of AR reported anxiety after screening. National Breast Screening Study participation was a positive experience for 93%. An intention to do breast self-examination (BSE) was reported by 89% of AR and 79% of DR. Forgetfulness was a major impediment to BSE. Disincentives for screening were excessive distance to center, painful mammography, fear of radiation, lack of time, and preference for own physician. Convenient location, punctual appointments, and courteous and supportive staff should enhance screening compliance.

Adult↗
PubMed2000

Selegiline for Alzheimer's disease.

BACKGROUND: Alzheimer's disease is the most common cause of dementia in older people accounting for some 60% of cases with late-onset cognitive deterioration. It is now thought that several neurotransmitter dysfunctions are involved from an early stage in the pathogenesis of Alzheimer's disease-associated cognitive decline. The efficacy of selegiline for symptoms of Alzheimer's disease remains controversial and is reflected by its low rate of prescription and the lack of approval by several regulatory authorities in Europe and elsewhere. Reasons for this uncertainty involve the modest overall effects observed in some trials, the lack of benefit observed in several trials, the use of cross-over designs which harbour methodological problems in a disease like dementia and the difficulty in interpreting results from trials when a variety of measurement scales are used to assess outcomes. OBJECTIVES: The objective of this review is to assess whether or not selegiline improves the well-being of patients with Alzheimer's disease. SEARCH STRATEGY: The Cochrane Dementia and Cognitive Impairment Group Register of Clinical Trials, was searched using the terms 'selegiline', 'l-deprenyl', "eldepryl" and "monamine oxidase inhibitor-B". MEDLINE, PsycLIT and EMBASE electronic databases were searched with the above terms in addition to using the group strategy (see group details) to limit the searches to randomised controlled trials. SELECTION CRITERIA: All unconfounded, double-blind, randomised controlled trials in which treatment with selegiline was administered for more than a day and compared to placebo in patients with dementia. DATA COLLECTION AND ANALYSIS: Data were extracted independently by the reviewers (JSB & LF), pooled where appropriate and possible, and the weighted or standardised mean differences (95%CI) estimated. Where possible, intention-to-treat data were used but usually the meta analyses were restricted to completers' data (data on people who completed the study). MAIN RESULTS: There are 15 included trials. All trials examined the cognitive effects of selegiline, and in addition, 12 trials examined the behavioural and mood effects. The results of 8 trials suggested some beneficial effect of selegiline in the treatment of cognitive deficits and in 3 trials in the treatment of behaviour and mood. The meta-analysis revealed benefits on memory function as evidenced by improvement in the memory tests from several cognitive tests. Pooling the data for all cognitive tests suggested significant benefits in those subjects treated with selegiline as compared to controls. There were benefits in mood and behaviour as demonstrated by measurements on the Brief Psychiatric Rating Scale and the Dementia Mood Assessment Scale. The global rating scales showed no effect of selegiline. Unfortunately, the evidence using standardised global cognitive scales was extremely limited, for both the MMSE and ADAS-cog. A variety of adverse effects were recorded, but very few patients left a trial as a direct result of the intervention. REVIEWER'S CONCLUSIONS: Although the evidence for a beneficial effect of selegiline on patients with Alzheimer's disease is promising there is not yet enough evidence to recommend its use routinely in practice. The individual patient data review will yield further evidence on the effects of selegiline compared to control as would additional studies evaluating the use of selegiline for the endpoints of standardised cognitive scales, clinician impression of global change, dependency and caregiver quality of life.

Alzheimer Disease↗
PubMed2000

A comparison of drugs versus placebo for the treatment of dysthymia.

OBJECTIVES: Dysthymia is a depressive disorder of chronic nature but of less severity than major depression, which depressive symptoms are more or less continuous for at least two years. The aim of this review was to conduct a systematic review of all RCTs comparing drugs and placebo for dysthymia. SEARCH STRATEGY: Electronic searches of Cochrane Library, EMBASE, MEDLINE, PsycLIT, Biological Abstracts and LILACS; reference searching; personal communication; conference abstracts; unpublished trials from the pharmaceutical industry; book chapters on the treatment of depression. SELECTION CRITERIA: The inclusion criteria for all randomised controlled trials were that they should focus on the use of drugs versus placebo for dysthymic patients. Exclusion criteria were: non randomised, mixed major depression/ dysthymia (trials not providing separate data) and depression secondary to other disorders (e.g. substance abuse). DATA COLLECTION AND ANALYSIS: The reviewers extracted the data independently. In order to achieve an intention-to-treat analysis, when trials failed to report it was assumed that people who died or dropped out had no improvement. Authors of relevant trials were contacted for additional and missing data. Absence of treatment response as defined by authors was the main measure of outcome used. Relative Risks (RR) and 95% confidence intervals (CI) of dichotomous data were calculated with the Random Effects Model. Where possible, number needed to treat (NNT) and number needed to harm (NNH) were estimated, taking the reciprocal of the absolute risk reduction. MAIN RESULTS: Currently the review includes 15 trials. Similar results were obtained in terms of efficacy for different groups of drugs, such as tricyclic (TCA), selective serotonin reuptake inhibitors (SSRI), monoamine oxidase inhibitors (MAOI) and other drugs (sulpiride, amineptine, and ritanserin). The pooled RR for absence of treatment response was 0. 68 (95% CI 0.59-0.78) for TCA and the NNT was 4.3 (95% CI 3.2-6.5). SSRIs showed similar RR for this outcome: 0.64 (95% CI 0.55-0.74), the NNT being 4.7 (95% CI 3.5-6.9). Concerning MAOIs, the RR was 0. 59 (95% CI 0.48-0.71) and the NNT was 2.9 (95% CI 2.2-4.3). Other drugs (amisulpride, amineptine and ritanserin) showed similar results in terms of absence of treatment response. Using more stringent criteria for improvement - full remission - the results were unchanged. Patients treated on TCA were more likely to report adverse events, compared with placebo. REVIEWER'S CONCLUSIONS: Drugs are effective in the treatment of dysthymia with no differences between and within class of drugs. Tricyclic antidepressants are more likely to cause adverse events and dropouts. As dysthymia is a chronic condition, there remains little information on quality of life and medium or long-term outcome.

Antidepressive Agents↗
PubMed2001

Pelvic floor muscle training for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training is the most commonly recommended physical therapy treatment for women with stress leakage of urine. It is also used in the treatment of women with mixed incontinence, and less commonly for urge incontinence. Adjuncts, such as biofeedback or electrical stimulation, are also commonly used with pelvic floor muscle training. The content of pelvic floor muscle training programmes is highly variable. OBJECTIVES: To determine the effects of pelvic floor muscle training for women with symptoms or urodynamic diagnoses of stress, urge and mixed incontinence, in comparison to no treatment or other treatment options. SEARCH STRATEGY: Search strategy: We searched the Cochrane Incontinence Group trials register (May 2000), Medline (1980 to 1998), Embase (1980 to 1998), the database of the Dutch National Institute of Allied Health Professions (to 1998), the database of the Cochrane Rehabilitation and Related Therapies Field (to 1998), Physiotherapy Index (to 1998) and the reference lists of relevant articles. We handsearched the proceedings of the International Continence Society (1980 to 2000). We contacted investigators in the field to locate studies. Date of the most recent searches: May 2000. SELECTION CRITERIA: Randomised trials in women with symptoms or urodynamic diagnoses of stress, urge or mixed incontinence that included pelvic floor muscle training in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. Sensitivity analysis on the basis of diagnosis was planned and undertaken where appropriate. MAIN RESULTS: Forty-three trials met the inclusion criteria. The primary or only reference for 15 of these was a conference abstract. The pelvic floor muscle training programs, and comparison interventions, varied markedly. Outcome measures differed between trials, and methods of data reporting varied, making the data difficult to combine. Many of the trials were small. Allocation concealment was adequate in five trials, and nine trials used assessors masked to group allocation. Thirteen trials reported that there were no losses to follow up, seven trials had dropout rates of less than 10%, but in the remaining trials the proportion of dropouts ranged from 12% to 41%. Pelvic floor muscle training was better than no treatment or placebo treatments for women with stress or mixed incontinence. 'Intensive' appeared to be better than 'standard' pelvic floor muscle training. PFMT may be more effective than some types of electrical stimulation but there were problems in combining the data from these trials. There is insufficient evidence to determine if pelvic floor muscle training is better or worse than other treatments. The effect of adding pelvic floor muscle training to other treatments (e.g. electrical stimulation, behavioural training) is not clear due to the limited amount of evidence available. Evidence of the effect of adding other adjunctive treatments to PFMT (e.g. vaginal cones, intravaginal resistance) is equally limited. The effectiveness of biofeedback assisted PFMT is not clear, but on the basis of the evidence available there did not appear to be any benefit over PFMT alone at post treatment assessment. Long-term outcomes of pelvic floor muscle training are unclear. Side effects of pelvic floor muscle training were uncommon and reversible. A number of the formal comparisons should be viewed with caution due to statistical heterogeneity, lack of statistical independence, and the possibility of spurious confidence intervals in some instances. REVIEWER'S CONCLUSIONS: Pelvic floor muscle training appeared to be an effective treatment for adult women with stress or mixed incontinence. Pelvic floor muscle training was better than no treatment or placebo treatments. The limitations of the evidence available mean that is difficult to judge if pelvic floor muscle training was better or worse than other treatments. Most trials to date have studied the effect of treatment in younger, premenopausal women. The role of pelvic floor muscle training for women with urge incontinence alone remains unclear. Many of the trials were small with poor reporting of allocation concealment and masking of outcome assessors. In addition there was a lack of consistency in the choice and reporting of outcome measures that made data difficult to combine. Methodological problems limit the confidence that can be placed in the findings of the review. Further, large, high quality trials are necessary.

Female↗
PubMed2001

Interferon in relapsing-remitting multiple sclerosis.

BACKGROUND: Recombinant interferons have been shown to suppress both the clinical and magnetic resonance imaging (MRI) measures of disease activity in patients with relapsing remitting multiple sclerosis (RRMS). OBJECTIVES: We performed a Cochrane review of all randomised, placebo-controlled trials of recombinant interferons in RRMS. SEARCH STRATEGY: Of 208 articles identified by a predefined search strategy, seven of these, reporting randomised trials, met all the selection criteria and form the subject of this review. SELECTION CRITERIA: The trials selected were double-blind, placebo-controlled, randomised trials of RRMS patients who were treated with recombinant interferon, given by the subcutaneous or the intramuscular route. DATA COLLECTION AND ANALYSIS: The quality of the trials was variable, with substantial methodological inadequacies in allocation concealment, high proportion and incomplete description of dropouts and failure to adhere to the principles of intention to treat analysis. The baseline characteristics were largely comparable between treatment and placebo groups. Because of prominent treatment-associated side effects, which could be easily identified by patients, these trials could be considered as single blind rather than double-blind. MAIN RESULTS: Although 1215 patients were included in this review, only 919 (76%) contributed to the results concerning exacerbations and progression of the disease at two years. Specifically interferon significantly reduced the occurrence of exacerbations (RR =0.80, 95% CI [0.73,0.88], p<0.001) and progression of the disease (RR =0.69, 95% CI [0.55,0.87], p= 0.002) two years after randomisation. However, the correct assignment of dropouts was essential to the demonstration of efficacy, most conspicuously concerning the effect of the drug on disease progression. If interferon-treated patients who dropped out were deemed to have progressed (worst case scenario) the significance of these effects was lost (RR = 1.31, CI [0.60,2.89], p = 0.5). The evolution in magnetic resonance imaging (MRI) technology in the decade in which these trials were performed and different reporting of data among trials made it impossible to perform a quantitative analysis of the MRI results. Both clinical and laboratory side effects reported in the trials were more frequent in treated patients than in controls. No information was available regarding side effects and adverse events after two years of follow-up. The impact of interferon treatment (and its side effects) on the quality of life of patients was not reported in any trial included in this review. REVIEWER'S CONCLUSIONS: The efficacy of interferon on exacerbations and disease progression in patients with relapsing remitting MS was modest after one and two years of treatment. It was not possible to conduct a quantitative analysis beyond two years. Longer follow-up and more uniform reporting of clinical and MRI outcomes among these trials might have allowed for a more convincing conclusion.

Humans↗
PubMed2001

Dopamine agonists for cocaine dependence.

BACKGROUND: Cocaine is a major drug of abuse. Cocaine dependence is a common and serious condition, which has become nowadays a substantial public health problem. There is a wide and well documented range of consequences associated to chronic use of this drug, such as medical, psychological and social problems, including the spread of infectious diseases (e.g. AIDS, hepatitis and tuberculosis), crime, violence and neonatal drug exposure. Therapeutic management of the cocaine addicts includes an initial period of abstinence from the drug. During this phase the subjects may experience, besides the intense craving for cocaine, symptoms such as depression, fatigue, irritability, anorexia, and sleep disturbances. It was demonstrated that the acute use of cocaine may enhance dopamine transmission and chronically it decreases dopamine concentrations in the brain. Pharmacological treatment that affects dopamine could theoretically reduce these symptoms and contribute to a more successful therapeutic approach. OBJECTIVES: To evaluate the efficacy and acceptability of dopamine agonists for treating cocaine dependence. SEARCH STRATEGY: We searched: The Cochrane Controlled Trials Register (Cochrane Library, issue 4, 2000), MEDLINE (from 1966 - 2000), EMBASE (from 1980 - 2000), LILACS (from 1982 - 2000), PsycLIT (from 1974 - 2000), Biological Abstracts (1982 to 2000). Reference searching; personal communication; conference abstracts; unpublished trials from pharmaceutical industry; book chapters on treatment of cocaine dependence. SELECTION CRITERIA: The inclusion criteria for all randomised controlled trials were that they should focus on the use of dopamine agonists on the treatment of cocaine dependence. Trials including patients with additional diagnosis such as opiate dependence were also eligible. DATA COLLECTION AND ANALYSIS: The reviewers extracted the data independently and Relative Risks, weighted mean difference and number needed to treat were estimated. The reviewers assumed that people who died or dropped out had no improvement and tested the sensitivity of the final results to this assumption. MAIN RESULTS: Twelve studies were included, with 587 participants randomised. Amantadine and Bromocriptine were compared to placebo in most of trials. In two studies amantadine was directly compared to bromocriptine, while amantadine was compared to desipramine, an antidepressant in three. The main efficacy outcome presented was positive urine sample for cocaine metabolites, with no significant differences between interventions. When retention in treatment was assessed as an acceptability measure, it was found a similar rate of patients remaining in treatment in both placebo and active drugs. There were no significant differences in trials where participants had primary cocaine dependence or had additional diagnosis of opioid dependence and/or were in methadone maintenance treatment. REVIEWER'S CONCLUSIONS: Current evidence does not support the clinical use of dopamine agonists in the treatment of cocaine dependence. Given the high rate of dropouts in this population, clinicians may consider adding psychotherapeutic supportive measures aiming to keep patients in treatment.

Amantadine↗
PubMed2001

Antidepressants versus psychological treatments and their combination for bulimia nervosa.

BACKGROUND: Psychotherapeutic approaches, mainly cognitive behavior therapy, and antidepressant medication are the two treatment modalities that have received most support in controlled outcome studies of bulimia nervosa. OBJECTIVES: The primary objective was to conduct a systematic review of all RCTs comparing antidepressants with psychological approaches or comparing their combination with each single approach for the treatment of bulimia nervosa. SEARCH STRATEGY: (1) electronic searches of MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1999) (2) the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register - ongoing (3) handsearches of the references of all identified trials (4) contact with the pharmaceutical companies and the principal investigator of each included trial (5) handsearch of the International Journal of Eating Disorders - ongoing SELECTION CRITERIA INCLUSION CRITERIA: every randomized controlled trial in which antidepressants were compared with psychological treatments or the combination of antidepressants with psychological approaches was compared to each treatment alone, to reduce the symptoms of bulimia nervosa in patients of any age or gender. Quality criteria: reports were considered adequate if they were classified as A or B according to the Cochrane Manual. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers for each included trial. The main outcome for efficacy was full remission of bulimic symptoms, defined as 100% reduction in binge or purge episodes from baseline to endpoint. Dichotomous data was evaluated by the relative risks and 95% confidence intervals around this measure, based on the random effects model; continuous data was evaluated by the average difference and the 95% confidence interval. Number needed to treat (NNT) and number needed to harm (NNH) were calculated using the inverse of the absolute risk reduction. MAIN RESULTS: Five trials were included in comparison one (antidepressants versus psychological treatments), five in comparison two (antidepressants versus the combination) and seven in comparison three (psychological treatments versus the combination). Remission rates were 20% for single antidepressants compared to 39% for single psychotherapy (DerSimonian-Laird Relative Risk = 1.28; 95% Confidence Interval = 0.98;1.67). Dropout rates were higher for antidepressants than for psychotherapy (DerSimonian-Laird Relative Risk = 2.18; 95% Confidence Interval = 1.09;4.35). The NNH for a mean treatment duration of 17.5 weeks was 4 (95% confidence interval = 3;11). Comparison two found remission rates of 42% for the combination versus 23% for antidepressants (DerSimonian-Laird Relative Risk = 1.38; 95% Confidence Interval = 0.98;1.93). Comparison three showed a 36% pooled remission rate for psychological approaches compared to 49% for the combination (DerSimonian-Laird Relative Risk = 1.21; 95% Confidence Interval = 1.02;1.45). The NNT for a mean treatment duration of 15 weeks was 8 (95% Confidence Interval = 4;320). Dropout rates were higher for the combination compared to single psychological treatments (DerSimonian-Laird Relative Risk = 0.57; 95% Confidence Interval = 0.38;0.88). The NNH was 7 (95% Confidence Interval = 4;21). REVIEWER'S CONCLUSIONS: Using a more conservative statistical approach, combination treatments were superior to single psychotherapy. This was the only statistically significant difference between treatments. The number of trials might be insufficient to show the statistical significance of a 19% absolute risk reduction in efficacy favouring psychotherapy or combination treatments over single antidepressants. Psychotherapy appeared to be more acceptable to subjects. When antidepressants were combined to psychological treatments, acceptability of the latter was significantly reduced.

Antidepressive Agents↗
PubMed2001

Antidepressants versus placebo for people with bulimia nervosa.

BACKGROUND: Bulimia Nervosa (BN) represents an important public health problem and is related to serious morbidity and even mortality. This review attempted to systematically evaluate the use of antidepressant medications compared with placebo for the treatment of bulimia nervosa. OBJECTIVES: The primary objective of this review was to determine whether using antidepressant medications was clinically effective for the treatment of bulimia nervosa. The secondary objectives were: (i) to examine whether there was a differential effect for the various classes/types of antidepressants with regard to effectiveness and tolerability (ii) to test the hypothesis that the effect of antidepressants on bulimic symptoms was independent of its effect on depressive symptoms SEARCH STRATEGY: (1) electronic searches of MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1997) (2) the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register - ongoing (3) inspection of the references of all identified trials (4) contact with the pharmaceutical companies and the principal investigator of each included trial (5) inspection of the International Journal of Eating Disorders - ongoing SELECTION CRITERIA INCLUSION CRITERIA: every randomized, placebo-controlled trial in which antidepressant medications were compared to placebo to reduce the symptoms of bulimia nervosa in patients of any age or gender. Quality criteria: reports were considered adequate if they were classified as A or B according to the Cochrane Manual. The Jadad scale, with a cut off of 2 points, was applied to check the validity of the above referred criterion but was not used as an inclusion criterion. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers for each included trial. Dichotomous data were evaluated by the relative risk with 95% confidence intervals (CI) around this measure, based on the random effects model; continuous data were evaluated by the standardised mean difference with the 95% CI. NNT was calculated using the inverse of the absolute risk reduction. MAIN RESULTS: Currently the review includes 16 trials comparing antidepressants with placebo: 6 trials with TCAs (imipramine, desipramine and amitryptiline), 3 with SSRIs (fluoxetine), 4 with MAOIs (phenelzine, isocarboxazid and brofaromine) and 3 with other classes of drugs (mianserine, trazodone and bupropion). Similar results were obtained in terms of efficacy for these different groups of drugs. The pooled RR for remission of binge episodes was 0.88 (95% CI 0.83-0.93; p<0,001) favoring drugs. The NNT for a mean treatment duration of 8 weeks, taking the non-remission rate in the placebo controls of 92% as a measure of the baseline risk was 9 (95% CI 6 - 16). The RR for clinical improvement, defined as a reduction of 50% or more in binge episodes was 0.63 (95% CI 0.55-0.74) and the NNT for a mean treatment duration of 9 weeks was 4 (95% CI 3 - 6), with a non-improvement rate of 67% in the placebo group. Patients treated with antidepressants were more likely to interrupt prematurely the treatment due to adverse events. Patients treated with TCAs dropped-out due to any cause more frequently that patients treated with placebo. The opposite was found for those treated with fluoxetine, suggesting it may be a more acceptable treatment. Independence between antidepressant and antibulimic effects could not be evaluated due to incomplete published data. REVIEWER'S CONCLUSIONS: The use of a single antidepressant agent was clinically effective for the treatment of bulimia nervosa when compared to placebo, with an overall greater remission rate but a higher rate of dropouts. No differential effect regarding efficacy and tolerability among the various classes of antidepressants could be demonstrated.

Antidepressive Agents↗
PubMed2002

Indomethacin for the treatment of Alzheimer's disease patients.

BACKGROUND: Inflammatory processes involving cytokines, prostaglandins, free radicals and glial cells have been implicated in the pathogenesis of Alzheimer's disease. Non-steroidal anti-inflammatory drugs such as indomethacin attenuate inflammatory reactions. Hence, there may be a role for some of these drugs in the treatment of Alzheimer's disease. OBJECTIVES: To examine the efficacy of indomethacin in the treatment of patients suffering from Alzheimer's disease. SEARCH STRATEGY: The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (which contains records from many different medical and trials databases) on 14 June 2001 using the terms indomethacin and indome* and NSAIDS. In addition two independent reviewers systematically searched relevant computerized databases and Internet sites. This was supplemented by hand searching and additional references sought from selected papers. SELECTION CRITERIA: Single or multi-centre placebo-controlled randomized trials examining the efficacy of indomethacin in patients diagnosed with Alzheimer's disease were eligible for selection for this review. Using a standard extraction form, inclusion/exclusion criteria were set to ensure design quality and lack of bias of all trials included. DATA COLLECTION AND ANALYSIS: Data were collected independently by two reviewers and any discrepancies were subject to discussion. Corresponding authors were contacted for any missing data needed for statistical analysis. MAIN RESULTS: Only one study was selected for this review (~~Rogers 1993~~). We detected no statistically significant difference between indomethacin treatment and placebo for the individual cognitive tests, Mini Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale ( ADAS), Boston Naming Test (BNT) and Token Test (TK). Dropouts and death rate were the only reported results that were amenable to evaluation. The dropout rate was higher in the indomethacin group (10/24) than in the control group (6/20). Gastrointestinal adverse events were more prevalent in the treatment group (5/24 compared with 1/20 in control group). There was no statistically significant difference in death rate between the two groups (p=0.9). REVIEWER'S CONCLUSIONS: On the basis of this one trial and subsequent analysis of data as reported by the authors, indomethacin cannot be recommended for the treatment of mild to moderate severity Alzheimer's disease. At doses of 100-150 mg daily, serious side effects will limit its use.

Alzheimer Disease↗
PubMed2004

Hyperbaric oxygen therapy for chronic wounds.

BACKGROUND: Chronic wounds are common and present a health problem with significant effect on quality of life. The wide range of therapeutic strategies for such wounds reflects the various pathologies that may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing. OBJECTIVES: To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb (diabetic foot ulcers, venous and arterial ulcers and pressure ulcers). SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Trial Register (searched 6 February 2003), CENTRAL (The Cochrane Library Issue 1, 2003), Medline (1966 - 2003), EMBASE (1974 - 2003), DORCTHIM (1996 - 2003), and reference lists of articles. Relevant journals were handsearched and researchers in the field were contacted. SELECTION CRITERIA: Randomised studies comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy). DATA COLLECTION AND ANALYSIS: Three reviewers independently evaluated the quality of the relevant trials using the validated Oxford-Scale (Jadad 1996) and extracted the data from the included trials. MAIN RESULTS: Five trials contributed to this review. Diabetic foot ulcer (4 trials, 147 patients): Pooled data of three trials with 118 patients showed a reduction in the risk of major amputation when adjunctive HBOT was used, compared to the alternative therapy (RR 0.31, 95% CI 0.13 to 0.71). Sensitivity analysis for the allocation of dropouts did not significantly alter that result. This analysis predicts that we would need to treat 4 individuals with HBOT in order to prevent 1 amputation in the short term (NNT 4, 95% CI 3 to 11). There was no statistically significant difference in minor amputation rate (pooled data of two trials with 48 patients). Healing rates were reported in one trial (Abidia 2003) which showed a significant improvement in the chance of healing 1 year after therapy (RR for failure to heal with sham 2.3, 95%CI 1.1 to 4.7, P=0.03), although no effect was determined immediately post HBOT, nor at 6 months. Further, the beneficial effect after 1 year was sensitive to allocation of dropouts. Venous ulcer: (1 trial, 16 patients): This trial reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and healing rate) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at 6 weeks (WMD 33%, 95%CI 19% to 47%, P<0.00001). Arterial and pressure ulcers: No trials that satisfied inclusion criteria were located. REVIEWERS' CONCLUSIONS: In people with foot ulcers due to diabetes, HBOT significantly reduced the risk of major amputation and may improve the chance of healing at 1 year. The application of HBOT to these patients may be justified where HBOT facilities are available, however economic evaluations should be undertaken. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously however, and an appropriately powered trial of high methodological rigour is justified to verify this finding and further define those patients who can be expected to derive most benefit from HBOT. Regarding the effect of HBOT on chronic wounds associated with other pathologies, any benefit from HBOT will need to be examined in further, rigorous randomised trials. The routine management of such wounds with HBOT is not justified by the evidence in this review.

Amputation, Surgical↗
PubMed2003

Amitriptyline versus other types of pharmacotherapy for depression.

BACKGROUND: For many years amitriptyline has been considered one of the reference compounds for the pharmacological treatment of depression. However, new tricyclic drugs, heterocyclic compounds and the selective serotonin reuptake inhibitors have been introduced on the market with the claim of a more favourable tolerability/efficacy profile. OBJECTIVES: The aim of the present systematic review was to investigate the tolerability and efficacy of amitriptyline in comparison with the other tricyclic/heterocyclic antidepressants and with the selective serotonin reuptake inhibitors. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (2002-3) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched. Key journals and conference abstracts were handsearched. Pharmaceutical companies were contacted for information on unpublished materials. SELECTION CRITERIA: Only randomised controlled trials were included. Study participants were of either sex and any age with a primary diagnosis of depression. Included trials compared amitriptyline with another tricyclic/heterocyclic antidepressant or with one of the selective serotonin reuptake inhibitors. DATA COLLECTION AND ANALYSIS: Data were extracted using a standardised form. The number of patients undergoing the randomisation procedure, the number of patients who completed the study and the number of improved patients were extracted. In addition, group mean scores at the end of the trial on Hamilton Depression Scale or any other depression scale were extracted. In the tolerability analysis, the number of patients failing to complete the study and the number of patients complaining of side-effects was extracted. MAIN RESULTS: The estimate of the overall odds ratio for responders showed that more subjects responded to amitriptyline in comparison with the control antidepressant group (odds ratio 1.12, 95% confidence interval 1.01, 1.23, number needed to treat 50). The estimate of the efficacy of amitriptyline and control agents on a continuous outcome revealed an effect size which also significantly favoured amitriptyline (Standardised Mean Difference 0.13, 95% confidence interval 0.04, 0.23). Whilst these differences are statistically significant, their clinical significance is less clear. When the efficacy analysis was stratified by drug class, no difference in outcome emerged between amitriptyline and either tricyclic or selective serotonin reuptake inhibitor comparators. The dropout rate in patients taking amitriptyline and control agents was similar; however, the estimate of the proportion of patients who experienced side-effects significantly favoured control agents in comparison with amitriptyline (odds ratio 0.63, 95% confidence interval 0.56, 0.71). When the tolerability analysis was stratified by drug class, the dropout rate in patients taking amitriptyline and the selective serotonin reuptake inhibitors significantly favoured the latter (odds ratio 0.84, 95% confidence interval 0.75,0.95, number needed to harm 40). When the responder analysis was stratified by study setting amitriptyline was more effective than control ADs in inpatients (odds ratio 1.22, 95% confidence interval 1.04, 1.42, number needed to treat 24), but not in outpatients (odds ratio 1.01, 95% confidence interval 0.88, 1.17, number needed to treat = 200). REVIEWER'S CONCLUSIONS: This present systematic review indicates that amitriptyline is at least as efficacious as other tricyclics or newer compounds. However, the burden of side-effects in patients receiving it was greater. In comparison with the selective serotonin reuptake inhibitors amitriptyline was less well tolerated, and although counterbalanced by a higher proportion of responders, the difference was not statistically significant.

Amitriptyline↗
PubMed2006

Meditation therapy for anxiety disorders.

BACKGROUND: Anxiety disorders are characterised by long term worry, tension, nervousness, fidgeting and symptoms of autonomic system hyperactivity. Meditation is an age-old self regulatory strategy which is gaining more interest in mental health and psychiatry. Meditation can reduce arousal state and may ameliorate anxiety symptoms in various anxiety conditions. OBJECTIVES: To investigate the effectiveness of meditation therapy in treating anxiety disorders SEARCH STRATEGY: Electronic databases searched include CCDANCTR-Studies and CCDANCTR-References, complementary and alternative medicine specific databases, Science Citation Index, Health Services/Technology Assessment Text database, and grey literature databases. Conference proceedings, book chapters and references were checked. Study authors and experts from religious/spiritual organisations were contacted. SELECTION CRITERIA: Types of studies: Randomised controlled trials. TYPES OF PARTICIPANTS: patients with a diagnosis of anxiety disorders, with or without another comorbid psychiatric condition. Types of interventions: concentrative meditation or mindfulness meditation. Comparison conditions: one or combination of 1) pharmacological therapy 2) other psychological treatment 3) other methods of meditation 4) no intervention or waiting list. Types of outcome: 1) improvement in clinical anxiety scale 2) improvement in anxiety level specified by triallists, or global improvement 3) acceptability of treatment, adverse effects 4) dropout. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two reviewers using a pre-designed data collection form. Any disagreements were discussed with a third reviewer, and the authors of the studies were contacted for further information. MAIN RESULTS: Two randomised controlled studies were eligible for inclusion in the review. Both studies were of moderate quality and used active control comparisons (another type of meditation, relaxation, biofeedback). Anti-anxiety drugs were used as standard treatment. The duration of trials ranged from 3 months (12 weeks) to 18 weeks. In one study transcendental meditation showed a reduction in anxiety symptoms and electromyography score comparable with electromyography-biofeedback and relaxation therapy. Another study compared Kundalini Yoga (KY), with Relaxation/Mindfulness Meditation. The Yale-Brown Obsessive Compulsive Scale showed no statistically significant difference between groups. The overall dropout rate in both studies was high (33-44%). Neither study reported on adverse effects of meditation. AUTHORS' CONCLUSIONS: The small number of studies included in this review do not permit any conclusions to be drawn on the effectiveness of meditation therapy for anxiety disorders. Transcendental meditation is comparable with other kinds of relaxation therapies in reducing anxiety, and Kundalini Yoga did not show significant effectiveness in treating obsessive-compulsive disorders compared with Relaxation/Meditation. Drop out rates appear to be high, and adverse effects of meditation have not been reported. More trials are needed.

Anxiety Disorders↗
PubMed2006

Pharmacotherapy augmentation strategies in treatment-resistant anxiety disorders.

BACKGROUND: A large proportion of patients with anxiety disorders fail to respond to first-line medication interventions, despite evidence of the effectiveness of these agents. OBJECTIVES: To assess the effects of medication versus placebo augmentation in the treatment of patients with anxiety disorders who have failed to respond adequately to first-line drug therapies. SEARCH STRATEGY: The Cochrane Depression, Anxiety & Neurosis Group (CCDAN) specialised registers (CCDANCTR-Studies and CCDANCTR-References) were searched on 3/8/2005, MEDLINE (January 1966 to July 2005) and PsycINFO (1966 to 2005, Part A). Unpublished trials were identified through the Controlled Trials database and the National Institute of Health's Computer Retrieval of Information on Scientific Projects (CRISP) service (1972 to 2005). Additional studies in any language were sought in reference lists of retrieved articles. SELECTION CRITERIA: All randomised controlled trials (RCTs) of the medication augmentation of pharmacotherapy for treatment resistant anxiety disorders. DATA COLLECTION AND ANALYSIS: Two raters independently assessed RCTs for inclusion in the review, collated trial data, and assessed trial quality. Investigators were contacted to obtain missing data. Summary statistics were stratified by class of augmentation agent and anxiety disorder. Overall effect estimates were calculated using a random-effects model, heterogeneity was assessed and subgroup/sensitivity analyses were undertaken. MAIN RESULTS: Twenty eight short-term (average of seven weeks) randomised controlled trials (740 participants) were included in the review, 20 of which investigated augmentation of medication for treatment-resistant obsessive compulsive disorder (OCD). Summary statistics for responder status from nine trials demonstrate overall superiority of a variety of medication agents to placebo (relative risk of non-response (RR) 3.16, 95% CI 1.08 to 9.23). Similarly, symptom severity was significantly reduced in the medication groups, relative to placebo (number of trials (N) = 14, standardised mean difference (SMD) -0.87, 95% CI -1.37 to -0.36). There is no evidence of a difference between medication and placebo in total dropout rate, or in the number of dropouts due to adverse events. AUTHORS' CONCLUSIONS: Medication augmentation can be an effective and well-tolerated short-term treatment strategy for non-responders to first-line pharmacotherapy of anxiety disorders. However, any conclusions must be tentative in view of methodological and clinical heterogeneity, and the fact that much of the relevant database is based on antipsychotic augmentation trials in OCD patients resistant to serotonin reuptake inhibitors (SRIs). Additional data are needed to address several areas, including the efficacy of augmentation over the longer-term, and the value of medication augmentation in comparison to other strategies (e.g. switching medication, adding psychotherapy).

Anti-Anxiety Agents↗
PubMed1995

Beneficial clinical effect of very early enalapril treatment in patients with acute left ventricular failure complicating myocardial infarction.

Acute myocardial infarction (AMI) leads to left ventricular dysfunction, the extent of which predicts mortality. We studied the effect of very early enalapril treatment in patients with left ventricular failure (Killip classification II-III) resulting from AMI. In a double-blind randomized trial, patients on conventional treatment were started on placebo (PL, n = 15) or 2.5 mg enalapril (EN, n = 15) twice daily as early as 24 to 30 h after AMI and were followed up over a period of 21 days. One patient died in each treatment group. There were three dropouts in the placebo group (progressive heart failure requiring antiotensin-converting enzyme inhibition) and one dropout in the enalapril group (malignant ventricular arrhythmias). Plasma atrial natriuretic peptide (ANP) and norepinephrine decreased similarly in both groups from elevated baseline concentrations. The patients with the highest baseline ANP levels died in both groups: EN: 579 fmol/ml (mean 65.3 +/- 34.4 fmol/ml), PL: 403 fmol/ml (mean 63.5 +/- 37.6 fmol/ml). Killip classification improved in 9 of 13 patients on enalapril but only in 5 of 11 patients on placebo. On echocardiography an increase in fractional shortening (FS) (3.2 +/- 7.5%, p < 0.05) was found with enalapril only. Patients on placebo required more diuretics, and plasma aldosterone increased threefold. Thus, very early enalapril treatment may help prevent left ventricular failure after AMI. Extremely high initial plasma ANP concentrations may predict an unfavorable outcome.

Aged↗
PubMed2005

Impact of traumatic experiences and violent acts upon response to treatment of a sample of Colombian women with eating disorders.

OBJECTIVE: The current article compared the impact of exposure to sexual trauma and other types of physical threats against the patient or the patient's family on response to treatment, relapse, and dropout rates in 160 Colombian women between 12 and 49 years of age with eating disorders. METHOD: A comparison was made to 70 cases with unsatisfactory response to treatment and 90 controls with a better response to treatment goals. RESULTS: Forty-five percent had a history of sexual abuse, other violent traumas, or both. Significant statistical differences were observed between both groups in exposure variables. The highest probability of poor outcome was observed in patients with sexual abuse and exposure to other violent acts (odds ratio [OR] = 6.37, 95% confidence interval [CI] = 2.1-19.07). The risk of dropout or relapse was, respectively, 10 and 3 times greater among those exposed. DISCUSSION: Violent social conditions should be noted as another form of trauma with potential impact on outcome in Colombian women with eating disorders. (

Adolescent↗
PubMed2006

Role of therapeutic alliance in family therapy for adolescent anorexia nervosa.

OBJECTIVE: The purpose of this study is to examine the role of therapeutic alliance in predicting treatment dropout, response and outcome in a cohort of adolescents with anorexia nervosa (AN) and their families who were treated using a manualized form of family-based therapy (FBT). METHOD: Independent assessors scored early and late therapeutic alliances for patients and parents using the Working Alliance Inventory-Observer (WAIo). Outcomes were weights and scores on the subscales of the Eating Disorder Examination at the end of 12 months of FBT. RESULTS: Therapeutic alliance throughout treatment was strong both for adolescents and for their parents. A strong early alliance with adolescents was associated with early treatment response in terms of weight gain. A strong early alliance with parents prevented dropout, whereas a strong late parental alliance predicted their child's total weight gain at the end of treatment. CONCLUSION: Therapeutic alliance in both patients and parents treated with FBT is generally strong and likely contributes to treatment retention and treatment outcome.

Adolescent↗
PubMed2001

Subjective health measures and acute treatment outcomes in geriatric depression.

BACKGROUND: Prior research suggests that elderly patients are less likely to respond to antidepressant treatment if they have low self-rated health. However, successful treatment for depression has been associated with improvement in self-rated health and other health measures. OBJECTIVES: To examine measures of self-rated health, physical disability, and social function as predictors of treatment response in late-life depression, and to assess these same health measures as treatment outcomes. We hypothesized that greater impairment in these measures would predict poorer treatment response, and that these measures would show significant improvements with recovery from depression. METHOD: Subjects were enrolled in a depression intervention study for people aged 60 and older with recurrent unipolar major depression; they were assessed with measures of self-rated health, physical disability, and social functioning at baseline and at the end of treatment. Baseline measures were compared between the 88 remitters, 11 non-remitters, and seven dropouts. Additionally, changes in the measures were examined in subjects who recovered from the index depressive episode. RESULTS: Subjects with poorer self-rated health at baseline were more likely both to drop out of treatment and to not respond to adequate treatment. This relationship was independent of demographic measures, severity of depression, physical and social functioning, medical illness, personality, hopelessness, overall medication use, and side effects or non-compliance with treatment. CONCLUSION: Although this finding is preliminary because of the small number of dropouts and non-remitters, it suggests that lower self-rated health may independently predict premature discontinuation of treatment for depression. Additionally, subjects who recovered from depression showed significant improvements in self-rated health, physical disability, and social functioning.

Activities of Daily Living↗
PubMedDate not supplied

A coded histologic study of hepatic graft-versus-host disease after human bone marrow transplantation.

We tested the hypothesis that liver histology from patients with graft-versus-host disease could be distinguished from other common liver diseases. Liver biopsies from 33 allogeneic marrow transplant recipients with acute and chronic graft-versus-host disease and 37 nontransplant liver disease patients without graft-versus-host disease were recut, restained and coded for blind review. Analysis of individual histologic features showed significantly more cytologic aberration of bile duct epithelium and more cholestasis among biopsies with graft-versus-host disease when compared to biopsies without graft-versus-host disease (p less than or equal to 0.05). The duration of graft-versus-host preceding the biopsy influenced the histologic features. Biopsies before Day 35 showed frequent acidophilic bodies but infrequent bile duct changes. Biopsies from Days 35 to 90 posttransplant had more frequent bile duct exocytosis and disruption, and biopsies from patients with chronic graft-versus-host disease (beyond Day 90) showed more frequent portal fibrosis and bile duct dropout. Pattern assessment of coded biopsies showed that a histologic diagnosis of graft-versus-host disease had a positive predictive value of 86%, a sensitivity of 66% and a specificity of 91%. False-negative diagnoses occurred most frequently in biopsies obtained less than 4 weeks posttransplant, usually because bile duct abnormalities were not present. False-positive diagnoses of graft-versus-host disease occurred in nongraft-versus-host disease biopsies with periportal inflammation and proliferated bile ducts. However, biopsies of chronic graft-versus-host disease had more frequent dropout and disruption of bile duct epithelium than did biopsies of acute or chronic hepatitis.(ABSTRACT TRUNCATED AT 250 WORDS)

Biopsy, Needle↗