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PubMed2004

Interactive Health Communication Applications for people with chronic disease.

BACKGROUND: Interactive Health Communication Applications (IHCAs) are computer-based, usually web-based health information packages for patients that combine information with at least one of social support, decision support, or behaviour change support. These are innovations in health care and their effects on health are uncertain. OBJECTIVES: To assess the effects of IHCAs for people with chronic disease. SEARCH STRATEGY: We designed a four-part search strategy. First, we searched electronic bibliographic databases for published work; second, we searched the grey literature and third, we searched for ongoing and recently completed clinical trials in the appropriate databases. Finally, researchers of included studies were contacted, and reference lists from relevant primary and review articles were followed up. As IHCAs require relatively new technology, the search commenced at 1990 where possible. SELECTION CRITERIA: Randomised controlled trials (RCTs) of Interactive Health Communication Applications for adults and children with chronic disease. DATA COLLECTION AND ANALYSIS: One reviewer screened abstracts. Two reviewers screened all candidate studies to determine eligibility, apply quality criteria, and extract data from included studies. Authors of included RCTs were contacted for missing data. Results of RCTs were pooled using a random effects model and standardised mean differences (SMDs) were calculated to provide net effect sizes. MAIN RESULTS: We screened 24,757 unique citations and retrieved 958 papers for further assessment, yielding 28 RCTs involving 4042 participants. One of these had an inadequate method of concealment of allocation, and sensitivity analyses were performed to determine the effects of including or excluding these data in the meta-analyses. Results in the abstract are from the meta-analyses excluding data from this study.IHCAs were found to have a positive effect on knowledge (SMD 0.49; 95% confidence interval (CI) 0.14 to 0.84) and on social support (SMD 0.47; 95% CI 0.28 to 0.66). IHCAs were found to have no effect on self-efficacy (SMD 0.15; 95% CI -0.13 to 0.43) or behavioural outcomes (SMD -0.09; 95% CI -0.49 to 0.32). IHCAs had a negative effect on clinical outcomes (SMD -0.32; 95% CI -0.63 to -0.02). REVIEWERS' CONCLUSIONS: The number and range of IHCAs is increasing rapidly; however there is a shortage of high quality evaluative data. Consumers who wish to increase their knowledge or social support amongst people with a similar problem may find an IHCA helpful. However, consumers whose primary aim is to achieve optimal clinical outcomes should not use an IHCA at present. Further research is needed to determine the reason for this negative effect on clinical outcomes, whether an optimal IHCA can achieve behaviour change and improved health outcomes, and if so, what are the essential features of such an IHCA, and the extent to which they differ according to patient group or condition.

Retraction of Publication as Topic↗

PubMed2005

Interactive Health Communication Applications for people with chronic disease.

BACKGROUND: Interactive Health Communication Applications (IHCAs) are computer-based, usually web-based, information packages for patients that combine health information with at least one of social support, decision support, or behaviour change support. These are innovations in health care and their effects on health are uncertain. OBJECTIVES: To assess the effects of IHCAs for people with chronic disease. SEARCH STRATEGY: We designed a four-part search strategy. First, we searched electronic bibliographic databases for published work; second, we searched the grey literature; and third, we searched for ongoing and recently completed clinical trials in the appropriate databases. Finally, researchers of included studies were contacted, and reference lists from relevant primary and review articles were followed up. As IHCAs require relatively new technology, the search time period commenced at 1990, where possible, and ran until 31 December 2003. SELECTION CRITERIA: Randomised controlled trials (RCTs) of IHCAs for adults and children with chronic disease. DATA COLLECTION AND ANALYSIS: One reviewer screened abstracts for relevance. Two reviewers screened all candidate studies to determine eligibility, apply quality criteria, and extract data from included studies. Authors of included RCTs were contacted for missing data. Results of RCTs were pooled using random-effects model with standardised mean differences (SMDs) for continuous outcomes and odds ratios for binary outcomes; heterogeneity was assessed using the I(2 )statistic. MAIN RESULTS: We identified 24 RCTs involving 3739 participants which were included in the review.IHCAs had a significant positive effect on knowledge (SMD 0.46; 95% confidence interval (CI) 0.22 to 0.69), social support (SMD 0.35; 95% CI 0.18 to 0.52) and clinical outcomes (SMD 0.18; 95% CI 0.01 to 0.35). Results suggest it is more likely than not that IHCAs have a positive effect on self-efficacy (a person's belief in their capacity to carry out a specific action) (SMD 0.24; 95% CI 0.00 to 0.48). IHCAs had a significant positive effect on continuous behavioural outcomes (SMD 0.20; 95% CI 0.01 to 0.40). Binary behavioural outcomes also showed a positive effect for IHCAs, although this result was not statistically significant (OR 1.66; 95% CI 0.71 to 3.87). It was not possible to determine the effects of IHCAs on emotional or economic outcomes. AUTHORS' CONCLUSIONS: IHCAs appear to have largely positive effects on users, in that users tend to become more knowledgeable, feel better socially supported, and may have improved behavioural and clinical outcomes compared to non-users. There is a need for more high quality studies with large sample sizes to confirm these preliminary findings, to determine the best type and best way to deliver IHCAs, and to establish how IHCAs have their effects for different groups of people with chronic illness.

Adaptation, Psychological↗

PubMed2004

Dan Shen agents for acute ischaemic stroke.

BACKGROUND: Based mainly on experimental data which indicates improvement to the cerebral microcirculation, Dan Shen, a form of herbal medicine, is widely used in the treatment of acute ischaemic stroke in China. We aimed to assess the evidence from randomised controlled trials of their effects. OBJECTIVES: To review the randomised or quasi-randomised controlled trials of Dan Shen agents for acute ischaemic stroke. The primary objective was to determine whether Dan Shen agents improve functional outcome without causing undue harm in patients with acute ischaemic stroke. Secondary objectives were to assess the effect of Dan Shen agents on impairment and on quality of life. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched September 2003), the register of the Cochrane Complementary Field (last searched September 2003) and the Chinese Stroke Trials Register (last searched September 2003). In addition we searched the following bibliographic databases: The Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002), MEDLINE (1996 to December 2002), EMBASE (1980 to December 2002), CINAHL (1982 to December 2002), AMED (1985 to December 2002) and China Biological Medicine Database (CBM-disc 1979 to December 2002). We handsearched 10 Chinese journals, searched clinical trials and research databases, scanned reference lists and contacted the pharmaceutical company manufacturing Dan Shen. SELECTION CRITERIA: Randomised controlled trials or quasi-randomised controlled clinical trials comparing Dan Shen agents with placebo or open control (no placebo) in patients with acute ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data. MAIN RESULTS: Eight potentially eligible trials were identified, of which three trials (304 patients) were included. Two trials were excluded and three trials are awaiting assessment. Numbers of deaths and dependent patients at the end of follow-up of at least three months were not reported in the three included trials. Only one trial reported adverse events. Three trials measured the outcome "significant improvement in neurological deficit at the end of treatment". Compound Dan Shen agents were associated with a significant increase in the number of patients with the outcome (Peto Odds Ratio (OR) 2.72, 95% Confidence Interval (CI) 1.10 to 6.72). No deaths were reported within the first two weeks of treatment or during the whole follow-up period (21 to 28 days). The trials did not include any assessment of quality of life. REVIEWERS' CONCLUSIONS: There were too few patients and outcome events to draw reliable conclusions from the present data. The methodological qualities of all included studies were poor. Further high-quality randomised controlled trials should be performed.

Acute Disease↗

PubMed2005

Cognitive behavioural therapy for anxiety disorders in children and adolescents.

BACKGROUND: Childhood and adolescent anxiety disorders are relatively common, occurring in between 5-18% of all children and adolescents. They are associated with significant morbidity and impairment in social and academic functioning, and when persistent, there is a risk of depression, suicide attempts and substance abuse in adulthood. There is accumulating evidence for the efficacy of cognitive behavioural therapy (CBT), with a number of randomised controlled trials (RCTs) suggesting benefit. OBJECTIVES: To determine whether CBT is an effective treatment for childhood and adolescent anxiety disorders in comparison to waiting list or attention controls. SEARCH STRATEGY: Search of the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register, which includes relevant randomised controlled trials from the bibliographic databases - The Cochrane Library ( to January 2004), EMBASE, (1970-2004) MEDLINE (1970-2004) and PsycINFO (1970-2004). We also searched the references of all included studies and relevant textbooks, and contacted authors in order to identify further trials. SELECTION CRITERIA: . Each identified study was assessed for possible inclusion by two reviewers independently. Inclusion criteria consisted of randomised controlled trials of CBT versus waiting list/attention controls in children (more than six years of age) and adolescents (under the age of 19 years) with a DSM (Diagnostic Statistical Manual) or ICD (International Classification of Diseases) anxiety diagnosis; and excluding simple phobia, obsessive compulsive disorder and post-traumatic stress disorder. Each study was required to conform to the principles of CBT through use of a protocol and comprising at least eight sessions of CBT. DATA COLLECTION AND ANALYSIS: The methodological quality of included trials was assessed by two reviewers independently. The dichotomous outcome of remission of anxiety diagnosis was pooled using relative risk (RR) with 95% confidence intervals. Means and standard deviations of anxiety symptom continuous scores were pooled using the standardised mean difference (SMD). Heterogeneity was assessed and intention-to-treat (ITT) analyses undertaken. The presence of publication bias was assessed using funnel plots. MAIN RESULTS: Thirteen studies with 498 subjects and 311 controls met the inclusion criteria and were included in the analyses. The studies involved community or outpatient subjects only, with anxiety of only mild to moderate severity. ITT analyses showed a response rate for remission of any anxiety diagnosis of 56% for CBT versus 28.2% for controls (RR 0.61,95%CI 0.53 to 0.69), with no evidence of heterogeneity. The number needed to treat (NNT) was 3.0 (95%CI 2.5 to 4.5). For reduction in anxiety symptoms, the SMD was -0.58 (95% CI 0.76 to -0.40) with no significant heterogeneity indicated. Individual, group and family/parental formats of CBT produced fairly similar outcomes. AUTHORS' CONCLUSIONS: Cognitive behavioural therapy appears an effective treatment for childhood and adolescent anxiety disorders in comparison to waiting list or attention control. There was no evidence for a difference between an individual, group or parental/family format. CBT can be recommended for the treatment of childhood and anxiety disorders, although with only just over half improving, there is a need for further therapeutic developments.

Adolescent↗

PubMed2005

Multisystemic Therapy for social, emotional, and behavioral problems in youth aged 10-17.

BACKGROUND: Multisystemic Therapy (MST) is an intensive, home-based intervention for families of youth with social, emotional, and behavioral problems. Masters-level therapists engage family members in identifying and changing individual, family, and environmental factors thought to contribute to problem behavior. Intervention may include efforts to improve communication, parenting skills, peer relations, school performance, and social networks. Most MST trials were conducted by program developers in the USA; results of one independent trial are available and others are in progress. OBJECTIVES: To provide unbiased estimates of the impacts of MST on restrictive out-of-home living placements, crime and delinquency, and other behavioral and psychosocial outcomes for youth and families. SEARCH STRATEGY: Electronic searches were made of bibliographic databases including the Cochrane Library, C2-SPECTR, PsycINFO, Science Direct and Sociological Abstracts) as well as government and professional websites, from 1985 to January 2003. Reference lists of articles were examined, and experts were contacted. SELECTION CRITERIA: Studies where youth (age 10-17) with social, emotional, and/or behavioral problems were randomised to licensed MST programs or other conditions (usual services or alternative treatments). DATA COLLECTION AND ANALYSIS: Two reviewers independently reviewed 266 titles and abstracts; 95 full-text reports were retrieved, and 35 unique studies were identified. Two reviewers independently read all study reports for inclusion. Eight studies were eligible for inclusion. Two reviewers independently assessed study quality and extracted data from these studies.Significant heterogeneity among studies was identified (assessed using Chi-square and I(2)), hence random effects models were used to pool data across studies. Odds ratios were used in analyses of dichotomous outcomes; standardised mean differences were used with continuous outcomes. Adjustments were made for small sample sizes (using Hedges g). Pooled estimates were weighted with inverse variance methods, and 95% confidence intervals were used. MAIN RESULTS: Pooled results show no significant effects of MST on the likelihood or duration of restrictive out-of-home placements, proportion of youth who were arrested or convicted, or numbers of arrests/convictions within one-year post-intervention. There were no significant differences on drug tests or self-reported drug use at a 6-month follow-up. In analyses of post-treatment data for program completers, there were no significant between-group differences on self-reported delinquency, peer relations, youth behavior problems, youth psychiatric symptoms, parent psychiatric symptoms, or family functioning. AUTHORS' CONCLUSIONS: There is little evidence of the superiority of MST over other interventions with youth. There is also no evidence that MST has harmful effects.

Adolescent↗

PubMed2005

Multisystemic Therapy for social, emotional, and behavioral problems in youth aged 10-17.

BACKGROUND: Multisystemic Therapy (MST) is an intensive, home-based intervention for families of youth with social, emotional, and behavioral problems. Masters-level therapists engage family members in identifying and changing individual, family, and environmental factors thought to contribute to problem behavior. Intervention may include efforts to improve communication, parenting skills, peer relations, school performance, and social networks. Most MST trials were conducted by program developers in the USA; results of one independent trial are available and others are in progress. OBJECTIVES: To provide unbiased estimates of the impacts of MST on restrictive out-of-home living arrangements, crime and delinquency, and other behavioral and psychosocial outcomes for youth and families. SEARCH STRATEGY: Electronic searches were made of bibliographic databases (including the Cochrane Library, C2-SPECTR, PsycINFO, Science Direct and Sociological Abstracts) as well as government and professional websites, from 1985 to January 2003. Reference lists of articles were examined, and experts were contacted. SELECTION CRITERIA: Studies where youth (age 10-17) with social, emotional, and/or behavioral problems were randomised to licensed MST programs or other conditions (usual services or alternative treatments). DATA COLLECTION AND ANALYSIS: Two reviewers independently reviewed 266 titles and abstracts; 95 full-text reports were retrieved, and 35 unique studies were identified. Two reviewers independently read all study reports for inclusion. Eight studies were eligible for inclusion. Two reviewers independently assessed study quality and extracted data from these studies. Significant heterogeneity among studies was identified (assessed using Chi-square and I(2)), hence random effects models were used to pool data across studies. Odds ratios were used in analyses of dichotomous outcomes; standardised mean differences were used with continuous outcomes. Adjustments were made for small sample sizes (using Hedges g). Pooled estimates were weighted with inverse variance methods, and 95% confidence intervals were used. MAIN RESULTS: The most rigorous (intent-to-treat) analysis found no significant differences between MST and usual services in restrictive out-of-home placements and arrests or convictions. Pooled results that include studies with data of varying quality tend to favor MST, but these relative effects are not significantly different from zero. The study sample size is small and effects are not consistent across studies; hence, it is not clear whether MST has clinically significant advantages over other services. AUTHORS' CONCLUSIONS: There is inconclusive evidence of the effectiveness of MST compared with other interventions with youth. There is no evidence that MST has harmful effects.

Adolescent↗

PubMed2004

Surgery versus sclerotherapy for the treatment of varicose veins.

BACKGROUND: Varicose veins are a relatively common condition and account for around 54,000 in-patient hospital episodes per year. The two most common interventions for varicose veins are surgery and sclerotherapy. However, there is little comparative data regarding their effectiveness. OBJECTIVES: To identify whether the use of surgery or sclerotherapy should be recommended for the management of primary varicose veins. SEARCH STRATEGY: Thirteen electronic bibliographic databases were searched covering biomedical, science, social science, health economic and grey literature (including current research). In addition, the reference lists of relevant articles were checked and various health services research-related resources were consulted via the internet. These included health economics and HTA organisations, guideline producing agencies, generic research and trials registers, and specialist sites. SELECTION CRITERIA: All studies that were described as randomised controlled trials comparing surgery with sclerotherapy for the treatment of primary varicose veins were identified. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted and summarised data from the eligible studies using a data extraction sheet for consistency. All studies were cross-checked independently by the reviewers. MAIN RESULTS: A total of 2306 references were found from our searches, 61 of which were identified as potential trials comparing surgery and sclerotherapy. However, only nine randomised trials, described in a total of 14 separate papers, fulfilled the inclusion criteria. Fifty trials were excluded and one trial is ongoing and is due for completion in 2004. The trials used a variety of outcome measures and classification systems which made direct comparison between trials difficult. However, the trend was for sclerotherapy to be evaluated as significantly better than surgery at one year; after one year (sclerotherapy resulted in worse outcomes) the benefits with sclerotherapy were less, and by three to five years surgery had better outcomes. The data on cost-effectiveness was not adequately reported. REVIEWERS' CONCLUSIONS: There was insufficient evidence to preferentially recommend the use of sclerotherapy or surgery. There needs to be more research that specifically examines both costs and outcomes for surgery and sclerotherapy.

Humans↗

PubMed2005

Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin.

BACKGROUND: Self-monitoring of blood glucose (SMBG) has been found to be effective for patients with type 1 diabetes and for patients with type 2 diabetes using insulin. There is much debate on the effectiveness of SMBG as a tool in the self-management for patients with type 2 diabetes who are not using insulin. OBJECTIVES: The objective of this review was to assess the effects of SMBG in patients with type 2 diabetes mellitus who are not using insulin. SEARCH STRATEGY: Studies were obtained from searches of multiple electronic bibliographic databases supplemented with hand searches of references of retrieved articles. Date of last search: September 2004. SELECTION CRITERIA: We included randomised controlled trails investigating the effects of SMBG compared with usual care and/or with self-monitoring of urine glucose in patients with type 2 diabetes who where not using insulin. Included studies should have used at least one of the following outcome measures: glycaemic control, quality of life, well-being, patient satisfaction, or hypoglycaemic episodes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data from included studies and assessed study quality. Data from the studies were compared to decide whether they were sufficiently homogeneous to pool in a meta-analysis. MAIN RESULTS: Six randomised controlled trials were included in the review. Four trials compared SMBG with usual care, one trial compared SMBG with self-monitoring of urine glucose and there was one three-armed trial comparing SMBG with self-monitoring of urine glucose and usual care. Because of the differences in patient characteristics, interventions and outcomes between the studies, it was not possible to perform a meta-analysis. The methodological quality of studies was low. Two of the six studies reported a significant lowering effect of self-monitoring of blood glucose on HbA1c. However, one of these studies had a co-intervention with education on diet and lifestyle. There were few data on the effects of other outcomes and these effects were not statistically significant. AUTHORS' CONCLUSIONS: From this review we concluded that self-monitoring of blood glucose might be effective in improving glycaemic control in patients with type 2 diabetes who are not using insulin. To assess the potential beneficial effects of SMBG in these patients a large and well-designed randomised controlled trial is required. This long-term trial should also investigate patient-related outcomes like quality of life, well-being and patient satisfaction, and provide adequate education to the patient to allow SMBG to be effective.

Blood Glucose Self-Monitoring↗

PubMed2006

Acupuncture for treatment of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS), a disorder of altered bowel habits associated with abdominal pain or discomfort. The pain, discomfort, and impairment from IBS often lead to healthcare medical consultation (Talley 1997) and workplace absenteeism, and associated economic costs (Leong 2003). A recent randomized controlled trial shows variable results but no clear evidence in support of acupuncture as an effective treatment for IBS (Fireman 2001). OBJECTIVES: The objective of this systematic review is to determine whether acupuncture is more effective than no treatment, more effective than 'sham' (placebo) acupuncture, and as effective as other interventions used to treat irritable bowel syndrome. Adverse events associated with acupuncture were also assessed. SEARCH STRATEGY: The following electronic bibliographic databases were searched irrespective of language, date of publication, and publication status: MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, EMBASE, the Chinese Biomedical Database, the Cumulative Index to Nursing and Allied Health (CINAHL), and the Allied and Complementary Medicine Database (AMED). References in relevant reviews and RCTs were screened by hand. The last date for searching for studies was 7 February 2006. SELECTION CRITERIA: Published reports of randomized controlled trials (RCTs) and quasi-randomised trials of acupuncture therapy for IBS. DATA COLLECTION AND ANALYSIS: All eligible records identified were dually evaluated for eligibility and dually abstracted. Methodological quality was assessed using the Jadad scale and the Linde Internal Validity Scale. Data from individual trials were combined for meta-analysis when the interventions were sufficiently similar. Heterogeneity was assessed using the I squared statistic. MAIN RESULTS: Six trials were included. The proportion of responders, as assessed by either the global symptom score or the patient-determined treatment success rate, did not show a significant difference between the acupuncture and the sham acupuncture group with a pooled relative risk of 1.28 (95% CI 0.83 to 1.98; n=109). Acupuncture treatment was also not significantly more effective than sham acupuncture for overall general well-being, individual symptoms (e.g., abdominal pain, defecation difficulties, diarrhea, and bloating), the number of improved patients assessed by blinded clinician, or the EuroQol score. For two of the studies without a sham control, acupuncture was more effective than control treatment for the improvement of symptoms: acupuncture versus herbal medication with a RR of 1.14(95% CI 1.00 to 1.31; n=132); acupuncture plus psychotherapy versus psychotherapy alone with a RR of 1.20 (95% CI 1.03 to 1.39; n=100). When the effect of ear acupuncture treatment was compared to an unclearly specified combination of one or more of the drugs diazepam, perphenazine or domperidone, the difference was not statistically significant with a RR of 1.49(95% CI 0.94 to 2.34; n=48). AUTHORS' CONCLUSIONS: Most of the trials included in this review were of poor quality and were heterogeneous in terms of interventions, controls, and outcomes measured. With the exception of one outcome in common between two trials, data were not combined. Therefore, it is still inconclusive whether acupuncture is more effective than sham acupuncture or other interventions for treating IBS.

Acupuncture Therapy↗

PubMed2005

Long-term non-pharmacological weight loss interventions for adults with prediabetes.

BACKGROUND: Most persons with prediabetes (impaired glucose tolerance or impaired fasting glucose) are overweight, and obesity worsens the metabolic and physiologic abnormalities associated with this condition. Prediabetes is an important risk factor for the development of type 2 diabetes. OBJECTIVES: The objective of this review was to assess the effectiveness of dietary, physical activity, and behavioral weight loss, and weight control interventions for adults with prediabetes. SEARCH STRATEGY: Studies were obtained from computerized searches of multiple electronic bibliographic databases, supplemented by hand searches of selected journals, and consultation with experts in obesity research. The last search was conducted May, 2004. SELECTION CRITERIA: Studies were included if they were published or unpublished randomized controlled trials in any language and examined weight loss or weight control strategies using one or more dietary, physical activity, or behavioral interventions, with a follow-up interval of at least 12 months. DATA COLLECTION AND ANALYSIS: Effects were combined using a random-effects model. MAIN RESULTS: Nine studies were identified, with a total of 5,168 participants. Follow-up ranged from 1 to 10 years. Quantitative synthesis was limited by the heterogeneity of populations, settings, and interventions and by the small number of studies that examined outcomes other than weight. Overall, in comparisons with usual care, four studies with a follow-up of one year reduced weight by 2.8 kg (95 % confidence interval (CI) 1.0 to 4.7) (3.3% of baseline body weight) and decreased body mass index by 1.3 kg/m(2) (95% CI 0.8 to 1.9). Weight loss at two years was 2.6 kg (95% CI 1.9 to 3.3) (three studies). Modest improvements were noted in the few studies that examined glycemic control, blood pressure, or lipid concentrations (P > 0.05). No data on quality of life or mortality were found. The incidence of diabetes was significantly lower in the intervention groups versus the controls in three of five studies examining this outcome at 3 to 6 years follow-up. AUTHORS' CONCLUSIONS: Overall, weight loss strategies using dietary, physical activity, or behavioral interventions produced significant improvements in weight among persons with prediabetes and a significant decrease in diabetes incidence. Further work is needed on the long-term effects of these interventions on morbidity and mortality and on how to implement these interventions in diverse community settings.

Adult↗

PubMed2006

Psychological therapies for people with borderline personality disorder.

BACKGROUND: Borderline personality disorder (BPD) is a relatively common personality disorder with a major impact on health services as those affected often present in crisis, often self-harming. OBJECTIVES: To evaluate the effects of psychological interventions for people with borderline personality disorder. SEARCH STRATEGY: We conducted a systematic search of 26 specialist and general bibliographic databases (December 2002) and searched relevant reference lists for further trials. SELECTION CRITERIA: All relevant clinical randomised controlled trials involving psychological treatments for people with BPD. The definition of psychological treatments included behavioural, cognitive-behavioural, psychodynamic and psychoanalytic. DATA COLLECTION AND ANALYSIS: We independently selected, quality assessed and data extracted studies. For binary outcomes we calculated a standard estimation of the risk ratio (RR), its 95% confidence interval (CI), and where possible the number need to help/harm (NNT/H). For continuous outcomes, endpoint data were preferred to change data. Non-skewed data from valid scales were summated using a weighted mean difference (WMD). MAIN RESULTS: We identified seven studies involving 262 people, and five separate comparisons. Comparing dialectical behaviour therapy (DBT) with treatment as usual studies found no difference for the outcome of still meeting SCID-II criteria for the diagnosis of BPD by six months (n=28, 1 RCT, RR 0.69 CI 0.35 to 1.38) or admission to hospital in previous three months (n=28, 1 RCT, RR 0.77 CI 0.28 to 2.14). Self harm or parasuicide may decrease at 6 to 12 months (n=63, 1 RCT, RR 0.81 CI 0.66 to 0.98, NNT 12 CI 7 to 108). One study detected statistical difference in favour of people receiving DBT compared with those allocated to treatment as usual for average scores of suicidal ideation at 6 months (n=20, MD -15.30 CI -25.46 to -5.14). There was no difference for the outcome of leaving the study early (n=155, 3 RCTs, RR 0.74 CI 0.52 to 1.04). For the outcome of interviewer-assessed alcohol free days, skewed data are reported and tend to favour DBT. When a substance abuse focused DBT was compared with comprehensive validation therapy plus 12-step substance misuse programme no clear differences were found for service outcomes (n=23, 1 RCT, RR imprisoned 1.09 CI 0.64 to 1.87) or leaving the study early (n=23, 1 RCT, RR 7.58 CI 0.44 to 132.08). When dialectical behaviour therapy-oriented treatment is compared with client centred therapy no differences were found for service outcomes (n=24, 1 RCT, RR admitted 0.33 CI 0.08 to 1.33). However, fewer people in the DBT group displayed indicators of parasuicidal behaviour (n=24, RR 0.13 CI 0.02 to 0.85, NNT 2 CI 2 to 11). There were no differences for outcomes of anxiety and depression (n=24, 1 RCT, RR anxiety BAI >/=10 0.60 CI 0.32 to 1.12; RR depression HDRS >/=10 0.43 CI 0.14 to 1.28) but people who received DBT had less general psychiatric severity than those in the control (MD BPRS at 6 months -7.41 CI -13.72 to -1.10). Finally this one relevant study reports skewed data for suicidal ideation with considerably lower scores for people allocated to DBT. When psychoanalytically oriented partial hospitalization was compared with general psychiatric care the former tended to come off best. People who received treatment in a psychoanalytic orientated day hospital were less likely to be admitted into inpatient care when measured at different time points (e.g. n=44, RR admitted to inpatient 24 hour care >18 to 24 months 0.05 CI 0.00 to 0.77, NNT 3 CI 3 to 10) Fewer people in psychoanalytically oriented partial hospitalization needed day hospital intervention in the 18 months after discharge (n=44, 1 RCT, RR 0.04 CI 0.00 to 0.59, NNT 2 CI 2 to 8). More people in the control group took psychotropic medication by the 30 to 36 month follow-up, than those receiving psychoanalytic treatment (n=44, 1 RCT, RR 0.44 CI 0.25 to 0.80, NNT 3 CI 2 to 7). Anxiety and depression scores were generally lower in the psychoanalytically oriented partial hospitalization group (n=44, 1 RCT, RR >/=14 on BDI 0.52 CI 0.34 to 0.80, NNT 3 CI 3 to 6), as are global severity scores. People receiving psychoanalytic care in a day hospital had better social improvement in social adjustment using the SAS-SR at 6 to 12 months compared with people in general psychiatric care (MD -0.70 CI -1.08 to -0.32). Rates of attrition were the same (n=44, 1 RCT, RR leaving the study early 1.00 CI 0.23 to 4.42). AUTHORS' CONCLUSIONS: This review suggests that some of the problems frequently encountered by people with borderline personality disorder may be amenable to talking/behavioural treatments but all therapies remain experimental and the studies are too few and small to inspire full confidence in their results. These findings require replication in larger 'real-world' studies.

Behavior Therapy↗

PubMed2006

Pharmacological interventions for people with borderline personality disorder.

BACKGROUND: Borderline Personality Disorder (BPD) is prevalent (2% in the general population, 20% among psychiatry in-patients) and has a major impact on health facilities as those affected often present in crisis but then make poor use of further attempts to help them. OBJECTIVES: To evaluate the effects of pharmacological interventions for people with borderline personality disorder. SEARCH STRATEGY: We conducted a systematic search of 26 specialist and general bibliographic databases (October 2002) and searched relevant reference lists for further trials. SELECTION CRITERIA: We included all randomised clinical trials comparing any psychoactive drugs with any other treatment for people with borderline personality disorder. DATA COLLECTION AND ANALYSIS: We independently selected, quality assessed and data extracted studies. For binary outcomes we calculated a standard estimation of the risk ratio (RR), its 95% confidence interval (CI), and where possible the number need to help/harm (NNT/H). For continuous outcomes, endpoint data were preferred to change data. Non-skewed data from valid scales were synthesised using a weighted mean difference (WMD). MAIN RESULTS: We found ten small (total n=554), short, randomised studies involving eight comparisons from which we could extract usable data. Studies comparing antidepressants with placebo were small (total n=79, 2 RCTs) but for ratings of anger fluoxetine may offer some improvement for those on antidepressant therapy over placebo (n=22, 1 RCT, RR anger not improved 0.30 CI 0.10 to 0.85, NNT 2 CI 2 to 9). The one small study investigating the important outcome of attempted suicide found no difference between mianserin and placebo (n=38, 1 RCT, RR 0.82 CI 0.44 to 1.54). Haloperidol may be better than antidepressants for symptoms of hostility and psychotism. There were few differences between MAOIs and placebo except that people given MAOIs were less hostile (n=62, 1 RCT, MD -9.19 CI -16.12 to -2.26). Although some ratings were statistically significant the comparison of MAOIs with antipsychotics did not show convincing differences. Antipsychotics may effect some mental state symptoms more effectively than placebo but results are difficult to interpret clinically and there is little evidence of advantage of one antipsychotic over another. Finally mood stabilisers such as divalporex may help mental state (n=16, 1 RCT, RR no improvement in mental state 0.58 CI 0.36 to 0.94, NNT 3 CI 2 to 17) but data are far from conclusive. AUTHORS' CONCLUSIONS: Pharmacological treatment of people with BPD is not based on good evidence from trials and it is arguable that future use of medication should be from within randomised trials. Current trials suggest that the positive effect of antidepressants, in particular, could be considerable. Well designed, conducted and reported clinically meaningful trials are possible and needed with, perhaps, the question of antidepressant versus placebo being addressed first.

Antidepressive Agents↗

PubMed2006

Bisphosphonates for advanced prostate cancer.

BACKGROUND: Prostate cancer is the most common cancer in men in many western countries. It is characterized by its propensity for bone metastases which occur in more than 80% of patients with advanced disease. Patients are at risk of complications including pain, hypercalcaemia, bone fracture and spinal cord compression. Hormonal treatment is the mainstay of treatment for these patients but most of them will then become hormone refractory. Bisphosphonates act by inhibiting osteoclast activities and are a potential therapeutic option for metastatic prostate cancer. In addition, they have been shown to reduce pain in patients with bone metastases as a consequence of multiple myeloma. Early uncontrolled studies of bisphosphonates in metastatic prostate cancer patients have shown encouraging results. OBJECTIVES: The objective of this review was to determine the effectiveness of bisphosphonates in relieving pain in patients with bone metastases from prostate cancer. SEARCH STRATEGY: Studies were identified by electronic search of bibliographic databases including MEDLINE, EMBASE, CancerLit and the Cochrane Controlled Trials Register. Handsearching included Proceedings of American Society of Clinical Oncology and reference lists of all eligible trials identified. SELECTION CRITERIA: Randomised controlled studies comparing the effectiveness of bisphosphonates with placebo or open control for pain relief in patients with bone metastases from prostate cancer. DATA COLLECTION AND ANALYSIS: Data were extracted from eligible studies and included study design, participants, interventions and outcomes. Comparable data were pooled together for meta-analysis with intention-to-treat principle. Outcomes included pain response, analgesic consumption, skeletal events (including pathological fractures, spinal cord compression, bone radiotherapy, bone surgery), prostate cancer death, disease progression, radiological response, PSA response, adverse events, performance status, quality of life and comparisons between different routes, doses and types of bisphosphonates. MAIN RESULTS: One thousand nine hundred and fifty-five patients from ten studies were included in this review. The pain response rates were 27.9% and 21.1% for the treatment group and the control group, respectively, with an absolute risk difference of 6.8%. The OR for pain response was 1.54 (95% CI 0.97 to 2.44, P = 0.07), showing a trend of improved pain relief in the bisphosphonate group, although this was not statistically significant. The rates for skeletal events were 37.8% and 43.0% for the treatment group and the control group, respectively, with an absolute risk difference of 5.2%. The OR for skeletal events was 0.79 (95% CI 0.62 to 1.00, P = 0.05). A significant increase in nausea was observed in patients who received bisphosphonates compared to placebo. No increase in other adverse events was observed. There was no statistically significant difference between the bisphosphonate group and the control group in terms of prostate cancer death, disease progression, radiological response and PSA response. There are insufficient data to guide the choice of bisphosphonates or the dose and the route of administration . AUTHORS' CONCLUSIONS: Bisphosphonates should be considered for patients with metastatic prostate cancer for the treatment of refractory bone pain and prevention of skeletal events. More research is needed to guide the choice of bisphosphonates, optimal treatment schedule as well as cost-benefit comparisons. Combining results from different studies is difficult because different tools were used to assess pain, and also, bisphosphonates vary considerably in potency. This review highlights the need for standardisation and co-ordination among researchers in cancer pain studies.

Bone Density Conservation Agents↗

PubMed2026

Cardiorespiratory training for people with stroke.

RATIONALE: Low levels of cardiorespiratory fitness are common after stroke and are associated with post-stroke disability and increased risk of secondary stroke. Cardiorespiratory training interventions aim to increase cardiorespiratory fitness, improve physical function, reduce disability, and help prevent future strokes. Clinical guidelines recommend exercise as part of lifestyle modification for secondary prevention, and strongly recommend exercise for rehabilitation. This review is one of three reviews that were originally a single review on physical fitness training for stroke. OBJECTIVES: The primary objective of this review was to determine whether cardiorespiratory training after stroke has an effect on death, disability, adverse events, risk factors, fitness, walking, and indices of physical function when compared to a non-exercise control. SEARCH METHODS: In April 2025, we searched nine bibliographic databases and two trials registers to identify studies for inclusion in the review. We checked reference lists, tracked citations, and contacted experts. ELIGIBILITY CRITERIA: We included randomised controlled trials comparing cardiorespiratory training interventions with usual care, no intervention, or a non-exercise intervention in people with stroke. OUTCOMES: Our critical outcomes were death, disability, adverse events, risk factors, fitness, walking, and indices of physical function, assessed at the end of the intervention and the end of the longest follow-up. RISK OF BIAS: We used the Cochrane RoB 1 tool to assess the risk of bias in the included studies. SYNTHESIS METHODS: The studies evaluated different comparisons (e.g. cardiorespiratory training versus no intervention/waiting list control or versus attention control or versus usual care), which we synthesised into a single comparison: cardiorespiratory training versus control. We used random-effects meta-analysis on arm-level data (risk difference (RD) for dichotomous data, and mean difference (MD) or standardised mean difference (SMD) for continuous data, with 95% confidence intervals (CIs)). For outcome data that we did not meta-analyse, we followed Synthesis Without Meta-analysis (SWiM) guidance. We used GRADE to assess the certainty of the evidence for critical outcomes. INCLUDED STUDIES: We included 53 studies (2672 participants, with an average age of 61.9 years). Most studies recruited ambulatory participants in the early subacute (7 days to 3 months) or chronic (> 6 months) phases of recovery. Exercise duration recommendations were met in 49 studies, and frequency recommendations in 48. Twenty-eight studies lacked balanced exposure between groups. Programme duration was 12 weeks or more in 16 studies (maximum: 24 weeks). Sixteen studies had a post-intervention follow-up period (12 weeks to 12 months from baseline). One study planned a six-month follow-up but did not report it. SYNTHESIS OF RESULTS: Cardiorespiratory training does not increase or decrease deaths at the end of intervention (RD 0.00, 95% CI -0.01 to 0.01; 36 studies, 1563 participants; high-certainty evidence) or the end of follow-up (RD -0.00, 95% CI -0.02 to 0.02; 10 studies, 713 participants; high-certainty evidence). Cardiorespiratory training may improve indices of disability slightly at the end of intervention (SMD 0.35, 95% CI 0.12 to 0.57; 17 studies, 1073 participants; very low-certainty evidence), but the evidence is very uncertain. Re-expressed using the Barthel Index (0 to 20), the equivalent effect is MD 1.68, 95% CI 0.59 to 2.74. It is unclear if the effect is clinically meaningful (the minimal clinically important difference (MCID) is +1.85). The effect is unclear at the end of follow-up (SMD -0.14, 95% CI -0.36 to 0.08; 5 studies, 347 participants; low-certainty evidence). Cardiorespiratory training does not increase or decrease the incidence of secondary cardiovascular or cerebrovascular events at the end of intervention (RD -0.00, 95% CI -0.03 to 0.02; 8 studies, 544 participants; high-certainty evidence) and probably does not affect them at the end of follow-up (RD -0.02, 95% CI -0.08 to 0.04; 4 studies, 412 participants; moderate-certainty evidence). It is very uncertain whether cardiorespiratory training affects systolic blood pressure (mmHg) at the end of intervention (MD -2.12, 95% CI -5.81 to 1.57; 9 studies, 535 participants; very low-certainty evidence) (MCID -2 mmHg) or follow-up (MD 0.93, 95% CI -4.30 to 6.16; 3 studies, 155 participants; very low-certainty evidence); the 95% CIs include the MCID. Cardiorespiratory training probably results in a slight improvement in cardiorespiratory fitness (VO2 ml/kg/min) at the end of intervention (MD 2.37, 95% CI 1.39 to 3.36; 13 studies, 608 participants; moderate-certainty evidence); it is unclear if the effect is clinically meaningful (MCID +3.5 ml/kg/min). The effect may be similar at the end of follow-up (MD 2.76, 95% CI 1.36 to 4.16; 5 studies, 237 participants; low-certainty evidence). Subgroup analysis favoured longer interventions. Cardiorespiratory training probably results in a slight increase in comfortable walking speed (metres per second) at the end of intervention (MD 0.08, 95% CI 0.04 to 0.12; 16 studies, 647 participants; moderate-certainty evidence), but the effect is not clinically meaningful (MCID +0.13). The effect is unclear at the end of follow-up (MD 0.02, 95% CI -0.05 to 0.10; 3 studies, 182 participants; low-certainty evidence). Cardiorespiratory training may improve indices of balance at the end of intervention (SMD 0.31, 95% CI 0.15 to 0.47; 18 studies, 772 participants; very low-certainty evidence), but the evidence is very uncertain. Re-expressing using the Berg Balance Scale, the equivalent effect is MD 2.09, 95% CI 1.10 to 3.07; and it is unclear if it is clinically meaningful (MCID of +2). The effect is unclear at the end of follow-up (MD 0.90, 95% CI -1.32 to 3.12; 6 studies, 253 participants; low-certainty evidence). Overall, our certainty about the evidence is limited for most outcomes by imprecision (small number of studies and participants) or risks of bias (e.g. imbalanced exposure doses) or both. AUTHORS' CONCLUSIONS: Cardiorespiratory training after stroke does not affect mortality or the incidence of secondary events at the end of the aerobic exercise training programme or end of follow-up. It may increase fitness, reduce disability, increase walking speed, and improve balance at the end of intervention, but it is unclear if these improvements are clinically meaningful. Further well-designed randomised trials are needed to fully understand the potential benefits and long-term effects of cardiorespiratory training and the optimal exercise prescription. FUNDING: No dedicated funding REGISTRATION: Protocol (and previous versions) available via DOI 10.1002/14651858.CD003316.

Humans↗

PubMed2005

Evidence based medicine in inborn errors of metabolism: is there any and how to find it.

Evidence based medicine (EBM) represents an attempt to assist healthcare providers in basing clinical decisions on the best available evidence. That evidence in the treatment realm usually takes the form of clinical trials (CTs), with the randomized controlled clinical trial (CCT or RCT) being the gold standard. Many specialties such as internal medicine have embraced EBM. Medical geneticists who care for patients with inborn errors of metabolism (IEM) have by and large not benefited from the EBM movement. IEM are rare genetic conditions, many of which are treatable. Therefore, the principles of EBM should be applicable to IEM. Notably, Archibald Cochrane, one of the founders of EBM, suffered from porphyria, an IEM. The principles of EBM as applied to IEM are explored herein. The author hypothesized that EBM has not infiltrated the specialty of medical genetics, that few controlled trials for IEM have been published, and that where CTs have been carried out in IEM they can be difficult to find with electronic bibliographic database searches. To test the hypothesis, MEDLINE searches for CTs were carried out for a few representative IEM. The search results support the hypothesis. In this article, the principles of EBM are introduced and its history reviewed as background information to lay the groundwork for further discussion. Next, the dearth of evidence base in IEM, impediments to the application of EBM to IEM, steps to be taken to improve the evidence base for IEM, and finally strategies to make it easier to find CTs for IEM in database searches are all discussed.

Evidence-Based Medicine↗

PubMed1985

Transferring a national information system from the public sector to the private sector--how the Administration on Aging did it.

The Administration on Aging (AoA) sponsored a national information system known as the SCAN system. The SCAN bibliographic database went on-line in March 1982. Congress, however, had repealed the authority for the clearinghouse, so the Government let all of the services of SCAN expire by September 1982. The Government then tried to keep the SCAN information accessible by offering it to the private sector. The Government solicited applicants through both the Federal Register and the Commerce Business Daily. As a result, the American Association of Retired Persons (AARP) and AoA signed an agreement calling for AARP to make such of the SCAN information accessible on-line and to update it.

Aged↗

PubMed2003

Systematic review of the safety and effectiveness of methods used to establish pneumoperitoneum in laparoscopic surgery.

BACKGROUND: A systematic review was conducted to determine which of the methods of obtaining peritoneal access and establishing pneumoperitoneum is the safest and most effective. METHODS: Studies that met the inclusion criteria were identified from six bibliographic databases up to May 2002, the internet, hand-searches and reference lists. They were critically appraised using a validated checklist and data were extracted using standardized protocols. RESULTS: Meta-analysis of prospective, non-randomized studies of open versus closed (needle/trocar) access indicated a trend during open access towards a reduced risk of major complications (pooled relative risk (RR(p)) 0.30, 95 per cent confidence interval (c.i.) 0.09 to 1.03). Open access was also associated with a trend towards a reduced risk of access-site herniation (RR(p) 0.21, 95 per cent c.i. 0.04 to 1.03) and, in non-obese patients, a 57 per cent reduced risk of minor complications (RR(p) 0.43, 95 per cent c.i. 0.20 to 0.92) and a trend for fewer conversions to laparotomy (RR(p) 0.21, 95 per cent c.i. 0.04 to 1.17). Data on major complications in studies of direct trocar versus needle/trocar access were inconclusive. Minor complications in randomized controlled trials were fewer with direct trocar access (RR(p) 0.19, 95 per cent c.i. 0.09 to 0.40), predominantly owing to a reduction in extraperitoneal insufflation. CONCLUSION: The evidence on the comparative safety and effectiveness of the different access methods was not definitive, but there were trends in the data that merit further exploration.

Controlled Clinical Trials as Topic↗

PubMed2004

Systematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence.

BACKGROUND: The aim was to determine the safety and effectiveness of the implantation of an artificial bowel sphincter for the treatment of severe faecal incontinence. METHOD: Medical bibliographic databases, the internet and reference lists were searched from January 1966 to January 2003. Only the lowest level of evidence was available for inclusion in this systematic review. Case series and case reports were selected to assess safety, whereas only case series were selected to assess effectiveness. RESULTS: Fourteen studies met the inclusion criteria. A number of safety issues were reported, including high explantation rates, and rates of adverse events owing to infection, device malfunction, ulceration and pain. Results in published reports were not analysed on an intention-to-treat basis. Continence, quality of life and manometry scores were reported for patients with a functioning device at the end of follow-up. These patients experienced a significant improvement in their level of continence. As no outcome data were presented for those with a non-functioning or explanted device, it is possible that such patients may have a worsened degree of incontinence or decreased quality of life. CONCLUSION: Implantation of an artificial bowel sphincter is of uncertain benefit and may possibly harm many patients. Patient selection is therefore critical and should be enhanced by higher-quality research.

Anal Canal↗