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Exercise and mental health: a review.

With the advent of programmes to raise the level of fitness in the general population, and alliances between primary health care and community leisure services, the potential of exercise in promoting mental as well as physical health deserves investigation. In contrast to USA and continental Europe, there is a paucity of British research studies systematically exploring the mental health benefits of exercise. The recent rapid growth of exercise prescription among general practitioners presents an opportunity for future research. This review of eleven randomised control trials (RCTs) suggests a causal relationship between exercise and mental health based upon studies in various settings. The methodological difficulties associated with randomised control trials of psycho-social interventions are discussed. The value of future randomised control trials which incorporate examination of perceived acceptability and health economics is indicated.

Exercise↗

Oral contraceptives and mood.

The past 40 years of research on the mood and behavioural effects of combined oral contraceptives (OCs) have yielded inconclusive results due to dramatic changes in the compounds and to methodological flaws inherent in studies undertaken to assess the effects of OCs. Since the late 1960s, the dosages of oestrogen and progestin in marketed OCs significantly declined and novel progestins were developed to deliver higher levels of progestogenic activity with a lower risk of adverse oestrogenic and androgenic effects. This review evaluates controlled, comparative studies that have focused on the efficaciousness of OCs as treatment for premenstrual syndrome (PMS) and those examining whether OCs may cause negative mood. It is suggested that the mood and behavioural effects of OCs might be attributed to different progestin compounds and possibly, their oestrogen ratios. There is a great need for more longitudinal, randomised, placebo-controlled studies to further clarify the mood and behavioural effects of OCs.

Affect↗

Laparoscopic colposuspension: a systematic review.

OBJECTIVE: To determine the effectiveness of laparoscopic colposuspension for the treatment of stress urinary incontinence. DESIGN: Systematic review. SETTING: Teaching hospitals. POPULATION: Women with symptoms or urodynamic diagnosis of stress, urge or mixed incontinence. METHODS: Randomised and 'quasi-randomised trials' in women with symptoms or urodynamic diagnoses of stress, urge or mixed incontinence including laparoscopic surgery in at least one arm of the trial were identified from the Cochrane Incontinence Review Group's Specialised Register of Controlled Trials. MAIN OUTCOME MEASURES: Subjective cure, objective cure, quality of life measurements and surgical outcome measures. RESULTS: Eight trials met the inclusion criteria. Five trials compared laparoscopic (n = 233) with open (n = 254) colposuspension. Risk of a positive stress test at follow up was significantly less in the open group (relative risk [RR] 0.89, 95% confidence interval [CI] 0.82 to 0.98). When one poor quality trial was excluded from the analysis, the relative risk was still less in the open group, but was no longer significant (RR 0.91, 95% CI 0.82 to 1.01). If considered as risk difference there is a 9% significantly higher risk of failure for laparoscopic colposuspension, however, excluding one poor quality trial, this risk of failure is non-significant at 8%. Analysis of subjective cure showed no difference between the groups. A trend was shown towards a higher complication rate, less post-operative pain, shorter hospital stay and time to return to normal function for laparoscopic compared with open colposuspension. Three trials compared different methods of laparoscopic colposuspension. Data from these trials could not be combined in view of the differences in the trials. Based on a single trial, two sutures were better than one. Sutures were as effective as mesh/staples. No conclusion could be drawn about the benefits of transperitoneal or extraperitoneal access. CONCLUSIONS: It is difficult to make valid conclusions as the evidence is limited by short term follow up and small numbers of trials and participants. However, it is possible that no difference exists between laparoscopic and open colposuspension for either objective or subjective cure. Further, well designed and adequately powered randomised controlled trials are required.

Female↗

Prompts to encourage appointment attendance for people with serious mental illness.

BACKGROUND: Prompts to encourage attendance at clinics are often used in day-to-day practice by diligent carers of people with mental health problems. These may take the form of telephone prompting, financial incentives or issuing a copy of the referral letter to the appointee. OBJECTIVES: To estimate the effects of simple prompting by professional carers to encourage attendance at clinics for those with serious mental illness. SEARCH STRATEGY: Methodical searches of Biological Abstracts (1985-2000), CINAHL (1982-2000), Cochrane Schizophrenia Group's Register (June 2000), Cochrane Library (Issue 2, 2000), EMBASE (1980-2000), MEDLINE (1966-2000) and PsycLIT (1887-2000) were undertaken. These were supplemented by searching of reference lists, personal contact and hand searching of high yield journals. SELECTION CRITERIA: All relevant randomised (or quasi-randomised) studies comparing the addition of 'prompts' to standard care for those with serious mental illnesses such as schizophrenia. Prompts had the stated purpose of encouraging attendance or contact with mental health teams and could be text-based, electronic, by telephone call, by personal visit, or could employ financial or other rewards. DATA COLLECTION AND ANALYSIS: Studies and data were independently selected and extracted. For homogeneous dichotomous data the random effects relative risk (RR), the 95% confidence intervals (CI) and, where appropriate, the number needed to treat (NNT) were calculated on an intention-to-treat basis. For continuous data the reviewers calculated weighted mean differences. MAIN RESULTS: Only three relevant trials were identified (total n=597). It is not clear whether there is any real difference between attendance of those prompted by telephone one or two days before the appointment, and those given the standard appointment management system (2 trials, n=457, RR missed appointment 0.84 CI 0.7 to 1.1). Text-based prompts, a few days before the appointment day, did increase clinic attendance when compared with no prompt (2 trials, n=200, RR missed appointment 0.6 CI 0.4 to 0.9, NNT 6 CI 2 to 14). Only one small study (n=61) reported data on the combination of telephone and text-based prompts versus no prompt (RR missed appointments 0.7 CI 0.4 to 1.2). When telephone prompts were compared with text-based prompts (1 trial, n=75), the latter, in the form of an 'orientation statement' (a short paragraph, taking about 30 seconds to read, explaining the programme of care, the fee system, and providing gentle encouragement) may be somewhat more effective than the telephone prompt (RR missed appointments 1.9 CI 0.98 to 3.8). One last study (n=120) compared a standard letter prompt with a letter 'orientation statement'. Overall, results tended to favour the orientation statement approach rather than the simple letter prompting attendance but the results did not reach conventional levels of statistical significance (RR missed appointments 1.6 CI 0.9 to 2.9). REVIEWER'S CONCLUSIONS: There is evidence that a simple prompt to attend clinic, very close to the time of the appointment may encourage attendance, and a simple orientation-type letter, 24 hours before the clinic appointment, may be more effective than a telephone prompt. This simple intervention could be a more cost effective means of encouraging compliance at first attendance, but supplementing these data with the results of large, well designed, conducted and reported randomised studies would be desirable.

Appointments and Schedules↗

Exercise therapy for chronic fatigue syndrome.

BACKGROUND: Chronic fatigue syndrome (CFS) is an illness characterised by persistent medically unexplained fatigue. CFS is a serious health-care problem with a prevalence of up to 3%. Treatment strategies for CFS include psychological, physical and pharmacological interventions. OBJECTIVES: To investigate the relative effectiveness of exercise therapy and control treatments for CFS. SEARCH STRATEGY: CCDANCTR-Studies and CENTRAL were searched using "Chronic Fatigue" and Exercise. The Journal of Chronic Fatigue Syndrome and CFS conferences were handsearched. Experts in the field were contacted. Clinicaltrials.gov and controlled-trials.com were searched. SELECTION CRITERIA: Only Randomised Controlled Trials (RCT) including participants with a clinical diagnosis of CFS and of any age were included. DATA COLLECTION AND ANALYSIS: The full articles of studies identified were inspected by two reviewers (ME and HMG). Continuous measures of outcome were combined using standardised mean differences. An overall effect size was calculated for each outcome with 95% confidence intervals. One sensitivity analysis was undertaken to test the robustness of the results. MAIN RESULTS: Nine studies were identified for possible inclusion in this review, and five of those studies were included. At 12 weeks, those receiving exercise therapy were less fatigued than the control participants (SMD -0.77, 95% CIs -1.26 to -0.28). Physical functioning was significantly improved with exercise therapy group (SMD -0.64, CIs -0.96 to -0.33) but there were more dropouts with exercise therapy (RR 1.73, CIs 0.92 to 3.24). Depression was non-significantly improved in the exercise therapy group compared to the control group at 12 weeks (WMD -0.58, 95% CIs -2.08 to 0.92). Participants receiving exercise therapy were less fatigued than those receiving the antidepressant fluoxetine at 12 weeks (WMD -1.24, 95% CIs -5.31 to 2.83). Participants receiving the combination of the two interventions, exercise + fluoxetine, were less fatigued than those receiving exercise therapy alone at 12 weeks, although again the difference did not reach significance (WMD 3.74, 95% CIs -2.16 to 9.64). When exercise therapy was combined with patient education, those receiving the combination were less fatigued than those receiving exercise therapy alone at 12 weeks (WMD 0.70, 95% CIs -1.48 to 2.88). REVIEWERS' CONCLUSIONS: There is encouraging evidence that some patients may benefit from exercise therapy and no evidence that exercise therapy may worsen outcomes on average. However the treatment may be less acceptable to patients than other management approaches, such as rest or pacing. Patients with CFS who are similar to those in these trials should be offered exercise therapy, and their progress monitored Further high quality randomised studies are needed.

Depression↗

[Pool exercise therapy of rheumatoid arthritis].

Aquatic therapy is a subgroup of balneotherapy and consists of exercises in a hot water pool. It uses the physical properties of water to achieve better mobility for patients whose pain, lack of muscle strength, and joint deformities are inhibiting factors when exercising on land. Pool therapy shows positive effects as part of the treatment of rheumatoid arthritis patients, but too few studies with an acceptable design and a well-defined patient group have been carried out. The documentation available on aquatic therapy indicates that more large clinical, controlled, and randomised studies must be conducted.

Arthritis, Rheumatoid↗

Haloperidol versus placebo for schizophrenia.

BACKGROUND: Haloperidol was developed in the late 1950s for use in the field of analgesia. Research subsequently demonstrated effects on hallucinations, delusions, aggressiveness, impulsiveness and states of excitement and led to the introduction of haloperidol as an antipsychotic. OBJECTIVES: To evaluate the clinical effects of haloperidol for the management of schizophrenia and other similar serious mental illnesses compared to placebo. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1985-1998), CINAHL (1982-1998), The Cochrane Library (1998, Issue 4), The Cochrane Schizophrenia Group's Register (December 2000), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1998), and SCISEARCH (January 1974-December 1998) were undertaken. References of all identified studies were searched for further trial citations. Authors of trials and pharmaceutical companies were contacted for further information and archive material. SELECTION CRITERIA: All relevant randomised controlled trials comparing use of haloperidol (any dose) with placebo for those with schizophrenia or other similar serious, non-affective psychotic illnesses (however diagnosed). The main outcomes of interest were death, loss to follow up, clinical and social response, relapse and severity of adverse effects. DATA COLLECTION AND ANALYSIS: Reviewers evaluated data independently and analysed on an intention-to-treat basis, assuming that people who left the study early, or were lost to follow up, had no improvement. Where possible and appropriate, dichotomous data were analysed using relative risk (RR) and their 95% confidence intervals (CI) calculated. If appropriate, the number needed to treat (NNT) or number needed to harm (NNH) was estimated. For continuous data, weighted mean differences were calculated. Continuous data were excluded if loss to follow up was greater than 50%. All data were inspected for heterogeneity. MAIN RESULTS: Seventy-four trials were identified but only 20 included. More people allocated to haloperidol improved in the first six weeks of treatment than those given placebo (three trials, n=159, RR failing to produce a marked improvement 0.44 CI 0.3 to 0.6, NNT 3 CI 2 to 5). A further eight trials (n=313) also found a difference favouring haloperidol across the 6-24 week period (RR no marked global improvement 0.68 CI 0.6 to 0.8 NNT 3 CI 2.5 to 5) but this may be an overestimate of effect as small negative studies were not identified. About half of those entering studies failed to complete the short trials, although, at 0-6 weeks, 10 studies found a difference that favoured haloperidol (n=686, RR 0.82 CI 0.7 to 0.95, NNT 8 CI 5 to 17). Limited adverse effect data do, nevertheless, support the clinical impression that haloperidol is a potent cause of movement disorders, at least in the short term. Haloperidol promotes acute dystonia (three trials, n=135, RR 4.7 CI 1.7 to 44, NNH 5 CI 3 to 9 - not assuming those who left early from placebo suffered dystonis), akathisia (three trials, n=129, RR 6.5 CI 1.5 to 28, NNH 6 CI 4 to 14) and parkinsonism (four trials, n=165, RR 8.9 CI 2.6 to 31, NNH 3 CI 2 to 5). REVIEWER'S CONCLUSIONS: Haloperidol is a potent antipsychotic drug but with a high propensity to cause adverse effects. Given no choice of drug, use of haloperidol to counter the damaging and potentially dangerous consequences of untreated schizophrenia is justified. If a choice of drug is available, however, people with schizophrenia and clinicians may wish to start another antipsychotic with less likelihood of causing parkinsonism, akathisia and acute dystonias. For countries where haloperidol is not widely used, it should not be a control drug of choice for randomised trials of new antipsychotics.

Antipsychotic Agents↗

Haloperidol versus placebo for schizophrenia.

BACKGROUND: Haloperidol was developed in the late 1950s for use in the field of anaesthesia. Research subsequently demonstrated effects on hallucinations, delusions, aggressiveness, impulsiveness and states of excitement and led to the introduction of haloperidol as an antipsychotic. OBJECTIVES: To evaluate the clinical effects of haloperidol for the management of schizophrenia and other similar serious mental illnesses compared to placebo. SEARCH STRATEGY: We initially electronically searched the databases of Biological Abstracts (1985-1998), CINAHL (1982-1998), The Cochrane Library (1998, Issue 4), The Cochrane Schizophrenia Group's Register (December 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1998), and SCISEARCH. We also checked references of all identified studies for further trial citations and contacted the authors of trials and pharmaceutical companies for further information and archive material. For the 2005 update we searched The Cochrane Library (2005, Issue 6). SELECTION CRITERIA: We included all relevant randomised controlled trials comparing the use of haloperidol (any oral dose) with placebo for those with schizophrenia or other similar serious, non-affective psychotic illnesses (however diagnosed). Our main outcomes of interest were death, loss to follow up, clinical and social response, relapse and severity of adverse effects. DATA COLLECTION AND ANALYSIS: We evaluated data independently and analysed on an intention-to-treat basis, assuming that people who left the study early, or were lost to follow-up, had no improvement. Where possible and appropriate, we analysed dichotomous data using Relative Risk (RR) and calculated their 95% confidence intervals (CI). If appropriate, the number needed to treat (NNT) or number needed to harm (NNH) was estimated. For continuous data, we calculated weighted mean differences. We excluded continuous data if loss to follow up was greater than 50% and inspected data for heterogeneity. MAIN RESULTS: Twenty-one trials randomising 1519 people are now included in this review. One new trial, Kane 2002 (n=414) has been added but it did not affect the overall results. More people allocated haloperidol improved in the first six weeks of treatment than those given placebo (3RCTs n=159, RR failing to produce a marked improvement 0.44 CI 0.3 to 0.6, NNT 3 CI 2 to 5). A further eight trials also found a difference favouring haloperidol across the 6-24 week period (8 RCTs n=308 RR no marked global improvement 0.68 CI 0.6 to 0.8 NNT 3 CI 2.5 to 5) but this may be an over estimate of effect as small negative studies were not identified. About half of those entering studies failed to complete the short trials, although, at 0-6 weeks, 11 studies found a difference that marginally favoured haloperidol (11 RCTs n=898, RR 0.8 CI 0.7 to 0.9, NNT 59 CI 38 to 200). Adverse effect data does, nevertheless, support clinical impression, that haloperidol is a potent cause of movement disorders, at least in the short term. Haloperidol promotes acute dystonia (3 RCTs n=93, RR 4.7 CI 1.7 to 44, NNH 5 CI 3 to 9), akathisia (4 RCTs n=333, RR 2.6 CI 1.4 to 4.8, NNH 7 CI 3 to 25) and parkinsonism (4 RCTs n=163, RR 11.7 CI 2.9 to 47, NNH 3 CI 2 to 5). AUTHORS' CONCLUSIONS: Haloperidol is a potent antipsychotic drug but has a high propensity to cause adverse effects. Where there is no treatment option, use of haloperidol to counter the damaging and potentially dangerous consequences of untreated schizophrenia is justified. However, where a choice of drug is available, people with schizophrenia and clinicians may wish to prescribe an alternative antipsychotic with less likelihood of adverse effects such as parkinsonism, akathisia and acute dystonias. Haloperidol should not be a control drug of choice for randomised trials of new antipsychotics.

Antipsychotic Agents↗

Surgical interventions for bilateral congenital cataract.

BACKGROUND: Congenital cataracts are opacities of the lens in one or both eyes of children, causing a reduction in vision bad enough to require surgery. Cataract is the largest preventable cause of visual loss in childhood. Paediatric cataracts provide different challenges to those in adults. Intense inflammation, amblyopia and posterior capsule opacification can affect results of treatment. Two treatments commonly considered for congenital cataract are lensectomy and lens aspiration. OBJECTIVES: The objective of this review is to assess the effects of surgical treatments for bilateral symmetrical congenital cataracts. Success is measured according to the vision attained and occurrence of adverse events. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register - CENTRAL (which includes the Cochrane Eyes and Vision Group specialised register), MEDLINE, EMBASE, the Science Citation Index and the reference list of the included study. We also contacted trial investigators and experts in the field for details of further studies. SELECTION CRITERIA: We included all prospective, randomised controlled trials that compared one type of cataract surgery to another or to no surgery, in children aged 15 years or younger with bilateral congenital cataracts. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data. No meta-analysis was performed. MAIN RESULTS: One trial met the inclusion criteria. This trial randomised 130 eyes of 65 children. Follow up of 56 children at three years found no difference in visual acuity between lensectomy and lens aspiration with primary capsulotomy. Secondary opacification developed at a higher rate in the lens aspiration group (66%) compared to the lensectomy group (2%). REVIEWER'S CONCLUSIONS: The two methods of surgery for bilateral congenital cataracts in this review have good visual results but the incidences of side effects differ. Further randomised trials are required to inform modern practice.

Cataract↗