Intermittent versus continuous androgen suppression for prostatic cancer.

BACKGROUND: After lung cancer, prostate cancer is the most common cause of death among males. The aim of treatment is to prevent disease-related morbidity and mortality while minimizing intervention-related adverse events. Androgen suppression therapy (AST) to reduce circulating serum testosterone and disease progression is considered a mainstay of treatment for men with advanced prostate cancer. It has been increasingly utilized for early stage disease despite a lack of evidence of effectiveness. OBJECTIVES: Evaluate the effectiveness and safety of intermittent androgen suppression (IAS) compared to continuous androgen suppression for treating prostatic cancer. SEARCH STRATEGY: The following databases were searched to identify randomised or quasi-randomised, controlled trials comparing intermittent and continuous androgen suppression in the treatment of any stage of prostate cancer: the Cochrane Central Register of Controlled Trials; EMBASE and LILACS. SELECTION CRITERIA: Studies were included if they were randomised or quasi-randomized, and compare the effects of IAS versus CAS. DATA COLLECTION AND ANALYSIS: Two reviewers selected relevant trials, assessed methodological quality and extracted data. MAIN RESULTS: Five randomized studies involving 1382 patients were included in this review. All the included studies involved advanced (T3 or T4) prostate cancer, had relatively small populations, and were of short duration. Few events were reported and did not assess disease-specific survival or metastatic disease. Only one study (N = 77) evaluated biochemical outcomes. A subgroup analysis found no significant differences in biochemical progression (defined by the authors as PSA >/= 10 ng/mL) between IAS and CAS for Gleason scores 4 - 6, 7, and 8 - 10. For patients with a Gleason score > 6, reduction in biochemical progression favoured the IAS group (RR 0.10, 95% CI 0.01 to 0.67, P = 0.02). Studies primarily reported on adverse events. One trial (N = 43) found no difference in adverse effects (gastrointestinal, gynecomastia and asthenia) between IAS ( two events) and CAS (five events), with the exception of impotence, which was significantly lower in the IAS group (RR 0.72, 95% CI 0.56 to 0.92, P = 0.008). AUTHORS' CONCLUSIONS: Data from RCTs comparing IAS to CAS are limited by small sample size and short duration. There are no data for the relative effectiveness of IAS versus CAS for overall survival, prostate cancer-specific survival, or disease progression. Limited information suggests IAS may have slightly reduced adverse events. Overall, IAS was also as effective as CAS for potency, but was superior during the interval of cycles (96%).

Family interventions for bipolar disorder.

BACKGROUND: Pharmacological treatments are the principal intervention for bipolar disorder. Alone, however, they are not sufficient to control symptoms and maintain psychosocial functioning. Adjunctive psychosocial interventions may help to improve the patient's condition and the course of the illness. Family interventions are deserving of special attention, since they may help to relieve the burden of care borne by relatives and caregivers, which in turn may facilitate the task of supporting the patient. OBJECTIVES: The objective of this review was to investigate the effectiveness of family interventions in the treatment of bipolar disorder compared with no intervention and other forms of intervention. SEARCH STRATEGY: We searched the electronic databases CCDANRCT-Studies and CCDANCTR-References on 1/8/2007, CENTRAL (2006-3), MEDLINE (2006), EMBASE (2006) and LILACS (2006), and searched the reference lists of included studies. We also made personal contact with authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-randomised trials. Participants were people with bipolar disorder and their relatives or caregivers; family psychosocial interventions of any type were considered; primary outcomes were changes in the status of symptoms and relapse rates. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two review authors. Quality assessment of included studies was carried out. The findings were presented descriptively. Where there were sufficient studies, dichotomous data were combined using relative risk, and continuous data were combined using weighted mean difference, with their 95% CIs. MAIN RESULTS: Seven RCTs were included in the review, involving a total of 393 participants. All of the included studies assessed psychoeducational methods, and one study also assessed a type of systems psychotherapy. In all trials, participants continued to receive pharmacotherapy treatment. Due to the diversity of interventions, outcome measures and endpoints used across studies, it was not possible to perform meta-analyses for primary outcomes. Five studies compared a variety of family interventions, involving carers, families or spouses, against no intervention, with individual findings indicating no significant added effect for family interventions. Three studies compared one type or modality of family intervention against another family intervention, with inconsistent findings. AUTHORS' CONCLUSIONS: To date there is only a small and heterogeneous body of evidence on the effectiveness of family oriented approaches for bipolar disorder, and it is not yet possible to draw any definite conclusions to support their use as an adjunctive treatment for bipolar disorder. Further well designed RCTs should be a research priority.

Psychosocial interventions for cocaine and psychostimulant amphetamines related disorders.

BACKGROUND: The consumption of psychostimulants for non-medical reasons probably occurs because of their euphoriant and psychomotor-stimulating properties. Chronic consumption of these agents results in development of stereotyped behaviour, paranoia, and possibly aggressive behaviour. Psychosocial treatments for psychostimulant use disorder are supposed to improve compliance, and to promote abstinence. Evidence from randomised controlled trials in this subject needs to be summarised. OBJECTIVES: To conduct a systematic review of all RCTs on psychosocial interventions for treating psychostimulant use disorder. SEARCH STRATEGY: Electronic searches of Cochrane Library, EMBASE, MEDLINE, and LILACS (to may 2006); reference searching; personal communication; conference abstracts; unpublished trials from pharmaceutical industry; book chapters on treatment of psychostimulants abuse/ dependence. SELECTION CRITERIA: All randomised-controlled trials focusing on psychosocial interventions for treating psychostimulants abuse/ dependence. DATA COLLECTION AND ANALYSIS: Three authors extracted the data independently and Relative Risks, weighted mean difference and number needed to treat were estimated, when possible. The reviewers assumed that people who died or dropped out had no improvement (intention to treat analysis) and tested the sensitivity of the final results to this assumption. MAIN RESULTS: Twenty-seven randomised controlled studies (3663 participants) fulfilled inclusion criteria and had data that could be used for at least one of the main comparisons. There was a wide heterogeneity in the interventions evaluated: this did not allow to provide a summary estimate of effect and results cannot be summarised in a clear cut way. The comparisons between different type of Behavioural Interventions showed results in favour of treatments with some form of Contingency management in respect to both reducing drop outs and lowering cocaine use.. AUTHORS' CONCLUSIONS: Overall this review reports little significant behavioural changes with reductions in rates of drug consumption following an intervention. Moreover, with the evidence currently available, there are no data supporting a single treatment approach that is able to comprise the multidimensional facets of addiction patterns and to significantly yield better outcomes to resolve the chronic, relapsing nature of addiction, with all its correlates and consequences.

Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft.

BACKGROUND: Following coronary artery bypass graft (CABG), the main causes of postoperative morbidity and mortality are postoperative pulmonary complications, respiratory dysfunction and arterial hypoxemia. Incentive spirometry is a treatment technique that uses a mechanical device (an incentive spirometer) to reduce such pulmonary complications during postoperative care. OBJECTIVES: To assess the effects of incentive spirometry for preventing postoperative pulmonary complications in adults undergoing CABG. SEARCH STRATEGY: We searched CENTRAL on The Cochrane Library (Issue 2, 2004), MEDLINE (1966 to December 2004), EMBASE (1980 to December 2004), LILACS (1982 to December 2004), the Physiotherapy Evidence Database (PEDro) (1980 to December 2004), Allied & Complementary Medicine (AMED) (1985 to December 2004), CINAHL (1982 to December 2004), and the Database of Abstracts of Reviews of Effects (DARE) (1994 to December 2004). References were checked and authors contacted. No language restrictions were applied. SELECTION CRITERIA: Randomized controlled trials comparing incentive spirometry with any type of prophylactic physiotherapy for prevention of postoperative pulmonary complications in adults undergoing CABG. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated the quality of trials using the guidelines of the Cochrane Reviewers' Handbook and extracted data from included trials. MAIN RESULTS: Four trials with 443 participants contributed to this review. There was no significant difference in pulmonary complications (atelectasis and pneumonia) between treatment with incentive spirometry and treatment with positive pressure breathing techniques (continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and intermittent positive pressure breathing (IPPB)) or preoperative patient education. Patients treated with incentive spirometry had worse pulmonary function and arterial oxygenation compared with positive pressure breathing (CPAP, BiPAP, IPPB). AUTHORS' CONCLUSIONS: Individual small trials suggest that there is no evidence of benefit from incentive spirometry in reducing pulmonary complications and in decreasing the negative effects on pulmonary function in patients undergoing CABG. In view of the modest number of patients studied, methodological shortcomings and poor reporting of the included trials, these results should be interpreted cautiously. An appropriately powered trial of high methodological rigour is needed to determine those patients who may derive benefit from incentive spirometry following CABG.

Psychosocial interventions for erectile dysfunction.

BACKGROUND: Normal sexual function is a biopsychosocial process and relies on the coordination of psychological, endocrine, vascular, and neurological factors. Recent data show that psychological factors are involved in a substantial number of cases of erectile dysfunction (ED) alone or in combination with organic causes. However, in contrast to the advances in somatic research of erectile dysfunction, scientific literature shows contradictory reports on the results of psychotherapy for the treatment of ED. OBJECTIVES: To evaluate the effectiveness of psychosocial interventions for the treatment of ED compared to oral drugs, local injection, vacuum devices and other psychosocial interventions, that may include any psycho-educative methods and psychotherapy, or both, of any kind. SEARCH STRATEGY: The following databases were searched to identify randomised or quasi-randomised controlled trials: MEDLINE (1966 to 2007), EMBASE (1980 to 2007), psycINFO (1974 to 2007), LILACS (1980 to 2007), DISSERTATION ABSTRACTS (2007) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2007). Besides this electronic search cross checking the references of all identified trials, contact with the first author of all included trials was performed in order to obtain data on other published or unpublished trials. Handsearch of the International Journal of Impotence Research and Journal of Sex and Marital Therapy since its first issue and contact with scientific societies for ED completed the search strategy. SELECTION CRITERIA: All relevant randomised and quasi-randomised controlled trials evaluating psychosocial interventions for ED. DATA COLLECTION AND ANALYSIS: Authors of the review independently selected trials found with the search strategy, extracted data, assessed trial quality, and analysed results. For categorical outcomes the pooled relative risks (RR) were calculated, and for continuous outcomes mean differences between interventions were calculated as well. Statistical heterogeneity was addressed. MAIN RESULTS: Nine randomised (Banner 2000; Baum 2000; Goldman 1990; Kilmann 1987; Kockott 1975; Melnik 2005; Munjack 1984; Price 1981; Wylie 2003) and two quasi-randomised trials (Ansari 1976; Van Der Windt 2002), involving 398 men with ED (141 in psychotherapy group, 109 received medication, 68 psychotherapy plus medication, 20 vacuum devices and 59 control group) met the inclusion criteria. In data pooled from five randomised trials (Kockott 1975; Ansari 1976; Price 1981; Munjack 1984; Kilmann 1987), group psychotherapy was more likely than the control group (waiting list - a group of participants who did not receive any active intervention) to reduce the number of men with "persistence of erectile dysfunction" at post-treatment (RR 0.40, 95% CI 0.17 to 0.98, N = 100; NNT 1.61, 95% CI 0.97 to 4.76). At six months follow up there was continued maintenance of reduction of men with "persistence of ED" in favour of group psychotherapy (RR 0.43, 95% CI 0.26 to 0.72, N = 37; NNT 1.58, 95% CI 1.17 to 2.43). In data pooled from two randomised trials (Price 1981; Kilmann 1987), sex-group psychotherapy reduced the number of men with "persistence of erectile dysfunction" in post-treatment (RR 0.13, 95% CI 0.04 to 0.43, N = 37), with a 95% response rate for sex therapy and 0% for the control group (waiting list - no treatment) (NNT 1.07, 95% CI 0.86 to 1.44). Treatment response appeared to vary between patient subgroups, although there was no significant difference in improvement in erectile function according to mean group age, type of relationship, and severity of ED. In two trials (Melnik 2005; Banner 2000) that compared group therapy plus sildenafil citrate versus sildenafil, men randomised to receive group therapy plus sildenafil showed significant reduction of "persistence of ED" (RR 0.46, 95% CI 0.24 to 0.88; NNT 3.57, 95% CI 2 to 16.7, N = 71), and were less likely than those receiving only sildenafil to drop out (RR 0.29, 95% CI 0.09 to 0.93). One small trial (Melnik 2005) directly compared group therapy and sildenafil citrate. It found a significant difference favouring group therapy versus sildenafil in the mean difference of the IIEF (WMD -12.40, 95% CI -20.81 to -3.99, N = 20). No differences in effectiveness were found between psychosocial interventions versus local injection and vacuum devices. AUTHORS' CONCLUSIONS: There was evidence that group psychotherapy may improve erectile function. Treatment response varied between patient subgroups, but focused sex-group therapy showed greater efficacy than control group (no treatment). In a meta-analysis that compared group therapy plus sildenafil citrate versus sildenafil, men randomised to receive group therapy plus sildenafil showed significant improvement of successful intercourse, and were less likely than those receiving only sildenafil to drop out. Group psychotherapy also significantly improved ED compared to sildenafil citrate alone. Regarding the effectiveness of psychosocial interventions for the treatment of ED compared to local injection, vacuum devices and other psychosocial techniques, no differences were found.

Dipyrone for acute primary headaches.

BACKGROUND: Dipyrone is used to treat headaches in many countries, but is not available in others (particularly the USA and UK) because of its association with potentially life-threatening blood dyscrasias such as agranulocytosis. OBJECTIVES: To determine the effectiveness and safety of dipyrone for acute primary headaches in adults and children. SEARCH STRATEGY: We searched the Cochrane Pain, Palliative & Supportive Care Group's Trials Register; the Cochrane Central Register of Controlled Trials; MEDLINE; EMBASE; LILACS, and the reference lists of included studies. SELECTION CRITERIA: Double-blind randomised controlled trials of dipyrone for the symptomatic relief of acute primary headaches in adults and children. DATA COLLECTION AND ANALYSIS: Three authors independently screened articles, extracted data, assessed trial quality and analysed results. Relative risks (RRs), risk differences (RDs), weighted mean differences (WMDs), and numbers-needed-to-treat (NNTs) were calculated as appropriate. MAIN RESULTS: Four trials involving a total of 636 adult subjects were included. Methodological quality was generally high. One study each evaluated oral and intravenous dipyrone for episodic tension-type headache (ETTH); two trials evaluated intravenous dipyrone for migraine, but only one of these described pain outcomes. No pediatric trials were identified. The largest trial (n = 356) evaluated two doses (0.5 g, 1 g) of oral dipyrone for ETTH, which were significantly better than placebo for pain relief. The 1 g dose was also significantly better than acetylsalicylic acid (ASA) 1 g . A smaller trial (n = 60) evaluated intravenous dipyrone 1 g versus placebo for ETTH. RRs were statistically significant favouring dipyrone for pain-free and headache improvement outcomes. Finally, one trial (n = 134) evaluated intravenous dipyrone 1 g versus placebo for pain outcomes in patients with migraine. RRs were again statistically significant favouring dipyrone for pain-free and headache improvement outcomes. Two of the four trials assessed adverse events. No serious adverse events were reported, and no significant differences in adverse events were detected between dipyrone and comparators (placebo and ASA). AUTHORS' CONCLUSIONS: Evidence from a small number of trials suggests that dipyrone is effective for ETTH and migraine. No serious adverse events were observed in the included trials, but agranulocytosis is rare and would probably not be observed in such a relatively small sample. A study now ongoing in Latin America may clarify the true risk of agranulocytosis associated with dipyrone use.

Passiflora for anxiety disorder.

BACKGROUND: Anxiety is a very common mental health problem in the general population and in the primary care setting. Herbal medicines are popularly used worldwide and could be an option for treating anxiety if shown to be effective and safe. Passiflora (passionflower extract) is one of these compounds. OBJECTIVES: To investigate the effectiveness and safety of passiflora for treating any anxiety disorder. SEARCH STRATEGY: The following sources were used: electronic databases: Cochrane Collaboration Depression, Anxiety and Neurosis Cochrane Controlled Trials Register (CCDANCTR-Studies), Medline and Lilacs; Cross-checking references; contact with authors of included studies and manufacturers of passiflora. SELECTION CRITERIA: Relevant randomised and quasi-randomised controlled trials of passiflora using any dose, regime, or method of administration for people with any primary diagnosis of general anxiety disorder, anxiety neurosis, chronic anxiety status or any other mental health disorder in which anxiety is a core symptom (panic disorder, obsessive compulsive disorder, social phobia, agoraphobia, other types of phobia, postraumatic stress disorder). Effectiveness was measured using clinical outcome measures such as Hamilton Anxiety Scale (HAM-A) and other scales for anxiety symptoms. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the trials found through the search strategy, extracted data, performed the trial quality analyses and entered data. Where any disagreements occured, the third reviewer was consulted. Methodological quality of the trials included in this review was assessed using the criteria described in the Cochrane Handbook. For dichotomous outcomes, relative risk with 95% confidence intervals (CI) were calculated, and for continuous outcomes, weighted mean difference with 95%CI was used. MAIN RESULTS: Two studies, with a total of 198 participants, were eligible for inclusion in this review. Based on one study, a lack of difference in the efficacy of benzodiazepines and passiflora was indicated. Dropout rates were similar between the two interventions. Although the findings from one study suggested an improvement in job performance in favour of passiflora (post-hoc outcome) and one study showed a lower rate of drowsiness as a side effect with passiflora as compared with mexazolam, neither of these findings reached statistical significance. AUTHORS' CONCLUSIONS: RCTs examining the effectiveness of passiflora for anxiety are too few in number to permit any conclusions to be drawn. RCTs with larger samples that compare the effectiveness of passiflora with placebo and other types of medication, including antidepressants, are needed.

Intragastric balloon for obesity.

BACKGROUND: Obesity is one of the major public health problems of modern society. Intragastric balloon (IGB) treatment for obesity has been developed as a temporary aid. Its primary objective is the treatment of obese people, who have had unsatisfactory results in their clinical treatment for obesity, despite of being cared for by a multidisciplinary team, and super obese patients with a higher surgical risk. However, the effects of different IGB procedures compared with conventional treatments and with each other are uncertain. OBJECTIVES: To assess the effects of intragastric balloon in people with obesity. SEARCH STRATEGY: Studies were obtained from computerised searches of MEDLINE, EMBASE, LILACS, The Cochrane Library and other electronic databases. Furthermore, reference lists of relevant articles and hand searches of selected journals were performed. Experts in the field were contacted. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials fulfilling the inclusion criteria were used. Short term weight loss is common, so studies were included if they reported measurements after a minimum of four weeks follow-up. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked independently by two reviewers. Two reviewers independently assessed the quality of trials. MAIN RESULTS: Nine randomised controlled trials involving 395 patients were included. Six out of nine studies had a follow-up of less than one year, the longest study duration was 24 months. Only a third of the analysed studies revealed a low risk of bias. No information was available on quality of life, all-cause mortality and morbidity. Compared with conventional management, IGB did not show convincing evidence of a greater weight loss. On the other hand, complications of intragastric balloon placement occurred, however few of a serious nature. The relative risks for minor complications like gastric ulcers and erosions were significantly raised. AUTHORS' CONCLUSIONS: Evidence from this review is limited for decision making, since there was large heterogeneity in IGB trials, regarding both methodological and clinical aspects. However, a co-adjuvant factor described by some authors in the loss and maintenance of weight has been the motivation and the encouragement to changing eating habits following a well-organized diet and a program of behavioural modification. The IGB alone and the technique of positioning appear to be safe. Despite the evidence for little additional benefit of the intragastric balloon in the loss of weight, its cost should be considered against a program of eating and behavioural modification.

Valerian for anxiety disorders.

BACKGROUND: Anxiety disorders are very common mental health problems in the general population and in primary care settings. Herbal medicines are popular and used worldwide and might be considered as a treatment option for anxiety if shown to be effective and safe. OBJECTIVES: To investigate the effectiveness and safety of valerian for treating anxiety disorders. SEARCH STRATEGY: Electronic searches: The Cochrane Collaboration Depression, Anxiety and Neurosis Cochrane Controlled Trials Register (CCDANCTR-Studies and CCDANCTR-References) searched on 04/08/2006, MEDLINE, Lilacs. References of all identified studies were inspected for additional studies. First authors of each included study, manufacturers of valerian products, and experts in the field were contacted for information regarding unpublished trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-randomised trials of valerian extract of any dose, regime, or method of administration, for people with any primary diagnosis of general anxiety disorder, anxiety neurosis, chronic anxiety status, or any other disorder in which anxiety is the primary symptom (panic disorder, obsessive compulsive disorder, social phobia, agoraphobia, other types of phobia, postraumatic stress disorder). Effectiveness was measured using clinical outcome measures and other scales for anxiety symptoms. DATA COLLECTION AND ANALYSIS: Two review authors independently applied inclusion criteria, extracted and entered data, and performed the trial quality assessments. Where disagreements occurred, the third review author was consulted. Methodological quality of included trials was assessed using Cochrane Handbook criteria. For dichotomous outcomes, relative risk (RR) was calculated, and for continuous outcomes, the weighted mean difference (WMD) was calculated, with their respective 95% confidence intervals. MAIN RESULTS: One RCT involving 36 patients wih generalised anxiety disorder was eligible for inclusion. This was a 4 week pilot study of valerian, diazepam and placebo. There were no significant differences between the valerian and placebo groups in HAM-A total scores, or in somatic and psychic factor scores. Similarly, there were no significant differences in HAM-A scores between the valerian and diazepam groups, although based on STAI-Trait scores, significantly greater symptom improvement was indicated in the diazepam group. There were no significant differences between the three groups in the number of patients reporting side effects or in dropout rates. AUTHORS' CONCLUSIONS: Since only one small study is currently available, there is insufficient evidence to draw any conclusions about the efficacy or safety of valerian compared with placebo or diazepam for anxiety disorders. RCTs involving larger samples and comparing valerian with placebo or other interventions used to treat of anxiety disorders, such as antidepressants, are needed.

Penfluridol for schizophrenia.

BACKGROUND: Penfluridol, available since 1970, is an unusual long acting oral antipsychotic agent for the treatment of schizophrenia. It may be considered a depot medication as it is administered once a week. OBJECTIVES: To review the effects of penfluridol for treatment of those with schizophrenia and schizophrenia-like illnesses in comparison to placebo, other antipsychotic medication or no intervention. SEARCH STRATEGY: We undertook electronic searches of the Cochrane Schizophrenia Group's Register (2005), the Cochrane Central Register of Controlled Trials (2003-5) and LILACS (1982-2005). We hand searched references of all identified studies and sought citations of these studies in the Science Citation Index. We contacted the authors of trials and the manufacturer of penfluridol. SELECTION CRITERIA: We reliably selected all randomised clinical trials comparing penfluridol to placebo or typical or atypical antipsychotic drugs for schizophrenia or serious mental illness. DATA COLLECTION AND ANALYSIS: We independently extracted and analysed data on an intention-to-treat basis. We calculated the relative risk (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data using a random effects model, and where possible calculated the number needed to treat. We calculated weighted mean differences (WMD) for continuous data. MAIN RESULTS: We included twenty-five studies with a total of 1024 participants. Most of these studies were undertaken in the 1970s when penfluridol was launched. Ten studies, with 365 patients, compared penfluridol to placebo. In the meta-analysis of medium-term lasting studies, penfluridol was superior to placebo in the main efficacy measures: 'improvement in global state' (n=159, 4 RCTs, RR 0.69 CI 0.6 to 0.8, NNT 3 CI 2 to 10) and 'needing additional antipsychotic' (n=138, 5 RCTs, RR 0.43 CI 0.2 to 0.8, NNT 3 CI 1.8 to 20).A total of 449 patients from eleven studies were randomised to penfluridol or oral typical antipsychotics. There were no particular differences between penfluridol versus chlorpromazine, fluphenazine, trifluoperazine, thioridazine, or thiothixene for the main outcome measures in medium-term trials: 'improvement on global state' (N=2 studies), 'leaving the study early' (N=6), 'needing additional antipsychotic' (N=3), needing antiparkinsonian medication (N=2), and side-effects. Six studies, with 274 patients, compared penfluridol to depot typical antipsychotics. In general, for the efficacy and safety measures, no differences were established, but penfluridol was superior in keeping the patients in treatment; 'leaving the study early' (n=218, 5RCTs, RR 0.55 CI 0.3 to 0.97, NNT 6 CI 3.4 to 50). AUTHORS' CONCLUSIONS: Although there are shortcomings and gaps in the data, there appears to be enough overall consistency for different outcomes. The efficacy and adverse effects profile of penfluridol are similar to other typical antipsychotics; both oral and depot. Furthermore, penfluridol is shown to be an adequate treatment option for people with schizophrenia, especially those who do not respond to oral medication on a daily basis and do not adapt well to depot drugs. One of the results favouring penfluridol was a lower drop out rate in medium term when compared to depot medications. It is also an option for chronic sufferers of schizophrenia with residual psychotic symptoms who nevertheless need continuous use of antipsychotic medication. An additional benefit of penfluridol is that it is a low-cost intervention.

Drugs for treating paracoccidioidomycosis.

BACKGROUND: Paracoccidioidomycosis is a fungal infection found in particular geographic localities in Latin America. Treatment can last for up to two years is often associated with complications, including relapse, but people may die without it. OBJECTIVES: To evaluate drugs used for treating paracoccidioidomycosis. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (January 2006), CENTRAL (The Cochrane Library 2005, Issue 4), PubMed (1966 to January 2006), EMBASE (1974 to January 2006), LILACS (1982 to January 2006), conference proceedings, and reference lists. We also contacted researchers and pharmaceutical companies. SELECTION CRITERIA: Randomized controlled trials comparing drugs for treating people with paracoccidioidomycosis. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial eligibility and methodological quality, and extracted data, including adverse events. MAIN RESULTS: One trial with 42 participants met the inclusion criteria that compared imidazoles (itraconazole and ketoconazole) with sulfadiazine. No difference was detected for cure or clinical improvement, or serological titres after 10 months of treatment, and there was no difference detected in adverse events. AUTHORS' CONCLUSIONS: The small number of participants and the short follow-up period impede definitive conclusions.

Interventions to promote the wearing of hearing protection.

BACKGROUND: Noise induced hearing loss can only be prevented by eliminating or lowering noise exposure levels. Where the source of the noise can not be eliminated workers have to rely on hearing protective equipment. Several trials have been conducted to study the effectiveness of interventions to influence the wearing of hearing protection and to decrease noise exposure. We aimed to establish whether interventions to increase the wearing of hearing protection are effective. OBJECTIVES: To summarise the evidence for the effectiveness of interventions to enhance the wearing of hearing protection among workers exposed to noise in the workplace. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2 2005), MEDLINE (1966 to June 2005), EMBASE (1980 to June 2005), NIOSHTIC, CISDOC, CINAHL, LILACS (1982 to June 2005) and Scientific Electronic Library Online. The date of the last search was June 2005. SELECTION CRITERIA: Studies were included if they had a randomised design, if they were among noise exposed (> 80 dB(A)) workers or pupils, if there was some kind of intervention to promote the wearing of hearing protection (compared to another intervention or no intervention), and if the outcome measured was the amount of use of hearing protection or a proxy measure thereof. DATA COLLECTION AND ANALYSIS: Two reviewers selected relevant trials, assessed methodological quality and extracted data. There were no cases where the pooling of data was appropriate. MAIN RESULTS: Two studies were found. One study was a two-phased randomised controlled trial. A computer-based intervention tailored to the risk of an individual worker lasting 30 minutes was not found to be more effective than a video providing general information among workers, around 80% of whom already used hearing protection. The second phase of the trial involved sending a reminder to the home address of participants at 30 days, 90 days or at both 30 and 90 days after the intervention, or no reminder. No significant differences in the mean use of hearing protection were found. A second randomised controlled trial evaluated the effect of a four year school based hearing loss prevention programme among pupils working at their parents farms (N=753) in a cluster randomised controlled trial. The intervention group was twice as likely to wear some kind of hearing protection as the control group that received only minimal intervention. All results are based on self reported use of hearing protection. AUTHORS' CONCLUSIONS: Limited evidence does not show whether tailored interventions are more or less effective than general interventions in workers, 80% of whom already use hearing protection. Long lasting school based interventions may increase the use of hearing protection substantially. These results are based on single studies only. Better interventions to enhance the use of hearing protection need to be developed and evaluated in order to increase the prevention of noise induced hearing loss among workers.

Interventions for treating posterior cruciate ligament injuries of the knee in adults.

BACKGROUND: Injuries of the posterior cruciate ligament (PCL) of the knee frequently occur in automobile accidents and sports injuries, although they are less frequent overall than injuries of the anterior cruciate ligament (ACL). Some patients show significant symptoms and subsequent articular deterioration, while others are essentially asymptomatic, maintaining habitual function. Management of PCL injuries remains controversial and prognosis can vary widely. Interventions extend from non-operative (conservative) procedures to reconstruction of the PCL, in the hope that the surgical procedure may have a positive effect in the reduction/prevention of future osteoarthritic changes in the knee. OBJECTIVES: To determine the effectiveness and safety of surgical and conservative interventions for PCL injuries in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group Specialised Register (April 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE via PubMed (1966 to April 2004), EMBASE (1966 to April 2004), CINAHL (1982 to April 2004), LILACS (1982 to April 2004), SportsDiscus (1975 to April 2004), and reference lists of articles. SELECTION CRITERIA: Randomized or quasi-randomized clinical trials comparing various methods of operative and conservative interventions, and comparisons with each other for the treatment of PCL injuries. DATA COLLECTION AND ANALYSIS: References found with the search strategy were evaluated independently by two review authors. MAIN RESULTS: No randomized or quasi-randomized controlled studies meeting the selection criteria were identified. AUTHORS' CONCLUSIONS: Future research should include randomized controlled trials of acute isolated PCL injuries, or PCL injuries when combined with other ligament injuries of the knee, treated operatively and conservatively. Adequate numbers of patients and an objective methodology for patient evaluation must be used in future studies of these interventions to determine the long-term results.

Interventions for tears of the rotator cuff in adults.

BACKGROUND: Tears of the rotator cuff tendons, which surround the joints of the shoulder, are one of the most common causes of pain and disability in the upper extremity. OBJECTIVES: To review the efficacy and safety of common interventions for tears of the rotator cuff in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised trail register (July 2002), the Cochrane Controlled Trials Register (The Cochrane Library issue 2, 2002), MEDLINE (1966 to December 2001), EMBASE (1974 to December 2001), Biological Abstracts (1980 to December 2001), LILACS (1982 to December 2001), CINAHL (November 1982 to December 2001), Science Citation Index and reference lists of articles. We also contacted authors and handsearched conference proceedings focusing on shoulder conditions. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials involving tears of the rotator cuff were the focus of this review. All trials involving conservative interventions or surgery were included (non-steroidal anti-inflammatory drugs, intra-articular or subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, and open or arthroscopic surgery). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed suitability for inclusion, methodological quality and extracted data. Dichotomous data were presented as relative risks (RR) and 95% confidence intervals (CI), using the fixed effects model. MAIN RESULTS: Eight trials involving 455 people were included and 393 patients analysed. Trials were grouped in eight categories of conservative or surgical treatment. The median quality score of all trials combined was 16 out of a possible 24 points, with a range of 12-18. In general, included trials differed on diagnostic criteria for rotator cuff tear, there was no uniformity in reported outcome measures, and data which could be summarised were rarely reported. Only results from two studies comparing open repair to arthroscopic debridement could be pooled. There is weak evidence for the superiority of open repair of rotator cuff tears compared with arthroscopic debridement. REVIEWER'S CONCLUSIONS: There is little evidence to support or refute the efficacy of common interventions for tears of rotator cuff in adults. As well as the need for further well designed clinical trials, uniform methods of defining interventions for rotator cuff tears and validated outcome measures are also essential.

Trifluoperazine for schizophrenia.

BACKGROUND: Trifluoperazine is an inexpensive accessible 'high potency' antipsychotic drug, widely used to treat schizophrenia or related psychoses. OBJECTIVES: To estimate the effects of trifluoperazine compared with placebo and other drugs. SEARCH STRATEGY: Searches of the Cochrane Schizophrenia Group's register of trials (March 2002), supplemented with hand searching, reference searching, personal communication and contact with industry. SELECTION CRITERIA: All clinical randomised trials involving people with schizophrenia and comparing trifluoperazine with any other treatment. DATA COLLECTION AND ANALYSIS: Studies were reliably selected and quality rated and data was extracted. For dichotomous data, relative risks (RR) were estimated, with 95% confidence intervals (CI). Where possible, we undertook intention-to-treat analyses. For statistically significant results, the number needed to treat (NNT) was calculated. We estimated heterogeneity (I-square technique) and publication bias. MAIN RESULTS: 1162 people from 13 studies were randomised to trifluoperazine or placebo. For global improvement, small short-term studies favoured trifluoperazine (n=95, 3 RCTs, RR 0.62 CI 0.49 to 0.78 NNT 3 CI 2 to 4). Loss to follow up was about 12% in both groups (n=280, 7 RCTs, RR 0.99 CI 0.62 to 1.57) and more people allocated trifluoperazine used antiparkinson drugs to alleviate movements disorders compared with placebo (n=195, 4 RCTs, RR 5.06 CI 2.49 to 10.27, NNH 4 CI 2 to 9). 2230 people from 49 studies were randomised to trifluoperazine or another older generation antipsychotic. Trifluoperazine was not clearly different in terms of 'no substantial improvement' (n=1016, 27 RCTs, RR 1.06 CI 0.98 to 1.14) or leaving the study early (n=930, 22 RCTs, RR 1.15 CI 0.83 to 1.58). Almost identical numbers of people reported at least one adverse event (60%) in each group (n=585, 14 RCTs, RR 0.99 CI 0.87 to 1.13), although trifluoperazine was more likely to cause extrapyramidal adverse effects overall when compared to low potency antipsychotics such as chlorpromazine (n=130, 3 RCTs, RR 1.66 CI 1.03 to 2.67, NNH 6 CI 3 to 121). One small study (n=38) found no clear differences between trifluoperazine and the atypical drug, sulpiride. REVIEWER'S CONCLUSIONS: Although there are shortcomings and gaps in the data, there appears to be enough consistency over different outcomes and periods to confirm that trifluoperazine is an antipsychotic of similar efficacy to other commonly used neuroleptics for people with schizophrenia. Its adverse events profile is similar to that of other drugs. It has been claimed that trifluoperazine is effective at low doses for patients with schizophrenia but this does not appear to be based on good quality trial based evidence.

Dopamine agonists for cocaine dependence.

BACKGROUND: 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: Electronic searches of Cochrane Library, EMBASE, MEDLINE, PsycLIT, Biological Abstracts and LILACS; reference searching; personal communication; conference abstracts; unpublished trials from pharmaceutical industry; book chapters on treatment of cocaine dependence, was performed for the primary version of this review in 2001. Another search of the electronic databases was done in December of 2002 for this update. The specialised register of trials of the Cochrane Group on Drugs and Alcohol was searched until February 2003. 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. 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: Seventeen studies were included, with 1224 participants randomised. Amantadine, bromocriptine, and pergolide were the drugs evaluated. The main outcomes evaluated were positive urine sample for cocaine metabolites, for efficacy, and retention in treatment, as an acceptability measure. There were no significant differences between interventions, and 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 other supportive measures aiming to keep patients in treatment.