Bernardo Go Soares

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 METHODS: 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Library, EMBASE, MEDLINE, and LILACS (to may 2006); reference searching; personal communication; conference abstracts; unpublished trials from pharmaceutical industry; book chapters on treatment of psychostimulants abuse/ dependence.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. Language: en

Amisulpride for schizophrenia.

BACKGROUNDnThe treatment of schizophrenia with old, typical antipsychotic drugs such as haloperidol can be problematic, because many people treated with these drugs will suffer from movement disorders. Amisulpride is said to be an atypical antipsychotic which induces less movement disorder and which is effective for the negative symptoms of schizophrenia.nnnOBJECTIVESnTo evaluate the effects of amisulpride as compared with placebo, typical and atypical antipsychotic drugs for schizophrenia.nnnSEARCH STRATEGYnThe authors carried out electronic searches of Biological Abstracts (1982-1999), CINAHL (1982-1999), Cochrane Library (Issue 4, 1999), Cochrane Schizophrenia Groups Register (November 2000), EMBASE (1980-1999), LILACS(1982-1999), MEDLINE (1966-1999) and PsycLIT (1974-1999). They checked all identified studies for further trial citations, and sought these studies in the Science Citation Index. They also contacted authors of trials and the manufacturer of amisulpride.nnnSELECTION CRITERIAnAll randomised controlled trials comparing amisulpride to placebo, typical or atypical antipsychotic drugs for schizophrenia or other non-affective serious mental illnesses.nnnDATA COLLECTION AND ANALYSISnData were independently extracted and analysed on an intention-to-treat basis. The relative risk (RR) and 95% confidence intervals (CI) of dichotomous data were calculated using a random effects model, and, where possible, the number needed to treat was calculated. Weighted mean differences (WMD) were calculated for continuous data.nnnMAIN RESULTSnThis review currently includes 19 randomised studies with a total of 2443 participants. Most trials were of short duration. Data from 4 trials with 514 participants with predominantly negative symptoms suggest that low-dose (up to 300mg/day) amisulpride was a more acceptable treatment than placebo (n=514, RR 0.6 CI 0.5 to 0.8, NNT 3 CI 3 to 7), the improvement of the participants global state (n=242, RR 0.6 CI 0.5 to 0.8, NNT 3 CI 2 to 6) and the treatment of negative symptoms (n=177, WMD -10.1 CI -16.6 to -3.5). Amisulpride was shown to be more likely to cause extrapyramidal symptoms than placebo in two studies (n=269, RR 2.2 CI 1.2 to 4.2), but this result did not hold calculating the risk reduction so that an NNT-statistic could not be indicated. Compared to typical antipsychotics, the pooled results of a total of fourteen trials suggest that amisulpride was more effective in improving global state (n=651, RR 0.7 CI 0.5 to 0.9, NNT 6 CI 4 to 11), the general mental state (n=695, WMD -4.2 CI -6.5 to -1.9) and the negative symptoms of schizophrenia (n=506, WMD -2.8 CI -4.3 to -1.3). Regarding positive symptoms, amisulpride was as effective as typical antipsychotics. Amisulpride was less prone to cause at least one general adverse event (n=751, RR 0.9 CI 0.8 to 0.97, NNH 9 CI 6 to 18), one extrapyramidal symptom (n=771, RR 0.7 CI 0.6 to 0.9, NNH 5 CI 4 to 9) or to require the use of antiparkinson medication (n=851, RR 0.6 CI 0.5 to 0.8, NNH 4 CI 3 to 6). No clear differences in other adverse events compared to typical drugs were found. Amisulpride also seemed to be more acceptable than conventional drugs as measured by the outcome leaving the studies early (n=1512, RR 0.8 CI 0.7 to 0.9, NNT 16 CI 9 to 69) than conventional drugs, but this result might have been overestimated due to a publication bias which could not be excluded with certainty. A single trial compared amisulpride to another atypical antipsychotic, risperidone. With the exception of agitation, which was more frequent in the amisulpride group (n=228, RR 3.4 CI 1.2 to 10.1, NNH 11 CI 6 to 50) no significant differences were recorded on efficacy or acceptability.nnnREVIEWERS CONCLUSIONSnThis systematic review confirms that amisulpride is an effective atypical antipsychotic drug for those with schizophrenia. Amisulpride may offer a good general profile, at least compared to high-potency typical antipsychotics. It may also yield better results in some specific outcomes related to efficacy, such as improvement of global state and general negative symptoms. It might be more acceptable and more tolerable than high-potency conventional antipsychotics, especially regarding extrapyramidal side-effects. Longer term randomised trials are needed to evaluate the comparative value of amisulpride, particularly compared to other expensive atypical antipsychotics. These should focus on important outcomes which have not been sufficiently monitored such as service use, family burden and quality of life.

Sulpiride for schizophrenia

BACKGROUNDnThe antipsychotic drug sulpiride was formulated over 20 years ago and was marked as having a low incidence of adverse effects and an effect on the negative symptoms of schizophrenia. This relatively inexpensive antipsychotic drug has a similar neuropharmacological profile to several novel atypical drugs.nnnOBJECTIVESnTo estimate the clinical efficacy and tolerability of sulpiride.nnnSEARCH STRATEGYnElectronic searches of Biological Abstracts (1982-1997), CINAHL (1982-1998), Cochrane Schizophrenia Groups Register (March 1998), Cochrane Library (Issue 1, 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1997), SIGLE (1994-1998), and Sociofile (1974-1997) were supplemented by reference searching, contacting authors and the manufacturers of sulpiride.nnnSELECTION CRITERIAnAll randomised or quasi-randomised clinical trials focusing on the use of different doses of sulpiride or comparing sulpiride to (i) placebo; (ii) typical antipsychotic drugs; or (iii) atypical antipsychotic drugs, for those with schizophrenia or serious mental illness were selected.nnnDATA COLLECTION AND ANALYSISnTrials were reliably selected and quality rated. Data were independently extracted, by two reviewers (BGOS, MF), and analysed on an intention-to-treat basis. It was assumed that people who did not complete the follow up had no improvement. Authors of trials were contacted for additional and missing data. Relative risk (RR) and 95% confidence intervals (CI) of dichotomous data were calculated with the random effects model and weighted mean difference (WMD) was calculated for continuous data.nnnMAIN RESULTSnThe review currently includes 18 studies (30 citations). Studies are generally small and of poor quality. Limited evidence suggests that there is little difference between sulpiride and other drugs although the incidence of side effects may be less for sulpiride. There are no clear findings relating to negative symptoms.nnnREVIEWERS CONCLUSIONSnSulpiride may be an effective antipsychotic drug but evidence is limited and data relating to claims for its value against negative symptoms is not trial-based.

Sulpiride augmentation for schizophrenia.

BACKGROUNDnSulpiride may be used in combination with other antipsychotic drugs in the hope of augmenting effectiveness - especially for those whose schizophrenia has proved resistant to treatment.nnnOBJECTIVESnTo evaluate the effects of sulpiride augmentation versus monotherapy for people with schizophrenia.nnnSEARCH STRATEGYnWe searched the Cochrane Schizophrenia Group Trials Register (July 2009) which is based on regular searches of CINAHL, EMBASE, MEDLINE and PsycINFO.nnnSELECTION CRITERIAnAll relevant randomised clinical trials (RCTs).nnnDATA COLLECTION AND ANALYSISnWe extracted data independently. For dichotomous data we calculated relative risks (RR) and their 95% confidence intervals (CI) based on a fixed-effect model. For continuous data, we calculated weighted mean differences (WMD) again based on a fixed-effect model.nnnMAIN RESULTSnWe included three short-term and one long-term trial (total N=221). All participants had schizophrenia that was either treatment-resistant or with prominent negative symptoms. All studies compared sulpiride plus clozapine with clozapine (+/- placebo), were small and at considerable risk of bias.Short-term data of no clinically significant response in global state tended to favour sulpiride augmentation of clozapine compared with clozapine alone (n=193, 3 RCTs, RR 0.58 CI 0.3 to 1.09).People allocated to sulpiride plus clozapine had more movement disorders (n=70, 1 RCT, RR 48.24 CI 3.05 to 762.56) and an increase in serum prolactin (skewed data, 1 RCT), but less incidence of hypersalivation (n=162, 3 RCTs, RR 0.49 CI 0.29 to 0.83) and less weight gain (n=64, 1 RCT, RR 0.30 CI 0.09 to 0.99). The augmentation of clozapine by sulpiride also caused less appetite loss (n=70, 1 RCT, RR 0.09 CI 0.01 to 0.70, NNT 4 CI 4 to 12, Z=2.31, P=0.02) and less abdominal distension (n=70, 1 RCT, RR 0.10 CI 0.01 to 0.78, NNT 5 CI 4 to 19, Z=2.20, P=0.03).Long-term data showed no significant difference in global state (n=70, 1 RCT, RR 0.67 CI 0.42 to 1.08) and relapse (n=70, 1 RCT, RR 0.85 CI 0.5 to 1.3).nnnAUTHORS CONCLUSIONSnSulpiride plus clozapine is probably more effective than clozapine alone in producing clinical improvement in some people whose illness has been resistant to other antipsychotic drugs including clozapine. However, much more robust data are needed.

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

BACKGROUNDnInjuries 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.nnnOBJECTIVESnTo determine the effectiveness and safety of surgical and conservative interventions for PCL injuries in adults.nnnSEARCH METHODSnWe searched the Cochrane Bone, Joint and Muscle Trauma 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.nnnSELECTION CRITERIAnRandomized or quasi-randomized clinical trials comparing various methods of operative and conservative interventions, and comparisons with each other for the treatment of PCL injuries.nnnDATA COLLECTION AND ANALYSISnReferences found with the search strategy were evaluated independently by two review authors.nnnMAIN RESULTSnNo randomized or quasi-randomized controlled studies meeting the selection criteria were identified.nnnAUTHORS CONCLUSIONSnFuture 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.

Exercise interventions for shoulder dysfunction in patients treated for head and neck cancer

BACKGROUNDnShoulder dysfunction is a common problem in patients treated for head and neck cancer. Both neck dissections and radiotherapy can cause morbidity to the shoulder joint. Exercise interventions have been suggested as a treatment option for this population.nnnOBJECTIVESnTo evaluate the effectiveness and safety of exercise interventions for the treatment of shoulder dysfunction caused by the treatment of head and neck cancer.nnnSEARCH METHODSnWe searched the Cochrane ENT Group Trials Register; CENTRAL; PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the search was 7 July 2011.nnnSELECTION CRITERIAnRandomized controlled trials (RCTs) comparing any type of exercise therapy compared with any other intervention in patients with shoulder dysfunction due to treatment of head and neck cancer.nnnDATA COLLECTION AND ANALYSISnTwo review authors independently selected trials, assessed risk of bias and extracted data from studies. We contacted study authors for information not provided in the published articles.nnnMAIN RESULTSnThree trials involving 104 people were included. We classified one study as having low risk of bias; the others had some limitations and we classified them as having high risk of bias.Two studies (one with low risk of bias and the other with high risk of bias) applied progressive resistance training (PRT) combined with range of motion exercises and stretching; the comparison group received standard care. Pooled data demonstrated that PRT can improve shoulder pain (mean difference (MD) -6.26; 95% confidence interval (CI) -12.20 to -0.31) and shoulder disability (MD -8.48; 95% CI -15.07 to -1.88), both measured using the Shoulder Pain and Disability Index (SPADI) (range 0 to 100). Similarly, secondary outcomes were also improved: active range of motion for external rotation (MD 14.51 degrees; 95% CI 7.87 to 21.14), passive range of motion for abduction (MD 7.65 degrees; 95% CI 0.64 to 14.66), forward flexion (MD 6.20 degrees; 95% CI 0.69 to 11.71), external rotation (MD 7.17 degrees; 95% CI 2.20 to 12.14) and horizontal abduction (MD 7.34 degrees; 95% CI 2.86 to 11.83). Strength and resistance of scapular muscles was assessed in one study and the results showed a statistically significant benefit of PRT. The studies did not demonstrate a statistically significant difference in quality of life. Only two non-serious adverse events were described in the PRT group compared with none in the standard care group.One study with high risk of bias used a broad spectrum of techniques including free active exercises, stretching and postural care for a period of three months following surgery. This study did not demonstrate a difference between the exercise group and routine postoperative physiotherapy care in shoulder function and quality of life, but serious methodological limitations could explain this. No serious adverse events were reported.nnnAUTHORS CONCLUSIONSnLimited evidence from two RCTs demonstrated that PRT is more effective than standard physiotherapy treatment for shoulder dysfunction in patients treated for head and neck cancer, improving pain, disability and range of motion of the shoulder joint, but it does not improve quality of life. However, although statistically significant the measured benefits of the intervention may be small. Other exercise regimes were not shown to be effective compared to routine postoperative physiotherapy. Further studies which apply other exercise interventions in head and neck cancer patients in the early postoperative and radiotherapy period are needed, with long-term follow-up.

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 Groups 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.

Sulpiride Augmentation for Schizophrenia

Jijun Wang, Ichiro M. Omori, Mark Fenton, and Bernardo Soares Department of EEG Source Imaging, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, 600 Wan Ping NanRoad,Shanghai200030,Shanghai,China; CochraneSchizophreniaGroup,UniversityofNottingham,Nottingham,UK;Databaseof Uncertainties about the Effects of Treatments (DUETs), James Lind Initiative, Oxford, UK; Brazilian Cochrane Centre, Universidade Federal de Sao Paulo, Sao Paulo, Brazil