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PubMed2005

Cephalic version by moxibustion for breech presentation.

BACKGROUND: Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin) to the acupuncture point Bladder 67 (BL67) (Chinese name Zhiyin), located at the tip of the fifth toe, has been proposed as a way of correcting breech presentation. As caesarean section is often suggested for breech babies due to the potential difficulties during labour, it is preferable to turn the baby before labour starts. OBJECTIVES: To examine the effectiveness and safety of moxibustion on changing the presentation of an unborn baby in the breech position, the need for external cephalic version (ECV), mode of birth, and perinatal morbidity and mortality for breech presentation. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (30 August 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2004), MEDLINE (1966 to March 2004), EMBASE (1980 to March 2004), CINAHL (1982 to March 2004), MIDIRS (1982 to March 2004), CISCOM (9 March 2004) and bibliographies of relevant papers. SELECTION CRITERIA: The inclusion criteria were published and unpublished randomised controlled trials comparing moxibustion (either alone or in combination with acupuncture) with a control group (no moxibustion), or other methods (e.g. external cephalic version, acupuncture) in women with a singleton breech presentation. DATA COLLECTION AND ANALYSIS: Both authors assessed eligibility and quality of trials independently. The outcome measures were baby's presentation at birth, need for external cephalic version, mode of birth, perinatal morbidity and mortality, maternal complications and maternal satisfaction, and adverse events. MAIN RESULTS: Three trials involving a total of 597 women were included. Due to differences in interventions and sample size it was not appropriate to perform a meta-analysis for the main outcome. Only one trial reported on other outcome measures relevant to this review. Moxibustion reduced the need for ECV (relative risk (RR) 0.47, 95% confidence interval (CI) 0.33 to 0.66) and resulted in decreased use of oxytocin before or during labour for women who had vaginal deliveries (RR 0.28, 95% CI 0.13 to 0.60). AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of moxibustion to correct a breech presentation. Moxibustion may be beneficial in reducing the need for ECV, and decreasing the use of ocytocin, however there is a need for well-designed randomised controlled trials to evaluate moxibustion for breech presentation which report on clinically relevant outcomes as well as the safety of the intervention.

Breech Presentation↗

PubMed2000

Carotid angioplasty and stenting.

The endovascular management of carotid artery disease is a rapidly developing area currently under evaluation in Europe and the US. The technique is a simple progression of those skills used in peripheral vessels and involves the percutaneous placement of a metallic stent. Current data indicate that it may well offer a similar safety profile and efficacy at stroke prevention as conventional endarterectomy, but as yet there has only been one randomised controlled trial (CAVATAS). Future developments include the identification of a cohort of patients best treated with this technology, the evaluation of cerebral protection systems, and optimisation of pharmacological support.

Angioplasty, Balloon↗

PubMed2005

[Systematic review of the effects of therapy in infants with the KISS-syndrome (kinetic imbalance due to suboccipital strain)].

OBJECTIVE: To establish the effects of manual therapy, chiropractic, or osteopathic treatment of the KISS-syndrome (kinetic imbalance due to suboccipital strain) in infants with positional preference, plagiocephaly, and colic. DESIGN: Systematic review of the literature. METHOD: PubMed, Embase and the Cochrane Library were searched for articles on the effects of manual therapy, chiropractic and osteopathy on the KISS-syndrome. Experts in the field of manual medicine and osteopathy were asked to provide relevant articles. The bibliography in a textbook of manual therapy for children was hand-searched for additional references to the KISS-syndrome. RESULTS: No clinical trials were found that evaluated the effects of manual therapy or osteopathy on either the KISS-syndrome or its symptoms. Pooled analysis of two randomised clinical trials on the effects of chiropractic in infantile colic showed no statistically significant difference between active and control treatments. In addition, we found that 22% of infants showed short episodes of apnoea during manual therapy of the spine, and that one case has been described in which such apnoea resulted in death. CONCLUSION: Given the absence of evidence of beneficial effects of spinal manipulation in infants and in view of its potential risks, manual therapy, chiropractic and osteopathy should not be used in infants with the KISS-syndrome, except within the context of randomised double-blind controlled trials.

Apnea↗

PubMed2001

Mannitol for acute stroke.

BACKGROUND: Mannitol is an osmotic agent and a free radical scavenger so it might decrease oedema and tissue damage in stroke. OBJECTIVES: To test whether treatment with mannitol reduces short and long-term case fatality and dependency after acute ischaemic stroke or cerebral parenchymal haemorrhage. SEARCH STRATEGY: We searched the Cochrane Stroke Group Specialised Trials Register. In addition to this, supplementary MEDLINE searches were performed. The Chinese Stroke Trials Register was checked and the Latin-American databank LILACS was searched with the search term MANNITOL and its variations in the Portuguese and Spanish languages. A search was performed of Masters and Ph.D. degree theses in the databank of Sao Paulo University, and in abstracts of medical congresses on neurology and neurosurgery from 1965 to 1997 in Brazil. SELECTION CRITERIA: Truly randomised unconfounded clinical trials comparing the effect of mannitol with placebo or open control in patients with acute ischaemic stroke or parenchymal haemorrhage were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the trials to be included in the review. After reaching an agreement on which trials to include, two of the reviewers extracted data from the trials and performed the data analysis. Accuracy of data extraction was checked by comparing the results. Included trials were tabulated for methodological quality including the method of randomisation and blinding, and stating if CT was performed, if patients were lost to follow-up and if intention-to-treat analysis was performed. Data synthesis and analysis was performed using the Cochrane Review Manager software. MAIN RESULTS: Only one trial fulfilled the inclusion criteria. The number of included patients was small (36 treated and 41 controls) and the follow up was short. Neither beneficial nor harmful effects of mannitol could be proved. Case fatality, the proportion of dependent patients at the end of the follow up and side effects were not reported and were not available from the investigators. The planned outcome analyses and sensitivity analyses could not be performed due to lack of appropriate trials. REVIEWER'S CONCLUSIONS: There is currently not enough evidence to decide whether the routine use of mannitol in acute stroke would result in any beneficial or harmful effect. The routine use of mannitol in all patients with acute stroke is not supported by any evidence from randomised controlled clinical trials. Further trials are needed to confirm or refute the routine use of mannitol in acute stroke.

Acute Disease↗

PubMed2004

Dual chamber versus single chamber ventricular pacemakers for sick sinus syndrome and atrioventricular block.

BACKGROUND: Dual chamber pacing or single chamber atrial pacing ('physiologic' pacing) is believed to have an advantage over single chamber ventricular pacing in that it resembles cardiac physiology more closely by maintaining atrioventricular (AV) synchrony and dominance of the sinus node, which in turn may reduce cardiovascular morbidity and mortality thus contributing to patient survival and quality of life. However, a significant proportion of pacemakers currently implanted are single chamber ventricular pacemakers. OBJECTIVES: The objective of this review was to assess the short- and long-term clinical effectiveness of dual chamber pacemakers compared to single chamber ventricular pacemakers in adults with AV block, sick sinus syndrome or both. An additional objective was to assess separately any potential differences in effectiveness between dual chamber pacing and single chamber atrial pacing. The clinical effectiveness of single chamber atrial pacing versus single chamber ventricular pacing was not examined. SEARCH STRATEGY: The Cochrane Controlled Trials Register (The Cochrane Library Issue 3, 2002), MEDLINE (1966 to 2002), EMBASE (1980 to 2002) and the Science Citation Index (1980 to 2002) were searched on 19th August 2002. Citation lists and web sites were checked and researchers in the field contacted. SELECTION CRITERIA: Parallel group or crossover randomised controlled trials of at least 48 hours duration comparing dual chamber pacing and single chamber ventricular pacing, and investigating cardiovascular morbidity, mortality, patient related quality of life, exercise capacity and complication rates. DATA COLLECTION AND ANALYSIS: Data was extracted onto pre-piloted data extraction forms. Quality assessment was undertaken using a checklist, with a sub-sample of quality data independently extracted by a second reviewer. Where appropriate data was available, meta-analysis was performed. Where meta-analysis was not possible, the number of studies showing a positive, neutral or negative direction of effect and statistical significance were simply counted. MAIN RESULTS: Five parallel and 26 crossover randomised controlled trials were identified. The quality of reporting was found to be poor. Pooled data from parallel studies shows a statistically non-significant preference for physiologic pacing (primarily dual chamber pacing) for the prevention of stroke, heart failure and mortality, and a statistically significant beneficial effect regarding the prevention of atrial fibrillation (odds ratio (OR) 0.79, 95% CI 0.68 to 0.93). Both parallel and crossover studies favour dual chamber pacing with regard to pacemaker syndrome (parallel: Peto OR 0.11, 95% CI 0.08 to 0.14; crossover: standardised mean difference (SMD) -0.74, 95% CI - 0.95 to -0.52). Pooled data from crossover studies shows a statistically significant trend towards dual chamber pacing being more favourable in terms of exercise capacity (SMD -0.24, 95% CI -0.03 to -0.45). No individual studies reported a significantly more favourable outcome with single chamber ventricular pacing. REVIEWERS' CONCLUSIONS: This review shows a trend towards greater effectiveness with dual chamber pacing compared to single chamber ventricular pacing, which supports the current British Pacing and Electrophysiology Group's Guidelines regarding atrioventricular block. Additional randomised controlled trial evidence from ongoing trials in this area will further inform the debate.

Cardiac Pacing, Artificial↗

PubMed2006

Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.

BACKGROUND: Acute anterior dislocation is the commonest type of shoulder dislocation and usually results from an injury. Subsequently, the shoulder is less stable and more susceptible to redislocation, especially in active young adults. OBJECTIVES: To compare methods of conservative (non-surgical) management versus no treatment or different methods of conservative management after closed reduction of traumatic anterior dislocation of the shoulder. Interventions include methods of postreduction immobilisation and rehabilitation. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE, EMBASE, the National Research Register (UK), conference proceedings and reference lists of articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing various conservative interventions versus control (no or sham treatment) or other conservative interventions applied after closed reduction of traumatic anterior dislocation of the shoulder. DATA COLLECTION AND ANALYSIS: All authors selected trials, assessed methodological quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: One flawed quasi-randomised trial was included. A "preliminary report" gave the results for 40 adults with primary traumatic anterior dislocation of the shoulder treated by post-reduction immobilisation with the arm in either external or internal rotation. There was no statistically significant difference between the two groups in the failure to return to pre-injury sports by previously active athletes, in redislocation or shoulder instability. Similar numbers of participants of the two groups removed their immobiliser before one week had passed. AUTHORS' CONCLUSIONS: There is a lack of evidence from randomised controlled trials to inform the choices for conservative management following closed reduction of traumatic anterior dislocation of the shoulder. Sufficiently powered, good quality, well reported randomised controlled trials with long-term surveillance of conservative management are required. In particular, trials examining the type and duration of immobilisation would be useful.

Humans↗

PubMed2003

Should obstetricians support a 'term cephalic trial'?

Recent analyses of the published data suggest that the risks of elective Caesarean delivery in an uncomplicated pregnancy may not outweigh the benefits of vaginal birth by as much as has been supposed. Indeed, this balance may be so close that the place of elective Caesarean delivery of a term cephalic baby might be considered as a worthwhile subject of a randomised controlled trial. We discuss the potential consequences of such a trial and what effect it could have on obstetric practice.

Attitude of Health Personnel↗

PubMed1994

Effectiveness of routine self monitoring of peak flow in patients with asthma. Grampian Asthma Study of Integrated Care (GRASSIC).

OBJECTIVE: To evaluate the effectiveness of routine self monitoring of peak flow for asthma outpatients. DESIGN: Pragmatic randomised trial. SETTING: Hospital outpatient clinics and general practices in north east Scotland. MAIN OUTCOME MEASURES: Use of bronchodilators and inhaled and oral steroids; number of general practice consultations and hospital admissions for asthma; sleep disturbance and other restrictions on normal activity; psychological aspects of health including perceived control of asthma. RESULTS: After one year there were no significant differences between patients randomised between self monitoring of peak flow and conventional monitoring. However, those given a peak flow meter recorded an increase in general practice consultations that was nearly significant. Among patients whose asthma was judged on entry to be more severe, those allocated to self monitoring used more than twice as many oral steroids (2.2; 95% confidence interval 1.1 to 4.6). Patients who already possessed a peak flow meter at the start of the study recorded higher morbidity over the course of the year than those eligible for randomisation. CONCLUSION: Prescribing peak flow meters and giving self management guidelines to all asthma patients is unlikely to improve mortality or morbidity. Patients whose asthma is severe may benefit from such an intervention.

Ambulatory Care↗

PubMed1997

Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery.

AIMS: To compare the relative antiinflammatory potency and safety of topical diclofenac-gentamicin with betamethasone-neomycin following strabismus surgery. METHODS: A single centre, single observer, prospective, randomised, and double masked clinical trial of 25 children undergoing bilateral symmetrical horizontal strabismus surgery was carried out. One eye received diclofenac-gentamicin and the contralateral eye received betamethasone-neomycin; both treatments were instilled four times a day for 4 weeks postoperatively. Ocular inflammation was assessed at 1 and 4 weeks postoperatively, objectively by comparison with a photographic chart and subjectively by questionnaire. RESULTS: There was no statistically significant difference in the rate of resolution of the inflammatory response between each group at both visits. CONCLUSION: Diclofenac appears to be as effective as betamethasone in controlling postoperative inflammation following strabismus surgery and may offer a safer alternative to the use of topical steroids.

Anti-Bacterial Agents↗

PubMed2000

Interventions for early stage Hodgkin's disease in children.

BACKGROUND: Hodgkin's Disease is one of the most curable cancers in children, particularly at the early stages. The debate rests now more with retention of high cures and eliminating treatment sequelae. OBJECTIVES: To assess relapse free survival and overall survival rates in children with Stage l-llA Hodgkin's Disease treated with radiotherapy, chemotherapy or a combination of the two treatments. SEARCH STRATEGY: MEDLINE, EMBASE, CINAHL, Cancer-CD and the Cochrane Library were searched for randomised controlled trials. Key words included 'Hodgkin's Disease', 'Reed-Sternberg cells' and variations of 'child'. SELECTION CRITERIA: Treatments with a combination of the following therapies; involved field radiotherapy, extended field radiotherapy, anthracycline based chemotherapy regimens, or alkylating chemotherapy agents. Patients included children to 19 years of age. DATA COLLECTION AND ANALYSIS: Seven papers were identified as meeting the selection criteria. Of these four were usable, though one only covered a small section of the paper. It was not possible to combine the outcomes as they covered different treatment regimens and the numbers in one study were inaccurate. MAIN RESULTS: The results comparing IF with EF radiotherapy for children are based on one large multi-centred trial. Although the study is substantial and methodologically rigorous, the evidence for efficacy rests simply on this one trial. The results from the other three studies are not generalizable. The outcomes could not be combined as the studies assessed different treatment regimens. In addition there is little evidence to suggest that the methodological quality, particularly in terms of randomisation and simple arithmetic, is of a sufficiently robust nature in two of the studies. REVIEWER'S CONCLUSIONS: The treatment of Hodgkin's Disease Stage l -llA for children has undergone considerable evolution and development in the previous three decades with the introduction and refinement of combined modality treatments. There is now overall consensus that the prognosis for these patients following a short course of chemotherapy and low dose local radiotherapy is very good with a large percentage achieving long-term survival or relapse free survival. The main issues and problems facing practitioners in the field is the reduction and management of late effects and sequelae of treatment. The evidence for this overall agreement is based on a mass of cohort studies that have influenced changes in practice and significantly improved outcomes. However, apart from the collaborative study looking at radiotherapy alone, there is little evidence from randomised controlled trials to support this consensus.

Antineoplastic Agents↗

PubMed2001

Intravenous immunoglobulin for Guillain-Barré syndrome.

BACKGROUND: Guillain-Barré syndrome is a potentially serious, acute, paralysing, probably autoimmune disease caused by inflammation of the peripheral nerves. Recovery has been shown to be speeded by plasma exchange which replaces the patient's own plasma with a plasma substitute. Intravenous immunoglobulin purified from donated blood is beneficial in other autoimmune diseases and is easier to administer. OBJECTIVES: To determine the efficacy of intravenous immunoglobulin in comparison with no treatment or other treatments for treating Guillain-Barré syndrome and to determine the most efficacious dose. SEARCH STRATEGY: Search of the Cochrane Neuromuscular Disease Group register using Guillain-Barré syndrome and acute polyradiculoneuritis as the search terms, bibliographies of trials and contact with their authors and other experts. SELECTION CRITERIA: Randomised and quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two reviewers examined the titles and abstracts of all the papers retrieved by the search, extracted the data onto forms designed for this review, and independently assessed the quality of the trials. MAIN RESULTS: The only trial comparing intravenous immunoglobulin with supportive treatment was inadequate to establish its value. Another Cochrane systematic review has shown that plasma exchange (PE) hastens recovery. Plasma exchange has become the gold standard against which other treatments need to be compared. We found three randomised trials that compared intravenous immunoglobulin with PE. We were able to combine the results of the two largest trials in a metaanalysis involving 398 patients. The primary outcome measure in this review was the change in a 7 grade disability scale four weeks after randomisation. The weighted mean difference of this measure was not significant, being only 0.11 (95% CI -0.14 to 0.37) of a disability grade more improvement in the intravenous immunoglobulin group than the PE group. There were also no significant differences in other outcome measures, including time to walk unaided, mortality, and proportion of patients unable to walk without aid after a year but some of these outcome measures were only available for one trial. We also reviewed one trial involving 249 patients which compared PE followed by intravenous immunoglobulin with PE alone and another involving 37 patients which compared immunoabsorption followed by intravenous immunoglobulin with immunoabsorption alone. Neither revealed any significant differences between the regimens with and without intravenous immunoglobulin. We did not discover any dose ranging studies of intravenous immunoglobulin except for one that is ongoing. REVIEWER'S CONCLUSIONS: There are no adequate trials to determine whether intravenous immunoglobulin is more beneficial than placebo. Intravenous immunoglobulin and plasma exchange have a similar ability to speed the recovery from Guillain-Barré syndrome. Giving intravenous immunoglobulin after plasma exchange is not significantly better than plasma exchange alone. Randomised trials are needed to decide whether intravenous immunoglobulin helps in mild Guillain-Barré syndrome or in disease which has lasted more than two weeks. Randomised trials also need to establish the optimal dose.

Child↗

PubMed2001

Methyl-xanthines for exacerbations of chronic obstructive pulmonary disease.

BACKGROUND: International guidelines currently recommend the use of methyl-xanthines for exacerbations of chronic obstructive pulmonary disease (COPD) for patients who have incomplete responses to bronchodilators. However, available clinical trials are small and underpowered to evaluate the benefits and risks of methyl-xanthines in this acute setting. OBJECTIVES: To determine the benefit of methyl-xanthines compared to standard care for COPD exacerbations. SEARCH STRATEGY: Randomised controlled trials (RCTs) were identified from the Cochrane Airways Review Group COPD Register which is a compilation of systematic searches of CINAHL, EMBASE, MEDLINE and CENTRAL and hand searching of 20 respiratory journals. In addition, primary authors and content experts were contacted to identify eligible studies. Bibliographies from included studies, known reviews and texts were also searched. SELECTION CRITERIA: Only RCTs were eligible for inclusion. Studies were included if patients presented with acute COPD exacerbations and were treated with either methyl-xanthines (oral or intravenous) or placebo (with or without standard care) early in the acute treatment. Studies also needed to report either pulmonary function or admission results. Two reviewers independently selected potentially relevant articles and selected articles for inclusion. Methodological quality was independently assessed by two reviewers. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers if the authors were unable to verify the validity of information. Missing data were obtained from authors or calculated from other data presented in the paper. The data were analysed using the Cochrane Review Manager 4.0.4 Studies were pooled to yield weighted mean differences (WMD) or odds ratios (OR) and reported using 95% confidence intervals (95%CI). MAIN RESULTS: From 28 identified references, 4 RCTs met inclusion criteria (172 patients). Mean change in forced expiratory volume in one second (FEV1) at 2 hours was similar in methyl-xanthine and placebo groups (FEV1 WMD: -8 ml; 95% CI: -85 to 69 ml). The only study to report hospitalization rates showed a non-significant reduction with methyl-xanthines (OR: 0.3; 95% CI: 0.1 to 1.8) among 39 patients. Patients receiving methyl-xanthines had similar improvements in symptom scores, but reported more gastrointestinal side effects (OR: 5.3; 95% CI: 1.3 to 21.0) than patients receiving placebo. REVIEWER'S CONCLUSIONS: There is no evidence to support the routine use of methyl-xanthines for COPD exacerbations. Methyl-xanthines do not appreciably improve FEV1 during COPD exacerbations and cause adverse effects; evidence of their effect on admissions is limited.

Aminophylline↗

PubMed2004

Physical therapies for reducing and controlling lymphoedema of the limbs.

BACKGROUND: Lymphoedema is the accumulation of excess fluid in the body caused by obstruction of the lymphatic drainage mechanisms. Management involves decongesting the reduced lymphatic pathways in order to reduce the size of the limb. There is a great deal of debate as to which components of a physical treatment programme are the most crucial. OBJECTIVES: To assess the effect of physical treatment programmes on: volume, shape, condition and long-term control of oedema in lymphoedematous limbs; psycho-social benefits. SEARCH STRATEGY: We searched the Cochrane Breast Cancer Group trials register (September 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4,2003), MEDLINE, EMBASE, CINAHL, UnCover, PASCAL, SIGLE, reference lists produced by The British Lymphology Society, the National Research Register (NRR) and The International Society of Lymphology congress proceedings. SELECTION CRITERIA: Randomised controlled clinical trials that tested physical therapies with a follow-up period of at least six months. DATA COLLECTION AND ANALYSIS: Two blinded reviewers independently assessed trial quality and extracted data . Meta-analysis was not performed due to the poor quality of the trials. MAIN RESULTS: Only three studies involving 150 randomised patients were included. Since none studied the same intervention it was not possible to combine the data. One crossover study of manual lymph drainage (MLD) followed by self-administered massage versus no treatment, concluded that improvements seen in both groups were attributable to the use of compression sleeves and that MLD provided no extra benefit at any point during the trial. Another trial looked at hosiery versus no treatment and had a very high dropout rate, with only 3 out of 14 participants in the intervention group finishing the trial and only 1 out of 11 in the control group. The authors concluded that wearing a compression sleeve is beneficial. The bandage plus hosiery versus hosiery alone trial, concluded that in this mixed group of participants bandage plus hosiery resulted in a greater reduction in excess limb volume than hosiery alone and this difference in reduction was maintained long-term. REVIEWERS' CONCLUSIONS: All three trials have their limitations and have yet to be replicated, so their results must be viewed with caution. There is a clear need for well-designed, randomised trials of the whole range of physical therapies if the best approach to managing lymphoedema is to be determined.

Bandages↗

PubMed2006

Lithium versus antidepressants in the long-term treatment of unipolar affective disorder.

BACKGROUND: The main rationale for the use of lithium in the long-term treatment of unipolar affective disorder is its efficacy in treating bipolar affective disorder and resistant depression. However, there is considerable uncertainty about which pharmacological intervention is most effective in the long-term treatment of recurrent unipolar affective disorder. OBJECTIVES: To assess the effects of lithium versus antidepressants for the long-term treatment of recurrent affective disorder. SEARCH STRATEGY: We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Registers (CCDANCTR-Studies and CCDANCTR-References) on 2/9/2005. Reference lists of relevant papers and major textbooks of affective disorder were checked. Experts in the field and pharmaceutical companies were contacted regarding unpublished material. SELECTION CRITERIA: Randomised controlled trials comparing lithium against antidepressant medication for the long-term treatment of patients with a diagnosis of affective disorder. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We collected adverse effects information from the trials. MAIN RESULTS: Eight trials involving 475 people were included. Two of the studies included a mixed group of participants with either bipolar or unipolar disorder. Relapse was defined as admission to hospital and when all kinds of relapses were considered (both depressive and manic), there was a statistically significant difference in favour of lithium (relative risk (RR) fixed effect 0.34, 95% CI 0.14 to 0.82). The results did not exclude the point of no effect, when the random-effects model was used (RR random effects 0.40, 95% CI 0.14 to 1.18). There were no other statistically significant differences between lithium and antidepressants according to all other outcomes considered. Manic or depressive relapse was defined as prescription of non-study medication for mood disorder, manic or depressive relapse (as defined by the study authors), quality of life, social functioning, occupational functioning, overall drop-out rate, drop-out rate due to side-effects, troublesome side-effects, mortality due to all causes and specifically suicides. AUTHORS' CONCLUSIONS: There was adequate efficacy evidence for lithium or antidepressants preventing relapse in unipolar affective disorder, however their relative efficacy was unknown. When considering lithium or antidepressant long-term therapy, patients and clinicians should take into account the patient's clinical history, the side-effects and the individual's likely adherence to the recommended treatment regime. Large-scale, long-term randomised trials in unselected groups of subjects with unipolar affective disorder are needed.

Antidepressive Agents↗

PubMed2005

Fluoxetine versus other types of pharmacotherapy for depression.

BACKGROUND: Depression is common in primary care and it is associated with marked personal, social and economic morbidity, and creates significant demands on service providers in terms of workload. Treatment is predominantly pharmaceutical or psychological. Fluoxetine, the first of a group of antidepressant (AD) agents known as selective serotonin reuptake inhibitors (SSRIs), has been studied in many randomised controlled trials (RCTs) in comparison with tricyclic (TCA), heterocyclic and related ADs, and other SSRIs. These comparative studies provided contrasting findings. In addition, systematic reviews of RCTs have always considered the SSRIs as a group, and evidence applicable to this group of drugs might not be applicable to fluoxetine alone. The present systematic review assessed the efficacy and tolerability profile of fluoxetine in comparison with TCAs, SSRIs and newer agents. OBJECTIVES: To determine the efficacy of fluoxetine, compared with other ADs, in alleviating the acute symptoms of depression, and to review its acceptability. SEARCH STRATEGY: Relevant studies were located by searching the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL), Medline (1966-2004) and Embase (1974-2004). Non-English language articles were included. SELECTION CRITERIA: Only RCTs were included. For trials which have a crossover design only results from the first randomisation period were considered. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two reviewers using a standard form. Responders to treatment were calculated on an intention-to-treat basis: drop-outs were always included in this analysis. When data on drop-outs were carried forward and included in the efficacy evaluation, they were analysed according to the primary studies; when dropouts were excluded from any assessment in the primary studies, they were considered as treatment failures. Scores from continuous outcomes were analysed including patients with a final assessment or with the last observation carried forward. Tolerability data were analysed by calculating the proportion of patients who failed to complete the study and who experienced adverse reactions out of the total number of randomised patients. The primary analyses used a fixed effects approach, and presented Peto Odds Ratio (PetoOR) and Standardised Mean Difference (SMD). MAIN RESULTS: On a dichotomous outcome fluoxetine was less effective than dothiepin (PetoOR: 2.09, 95% CI 1.08 to 4.05), sertraline (PetoOR: 1.40, 95% CI 1.11 to 1.76), mirtazapine (PetoOR: 1.64, 95% CI 1.01 to 2.65) and venlafaxine (Peto OR: 1.40, 95% CI 1.15 to 1.70). On a continuous outcome, fluoxetine was more effective than ABT-200 (Standardised Mean Difference (SMD) random effects: - 1.85, 95% CI - 2.25 to - 1.45) and milnacipran (SMD random effects: - 0.38, 95% CI - 0.71 to - 0.06); conversely, it was less effective than venlafaxine (SMD random effect: 0.11, 95% CI 0.00 to 0.23), however these figures were of borderline statistical significance. Fluoxetine was better tolerated than TCAs considered as a group (PetoOR: 0.78, 95% CI 0.68 to 0.89), and was better tolerated in comparison with individual ADs, in particular than amitriptyline (PetoOR: 0.64, 95% CI 0.47 to 0.85) and imipramine (PetoOR: 0.79, 95% CI 0.63 to 0.99), and among newer ADs than ABT-200 (PetoOR: 0.21, 95% CI 0.10 to 0.41), pramipexole (PetoOR: 0.20, 95% CI 0.08 to 0.47) and reboxetine (PetoOR: 0.61, 95% CI 0.40 to 0.94). AUTHORS' CONCLUSIONS: There are statistically significant differences in terms of efficacy and tolerability between fluoxetine and certain ADs, but the clinical meaning of these differences is uncertain, and no definitive implications for clinical practice can be drawn. From a clinical point of view the analysis of antidepressants' safety profile (adverse effect and suicide risk) remains of crucial importance and more reliable data about these outcomes are needed. Waiting for more robust evidence, treatment decisions should be based on considerations of clinical history, drug toxicity, patient acceptability, and cost. We need for large, pragmatic trials, enrolling heterogeneous populations of patients with depression to generate clinically relevant information on the benefits and harms of competitive pharmacological options. A meta-analysis of individual patient data from the randomised trials is clearly necessary.

Antidepressive Agents↗

PubMed1977

Combined therapy of oral cancer bleomycin and radiation: a clinical trial.

A concurrent randomised controlled clinical trial to evaluate a combination of Bleomycin and radiation as against radiation only in the treatment of advanced oral cancer has been conducted at the Cancer Institute, Madras, since 1971. All T3 and T4 previously untreated oral squamous cell carcinomas with N0, N1 and N2 regional nodes, or N3 nodes confined to the submandibular region, without systemic metastases or gross infiltration of the temporal and infratemporal fossa producing total trismus, and in decent general health were eligible for the trial. Patients with gross active pulmonary tuberculosis were excluded, as were recurrent carcinomas. Age, external fungation of growth or radiological bone invasion were no bar. Randomisation was done by the sealed envelope technique. The study group received concurrent fractionated cobalt 60 teletherapy using two opposing fields and 10-15 mg of Intra-arterial or Intravenous Bleomycin. The controls received fractionated cobalt teletherapy and i.v. or i.m. distilled water on the same protocol as the Bleomycin cases. All cases were evaluated double blind 8 weeks after the end of radiation therapy, and were classified as 'favourable response' or 'failure'. The criterion of 'favourable response' was 'total clinical healing of the tumour within the volume of irradiation with no subsequent recurrence within that volume, whatever the length of follow up'. Anything else was reported as a failure. A long term follow up of 3 years is also available. 136 cases have completed the trial. The favourable response in the study group was 77% as against 20.9% in the control group. The differential response is statistically significant. The present study is the fourth in the series of combined therapeutic trials conducted in advanced oral squamous cell carcinoma since 1958. (Krishnamurthi and Shanta, 1963, 1965, 1967 and 1971). A concurrent randomised controlled clinical trial to evaluate the combination of Bleomycin and radiation as against radiation only in treatment of advanced oral cancer has been conducted at the Cancer Institute, Madras since 1971.

Bleomycin↗

PubMed2006

An update on therapeutic drug monitoring for antiretroviral drugs.

There is an increasing uptake of TDM of antiretroviral drugs, particularly in Europe. There is consensus that current antiretroviral drugs meet most of the criteria of drugs that can be considered as candidates for a TDM strategy. This review examines the pharmacokinetic-pharmacodynamic relationship for protease inibitors and non nucleoside reverse transcriptase inhibitor, give an overview of the published randomised clinical trials and then summarises the scenarios for use of TDM. Finally the development of the inhibitory quotient (IQ) concept is discussed.

Drug Monitoring↗

PubMed1998

Perioperative red cell transfusion: evidence, guidelines and practice.

Although we still do not know enough about the influence of anaemia and transfusion on outcomes for the surgical patient, it is possible to develop a general consensus about many aspects of management. A quality programme to improve consistency of practice in these consensus areas is feasible. (Table 6) This should be linked with further randomised trials to evaluate the clinical effectiveness of alternative regimes.

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