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PubMed2001

Recombinant human erythropoietin for chronic renal failure anaemia in pre-dialysis patients.

BACKGROUND: Treatment with recombinant human erythropoietin (rHu EPO) in dialysis patients has been shown to be highly effective in terms of correcting anaemia and improving quality of life. There is debate concerning the benefits of rHu EPO use in pre-dialysis patients. There is a concern that rHu EPO may accelerate the deterioration in renal function, however the opposing view is that if rHu EPO is as effective in pre-dialysis patients that by improving the patients sense of well-being the onset of dialysis could be delayed. OBJECTIVES: To assess the effects of rHu EPO use in pre-dialysis patients with renal anaemia. SEARCH STRATEGY: We searched MEDLINE (1980 to May Week 3 2001), EMBASE (1984 to Week 24 2001), BIOSIS (1985 to January 1997), CINAHL (1982 to October 1997), The Cochrane Library (Issue 1, 1997), CHEMABS (1984 to November 1996), SIGLE (1980 to June 1996), CRIB (10th edition, 1995), UK NRR (14TH consolidation, September 1996), RSC ( 1980 to February 1997), HealthSTAR (1995 to October 1997), IBSS (1984 to July 1997), NEED (July 1997) and reference lists of relevant articles. We contacted biomedical companies and investigators in the field and we hand searched Kidney International (including all supplements but excluding all conference proceedings except for 1994) July 1983 to May 1997 inclusive. The internet was also searched on: August 1997. We had also identified some studies from a previous broad search for all randomised controlled trials (RCTs) relevant to the management of end-stage renal disease. Date of the most recent search: June 2001. SELECTION CRITERIA: RCTs or quasi-RCTs comparing the use of rHu EPO with no rHu EPO or placebo in pre-dialysis patients. DATA COLLECTION AND ANALYSIS: Only published data were used. Data were abstracted by a single investigator onto a standard form. A sample of the data abstracted was double-checked by another reviewer. The data abstracted were relevant to the predetermined outcome measures. Some authors were contacted to clarify how patients were allocated to groups. All authors from included studies were contacted for missing information. MAIN RESULTS: Twelve studies with a total of 232 participants met the inclusion criteria and where possible data from these were summated by meta-analyses (Peto's Odds Ratio (OR) and Weighted Mean Difference (WMD)). The majority of the trials included small numbers and were of short duration (8-10 weeks) with the exception of three trials. There was a marked improvement in haemoglobin (mean difference 2.3g/dL, 95% CI 1.37 to 3.23) and haematocrit (WMD 9.92%, 95% CI 8.78 to 11.05) with the treatment and a decrease in the number of patients requiring blood transfusion (OR 0.25, 95% CI 0.09 to 0.69). The data from all studies which reported quality of life or exercise capacity demonstrated an improvement in the rHu EPO group. None of the measures of progression of renal disease (when a summary statistic was calculated) demonstrated a statistically significant difference. Though the requirement for antihypertensive treatment appears to be increased by rHu EPO (OR 1.84, 95% CI 1.02 to 3.32), there was no other statistically significant increase in adverse events. Based on the limited current evidence, decisions therefore have to be made on whether the putative benefits in terms of quality of life identified in the review are worth the extra costs of pre-dialysis rHu EPO. REVIEWER'S CONCLUSIONS: This review has shown that treatment with rHu EPO in pre-dialysis patients corrects anaemia and avoids the requirement for blood transfusions. There are also improvements in quality of life and exercise capacity. There may be increased hypertension. Most of the trials were not of sufficient duration to assess the effects of rHu EPO on progression of renal disease. In the long term, questions still remain about whether pre-dialysis rHu EPO either speeds up or delays the onset of dialysis. Thus there is insufficient evidence on the total costs and benefits of treating pre-dialysis patients with rHu EPO.

Anemia↗
PubMed2003

Open general medical wards versus specialist psychiatric units for acute psychoses.

BACKGROUND: As international healthcare policy has moved away from treating people with severe mental illness in large inpatient psychiatric institutions, beds for people with acute psychiatric disorders are being established in specialised psychiatric units in general hospitals. In developing countries, however, limited resources mean that it is not always possible to provide discrete psychiatric units, either in general hospitals or in the community. An alternative model of admission, used in the Caribbean, is to treat the person with acute psychosis in a general hospital ward. OBJECTIVES: To compare the outcomes for people with acute psychoses who have been admitted to open medical wards with those admitted to conventional psychiatric units. SEARCH STRATEGY: The Cochrane Schizophrenia Group's study-based register was searched (November 2001). This register is compiled from searches of BIOSIS, CINAHL, The Cochrane Library, EMBASE, LILACS, MEDLINE, PsycINFO, PSYNDEX, Sociofile, and many conference proceedings. SELECTION CRITERIA: All relevant randomised or quasi-randomised trials, allocating anyone thought to be suffering from an acute psychotic episode to either acute management on general medical wards, or acute management in a specialist psychiatric unit. The primary outcomes of interest were length of stay in hospital and relapse. DATA COLLECTION AND ANALYSIS: Studies were reliably selected, assessed for quality, and their data would have been extracted. Homogeneous data were to have been synthesised. For binary data, the risk ratios (RR) and 95% confidence intervals (CI) were to have been calculated on an-intention-to-treat basis. If possible, the number needed to treat/harm statistic (NNT/H) was to have been calculated. For continuous data, weighted mean differences (WMD) were to have been calculated and only data from valid scales would have been reported in this review. MAIN RESULTS: We identified no relevant randomised trials. REVIEWER'S CONCLUSIONS: The Caribbean practice of treating people with severe mental illness on general medical wards has been influenced by socio-economic factors rather than evidence from randomised trials. This practice affords an opportunity for a well designed, well conducted and reported randomised trial, now impossible in many other settings.

Acute Disease↗
PubMed2003

Prophylactic antibiotics for preventing early central venous catheter Gram positive infections in oncology patients.

BACKGROUND: Long-term tunnelled central venous catheters (TCVC) are increasingly used in oncology patients. Despite guidelines on insertion, maintenance and use, infections remain an important complication. Most infections are caused by Gram-positive bacteria. Therefore antimicrobial prevention strategies aimed at these micro-organisms could potentially decrease the majority of the TCVC infections. OBJECTIVES: To determine the efficacy of administering antibiotics prior to insertion of a TCVC with or without vancomycin/heparin flush technique in the first 45 days after insertion of the catheter to prevent Gram-positive catheter-related infections in oncology patients. SEARCH STRATEGY: We searched MEDLINE, EMBASE,and CENTRAL up to July 2001. Reference lists from relevant articles were scanned and conference proceedings were hand searched. The authors of eligible studies were contacted to obtain additional information. SELECTION CRITERIA: We selected randomized controlled trials giving prophylactic antibiotics prior to insertion of the TCVC, and trials using the combination of an antibiotic and heparin to flush the TCVC in oncology patients. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the studies for inclusion, extracted the data and assessed the quality. MAIN RESULTS: We included eight trials totalling 527 patients. Four reported on vancomycin/teicoplanin prior to insertion of the TCVC, and four reported on antibiotic flushing combined with heparin. The overall effect of an antibiotic prior to catheter insertion decreases the number of Gram-positive TCVC infections (odds ratio [OR] = 0.55, 95% confidence interval [CI] 0.29 to1.04). Given an expected infection rate of TCVC during the first 45 days of up to 30% this OR implies that the number needed to treat (NNT) will be 10 (95% CI 4 to13), this means vancomycin needs to be given to 10 patients to prevent one TCVC infection. Flushing the TCVC with antibiotics and heparin proved to be beneficial (OR = 0.35, 95% CI 0.16 -to 0.77). For intraluminal colonization the baseline infection-rate is 15% which leads to a NNT of 13 (95% CI 5 to 23). REVIEWER'S CONCLUSIONS: Both interventions lead to a positive overall effect but should be considered with care due to the small number of studies. Depending on the baseline TCVC infection rate it is justified to administer antibiotics prior to the TCVC insertion or to flush the catheter with a combination of an antibiotic and heparin, if the catheter-related infection rate is high.

Antibiotic Prophylaxis↗
PubMed2004

Graduated driver licensing for reducing motor vehicle crashes among young drivers.

BACKGROUND: Graduated driver licensing (GDL) has been proposed as a means of reducing crash rates among novice drivers by gradually introducing them to higher risk driving situations. OBJECTIVES: To examine the effectiveness of GDL systems in reducing crash rates of young drivers. SEARCH STRATEGY: Studies were identified through searches of MEDLINE, EMBASE, CINAHL, Healthstar, Web of Science, NTIS Bibliographic Database, TRIS Online, SIGLE, the World Wide Web, relevant conference proceedings, consultation with experts and authors, and reference lists. The search was not restricted by language or publication status. SELECTION CRITERIA: Studies were included if: 1) they compared outcomes pre- and post-implementation of a GDL program within the same jurisdiction, 2) comparisons were made between jurisdictions with and without GDL, or 3) both. Studies had to report at least one objective, quantified outcome. Two reviewers independently screened searches and assessed the full text of potentially relevant studies for inclusion using a standard form. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked by a second. Additional data were requested from authors. Results were not pooled due to substantial heterogeneity between studies. Percentage change was calculated for each year after the intervention, using one year prior to the intervention as the baseline rate. Results were adjusted by internal controls. Analyses were stratified by different denominators (population, licensed drivers). Results were calculated for the different crash types (overall, injury, fatal, night-time, alcohol, and those resulting in hospitalization). Results were presented for 16 year-olds alone and all teenage drivers combined. MAIN RESULTS: We included 13 studies evaluating 12 GDL programs that were implemented between 1979 and 1998 in the US (n=7), Canada (3), New Zealand (1), and Australia (1). Programs varied in their restrictions during the intermediate stage: e.g. night curfews (8); limitations of extra passengers (2); roadway restrictions (1). Based on the Insurance Institute for Highway Safety classification scheme, no programs were good, six were acceptable, five were marginal, and one was poor. Reductions in crash rates were seen in all jurisdictions and for all crash types. Among 16 year-old drivers, the median decrease in per population overall crash rates during the first year was 31% (range 26-41%). Per population injury crash rates were similar (median 28%, range 4-43%). Results for all teenage drivers, rates per licensed driver, and rates adjusting for internal controls were generally reduced when comparing within jurisdictions. REVIEWERS' CONCLUSIONS: The existing evidence shows that GDL is effective in reducing the crash rates of young drivers, although the magnitude of the effect is unclear. The conclusions are supported by consistent direction of the findings, and the temporal relationship and plausibility of the association. The reviewers have made recommendations for primary research on GDL (e.g. study methods, standardized reporting of outcomes and results, long-term follow-up). The project has also shown what is needed to carry out systematic reviews of observational studies (e.g. quality assessment instruments).

Accidents, Traffic↗
PubMed2002

Immunoglobulin infusion for isoimmune haemolytic jaundice in neonates.

BACKGROUND: Exchange transfusion and phototherapy have traditionally been used to treat jaundice and avoid the associated neurological complications. Exchange transfusion is not without risk and intravenous immunoglobulin has been suggested as an alternative therapy for isoimmune haemolytic jaundice to reduce the need for exchange transfusion. OBJECTIVES: To assess whether the use of intravenous immunoglobulin, in newborn infants with isoimmune haemolytic jaundice, is effective in reducing the need for exchange transfusion. SEARCH STRATEGY: The search strategy of the Cochrane Neonatal Review group was used. Searches were made of MEDLINE 1966-2002, EMBASE Drugs and Pharmacology 1990-2002, Cochrane Controlled Trials Register, The Cochrane Library, Issue 1, 2002, expert informants, review articles, cross references, and hand searching of abstracts and conference proceedings of the annual meetings of The Society for Pediatric Research 1990-2001 and The European Society for Paediatric Research 1990-2001. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials of the use of intravenous immunoglobulin in the treatment of isoimmune haemolytic disease were considered. DATA COLLECTION AND ANALYSIS: The standard methods of the Cochrane Collaboration and its Neonatal Review Group were used. Studies were assessed for inclusion and quality by two reviewers working independently, with the second reviewer blinded to trial author, institution and journal of publication. Data were extracted independently by the two reviewers. Any differences of opinion were discussed and a consensus reached. Investigators were contacted for additional or missing information. For categorical outcomes, the relative risk (RR), risk difference (RD) and the number needed to treat (NNT) were calculated. For continuous variables, the weighted mean difference (WMD) was calculated. MAIN RESULTS: Seven studies were identified. Three of these fulfilled the inclusion criteria and included a total of 189 infants. Term and preterm infants and infants with rhesus and ABO incompatibility were included. The use of exchange transfusion decreased significantly in the immunoglobulin treated group (typical RR 0.28, 95% CI 0.17, 0.47; typical RD -0.37, 95% CI -0.49, -0.26; NNT 2.7). The mean number of exchange transfusions per infant was also significantly lower in the immunoglobulin treated group (WMD -0.52, 95% CI -0.70, -0.35). None of the studies assessed long term outcomes. REVIEWER'S CONCLUSIONS: Although the results show a significant reduction in the need for exchange transfusion in those treated with intravenous immunoglobulin, the applicability of the results is limited. The number of studies and infants included is small and none of the three included studies was of high quality. The protocols of two of the studies mandated the use of early exchange transfusion, limiting the generalizability of the results. Further well designed studies are needed before routine use of intravenous immunoglobulin can be recommended for the treatment of isoimmune haemolytic jaundice.

Anemia, Hemolytic↗
PubMed2002

Rehabilitation for distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. OBJECTIVES: To examine the evidence for effectiveness of rehabilitation intervention(s) for adults with conservatively or surgically treated distal radial fractures. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (January 2002), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), the Cochrane Rehabilitation and Related Therapies Field database, MEDLINE (1966 to January 2002), EMBASE (1988 to 2001 Week 50), CINAHL (1982 to December Week 2 2001), Current Controlled Trials (December 2001), AMED, PEDro, conference proceedings and reference lists of articles. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials evaluating rehabilitation as part of the management of fractures of the distal radius sustained by skeletally mature patients. Rehabilitation interventions such as active and passive mobilisation exercises, and training for activities of daily living, could be used on their own or in combination, and be applied in various ways by various clinicians. DATA COLLECTION AND ANALYSIS: All trials meeting the selection criteria were independently assessed by all three reviewers for methodological quality. Data were extracted independently by two reviewers. The trials were grouped into categories relating to the main comparisons, and to when the intervention(s) commenced (for example, during or after plaster cast immobilisation). Quantitative data are presented using relative risks or mean differences together with 95 per cent confidence limits. MAIN RESULTS: Twelve trials, involving 601 mainly female and older patients, were included. Initial treatment was conservative, involving plaster cast immobilisation, in all but 20 patients whose fractures were fixed surgically. Though some trials were well conducted, others were methodologically compromised. No trial provided definitive evidence. Only very limited pooling of results from comparable trials was possible. During immobilisation, there was weak evidence of improved hand function in the short term, but not in the longer term, for early occupational therapy (1 trial), and of a lack of differences in outcome between supervised and unsupervised exercises (1 trial). Post-immobilisation, there was weak evidence of a lack of clinically significant differences in outcome in patients receiving formal rehabilitation therapy (3 trials), passive mobilisation (2 trials) or whirlpool immersion (1 trial) compared with no intervention. There was weak evidence of a short-term benefit of continuous passive motion (post external fixation) (1 trial), intermittent pneumatic compression (1 trial) and ultrasound (1 trial). There was weak evidence of better short-term hand function in patients given physiotherapy than in those given instructions for home exercises by a surgeon (1 trial). REVIEWER'S CONCLUSIONS: The available evidence from randomised trials is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius.

Adult↗
PubMed2006

Rehabilitation for distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. OBJECTIVES: To examine the effects of rehabilitation interventions in adults with conservatively or surgically treated distal radial fractures. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2005), MEDLINE, EMBASE, CINAHL, AMED, PEDro, OTseeker and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials evaluating rehabilitation as part of the management of fractures of the distal radius sustained by adults. Rehabilitation interventions such as active and passive mobilisation exercises, and training for activities of daily living, could be used on their own or in combination, and be applied in various ways by various clinicians. DATA COLLECTION AND ANALYSIS: The authors independently selected and reviewed trials. Study authors were contacted for additional information. No data pooling was done. MAIN RESULTS: Fifteen trials, involving 746 mainly female and older patients, were included. Initial treatment was conservative, involving plaster cast immobilisation, in all but 27 participants whose fractures were fixed surgically. Though some trials were well conducted, others were methodologically compromised. For interventions started during immobilisation, there was weak evidence of improved hand function for hand therapy in the days after plaster cast removal, with some beneficial effects continuing one month later (one trial). There was weak evidence of improved hand function in the short term, but not in the longer term (three months), for early occupational therapy (one trial), and of a lack of differences in outcome between supervised and unsupervised exercises (one trial). For interventions started post-immobilisation, there was weak evidence of a lack of clinically significant differences in outcome in patients receiving formal rehabilitation therapy (four trials), passive mobilisation (two trials), ice or pulsed electromagnetic field (one trial), or whirlpool immersion (one trial) compared with no intervention. There was weak evidence of a short-term benefit of continuous passive motion (post external fixation) (one trial), intermittent pneumatic compression (one trial) and ultrasound (one trial). There was weak evidence of better short-term hand function in participants given physiotherapy than in those given instructions for home exercises by a surgeon (one trial). AUTHORS' CONCLUSIONS: The available evidence from randomised controlled trials is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius.

Adult↗
PubMed2002

High first dose quinine regimen for treating severe malaria.

BACKGROUND: Quinine is used for treating severe malaria. There are arguments for giving an initial high dose. We examined the evidence for and against this policy. OBJECTIVES: To assess clinical outcomes and adverse events of a high first (loading) dose regimen of quinine with a uniform (no loading) dose regimen in people with severe malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group specialized trials register (May 2002), The Cochrane Controlled Trials Register (Issue 2, 2002), MEDLINE (1966 to April 2002), EMBASE (1988 to March 2002), LILACS (www.bireme.br; accessed February 2002), and conference proceedings for relevant abstracts. We also contacted researchers working in the field and checked the reference lists of all studies. SELECTION CRITERIA: Randomized controlled trials. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of the trials and extracted data. Review Manager (Version 4.1) was used to analyse the data: Relative Risk for binary data and weighted mean difference (WMD) for continuous data. Study authors were contacted for additional information. MAIN RESULTS: Three small trials, with two contributing to a meta-analysis of 72 participants. Loading dose was associated with fewer deaths, but this was not statistically significant (RR 0.43; 95% confidence interval (CI) 0.09 to 2.15). Loading dose was associated with faster clearance of parasites (WMD 7.44; 95% CI 1.64 to 13.2 hours), resolution of fever (WMD 11.11; 95% CI 2.18 to 20.04 hours), and transient hearing loss (RR 3.14; 95% CI 1.05 to 9.38). No significant difference was detected for recovery of consciousness, neurological sequelae, or convulsions, but the numbers were small. REVIEWER'S CONCLUSIONS: Quinine loading dose reduced fever clearance time and parasite clearance time. Data are insufficient to confirm or refute whether a loading dose reduced the risk of death or convulsions.

Adult↗
PubMed2004

High first dose quinine regimen for treating severe malaria.

BACKGROUND: Quinine is used for treating severe malaria. There are arguments for giving an initial high dose. We examined the evidence for and against this policy. OBJECTIVES: To assess the clinical outcomes and adverse events of a high first (loading) dose regimen of quinine compared with a uniform (no loading) dose regimen in people with severe malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group's trials register (April 2004), CENTRAL (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to April 2004), EMBASE (1974 to April 2004), LILACS (1982 to April 2004), and conference proceedings for relevant abstracts. We also contacted researchers working in the field and checked the reference lists of all studies. SELECTION CRITERIA: Randomized controlled trials comparing a high first (loading) dose of intravenous quinine with a uniform (no loading) dose of intravenous quinine in people with severe malaria. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of the trials and extracted data (including adverse event data). We used Review Manager 4.2 to analyse the data: relative risk (RR) for binary data and weighted mean difference (WMD) for continuous data with 95% confidence intervals (CI). We contacted study authors for additional information. MAIN RESULTS: Four trials (n = 144) met the inclusion criteria. Loading dose was associated with fewer deaths, but this was not statistically significant (RR 0.62, CI 0.19 to 2.04, 3 trials). Loading dose was associated with faster clearance of parasites (WMD -7.44 hours, CI -13.24 to -1.64 hours, 2 trials), resolution of fever (WMD -11.11 hours, CI -20.04 to -2.18 hours, 2 trials). No statistically significant difference was detected for recovery of consciousness, neurological sequelae, or convulsions, but the numbers were small. REVIEWERS' CONCLUSIONS: Quinine loading dose reduced fever clearance time and parasite clearance time. Data are insufficient to directly demonstrate an impact of loading dose on risk of death.

Adult↗
PubMed2005

Systemic administration of local anesthetic agents to relieve neuropathic pain.

BACKGROUND: Lidocaine, mexiletine, tocainide, and flecainide are local anesthetics which give an analgesic effect when administered orally or parenterally. Early reports described the use of intravenous lidocaine or procaine to relieve cancer and postoperative pain (Keats 1951; Gilbert 1951; De Clive-Lowe 1958; Bartlett 1961). Interest reappeared decades later when patient series and clinical trials reported that parenteral lidocaine and its oral analogs tocainide, mexiletine, and flecainide relieved neuropathic pain in some patients (Boas 1982; Lindblom 1984; Petersen 1986; Dunlop 1988; Bach 1990; Awerbuch 1990). With the recent publication of clinical trials with high quality standards, we have reviewed the use of systemic lidocaine and its oral analogs in neuropathic pain to update our knowledge, to measure their benefit and harm, and to better define their role in therapy. OBJECTIVES: To evaluate pain relief and adverse effect rates between systemic local anesthetic-type drugs and other control interventions. SEARCH STRATEGY: We searched MEDLINE (1966 through 15 May 2004), EMBASE (January 1980 to December 2002), Cancer Lit (through 15 December 2002), Cochrane Central Register of Controlled Trials (2nd Quarter, 2004), System for Information on Grey Literature in Europe (SIGLE), and LILACS, from January 1966 through March 2001. We also hand searched conference proceedings, textbooks, original articles and reviews. SELECTION CRITERIA: We included trials with random allocation, that were double blinded, with a parallel or crossover design. The control intervention was a placebo or an analgesic drug for neuropathic pain from any cause. DATA COLLECTION AND ANALYSIS: We collected efficacy and safety data from all published and unpublished trials. We calculated combined effect sizes using continuous and binary data for pain relief and adverse effects as primary and secondary outcome measurements, respectively. MAIN RESULTS: Thirty-two controlled clinical trials met the selection criteria; two were duplicate articles. The treatment drugs were intravenous lidocaine (16 trials), mexiletine (12 trials), lidocaine plus mexiletine sequentially (one trial), and tocainide (one trial). Twenty-one trials were crossover studies, and nine were parallel. Lidocaine and mexiletine were superior to placebo [weighted mean difference (WMD) = -11; 95% CI: -15 to -7; P <0.00001], and limited data showed no difference in efficacy (WMD = -0.6; 95% CI: -7 to 6), or adverse effects versus carbamazepine, amantadine, gabapentin or morphine. In these trials, systemic local anesthetics were safe, with no deaths or life-threatening toxicities. Sensitivity analysis identified data distribution in three trials as a probable source of heterogeneity. There was no publication bias. AUTHORS' CONCLUSIONS: Lidocaine and oral analogs were safe drugs in controlled clinical trials for neuropathic pain, were better than placebo, and were as effective as other analgesics. Future trials should enroll specific diseases and test novel lidocaine analogs with better toxicity profiles. More emphasis is necessary on outcomes measuring patient satisfaction to assess if statistically significant pain relief is clinically meaningful. NOTES: Notes 2017 A restricted search in June 2017 did not identify any potentially relevant studies likely to change the conclusions. Therefore, this review has now been stabilised following discussion with the authors and editors. If appropriate, we will update the review if new evidence likely to change the conclusions is published, or if standards change substantially which necessitate major revisions. 2019 We performed another restricted search in September 2019 but did not identify any potentially relevant studies likely to change the conclusions. Therefore, this review has now been stabilised following discussion with the authors and editors, and we will reassess the review for updating in 2020. If appropriate, we will update the review sooner if new evidence likely to change the conclusions is published, or if standards change substantially which necessitate major revisions. 2020 We performed another restricted search in September 2020 but again did not identify any potentially relevant studies likely to change the conclusions. This area of research is not active and therefore this review has now been stabilised following discussion with the authors and editors; we will reassess the review for updating in 2025. If appropriate, we will update the review sooner if new evidence likely to change the conclusions is published, or if standards change substantially which necessitate major revisions.

Administration, Oral↗
PubMed2005

In vitro fertilisation for unexplained subfertility.

BACKGROUND: In vitro fertilisation (IVF) is now a widely accepted treatment for unexplained infertility (RCOG 1998). However, with estimated live-birth rates per cycle varying between 13% and 28%, its effectiveness has not been rigorously evaluated in comparison with other treatments. With increasing awareness of the role of expectant management and less invasive procedures such as intrauterine insemination, concerns about multiple complications and costs associated with IVF, it is extremely important to evaluate the effectiveness of IVF against other treatment options in couples with unexplained infertility. OBJECTIVES: The aim of this review is to determine, in the context of unexplained infertility, whether IVF improves the probability of live-birth compared with (1) expectant management, (2) clomiphene citrate (CC), (3) intrauterine insemination (IUI) alone, (4) IUI with controlled ovarian stimulation, and (5) gamete intrafallopian transfer (GIFT). SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched 23 March 2004), the Cochrane Central Register of Controlled Trials (Cochrane Library Issue 3, 2004), MEDLINE (1970 to August 2004), EMBASE (1985 to August 2004) and reference lists of articles. We also handsearched relevant conference proceedings and contacted researchers in the field. SELECTION CRITERIA: Only randomised controlled trials were included. Live-birth rate per woman was the primary outcome of interest. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility and quality of trials. MAIN RESULTS: Ten randomised controlled trials were identified. In two we could not extract data separately for unexplained infertility cases, two were non-randomised, one did not report valid rates (included in the review but not in the meta-analysis); leaving four trials for analysis. One trial compared two different interventions (IVF versus IUI with or without ovarian stimulation) and one study compared three interventions (IVF versus IUI with ovarian stimulation and GIFT). The numbers of trials assessing the effectiveness of IVF with the other treatments were as follows: IVF versus expectant management (two), IVF versus IUI (one), IVF versus IUI with ovarian stimulation (two) and IVF versus GIFT (three). Live-birth rate per woman was reported in three studies and three studies determined clinical pregnancy rate per woman. Multiple pregnancy rate was reported in three trials. Two studies reported ovarian hyperstimulation syndrome (OHSS) as an outcome measure. There were no comparative data for clomiphene citrate and no comparative data on live-birth rates for GIFT. There was no evidence of a difference in live-birth rates between IVF and IUI either without (OR 1.96; 95% CI 0.88 to 4.4) or with (OR 1.15; 95% CI 0.55 to 2.4) ovarian stimulation. There were significantly higher clinical pregnancy rates with IVF in comparison to expectant management (OR 3.24; 95% CI 1.07 to 9.80). There was no significant difference between IVF and GIFT for the one RCT that reported live-birth rates (OR 2.57; 95% CI 0.93 to 7.08). However, there was a significant difference in the clinical pregnancy rates between IVF and GIFT, with pregnancy rates greater for IVF (OR 2.14; 95% CI 1.08 to 4.2). There was no evidence of a difference in the multiple pregnancy rates between IVF and IUI with ovarian stimulation (OR 0.63; 95% CI 0.27 to 1.5), however, IVF had a higher rate than GIFT (OR 6.3; 95% CI 1.7 to 23). Clinical heterogeneity was present among the studies included. However, there was no evidence of statistical heterogeneity, which allowed the studies to be combined for statistical analysis. AUTHORS' CONCLUSIONS: Any effect of IVF relative to expectant management, clomiphene citrate, IUI with or without ovarian stimulation and GIFT in terms of live-birth rates for couples with unexplained subfertility remains unknown. The studies included are limited by their small sample size so that even large differences might be hidden. Live-birth rates are seldom reported. Periods of follow up are inadequate and unequal. Adverse effects such as multiple pregnancies and ovarian hyperstimulation syndrome have also not been reported in most studies. Larger trials with adequate power are warranted to establish the effectiveness of IVF in these women. Future trials should not only report rates per woman/couple but also include adverse effects and costs of the treatments as outcomes. Factors that have a major effect on these outcomes such as fertility treatment, female partner's age, duration of infertility and previous pregnancy history should also be considered.

Clomiphene↗
PubMed2001

Kava extract for treating anxiety.

BACKGROUND: Synthetic anxiolytic drugs are effective for anxiety, but they are burdened with adverse events. Constraints on resources and time often render treatments such as psychological interventions impracticable. Thus, an effective and safe oral medication would be of considerable interest and a welcome addition to the therapeutic repertoire. OBJECTIVES: To systematically review the evidence regarding the efficacy and safety of kava extract for the symptomatic treatment of anxiety. SEARCH STRATEGY: Computerized literature searches were performed in the databases Medline, Embase, Biosis, AMED, CISCOM and the Cochrane Library (all from their respective inception to June 1998). The search terms used were kava, kawa, kavain, Piper methysticum and Rauschpfeffer (German common name for Piper methysticum). Manufacturers of kava preparations and experts on the subject were contacted and asked to contribute published and unpublished material. In addition, our own files were searched and the bibliographies of all of the studies identified were scanned for further trials. There were no restrictions regarding the language of publication. SELECTION CRITERIA: Randomized, double-blind trials of oral kava extract mono-preparations for the treatment of anxiety were included. Trials comparing kava with placebo were included. Trials assessing kava as one of several active constituents in a combination preparation or as a part of a combination treatment were excluded. DATA COLLECTION AND ANALYSIS: All publications were blinded prior to assessment by a person not involved in the study. Data on patients, interventions, methods, results and adverse events were extracted systematically. Methodological quality of all trials was evaluated using the scoring system developed by Jadad and colleagues. The screening of studies, selection, data extraction and the assessment of methodological quality were performed independently by the two reviewers. Disagreements in the evaluation of individual trials were resolved through discussion. MAIN RESULTS: Seven trials met the inclusion criteria. All of the reviewed trials suggest superiority of kava extract over placebo. The meta-analysis of three studies using the Hamilton Anxiety Score as a common outcome measure suggests a significant differential treatment effect in favour of kava extract (weighted mean difference: 9.69, 95% confidence interval: 3.54 - 15.83). Adverse events as reported in the reviewed trials were mild, transient and infrequent. REVIEWER'S CONCLUSIONS: These data imply that kava extract is superior to placebo and relatively safe as a symptomatic treatment for anxiety. These findings warrant further and more rigorous investigations into the efficacy and safety of kava extract.

Anxiety↗
PubMed2006

Topiramate for acute affective episodes in bipolar disorder.

BACKGROUND: Bipolar disorder is a common recurrent illness with high levels of chronicity. Treatment resistance persists despite the use of established medications, such as lithium and valproate. New medications are required for the treatment of refractory cases. Retrospective and open-label trials have suggested that the anticonvulsant topiramate may be efficacious in bipolar disorder. There is a need to clarify the evidence available in the form of randomised controlled trials for its use in bipolar disorder. OBJECTIVES: To review the evidence for the efficacy and acceptability of topiramate in the treatment of acute mood episodes in bipolar disorder. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis (CCDAN) group search strategy was used. The following databases were searched:The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), September 2003;The Cochrane Controlled Clinical Trials Register (CCCTR), September 2003;EMBASE (1980 to December 2003);MEDLINE (1966 to December 2003);LILACS;PsycLIT;Psyndex.Reference lists of relevant papers and major textbooks of mood disorder. Handsearches (specialist journals and conference proceedings). Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable published or unpublished trials. SELECTION CRITERIA: Randomised controlled trials which compared topiramate with placebo or with active agents in the treatment of any acute mood episodes in bipolar disorder. Participants were patients with bipolar disorder and were males and females of all ages. DATA COLLECTION AND ANALYSIS: Data extraction and methodological quality assessment were performed independently by two reviewers. For analysis, relative risk was used for binary efficacy outcomes and the weighted mean difference or standardised mean difference was used for continuously distributed outcomes. MAIN RESULTS: One randomised controlled trial met the inclusion criteria for the review, a comparison between topiramate and bupropion sustained release (SR) in the adjunctive treatment of depressed patients with bipolar disorder. However, the trial had several limitations in methodology and in the description of data. Its data regarding efficacy required clarification before it could be analysed according to the protocol of this systematic review. From the limited data available, topiramate had efficacy similar to bupropion SR in the adjunctive treatment of bipolar depression. Both groups of subjects suffered a high drop-out rate. There was no significant difference between the topiramate and the bupropion treated groups in those dropping out for any reason (relative risk 1.60, 95% confidence interval 0.65 to 3.96). There was no significant difference in those withdrawing from the study due to adverse effects (relative risk 1.50, 95% confidence interval 0.51 to 4.43). Although the data on weight loss were not analysed formally, weight loss was marked in the topiramate treated group. Several unpublished trials have been identified and data from these trials may be included in future reviews. AUTHORS' CONCLUSIONS: There is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness, either in monotherapy or as an adjunctive treatment.

Affective Disorders, Psychotic↗
PubMed2004

Number of embryos for transfer following in-vitro fertilisation or intra-cytoplasmic sperm injection.

BACKGROUND: The traditional reliance on the transfer of multiple embryos during in vitro fertilisation (IVF) in order to maximise the chance of pregnancy, has resulted in increasing rates of multiple pregnancies. Women undergoing IVF had a 20 - fold increased risk of twins and 400 - fold increased risk of higher order pregnancies (Martin 1998). The maternal and perinatal morbidity and mortality as well as national health service costs associated with multiple pregnancies is significantly high in comparison with singleton births (Luke 1992; Callahan 1994; Goldfarb 1996). Single embryo transfer is now being considered as an effective means of reducing this iatrogenic complication. This systematic review evaluates the effectiveness of elective two embryo transfer in comparison with single and more than two embryo transfer following IVF and ICSI (intra cytoplasmic sperm injection) treatment. OBJECTIVES: The aim of this review is to determine, whether in couples who undergo IVF/ICSI: (1) the elective transfer of two embryos improves the probability of livebirth compared with: (a) Single embryo transfer, (b) Three embryo transfer or (c) Four embryo transfer.(2) the elective transfer of three embryos improves the probability of livebirth compared with: (a) Single embryo transfer, or (b) Four embryo transfer, SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group's trials register (searched June 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), MEDLINE (1970 to 2003), EMBASE (1985 to 2003) and reference lists of articles. We also handsearched relevant conference proceedings and contacted researchers in the field. SELECTION CRITERIA: Only randomised controlled trials were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility and quality of trials. MAIN RESULTS: We found no studies that compared a policy of transferring multiple embryos on one cycle versus a policy of cryo- preservation and transfer of a single embryo over multiple cycles. We also found no trials comparing transfer of two versus three embryos. Three small, poorly reported trials compared transfer of two versus one embryo in a single cycle, and one small, poorly reported trial compared transfer of two versus four embryos in a single cycle. The clinical pregnancy rate per woman/couple associated with two embryo transfer was significantly higher compared to single embryo transfer (OR 2.08, 95% CI 1.24 to 3.50; test for overall effect p = 0.006). The live birth rate per woman/couple associated with two embryo transfer was also significantly higher than that associated with single embryo transfer (OR 1.90, 95% CI 1.12 to 3.22, test for overall effect p=0.02). The multiple pregnancy rate was significantly lower in women who had single embryo transfer (OR 9.97, 95% CI 2.61 to 38.19; p = 0.0008). The effectiveness of double embryo transfer versus four embryo transfer was tested in a single trial. There was no statistically significant differences in the clinical pregnancy rate (OR 0.75, 95% CI 0.26 to 2.16; p=0.6), and multiple pregnancy rates (OR 0.44. 95% CI 0.10 to 1.97; p = 0.28) between the two groups. The livebirth rate in the four embryo transfer group was higher compared to the two embryo transfer group, but the results were not statistically significant (OR 0.35, 95% CI 0.11 to 1.05; p = 0.06). REVIEWERS' CONCLUSIONS: The results of this systematic review suggest that live birth and pregnancy rates following single embryo transfer are lower than those following double embryo transfer as are the chances of multiple pregnancy including twins. As such, it is unlikely that the conclusions are robust enough to catalyse a change in clinical practice. The studies included are limited by their small sample size, so that even large differences might be hidden. Cumulative livebirth rates are seldom reported. The data were inadequate to draw conclusions about single embryo transfer and first frozen single embryo transfer (1FZET) or subsequent single frozen embryo transfers. Until more evidence is available single embryo transfer may not be the preferred choice for all patients undergoing IVF/ICSI. Clinicians may need to individualise protocols for couples based on their risks of multiple pregnancy. A definitive pragmatic, large multi centre randomised controlled trial comparing single embryo versus double embryo transfer in terms of clinical and cost effectiveness as well as acceptability is required. The primary outcome measured should be cumulative livebirth per woman/couple.

Embryo Transfer↗
PubMed2005

Group based training for self-management strategies in people with type 2 diabetes mellitus.

BACKGROUND: It has been recognised that adoption of self-management skills by the person with diabetes is necessary in order to manage their diabetes. However, the most effective method for delivering education and teaching self-management skills is unclear. OBJECTIVES: To assess the effects of group-based, patient-centred training on clinical, lifestyle and psychosocial outcomes in people with type 2 diabetes. SEARCH STRATEGY: Studies were obtained from computerised searches of multiple electronic bibliographic databases, supplemented by hand searches of reference lists of articles, conference proceedings and consultation with experts in the field. Date of last search was February 2003. SELECTION CRITERIA: Randomised controlled and controlled clinical trials which evaluated group-based education programmes for adults with type 2 diabetes compared with routine treatment, waiting list control or no intervention. Studies were only included if the length of follow-up was six months or more and the intervention was at least one session with the minimum of six participants. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. A meta-analysis was performed if there were enough homogeneous studies reporting an outcome at either four to six months, 12-14 months, or two years, otherwise the studies were summarised in a descriptive manner. MAIN RESULTS: Fourteen publications describing 11 studies were included involving 1532 participants. The results of the meta-analyses in favour of group-based diabetes education programmes were reduced glycated haemoglobin at four to six months (1.4%; 95% confidence interval (CI) 0.8 to 1.9; P < 0.00001), at 12-14 months (0.8%; 95% CI 0.7 to 1.0; P < 0.00001) and two years (1.0%; 95% CI 0.5 to 1.4; P < 0.00001); reduced fasting blood glucose levels at 12 months (1.2 mmol/L; 95% CI 0.7 to 1.6; P < 0.00001); reduced body weight at 12-14 months (1.6 Kg; 95% CI 0.3 to 3.0; P = 0.02); improved diabetes knowledge at 12-14 months (SMD 1.0; 95% CI 0.7 to 1.2; P < 0.00001) and reduced systolic blood pressure at four to six months (5 mmHg: 95% CI 1 to 10; P = 0.01). There was also a reduced need for diabetes medication (odds ratio 11.8, 95% CI 5.2 to 26.9; P < 0.00001; RD = 0.2; NNT = 5). Therefore, for every five patients attending a group-based education programme we could expect one patient to reduce diabetes medication. AUTHORS' CONCLUSIONS: Group-based training for self-management strategies in people with type 2 diabetes is effective by improving fasting blood glucose levels, glycated haemoglobin and diabetes knowledge and reducing systolic blood pressure levels, body weight and the requirement for diabetes medication.

Adult↗
PubMed2003

Drug therapies for reducing gastric acidity in people with cystic fibrosis.

BACKGROUND: Malabsorption of fat and protein contributes to the poor nutritional status in people with cystic fibrosis. Impaired pancreatic function may also result in increased gastric acidity leading in turn to heartburn, peptic ulcers and the impairment of oral pancreatic replacement therapy. The administration of gastric reducing agents has been used as an adjunct to pancreatic enzyme therapy to improve nutritional status, fat malabsorption and gastro-intestinal symptoms in people with cystic fibrosis. It is thus important to establish the current level of evidence regarding potential benefits of drug therapies that reduce gastric acidity in people with cystic fibrosis. OBJECTIVES: To assess the effect of drug therapies for reducing gastric acidity: in improving nutritional status; on symptoms associated with increased gastric acidity; fat absorption; lung function; quality of life and survival; and to determine if any adverse effects are associated with their use. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books and conference proceedings. Most recent search of the Group's register: April 2002. SELECTION CRITERIA: All randomised and quasi-randomised trials involving agents that reduce gastric acidity compared to placebo or a comparator treatment. DATA COLLECTION AND ANALYSIS: Both reviewers independently selected trials and assessed trial quality. MAIN RESULTS: Thirty-six trials were identified from the initial search. Eleven trials with 172 participants were suitable for inclusion. Five trials were limited to children and three trials enrolled only adults. One trial found that drug therapies which reduce gastric acidity improve gastro-intestinal symptoms such as abdominal pain. Five trials reported significant improvement in measures of fat malabsorption. Two trials reported no significant improvement in nutritional status. Only one trial reported measures of respiratory function and one trial reported an adverse effect with prostaglandin E2 analogue misoprostol. No trials have been identified which assess the effectiveness of agents that reduce gastric acidity in improving quality of life, the complications of increased gastric acidity, or survival. REVIEWER'S CONCLUSIONS: Trials have shown limited evidence that the agents which reduce gastric acidity in people with cystic fibrosis are associated with improvement in gastro-intestinal symptoms and fat absorption. Currently, there is insufficient evidence to indicate whether there is an improvement in nutritional status, lung function, quality of life, or survival. We therefore recommend large, multicentre, randomised controlled clinical trials are undertaken to evaluate these interventions.

Cystic Fibrosis↗
PubMed2002

Splenectomy versus conservative management for acute sequestration crises in people with sickle cell disease.

BACKGROUND: Acute splenic sequestration crises are a complication of sickle cell disease, with high mortality rates and frequent recurrence in survivors of first attacks. Splenectomy and blood transfusion, with their consequences, are the mainstay of long term management used in different parts of the world. OBJECTIVES: To assess whether splenectomy (total or partial) to prevent acute splenic sequestration crises in people with sickle cell disease improved survival and decreased morbidity in patients with sickle cell disease, as compared with regular blood transfusion. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, hand searching relevant journals and hand searching abstract books of conference proceedings Additional randomized controlled trials were sought from the reference lists of the studies found and reviews identified by the search strategy. Date of the most recent search: December 2001 SELECTION CRITERIA: All randomized or quasi-randomized controlled trials comparing splenectomy (total or partial) to prevent recurrence of acute splenic sequestration crises to no treatment or blood transfusion in people with sickle cell disease. DATA COLLECTION AND ANALYSIS: No trials of splenectomy for acute splenic sequestration were found. MAIN RESULTS: No trials of splenectomy for acute splenic sequestration were found. REVIEWER'S CONCLUSIONS: Splenectomy, if full, will prevent further sequestration and if partial, may reduce the recurrence of acute splenic sequestration crises but there is lack of evidence from trials that it improves survival and decreases morbidity in sickle cell disease. There is a need for a well-designed, adequately powered randomised controlled trial to assess the benefits and risks of splenectomy compared to transfusion programmes as a means of improving survival and decreasing mortality from ASS in people with sickle cell disease.

Acute Disease↗
PubMed2002

Drugs for preventing red blood cell dehydration in people with sickle cell disease.

BACKGROUND: Sickle cell disease is an inherited disorder of haemoglobin, which results in abnormal red blood cells. These can deform and cause blockages in blood vessels, leading to acute crises such as pain, stroke and splenic sequestration, and chronic organ and tissue damage. Recently research has begun to focus on therapies which prevent the red blood cells deforming by reducing the loss of water and ions from the cells. However, little is known about the effectiveness and safety of such drugs. OBJECTIVES: To assess the relative risks and benefits of drugs which aim to prevent sickle cell related crises by reducing red blood cell dehydration. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Date of the most recent search of the Group's specialised register: December 2001. SELECTION CRITERIA: All those randomised or quasi-randomised controlled trials of drugs which aim to prevent sickle cell crises by reducing red cell dehydration, compared to placebo or an alternative treatment. DATA COLLECTION AND ANALYSIS: Both reviewers independently selected trials for inclusion, assessed trial quality and extracted data from the included studies. MAIN RESULTS: Of the 27 trials identified, two met the inclusion criteria. The two trials tested the effectiveness of zinc sulphate and piracetam to prevent sickle cell related crises in a total of 246 patients. A reduction in pain crises was shown in the piracetam study over one year (weighted mean difference (WMD) -1.9 (95% CI -3.01, -0.79)), although blood counts were not significantly changed. The zinc trial showed a significant reduction in the total number of pain, haemolytic, aplastic and sequestration crises over one and a half years (WMD -2.83 (95% CI -3.51, -2.15)), but our analysis was limited by non-reporting of standard deviations for some data. Changes to red cell parameters and blood counts were inconsistent. No serious adverse events were noted in either trial. REVIEWER'S CONCLUSIONS: While the results of both zinc and piracetam for reducing sickle related crises are encouraging, larger, and/or longer term multicentre trials over a number of years are needed to evaluate the effectiveness of these therapies for patients with sickle cell disease.

Anemia, Sickle Cell↗