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PubMed2001

Speech and language therapy for dysarthria in Parkinson's disease.

BACKGROUND: Dysarthria is a common manifestation of Parkinson's disease which increases in frequency and intensity with the progress of the disease (Streifler 1984). Up to 20% of Parkinsonian patients are referred for speech and language therapy (S & L T), its aim being to improve the intelligibility of the patient's speech. OBJECTIVES: To compare the efficacy of speech and language therapy versus placebo or no interventions in patients with Parkinson's disease. SEARCH STRATEGY: Relevant trials were identified by electronic searches of MEDLINE, EMBASE, CINAHL, ISI-SCI, AMED, MANTIS, REHABDATA, REHADAT, GEROLIT, Pascal, LILACS, MedCarib, JICST-EPlus, AIM, IMEMR, SIGLE, ISI-ISTP, DISSABS, Conference Papers Index, Aslib Index to Theses, the Cochrane Controlled Trials Register, the CentreWatch Clinical Trials listing service, the metaRegister of Controlled Trials, ClinicalTrials.gov, CRISP, PEDro, NIDRR and NRR; and examination of the reference lists of identified studies and other reviews. SELECTION CRITERIA: Only randomised controlled trials (RCT) were included. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by KD and RW and differences settled by discussion. MAIN RESULTS: Three randomised controlled trials were found comparing speech and language therapy with placebo for speech disorders in Parkinson's disease. A total of 63 patients were examined. The loudness of the patients' voices were increased by between 7-18%, depending on the speaking task being performed. It is likely that this is a clinically significant improvement. After six months the degree of improvement was reduced but was still statistically significant. Overall measures of dysarthria were measured in two trials and also improved. The clinical significance of these improvements was less clear cut as intelligibility of speech was not measured in any of these studies. REVIEWER'S CONCLUSIONS: Considering the small number of patients examined, the methodological flaws in many of the studies, and the possibility of publication bias, there is insufficient evidence to support or refute the efficacy of speech and language therapy for dysarthria in Parkinson's disease. A Delphi-style survey is needed to develop a consensus as to what is 'standard' S< for dysarthria in Parkinson's disease. Then a large well designed placebo-controlled RCT is needed to demonstrate speech and language therapy's effectiveness for dysarthria in Parkinson's disease. The trial should conform to CONSORT guidelines. Outcome measures with particular relevance to patients should be chosen and the patients followed for at least 6 months to determine the duration of any improvement.

Dysarthria↗
PubMed2001

Non-pharmacological therapies for dysphagia in Parkinson's disease.

BACKGROUND: Dysphagia occurs frequently in Parkinson's disease although patients themselves may be unaware of swallowing difficulties. Speech and language therapists in conjunction with nurses and dietitians use techniques that aim to improve swallowing and reduce the risk of choking, aspiration and chest infections. OBJECTIVES: ~Bullet~To compare the efficacy and effectiveness of non-pharmacological swallowing therapy for dysphagia versus placebo or no intervention in patients with Parkinson's disease. ~Bullet~To compare one form of non-pharmacological swallowing therapy for dysphagia with another in patients with Parkinson's disease. SEARCH STRATEGY: Relevant trials were identified by electronic searches of MEDLINE, EMBASE, CINAHL, ISI-SCI, AMED, MANTIS, REHABDATA, REHADAT, GEROLIT, Pascal, LILACS, MedCarib, JICST-EPlus, AIM, IMEMR, SIGLE, ISI-ISTP, DISSABS, Conference Papers Index, Aslib Index to Theses, the Cochrane Controlled Trials Register, the CentreWatch Clinical Trials listing service, the metaRegister of Controlled Trials, ClinicalTrials.gov, CRISP, PEDro, NIDRR and NRR; and examination of the reference lists of identified studies and other reviews. SELECTION CRITERIA: Only randomised controlled trials (RCT) were included. We did not examine any trials using drugs or surgery to treat the dysphagia. We did not examine any trials where part of the therapist's advice was to insert a nasogastric or percutaneous gastrostomy tube. DATA COLLECTION AND ANALYSIS: Not applicable. MAIN RESULTS: No randomised controlled trials or controlled trials were found that examined the efficacy of non-pharmacological swallowing therapy for the treatment of dysphagia in Parkinson's disease. However there is one large RCT currently recruiting patients that will compare 'chin down' posture with thickened liquids in the treatment of dysphagia. The main outcomes will be the rates of aspiration and pneumonia. REVIEWER'S CONCLUSIONS: There is currently no evidence to support or refute the efficacy of non-pharmacological swallowing therapy for dysphagia in Parkinson's disease. Large well designed placebo-controlled RCTs are required to assess the effectiveness of swallowing therapy for dysphagia in Parkinson's disease and reported according to CONSORT guidelines. Suitable outcome measures should be chosen so that the efficacy and effectiveness of non-pharmacological swallowing therapy can be assessed and an economic analysis performed. Outcomes which have meaning to patients and carers should be used wherever possible since they need to know the value of this therapy in practical terms. The patients should be followed for at least 6 months to determine the duration of any improvement.

Deglutition↗
PubMed2002

Tracheal gas insufflation for the prevention of morbidity and mortality in mechanically ventilated newborn infants.

BACKGROUND: Tracheal gas insufflation (TGI) is a technique where a continuous flow of gas is instilled into the lower trachea during conventional mechanical ventilation. TGI can improve carbon dioxide removal with lower ventilation pressures and smaller tidal volumes, potentially decreasing secondary lung injury and chronic lung disease (CLD). OBJECTIVES: To assess whether, in mechanically ventilated neonates, the use of tracheal gas insufflation reduces mortality, CLD and other adverse clinical outcomes without significant side effects. SEARCH STRATEGY: Searches were made of MEDLINE 1966 to December 2001, CINAHL 1982 to December 2001, the Cochrane Controlled Trials Register (Cochrane Library, Issue 4, 2001) and conference and symposia proceedings. SELECTION CRITERIA: Randomised controlled trials (RCT) that include newborn infants who are mechanically ventilated, and compare TGI during conventional mechanical ventilation (CMV) with CMV alone. Primary outcomes - mortality, CLD and neurodevelopmental outcome; secondary outcomes - air leak, intraventricular haemorrhage, periventricular leukomalacia, duration of mechanical ventilation, duration of respiratory support, duration of oxygen therapy, duration of hospital stay, retinopathy of prematurity, immediate adverse effects. DATA COLLECTION AND ANALYSIS: Each reviewer assessed eligibility, trial quality and extracted data separately. Study authors were contacted for additional information if necessary. MAIN RESULTS: Only one small study was found to be eligible. This study found no evidence of effect on mortality, CLD or age at first extubation. The total duration of ventilation was 9.3 days shorter in the TGI group (95% CI from 15.7 to 2.9 days shorter). The age at complete weaning from ventilation was 26 days shorter in the TGI group (95% CI from 46 to 6 days shorter). There was no evidence of effect on the total duration of respiratory support, oxygen therapy or hospital stay. REVIEWER'S CONCLUSIONS: There is evidence from a single RCT that TGI may reduce the duration of mechanical ventilation in preterm infants - although the data from this small study do not give sufficient evidence to support the introduction of TGI into clinical practice. The technical requirements for performing TGI (as performed in the single included study) are great. There is no statistically significant reduction in the total duration of respiratory support or hospital stay. TGI cannot be recommended for general use at this time.

Humans↗
PubMed2002

Prostacyclin for pulmonary hypertension.

BACKGROUND: Primary pulmonary hypertension (PPH) is progressive, resulting in right ventricular failure. Survival seldom exceeds five years. Pulmonary hypertension can be idiopathic or associated with other conditions. It is common in patients with diffuse scleroderma and the CREST syndrome where it is clinically, haemodynamically and prognostically indistinguishable from idiopathic primary pulmonary hypertension. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. Iloprost is a chemically stable derivative of prostacyclin with similar biologic properties and can be given orally, by infusion or nebulised. OBJECTIVES: To determine the efficacy of prostacyclin or one of its analogues in idiopathic primary pulmonary hypertension. SEARCH STRATEGY: A search was carried out using the Cochrane controlled clinical trial register. SELECTION CRITERIA: Randomised controlled trials (RCTs) involving patients with primary pulmonary hypertension were selected by two reviewers. DATA COLLECTION AND ANALYSIS: Study quality was assessed and data extracted independently by two reviewers. Outcomes were analysed as continuous and dichotomous outcomes, using standard statistical techniques. MAIN RESULTS: Four RCTs were included, all of short duration (8-12 weeks). Three compared intravenous epoprostenol with conventional therapy, two were in PPH (n = 81 and n = 21) and one with pulmonary hypertension in scleroderma (n = 111). One compared intravenous Iloprost with placebo in 14 patients with scleroderma. Exercise capacity improved in patients treated with intravenous epoprostenol (Standardised Mean Difference) 0.69, 95% Confidence Intervals (CI) 0.40, 0.97. Several haemodynamic variables improved in the group treated with epoprostenol; e.g. mean pulmonary artery pressure fell: Weighted Mean Difference -6.3 mmHg (95% CI -3.9, -8.7). Mortality was improved Peto Odds Ratio 0.32 (95% CI 0.13, 0.77), although this effect was not significant when analysed using a more conservative random effects model: Odds Ratio 0.32 (95% CI 0.06, 1.58). Side effects and adverse events related to the indwelling catheter (sepsis and thrombosis) were common. REVIEWER'S CONCLUSIONS: Intravenous prostacyclin over 12 weeks improves exercise capacity, NYHA functional class and several cardiopulmonary haemodynamic variables. It may improve mortality.

Antihypertensive Agents↗
PubMed2005

Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain.

BACKGROUND: Chronic low-back pain (LBP) affects a significant proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an adjunct to the pharmacological management of pain. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. OBJECTIVES: The aim of this systematic review was to determine the effectiveness of TENS in the management of chronic LBP. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (Issue 2, 2005), MEDLINE, EMBASE and PEDro up to April 1, 2005. SELECTION CRITERIA: Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effect model was used throughout for calculating continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences (WMD) with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between the treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: The only two RCTs (175 patients) meeting eligibility criteria differed in study design, methodological quality, inclusion and exclusion criteria, type and method of TENS application, treatment schedule, co-interventions and final outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significant differences between treatment and control groups were shown for multiple outcome measures. Pre-planned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations and baseline patient characteristics were not possible due to the small number of included trials. AUTHORS' CONCLUSIONS: There is inconsistent evidence to support the use of TENS as a single treatment in the management of chronic LBP. Larger, multi-center, randomized controlled trials are needed to better assess the true effectiveness of TENS. Special attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low-back pain.

Chronic Disease↗
PubMed2001

Stapled versus handsewn methods for colorectal anastomosis surgery.

BACKGROUND: Randomized controlled trials comparing stapled with handsewn colorectal anastomosis have not shown either technique to be superior, perhaps because individual studies lacked statistical power. A systematic review, with pooled analysis of results, might provide a more definitive answer. OBJECTIVES: To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications. SEARCH STRATEGY: The RCT register of the Cochrane Review Group was searched for any trial or reference to a relevant trial (published, in-press, or in progress). All publications were sought through computerised searches of EMBASE, LILACS, MEDLINE, the Cochrane Controlled Clinical Trials Database, and through letters to industrial companies and authors. There were no limits upon language, date, or other criteria. SELECTION CRITERIA STUDIES: All randomized clinical trials (RCTs) in which stapled and handsewn colorectal anastomosis were compared. PARTICIPANTS: Adult patients submitted electively to colorectal anastomosis. INTERVENTIONS: Endoluminal circular stapler and handsewn colorectal anastomosis. OUTCOMES: a) Mortality b) Overall Anastomotic Dehiscence c) Clinical Anastomotic Dehiscence d) Radiological Anastomotic Dehiscence e) Stricture f) Anastomotic Haemorrhage g) Reoperation h) Wound Infection i) Anastomosis Duration j) Hospital Stay. DATA COLLECTION AND ANALYSIS: Data were independently extracted by the two reviewers (SASL, DM) and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomization (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up were recorded. The results of each RCT were summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by characteristics of the participants, the interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The Risk Difference method (random effects model) and NNT for dichotomous outcomes measures and weighted mean difference for continuous outcomes measures, with the corresponding 95% confidence interval, were presented in this review. Statistical heterogeneity was evaluated by using funnel plot and chi-square testing. MAIN RESULTS: Of the 1233 patients enrolled ( in 9 trials), 622 were treated with stapled, and 611 with manual, suture. The following main results were obtained: a) Mortality: result based on 901 patients; Risk Difference - 0.6% Confidence Interval -2.8% to +1.6%. b) Overall Dehiscence: result based on 1233 patients; Risk Difference 0.2%, 95% Confidence Interval -5.0% to +5.3%. c) Clinical Anastomotic Dehiscence : result based on 1233 patients; Risk Difference -1.4%, 95% Confidence Interval -5.2 to +2.3%. d) Radiological Anastomotic Dehiscence : result based on 825 patients; Risk Difference 1.2%, 95% Confidence Interval -4.8% to +7.3%. e) Stricture: result based on 1042 patients; Risk Difference 4.6%, 95% Confidence Interval 1.2% to 8.1%. Number needed to treat 17, 95% confidence interval 12 to 31. f) Anastomotic Hemorrhage: result based on 662 patients; Risk Difference 2.7%, 95% Confidence Interval - 0.1% to +5.5%. g) Reoperation: result based on 544 patients; Risk Difference 3.9%, 95% Confidence Interval 0.3% to 7.4%. h) Wound Infection: result based on 567 patients; Risk Difference 1.0%, 95% Confidence Interval -2.2% to +4.3%. i) Anastomosis duration: result based on one study (159 patients); Weighted Mean Difference -7.6 minutes, 95% Confidence Interval -12.9 to -2.2 minutes. j) Hospital Stay: result based on one study (159 patients), Weighted Mean Difference 2.0 days, 95% Confidence Interval -3.27 to +7.2 days. REVIEWER'S CONCLUSIONS: The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis, regardless of the level of anastomosis.

Adult↗
PubMed2005

Short term benefits for laparoscopic colorectal resection.

BACKGROUND: Colorectal resections are common surgical procedures all over the world. Laparoscopic colorectal surgery is technically feasible in a considerable amount of patients under elective conditions. Several short-term benefits of the laparoscopic approach to colorectal resection (less pain, less morbidity, improved reconvalescence and better quality of life) have been proposed. OBJECTIVES: This review compares laparoscopic and conventional colorectal resection with regards to possible benefits of the laparoscopic method in the short-term postoperative period (up to 3 months post surgery). SEARCH STRATEGY: We searched MEDLINE, EMBASE, CancerLit, and the Cochrane Central Register of Controlled Trials for the years 1991 to 2004. We also handsearched the following journals from 1991 to 2004: British Journal of Surgery, Archives of Surgery, Annals of Surgery, Surgery, World Journal of Surgery, Disease of Colon and Rectum, Surgical Endoscopy, International Journal of Colorectal Disease, Langenbeck's Archives of Surgery, Der Chirurg, Zentralblatt für Chirurgie, Aktuelle Chirurgie/Viszeralchirurgie. Handsearch of abstracts from the following society meetings from 1991 to 2004: American College of Surgeons, American Society of Colorectal Surgeons, Royal Society of Surgeons, British Assocation of Coloproctology, Surgical Association of Endoscopic Surgeons, European Association of Endoscopic Surgeons, Asian Society of Endoscopic Surgeons. SELECTION CRITERIA: All randomised-controlled trial were included regardless of the language of publication. No- or pseudorandomised trials as well as studies that followed patient's preferences towards one of the two interventions were excluded, but listed separately. RCT presented as only an abstract were excluded. DATA COLLECTION AND ANALYSIS: Results were extracted from papers by three observers independently on a predefined data sheet. Disagreements were solved by discussion. 'REVMAN 4.2' was used for statistical analysis. Mean differences (95% confidence intervals) were used for analysing continuous variables. If studies reported medians and ranges instead of means and standard deviations, we assumed the difference of medians to be equal to the difference of means. If no measure of dispersion was given, we tried to obtain these data from the authors or estimated SD as the mean or median. Data were pooled and rate differences as well as weighted mean differences with their 95% confidence intervals were calculated using random effects models. MAIN RESULTS: 25 RCT were included and analysed. Methodological quality of most of these trials was only moderate and perioperative treatment was very traditional in most studies. Operative time was longer in laparoscopic surgery, but intraoperative blood was less than in conventional surgery. Intensity of postoperative pain and duration of postoperative ileus was shorter after laparoscopic colorectal resection and pulmonary function was improved after a laparoscopic approach. Total morbidity and local (surgical) morbidity was decreased in the laparoscopic groups. General morbidity and mortality was not different between both groups. Until the 30th postoperative day, quality of life was better in laparoscopic patients. Postoperative hospital stay was less in laparoscopic patients. AUTHORS' CONCLUSIONS: Under traditional perioperative treatment, laparoscopic colonic resections show clinically relevant advantages in selected patients. If the long-term oncological results of laparoscopic and conventional resection of colonic carcinoma show equivalent results, the laparoscopic approach should be preferred in patients suitable for this approach to colectomy.

Blood Loss, Surgical↗
PubMed2004

Omega 3 fatty acids for prevention and treatment of cardiovascular disease.

BACKGROUND: It has been suggested that omega 3 (W3, n-3 or omega-3) fats from oily fish and plants are beneficial to health. OBJECTIVES: To assess whether dietary or supplemental omega 3 fatty acids alter total mortality, cardiovascular events or cancers using both RCT and cohort studies. SEARCH STRATEGY: Five databases including CENTRAL, MEDLINE and EMBASE were searched to February 2002. No language restrictions were applied. Bibliographies were checked and authors contacted. SELECTION CRITERIA: RCTs were included where omega 3 intake or advice was randomly allocated and unconfounded, and study duration was at least six months. Cohorts were included where a cohort was followed up for at least six months and omega 3 intake estimated. DATA COLLECTION AND ANALYSIS: Studies were assessed for inclusion, data extracted and quality assessed independently in duplicate. Random effects meta-analysis was performed separately for RCT and cohort data. MAIN RESULTS: Forty eight randomised controlled trials (36,913 participants) and 41 cohort analyses were included. Pooled trial results did not show a reduction in the risk of total mortality or combined cardiovascular events in those taking additional omega 3 fats (with significant statistical heterogeneity). Sensitivity analysis, retaining only studies at low risk of bias, reduced heterogeneity and again suggested no significant effect of omega 3 fats. Restricting analysis to trials increasing fish-based omega 3 fats, or those increasing short chain omega 3s, did not suggest significant effects on mortality or cardiovascular events in either group. Subgroup analysis by dietary advice or supplementation, baseline risk of CVD or omega 3 dose suggested no clear effects of these factors on primary outcomes. Neither RCTs nor cohorts suggested increased relative risk of cancers with higher omega 3 intake but estimates were imprecise so a clinically important effect could not be excluded. REVIEWERS' CONCLUSIONS: It is not clear that dietary or supplemental omega 3 fats alter total mortality, combined cardiovascular events or cancers in people with, or at high risk of, cardiovascular disease or in the general population. There is no evidence we should advise people to stop taking rich sources of omega 3 fats, but further high quality trials are needed to confirm suggestions of a protective effect of omega 3 fats on cardiovascular health. There is no clear evidence that omega 3 fats differ in effectiveness according to fish or plant sources, dietary or supplemental sources, dose or presence of placebo.

Cardiovascular Diseases↗
PubMed2003

Pharmacological management for agitation and aggression in people with acquired brain injury.

BACKGROUND: Of the many psychiatric symptoms that may result from brain injury, agitation and/or aggression are often the most troublesome. It is therefore important to evaluate the efficacy of psychotropic medication used in its management. OBJECTIVES: To evaluate the effects of drugs for agitation and/or aggression following acquired brain injury (ABI). SEARCH STRATEGY: We searched MEDLINE (1966-2002), EMBASE (1980-2002) and the Cochrane Controlled Trials Register (1996-2002), Web of Science Citation Index, reference lists of papers meeting the inclusion criteria and recent reviews. We handsearched Brain Injury and the Journal of Head Trauma Rehabilitation. There were no language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) that evaluated the efficacy of drugs acting on the central nervous system for agitation and/or aggression, secondary to ABI, in participants over 10 years of age. Studies using lower levels of evidence (i.e. case series studies, single case studies and controlled group comparison studies), were collated in an appendix. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. Authors were contacted where necessary for additional information. Studies of patients within six months after brain injury and/or in a confusional state, were distinguished from those of patients more than six months post-injury, or who were not confused. MAIN RESULTS: Six randomised controlled trials were identified. Four RCTs evaluated the beta-blockers, propranolol and pindolol, one RCT evaluated the central nervous system stimulant, methylphenidate and one RCT evaluated amantadine, a drug normally used in parkinsonism and related disorders. The best evidence of effectiveness in the management of agitation and/or aggression following ABI was for beta-blockers. Two RCTs found propranolol to be effective (one study early and one late after injury). However, these studies used relatively small numbers, have not been replicated, used large doses, and did not use a global outcome measure or long-term follow-up. Comparing early agitation to late aggression, there was no evidence for a differential drug response. Firm evidence that carbamazepine or valproate is effective in the management of agitation and/or aggression following ABI is lacking. REVIEWER'S CONCLUSIONS: Numerous drugs have been tried in the management of aggression in ABI but without firm evidence of their efficacy. It is therefore important to choose drugs with few side effects and to monitor their effect. Beta-blockers have the best evidence for efficacy and deserve more attention. The lack of evidence highlights the need for better evaluations of drugs for this important problem.

Adrenergic beta-Antagonists↗
PubMed2002

Debridement of diabetic foot ulcers.

BACKGROUND: Foot ulceration is thought to affect 15% of people with diabetes at some time in their lives. OBJECTIVES: The aim of this review is to assess the evidence for the effectiveness of debridement as a treatment for diabetic foot ulcers. SEARCH STRATEGY: Searches of electronic databases, hand searching journals, bibliographies and identification of unpublished work by written communication with recognised experts in the diabetic foot. SELECTION CRITERIA: Randomised controlled trials evaluating a method of debridement in the treatment of diabetic foot ulcers. The outcome had to include either complete healing or rate of healing. There was no restriction on articles/trials based on language or publication status. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality were undertaken by one reviewer and checked by an Editor of the Wounds Group. MAIN RESULTS: 5 RCTs of debridement were identified; 3 RCTs assessed the effectiveness of a hydrogel as a debridement method, 1 RCT evaluated surgical debridement and 1 RCT evaluated larval therapy. Pooling the 3 hydrogel RCTs suggested that hydrogels are significantly more effective than gauze or standard care in healing diabetic foot ulcers (absolute risk difference 0.23; 95% CI: 0.10,0.36). Surgical debridement and larval therapy showed no significant benefit in these small trials. Other debridement methods such as enzyme preparations or polysaccharide beads have not been evaluated in RCTs of people with diabetes. REVIEWER'S CONCLUSIONS: There is evidence to suggest that hydrogel increases the healing rate of diabetic foot ulcers. More research is needed to evaluate the effects of a range of widely used debridement methods and of debridement per se.

Combined Modality Therapy↗
PubMed2002

Electrical stimulation for the treatment of rheumatoid arthritis.

BACKGROUND: Electrical stimulation is one of several rehabilitation interventions suggested for the management of rheumatoid arthritis (RA) to enhance muscle performance. OBJECTIVES: To assess the effectiveness of electrical stimulation for improving muscle strength and function in clients with RA. SEARCH STRATEGY: We searched MEDLINE, Embase, Healthstar, Sports Discus, CINAHL, the Cochrane Controlled Trials Register, the PEDro database, the specialized registry of the Cochrane musculoskeletal group and the Cochrane field of physical and related therapies up to January 2002 according to the sensitive search strategy for RCTs designed for the Cochrane Collaboration. The search was complemented with handsearching of the reference lists. Key experts in the area were contacted for further articles. SELECTION CRITERIA: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs), case-control and cohort studies comparing ES against placebo or another active intervention in patients with RA were selected, according to an a priori protocol. No language restrictions were applied. DATA COLLECTION AND ANALYSIS: Two independent reviewers determined the studies to be included based on a priori inclusion criteria. Data were independently abstracted by the same two reviewers, and checked by a third reviewer using a pre-developed form. The same two reviewers, using a validated scale, independently assessed the methodological quality of the RCTs and CCTs. The data analysis was performed using Peto Odds ratios. MAIN RESULTS: Of the two relevant studies that were identified in the literature, only one RCT met the inclusion criteria. This RCT compared the effects of two electrostimulation (ES) protocols on hand function in general and on the performance of the first dorsal interosseous muscle in particular, in 15 patients with RA and secondary disuse atrophy of the first dorsal interosseous of the dominant hand. The results showed that ES had significant benefit when compared to a control no treatment group in terms of muscle strength and fatigue resistance of the first dorsal interosseous. Most favourable results were obtained by using a patterned stimulation derived from a fatigued motor unit of the first dorsal interosseous in a normal hand rather than a fixed 10 Hz stimulation frequency. Side effects of the ES application were not reported. REVIEWER'S CONCLUSIONS: ES was shown to have a clinically beneficial effect on grip strength and fatigue resistance for RA patients with muscle atrophy of the hand. However, these conclusions are limited by the low methodological quality of the trial included. More well-designed studies are therefore needed to provide further evidence of the benefits of ES in the management of RA.

Arthritis, Rheumatoid↗
PubMed2006

Oral betamimetics for maintenance therapy after threatened preterm labour.

BACKGROUND: Some women who have threatened to give birth prematurely, subsequently settle. They may then take oral tocolytic maintenance therapy to prevent preterm birth and to prolong gestation. OBJECTIVES: To assess the effects of oral betamimetic maintenance therapy after threatened preterm labour for preventing preterm birth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Trials Register (June 2005) and MEDLINE (from 1966 to August 2003). SELECTION CRITERIA: Randomised controlled trials comparing oral betamimetic with alternative tocolytic therapy, placebo or no therapy, for maintenance following treatment of threatened preterm labour. DATA COLLECTION AND ANALYSIS: Two review authors independently applied the selection criteria and carried out data extraction and quality assessment of studies. MAIN RESULTS: Eleven randomised controlled trials (RCTs) were included. No differences were seen for admission to the neonatal intensive care unit when betamimetics were compared with placebo (relative risk (RR) 1.29, 95% confidence interval (CI) 0.64 to 2.60; one RCT of terbutaline with 140 women) or with magnesium (RR 0.80, 95% CI 0.43 to 1.46; one RCT of 137 women). The rate of preterm birth (less than 37 weeks) showed no significant difference in four RCTs, two comparing ritodrine with placebo/no treatment and two comparing terbutaline with placebo/no treatment (RR 1.08, 95% CI 0.88 to 1.32, 384 women). No differences between betamimetics and placebo, no treatment or other tocolytics were seen for perinatal mortality and morbidity outcomes. Some adverse effects such as tachycardia were more frequent in the betamimetics groups than the groups allocated to placebo, no treatment or another type of tocolytic. AUTHORS' CONCLUSIONS: Available evidence does not support the use of oral betamimetics for maintenance therapy after threatened preterm labour.

Administration, Oral↗
PubMed2006

Early enteral nutrition within 24h of colorectal surgery versus later commencement of feeding for postoperative complications.

BACKGROUND: The role of early postoperative enteral nutrition after gastrointestinal surgery is controversial. Traditional management consist of 'nil by mouth', where patients receive fluids followed by solids when tolerated. Although several trials have implicated lower incidence of septic complications and faster wound healing upon early enteral feeding, other trials have shown opposite results. The immediate advantage of caloric intake could be a faster recovery with fewer complications, to be evaluated systematically. OBJECTIVES: To evaluate whether early commencement of postoperative enteral nutrition compared to traditional management (no nutritional supply) is associated with fewer complications in patients undergoing gastrointestinal surgery SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials, PUBMED, EMBASE, and LILACS from 1979 (first RCT published) to March 2006. We manually scanned the references from the relevant articles, and consulted primary authors for additional information. SELECTION CRITERIA: We looked for randomised controlled trials (RCT's) comparing early commencement of feeding (within 24 hours) with no feeding in patients undergoing gastrointestinal surgery. Early enteral nutrition is defined as all oral intakes (i.e. registered oral intake, supplemented oral feeding) and any kind of tube feeding (gastric, duodenal or jejunal) containing caloric content. No feeding is traditional management, defined as none caloric oral intake or any kind of tube feeding before bowel function. The definition 'no nutrition' includes non caloric placebo and water. DATA COLLECTION AND ANALYSIS: The three authors independently assessed the identified trials, and extracted the relevant data using a specifically developed data extraction sheet. Primary end points of interest were: Wound infections and intraabdominal abscesses, postoperative complications such as acute myocardial infarction, postoperative thrombosis or pneumonia, anastomotic leakages, mortality, length of hospital stay, and significant adverse effects. We combined data to estimate the common relative risk of postoperative complications, and calculated the associated 95% confidence intervals. For analysis, we used fixed effects model (risk ratios to summarise the treatment effect) whenever feasible. The treatment effect on length of stay was estimated using effect size (presented as mean +/- SD). Some outcomes were not analysed but presented in a descriptive way. We used a random effects model to estimate overall risk ratio and effect size. MAIN RESULTS: We identified thirteen randomised controlled trials, with a total of 1173 patients, all undergoing gastrointestinal surgery. Individual clinical complications failed to reach statistical significance, but the direction of effect indicates that earlier feeding may reduce the risk of post surgical complications. Mortality was the only outcome showing a significant benefit, but not necessarily associated with early commencement of feeding, as the reported cause of death was anastomotic leakage, reoperation, and acute myocardial infarction. AUTHORS' CONCLUSIONS: Although non-significant results, there is no obvious advantage in keeping patients 'nil by mouth' following gastrointestinal surgery, and this review support the notion on early commencement of enteral feeding.

Colon↗
PubMed2004

Hypnosis for schizophrenia.

BACKGROUND: Many people with schizophrenia continue to experience symptoms despite the use of conventional treatments. Alternative therapies such as hypnosis, in conjunction with conventional treatments, may prove beneficial to them. OBJECTIVES: To investigate the use of hypnosis for people with schizophrenia or schizophrenia-like illnesses compared to standard care and other interventions. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (January 2003), contacted the Cochrane Complementary Medicine Field for additional searching, hand searched references of included or excluded studies and made personal contact with authors of relevant trials. SELECTION CRITERIA: All randomised or double blind controlled trials that compared hypnosis with other treatments or standard care for people with schizophrenia. DATA COLLECTION AND ANALYSIS: Studies were reliably selected, quality assessed and data extracted. Data were excluded where more than 50% of participants in any group were lost to follow up. For binary outcomes we calculated a fixed effects risk ratio (RR) and its 95% confidence interval (CI). MAIN RESULTS: We included three studies (total n=149). When hypnosis was compared with standard treatment no one left between 1-8 weeks (n=70, 2 RCTs, Risk Difference 0.00 CI -0.09 to 0.09). Mental state scores were unaffected (n=60, 1 RCT, MD BPRS by 1 week -3.6 CI -12.05 to 4.8) as were measures of movement disorders and neurocognitive function. Compared with relaxation, hypnosis was also acceptable (n=106, 3 RCTs, RR leaving the study early 2.00 CI 0.2 to 2.15) and had no discernable effect on mental state (n=60, 1 RCT, MD BPRS by 1 week -3.4 CI -11.4 to 4.6), movement disorders or neurocognitive function. Hypnosis was as acceptable as music (Sibelius) by 4 weeks (n=36, RR leaving the study early 5.0, CI 0.3 to 97.4). REVIEWERS' CONCLUSIONS: The studies in this field are few, small, poorly reported and outdated. Hypnosis could be helpful for people with schizophrenia but to ascertain this requires better designed, conducted and reported randomised studies.

Humans↗
PubMed2003

New generation antipsychotics for first episode schizophrenia.

BACKGROUND: The new generation antipsychotics are associated with a lower risk of adverse effects compared with drugs such as haloperidol. Many treatment guidelines recommend the use of new generation ('atypical') antipsychotic drugs for people with a first episode of schizophrenia. OBJECTIVES: To examine the effects of the new generation antipsychotics for people with a first episode of schizophrenia or schizophrenia-like psychoses. SEARCH STRATEGY: The reviewers searched the Cochrane Schizophrenia Group's register (March 2002) and the included and excluded studies tables of relevant Cochrane reviews, references of all relevant studies, contacted industry and authors of relevant studies to identify further trials. SELECTION CRITERIA: Randomised clinical trials comparing new generation antipsychotics (amisulpride, clozapine, olanzapine, quetiapine, risperidone, sulpiride, ziprasidone, zotepine) with conventional antipsychotics for people with a first episode of schizophrenia or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by three reviewers, papers ordered, re-inspected and quality assessed. We independently extracted data but excluded them if loss to follow up was greater than 50%. For homogeneous dichotomous data, we calculated the relative risk (RR), the 95% confidence interval (CI) and, where appropriate, the number needed to treat (NNT), on an intention-to-treat basis. For continuous data, reviewers calculated weighted mean differences (WMD). MAIN RESULTS: We include two short-term studies (total n=266), one of which was a report of a sub-group of a larger study. One compared risperidone with an average of 6 mg/day haloperidol and the other olanzapine with an average of 11 mg/day haloperidol. Compared with olanzapine, significantly more people receiving haloperidol left the study early (n=83, 1 RCT, RR 0.43 CI 0.3 to 0.7, NNH 3 CI 2 to 8). This was not so for the risperidone versus haloperidol comparison (n=183, 1 RCT, RR=0.7 CI 0.4 to 1.1). In terms of global effects, studies reported no differences between risperidone and haloperidol (n=183, RR not much improved 1.0 CI 0.6 to 1.5), and olanzapine and the same control (n=83, RR needing at least one dose of benzodiazepine 0.8 CI 0.5 to 1.1). More people allocated to olanzapine had clinically significant improvement in mental state compared with those given haloperidol (n=83, RR no 'clinically significant improvement' 0.45 CI 0.3 to 0.7, NNH 3 CI 2 to 6). In the risperidone study, however, no such difference was apparent (n=183, RR 'no clinically significant improvement in mental state' 0.85 CI 0.6 to 1.2). Significantly more people given haloperidol (4-16mg) experienced at least one adverse event when compared with risperidone (4-16mg) (n=183, RR 0.9 CI 0.8 to 0.98, NNH 8 CI 4 to 50). Use of anticholinergic medication for extrapyramidal adverse events was less prevalent for people allocated either olanzapine (n=83, RR 0.3 CI 0.2 to 0.7, NNH 4 CI 2 to 14) or risperidone (n=183, RR 0.7 CI 0.5 to 0.9, NNH 4 CI 3 to 9) compared with those given haloperidol. There are no data at all on outcomes such as compliance, cost, social and cognitive functioning, relapse, rehospitalisation, or quality of life. There are no medium to long-term data. Eight ongoing studies may provide more information. REVIEWER'S CONCLUSIONS: The results of this review are inconclusive. Whether the use of new generation antipsychotics really makes the treatment less off putting and enhances long-term compliance is unclear. Pragmatic, well-designed and reported long-term trials would be useful to answer this question.

Antipsychotic Agents↗
PubMed2004

Interventions for recurrent idiopathic epistaxis (nosebleeds) in children.

BACKGROUND: Recurrent idiopathic epistaxis (nosebleeds) in children is repeated nasal bleeding in patients up to the age of 16 for which no specific cause has been identified. Although nosebleeds are very common in children, and most cases are self-limiting or settle with simple measures (such as pinching the nose), more severe recurrent cases can require treatment from a healthcare professional. However, there is no consensus on the effectiveness of the different clinical interventions currently used in managing this condition. OBJECTIVES: To assess the effects of different interventions for the management of recurrent idiopathic epistaxis in children. SEARCH STRATEGY: We searched the Cochrane ENT Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3, 2003), MEDLINE (January 1966 to August 2003), EMBASE (January 1980 to August 2003), CINAHL (January 1982 to August 2003), and reference lists of relevant articles. SELECTION CRITERIA: We identified all randomised controlled trials (with or without blinding) in which any surgical or medical intervention for the treatment of recurrent idiopathic epistaxis in children was evaluated in comparison with either no treatment, a placebo, or another intervention, and in which the frequency and severity of episodes of nasal bleeding following treatment was stated or calculable. The full text articles of all the retrieved trials of possible relevance were reviewed by the two reviewers and the inclusion criteria applied independently. DATA COLLECTION AND ANALYSIS: Trials were graded for methodological quality using the Cochrane approach. Data extraction was performed in a standardised manner by one reviewer and rechecked by the other, and where necessary investigators were contacted to obtain missing information. A meta-analysis was not undertaken because of the heterogeneity of the treatments, procedures and quality of the included trials. A narrative overview of the results is therefore presented. MAIN RESULTS: Three studies - two randomised controlled trials (RCTs) and one controlled clinical trial (CCT) - involving 256 participants satisfied the inclusion criteria. One RCT compared Naseptin antiseptic cream with no treatment, the second RCT compared Vaseline(R) petroleum jelly with no treatment, and the CCT compared Naseptin antiseptic cream with silver nitrate cautery. Overall, results were inconclusive, with no statistically significant difference found between the compared treatments. No serious adverse effects were reported from any of the interventions, although children receiving silver nitrate cautery reported that it was a painful experience (despite the use of local anaesthetic). REVIEWER'S CONCLUSIONS: The optimal management of children with recurrent idiopathic epistaxis is unknown. High quality randomised controlled trials comparing interventions either with placebo or no treatment, and with a follow-up period of at least a year, are needed to assess the relative merits of the various treatments currently in use.

Administration, Intranasal↗
PubMed2005

Unit-dose packaged drugs for treating malaria.

BACKGROUND: Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly. OBJECTIVES: To summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (November 2004), CENTRAL (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to November 2004), EMBASE (1980 to November 2004), LILACS (November 2004), conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field. SELECTION CRITERIA: Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria. DATA COLLECTION AND ANALYSIS: We independently assessed study eligibility and methodological quality, and extracted data for an intention to treat analysis, where possible. We combined binary data using relative risk (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact study authors for additional information. MAIN RESULTS: Three quasi-RCTs (895 participants) and one cluster-RCT (6 health facilities) met the inclusion criteria. Trials were of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials.A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (6 clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 1.76 to 2.61; 299 participants). AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure. Unit-dose packaging supported by prescriber training and patient information appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations.

Antimalarials↗
PubMed2006

Acupuncture for neck disorders.

BACKGROUND: Neck pain is one of the three most frequently reported complaints of the musculoskeletal system. Treatments for neck pain are varied, as are the perceptions of benefits. Acupuncture has been used as an alternative to more traditional treatments for musculoskeletal pain. This review summarizes the most current scientific evidence on the effectiveness of acupuncture for acute, subacute and chronic neck pain. OBJECTIVES: To determine the effects of acupuncture for individuals with neck pain. SEARCH STRATEGY: We searched CENTRAL (2006, issue 1) and MEDLINE, EMBASE, MANTIS, CINAHL from their beginning to February 2006. We searched reference lists and the acupuncture database TCMLARS in China. SELECTION CRITERIA: Any published trial using randomized (RCT) or quasi-randomized (quasi-RCT) assignment to the intervention groups, either in full text or abstract form, were included. DATA COLLECTION AND ANALYSIS: Two reviewers made independent decisions for each step of the review: article inclusion, data abstraction and assessment of trial methodological quality. Study quality was assessed using the Jadad criteria. Consensus was used to resolve disagreements. When clinical heterogeneity was absent, we combined studies using random-effects meta-analysis models. MAIN RESULTS: We did not find any trials that examined the effects of acupuncture for acute or subacute pain, but we found 10 trials that examined acupuncture treatments for chronic neck pain. Overall, methodological quality had a mean of 2.3/5 on the Jadad Scale. For chronic mechanical neck disorders, there was moderate evidence that acupuncture was more effective for pain relief than some types of sham controls, measured immediately post-treatment. There was moderate evidence that acupuncture was more effective than inactive, sham treatments measured immediately post-treatment and at short-term follow-up (pooled standardized mean difference (SMD) -0.37, 95% confidence interval (CI) -0.61 to -0.12). There was limited evidence that acupuncture was more effective than massage at short-term follow-up. For chronic neck disorders with radicular symptoms, there was moderate evidence that acupuncture was more effective than a wait-list control at short-term follow-up. AUTHORS' CONCLUSIONS: There is moderate evidence that acupuncture relieves pain better than some sham treatments, measured at the end of the treatment. There is moderate evidence that those who received acupuncture reported less pain at short term follow-up than those on a waiting list. There is also moderate evidence that acupuncture is more effective than inactive treatments for relieving pain post-treatment and this is maintained at short-term follow-up.

Acupuncture Therapy↗