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J P Higgins

Publications and source records attributed to J P Higgins.

At least 19 recordsLinked to original sources

Fluoride gels for preventing dental caries in children and adolescents.

BACKGROUND: Topically applied fluoride gels have been widely used as a caries-preventive intervention in dental surgeries and school-based programs for over two decades. OBJECTIVES: To determine the effectiveness and safety of fluoride gels in the prevention of dental caries in children and to examine factors potentially modifying their effect. SEARCH STRATEGY: Multiple electronic database searches, reference lists of articles, journal handsearch, selected authors and manufacturers. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride gel with placebo or no treatment in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). DATA COLLECTION AND ANALYSIS: Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Study authors were contacted for missing data. The primary outcome measure was the prevented fraction (PF), that is the caries increment in the treatment group expressed as a percentage of the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects meta-regression analyses. MAIN RESULTS: Twenty-five studies were included, involving 7747 children. For the 23 that contributed data for meta-analysis, the D(M)FS pooled prevented fraction estimate was 28% (95% CI, 19% to 37%; p<0.0001). There was clear heterogeneity, confirmed statistically (p<0.0001). The effect of fluoride gel varied according to type of control group used, with D(M)FS PF on average being 19% (95% CI, 5% to 33%; p<0.009) higher in non-placebo controlled trials. A funnel plot of the 23 studies indicated a relationship between prevented fraction and study precision. Only two trials reported on adverse events. REVIEWER'S CONCLUSIONS: There is clear evidence of a caries-inhibiting effect of fluoride gel. The best estimate of the magnitude of this effect, based on the 14 placebo-controlled trials, is a 21% reduction (95% CI, 14 to 28%) in D(M)FS. This corresponds to an NNT of 2 (95% CI, 1 to 3) to avoid 1 D(M)FS in a population with a caries increment of 2.2 D(M)FS/year, or an NNT of 24 (95% CI, 18 to 36) based on an increment of 0.2 D(M)FS/year. There is little information concerning deciduous dentition, on adverse effects or on acceptability of treatment. Future trials should include assessment of potential adverse effects.

Adolescent↗

Ischial pressure sore reconstruction using an inferior gluteal artery perforator (IGAP) flap.

Perforator-flap technique has revolutionised the practice of free tissue transfer with the goal of muscle sparing for function and strength. These concepts are being widely explored for breast reconstruction. The field of pressure-sore reconstruction presents a new application for this technique, preserving muscle for function in ambulatory patients and for future reconstruction in paraplegic patients. Just as the superior gluteal artery perforator flap holds promise for sacral and trochanteric reconstruction, the inferior gluteal artery perforator flap may provide a muscle-sparing alternative for ischial reconstruction. A case report of the successful use of an inferior gluteal artery perforator flap for ischial pressure-sore reconstruction is described, including the surgical technique employed for flap harvest, and 2 year's follow-up.

Humans↗

Coadministration of either cyclosporine or steroids with humanized monoclonal antibodies against CD80 and CD86 successfully prolong allograft survival after life supporting renal transplantation in cynomolgus monkeys.

BACKGROUND: Recent studies have shown some efficacy using monotherapy with monoclonal antibodies (mAb) against CD80 and CD86 receptors after life-supporting renal transplantation in non-human primates. Our study was designed to evaluate the efficacy of combinations of the same mAbs with either microemulsion cyclosporine (CsA) or steroids. METHODS: Unilateral renal transplantation was performed in 16 blood group-matched and MLR-mismatched cynomolgus monkeys that were assigned to four different treatment groups. All monkeys in groups I, II, and IV were treated with the combination of a CD80 (h1F1) and CD86 (h3D1) mAb given at 20 mg/kg each preoperatively, then 5 mg/kg at weekly intervals starting postoperative (po) day 0 until poday 56 (9 doses). In group I the animals (n=4) were treated with mAbs only. In group II (n=4) mAbs were combined with a CsA regimen adjusted daily to maintain target 24 hr trough levels of 150-300 ng/ml CsA for poday 0 to poday 56. In group III (n=4) the animals received CsA monotherapy according to the same regimen as group II. In group IV methylprednisone was administered at 2 mg/kg IV on poday 0-2, then at 0.5 mg/kg/day prednisone per gavage that was and tapered to 0.2 mg/kg/day on which they were maintained until poday 56. All animals were off all immunosuppressive treatment after poday 56 and were then followed until poday 119. RESULTS: The mean survival of groups I-IV was 74 (range 9-119 days), 113 (96-119 days), 39 (22-71 days), and 79 days (6 to 119), respectively. All animals in group I showed clinical evidence of acute severe rejection (fever, creatinine increase, anuria) within the first week posttransplant, including those that retained renal function until poday 119. Only one animal in group II had a moderate clinical rejection during the treatment period and three of four animals survived the intended follow-up period. All animals in group III had multiple biopsy proven or severe clinical rejection episodes within the first 21 days and only one animal survived beyond poday 40. Moderate or severe acute rejection was diagnosed in three of four animals of group IV within the first 28 days post transplant and only one animal survived until poday 119. CONCLUSION: Our data show that combining a calcineurin inhibitor or prednisone with mAbs designed to block costimulatory signals does not antagonize the immunosuppressive efficacy of these mAbs. In addition, combining CsA with mAbs directed against the CD80 and CD86 receptors significantly prolongs graft survival when compared to CsA monotherapy. Therefore clinical trials of humanized mAbs to CD80 and CD86 used in combination with conventional immunosuppression can be considered.

Animals↗

Meta-analysis of continuous outcome data from individual patients.

Meta-analyses using individual patient data are becoming increasingly common and have several advantages over meta-analyses of summary statistics. We explore the use of multilevel or hierarchical models for the meta-analysis of continuous individual patient outcome data from clinical trials. A general framework is developed which encompasses traditional meta-analysis, as well as meta-regression and the inclusion of patient-level covariates for investigation of heterogeneity. Unexplained variation in treatment differences between trials is considered as random. We focus on models with fixed trial effects, although an extension to a random effect for trial is described. The methods are illustrated on an example in Alzheimer's disease in a classical framework using SAS PROC MIXED and MLwiN, and in a Bayesian framework using BUGS. Relative merits of the three software packages for such meta-analyses are discussed, as are the assessment of model assumptions and extensions to incorporate more than two treatments.

Alzheimer Disease↗

Meta-analysis of ordinal outcomes using individual patient data.

Meta-analyses are being undertaken in an increasing diversity of diseases and conditions, some of which involve outcomes measured on an ordered categorical scale. We consider methodology for undertaking a meta-analysis on individual patient data for an ordinal response. The approach is based on the proportional odds model, in which the treatment effect is represented by the log-odds ratio. A general framework is proposed for fixed and random effect models. Tests of the validity of the various assumptions made in the meta-analysis models, such as a global test of the assumption of proportional odds between treatments, are presented. The combination of studies with different definitions or numbers of response categories is discussed. The methods are illustrated on two data sets, in a classical framework using SAS and MLn and in a Bayesian framework using BUGS. The relative merits of the three software packages for such meta-analyses are discussed.

Alzheimer Disease↗

Predominance of NK1.1+TCR alpha beta+ or DX5+TCR alpha beta+ T cells in mice conditioned with fractionated lymphoid irradiation protects against graft-versus-host disease: "natural suppressor" cells.

We developed a nonmyeloablative host conditioning regimen in a mouse model of MHC-mismatched bone marrow transplantation that not only reduces radiation toxicity, but also protects against graft-vs-host disease. The regimen of fractionated irradiation directed to the lymphoid tissues and depletive anti-T cell Abs results in a marked change in the residual host T cells, such that NK1.1+ or DX5+asialo-GM1+ T cells become the predominant T cell subset in the lymphoid tissues of C57BL/6 and BALB/c mice, respectively. The latter "natural suppressor" T cells protect hosts from graft-vs-host disease after the infusion of allogeneic bone marrow and peripheral blood cells that ordinarily kill hosts conditioned with sublethal or lethal total body irradiation. Protected hosts become stable mixed chimeras, but fail to show the early expansion and infiltration of donor T cells in the gut, liver, and blood associated with host tissue injury. Cytokine secretion and adoptive transfer studies using wild-type and IL-4(-/-) mice showed that protection afforded by NK1.1+ and DX5+asialo-GM1+ T cells derived from either donors or hosts conditioned with lymphoid irradiation is dependent on their secretion of high levels of IL-4.

Animals↗

Apoptosis and allograft rejection in the absence of CD8+ T cells.

BACKGROUND: The requirement for cytotoxic T lymphocytes during allograft rejection is controversial. We previously demonstrated that CD8+ T cells are not necessary for allograft rejection or for the induction of apoptosis in rat small intestinal transplantation. In this study, we examined the mechanisms of apoptosis and rejection after liver transplantation in the absence of CD8+ T cells. METHODS: Either Lewis or dark agouti rat liver grafts were transplanted into Lewis recipients to create syngeneic and allogeneic combinations. CD8+ T cells were depleted in an additional allogeneic group by treatment with OX-8 mAb on day -1 and day 1 after liver transplant. RESULTS: Apoptosis and rejection were observed in both the CD8+ T cell-depleted allogeneic and allogeneic grafts by hematoxylin and eosin staining, terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling staining, and radiolabeled-annexin V in vivo imaging. Granzyme B and FasL were expressed in all allogeneic transplants, including those depleted of CD8+ T cells, indicating that a mononuclear cell other than a CD8+ T cell can be the source of these molecules during allograft rejection. Activation of the caspase cascade was detected in all rejecting allografts. Caspases 3, 8, and 9 were activated at similar significantly elevated levels in both allogeneic and CD8+ T cell-depleted liver grafts. CONCLUSION: These data indicate that in the absence of CD8+ T cells an alternative pathway, associated with granzyme B and FasL expression and activation of the caspase cascade, can mediate apoptosis and graft rejection.

Animals↗

Allogeneic bone marrow cells that facilitate complete chimerism and eliminate tumor cells express both CD8 and T-cell antigen receptor-alphabeta.

Nonmyeloablative host conditioning regimens have been used in clinical allogeneic bone marrow and hematopoietic progenitor transplantation to effectively treat lymphohematopoietic tumors and reduce early toxicity. However, severe graft-versus-host disease (GVHD) remains a major problem. The goal of the current study was to determine whether specific subsets of cells in allogeneic bone marrow transplants can effectively treat the BCL(1) B-cell lymphoma in nonmyeloablated BALB/c mouse hosts given a single dose of sublethal (450 cGy) total body irradiation, without inducing severe GVHD. The experimental results show that high doses of whole bone marrow cells from major histocompatiblity complex (MHC)-mismatched donors eliminate both normal and malignant host-type lymphohematopoietic cells without causing injury to nonlymphohematopoietic host tissues. The CD8(+)T-cell antigen receptor-alphabeta+ (TCRalphabeta+) T cells within the marrow transplants mediated the killing of the tumor cells via both perforin- and FasL-dependent pathways. Cells present in marrow transplants from either CD8-/- or TCRalpha-/- donors failed to eliminate malignant and normal host lymphohematopoietic cells. Addition of small numbers of blood mononuclear cells to the marrow inoculum caused lethal GVHD. Thus, the resident allogeneic bone marrow CD8(+) TCRalphabeta+ T cells had the unique capacity to eliminate the host lymphohematopoietic cells without nonlymphohematopoietic tissue injury. (Blood. 2001;97:3458-3465)

Adoptive Transfer↗

Dietary fat intake and prevention of cardiovascular disease: systematic review.

OBJECTIVE: To assess the effect of reduction or modification of dietary fat intake on total and cardiovascular mortality and cardiovascular morbidity. DESIGN: Systematic review. DATA SOURCES: Cochrane Library, Medline, Embase, CAB abstracts, SIGLE, CVRCT registry, and biographies were searched; trials known to experts were included. INCLUDED STUDIES: Randomised controlled trials stating intention to reduce or modify fat or cholesterol intake in healthy adult participants over at least six months. Inclusion decisions, validity, and data extraction were duplicated. Meta-analysis (random effects methodology), meta-regression, and funnel plots were performed. RESULTS: 27 studies (30 902 person years of observation) were included. Alteration of dietary fat intake had small effects on total mortality (rate ratio 0.98; 95% confidence interval 0.86 to 1.12). Cardiovascular mortality was reduced by 9% (0.91; 0.77 to 1.07) and cardiovascular events by 16% (0.84; 0.72 to 0.99), which was attenuated (0.86; 0.72 to 1.03) in a sensitivity analysis that excluded a trial using oily fish. Trials with at least two years' follow up provided stronger evidence of protection from cardiovascular events (0.76; 0.65 to 0.90). CONCLUSIONS: There is a small but potentially important reduction in cardiovascular risk with reduction or modification of dietary fat intake, seen particularly in trials of longer duration.

Cardiovascular Diseases↗

Dietary advice given by a dietitian versus other health professional or self-help resources to reduce blood cholesterol.

BACKGROUND: The average level of blood cholesterol is an important determinant of the risk of coronary heart disease. Blood cholesterol can be reduced by dietary means. Although dietitians are trained to provide dietary advice, for practical reasons it is also given by other health professionals and occasionally through the use of self-help resources. OBJECTIVES: To assess the effects of dietary advice given by a dietitian compared with another health professional, or the use of self-help resources, in reducing blood cholesterol in adults. SEARCH STRATEGY: We searched The Cochrane Library (to Issue 2 1999), MEDLINE (1966 to January 1999), EMBASE (1980 to December 1998), Cinahl (1982 to December 1998), Human Nutrition (1991 to 1998), Science Citation Index, Social Sciences Citation Index, hand searched conference proceedings on nutrition and heart disease, and contacted experts in the field. SELECTION CRITERIA: Randomised trials of dietary advice given by a dietitian compared with another health professional or self-help resources. The main outcome was difference in blood cholesterol between dietitian groups compared with other intervention groups. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Eleven studies with 12 comparisons were included, involving 704 people receiving advice from dietitians, 486 from other health professionals and 551 people using self-help leaflets. Four studies compared dietitian with doctor, seven with self-help resources, and one compared dietitian with nurse. Participants receiving advice from dietitians experienced a greater reduction in blood cholesterol than those receiving advice only from doctors (-0.25 mmol/L (95% CI -0.37, -0.12 mmol/L)). There was no statistically significant difference in change in blood cholesterol between dietitians and self-help resources (-0.10 mmol/L (95% CI -0.22, 0.03 mmol/L)). No statistically significant differences were detected for secondary outcome measures between any of the comparisons with the exception of dietitian versus nurse for HDLc, where the dietitian groups showed a greater reduction (-0.06 mmol/L (95% CI -0.11, -0.01)). No significant heterogeneity between the studies was detected. REVIEWER'S CONCLUSIONS: Dietitians were better than doctors at lowering blood cholesterol in the short to medium term, but there was no evidence that they were better than self-help resources. The results should be interpreted with caution as the studies were not of good quality and the analysis was based on a limited number of trials. More evidence is required to assess whether change can be maintained in the longer term. There was no evidence that dietitians provided better outcomes than nurses.

Cholesterol↗

Opioids for the palliation of breathlessness in terminal illness.

BACKGROUND: Breathlessness is a common symptom in people with advanced disease. The most effective treatments are aimed at treating the underlying cause of the breathlessness but this may not be possible and symptomatic treatment is often necessary. Strategies for the symptomatic treatment of breathlessness have never been systematically evaluated. Opioids are commonly used to treat breathlessness: the mechanisms underlying their effectiveness are not completely clear and there have been few good-sized trials in this area. OBJECTIVES: To determine the effectiveness of opioid drugs given by any route in relieving the symptom of breathlessness in patients who are being treated palliatively. SEARCH STRATEGY: An electronic search was carried out of Medline, Embase, Cinahl, the Cochrane library, Dissertation Abstracts, Cancercd and SIGLE. Review articles and reference lists of retrieved articles were hand searched. Date of most recent search: May 1999 SELECTION CRITERIA: Randomised double-blind, controlled trials comparing the use of any opioid drug against placebo for the relief of breathlessness were included. Patients with any illness suffering from breathlessness were included and the intervention was any opioid, given by any route, in any dose. DATA COLLECTION AND ANALYSIS: Studies identified by the search were imported into a reference manager database. The full texts of the relevant studies were retrieved and data were independently extracted by two reviewers. Studies were quality scored according to the Jadad scale. The primary outcome measure used was breathlessness and the secondary outcome measure was exercise tolerance. Studies were divided into non-nebulised and nebulised and were analysed both separately and together. A qualitative analysis was carried out of adverse effects of opioids. Where appropriate, meta-analysis was carried out. MAIN RESULTS: Eighteen studies were identified of which nine involved the non-nebulised route of administration and nine the nebulised route. A small but statistically significant positive effect of opioids was seen on breathlessness in the analysis of studies using non-nebulised opioids. There was no statistically significant positive effect seen for exercise tolerance in either group of studies or for breathlessness in the studies using nebulised opioids. REVIEWER'S CONCLUSIONS: There is evidence to support the use of oral or parenteral opioids to palliate breathlessness although numbers of patients involved in the studies were small. No evidence was found to support the use of nebulised opioids. Further research with larger numbers of patients, using standardised protocols and with quality of life measures is needed.

Apnea↗

Interventions for promoting smoke alarm ownership and function.

BACKGROUND: Residential fires caused at least 67 deaths and 2,500 non-fatal injuries to children aged 0-16 in the United Kingdom in 1998. Smoke alarm ownership is associated with a reduced risk of residential fire death. OBJECTIVES: We evaluated interventions to promote residential smoke alarms, to assess their effect on smoke alarm ownership, smoke alarm function, fires and burns and other fire-related injuries. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Injuries Group database, MEDLINE, EMBASE, PsycLIT, CINAHL, ERIC, Dissertation Abstracts, International Bibliography of Social Sciences, ISTP, FIREDOC and LRC. Conference proceedings, published case studies, and bibliographies were systematically searched, and investigators and relevant organisations were contacted, to identify trials. SELECTION CRITERIA: Randomised, quasi-randomised or nonrandomised controlled trials completed or published after 1969 evaluating an intervention to promote residential smoke alarms. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: We identified 26 trials, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR=1.26; 95% CI: 0.87 to 1.82) or having a functional alarm (OR=1.19; 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR=1.96; 1.03 to 3.72) and function (OR=1.72; 0.78 to 3.80). Results were sensitive to trial quality, however, and effects on fire-related injuries were not reported. In two non randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire-related injuries. Media and community education showed little benefit in non randomised trials. REVIEWER'S CONCLUSIONS: Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give-away programmes apparently reduce fire-related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give-away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.

Burns↗

Genetic analysis of a papillary thyroid carcinoma in a patient with MEN1.

BACKGROUND: MENI is an inherited tumor syndrome characterized by the development of tumors of the parathyroid, the anterior pituitary and the pancreatic islets. Tumors of these endocrine glands in MEN1 patients demonstrate loss of heterozygosity (LOH) at the locus of the MEN1 tumor suppressor gene. Menin, the protein encoded by the MEN1 gene, is ubiquitously expressed in endocrine tissue, and less commonly these patients can present with tumors of other endocrine tissues, including thyroid and adrenal. We hypothesize that MEN1 gene mutation may be involved in the oncogenesis of other less common tumors. METHODS: We report a MEN1 patient who was found to have metastatic papillary thyroid cancer at the time of neck exploration for hyperparathyroidism. Genetic analysis of tumor tissue was performed using one intragenic (D11S4946) and two flanking (D11S4945 and D11S4940) polymorphic markers. RESULTS: Two of the markers were informative. Consistent with previous studies, there was LOH in the parathyroid adenoma identified with the intragenic marker D11S4946. However, the papillary cancer was found to be heterozygous at two informative markers. CONCLUSIONS: The lack of obvious LOH of the MEN1 locus in the papillary cancer suggests that, in contrast to parathyroid adenoma, deletion of the MEN1 tumor suppressor gene is not etiologically related to the oncogenesis of the papillary cancer in this patient.

Biomarkers, Tumor↗

Ovarian non-Hodgkin's lymphoma: a clinicopathologic study of eight primary cases.

Primary (localized) non-Hodgkin's lymphoma (NHL) of the ovary is rare. We studied eight cases of primary ovarian NHL to better understand the clinicopathologic and immunophenotypic features of these tumors. The patients ranged in age from 29 to 62 years (mean 47 years). Pelvic complaints were the most common symptoms; however, three of eight neoplasms were discovered incidentally. All tumors were unilateral and Ann Arbor stage I(E). The three incidental NHL were microscopic (largest 1.2 cm), whereas the grossly evident lesions ranged from 7.5 to 20 cm (mean 13.3). Each tumor was classified according to the World Health Organization Classification as follows: diffuse large B-cell lymphoma (three cases), follicular lymphoma (two cases), Burkitt lymphoma (one case), T-cell anaplastic large cell lymphoma (one case), and precursor T-lymphoblastic lymphoma (one case). Six tumors were of B-cell lineage, and two tumors were of T-cell lineage. All three diffuse large B-cell lymphomas were positive for BCL-6, two were positive for CD10, and two were positive for BCL-2. Estrogen and progesterone receptors were negative in all NHLs assessed. Patients were treated by various combinations of surgery, chemotherapy, and radiotherapy. Clinical follow-up ranged from 1.3 to 11.7 years (mean 5.2) and all patients were alive without disease at last follow-up. We conclude that most patients with primary ovarian NHL present with symptoms attributable to an ovarian mass, but in a subset of patients ovarian NHL may be detected incidentally. With appropriate therapy, patients appear to have a favorable prognosis although follow-up is short for some patients in this study.

12E7 Antigen↗

Dynamics of the 1 3 pi g state of K2 on helium nanodroplets.

Fluorescence following optical excitation of the 1 3 sigma u+ state of K2 prepared on helium nanodroplets to the predissociative 1 3 pi g state yields molecular emission from both the (B)1 1 pi u and (A)1 1 sigma u+ K2 states as well as atomic emission from the expected 4 2P3/2, 1/2-->4 2S1/2 dissociation channel. A approximately 12 cm-1 red shift is observed in the molecular emission excitation spectrum compared to the atomic emission excitation spectrum. Time-correlated photon counting measurements demonstrate the rise time for both atomic and molecular products to be < 80 ps, independent of vibrational level excited. This lifetime is interpreted as the total depopulation time for the optically excited 1 3 pi g state, which is dominated by intersystem crossing at low vibrational energy and by predissociation at the highest vibrational level. It is deduced that the timescale for intersystem crossing must be of the order of 10 ps. Symmetry restrictions for the isolated K2 imply that the intersystem crossing from the 1 3 pi g state to the (B)1 1 pi u and (A)1 1 sigma u+ states must be induced by interaction with the helium nanodroplet.

Journal Article↗

Hypothenar hammer syndrome after radial forearm flap harvest: a case report.

A case of acute hypothenar hammer syndrome (HHS) in a high-risk laborer in whom the radial artery had been surgically removed during a prior radial forearm flap harvest is reported. Studies estimating the true incidence of HHS among laborers are reviewed to define the risk of this complication. Two major risk factors must be considered in the assessment of a patient for radial forearm flap harvest. First, the risk for immediate vascular compromise is determined by using a standard Allen's test to assess ulnar artery contribution to hand perfusion. Second, the risk for future vascular compromise is determined. When patients at high risk for HHS are recognized the surgeon should consider other reconstructive alternatives. If the superficial palmar arch is patent and complete and a radial forearm flap is performed, postoperative activity modification and risk counseling should be provided.

Fingers↗

Interventions for treating hallux valgus (abductovalgus) and bunions.

BACKGROUND: Hallux valgus is classified as an abnormal deviation of the great toe (hallux) towards the midline of the foot. OBJECTIVES: To identify and evaluate the evidence from randomised trials of interventions used to correct hallux valgus. SEARCH STRATEGY: Medline (1966-October 1998), Embase (1980-1998), Cinahl (1982-1998), Amed (1993-1998), the Cochrane Controlled Trials Register, the Cochrane Musculoskeletal Injuries Trials Register and bibliographies of identified trials were searched. Hand searching of podiatry journals was undertaken. Date of the most recent search: October 1998. SELECTION CRITERIA: Randomised or quasi-randomised trials of both conservative and surgical treatments of hallux valgus. Excluded were studies comparing areas of surgery not specific to the control of the deformity such as use of anaesthetics or tourniquet placement. DATA COLLECTION AND ANALYSIS: Methodological quality of trials which met the inclusion criteria was independently assessed by two reviewers. Data extraction was undertaken by one reviewer and confirmed by another. The trials were grouped according to the interventions being compared, but the dissimilarity in the comparisons prevented pooling of results. MAIN RESULTS: The methodological quality of the 12 included trials was poor and trial sizes were small. Two trials involving 150 patients evaluated conservative treatments. There was no difference in outcomes between treatment and no treatment. Two trials involving 133 patients compared Keller's arthroplasty with other surgical techniques. In general, there was no advantage in using Keller's over the other techniques, particularly in terms of range of motion and intermetatarsal angle. Three trials involving 205 patients compared chevron (and chevron-type) osteotomy with other techniques. The chevron osteotomy offered no advantages in these trials. For some outcomes, other techniques gave better results. Three trials involving 157 patients compared outcomes between original operations and surgeon's adaptations. There was no advantage found for any of the adaptations. Two trials involving 95 patients evaluated methods of post-operative rehabilitation. The use of continuous passive motion appeared to give an improved range of motion and earlier recovery following surgery; early weightbearing was not found to be detrimental to final outcome. REVIEWER'S CONCLUSIONS: There is insufficient evidence from randomised trials to determine which methods of either conservative, operative or post-operative treatment are the most appropriate for the hallux valgus. It is notable that the numbers of patients remaining dissatisfied at follow-up were consistently high (25 to 33%), even when the hallux valgus angle and pain had improved. Assessment of future research should focus on evaluating basic intervention types in eligible patients with similar degrees of deformity. Future research should include patient-focused outcomes, standardised assessment criteria and longer surveillance periods.

Hallux Valgus↗

Lecithin for dementia and cognitive impairment.

BACKGROUND: People with Alzheimer's disease have been found to have a relative lack of the enzyme responsible for converting choline into acetylcholine within the brain. Lecithin is a major dietary source of choline, so extra consumption may assist in the production of acetylcholine and reduce some of the symptoms of dementia. OBJECTIVES: To determine the efficacy of lecithin in the treatment of dementia or cognitive impairment. SEARCH STRATEGY: The Cochrane Dementia and Cognitive Impairment Group Register of Clinical Trials has been searched, as have the electronic databases MEDLINE, EMBASE, Psychlit, ISI and Current Contents. Reference lists and relevant books have been examined. SELECTION CRITERIA: All unconfounded, randomised trials comparing lecithin with placebo in a treatment period longer than one day, in patients with dementia of the Alzheimer type, vascular dementia, mixed vascular and Alzheimer's disease, unclassified or other dementia or unclassified cognitive impairment not fulfilling the criteria for dementia are eligible for inclusion. DATA COLLECTION AND ANALYSIS: Data are extracted by two independent reviewers and cross checked. Meta-analyses are performed when more than one trial provide data on a comparable outcome on sufficiently similar patients. Random effects analyses are performed whenever heterogeneity between results appears to be present. Standardised mean difference are used due do the use of different scales and periods of treatment. Odds ratios for dichotomous data are pooled using the Mantel-Haenszel or DerSimonian and Laird methods. MAIN RESULTS: Eleven randomised trials have been identified involving patients with Alzheimer's disease (265 patients) and Parkinsonian dementia (21 patients). No trials reported any clear clinical benefit of lecithin. Few trials contributed data to meta-analyses. The only statistically significant result was in favour of placebo for adverse events, based on one trial, which appears likely to be a spurious result. REVIEWER'S CONCLUSIONS: Evidence from randomised trials does not support the use of lecithin in the treatment of patients with dementia or cognitive impairment. A moderate effect cannot be ruled out, but results from the small trials to date do not indicate priority for a large randomised trial.

Alzheimer Disease↗