Topical non-steroidal anti-inflammatory agents for diabetic cystoid macular oedema.

BACKGROUND: Diabetic cystoid macular oedema (CMO) is a condition which involves fluid accumulation in the inner portion of the retina. It often follows changes in retinal blood vessels which enhance the fluid to come out of vessels. Although it may be asymptomatic, symptoms are primarily painless loss of central vision, often with the complaint of seeing black spots in front of the eye.It is reported that CMO may resolve spontaneously, or fluctuate for months, before causing loss of vision. If left untreated or undiagnosed, progression of CMO may lead to permanent visual loss.It has been noted that patients with diabetic retinopathy have elevated inflammatory markers, and therefore it is likely that inflammation aids in the progression of vascular disease in these patients. Several topical non-steroidal anti-inflammatory drugs (NSAIDs) such as ketorolac 0.5%, bromfenac 0.09%, and nepafenac 0.1%, have therefore also been used topically to treat chronic diabetic CMO. Hence this review was conducted to find out the effects of topical NSAIDs in diabetic CMO. OBJECTIVES: To assess the effects of topical non-steroidal anti-inflammatory drugs (NSAIDs) for diabetic cystoid macular oedema (CMO). SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to January 2015), EMBASE (January 1980 to January 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to January 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 12 January 2015. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs investigating the effects of topically applied NSAIDs in the treatment of people with diabetic CMO aged 18 years of age or over. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and screened all available titles and abstracts for inclusion. There were no discrepancies and we did not have to contact trial investigators for missing data. MAIN RESULTS: We did not identify any RCTs matching the inclusion criteria for this review. AUTHORS' CONCLUSIONS: The review did not identify any RCTs investigating the effects of topical NSAIDs in the treatment of diabetic CMO. Most of the studies identified through the electronic searches had been conducted to analyse the effect of topical NSAIDs for pseudophakic CMO.In the absence of high quality evidence, clinicians need to use their clinical judgement and other low level evidence, such as observational non-randomised trials, to decide whether to use topical NSAIDs in cases of diabetic CMO.More research is needed to better understand the cause of this condition and its pathophysiology. This systematic review has identified the need for well designed, adequately powered RCTs to assess possible beneficial and adverse effects of topical NSAIDs in people with diabetic CMO. Future trials should aim to include a large sample size with an adequate follow-up period of up to one year.

Sentinel node biopsy versus low axillary sampling in women with clinically node negative operable breast cancer.

BACKGROUND: Sentinel node biopsy (SNB) was initially conceived as excision of the first station axillary lymph node(s) (LN) identified by radioactive and/or blue dye uptake. The definition was subsequently enlarged to also include palpable lymph nodes in the vicinity of sentinel node(s) (SN). We reasoned that the excision of this combination of nodes might be best achieved by sampling the lower axilla. METHODS: Each patient underwent low axillary sampling (LAS) and identification of SN in the excised specimen followed by complete axillary lymph node dissection (ALND). LAS was defined as excision of all fibrofatty tissue overlying the second digitation of serratus anterior below the intercostobrachial nerve and was carried out following a pre-operative injection of radioactive colloid and an intra-operative injection of blue dye. Blue and/or hot nodes (B&/HN) in the dissected tissue and remaining axilla, along with any palpable nodes within the sampled tissue, were defined as SN. The primary endpoint of the study was to compare false negative rates (FNR) of SN with that of LAS in predicting axillary LN status (NCT00128362). FINDINGS: The study was performed between March 2004 and December 2011 in 478 women with clinically node negative axilla. On histopathological evaluation the median tumor size was 2.5 cm and axillary nodal metastases were found in 34.1% of patients. The FNR of SNB (12.7%, 95% CI 8.1-19.4) and LAS (10.5%, 95% CI 6.6-16.2) were not significantly different (p = 0.56). The FNR of B&/HN alone, without palpable nodes, (29.0%, 95% CI 22.5-36.6) was significantly inferior to those of SNB (p = 0.0007) and LAS (p = 0.0003). INTERPRETATION: LAS is as accurate as SNB in predicting axillary LN status in women with clinically node negative operable breast cancer. Confining SNB procedure to excision of B&/HN, significantly increases the risk of leaving behind metastatic lymph nodes in the axilla. LAS is an effective and low cost procedure that minimizes axillary surgery and can be implemented widely. Registry Name: Clinicaltrials.gov. REGISTRATION NUMBER: NCT00128362.

Zinc supplements for treating thalassaemia and sickle cell disease.

BACKGROUND: Haemoglobinopathies, inherited disorders of haemoglobin synthesis (thalassaemia) or structure (sickle cell disease), are responsible for significant morbidity and mortality throughout the world. The WHO estimates that, globally, 5% of adults are carriers of a haemoglobin condition, 2.9% are carriers of thalassaemia and 2.3% are carriers of sickle cell disease. Carriers are found worldwide as a result of migration of various ethnic groups to different regions of the world. Zinc is an easily available supplement and intervention programs have been carried out to prevent deficiency in people with thalassaemia or sickle cell anaemia. It is important to evaluate the role of zinc supplementation in the treatment of thalassaemia and sickle cell anaemia to reduce deaths due to complications. OBJECTIVES: To assess the effect of zinc supplementation in the treatment of thalassaemia and sickle cell disease. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of most recent search: 01 February 2013. SELECTION CRITERIA: Randomised, placebo-controlled trials of zinc supplements for treating thalassaemia or sickle cell disease administered at least once a week for at least a month. DATA COLLECTION AND ANALYSIS: Two review authors assessed the eligibility and risk of bias of the included trials, extracted and analysed data and wrote the review. We summarised results using risk ratios or rate ratios for dichotomous data and mean differences for continuous data. We combined trial results where appropriate. MAIN RESULTS: We identified nine trials for inclusion with all nine contributing outcome data. Two trials reported on people with thalassaemia (n = 152) and seven on sickle cell anaemia (n = 307).In people with thalassaemia, in one trial, the serum zinc level value showed no difference between the zinc supplemented group and the control group, mean difference 47.40 (95% confidence interval -12.95 to 107.99). Regarding anthropometry, in one trial, height velocity was significantly increased in patients who received zinc supplementation for one to seven years duration, mean difference 3.37 (95% confidence interval 2.36 to 4.38) (total number of participants = 26). In one trial, however, there was no difference in body mass index between treatment groups.Zinc acetate supplementation for three months (in one trial) and one year (in two trials) (total number of participants = 71) was noted to increase the serum zinc level significantly in patients with sickle cell anaemia, mean difference 14.90 (95% confidence interval 6.94 to 22.86) and 20.25 (95% confidence interval 11.73 to 28.77) respectively. There was no significant difference in haemoglobin level between intervention and control groups, at either three months (one trial) or one year (one trial), mean difference 0.06 (95% confidence interval -0.84 to 0.96) and mean difference -0.07 (95% confidence interval -1.40 to 1.26) respectively. Regarding anthropometry, one trial showed no significant changes in body mass index or weight after one year of zinc acetate supplementation. In patients with sickle cell disease, the total number of sickle cell crises at one year were significantly decreased in the zinc sulphate supplemented group as compared to controls, mean difference -2.83 (95% confidence interval -3.51 to -2.15) (total participants 130), but not in zinc acetate group, mean difference 1.54 (95% confidence interval -2.01 to 5.09) (total participants 22). In one trial at three months and another at one year, the total number of clinical infections were significantly decreased in the zinc supplemented group as compared to controls, mean difference 0.05 (95% confidence interval 0.01 - 0.43) (total number of participants = 36), and mean difference -7.64 (95% confidence interval -10.89 to -4.39) (total number of participants = 21) respectively. AUTHORS' CONCLUSIONS: According to the results, there is no evidence from randomised controlled trials to indicate any benefit of zinc supplementation with regards to serum zinc level in patients with thalassaemia. However, height velocity was noted to increase among those who received this intervention.There is mixed evidence on the benefit of using zinc supplementation in people with sickle cell disease. For instance, there is evidence that zinc supplementation for one year increased the serum zinc levels in patients with sickle cell disease. However, though serum zinc level was raised in patients receiving zinc supplementation, haemoglobin level and anthropometry measurements were not significantly different between groups. Evidence of benefit is seen with the reduction in the number of sickle cell crises among sickle cell patients who received one year of zinc sulphate supplementation and with the reduction in the total number of clinical infections among sickle cell patients who received zinc supplementation for both three months and for one year.The conclusion is based on the data from a small group of trials,which were generally of good quality, with a low risk of bias. The authors recommend that more trials on zinc supplementation in thalassaemia and sickle cell disease be conducted given that the literature has shown the benefits of zinc in these types of diseases.

Desmopressin acetate (DDAVP) for preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders.

BACKGROUND: Congenital bleeding disorders can cause obstetric haemorrhage during pregnancy, labour and following delivery. Desmopressin acetate is found to be an effective drug which can reduce the risk of haemorrhage and can also stop bleeding in certain congenital bleeding disorders. Its use in pregnancy has been controversial. Hence beneficial and adverse effects of desmopressin acetate in these groups of pregnant women should be evaluated. OBJECTIVES: To determine the efficacy of desmopressin acetate in preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and abstract books of conferences proceedings. We also searched for any randomised controlled trials in a registry of ongoing trials and the reference lists of relevant articles and reviews.Date of most recent search: 28 February 2013. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials investigating the efficacy of desmopressin acetate versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible. DATA COLLECTION AND ANALYSIS: No trials matching the selection criteria were eligible for inclusion. MAIN RESULTS: No trials matching the selection criteria were eligible for inclusion. AUTHORS' CONCLUSIONS: The review did not identify any randomised controlled trials investigating the relative effectiveness of desmopressin acetate for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with desmopressin acetate.Given the ethical considerations, future randomised controlled trials are unlikely. However, other high quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using desmopressin acetate in this population are needed.

Pathological complete response in locally advanced breast cancer: determinants and predictive significance.

BACKGROUND: Neoadjuvant chemotherapy is now the standard approach for most large breast cancers including locally advanced cancers of the breast. The majority of patients respond satisfactorily to chemotherapy with effective downsizing of tumours to consider breast conservation surgery. Pathological complete response (pathCR) is known to be a strong predictor of good outcome; however, many factors are known to influence the extent of response to chemotherapy. It has been observed that smaller the tumour, better is the response achieved in contrast to larger and locally advanced tumours where only one-third may respond well enough to merit breast conservation. Various other clinical, biological and molecular factors are also being evaluated as effective predictors of chemosensitivity. Most of these are either not easily available for all patients in developing countries or are overtly expensive and not applicable for all patients. METHODS: We evaluated the clinical and pathological predictors of response to chemotherapy in 1402 women with locally advanced breast cancer. RESULTS: There was a higher rate of pathCR in smaller tumours, younger women and ER-negative as well as triple negative tumours. The presence of ductal carcinoma in situ (DCIS) and lymphatic and vascular invasion (LVI) were associated with lower pathCR. CONCLUSION: In the absence of ready availability of expensive molecular and genomic assays, clinical parameters and standard histopathological variables can also be useful indicators of response to neoadjuvant chemotherapy. Additionally, they can help identify those who could be eventually conserved or have a better outcome.

Visual outcomes of cataract surgery in a rural population of South India: results from a population-based survey.

We aimed to assess the outcomes of cataract surgery in a rural population of south India. A house-to-house survey was carried out in 15 villages. Out of the 156 eyes operated on for cataract, the outcome was good, borderline and poor in 49.3%, 35.2% and 14.1% of the eyes respectively. There is a need to focus on the quality of cataract surgical services rather than just the number of cataract surgeries to reduce the burden of cataract blindness.

Acceptability and effectiveness of a breast health awareness programme for rural women in India.

BACKGROUND: Breast cancer being one of the leading cancers among women in developing countries, prevention or identification of the disease at an early stage is of paramount importance in saving as well as improving the quality of life. Breast health awareness appears to be a pragmatic method for this. OBJECTIVE: To determine the acceptability and effectiveness of an educational intervention programme on breast health awareness for rural women by trained female health workers. SETTINGS AND DESIGN: Community based non-randomised educational intervention study carried out over a period of 1 year. Three hundred and sixty rural women in the age group 30--59 years were randomly selected (and age-wise stratified), from a coastal village in Southern India. METHODS: Women were educated on breast health and breast self-examination by specifically trained health workers and their awareness and proficiency levels were evaluated at the end of 1 and 3 months post-intervention. STATISTICAL ANALYSIS: This was done using the Statistical Package for Social Sciences Version 10. RESULTS: Following the educational intervention, a significant increase in overall awareness regarding breast cancer (z=-15.807; P< 0.001) as well as in the performance of self-examination of the breast 321/342 (93%) was observed. Forgetfulness or being too busy appeared to be the two most frequently perceived barriers. CONCLUSION: This study clearly shows that a community oriented educational intervention programme emphasizing on proper technique can bring about the desirable behavioural change among women.