Comparison of two modes of vitamin B12 supplementation on neuroconduction and cognitive function among older people living in Santiago, Chile: a cluster randomized controlled trial. a study protocol [ISRCTN 02694183]

BACKGROUND: Older people have a high risk of vitamin B12 deficiency; this can lead to varying degrees of cognitive and neurological impairment. CBL deficiency may present as macrocytic anemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. Less is known about subclinical vitamin B12 deficiency and concurrent neuroconduction and cognitive impairment. A Programme of Complementary Feeding for the Older Population (PACAM) in Chile delivers 2 complementary fortified foods that provide approximately 1.4 μg/day of vitamin B12 (2.4 μg/day elderly RDA). The aim of the present study is to assess whether supplementation with vitamin B12 will improve neuroconduction and cognitive function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of clinical deficiency. METHODS: We designed a cluster double-blind placebo-controlled trial involving community dwelling people aged 70-79 living in Santiago, Chile. We randomized 15 clusters (health centers) involving 300 people (20 per cluster). Each cluster will be randomly assigned to one of three arms: a) a 1 mg vitamin B12 pill taken daily and a routine PACAM food; b) a placebo pill and the milk-PACAM food fortified to provide 1 mg of vitamin B12; c) the routine PACAM food and a placebo pill.The study has been designed as an 18 month follow up period. The primary outcomes assessed at baseline, 4, 9 and 18 months will be: serum levels of vitamin B12, neuroconduction and cognitive function. CONCLUSIONS: In view of the high prevalence of vitamin B12 deficiency in later life, the present study has potential public health interest because since it will measure the impact of the existing program of complementary feeding as compared to two options that provide higher vitamin B12 intakes that might potentially may contribute in preserving neurophysiologic and cognitive function and thus improve quality of life for older people in Chile. TRIAL REGISTRATION: ISRCTN: ISRCTN02694183

Thymectomy for non-thymomatous myasthenia gravis

Background Treatments currently used for patients with myasthenia gravis (MG) include steroids, non-steroid immune suppressive agents, plasma exchange, intravenous immunoglobulin and thymectomy. Data from randomized controlled trials (RCTs) support the use of some of these therapeutic modalities and the evidence for non-surgical therapies are the subject of other Cochrane reviews. Significant uncertainty and variation persist in clinical practice regarding the potential role of thymectomy in the treatment of people with MG. Objectives To assess the efficacy and safety of thymectomy in the management of people with non-thymomatous MG. Search methods On 31 March 2013, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2013, Issue 3), MEDLINE (January 1966 to March 2013), EMBASE (January 1980 to March 2013) and LILACS (January 1992 to March 2013) for RCTs. Two authors (RS and GC) read all retrieved abstracts and reviewed the full texts of potentially relevant articles. These two authors checked references of all manuscripts identified in the review to identify additional articles that were of relevance and contacted experts in the field to identify additional published and unpublished data. Where necessary, authors were contacted for further information. Selection criteria Randomized or quasi-randomized controlled trials of thymectomy against no treatment or any medical treatment, and thymectomy plus medical treatment against medical treatment alone, in people with non-thymomatous MG. We did not use measured outcomes as criteria for study selection. Data collection and analysis We planned that two authors would independently extract data onto a specially designed data extraction form and assess risk of bias; however, there were no included studies in the review. We would have identified any adverse effects of thymectomy from the included trials. Main results We did not identify any RCTs testing the efficacy of thymectomy in the treatment of MG. In the absence of data from RCTs, we were unable to do any further analysis. Authors’ conclusions There is no randomized controlled trial literature that allows meaningful conclusions about the efficacy of thymectomy on MG. Data from several class III observational studies suggest that thymectomy could be beneficial in MG. An RCT is needed to elucidate if thymectomy is useful, and to what extent, in MG