A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study).

UNLABELLED: Rationale Traditional Chinese Medications(TCM) have been reported to have beneficial effects in stroke patients, but were not rigorously evaluated by GCP standards. Aim This study tests the hypothesis that Neuroaid, a TCM widely used in China post-stroke, is superior to placebo in reducing neurological deficit and improving functional outcome in patients with acute cerebral infarction of an intermediate severity. Design This is a multicenter, randomised, double-blind, placebo-controlled study of Neuroaid in ischemic stroke patients with National Institute of Health Stroke Scale(NIHSS) 6-14 treated within 48 h of stroke onset. Neuroaid or placebo is taken (4 capsules) 3 times daily for 3 months. Treatments are assigned using block randomization, stratified for centers, via a central web-randomization system. With a power of 90% and two-sided test of 5% type I error, a sample size is 874. Allowing for a drop-out rate of up to 20%, 1100 individuals should be enrolled in this study. Study Outcomes The primary efficacy endpoint is the modified Rankin Scale(mRS) grades at 3 months. Secondary efficacy endpoints are the NIHSS score at 3 months; difference of NIHSS scores between baseline and 10 days, and between baseline and 3 months; difference of NIHSS sub-scores between baseline and 10 days, and between baseline and 3 months; mRS at 10 days, 1 month, and 3 months; Barthel index at 3 months; Mini Mental State Examination at 10 days and 3 months. Safety outcomes include complete blood count, renal and liver panels, and electrocardiogram. STUDY REGISTRATION: ClinicalTrials.gov identifier: NCT00554723.

Risk factors for dementia and impaired cognitive status in Thai elderly.

OBJECTIVE: To examine the association of physical and biochemical risk factors for dementia and cognitive status in an urban population based Thai elderly. MATERIAL AND METHOD: This study was part of an integrated health research project from 1997 to 1999. Subjects were 550 elders who lived in a community within 10 km from Siriraj Hospital, Bangkok, Thailand. They were 55 years and older. Thai mental state examination (TMSE) was applied to all subjects as the screening test for dementia. Those who scored less than or equal to 24 out of 30 were categorised as having cognitive impairment or suspected of having dementia, and they were then examined in detail for the diagnosis of dementia using the DSM IV criteria. Blood pressure and body weight were recorded. Blood was drawn for biochemical and haematological analysis including the serology for syphilis and thyroid function test as the basic screening investigation for dementia. Descriptive data, expressed as the mean, standard deviation, Pearson Chi square and ANOVA tests were analysed with SPSS 9.0 in the study. RESULTS: Of 550 subjects, 261 (47.45%) were classified as the normal subjects group, 49 (8.91%) as the cognitively impaired group, and 240 (43.82%) as the dementia group. 377 subjects (68.55%) were female and the distribution of females in each subgroup ranged from 63.3-75.5 per cent. The mean age in the normal group was 67.47 +/- 6.05 years, the cognitively impaired group was 70.14 years and the dementia group was 69.63 +/- 9.21 years. Systolic blood pressure (BP), diastolic BP, serum cholesterol, SGOT, GGT, serum albumin, haemoglobin, MCHC, neutrophil counts and weight were statistically significant factors that were associated with cognitive status. Both systolic and diastolic BP were high in the higher cognitive status group. Serum albumin, serum cholesterol levels and body weight were also higher in the high cognitive status group. CONCLUSION: This study demonstrated an association between nutritional status and cognitive status in Thai elderly. Poorer nutritional factor in lower cognitive function individuals might explain a lower of both systolic and diastolic BP in the dementia subjects compared to the healthy subjects.

The first world report of botulinum A toxin injection for status migrainosus.

The author reports the first ever documented publication in the world concerning the use of botulinum toxin A (BTX-A) injection for status migrainosus. A 58-year old man had been suffering from migraine without aura for 20 years. This last attack (a very severe throbbing headache) started over the left side of his head and he had tried several medications (paracetamol, aspirin, ergotamine, mefenamic acid, and diazepam) during the attack to no vail. Physical examination revealed an acutely ill patient with an agonizing pain condition. General and neurological examinations were normal. BTX-A solution was then injected into the Fung Chou point (classical Chinese acupuncture point for migraine) in the total amount of 25 international unit. Dramatic response was observed within 1 hour of injection and status migrainosus was abort within 10 hours. He was headache-free and had no further attack of migraine for another 2 months.