Efficacy of Thiamine in Patients With Clinically Suspected Dry Beriberi: An Open Labeled Hospital Bases Study in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- change in Overall Neuropathy Limitation Scale (ONLS) score
研究概览
简要总结
Abstract Background: Thiamine deficiency related disorders are increasingly being reported in countries where polished rice is the main dietary constituents and diet is not balanced in calorie, protein and micronutrients contents. Thiamine deficiency often associated with a sensory-motor neuropathy (dry beriberi) without Wernicke's encephalopathy and cardiac dysfunction.
Objectives: The objective of our study will be to evaluate the efficacy of thiamine in patients with clinically suspected dry beriberi.
Methods: This study will be a prospective, open labeled, self-controlled clinical trial (quasi-experimental study) carried out in the Neurology and Medicine Ward of Chittagong Medical College Hospital from July 2018 to June 2019. Fifty-five (55) patients of suspected dry beriberi will be recruited as per inclusion and exclusion criteria. All patients will be given 200mg IV Thiamine Hydrochloride per day for 1 week, then oral Tab. Thiamine 100mg twice daily for remaining 11week. They will be evaluated clinically before treatment and followed up at the end of 1 week, 6 week and 12 week after treatment. Assessment will be done by some clinical parameters like leg swelling, muscle cramp, muscle power, squat test, sensory impairments, deep tendon reflexes and by Overall Neuropathy Limitations Scale (ONLS) Score. Pre and post test treatment data will be recorded in a pre-designed case record form. To determine whether any o the difference between pretreatment and post treatment values were statistically significant or not, either Friedman's test or Cochran's Q test will be used. Analysis will be performed with SPSS windows version 23 and statistical significance will be defined as P<0.05 and confidence interval will be set at 95% level. Our study result is likely to sensitize the health professionals of this region about this neglected health issue by increasing awareness of the clinical spectrum of Thiamine Deficiency related Peripheral Neuropathy.
详细描述
This Self-controlled Clinical Trial will be conducted in Department of Neurology and Department of Medicine of Chittagong Medical College Hospital (CMCH) during July 2018 to June 2019. A total of 55 patients of possible beriberi will be included based on inclusion criteria. Patients with isolated cardiac/wet beriberi and with other known causes of peripheral neuropathy such as Diabetic, hereditary, Demyelinating (GBS, CIDP), metabolic (hepatic/renal impairment), history of intake of drugs (e.g. INH, Ethambutol, Phenytoin, Metronidazole, Dapsone etc.) and toxins exposure (As ,Organo-phosphate Compound, Pb ,Hg except alcohol) were excluded from study.
Operational Definitions:
Risk factors: Imbalanced diet (diet poor in thiamine/rich in carbohydrate or anti-thiamine factors), malnutrition, alcoholism, Gastro-Intestinal surgery, chronic diarrhoea, chronic vomiting, pregnancy or history of recent delivery, chronic, diuretics use, renal dialysis, total parenteral nutrition.
Possible/suspected neuritic (dry) beriberi: Risk factors + at least 2 of the following signs:
- Muscle weakness of upper and or lower limb (less than grade 5 power in MRC scale)
- Positive sensory symptoms (burning, tingling or pain)
- Objective sensory deficit (pain, touch, position, vibration sense )
- Absent or reduced deep tendon reflexes
- Positive squat test (unable to rise after squatting without help)
- Leg swelling Probable neuritic (dry) beriberi: Above symptoms recovered after thiamine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any person admitted to CMCH as a Suspected thiamine deficiency related peripheral Neuropathy / Possible dry-beriberi:
- •Risk factors + at least 2 of the following signs:
- •Risk factors include Imbalanced diet (diet poor in thiamine/rich in carbohydrate or anti-thiamine factors), malnutrition, alcoholism, Gastrointestinal surgery, chronic diarrhoea, chronic vomiting, pregnancy or history of recent delivery, chronic. diuretics use, renal dialysis, total parenteral nutrition.
- •Muscle weakness of upper and or lower limb (less than grade 5 power in MRC scale)
- •Positive sensory symptoms (burning, tingling or pain)
- •Objective sensory deficit (pain, touch, position, vibration sense )
- •Absent or reduced deep tendon reflexes
- •Positive squat test (unable to rise after squatting without help)
- •Leg swelling
- •Age 18 years and above.
排除标准
- •Patients with isolated cardiac/wet beriberi.
- •Patient with known causes of peripheral neuropathy such as Diabetic, hereditary, Demyelinating (GBS, CIDP), metabolic (hepatic/renal impairment), drugs (e.g. Isoniazid, Ethambutol, Phenytoin, Metronidazole, Dapsone etc.) Toxin (As ,Organo-phosphate Compound (OPC), Pb ,Hg except alcohol) etc.
- •Patients refuse to participate.
结局指标
主要结局
change in Overall Neuropathy Limitation Scale (ONLS) score
时间窗: before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment
it is score measuring functional status of peripheral neuropathy patients. lowest score is 0 (No disability) and highest score 12 (most disability)
次要结局
- change in deep tendon reflexes(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in touch sensation(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in leg swelling(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in muscle power(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in pain sensation(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in position sensation(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in muscle cramp(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in squat test(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
- change in vibration sensation(before treatment with Thiamine (baseline ) and after 1 week, 6week, 12 week of treatment)
研究者
Nayema Masrura
Thesis Student, Department of Neurology
Chittagong Medical College