Griggs Joanne L, Su Xiao Q, Mathai Michael L
Centre for Chronic Disease Prevention and Management, College of Health and Biomedicine, Victoria University, Melbourne, Victoria, Australia.
N Am J Med Sci. 2015 Nov;7(11):509-16. doi: 10.4103/1947-2714.170611.
Prader-Willi syndrome (PWS) results from a deletion of the paternal genes in the region of chromosome 15q11-q13. PWS develops hyperphagia, which when left unmanaged, leads to an excessive ingestion of food. To date there is inadequate pharmacological treatment or supplementation for modification of the PWS hyperphagia and/or the associated behaviors. Therefore, the best practice is familial supervision and restriction of diet and environment.
We aimed to determine if the natural supplement of Caralluma fimbriata extract (CFE) could attenuate hyperphagia or the associated appetite behaviors in children and adolescents with PWS over the 4-week pilot trial period.
We conducted a placebo-controlled, double-blind, randomized crossover trial over a 10-week period to investigate the effects of CFE on hunger control, in a cohort of children and adolescents with confirmed PWS (n =15, mean age 9.27 ± 3.16 years, body weight 43.98 ± 23.99 kg). Participants from Australia and New Zealand ingested CFE or a placebo of maltodextrin/cabbage leaf over a 4-week period, with a 2-week washout before the crossover to the other treatment. Weekly comparisons in appetite behavior, severity, and drive were recorded by parents, as scaled time-point measures on a hyperphagia questionnaire validated for PWS.
CFE administration was found to induce a significant accumulative easing of hyperphagia (P = 0.05), with decreases evident in one-third of the participants. Furthermore due to CFE supplementation, a significant decrease (P ≤ 0.05) was recorded in the category of behavior and a decrease in hyperphagia (n = 8, P = 0.009) was observed at the highest dose 1,000 mg/day (recommended adult dose). There were no reported adverse effects at any dose.
We demonstrate that an extract of the Indian cactus succulent Caralluma fimbriata eases hyperphagic appetite behavior within a cohort of children and adolescents (n = 15) with PWS without notable adverse effects. The outcomes of this study will have a potential positive impact on PWS management.
普拉德-威利综合征（PWS）是由15号染色体q11-q13区域的父系基因缺失引起的。PWS会出现食欲亢进，若不加以控制，会导致过度摄入食物。迄今为止，针对PWS食欲亢进和/或相关行为的改善，药物治疗或补充剂都不足。因此，最佳做法是家庭监督以及饮食和环境限制。
我们旨在确定在为期4周的试点试验期内，天然补充的肉苁蓉提取物（CFE）是否能减轻PWS儿童和青少年的食欲亢进或相关的食欲行为。
我们在10周内进行了一项安慰剂对照、双盲、随机交叉试验，以研究CFE对确诊为PWS的儿童和青少年队列（n = 15，平均年龄9.27±3.16岁，体重43.98±23.99 kg）饥饿控制的影响。来自澳大利亚和新西兰的参与者在4周内摄入CFE或麦芽糊精/卷心菜叶安慰剂，交叉使用另一种治疗前有2周的洗脱期。父母每周记录食欲行为、严重程度和驱动力的比较情况，作为在经PWS验证的食欲亢进问卷上的时间点量表测量值。
发现服用CFE可显著累积减轻食欲亢进（P = 0.05），三分之一的参与者有明显减轻。此外，由于补充CFE，行为类别有显著下降（P≤0.05），在最高剂量1000毫克/天（推荐成人剂量）时观察到食欲亢进有所减轻（n = 8，P = 0.009）。未报告任何剂量的不良反应。
我们证明，印度仙人掌肉质植物肉苁蓉的提取物可减轻一组患有PWS的儿童和青少年（n = 15）的食欲亢进行为，且无明显不良反应。本研究结果将对PWS的管理产生潜在的积极影响。
