Wang Guo-Hui, Wang Li-Hua, Wang Chen, Qin Li-Hong
Department of Neurology, First Affiliated Hospital of Jiamusi University, Jiamusi, China.
Medicine (Baltimore). 2018 May;97(19):e0636. doi: 10.1097/MD.0000000000010636.
This study explored the feasible efficacy and safety of the Spore Powder of Ganoderma Lucidum (SPGL) for treating patients with Alzheimer disease (AD).
Forty-two eligible patients with AD were recruited. These patients were randomly allocated to an intervention group and a control group equally. The patients in the intervention group underwent SPGL, whereas the subjects in the control received placebo. All patients were treated for a total of 6 weeks. The primary outcome was measured by Alzheimer's disease Assessment Scale-Cognitive (ADAS-cog). The secondary outcomes were measured by the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) and Neuropsychiatric Index (NPI). The adverse events were also recorded during the treatment period.
At the end of the treatment, GLSP did not show more encouraging outcomes in symptoms improvement, measured by the ADAS-cog (P = .31), and NPI (P = .79); and quality of life enhancement, measured by the WHOQOL-BREF (physical, P = .62; psychological, P = .69; social relationships, P = .75; environment, P = .82; overall quality of life, P = .74), compared with the control group. In addition, all adverse events were mild, and no significant differences were found between 2 groups.
The results of this study did not find the promising efficacy of SPGL for the treatment of AD after 6-week treatment. It may be because of the relative short-term of intervention. Future clinical trials with larger sample size and longer treatment period are urgently needed.
本研究探讨了灵芝孢子粉(SPGL)治疗阿尔茨海默病(AD)患者的可行性疗效及安全性。
招募了42例符合条件的AD患者。这些患者被随机平均分为干预组和对照组。干预组患者接受SPGL治疗,而对照组患者接受安慰剂治疗。所有患者共治疗6周。主要结局通过阿尔茨海默病认知评估量表(ADAS-cog)进行测量。次要结局通过世界卫生组织生活质量问卷(WHOQOL-BREF)和神经精神症状量表(NPI)进行测量。治疗期间还记录了不良事件。
治疗结束时,与对照组相比,通过ADAS-cog(P = 0.31)和NPI(P = 0.79)测量,SPGL在症状改善方面未显示出更令人鼓舞的结果;通过WHOQOL-BREF测量(生理方面,P = 0.62;心理方面,P = 0.69;社会关系方面,P = 0.75;环境方面,P = 0.82;总体生活质量方面,P = 0.74),在生活质量提高方面也未显示出更令人鼓舞的结果。此外,所有不良事件均为轻度,两组之间未发现显著差异。
本研究结果未发现SPGL在6周治疗后对AD治疗有显著疗效。这可能是由于干预时间相对较短。迫切需要未来进行更大样本量和更长治疗期的临床试验。