IRVINE3 Labs, Chieti-Pescara University, Chieti, Italy -
International Agency for Pharma Standard Supplements (IAPPS), Chieti, Italy -
Minerva Med. 2018 Oct;109(5):363-368. doi: 10.23736/S0026-4806.18.05573-8.
Post-traumatic stress disorder (PTSD) is associated to recurrent, obsessive recollection of severe traumatic events. This condition is still not completely understood. Elective treatment of PTSD is psychotherapy. Standardized supplements, used for improving chronic fatigue syndrome (i.e. Robuvit®, Horphag Research Ltd) can also be used to control some of the symptoms associated to PTSD, as well as to control the associated increased oxidative stress, present in many of these patients. The aim of this open registry was to evaluate the effects of supplementary Robuvit® 300 mg/day, added to standard management (SM), in subjects with PTSD over a period of 4 weeks, both on the psychological and the inflammatory level.
Otherwise healthy individuals with a diagnosis of PTSD were included in this registry. A clear main traumatic event occurred with different modalities in all subjects during or just after major earthquakes in Central Italy. SM included exposure therapy and psychotherapy. Supportive psychotherapy was used in all affected subjects. Subjects autonomously decided which group to enter (either SM or SM + Robuvit®), without any pre-defined group allocation or randomization. No placebo was used.
The two groups were comparable: 18 subjects (11 females; age range 25-49) were included in the SM group, and 16 subjects (8 females; age range 26-52) using SM in combination with Robuvit® supplementation. BMI of all subjects was below 25 kg/m2. After 4 weeks, the percentages of subjects with recurrent memories and dreams, transient walking-dissociative states and reactive flashbacks/hallucinations, alarm reactions and intense emotional distress, emotional numbness, social disinterest and detachment were significantly lower in the subjects treated with Robuvit® (P<0.05%). Sleeping problems, irritability, and fatigue were also significantly reduced with supplementation.
The results of our preliminary, pilot registry show that symptoms of PTSD as well as the high oxidative stress-related to the condition can be controlled and improved using Robuvit® as a supplementary management. The improvement with Robuvit® is faster and larger than that seen with standard management only. Supplementation is safe and well tolerated and may represent an important option in PTSD treatment.
创伤后应激障碍（PTSD）与对严重创伤事件的反复、强迫性回忆有关。这种情况仍未被完全理解。PTSD 的选择性治疗是心理治疗。标准化补充剂，用于改善慢性疲劳综合征（即 Robuvit®，Horphag Research Ltd），也可用于控制与 PTSD 相关的一些症状，以及控制许多此类患者存在的相关氧化应激增加。本开放性登记研究旨在评估补充 Robuvit® 300mg/天对 PTSD 患者的影响，为期 4 周，标准治疗（SM）上，观察心理和炎症水平的变化。
本登记研究纳入了被诊断为 PTSD 的健康个体。所有受试者均在意大利中部大地震期间或之后以不同方式经历了明确的主要创伤事件。SM 包括暴露疗法和心理治疗。所有受影响的受试者均接受支持性心理治疗。受试者自主决定进入哪个组（SM 或 SM+Robuvit®），没有预定义的分组或随机分组。未使用安慰剂。
两组具有可比性：SM 组纳入 18 例受试者（11 例女性；年龄 25-49 岁），SM+Robuvit® 组纳入 16 例受试者（8 例女性；年龄 26-52 岁）。所有受试者的 BMI 均低于 25kg/m2。4 周后，SM+Robuvit® 组受试者的记忆和梦境再现、短暂的分离状态、反应性闪回/幻觉、警报反应和强烈的情绪困扰、情绪麻木、社交兴趣和分离、睡眠问题、易怒和疲劳等症状的发生率显著低于 SM 组（P<0.05%）。
我们初步的、试点性登记研究结果表明，使用 Robuvit® 作为补充治疗可以控制和改善 PTSD 症状以及与病情相关的高氧化应激。Robuvit® 的改善效果比单独使用标准治疗更快、更大。补充剂安全且耐受良好，可能是 PTSD 治疗的重要选择。
