Irvine3 Labs, San Valentino Vascular Screening Project, Pescara, Italy -
Irvine3 Labs, San Valentino Vascular Screening Project, Pescara, Italy.
Minerva Surg. 2023 Aug;78(4):378-384. doi: 10.23736/S2724-5691.23.09885-4. Epub 2023 Mar 30.
The aim of this pilot registry study was to evaluate the efficacy of Robuvit (oak wood extract) on residual fatigue due to convalescence in otherwise healthy subjects within one month after surgery and chemotherapy for colon cancer. Robuvit has been clinically tested in subjects with fatigue (chronic fatigue syndrome), post-traumatic stress disorder, convalescence and burnout.
One group of patients followed the standard management (SM) and was designated as control group while the supplementation group followed the SM and additionally took two Robuvit capsules daily for six weeks (200 mg/day).The main study endpoints were the Karnofsky performance scale index, handgrip strength in kg, fitness test score on a treadmill, self-assessed work ability, fatigue score, oxidative stress and carcinoembryonic antigen (CEA) plasma levels. In addition, the mood of the patients was assessed using the 'brief mood introspection scale', BMIS.
Fifty-one subjects with fatigue linked to convalescence within 1 month after chemotherapy for colon cancer completed the study, 29 in the Robuvit group and 22 as controls. The two management groups were comparable for age and sex distribution. The main investigation parameters were also comparable at inclusion. No side effects or tolerability problems were observed in the six weeks of follow-up. Occasional use of painkillers, antinausea medication or anti-inflammatory agents was accepted. After six weeks, Robuvit supplementation significantly improved the Karnofsky performance scale index compared to controls. Hand grip strength (dynamometry), treadmill fitness test score and the self-assessed work ability were significantly improved with Robuvit as well. The fatigue score after six weeks was significantly improved with Robuvit (P<0.05) in comparison with SM controls. Mood was significantly improved after 6 weeks in the Robuvit patients compared to the control group. The examined study parameters improved in the patients of the control group as well, during a normal postchemotherapy convalescence, but in a lesser extend when compared to the supplementation group. Oxidative stress was high at inclusion in both groups. The decrease in oxidative stress - as plasma free radicals - was significantly higher with the supplementation (P<0.05). CEA values were within the normal values from inclusion and in the 6 weeks of the registry in all subjects.
In conclusion, Robuvit helps to reduce fatigue after chemotherapy and improves strength, performance, fitness, work ability and mood in these patients, without exposing them to the risk of side effects.
本研究旨在评估 Robuvit（橡木木提取物）对结肠癌患者化疗后一个月内康复期剩余疲劳的疗效。Robuvit 已在疲劳（慢性疲劳综合征）、创伤后应激障碍、康复和倦怠患者中进行了临床测试。
一组患者遵循标准管理（SM）并被指定为对照组，而补充组在遵循 SM 的基础上，另外每天服用 2 粒 Robuvit 胶囊，持续 6 周（每天 200 毫克）。主要研究终点为卡诺夫斯基绩效量表指数、握力（公斤）、跑步机体能测试评分、自我评估工作能力、疲劳评分、氧化应激和癌胚抗原（CEA）血浆水平。此外，还使用“简要情绪内省量表”（BMIS）评估患者的情绪。
51 名结肠癌化疗后 1 个月内出现疲劳症状的患者完成了研究，其中 Robuvit 组 29 名，对照组 22 名。两组管理组在年龄和性别分布方面具有可比性。主要调查参数在纳入时也具有可比性。在 6 周的随访期间未观察到任何副作用或耐受性问题。偶尔使用止痛药、止吐药或抗炎药是可以接受的。六周后，与对照组相比，Robuvit 补充剂显著提高了卡诺夫斯基绩效量表指数。握力（测力计）、跑步机体能测试评分和自我评估工作能力也得到了显著改善。六周后，与 SM 对照组相比，Robuvit 显著降低了疲劳评分（P<0.05）。与对照组相比，六周后 Robuvit 患者的情绪明显改善。对照组患者在正常化疗康复期间，上述检查参数也有所改善，但与补充组相比，改善程度较低。两组患者在纳入时的氧化应激均较高。补充剂可显著降低（P<0.05）血浆自由基等氧化应激。CEA 值在所有患者从纳入到登记的 6 周内均在正常范围内。
总之，Robuvit 有助于减轻化疗后的疲劳，并提高这些患者的力量、表现、体能、工作能力和情绪，而不会使他们面临副作用的风险。
