Lerman Robert H, Chang Jyh-Lurn, Konda Veera, Desai Anuradha, Montalto Michael B
is the former director of medicine and extramural clinical research; is the manager for medical affairs; is the director of nutrition research; is the therapeutic platform lead for foundational health; and is the senior director of medical affairs. All are located at Metagenics, Inc, in Gig Harbor, Washington.
Integr Med (Encinitas). 2015 Oct;14(5):52-61.
Tetrahydro iso-α acids (THIAAs), derived from Humulus lupulus (hops), have demonstrated anti-inflammatory effects in vitro and in an animal model of rheumatoid arthritis (RA). Undenatured type 2 collagen has been found to be effective in clinical studies in RA and osteoarthritis (OA).
The study intended to evaluate the efficacy and safety of a proprietary tablet containing 150 mg of n-enriched THIAA (nTHIAA) and 10 mg of undenatured type 2 collagen (UC-II) (containing 25% UC-II) in patients with arthritis.
The study was an open-label case series. This article also includes a case history for 1 participant.
The study was conducted at the Functional Medicine Research Center (FMRC) in Gig Harbor, WA, USA, from February 2013-June 2013.
Participants were 17 adults, 12 women, and 5 men aged 39-69 y, who had chronic joint pain involving various joints, 13 with probable OA and 4 with possible RA.
Participants took 2 tablets of nTHIAA + UC-II 2 ×/d with meals for 12 wk.
Participants completed arthritis-related and quality-of-life questionnaires, at weeks 2, 4, 8, and 12: (1) the visual analog scale for pain (VAS-P); (2) the medical symptoms questionnaire (MSQ), with the analysis particularly focusing on the joint/muscle subscale and total scores; (3) the health and wellness outcome questionnaire (MOS-SF36), with the analysis particularly focusing on the physical and mental subscales; (4) the arthritis impact questionnaire (AIQ), with the analysis particularly focusing on the arthritis symptoms and daily living subscales; (5) the health assessment questionnaire (HAQ-DI) with the analysis particularly focusing on question 26 (Q26), which indicates overall pain during the week prior to the survey; and (6) the arthritis impact measurement scales 2 (AIMS2). At 12 wk, participants also completed the visual analog scale for efficacy (VAS-E).
All participants completed the 12-wk evaluation, and all reported improvements in pain. Significant improvements in scores on the questionnaires were observed as early as 2 wk. For example, the total score on the MSQ was significantly decreased from a mean of 20.76 ± 2.90 (SE) at baseline to 12.24 ± 2.81 after 2 wk (P < .001). At 12 wk, the participants rated the supplement's efficacy at 7.6 ± 0.6 of 10. At baseline, 13 of the 17 participants were using analgesics for joint pain, compared with only 4 participants at 12 wk. Two of those 4 had reduced their analgesic dosages. The studied supplement was well tolerated, and no serious side effects occurred.
The supplement containing nTHIAA and UC-II is safe and efficacious in participants with chronic joint pain.
源自啤酒花的四氢异-α酸(THIAAs)在体外和类风湿性关节炎(RA)动物模型中已显示出抗炎作用。未变性II型胶原蛋白在RA和骨关节炎(OA)的临床研究中已被证明是有效的。
本研究旨在评估一种含有150毫克富含n的THIAA(nTHIAA)和10毫克未变性II型胶原蛋白(UC-II)(含25%UC-II)的专利片剂对关节炎患者的疗效和安全性。
本研究为开放标签病例系列。本文还包括1名参与者的病例史。
该研究于2013年2月至2013年6月在美国华盛顿州吉格港的功能医学研究中心(FMRC)进行。
参与者为17名成年人,12名女性和5名男性,年龄在39 - 69岁之间,患有涉及多个关节的慢性关节疼痛,其中13人可能患有OA,4人可能患有RA。
参与者每天随餐服用2片nTHIAA + UC-II,共服用12周。
参与者在第2、4、8和12周完成关节炎相关和生活质量问卷:(1)疼痛视觉模拟量表(VAS-P);(2)医学症状问卷(MSQ),分析特别关注关节/肌肉子量表和总分;(3)健康与幸福结局问卷(MOS-SF36),分析特别关注身体和心理子量表;(4)关节炎影响问卷(AIQ),分析特别关注关节炎症状和日常生活子量表;(5)健康评估问卷(HAQ-DI),分析特别关注问题26(Q26),该问题表明调查前一周的总体疼痛情况;以及(6)关节炎影响测量量表2(AIMS2)。在第12周时,参与者还完成了疗效视觉模拟量表(VAS-E)。
所有参与者均完成了12周的评估,且均报告疼痛有所改善。问卷调查得分早在2周时就有显著改善。例如,MSQ总分从基线时的平均20.76±2.90(标准误)显著降至2周后的12.24±2.81(P <.001)。在第12周时,参与者对该补充剂疗效的评分在10分制中为7.6±0.6。基线时,17名参与者中有13人因关节疼痛使用镇痛药,而在第12周时只有4人使用。这4人中的2人减少了镇痛药剂量。所研究的补充剂耐受性良好,未发生严重副作用。
含有nTHIAA和UC-II的补充剂对慢性关节疼痛参与者安全有效。