Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year.

Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year.
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DOI:
10.1186/1472-6882-12-44
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发表时间:
2012-04-18
影响因子:
--
通讯作者:
Cherkin D
Cherkin D
中科院分区:
医学3区
文献类型:
--
作者:
Bradley R;Sherman KJ;Catz S;Calabrese C;Oberg EB;Jordan L;Grothaus L;Cherkin D

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一些小型的非对照研究发现,接受有执照的自然疗法医生治疗的2型糖尿病患者的自我护理行为得到改善,临床风险降低。为了扩展这些发现并确定随机临床试验的可行性和前景,我们进行了一项前瞻性研究,以测量连续性自然疗法护理(ANC)在控制不佳的2型糖尿病患者中的效果。从一个大型综合医疗保健系统邀请40名2型糖尿病患者接受最多8次ANC访视,为期一年。要求参与者的血红蛋白A1 c(HbA 1c)值在7.5- 9.5%之间,并且至少有一个额外的心血管风险因素(即,高血压、高脂血症或超重)。标准化的工具,通过电话收集结果数据的自我护理,自我效能,糖尿病问题领域,感知压力,动机和情绪。计算入组研究后6个月和12个月评分较基线的变化。6个月和12个月临床风险因素的变化(即,计算ANC队列的HbA 1c、血脂和血压),并与使用电子病历数据构建的329例合格、未参与患者队列的变化进行比较。调整了年龄、性别、基线HbA 1c和糖尿病药物的队列间比较。6个月被预先指定为结局评估的主要终点。参与者在一年中平均进行了3.9次ANC访问,其中78%发生在进入研究后的六个月内。在6个月时,发现大多数患者报告的测量指标有显著改善,包括血糖检测(P = 0.001)、饮食(P = 0.001)、体力活动(P = 0.02)、情绪(P = 0.001)、自我效能(P = 0.0001)和改变生活方式的动机(P = 0.003)。血糖测试、情绪、自我效能和改变生活方式的动机在12个月时持续改善(所有P < 0.005)。对于临床结局,ANC队列6个月时的平均HbA 1c降低了-0.90%(P = 0.02),与常规治疗相比平均差异为-0.51%(P = 0.07)。12个月时的减少无统计学显著性(ANC队列为-0.34%,P = 0.14;与常规护理队列相比差异为-0.37%,P = 0.12)。对于控制不佳的2型糖尿病患者,在开始ANC后,注意到自我监测血糖、饮食、自我效能、动机和情绪的改善。研究参与者也经历了血糖降低,超过了那些没有接受ANC的类似患者。随机临床试验将是必要的,以确定是否ANC是负责这些好处。
Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC) in primary care patients with inadequately controlled type 2 diabetes. Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight). Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001), diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy (P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in glucose testing, mood, self-efficacy and motivation to change lifestyle persisted at 12-months (all P < 0.005). For clinical outcomes, mean HbA1c decreased by −0.90 % (P = 0.02) in the ANC cohort at 6-months, a −0.51 % mean difference compared to usual care (P = 0.07). Reductions at 12-months were not statistically significant (−0.34 % in the ANC cohort, P = 0.14; -0.37 % difference compared to the usual care cohort, P = 0.12). Improvements were noted in self-monitoring of glucose, diet, self-efficacy, motivation and mood following initiation of ANC for patients with inadequately controlled type 2 diabetes. Study participants also experienced reductions in blood glucose that exceeded those for similar patients who did not receive ANC. Randomized clinical trials will be necessary to determine if ANC was responsible for these benefits.
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