Download RP (n = 21)

RAY SRIRATANA TABUCANON: IUIAS TEFRDIDNI FRE’SAVE TEEUUO CAEDEEF IAUSIVYE
EIUVETIVEEDIECDIDS ISERU IIEOAVU VUEIAVAEE CIDIVEIUOECIADSEASEISFU2EOA UIUVE
EUTTAIEVERAIREOA UIACEIUIASDF IRSE SOECDIDS ISERU IIEOAVU VU, SINGLE BLIND
RANDOMIZED CONTROLLED TRIAL. THESIS ADVISOR: ASST.PROF. SOMKIAT SANGWATANAROJ,
BACKGROUND: The prevalence of diabetes retinopathy (DR) was increased in type 2 diabetes patients
(DM2) with coronary heart disease (CHD). Annual screening for diabetic retinopathy in DM2 were
recommended as a standard of care. Showing and explaning to DM2 patients with retinal photography may
motivate them to reduce CHD risk factors.
OBJECTIVE: The aim of the study was to determine the visual feedback effects by showing the patient’s
retinal photography for coronary heart disease risk factors reduction in DM2 with DR and CHD.
METHODS: Fourty three DM2 patients with DR and CHD were prospectively enrolled and randomly
assigned into two groups: showing and explaining retinal photography (RP) group and control group. The 6
minutes risk factor reduction education consisting of a basic knowledge of disease and related
complications, diet control, physical activity, smoking cessation, and a stress reduction were provided to
both groups. The primary end point was the difference of home blood pressure (BP) between baseline and
that at 3 months after the randomization. Home BP was defined as a mean of home BP measured by a digital
self-recorder twice a day for 7-consecuetive days. The secondary endpoints were the differences of body
weight, waist circumferences, moderate physical activity, smoking rate, HbA1c, and lipid profiles at 3
months.
RESULTS: A total of 21 patients in RP group and 22 patients in control group completed the study in a 3months period. The baseline characteristics between both groups were similar except for calcium channel
blocker (CCB) was used more in RP group.There were no smokers in both groups. Baseline systolic
BP/diastolic BP/mean arterial BP were 140±16/71±10/94±10 vs 132±18/69±10/90±11 mmHg for the
intervention and control groups respectively. After 3 months the changes in systolic BP/diastolic BP/mean
arterial BP were -8±14/-5±9/-6±9 vs +5±12/-1±9/+1±9 mmHg for the intervention and control groups
respectively (p = 0.01 for systolic BP, 0.10 for diastolic BP, 0.01 for mean arterial BP). There is an increasing
trend of physical activity and HDL-C in RP group (p = 0.14 for duration of duration of moderate physical
activity in 1 week, p = 0.26 for HDL-C)
CONCLUSIONS: Visual feedback of patients’ retinal photography for changing CHD risk factors in DM2 with
DR and CHD have statistically significant effect on systolic BP reduction. The remaining CHD risk factors
were not significantly different between both groups. There is an increasing trend of physical activity and
HDL-C in RP group.
Department : …………..Medicine…………….. Student’s signature ………………………………………
Field of study : ………...Medicine…………….. Advisor’s signature ………………………………………
Academic year : …………2012………………..
เรย์ ศรี รัตนาทาบูกานอน:
ผลของการใช้ ภาพถ่ ายจอประสาทตาของผู้ป่วยประกอบการให้ คาแนะนาต่ อการลดปั จจัยเสี่ยงของโรคหลอดเ
ลือดหัวใจEในผู้ป่วยเบาหวานชนิดที่E2Eที่มีเบาหวานขึน้ จอประสาทตาและโรคหลอดเลือดหัวใจ (SAVE TE
EUUO CAEDEEF IAUSIV’EIUIAS TEFRDIDNI FRYEIUVETIVEEDIECDIDS ISERU IIEOAVU VUE
IAVAEE CIDIVEIUOECIADSEASEISFUE2EOA UIUVEEUTTAIEVERAIREOA UIACEIUIASDF IRSE SOE
CDIDS ISERU IIEOAVU VU)
อาจารย์ที่ปรึกษาวิทยานิพนธ์หลัก ผศ.นพ.สมเกียรติ แสงวัฒนาโรจน์ , 141 หน้ า
ที่มาของการวิจัย:ผู้ป่วยเบาหวานชนิดที่2
ที่มีโรคหลอดเลือดหัวใจร่ วมด้ วยพบความชุกของเบาหวานขึ ้นจอประสาทตาเพิ่มขึ ้น ผู้ป่วยเบาหวานชนิดที่2
ทุกรายจาเป็ นต้ องตรวจจอประสาทตาปี ละครัง้ เป็ นมาตรฐาน
ดังนันการใช้
้
ภาพถ่ายจอประสาทตาของผู้ป่วยเองมาใช้ ประกอบการให้ คาแนะนาเพื่อควบคุมปัจจัยเสี่ยงของโรคหลอดเลื
อดหัวใจในผู้ป่วยเบาหวานชนิดที่2 ที่มีเบาหวานขึ ้นจอประสาทตาอาจทาให้ ผ้ ปู ่ วยเบาหวานชนิดที่2
ที่มีภาวะแทรกซ้ อนคือโรคเบาหวานขึ ้นจอประสาทตาและโรคหลอดเลือดหัวใจสามารถควบคุมปั จจัยเสี่ยงของโรคหลอดเ
ลือดหัวใจได้ ดีขึ ้น
วัตถุประสงค์ ของการวิจัย:เพื่อประเมินประสิทธิภาพของการให้ คาแนะนาผู้ป่วยเบาหวานชนิดที่ 2
ทีม่ ีโรคบาหวานขึ ้นจอประสาทตาร่ วมกับโรคหลอดเลือดหัวใจด้ วยภาพถ่ายจอประสาทตาประกอบในการลดปัจจัยเสี่ยงข
องโรคหลอดเลือดหัวใจ
วิธีการวิจัย:ทาการศึกษาในผู้ป่วยเบาหวานชนิดที่2ที่มีภาวะแทรกซ้ อนคือโรคเบาหวานขึ ้นจอประสาทตาและโรคหลอดเ
ลือดหัวใจจานวน 43 คน โดยผู้ป่วยจะถูกสุ่มเป็ น 2
กลุ่มคือกลุ่มให้ คาแนะนาการลดปัจจัยเสี่ยงของโรคหลอดเลือดหัวใจโดยใช้ ภาพถ่ายจอประสาทตาประกอบและกลุ่มควบ
คุม
การให้ คาแนะนาประกอบด้ วยความรู้ พื ้นฐานของโรคเบาหวานและภาวะแทรกซ้ อน,การควบคุมอาหาร,กิจกรรมทางกาย,
การเลิกบุหรี่ ,การลดความเครี ยดใช้ เวลาประมาณ 6 นาที
และเก็บข้ อมูลระดับความดันโลหิตโดยใช้ เครื่ องวัดความดันโลหิตอัตโนมัติด้วยตนเองเป็ นเวลา1สัปดาห์ ,ชัง่ น ้าหนัก ,
วัดรอบเอว, ระดับน ้าตาลสะสม,โคเลสเตอรอล,ไตรกรี เซอไรด์
,แอลดีแอลในเลือด,เอชดีแอลในเลือดก่อนและหลังเข้ าร่ วมวิจยั 3 เดือน
ผลการศึกษา: มีผ้ ปู ่ วยกลุ่มศึกษาจานวน 21 คนและผู้ป่วยกลุ่มควบคุมจานวน 22 คน ข้ อมูลพื ้นฐานใน 2
กลุ่มไม่แตกต่างกัน ยกเว้ นกลุ่มศึกษาใช้ ยากลุ่มปิ ดกันแคลเซี
้
ยมมากกว่ากลุ่มควบคุม หลังปรับข้ อมูลพื ้นฐาน
ความดันโลหิตซิสโตลิค/ความดันโลหิตไดแอสโตลิคความดันโลหิตเดลี่ย/ก่อนการศึกษาเท่ากับ140±16/71±10/94±10
และ 132±18/69±10 /90±11 มิลลิเมตรปรอทในกลุ่มศึกษาและควบคุมตามลาดับ หลังการศึกษา 3 เดือน
การเปลี่ยนแปลงของความดันโลหิตซิสโตลิค/ความดันโลหิตไดแอสโตลิค/ความดันโลหิตเดลี่ย เท่ากับ -8±14/-5±9/-6±9
และ +5±12/-1±9/+1±9 มิลลิเมตรปรอทในกลุ่มศึกษาและควบคุมตามลาดับ (p= 0.01 สาหรับความดันซิสโตลิค, 0.10
สาหรับความดันไดแอสโตลิคและ 0.01 สาหรับความดันโลหิตเดลี่ย)
และมีแนวโน้ มว่าผู้ป่วยในกลุ่มศึกษามีกิจกรรมระดับปานกลางและระดับเอชดีแอลในเลือดเพิ่มขึ ้น
สรุปผลการศึกษา :
การใช้ ภาพถ่ายจอประสาทตาของผู้ป่วยประกอบการให้ คาแนะนาต่อการลดปัจจัยเสี่ยงของโรคหลอดเลือดหัวใจ
ในผู้ป่วยเบาหวานชนิดที่ 2 ที่มีเบาหวานขึ ้นจอประสาทตาและโรคหลอดเลือดหัวใจ
นันสามารถลดความดั
้
นซิสโตลิคและความดันเดลี่ยได้ อย่างมีนยั สาคัญทางสถิติ
และมีแนวโน้ มว่าผู้ป่วยในกลุ่มศึกษามีกิจกรรมระดับปานกลางและระดับเอชดีแอลในเลือดเพิ่มขึ ้น
ภาควิชา……..อายุรศาสตร์ ………….. ลายมือชื่อนิสิต…………….………………….................................................
สาขาวิชา……….อายุรศาสตร์ …..……ลายมือชื่ออ.ที่ปรึกษาวิทยานิพนธ์หลัก……..…..………..................................
ปี การศึกษา……….2555……………. ลายมือชื่ออ.ที่ปรึกษาวิทยานิพนธ์ร่วม……..…..………...................................
Background
The prevalence of diabetes retinopathy was increased in type 2 diabetes patients with
coronary heart disease. Type 2 diabetes patients with coronary heart disease are classified as
high risk diabetes patients. Annual screening for diabetic retinopathy in type 2 diabetes mellitus
patients were recommended as a standard of care. Feedback of medical imaging results can reveal
visual evidence of actual bodily harm attributable to a given behavior. This may offer a particularly
promising approach to motivating changes in health behavior to decrease risk (1). Showing and
explaining to type2 diabetes patients with retinal photography may motivate them to reduce coronary
heart disease risk factors.
Method
Study design and population
The 3-month single blind randomized control trial was conducted at Cardiac center, King
Chulalongkorn Memmorial Hospital, Bangkok, Thailand. The Ethical Committee approved the study.
From February 8, 2012, through January 30, 2013, 43 type 2 diabetic patient with diabetic
retinopathy and coronary heart disease aged ≥ 18 years was recruited from 44 patients responding
to this study. Patient who could not understand the explanation, refused to participate in the study,
pregnant or having advanced cancer were excluded.
Intervention
All Type 2 diabetes mellitus patients with diabetic retinopathy and coronary heart disease
underwent coronary heart disease risk reduction counseling, standard treatment of coronary heart
disease by the physician in charge, and retinal photograph to screen for diabetic retinopathy (DR).
At baseline, data were collected on duration of type 2 diabetes mellitus, history of educational tutorial
on coronary heart disease risk reduction, family history of coronary heart disease, degree of diabetic
retinopathy, degree of coronary heart disease, smoking status, body weight, waist circumference,
height, Body Mass Index (BMI), duration of moderate physical activity, home blood pressure
monitoring, Glycosylated hemoglobin (HbA1c), total cholesterol, LDL-cholesterol, HDL-cholesterol
and triglyceride.
Home blood pressure monitoring was defined as a mean of home blood pressure (home
BP) measured by digital self-recorder twice a day for 7-consecuetive days (2).
Retinal photography was performed by a trained technician. The patient’s retinal
photography was interpreted by an ophthalmologist. Diagnosis of diabetic retinopathy was
diagnosis and grading by retinal photography following international clinical diabetic retinopathy
and diabetic macular edema disease severity scale (3).
-
-
No DR: No abnormalities.
Mild non-proliferative diabetic retinopathy (NPDR): microaneurysms only.
Moderate NPDR: more than just microaneurysms but less than severe NPDR.
Severe NPDR: Any of the following: (1) more than 20 intraretinal hemorrhages in each
of 4 quadrants, (2) definite venous beading in 2 or more quadrants, (3) prominent
intraretinal microvascular abnormalities in 1 or more quadrants and no signs of
proliferative retinopathy
PDR (proliferative diabetic retinopathy): neovascularization, vitreous/preretinal
hemorrhage.
Coronary heart disease is defined as one or more lesions with ≥ 50% stenosis by coronary
angiography.
The risk factor reduction education consisting of a basic knowledge of disease and related
complications, diet control, physical activity, smoking cessation, and stress reduction was a
standardized and provided to both groups (duration: 6 min) to ensure equal conditions, both groups
listened to a similar 6-minute education tutorial. Explaining the image was done with a concise and
easy to understand method.
Type 2 diabetes mellitus patients with diabetic retinopathy and coronary heart disease were
prospectively enrolled and randomly assigned into two groups: showing and explaining retinal
photograph (RP) group and control group. The RP group received image of their retina compared
with image of normal retina. The control group received only for the risk factor education.
Data were collected from participants on smoking status, body weight, waist
circumference, height, Body Mass Index (BMI), duration of moderate physical activity, home blood
pressure monitoring, Glycosylated hemoglobin (HbA1c), total cholesterol, LDL-cholesterol, HDLcholesterol, triglyceride in 3 months.
Outcomes
The primary outcome was the difference of home blood pressure monitoring at 3 months
(including systolic blood pressure, diastolic blood pressure and mean arterial blood pressure). The
secondary endpoints were the differences of body weight, waist circumference, duration of
moderate physical activity, smoking rate, HbA1c, and lipid profiles in 3 months.
Figure 1 Study Enrollment, Randomization, and Outcomes
Type 2 diabetes mellitus & CHD & DR (n=44)
Informed consent
Did not provide consent (n=1)
Baseline: Retinal photography & 7 days home BP monitoring
Baseline: 7 days home BP monitoring, BW, waist circumference, duration of moderate physical
activity, smoking status, HbA1c, total cholesterol, LDL-C, HDL-C, triglyceride
Randomization (n=43)
RP group (n=21)
Control group (n=22)
1 Died before reaching
primary end point (n=1)
Died before reaching
primary end point (n=1)
RP group (n=20)
Control group (n=21)
At 3 months: 7 days home BP monitoring
At 3 months: body weight, waist circumference, duration of moderate physical activity, smoking
status, HbA1c, total cholesterol, LDL-C, HDL-C, triglyceride
CHD = coronary heart disease, DR = diabetic retinopathy, BP = blood pressure,
HbA1c= glycosylated hemoglobin, LDL-C = low density liproprotein-cholesterol, HDL-C = high
density liproprotein-cholesterol, RP group = retinal photography group
Data analyses
For categorical data was show in number and percent. Continuous data was show in mean
and standard deviation. Analysis by Fisher’s exact tests for the categorical variables. Unpaired t test
for continuous variables. Linear regression analysis was used to adjusted for preexisting differences
in categorical variables of baseline characteristic. ANCOVA was used to adjusted for preexisting
differences in continuous variables of baseline characteristic. SPSS version 16 was used for data
analyses.
Results
Baseline characteristics did not differ significantly between RP group and control group
(Table 1), except for calcium channel blocker (CCB) was used more in RP group. The mean age was
64 years; 46% of patients were women, and the mean duration of type 2 diabetes mellitus was 5
years. No smokers in both groups. A total of 20 patients in RP group and 21 patients in control group
completed the study at 3 months.
Table 1 Baseline patient characteristics by Intervention group. Numbers are mean (SD) or
percentage (%)
Baseline Characteristic
Demographic
Age ( years) (mean (SD))
Female; n (%)
Duration of Type 2 diabetes; (years)
(mean(SD))
Income (Thai Baht) (mean (SD))
Family history of CAD
Hypertension; n (%)
Dyslipidemia; n (%)
Diabetic nephropathy; n (%)
Diabetic neuropathy; n (%)
Ischemic stroke; n (%)
Peripheral artery disease; n (%)
RP (n = 21)
Control (n = 22)
p-value
64 (10)
65 (12)
0.76
10 (48)
5 (1)
10 (45)
4 (2)
1.0
0.50
31,538(61257)
4 (19)
20 (95)
12 (58)
12 (58)
14 (67)
1 (5)
1 (5)
27,523 (64813)
5 (23)
18 (82)
15 (38)
15 (38)
14 (64)
2 (1)
3 (14)
0.84
1.0
0.35
0.54
0.54
1.0
1.0
0.61
Number of significant CAD; n (%)
Syntax score
2.5 (0.8)
20 (12)
2.5 (0.7)
22 (12)
0.92
0.58
Table 1(cont.) Baseline patient characteristics by treatment group. Numbers are mean (SD) or
number (percentages)
Baseline Characteristic
RP (n = 21)
Control (n =22) p-value
Medication; n (%)
- Diuretic
5 (24)
8 (36)
0.51
- Beta blocker
15 (71)
17 (77)
0.74
- ACEI/ARB
10 (48)
13 (59)
0.55
- Hydralazine
4 (19)
3 (14)
0.70
- Calcium channel blocker
10 (48)
3 (14)
0.02
- Aspirin
20 (95)
21 (95)
1.0
- Clopidogrel
13 (62)
15 (68)
0.74
- Sulfonylurea
3 (14)
8 (36)
0.16
- Metformin
4 (19)
1 (5)
0.19
- Insulin
15 (71)
9 (41)
0.07
- Fibrate
2 (10)
1 (5)
0.61
- Statin
19 (90)
0.23
22 (100)
Clinical [mean (SD)]
Systolic blood pressure; mmHg
Diastolic blood pressure; mmHg
Mean arterial blood pressure; mmHg
Height; cm
Body weight; kg
Body mass index; kg/m2
Waist circumference; cm
Duration of moderate physical activity;
minute/week
Laboratory measurements [mean (SD)]
HbA1c; %
Cholesterol; mg/dl
LDL; mg/dl
140(16)
71 (10)
94 (10)
160 (11)
67 (14)
26 (4)
95 (10)
103 (128)
132 (18)
69 (10)
90 (11)
161 (10)
67 (14)
26 (4)
95 (11)
195 (367)
0.12
0.42
0.17
0.28
0.87
0.94
0.96
0.28
7.9 (2)
162 (30)
96 (31)
7.4 (1)
164 (30)
110 (52)
0.42
0.90
0.28
HDL; mg/dl
Triglyceride; mg/dl
GFR; ml/min/1.73 m2
43 (11)
152 (64)
40 (25)
38 (17)
139 (73)
49 (31)
0.21
0.57
0.31
RP = retinal photography
There were 2 deaths, one from each group (1 with congestive heart failure from RP group,
and 1 with intracerebral hemorrhage from control group) (Figure 1). Baseline systolic BP/ diastolic
BP/ mean arterial BP were 140±16/71±10/94±10 vs 132±18/69±10/90±11 mmHg for the RP and
control groups respectively (p = 0.12 for systolic BP, 0.42 for diastolic BP and 0.17 for mean arterial
BP). After 3 months systolic BP/ diastolic BP/ mean arterial BP were 132±16/66±9/88±9 vs
137±20/68±10/91±11 mmHg for the RP and control groups respectively.
Table 2. Changes in coronary heart disease risk factors.
RP (n = 21)
[mean (SD)]
-8 (14)
-5 (9)
-6 (9)
0 (2)
0 (1)
0 (3)
Control (n =22)
[mean (SD)]
+5 (12)
-1 (9)
+1 (9)
0 (4)
0(2)
0 (6)
Different
[mean (SD)]
13 (4)
4 (3)
7 (3)
0 (1)
0 (0)
0 (2)
Parameters
SBP change; mmHg
DBP change; mmHg
MABP change; mmHg
Body weight change; kg
BMI change; kg/m2
Waist circumference change; cm
Duration of moderate physical
activity change; minute/week
+74 (261)
-48 (276)
122 (82)
Laboratory measurements
HbA1c change; %
-0.4 (2)
-0.3 (1)
0.2 (0.5)
Cholesterol change; mg/dl
0 (32)
-7 (34)
7 (10)
LDL change; mg/dl
-4 (27)
-10 (32)
6 (9)
HDL change; mg/dl
+1.8 (10)
-1.5 (9)
3 (3)
TG change; mg/dl
-10 (92)
+1 (66)
10 (24)
SBP = systolic blood pressure, DBP = diastolic blood pressure, MABP = mean arterial blood
pressure, BMI = body mass index, HbA1c = glycosylated hemoglobin, LDL = low density lipoprotein,
HDL = high density lipoprotein, TG = triglyceride, RP = retinal photography
p-value
0.01
0.10
0.01
0.78
0.70
0.9
0.14
0.78
0.49
0.50
0.26
0.66
The primary outcomes for the changes in systolic BP/ diastolic BP/ mean arterial BP were 8±14/-5±9/-6±9 vs +5±12/-1±9/+1±9 mmHg for the RP and control groups respectively (p = 0.01 for
systolic BP, 0.01 for diastolic BP and 0.01 for mean arterial BP) (Table 2). Linear regression analysis
was adjusted for CCB, there was no significant influence of CCB on systolic BP, diastolic BP and
mean arterial BP (p= 0.27, 0.36 and 0.24 respectively).The secondary outcomes for the changes in
body weight, waist circumferences, moderate physical activity, HbA1c, lipid profiles were not
significantly different between both groups. However, there is an increasing trend of physical activity
and HDL-C in RP group (p = 0.14 for duration of duration of moderate physical activity in 1 week, p
= 0.26 for HDL-C)
Discussion
Type 2 diabetes mellitus with coronary heart disease remains major cardiovascular problem
and major cause of hospitalization in Thailand(4). The prevalence of diabetes retinopathy was
increased in type 2 diabetes patients with coronary heart disease. We hypothesized that visual
feedback with retinal photography add on the education about coronary heart disease risk factors
reduction may be more effective than education alone. Since getting people to change their health
behaviors is generally very difficult and new intervention are needed by giving people visual
evidence of how certain behaviors may be damaging their body could be an effective approach(1).
This study found that education about coronary risk factors reduction combined with showing and
explaining of patients’ retinal photography , as a potential motivation tool, was feasible, and led to a
systolic and mean arterial blood pressure reduction after 3 months. Potential explanations for the
results might be that visual feedback of patients’ medical images has a potential educationalmotivational role, capturing a teachable moment. This study found that there is a trend of increasing
physical activity and HDL-C in RP group. Annual screening for diabetic retinopathy in type 2
diabetes mellitus patients are recommended as a standard of care. Retinal photography combined
with education about coronary heart disease risk factors reduction in high risk diabetes patients for
a better self-care in clinical practice have a benefit effect.
However, the study has several important limitation such as small number of study
population, short duration of follow up and no assessment about knowledge and motivation after
completion of education about coronary risk factors reduction. Their can’t prove causality between
the presence of diabetic retinopathy and motivation for reducing coronary heart disease risk factors..
To evaluate the long term outcomes, a prolongation of follow-up time was required.
In conclusion, this study shows that visual feedback of patients’ retinal photography (RP) for
changing coronary heart disease risk factors in type 2 diabetes mellitus with diabetic retinopathy and
coronary heart disease have significant short term effect on systolic BP and mean arterial BP
reduction. The remaining coronary heart disease risk factors were not significantly different .
However, there is a trend of increasing physical activity and HDL-C in RP group.
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