Combined Western and Traditional Chinese Medicine Daycare for CKD Patients
Combined Western and Traditional Chinese Medicine Daycare for CKD Patients
The annual report of USRDS shows than Taiwan has the highest prevalence of
 end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors
 associated with chronic renal failure are age, diabetes, hypertension, chronic
 glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic
 kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And
 these possible prognostic factors associating with the disease progression and ultimately
 increase the morbidity and mortality. End-stage renal failure is an irreversible course often
 with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often
 use Chinese medicine or acupuncture to help them to ease the symptom.

 The aim of this study is to investigate the efficacy of combined Western medicine and
 traditional Chinese medicine daycare model for chronic kidney disease patients. The study
 approach to investigate whether combination of Western medicine and traditional Chinese
 medicine daycare model can improve the clinical symptoms and quality of life as well as the
 laboratory biochemistries data.
Keywords：chronic kidney disease , Day care, Traditional Chinese Medicine(TCM)

 Background and purpose:

 The annual report of USRDS shows than Taiwan has the highest prevalence of
 end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors
 associated with chronic renal failure are age, diabetes, hypertension, chronic
 glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic
 kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And
 these possible prognostic factors associating with the disease progression and ultimately
 increase the morbidity and mortality. End-stage renal failure is an irreversible course often
 with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often
 use Chinese medicine or acupuncture to help them to ease the symptom.

 The aim of this study is to investigate the efficacy of combined Western medicine and
 traditional Chinese medicine daycare model for chronic kidney disease patients. The study
 approach to investigate whether combination of Western medicine and traditional Chinese
 medicine daycare model can improve the clinical symptoms and quality of life as well as the
 laboratory biochemistries data.

 Material and methods:

 A total of 60 volunteers of patients with chronic kidney disease will be recruited from the
 Chinese medicine or Western medicine clinics. After diagnosis by nephrology physician, 30
 patients will be distributed to combinational Western and TCM daycare model, one time a week,
 for 12 weeks (12 treatment in total). Another 30 patients will enter Western daycare model.
 The assignment depends on the patients' own will. The TCM day care model will be provided by
 a team work clinical care system organized by doctors, nurses, pharmacists and case managers.
 This model will provide a comprehensive TCM care system for every visit. Laboratory
 biochemistries analysis and other questionnaires including SF36 health survey, Pittsburgh
 Sleep Quality Index, Beck Depression Inventory-II, FACIT-fatigue Scale and the 5-D itch scale
 will be completed at baseline, 6weeks, and 12 weeks after join this study. Instrumental
 examinations including heart rate variability and traditional Chinese medicine four
 examinations will be given before and after intervention.

 Predict results:

 The investigators expect that the efficacy of this combined western medicine and traditional
 Chinese medicine day care model will be superior to the "pre-ESRD prevention and education
 program" which execute since 2006 in improving edema, fatigue, physical function and quality
 of life. The effectiveness of combined therapy can be measured by questionnaires. Moreover,
 the investigators will further speculate the mechanism by analyzing laboratory data.
Inclusion Criteria:

 1. Fit CKD definition by National Kidney Foundation's Kidney Disease Outcome Quality
 Initiative（NKF-KDOQI, pre-ESRD stage IIIb~IV (GFR: 15-44).

 2. at least 20 years old volunteers.

 3. The participants had no allergy to acupuncture needle in the past, or without
 contraindications to acupuncture treatment.

 4. The participants agreed to join the trial and sign informed consent form after
 thorough explanation.

 Exclusion Criteria:

 1. Age less than 20 years old.

 2. Using immunosuppressive drug or receiving chemotherapy.

 3. Had substance abuse in the past, or having substance abuse.

 4. Pregnancy women or breastfeeding women.

 5. Mental or behavioral disorders which leads to inability to cooperation.

 6. Arrhythmia patients who have pacemaker.

 7. Patient who have skin infection or wound infection near acupoints.

 8. Patient who have coagulation abnormalities or low platelet count by blood tests
 (platelet≤150000 / uL).

 9. Participating other clinical trials.

 10. Patient with serious diseases such as myocardial infarction, severe arrhythmia, heart
 failure, chronic obstructive airway disease, or cancer.

 11. Patients who have limb edema and severe skin lesions not suitable for acupuncture or
 massage.

 12. Patients who took Chinese herbal medicine or received acupuncture treatment in the
 past 2 weeks.

 13. Patients who disagree to sign informed consent form.