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The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine.
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine. "Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect.
The purpose of this study is to evaluate the treatment effect of Xiao-Feng-San and Shian Fang Hwa Ming Yiin on uremic pruritus among hemodialysis patients in this randomized, double-blind, placebo-controlled study design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin | Experimental | Xiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months |
|
| Placebo | Placebo Comparator | Similar placebo 4g twice a day for two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin | Drug | "Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale(VAS) | Measuring itch intensity | on starting day (day 0) |
| Visual Analogue Scale(VAS) | Measuring itch intensity | on day 28 |
| Visual Analogue Scale(VAS) | Measuring itch intensity | on day 56 |
| Visual Analogue Scale(VAS) | Measuring itch intensity | on day 84 |
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness | on starting day (day 0) |
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness | on day 28 |
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness | on day 56 |
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiun-Liang Chen, Ph.D | Contact | +88633196200 | 2611 | a12015@adm.cgmh.org.tw |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20558560 | Background | Mathur VS, Lindberg J, Germain M, Block G, Tumlin J, Smith M, Grewal M, McGuire D; ITCH National Registry Investigators. A longitudinal study of uremic pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Aug;5(8):1410-9. doi: 10.2215/CJN.00100110. Epub 2010 Jun 17. | |
| 28923831 | Background | Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, Hasegawa T, Kleophas W, Bieber BA, Tentori F, Robinson BM, Pisoni RL. International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2000-2007. doi: 10.2215/CJN.03280317. Epub 2017 Sep 18. |
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|
| Placebo | Drug | Similar placebo 4g twice a day for two months |
|
| on day 84 |
| 19190625 | Background | Kuypers DR. Skin problems in chronic kidney disease. Nat Clin Pract Nephrol. 2009 Mar;5(3):157-70. doi: 10.1038/ncpneph1040. Epub 2009 Feb 3. |
| 11812197 | Background | Szepietowski JC, Morita A, Tsuji T. Ultraviolet B induces mast cell apoptosis: a hypothetical mechanism of ultraviolet B treatment for uraemic pruritus. Med Hypotheses. 2002 Feb;58(2):167-70. doi: 10.1054/mehy.2001.1505. |
| 21796811 | Background | Kim KH, Lee MS, Choi SM. Acupuncture for treating uremic pruritus in patients with end-stage renal disease: a systematic review. J Pain Symptom Manage. 2010 Jul;40(1):117-25. doi: 10.1016/j.jpainsymman.2009.11.325. |
| 15663539 | Background | Okada K, Matsumoto K. Effect of skin care with an emollient containing a high water content on mild uremic pruritus. Ther Apher Dial. 2004 Oct;8(5):419-22. doi: 10.1111/j.1526-0968.2004.00175.x. |
| 18821119 | Background | Young TA, Patel TS, Camacho F, Clark A, Freedman BI, Kaur M, Fountain J, Williams LL, Yosipovitch G, Fleischer AB Jr. A pramoxine-based anti-itch lotion is more effective than a control lotion for the treatment of uremic pruritus in adult hemodialysis patients. J Dermatolog Treat. 2009;20(2):76-81. doi: 10.1080/09546630802441218. |
| 8730431 | Background | Tarng DC, Cho YL, Liu HN, Huang TP. Hemodialysis-related pruritus: a double-blind, placebo-controlled, crossover study of capsaicin 0.025% cream. Nephron. 1996;72(4):617-22. doi: 10.1159/000188949. |
| 2884733 | Background | Russo GE, Spaziani M, Guidotti C, Scarpellini MG, Leri O, Bonini S, Crisciotti C, Carmenini G. [Pruritus in chronic uremic patients in periodic hemodialysis. Treatment with terfenadine (an antagonist of histamine H1 receptors)]. Minerva Urol Nefrol. 1986 Oct-Dec;38(4):443-7. No abstract available. Italian. |
| 23548570 | Background | Rayner H, Baharani J, Smith S, Suresh V, Dasgupta I. Uraemic pruritus: relief of itching by gabapentin and pregabalin. Nephron Clin Pract. 2012;122(3-4):75-9. doi: 10.1159/000349943. Epub 2013 Mar 28. |
| 28720208 | Background | Simonsen E, Komenda P, Lerner B, Askin N, Bohm C, Shaw J, Tangri N, Rigatto C. Treatment of Uremic Pruritus: A Systematic Review. Am J Kidney Dis. 2017 Nov;70(5):638-655. doi: 10.1053/j.ajkd.2017.05.018. Epub 2017 Jul 15. |
| 21196758 | Background | Cheng HM, Chiang LC, Jan YM, Chen GW, Li TC. The efficacy and safety of a Chinese herbal product (Xiao-Feng-San) for the treatment of refractory atopic dermatitis: a randomized, double-blind, placebo-controlled trial. Int Arch Allergy Immunol. 2011;155(2):141-8. doi: 10.1159/000318861. Epub 2010 Dec 22. |
| 26721214 | Background | Chen HY, Lin YH, Chen YC. Identifying Chinese herbal medicine network for treating acne: Implications from a nationwide database. J Ethnopharmacol. 2016 Feb 17;179:1-8. doi: 10.1016/j.jep.2015.12.032. Epub 2015 Dec 22. |