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Sericin cream reduces pruritus in hemodialysis patients: a randomized, double-blind, placebo-controlled experimental study.

Aramwit P, Keongamaroon O, Siritientong T, Bang N, Supasyndh O - BMC Nephrol (2012)

Bottom Line: Moreover, a significant difference was also found in skin irritation between the two treatments (p = 0.013 for arms and p = 0.027 for legs, respectively).At the end of the study, the skin pigmentation level was significantly reduced on both the arms (p = 0.032) and legs (p = 0.021) of the sericin-treated side compared with the side treated with cream base.A better quality of life was found in all domains tested although statistically significant differences before and after treatment was found only in the patients' pain scores, the effect of kidney disease on daily life, sleep quality and symptoms or problems related to kidney disease.

View Article: PubMed Central - HTML - PubMed

Affiliation: Bioactive Resources for Innovative Clinical Applications Research Unit and Department of Pharmacy Practice, Chulalongkorn University, Bangkok 10330, Thailand. aramwit@gmail.com

ABSTRACT

Background: Uremic pruritus (UP) is a significant complication in ESRD patients and substantially impairs their quality of life. UP is considered to be a skin manifestation of chronic inflammation. Because sericin can suppress the release of pro-inflammatory cytokines, the purpose of this study was to investigate the short-term safety and efficacy of sericin cream for treating UP in hemodialysis patients.

Methods: This study used a double-blind design to investigate the effects of random topical administration of sericin cream and cream base (placebo) on either the right or left extremities of hemodialysis patients for 6 weeks. Skin hydration, irritation and pigmentation were evaluated every 2 weeks using Skin Diagnostic SD27. The visual analog scale for itching was also evaluated every 2 weeks, and the Kidney Disease Quality of Life Short Form was performed on the day of each patient's enrollment and after 6 weeks of treatment.

Results: Fifty dialysis patients were enrolled, 47 of which completed the study. The hydration of the skin of the patients' extremities increased significantly after administration of sericin cream; significant differences were found between sericin treatment and control after 6 weeks of treatment (p = 0.041 for arms and p = 0.022 for legs, respectively). Moreover, a significant difference was also found in skin irritation between the two treatments (p = 0.013 for arms and p = 0.027 for legs, respectively). At the end of the study, the skin pigmentation level was significantly reduced on both the arms (p = 0.032) and legs (p = 0.021) of the sericin-treated side compared with the side treated with cream base. The mean itching score decreased significantly from moderate to severe at the time of enrollment to mild pruritus after 6 weeks of treatment (p = 0.002). A better quality of life was found in all domains tested although statistically significant differences before and after treatment was found only in the patients' pain scores, the effect of kidney disease on daily life, sleep quality and symptoms or problems related to kidney disease.

Conclusions: We conclude that sericin cream has a high potential for reducing UP in hemodialysis patients.The trial registration number of this study is ISRCTN16019033; its public title is "sericin cream reduces pruritus in hemodialysis patients".

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Related in: MedlinePlus

Changes in skin parameters of hydration and irritation and pigmentation on the legs. Detailed legend: The changes in the skin parameters of hydration (measured by Corneometer), irritation and pigmentation (measured by Mexameter) on patients’ legs treated with sericin cream or cream base at weeks 2, 4 and 6 of treatment compared to baseline (* indicates significant differences compared to baseline; # indicates significant differences between treatment) (p  < 0.05).
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Figure 2: Changes in skin parameters of hydration and irritation and pigmentation on the legs. Detailed legend: The changes in the skin parameters of hydration (measured by Corneometer), irritation and pigmentation (measured by Mexameter) on patients’ legs treated with sericin cream or cream base at weeks 2, 4 and 6 of treatment compared to baseline (* indicates significant differences compared to baseline; # indicates significant differences between treatment) (p  < 0.05).

Mentions: The level of skin hydration in the patients’ extremities increased after treatment with either sericin or cream base. The same patients received sericin and placebo (cream base) treatment and that application of each compound were confined to one side of the body. On the sericin-treated side of the body, the skin hydration of the arms was 28.67 ± 7.11 at baseline, and it increased to 33.62 ± 6.93 after treatment for 6 weeks (p = 0.047), while the skin hydration of the legs, which was 25.10 ± 7.67 at baseline, increased to 29.05 ± 7.74 after 6 weeks of treatment (p = 0.025). On the cream-base-treated side of the body, the skin hydration of the arms was 27.55 ± 7.84 at baseline, and it increased to 29.40 ± 4.92 after treatment for 6 weeks (p = 0.593); the skin hydration of the legs, which was 23.29 ± 7.37 at baseline, changed to 26.02 ± 6.47 after 6 weeks of treatment (p = 0.276). The skin hydration changes were significantly higher on the side that received the sericin cream than on the side that received the cream base, and a significant difference between the sericin cream and cream base treatments was found in the level of skin hydration in both the arms and legs during the sixth week of treatment (p = 0.041 for arms and p = 0.022 for legs, respectively). Table 3 shows the skin parameters for hydration (measured by the Corneometer) and for irritation and pigmentation (measured by the Mexameter) of the subjects’ extremities at weeks 2, 4 and 6 after treatment. Figure 1 and 2 illustrate the percent changes in the parameters of the skin that received the sericin cream or the cream base during weeks 2–6 compared to the baseline. Six weeks after treatment, the average level of skin hydration on the side of the body that received the sericin cream was significantly increased compared to the baseline (p = 0.047 for arms and p = 0.025 for legs), while the side that received the cream base showed no significant difference (p = 0.593 for arms and p = 0.276 for legs) in skin hydration. The arms of the patients who were treated with the sericin cream showed significant differences in the level of skin hydration four weeks after the treatment compared to baseline (p = 0.022).


Sericin cream reduces pruritus in hemodialysis patients: a randomized, double-blind, placebo-controlled experimental study.

Aramwit P, Keongamaroon O, Siritientong T, Bang N, Supasyndh O - BMC Nephrol (2012)

Changes in skin parameters of hydration and irritation and pigmentation on the legs. Detailed legend: The changes in the skin parameters of hydration (measured by Corneometer), irritation and pigmentation (measured by Mexameter) on patients’ legs treated with sericin cream or cream base at weeks 2, 4 and 6 of treatment compared to baseline (* indicates significant differences compared to baseline; # indicates significant differences between treatment) (p  < 0.05).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3472272&req=5

Figure 2: Changes in skin parameters of hydration and irritation and pigmentation on the legs. Detailed legend: The changes in the skin parameters of hydration (measured by Corneometer), irritation and pigmentation (measured by Mexameter) on patients’ legs treated with sericin cream or cream base at weeks 2, 4 and 6 of treatment compared to baseline (* indicates significant differences compared to baseline; # indicates significant differences between treatment) (p  < 0.05).
Mentions: The level of skin hydration in the patients’ extremities increased after treatment with either sericin or cream base. The same patients received sericin and placebo (cream base) treatment and that application of each compound were confined to one side of the body. On the sericin-treated side of the body, the skin hydration of the arms was 28.67 ± 7.11 at baseline, and it increased to 33.62 ± 6.93 after treatment for 6 weeks (p = 0.047), while the skin hydration of the legs, which was 25.10 ± 7.67 at baseline, increased to 29.05 ± 7.74 after 6 weeks of treatment (p = 0.025). On the cream-base-treated side of the body, the skin hydration of the arms was 27.55 ± 7.84 at baseline, and it increased to 29.40 ± 4.92 after treatment for 6 weeks (p = 0.593); the skin hydration of the legs, which was 23.29 ± 7.37 at baseline, changed to 26.02 ± 6.47 after 6 weeks of treatment (p = 0.276). The skin hydration changes were significantly higher on the side that received the sericin cream than on the side that received the cream base, and a significant difference between the sericin cream and cream base treatments was found in the level of skin hydration in both the arms and legs during the sixth week of treatment (p = 0.041 for arms and p = 0.022 for legs, respectively). Table 3 shows the skin parameters for hydration (measured by the Corneometer) and for irritation and pigmentation (measured by the Mexameter) of the subjects’ extremities at weeks 2, 4 and 6 after treatment. Figure 1 and 2 illustrate the percent changes in the parameters of the skin that received the sericin cream or the cream base during weeks 2–6 compared to the baseline. Six weeks after treatment, the average level of skin hydration on the side of the body that received the sericin cream was significantly increased compared to the baseline (p = 0.047 for arms and p = 0.025 for legs), while the side that received the cream base showed no significant difference (p = 0.593 for arms and p = 0.276 for legs) in skin hydration. The arms of the patients who were treated with the sericin cream showed significant differences in the level of skin hydration four weeks after the treatment compared to baseline (p = 0.022).

Bottom Line: Moreover, a significant difference was also found in skin irritation between the two treatments (p = 0.013 for arms and p = 0.027 for legs, respectively).At the end of the study, the skin pigmentation level was significantly reduced on both the arms (p = 0.032) and legs (p = 0.021) of the sericin-treated side compared with the side treated with cream base.A better quality of life was found in all domains tested although statistically significant differences before and after treatment was found only in the patients' pain scores, the effect of kidney disease on daily life, sleep quality and symptoms or problems related to kidney disease.

View Article: PubMed Central - HTML - PubMed

Affiliation: Bioactive Resources for Innovative Clinical Applications Research Unit and Department of Pharmacy Practice, Chulalongkorn University, Bangkok 10330, Thailand. aramwit@gmail.com

ABSTRACT

Background: Uremic pruritus (UP) is a significant complication in ESRD patients and substantially impairs their quality of life. UP is considered to be a skin manifestation of chronic inflammation. Because sericin can suppress the release of pro-inflammatory cytokines, the purpose of this study was to investigate the short-term safety and efficacy of sericin cream for treating UP in hemodialysis patients.

Methods: This study used a double-blind design to investigate the effects of random topical administration of sericin cream and cream base (placebo) on either the right or left extremities of hemodialysis patients for 6 weeks. Skin hydration, irritation and pigmentation were evaluated every 2 weeks using Skin Diagnostic SD27. The visual analog scale for itching was also evaluated every 2 weeks, and the Kidney Disease Quality of Life Short Form was performed on the day of each patient's enrollment and after 6 weeks of treatment.

Results: Fifty dialysis patients were enrolled, 47 of which completed the study. The hydration of the skin of the patients' extremities increased significantly after administration of sericin cream; significant differences were found between sericin treatment and control after 6 weeks of treatment (p = 0.041 for arms and p = 0.022 for legs, respectively). Moreover, a significant difference was also found in skin irritation between the two treatments (p = 0.013 for arms and p = 0.027 for legs, respectively). At the end of the study, the skin pigmentation level was significantly reduced on both the arms (p = 0.032) and legs (p = 0.021) of the sericin-treated side compared with the side treated with cream base. The mean itching score decreased significantly from moderate to severe at the time of enrollment to mild pruritus after 6 weeks of treatment (p = 0.002). A better quality of life was found in all domains tested although statistically significant differences before and after treatment was found only in the patients' pain scores, the effect of kidney disease on daily life, sleep quality and symptoms or problems related to kidney disease.

Conclusions: We conclude that sericin cream has a high potential for reducing UP in hemodialysis patients.The trial registration number of this study is ISRCTN16019033; its public title is "sericin cream reduces pruritus in hemodialysis patients".

Show MeSH
Related in: MedlinePlus