Abstract
OBJECTIVE : To observe the effect of the Traditional Chinese Medicine, modified Taohongsiwu
decoction versus pyridoxine on patients with hand-foot syndrome (HFS) from capecitabine,
sorafenib, and gefitinib chemotherapy for gastric,lung,breast,colon,or rectal cancer.
Also, to compare quality of life of patients in each group.
METHODS: Patients were assigned randomly to group A or B.
Group A was given modified Taohongsiwu decoction to soak hands and feet for 30 min,once daily.
Group B was given 100 mg pyridoxine orally,twice daily.
After a 2-week treamtment,the
……………………………………………………………………………………………………………………………………………………………
therapeutic effect was assessed by observing three major symptoms, including pain ulceration,
and muscular atrophy.
This was assessed with the HFS-14 questionnaire.
……………………………………………………………………………………………………………………………………………………………
Key words: Neoplasms; Hand-foot syndrome; Mod-ified Taohongsiwu decoction; Quality of life.
INTRODUCTION
Hand-foot syndrome (HFS), also known as plamar-plantar erythrodyesthesia, is a skin reaction that appears on the palms and/or soles after using certain chemotherapy drugs, including capeciated with fluorouracil, liposomal doxorudicin, or capecitabine.
The incidence of HFS is approximately 7.3%-63%.
Patients initially experience tingling or numbness in the fingers and/or toes, and later swelling, redness, desquamation, and tenderness or pain.
In severe cases, the acute pain and muscular atrophy lead to difficulty in movement,
………………………………………………………………………………………………………………………………………………………
which influences patient quality of life (QOL.).
Unfortunately, the mechanisms causing HFS have not been elucidated.
Therefore, effective methods to prevent and cure HFS are not established aside from temporary discontinuation of chemotherapy agents and drug dosage adjustment.
Consequently, chemotherapeutic effect is reduced.2,3
Pyridoxine(vitamin B6) is a common drug to treat or prevent HFS.
However, studies show that it has no effect on HFS from liposomal doxorubicin.
Moreover, a study on urea/lactic acid-based topical keratolytic agent cream for external application for prevention of HFS was also discouraging.5
With the wide use of capecitabine, fluorouracil, and sorafenib, the incidence of HFS is rapidly increasing.
In this study, the Traditional Chinese for its effect on treating and relieving the symptoms of KFS and improving QOL of patients.
……………………………………………………………………………………………………………………………………………………………..METHODS
Subjects
This study was designed as a double-blind, randomized, controlled trial(Figure 1).
All patients gave informed consent before participation, and the study was approved by the Clifford Hospital Ethics Committee.
Before treatment, groups were randomized by the computer in a ratio of 2:1, for Traditional Chinese Medisine or pyridoxine, respectively.
Patients, males and females, 36-78 years old, were histologically confirmed to have gastric, lung, breast, colon, or rectal cancer and
…………………………………………………………………………………………………………………………………………………………….HFS symptoms. Randomization was stratified by cancer diagnosis (gastric, lung, breast, colon, rectal).
All patients were randomized to receive either modified Taohongsiwa decoction or comparable placebo (pyridoxine) in a double-blind method.
Researchers (doctors) and the participants (patients) were blinded to the nature of the treatment each participant received.
The patients in group A were treated by soaking the affected hands and feet in Taohongsiwu decoction for 30 min once a day.
Patients in group B received 100 mg vitamin B6 twice daily.
………………………………………………………………………………………………………………………………………………………
The dose of vitamin B6 was based on small case reports and series that were available.
One hundred patients were enrolled in total, with 60 in group A and 32 in group B .
Eight patients were invaluable for HFS assessment (Table 1) .
In group A, 12 of 60 patients had gastric cancer (20%), 18 had lung cancer (30%), 12 had colon cancer (20%), and 6 had 6 rectal cancer (10%) .
In group B, 12 of 32 had gastric cancer (37.5%), 10 had lung ancer (31.5%), 9 had breast (37.5%), 10 had lung cancer (31.5%), 9 had breast cancer (28%), and I had colon cancer (4%).
According to the HFS grading scale (Table 2), group A had 22 cases in grade I (36.7%), 28 cases in group A had 22 cases in group I (36.7%), 28 cases in grade II (46.6%), and 10 cases in grade III (16.7%).
Group B had 10 cases in grade I (31.2%), 17 cases in grade II (53.2%), and five cases in grade III (15.6%).
……………………………………………………………………………………………………………………………………………………….
Treatment
Modified Taohongsiwu decoction was composed of Taoren (Semen Persicae) 30 g, Honghua (Flos Carthami) 30g, Shudihuang (Radix Rehmanniae Praepara)
………………………………………………………………………………………………………………………………………………..
92 patients were randomly assigned by thr computer in accordance with 2:1
………………………………………………………………………………………………………………………………………….
60 patients were assigned to the treatment group which was treated in the way of soaking the sick parts into the Taohongsiwu Decoction for external application.
…………………………………………………………………………………………………………………………………………..
The effect was evaluated after treatment for 1 week and 2 weeks, and the a 3-month follow-up was prformed.
No case was lost in the follow-up.
………………………………………………………………………………………………………………………………………………
60 cases were analyzed.
41 cases were recovered, 12 cases effective, 7 cases ineffective, and 0 getting worse.
………………………………………………………………………………………………………………………………………………
32 patients were assigned to the control group which reeived Vitamin B6 for oral taking.
……………………………………………………………………………………………………………………………………………….
The effect was evaluated after treatment for 1 week and 2 weeks, and the a 3-month follow-up was performed.
No case was lost in the follow-up.
………………………………………………………………………………………………………………………………………………..
32 cases were analyzed.
11 cases were recovered, 5 cases effective, 10 cases ineffective, and 6 getting worse.
…………………………………………………………………………………………………………………………………………….
ta) 30 g, Danggui (Radix Angelicae Sinensis) 30 g, Chuanxiong (Rhizoma Chuanxiong) 15 g, Baishao (Radix Paeoniae Alba) 15 g, Guizhi (Ramulus Cinnamomi) 15 g, Chuanniuxi (Radix Cyathulae) 15 g, Gancao (Radix Glycyrrhizae) 6 g, and Dazao (Fructus Jujubae) three pieces.
Herbs were decocted for about 45 min .
The decoction was used (group A) to soak affected hands and feet, and hot water was added to keep the decoction hotter than 39 ̊c during soaking, once a day, for 30 min cach time, with 7 days as one course.
The control group (group B) was orally administered 100 mg pyridoxine (vitamin B6) twice daily.
Both group received a 2-week treatment.
Effects were evaluated after one and two courscs of trcatment and an overall evaluation was conducted 3 months later.6-8
………………………………………………………………………………………………………………………………………………..
Statistical methods
The statistical software SPSS 16.0 (Chicago, IL, USA) was used for variance analysis of experimental data and the HFS-14 scale was used to measure the HFS-related QOL impairment.10
Abstract
OBJECTIVE : To observe the effect of the Traditional Chinese Medicine, modified Taohongsiwu
decoction versus pyridoxine on patients with hand-foot syndrome (HFS) from capecitabine,
sorafenib, and gefitinib chemotherapy for gastric,lung,breast,colon,or rectal cancer.
Also, to compare quality of life of patients in each group.
METHODS: Patients were assigned randomly to group A or B.
Group A was given modified Taohongsiwu decoction to soak hands and feet for 30 min,once daily.
Group B was given 100 mg pyridoxine orally,twice daily.
After a 2-week treamtment,the
……………………………………………………………………………………………………………………………………………………………
therapeutic effect was assessed by observing three major symptoms, including pain ulceration,
and muscular atrophy.
This was assessed with the HFS-14 questionnaire.
……………………………………………………………………………………………………………………………………………………………
Key words: Neoplasms; Hand-foot syndrome; Mod-ified Taohongsiwu decoction; Quality of life.
INTRODUCTION
Hand-foot syndrome (HFS), also known as plamar-plantar erythrodyesthesia, is a skin reaction that appears on the palms and/or soles after using certain chemotherapy drugs, including capeciated with fluorouracil, liposomal doxorudicin, or capecitabine.
The incidence of HFS is approximately 7.3%-63%.
Patients initially experience tingling or numbness in the fingers and/or toes, and later swelling, redness, desquamation, and tenderness or pain.
In severe cases, the acute pain and muscular atrophy lead to difficulty in movement,
………………………………………………………………………………………………………………………………………………………
which influences patient quality of life (QOL.).
Unfortunately, the mechanisms causing HFS have not been elucidated.
Therefore, effective methods to prevent and cure HFS are not established aside from temporary discontinuation of chemotherapy agents and drug dosage adjustment.
Consequently, chemotherapeutic effect is reduced.2,3
Pyridoxine(vitamin B6) is a common drug to treat or prevent HFS.
However, studies show that it has no effect on HFS from liposomal doxorubicin.
Moreover, a study on urea/lactic acid-based topical keratolytic agent cream for external application for prevention of HFS was also discouraging.5
With the wide use of capecitabine, fluorouracil, and sorafenib, the incidence of HFS is rapidly increasing.
In this study, the Traditional Chinese for its effect on treating and relieving the symptoms of KFS and improving QOL of patients.
……………………………………………………………………………………………………………………………………………………………..METHODS
Subjects
This study was designed as a double-blind, randomized, controlled trial(Figure 1).
All patients gave informed consent before participation, and the study was approved by the Clifford Hospital Ethics Committee.
Before treatment, groups were randomized by the computer in a ratio of 2:1, for Traditional Chinese Medisine or pyridoxine, respectively.
Patients, males and females, 36-78 years old, were histologically confirmed to have gastric, lung, breast, colon, or rectal cancer and
…………………………………………………………………………………………………………………………………………………………….HFS symptoms. Randomization was stratified by cancer diagnosis (gastric, lung, breast, colon, rectal).
All patients were randomized to receive either modified Taohongsiwa decoction or comparable placebo (pyridoxine) in a double-blind method.
Researchers (doctors) and the participants (patients) were blinded to the nature of the treatment each participant received.
The patients in group A were treated by soaking the affected hands and feet in Taohongsiwu decoction for 30 min once a day.
Patients in group B received 100 mg vitamin B6 twice daily.
………………………………………………………………………………………………………………………………………………………
The dose of vitamin B6 was based on small case reports and series that were available.
One hundred patients were enrolled in total, with 60 in group A and 32 in group B .
Eight patients were invaluable for HFS assessment (Table 1) .
In group A, 12 of 60 patients had gastric cancer (20%), 18 had lung cancer (30%), 12 had colon cancer (20%), and 6 had 6 rectal cancer (10%) .
In group B, 12 of 32 had gastric cancer (37.5%), 10 had lung ancer (31.5%), 9 had breast (37.5%), 10 had lung cancer (31.5%), 9 had breast cancer (28%), and I had colon cancer (4%).
According to the HFS grading scale (Table 2), group A had 22 cases in grade I (36.7%), 28 cases in group A had 22 cases in group I (36.7%), 28 cases in grade II (46.6%), and 10 cases in grade III (16.7%).
Group B had 10 cases in grade I (31.2%), 17 cases in grade II (53.2%), and five cases in grade III (15.6%).
……………………………………………………………………………………………………………………………………………………….
Treatment
Modified Taohongsiwu decoction was composed of Taoren (Semen Persicae) 30 g, Honghua (Flos Carthami) 30g, Shudihuang (Radix Rehmanniae Praepara)
………………………………………………………………………………………………………………………………………………..
92 patients were randomly assigned by thr computer in accordance with 2:1
………………………………………………………………………………………………………………………………………….
60 patients were assigned to the treatment group which was treated in the way of soaking the sick parts into the Taohongsiwu Decoction for external application.
…………………………………………………………………………………………………………………………………………..
The effect was evaluated after treatment for 1 week and 2 weeks, and the a 3-month follow-up was prformed.
No case was lost in the follow-up.
………………………………………………………………………………………………………………………………………………
60 cases were analyzed.
41 cases were recovered, 12 cases effective, 7 cases ineffective, and 0 getting worse.
………………………………………………………………………………………………………………………………………………
32 patients were assigned to the control group which reeived Vitamin B6 for oral taking.
……………………………………………………………………………………………………………………………………………….
The effect was evaluated after treatment for 1 week and 2 weeks, and the a 3-month follow-up was performed.
No case was lost in the follow-up.
………………………………………………………………………………………………………………………………………………..
32 cases were analyzed.
11 cases were recovered, 5 cases effective, 10 cases ineffective, and 6 getting worse.
…………………………………………………………………………………………………………………………………………….
ta) 30 g, Danggui (Radix Angelicae Sinensis) 30 g, Chuanxiong (Rhizoma Chuanxiong) 15 g, Baishao (Radix Paeoniae Alba) 15 g, Guizhi (Ramulus Cinnamomi) 15 g, Chuanniuxi (Radix Cyathulae) 15 g, Gancao (Radix Glycyrrhizae) 6 g, and Dazao (Fructus Jujubae) three pieces.
Herbs were decocted for about 45 min .
The decoction was used (group A) to soak affected hands and feet, and hot water was added to keep the decoction hotter than 39 ̊c during soaking, once a day, for 30 min cach time, with 7 days as one course.
The control group (group B) was orally administered 100 mg pyridoxine (vitamin B6) twice daily.
Both group received a 2-week treatment.
Effects were evaluated after one and two courscs of trcatment and an overall evaluation was conducted 3 months later.6-8
………………………………………………………………………………………………………………………………………………..
Statistical methods
The statistical software SPSS 16.0 (Chicago, IL, USA) was used for variance analysis of experimental data and the HFS-14 scale was used to measure the HFS-related QOL impairment.10
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