Therapeutic effect of Jinlongshe Granule () on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial.
OBJECTIVE
To evaluate the impact of Jinlongshe Granule (, JLSG) on quality of life (QOL) of stage IV gastric cancer patients.


METHODS
This randomized, double-blind and placebo-controlled clinical trial included 50 patients with advanced gastric cancer. They were equally randomized into a JLSG group and a placebo group. Patients in both groups received routine Chinese herbal decoctions according to Chinese medicine (CM) treatment based on syndrome differentiation. Patients in JLSG group received additional JLSG, and those in the placebo group received an additional placebo. In the JLSG group, 19 patients who completed the study were used for analysis. In the placebo group, finally the data of 20 patients who completed the study were used for analysis. The treatment course was at least 3 months, and the follow-up duration was at least 6 months in 5 interviews. Repeated measurements of the subscale items and individual items in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) obtained at the 5 interviews were compared using different patient groups, changes over time and changes within one group over time independently to observe the tendency of changes in the scores.


RESULTS
Using time as the variant, there was signifificant difference in 4 functional scales (physical, role, emotional and social, P<0.05), 3 symptom scales (fatigue, nausea and vomiting and pain,P<0.05) and a global health status/QOL scale (P<0.05) and 6 single symptoms dyspnoea (P>0.05), insomnia (P<0.05), appetite loss (P<0.05), constipation (P<0.05), diarrhea (P>0.05) and financial difficulties (P<0.05). There was also signifificant difference in these items between the two groups when the placebo group and group over time were used as variants (P<0.05 or P<0.01).


CONCLUSIONS
Additional use of JLSG on the basis of routine CM treatment could improve the somatic function, role function, emotional function, social function, cognitive function and general QOL of patients with advanced gastric cancer, and relieve the symptoms of fatigue, nausea and vomiting, pain, loss of appetite and constipation.
Department of Traditional Chinese Medicine, Changzheng Hospital, Second Military Medical University, Shanghai (, 200003), China.
Da-zhi
DZ
Sun
Jian-peng
JP
Jiao
Xuan
X
Zhang
Jing-yu
JY
Xu
Min
M
Ye
Li-juan
LJ
Xiu
Ying
Y
Zhao
Ye
Y
Lu
Xuan
X
Liu
Jing
J
Zhao
Jun
J
Shi
Zhi-feng
ZF
Qin
Pin-kang
PK
Wei
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D055815:Young Adult
D004365:Drugs, Chinese Herbal; D010919:Placebos; C000607360:jinlongshe