|
Accession number;99A0447094
|
| Title;Effect of Shakuyaku-kanzo-to(Tsumura TJ-68) on Muscle Cramps Accompanying Cirrhosis in a Placebo-controlled Double-blind Parallel Study. |
| Author;
KUMADA TAKASHI
(Ogaki Munic. Hosp.)
KUMADA HIROMITSU
(Fed. of Natl. Public Serv. and Affil. Personnel Mutual Aid Assoc., Toranomon Hosp.)
YOSHIBA MAKOTO
(Showa Univ., Fujigaoka Hospital)
NAKANO SATOSHI
(Ogaki Munic. Hosp.)
SUZUKI HIROSHI
(Yamanashi Med. Coll.)
TANGO TOSHIRO
(Inst. of Public Health)
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.15;NO.3;PAGE.499-523(1999)
|
| Figure&Table&Reference;FIG.2, TBL.21, REF.23 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In order to confirm the efficacy and safety of Tsumura Shakuyaku-kanzo-to Extract Granules(Tsumura TJ-68) on Muscle Cramps in patients with Liver Cirrhosis, a randomized double-blind placebo-controlled parallel study was conducted. 1) 126 patients who experienced 4 times or more attacks of muscle cramps during 2 weeks were enrolled in this study. The patients were treated with Tsumura TJ-68 or Placebo in a daily dose of 7.5g in 3 divided for two weeks. They were instructed to record frequency of muscle cramps, duration of the event, and degree of pain in a daily every day. 12 ineligible patients and 13 incomplete patients were excluded from the analysis. Efficacy of drug administration(improvement rate in frequency of muscle cramps and final general improvement rate) was assessed for 101 patients including 52 in the TJ-68-administered group(TJ-68-group) and 49 in the placebo-administered group(P-group). Safety and usefulness were assessed in 90 cases, 49 in the TJ-68-group and 41 in the P-group. 2) Improvement rate in frequency of muscle cramps where frequency in 14 days each for observation period and administration period was compared: Evaluation was divided into "markedly inproved"(IR=0%), "improved"(0<IR.LEQ.50%), "poor"(50<IR.LEQ.100%) and "worsened"(IR>100%). The improvement rate in frequencies of muscle cramps was significantly superior to P-group(Wilcoxon rank-sum test: p=0.011). "Markedly improved" or "improved" were 67.3% in the TJ-68-group and 36.7% in the P-group. 3) Final global improvement rate where changes in frequency of muscle cramps and degree of pain were added for comprehensive evaluation: TJ-68 was also fond to be significantly better than placebo(Wilcoxon rank-sum test: p<0.001). "Improved" or better response were 69.2% in the TJ-68-group and 28.6% in the P-group. 4) There was no significant difference between the two groups in global safety rating(Wilcoxon rank-sum test: p=0.125).... (author abst.) |
|
|
|
Related Articles;
|
