Determination of minimum effective dose of Shakuyaku-kanzo-to
In the analysis of the minimum effective dose of the medicine, 28 patients, 14 men and 14 women, in the age
range 57-86 years (mean age ± SD: 68.04 ± 10.33 years), were studied.
The treatment started with a total dose of 7.5 g/day for all patients, and at 2 weeks after the initiation, patients
were instructed that they could change their dosage depending on their symptom, that is, when the frequency of
the muscle cramps decreased, they could reduce the dosage. Then at 12 weeks after the initiation of the
medication, we found 5 patients still took 7.5 g/day, 5 patients took 5g/day , 8 patients 2.5 g/day, 5 patients 2.5 g
as needed and 5 patients finished (completed treatment).
We then compared these five groups for the therapeutic effect at 12 weeks since the first administration of
the drug.
Statistical Analysis
Statistical analyses were performed with the R software (8). The relationship between therapeutic effect and
the time required for the maximum therapeutic effect was analyzed by Pearson’s chi-square test. Differences in
response scores were tested by one-way ANOVA followed by Tukey's post-hoc test. A P value < 0.05 was
regarded as significant.
RESULTS
Therapeutic effect of Shakuyaku-kanzo-to on muscle cramps
After 2 weeks of administration, we evaluated the change in the frequency of painful muscle cramps. With
Shakuyaku-kanzo-to administration, 8 patients had a complete response; 6 patients had a partial response; 1
patient had a minor response; and 1 patient had no response, whereas with eperisone hydrochloride, only 1
patient had a complete response; 3 had a partial; 3 had a minor and residual 7 had no response (Table II).
Shakuyaku-kanzo-to therefore reduced the frequency of painful muscle cramps to 50％ or less of the original
frequency in more than 87% of the patients (14 of 16).
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