MATERIALS AND METHODS
Patients
Subjects in this study included 58 patients with lumbar spinal stenosis and painful muscle cramps. These
patients were assessed for eligibility for our study and had no electrolyte disturbances or muscle diseases. Table I
shows the demographic features of the patients. The patients were randomized, but not blinded, to 3 groups.
Sixteen of them were assigned to evaluate the therapeutic efficacy of Shakuyaku-kanzo-to for muscle cramps, 14
were for the therapeutic efficacy of eperisone hydrochloride for muscle cramps and 28 patients comprised the
group analyzed for the minimum effective dose of Shakuyaku-kanzo-to (Figure 1).
This study was performed according to the “Ethical Guideline for Clinical Study” of the Ministry of Health,
Labour and Welfare of Japan. It was approved by the Ethical Committee of the Kobe University Graduate
School of Medicine (permission number 1448) and informed consents were obtained from all the patients. All
patients and their families gave informed consent for inclusion in the study.
Table I. Demographic features of the patients enrolled in our study
Analysis of
therapeutic effect
group
Analysis of
therapeutic
effect of
eperisone
hydrochloride
group
Analysis of
minimum effective
dose group
N
16
14
28
Age
mean±SD (year)
67.9±8.6
66.7±9.5
68.1±12.3
Sex (M/F)
9/7
7/7
14/14
Height (cm)
158.6±8.8
159.7±7.9
160.0±9.6
Weight (kg)
61.5±9.3
60.8±9.0
62.1±8.9
Symptom duration
mean (range)(months)
17.2 (3-48)
16.8 (4-48)
17.4 (4-36)
Figure 1. Consort diagram of patient flow
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