In repeated-dose 28-day oral toxicity study design, the low dose is fixed as the no observed effect level (NOEL). But, in practice the low dose usually shows significant difference in few measurable items in most of the studies. We investigated 109 of repeated-dose 28-day oral toxicity studies in rats conducted according to the Chemical Substance Control Law, Japan and examined the measurable items (functional observational battery, urinalysis, hematology, blood chemistry and absolute and relative organ weights) of the low dose group which showed a statistical significant difference (P<0.05) compared to the respective control groups. The investigation revealed that, 205/12,167 (1.6%) measurable items showed a significant difference in the low dose groups. The significant difference shown by urinalysis was high (3.3%), followed by clinical chemistry parameters, hematology, relative organ weights and absolute organ weights (1.8-1.1%). We conclude from the investigation that the low dose may be considered as NOEL, if the significant difference of measurable items of it is about 2% (maximum <5%), compared to the control. However, due consideration may be given to the clinical relevance of the items that showed a significant difference.
Animals ; Chemistry, Clinical ; Hematology ; Japan ; Jurisprudence ; No-Observed-Adverse-Effect Level ; Organ Size ; Rats ; Urinalysis

In repeated-dose 28-day oral toxicity study design, the low dose is fixed as the no observed effect level (NOEL). But, in practice the low dose usually shows significant difference in few measurable items in most of the studies. We investigated 109 of repeated-dose 28-day oral toxicity studies in rats conducted according to the Chemical Substance Control Law, Japan and examined the measurable items (functional observational battery, urinalysis, hematology, blood chemistry and absolute and relative organ weights) of the low dose group which showed a statistical significant difference (P<0.05) compared to the respective control groups. The investigation revealed that, 205/12,167 (1.6%) measurable items showed a significant difference in the low dose groups. The significant difference shown by urinalysis was high (3.3%), followed by clinical chemistry parameters, hematology, relative organ weights and absolute organ weights (1.8-1.1%). We conclude from the investigation that the low dose may be considered as NOEL, if the significant difference of measurable items of it is about 2% (maximum <5%), compared to the control. However, due consideration may be given to the clinical relevance of the items that showed a significant difference.
Animals ; Chemistry, Clinical ; Hematology ; Japan ; Jurisprudence ; No-Observed-Adverse-Effect Level ; Organ Size ; Rats ; Urinalysis

We have continued a study on the preventive effects of acupuncture on recurrent tonsillitis. Among 239 patients with tonsillitis examined in 1980, 200 were included in the category of recurrent tonsillitis, showing a fever four or more times a year.
The preventive effects of acupuncture in these 200 patients are reported in this paper.
The subjects were 200 patients with recurrent tonsillitis treated in our department in 1980. The frequency, number of days and severity of fever and other symptoms (conditions of the nose and throat, snoring, colds and general condition) were followed for one year after the acupuncture treatment.
Of the 200 patients, 171, excluding the 29 in whom the results of research could not be obtained, were analyzed. With regard to the frequency of fever, the number of patients with a fever 12 or more times a year decreased from 102 before acupuncture therapy to nine after the treatment. The number of patients who did not have any fever and who had a fever one to three times after treatment was 30 and 69, respectively. Thus, 40.4% were not included in the category of recurrent tonsillitis, even though fever was present. In addition, there was a decrease in the severity and number of days of fever.
Favorable effects of the treatment on symptoms other than fever, such as conditions of the nose and throat, snoring, resistance to colds and general condition, were noted in more than 50% of the patients who did not have any fever after treatment or had a fever half as frequently as before treatment.
When the preventive effects on fever were determined according to age, improvement was observed in all age groups. From the viewpoint of the prevention of repetition of a high fever, the best results were obtained in patients 6-11 years of age, followed by those five years old or less.
Acupuncture treatment for recurrent tonsillitis is not so effective as tonsillectomy. However, we consider that acupuncture treatment is worth using prior to tonsillectomy to prevent the relapse of recurrent tonsillitis, taking into account operative stress on the living body and economic and personal problems arising from tonsillectomy.

We have conducted acupuncture treatment for prevening the relapse of recurrent tonsillitis. We previously noted the effectiveness of this treatment in 121 of 239 patients treated in 1980, especially in elementary school children. In the present study, we compared the annual days of absence from school and the body dimensions of children with tonsillitis given acupuncture treatment with those having tonsillar hypertrophy chosen by a school study, although there is a question on the latter's propriety as a control group in a strict sense, in order to investigate the degree of spontaneous healing included in the preventive effects of acupuncture treatment on the relapse of recurrent tonsillitis.
By May 1983, our reseach was completed in 22 children with tonsillitis given acupuncture treatment and 19 with tonsillar hypertrophy not given such therapy. In children with tonsillitis given acupuncture treatment, the average annual days of absence from school before treatment was 14.0, which was more than that for all children in the S elementary school, and that in the year after treatment was 6.5, approximating that for all children in the school. In children with tonsillar hypertrophy not given acupuncture treatment, the average number of days of absence was close to that for all children in the S elementary school in both years.
Among 14 children with tonsillitis given acupuncture treatment, lower values of height and weight were noted in eight and 12 children, respectively, at the beginning of treatment, as compared with the national averages. The body dimensions of children with tonsillar hypertrophy not given acupuncture treatment were similar to the national averages. Of 14 children with tonsillitis given acupuncture treatment, an increase to a value exceeding the national average was observed with both the height and weight in six children, the height in two and the weight in one within the year after treatment.
The above results show that children with tonsillitis have a problem from the educational and developmental standpoint, even if they do not have a focal tonsil. We think that acupuncture treatment is worth attempting prior to tonsillectomy, although it is not so surely effective as tonsillectomy, when the severity of operative stress on the living body due to tonsillectomy and the burden of medical expenses and the load on the patient's family caused by hospitalization are taken into consideration.