The present-paper discussed about the internal and external validity in single subject designs. Firstly, intrasubject replication was introduced as a method to increase the internal validity of single subject data. Secondly, it was pointed out that direct replication and systematic replication are effective in evaluating the external validity, and the experimental design for the direct replication and the systematic replication within a single experiment was introduced. Thirdly, the methods for dealing with individual differences which came out in repeating the replication were discussed. Finally, the theoretical differences between group comparison designs and single subject designs on the external validity were pointed out, and the merits of single subject designs in the clinical research of acupuncture were discussed.

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Artificial ureteral calculosis was produced by the injection of dental cement in anesthetized rats. EMG activities of body trunk and medial thigh muscles were recorded immediately after the operation using bipolar wire electrodes. Then vocalization thresholds were measured by electrical stimulation of the muscle using the same implanted electrodes. After the operation long-lasting periodic increases of the EMG activities were observed and decreases of pain thresholds were also observed in the same muscles.
These results suggest that artificial ureter calculosis rats are useful experimental model for the further study on the tender points formation.

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Effects of pretreatment with gold ion or coexistence of gold and silver ions on silver-induced contracture were studied to evaluate whether different uses of gold and silver needles in patients with rheumatoid arthritis are due to different actions of these heavy metals. Simultaneous application of 20μM gold ion and 5μM silver ion prolonged the time from ion application to tension development in single fibers of frog skeletal muscle 10 fold, compared with that observed upon silver ion alone. Such fibers showed no striation disorder. When 20μM gold ion was given to fibers immediately after development of silver-induced tention, the duration of a transient component of silver-contracture was shortened and a subsequent tonic contracture no longer observed. Delayed application of gold ion to fibers at which the tonic contracture is already appeared did not inhibit silver contracture. Even after pretreatment with gold, muscle fibers deteriorated upon silver application. These findings suggest that chemical interaction of both metal ions with membrane proteins is not simple, but depends on concentrations used, application order and time of gold application after exposure of fibers to silver.

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It has been thought that iatrogenic pneumothorax due to acupuncture is generally rare. But actually it does not seem rare accident. We have met 4 accidental pneumothorax cases in our clinic between 1987 and 1993. In this term 2147 patients had acupuncture therapy. And 749 of these patients had acupuncture in their thoracic cage. The incident rate of pneumothorax is 0.53% of 749 patients. Three pneumothorax cases had to be hospitalized to have care and obserbation. Therefore the iatrogenic pneumothorax should not be ignored and it should be avoided by careful, thoughtful therapeutic technic.

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At the Ambulatory Clinic for Collagen Disease and Rheumatism, the Second Department of Internal Medicine, Nagoya City University Hospital, acupuncture was performed on 8 patients with chronic fatigue syndrome who satisfied all of the following requirements: (1) cases which satisfied the diagnostic criteria established by the Center for Disease Control (CDC), USA and the Ministry of Health and Welfare Study Group, Japan; (2) cases which could be followed for long periods, (3) patients who gave informed consent to acupuncture, and (4) cases which were resistant to conventional drug therapies. Severe fatigue, which is the major symptom of this syndrome, was reduced markedly by acupuncture. Accompanying physical symptoms were also reduced in some cases. Immunologically, the percentages of gamma- and delta-T cells in peripheral blood, which had been lower than normal before treatment, improved significantly after acupuncture.
These results suggest that acupuncture provides a useful means of treating chronic fatigue syndrome which has conventionally been treated using drugs alone.

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The patients with the spondylosis deformans of the lumbar spine are often treated by acupuncture therapy. Forty patients (male 28, female 12, mean age 61.2 years old) with spondylosis deformans of lumbar spine were treated by the acupuncture therapy with therapeutic exercise and silver spike point (SSP) therapy in Meiji College of Oriental Medicine Hospital. The purpose of this study is to evaluate the clinical effect of our therapy using our painscale score. In our therapy, acupuncture points (Dachangshu-BL25, Shenshu-BL23, Ciliao-BL32, Baohuang-BL53 etc.) and SSP points on erector spinae muscle and gluteal muscle were used. As the result of this study, 22.5 % had excellent effect and 55.0 % had good effect by our therapy. It was concluded that our therapy is one of considerably effective therapy for the spondylosis deformans of the lumbar spine.

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We made inquiries into the actual condition of the education of the professional school, which is required to exalt the mind of the students to the spirit of acupuncturists, the professionals, (below we call it socializing function.) conducting the questionnaire on our students.
In July 1993, we conducted the unsigned questionnaire on 172 students of the 3rd grade of the faculty of acupuncture.
We classified the students into 3 types, “making good progress type”, “having trouble type” and “having no purpose type”, considering from the point of view of socializing function in 3 stages, before entering the school, studing in the school and graduating from the school. Consequently, about 80 percent of the students were “making good progress type” and there weren't any “having no purpose type” students. It seems to be one of the typical characteristics of professional schools. However about 10 percent are “having trouble type” students and we consider that the more internal inquiries on this type of the students and the educational consideration toward them are our questions to answer in the future.

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We have twice previously reported the results of our preliminary investigation regarding patients with hypertension. Recently, the focus of our interest has been on the blood pressure levels at the time of the third sound of korotkoff. We reported our findings regarding this topic in an oral presentation titled “Evaluation of acupunctural treatment in hypertensive patients” at the 9th Annual Central Japan Block Meeting of the Japanese Society of Acupuncture and Moxibustion Therapy.
Since then, we have accumulated further clinical experience regarding hypertensive patients. In this study, we investigated the third sound of korotkoff in patients diagnosed as borderline hypertension according to the WHO criteria for hypertension. The blood pressure during the third sound of korotkoff ranged from 100mmHg to 110mmHg in our patients. This difference in blood pressure noted during the decreasing phase of the blood pressure cycle may serve as a useful prognostic indicator in hypertensive patients.

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The efficacy of acupuncture haven't yet cleared. In modern socity was called stressful socity, individuals are exposed to a variety of stress. The patients with unidentified complaints without pathological signs who visited acupuncture clinic were increased.
We performed acupuncture on a patient with unidentified complaints caused by stress. The efficacy of acupuncture on theses unidentified complaints was assessd, by following the course of the patient's condition, recorded using the form desingnated for the management of unidentified complaints, developed by the Japanese Society Acupuncture.
After 21 round of acupuncture treatment, the chief complain and the accompanying decreased by 23% from the initial 23 to 17 at the end of the treatment. Thus this therapy was rated as slightly effective in this case.
The objective from designated for the management of unidentified complaints allowed a quantitative analysis of the course of complaints after the begining of acupuncture. Although only one patient was examined, acupuncture was suggested to be effective for unidentified complaints.

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Many patients present with indefinite symptoms which are thought to be due to stress. Recently, an increasing number of patients are being treated at acupunctural clinics for these symptoms. We describe a patient with bronchial asthma who presented with multiple indefinite symptoms. We decided to treat this patient with Taikyoku Ryohoh (Kurono-shiki basic meridian points for total conditioning of the body). A total of 21 treatments was given. Most of the symptoms, including asthma, disappeared as a result of Taikyoku Ryohoh. Moreover, patholoqical signs, which had been evident before treatment, were ameliorated. Clinical assessment charts for patients with indefinite symptoms were used to evaluate the effectiveness of treatment. These charts were devised by members of the indefinite symptoms study group of the Japanese Society of Acupuncture and Moxibustion. Indefinite symptoms were reduced by 43.6% after Taikyoku Ryohoh. Thus, this form of therapy was effective in treating indefinite symptoms.

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The objectives of treatment for diabetes mellitus are to prevent complications and to inhibit or reduce the progression of disease. For these purposes, a physiological blood glucose level must be maintained. Cramps in both legs and other symptoms believed to be complications of diabetes mellitus were treated by acupunctural therapy. A diagnosis of diabetes mellitus was made by internists in all patients evaluated in this study. We investigated whether our treatments had any effect on the diabetic status of these patients. Our records were kept on diabetes charts devised by members of the local branch of the Japanese Society of Acupuncture and Moxibustion Therapy. After beginning acupunctural treatment, the fasting blood glucose levels and levels of hemoglobin A_1C were improved. Both the fasting blood glucose level and the hemoglobin A_1C level serve as important indicators of symptoms and complications in patients with diabetes mellitus. Our findings have shown that acupunctural therapy is effective in treating diabetes mellitus. Treatment of diabetes by acupuncture also lead to the amelioration of symptoms due to its complications.

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Disappointingly little has been achieved by literally hundreds of attempts to evaluate acupuncture for chronic pain. Major methodological flaws are apparent in the vast majority of studies. Controlled studies have shown positive findings for low back pain, and equivocal results for migraine and asthma. Nevertheless larger scale studies are warranted for all these disorders, though other types of musculo-skeletal pain, tension headache and arthritis are also possible candidates.
Controlled trials of any treatment have become an immensely difficult and technical undertaking. They are expensive, time-consuming and ideally require the collaboration between practitioners and researchers and consultation with a statistician. It is not really possible for acupuncturists in private practice to mount such trials, and it is very difficult for a professional association or college. However, it is clear that there is no longer any point in conducting small, preliminary studies of acupuncture treatment. There are dozens of such studies, with some encouraging findings. The only way acupuncture can gain full acceptance as a valid form of treatment is through good controlled trials that are large enough to answer the questions they pose.
Ter Riet's list of criteria as a good starting point for anyone designing a trial of acupuncture. Specific points I would emphasize after reviewing the existing research on acupuncture are:
1. Trials should be single blind; it is not feasible to conduct double-blind trials. Some trials are nevertheless incorrectly described as double blind.
2. A range of outcome measures should be used, preferably with some independent assessment. An adequate follow-up is essential.
3. Considerable care needs to be taken in the choice of control group, especially with placebo controls. For a placebo I suggest a form of acupuncture treatment that is designed to have minimal effects. It will be the option that is the closest match to the true treatment and avoids the difficulties inherent in randomizing patients to a non-acupuncture treatment.
4. It is very useful to check the adequacy of any control treatment with a measure of credibility, or similar assessment, as the choice of control is frequently a matter for criticism.
5. Trials have generally been too small to permit firm conclusions. Ter Riet (Ter Riet, Kleijnen et al. 1990) implies that 50 patients per group are needed. This may not be necessary. However preliminary calculations of the necessary size for a reasonable power need to be carried out.

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