Objective: In clinical settings, new drugs are frequently administered to patients who have been excluded in the clinical trials. However, health professionals seldom recognize this. Focusing on monoclonal antibody drugs, we conducted a questionnaire survey of pharmaceutical companies and accumulated cases in which risk management differed between clinical trials and post-marketing.Methods: We obtained information on exclusion criteria for clinical trials of monoclonal antibody preparations from pharmaceutical companies. We compared these exclusion criteria with the contraindicated items in the package insert.Results: The most common exclusion criteria were “reproductive-related events”, “cancer-related events”, “HBV/HCV infection”,and “history of allergy/hypersensitivity”. The most common contraindications in the package insert were “history of allergy/hypersensitivity”, “other infectious diseases”, and “tuberculosis infection”. The average number of exclusion criteria for safety measures at the time of clinical trial was 10.1per drug, while that of contraindications was 2.1per drug; the difference was statistically significant. In addition, there were significant differences in one clinical trial exclusion criterion ( “upper age limit” ) and two contraindications ( “tuberculosis infection” and “other infectious diseases” ) between antineoplastic agents compared to therapeutic agents for autoimmune-related diseases. In half the products, serious adverse drug reactions related to the exclusion criteria that were not contraindicated were reported after marketing.Conclusion: Because the contraindications at the time of marketing are drastically fewer compared to the exclusion criteria at the time of clinical trials, pharmacists should inform doctors of it and carefully monitor the outcomes of new drugs that have not been used with patients with complications.

[Objective]To evaluate the efficacy of the different depth of acupuncture on the motor function and the pain with osteoarthritis of the knee.
[Design]Single blind randomized controlled trial.
[Method]Subjects were randomly allocated to one of two groups. Acupuncture needles were inserted about 3mm in the superficial acupuncture group and 10 to 20 mm in the deep acupuncture group. Subjects in both groups received the treatments for ten minutes on ten tender points. Acupuncture sessions were performed once a week for 8 weeks and without treatment 4 weeks.
[Outcome Measures]Pain intensity (visual analogue scale :VAS) , Objective evaluation of the motor function (Timed Up &Go test, 20m walking time, Time of going up and down stairs) and QOL (Western Ontario and MacMaster Universities osteoarthritis index :WOMAC).
All measurements were recorded at baseline, 4th, 8th and 11thweek.
[Result]Motor function improved significantly only in the superficial acupuncture group(P<0.05). The degree of pain decreased significantly in both groups (P<0.05).
[Conclusion]Superficial acupuncture provided the improvements on pain and motor function and contributed to the QOL improvement. Therefore the superficial acupuncture would be suggested to be one of the most effective method for the acupuncture treatment of OA of the knee.

[Purpose] This study investigated shoulder stiffness in university students and compared three different treatment procedures for shoulder stiffness.
[Method] The questionnaire (7 items) was distributed to 30 university students with a 3-month history of shoulder stiffness treated by three different treatments procedures. There were no abnormal findings on neuro logical examination.
[Result] The questionnaire response rate was 64.6%. The overall prevalence of shoulder stiffness was 61.9%, most patients had asthenopia and headache along with shoulder stiffness. However, immediately after the tender point and sham treatment periods, there were no remarkable clinical effect on shoulder stiffness, whereas after trigger point treatment, there were remarkable clinical effects on shoulder stiffness, as evaluated by the visual analogue scale.
[Conclusion] These results suggest that trigger point acupuncture treatment may be more effective for shoul- der stiffness in university students than other acupuncture treatments

[Purpose] This study investigated sports injuries in university students and compared two different acupuncture therapy procedures for chronic low back pain (LBP).
[Method] The questionnaire (12 items) was distributed to members of sports clubs at Meiji University of Oriental Medicine. Patients with LBP resulting from sports injuries who had had low back pain for more than a year were treated by two different acupuncture therapy procedures. There were no abnormal findings in their neurological examinations.
[Result] The questionnaire response rate was 68.6%. The overall prevalence rate of sports injuries was 77.6%, and LBP patients were the most common. On the other hand, during and after the preceding therapy, using the traditional acupoints for LBP, there was no remarkable clinical effect on LBP, whereas during and after the succeeding therapy using the trigger point, there were remarkable clinical effects on LBP, as evaluated by the visual analogue scale.
[Conclusion] These results suggest that trigger point acupuncture therapy may be more effective on chronic LBP in sports than therapy which uses traditional acupuncture.

Four fibromyalgia syndrome (FMS) patients with complaints of widespread pain, fatigue and difficulty sleeping received acupuncture therapy. The effects of acupuncture treatment were evaluated using a visual analogue scale (VAS), and a pain disability assessment scale (PDAS). After whole body acupuncture treatments, VAS and PDAS values were almost unchanged. However, VAS and PDAS values improved following a 3-treatment course of FMS-specific acupuncture treatments (electroacupuncture at the characteristic tender points of FMS). These results suggest that FMS-specific acupuncture treatment of fibromyalgia patients may relieve their commonly reported symptoms of pain, and fatigue.

[Objective] We analyzed the clinical findings in 5 patients with osteonecrosis in the medial condyle of the tibia. We also evaluated the usefulness of a tibial percussion test that we developed for examination of differences between the healthy and affected sides in percussion caused by knocking on the tibial rough surface.
[Methods] The subjects were 5 females, who consulted our hospital with a chief complaint of gonalgia and in whom conditions such as osteonecrosis in the medial condyle of the tibia were confirmed by MRI in 4 limbs. In addition to X-p, MRI findings, medical findings by interview, and findings by physical examination were evaluated as clinical findings. Furthermore, the tibial percussion test was performed.
[Results] The causes of pain in the knee joint were unclear in all patients. Pain was severe in 3 patients and marked in 2 patients. Physical examination showed marked tenderness in the medial articular gap and tenderness in the medial condyle of the tibia. In all patients, a difference in the percussion findings between the healthy and affected sides was confirmed by the tibial percussion test.
[Conclusions] These findings indicated that the tibia percussion test in addition to confirmation of characteristic clinical conditions, such as the initial condition of the disease and the severity of tenderness, is useful for the evaluation of conditions of this disease.

[Purpose] Elderly patients with chronic low back pain have often been treated by acupuncture andmoxibustion therapy, using the traditional acupoints for low back pain. But there are some patients who do not get a clinical effect. Therefore, we tried to treat three such patients with three sessions of trigger point acupuncture therapy, instead of using the traditional acupoints for low back pain.
[Methods] The patients were aged 74, 71 and 66, and had low back pain for at least 6 months. They hadround backs, but there were no extraordinary findings in their neurological examinations.
[Results] During and after the previous therapy using the traditional acupoints for low back pain, there wereno remarkable clinical effects on low back pain. But during and after the present therapy using trigger points, there were remarkable clinical effects on low back pain, as evaluated by the visual analogue scale (VAS) and the pain disability assessment scale (PDAS).
[Conclusion] These results suggest that the trigger point acupuncture therapy may be more effective on lowback pain in elderly patients than acupuncture therapy which uses the traditional acupoints.

The results of multi-center RCT of acupuncture and moxibustion for the prevention of the symptoms of common cold conducted by the financial support of the foundation for training and licensure examination in anma-massage-acupressure, acupuncture and moxibustion were briefly reviewed. Traditional acupuncture manipulation to the throat induced significant positive effects, however, more common indirect moxibustion to the neck for longer period did not induce the significant effect compared with no-treatment control. Several issues to be resolved were discussed and the shortage of duration of intervention was pointed out as one of the major issues. Then four pilot studies with long-lasting intervention of acupuncture or moxibustion were con-ducted. The effects tended to be more positive, however, they were still unclear. The selection of subjects (students in the acupuncture school) will be the next important issue to be examined.

Case Report : Acupuncture therapy for a fibromyalgia-like syndrome (FMS-like) patient. A 44-year-old woman complained of widespread pain, fatigue and poor quality sleep. Effects of acupuncture treatment were evaluated using a visual analogue scale (VAS), pain disability assessment scale (PDAS) and pressure pain thresholds (PPT) at tender sites of FMS. After 13 whole body acupuncture treatments PPT, VAS and PDAS were almost unchanged. However, three FMS-specific acupuncture treatments (eletroacupuncture at characteristic tender sites of FMS) increased PPT and improved VAS and PDAS. These results suggest that FMS-specific acu-puncture treatment may relieve widespread pain and fatigue symptoms in FMS-like patients.