We previously reported the psychological issues experienced by parents whose children were undergoing pediatric clinical trials in Japan. The aim of this study was to investigate the psychological burden on parents whose children participated in clinical trials of inhaled corticosteroids with higher risk of adverse effects than other drugs. A questionnaire survey was conducted on 49 parents of 72 children who participated in randomized controlled studies using two types of active trial drugs. Of 49 parents, 23 (47%) responded to the questionnaire at the completion of the trials. Regarding the reason for participating in the trial, 39% of the parents responded that they believed the drugs would have a positive effect, 9% responded that they were convinced by the explanations given during the informed consent procedure, and 9% responded that they had faith in the investigators. At the completion of trials, 87% of the parents were satisfied with participation in the trials, and 87% responded that they would recommend the trials to other parents. However, there were controversial issues and complaints in their responses. Some responses included useful proposals for improving the trials in the future. In conclusion, in the special pediatric trials of inhaled corticosteroids, the parents' psychological belief that the drugs would prove successful and their faith in the principal investigator overcome their anxiety about possible adverse effects of the drugs, which are the motivating force that constitutes the basis for clinical trial implementation. These results show that a robust foundation of clinical care prior to clinical trial involving children ensures more satisfying results for all parties concerned.
Some controversial issues concerning pediatric clinical trials exist in Japan. The aim of this study was to investigate the psychological issues specific to pediatric clinical trials. We encounter difficulties in the clinical setting when conducting pediatric trials in Japan, because of the well established universal health insurance system with a strong focus on patient benefit and the close relationship between parents and children which is common among Asian people. In order to define the specific pediatric issues, we conducted a study on the psychology of parents whose children had participated in clinical trials of antibacterial antibiotics for acute otitis media or anti-allergic agents. In this study, a questionnaire survey was conducted on 51 parents of 61 pediatric trial participants. Twenty-five parents (49%) responded to the questionnaire at the completion of clinical trial. From the responses, we attempted to identify important issues that have to be resolved. The results indicated several unique and deep psychological issues in the parents. Some parents felt a sense of guilt for receiving a stipend as a result of their children's participation in the trials. During the trials, parents tended to hide their vague anxieties over their children's physical conditions from the investigators and the clinic staff. We will conduct further analysis to identify the most critical psychological factor, the solution of which will facilitate successful implementation of clinical trials involving children in the future.
Six female patients with anorexia nervosa, who met the criteria shown by Halmi et al. or Suematsu, were treated by dietary therapies with behavioral modification and no medication, being compared with another six female patients treated by psychiatric counsel alone. Their lives in the hospital were restricted and isolated from their own families and relatives for the early period of admission, in which psychiatric counsels were regularly performed.In dietary therapy the meal contained 1200kcal per day for the first time and was gradually added by 200kcal per day at an interval of 7 to 14 days as the patients could eat completely. However, in patients who were severely undernourished and showed no desirable eating attitude nor modest weight gain, they were further given a nutrient such as "Sustagen" (200-400kcal per day) between meals. The gain of mean weight from 32kg to 42kg was found within a year by such diet therapies, while by psychiatric counsel alone that from 32kg to 45kg was visible within several years.It is concluded that these dietary therapies with behavioral modification may be useful to facilitate the patient's return to a regular eating attitude and ideal body weight.
