2.The immediate effects of various treatment styles
Masamichi NAKAMURA ; Mayumi YAKAME ; Hideki SAITO ; Makoto MURAI
Journal of the Japan Society of Acupuncture and Moxibustion 2012;62(2):140-147
[Objective]In clinical practice, it is important that patients experience symptomatic improvement or at least gain a certain level of satisfaction early on during a series of treatments. Most patients decide whether or not to return to the clinic based on these factors. At our school, students are trained in protocols from three different treatment styles:modern acupuncture, meridian acupuncture (based on classic acupuncture) and traditional Chinese medicine. In this study, we investigated the characteristics of each style, such as the presence of immediate effects and the types of sensations perceived by patients.
[Methods]Questionnaires were given before and after treatment to 177 patients who came to the clinic associated with our teacher training course for acupuncture, moxibustion and massage. We received valid responses from 169 patients. The practitioners surveyed were second-year students who had treated the surveyed patients 1.2 times on average prior to answering the questionnaire. Before treatment, patients were asked about their main complaints and symptoms, and afterward about changes in their symptoms, satisfaction level and other sensations. The resulting data was subjected to statistical analysis.
[Results]The style chosen by most practitioners was modern acupuncture, followed by meridian acupuncture, and then traditional Chinese acupuncture. Most lower back, leg and joint pain was treated with modern acupuncture protocols, while internal disorders were more often treated with meridian acupuncture or traditional Chinese acupuncture. All three styles were able to alleviate symptoms and achieve patient satisfaction with no statisticallysignificant differences among the three groups.
[Discussion]The results demonstrated that training practitioners in these three styles for one year helped them achieve positive and immediate effects. While there are many different styles of acupuncture, in actual clinical practice, the style is less important than how much a patient feels the effect of the treatment.
[Conclusion]All three styles, modern acupuncture, meridian acupuncture and traditional Chinese acupuncture, were able to alleviate symptoms and achieve patient satisfaction with no statistically significant differences among them.
3.Development of a Method to Determine the Level of Understanding of Package Inserts for Over-the-Counter Medication
Masayuki Hashiguchi ; Risa Kaneko ; Ai Hosaka ; Keiko Ueda ; Noriko Kodera ; Mayumi Nakamura ; Mikio Sakakibara ; Tatsuo Kurokawa ; Mayumi Mochizuki
Japanese Journal of Drug Informatics 2013;14(4):144-160
Objective: To develop a label comprehension study (LCS) of package inserts for over-the-counter medications in Japan, we evaluated whether it would be possible to detect differences in the level of understanding due to layout, and font size of different types of package insert using the interview method for LCS we developed previously.
Design: A face-to-face questionnaire investigation.
Methods: Two different types of package insert (including layout, and font size) for H2-antagonists (package insert groups A and B) were used. Study participants (≥18 years old) comprised consumers who visited a drugstore with a dispensing service in Saitama Prefecture. They were randomly assigned to group A or B and divided by age range (young, 18-39 years; middle-aged, 40-59 years; eldely, ≥60 years). First, the volunteers read the package insert with no time limitation and then answered 14 scenario-type questions during an interview to determine the level of understanding of the insert. When both the correct answer and correct reason were given, the response was judged as correct. The level of understanding of the package insert was calculated as the number of persons giving correct responses divided by all respondents.
Results: Questionnaire responses from 86 consumers (43 in each group) were obtained. The mean age in groups A and B was 46.5 years and 47.0 years, respectively. The mean level of understanding of the package insert (14 questions) in groups A and B was 50.2 and 38.1%, respectively. By age range, the mean level of understanding of the package insert in groups A and B in the young group was 60.6 and 56.9%, respectively, and there was no statistically significant difference between the two groups. However, the mean level of understanding in groups A and B was 56.9 and 35.0% in the middle-aged group and 26.3 and 14.5% in the elderly group, respectively. The mean understanding in group A was therefore higher than that in group B in both age ranges. The association between understanding and age within groups indicated that with increasing age, understanding was lower in both groups (group A, p=0.001; group B, p<0.001). There was no difference in the level of understanding between the young and middle-aged in group A, but the difference in group B was greater than 20%.
Conclusion: By comparing two package inserts of products in a similar pharmacological category using our LCS method, it suggested that font size and layout influenced consumers’ understanding of package inserts. It might be able to evaluate the difference in the understanding of the package insert by using our LCS method.
4.The effect of water polo training on bone mineral content.
MAYUMI IMAMURA ; YUTAKA MIYANAGA ; TORU FUKUBAYASHI ; NOBORU MESAKI ; JINJU NISHINO ; TOSHITAKA NAKAMURA
Japanese Journal of Physical Fitness and Sports Medicine 1992;41(2):200-205
An investigation was conducted to clarify both the effect of water polo training on bone mass and the effect of training-induced menstrual disorders on bone. The subjects were 12 female college water polo players and 7 age-matched sedentary college women as a control group.
Menstrual condition was evaluated by 12 montes of basal body temperature measurement. Seven of the water polo players were eumenorrheic, and five had training-dependent (reversible) menstrual disorders (two with amenorrhea and three with cycle disturbances) .
Bone mineral measurement revealed differences between the water polo players and the sedentary women. The eumenorrheic water polo players had a higher bone mineral density (BMD) in the lumbar spine and total body skeleton than the sedentary control group, being 11.2% and 11.3% higher, respectively.
Effects of menstrual disorders (including cycle disturbance) were clear in the water polo players. The BMD of water polo players with menstrual disorders was 9.8% and 9.6% lower in the total body and lumbar spine that of eumenorrheic water polo players.
Hormonal examinations revealed a lower serum estradiol level in water polo players with menstrual disordsers in comparison with eumenorrheic water polo playes. Serum estradiol level showed a positive correlation with both total body BMD (r=0, 78, p<0.01) and lumbar spine BMD (r=0.71, p<0.01) .
5.Purchase of Antimicrobials in Retail Pharmacies Whena Prescription is Not Required
Khaliun Nyambayar ; Keiko Nakamura ; Mayumi Ohnishi ; Rie Nakajima ; Vaanchig Urnaa ; Takehito Takano
Journal of Rural Medicine 2012;7(2):51-58
Objectives: The patterns of purchasing prescription antimicrobials with or without a prescription from retail pharmacies in Ulaanbaatar, Mongolia, were examined in relation to purchasers’ socioeconomic status and price of the product.
Methods: A survey was conducted at 250 randomly selected pharmacies in Ulaanbaatar. A total of 619 customers were interviewed, and the medicines they bought at the stores were examined by medical doctors. The use of prescriptions and advice in purchasing medicines and sociodemographic characteristics of the subjects were determined.
Results: Interviews were conducted with 297 customers who purchased prescription antimicrobials in front of the store in which they made their purchase. Among these 297 customers, only 19.5% (n=58) purchased medicine with a formal prescription, and 37.4% (n=111) purchased medicines on their own initiative and without the guidance of medical professionals. Purchase without a prescription was not associated with the subjects’ gender, age, educational status or area of residence. Lower-priced antimicrobials were purchased without prescriptions more frequently than those with a higher price (P<0.05).
Conclusion: The purchase of antimicrobials without prescriptions is common across all sociodemographic strata in Ulaanbaatar, Mongolia. Considering the increases in number of retail pharmacies and in sales of antimicrobials associated with economic development, measures to enforce regulations and to promote education among the general public and pharmacy professionals are required.
6.‘Febrile Children's Menu’ for Children with Fever
Saori FUKAMI ; Takahito NAKAMURA ; Katsuyasu YANAGIDA ; Shingo YAMADA ; Tsuyoshi YAMAGUCHI ; Mayumi SHIRAISHI ; Mikari ITO ; Tetsuaki SHUMIYA ; Naoko NISHIMURA ; Takao OZAKI
Journal of the Japanese Association of Rural Medicine 2012;61(1):1-7
The incidence of fever in children admitted to general hospitals is very high. Provision of adequate nutrition and fluid supplements to febrile children is very important, but with some children it is difficult to maintain an adequate intake. To address this problem, we devised a new ‘febrile children's menu’, utilizing preparation methods and foods to produce a palatable menu for patients with fever.
We introduced this ‘febrile children's menu‘ on January 6, 2011, providing it to 109 patients (age range: 1 to 8 years, average age: 3.3±1.9 years) over the ensuing 3-month period. We provided a mean 4.0±2.9 meals per day to each patient during their febrile stage (≥37.5°C). To evaluate the usefulness of the ‘febrile children's menu’, we investigated eating rates during the febrile period in all patients who had been provided with the menu, and performed a questiomaire survey on their parents/guardians. The mean eating rates during the febrile period were 39±30% for main meals, and 28±22% for side dishes. No significant difference was seen in the eating rates during the febrile period recorded over the 2-month period prior to introduction of the new menu to 112 febrile children (age range: 1 to 8 years, average age: 3.3±2.1 years), 39±30% for main meals, and 29±22% for side dishes. The questionnaire survey was responded by 43 parents/guardians (a recovery rate of 39%). The ‘febrile children's menu’ was assessed as ‘good’ by 67% of respondents, representing an overall favourable impression from the parents/guardians. With reference to the survey results, we will attempt to further improve the ‘febrile children's menu’ with the aim of increasing eating rates during the febrile period.
7.Improvement of Meals for Patients Undergoing Chemotherapy
Chinatsu YAMADA ; Tetsuaki SHUMIYA ; Tsuyosi YAMAGUCHI ; Shingo YAMADA ; Mayumi SHIRAISHI ; Katsuyasu YANAGIDA ; Takahito NAKAMURA ; Takumi UMEDA ; Mikari ITO ; Takao OZAKI
Journal of the Japanese Association of Rural Medicine 2013;62(2):106-111
In 2010, we at Konan Kosei Hospital introduced a menu with 8 days set as a cycle for inpatients undergoing chemotherapy. We have thus far used it for 258 patients. Over the 6-month period extending from October 2011 and March 2012, we performed a questionnaire survey on 23 patients (8 with lung cancer, 5 with acute myeloid leukemia and 3 with lymphoma) about their meals. On the basis of the findings, we have made a number of improvements in the menu. To the question of ease with which to eat, 96% of patients responded the meals were “easy to eat.” When it came to the volume of meals, 29% replied that breakfast was “small,” whereas 83% said lunch and dinner were “just right.” Cold chawan-mushi (custard-like egg and vegetable dish steamed in a cup) was difficult to eat for 7 patients, whereas there were indications that fish meals were also hard to eat. Based on this survey, we have increased the volume of breakfast, and replaced cold chawan- mushi with hot chawan-mushi. Furthermore, in order to reduce the smell peculiar to fish, we substituted kaba-yaki (spitchcocks) and ankake (food dressed with a thick, starchy sauce) fish- cooking styles for nitsuke (fish boiled and seasoned with sugar and soy sauce) and mushizakana (steamed fish) styles. Further surveys are necessary to produce a menu suitable for as many patients undergoing chemotherapy as possible.
8.Extension of the indications for operation and up-to date problems in the surgical therapy of acquired valvular disease. Analysis of 581 consecutive prosthetic valve replacement.
Yoshito KAWACHI ; Yoshihiro TOSHIMA ; Kohji MATUZAKI ; Yuuichiro NAKAMURA ; Toshihide ASOU ; Munetaka MASUDA ; Kazuhiko KINOSHITA ; Hisanori MAYUMI ; Jiro TANAKA ; Kouichi TOKUNAGA
Japanese Journal of Cardiovascular Surgery 1989;18(4):491-496
To evaluate the extension of the indications for operation and up-to-date problems in the surgical therapy of the acquired valvular disease, 581 consecutive patients of prosthetic valve replacement from January 1974 through December 1987 were analysed. The age at operation was 39.1 years (range 22 to 68) at 1974, but increased to 51.9 years (range 9 to 75) at 1987 (p<0.05). Early mortality was 3 deaths in 9 patients (33.3%) who were older than 70 years old, but its range was 0% through 7.7% in the younger patient group (p<0.05). Hospital mortality of the combined valve procedure for aortic, miral and tricuspid valvular disease was analysed. It was higher in the group of tricuspid valve replacement (30.0%) than the group of tricuspid annuloplasty (8.3%) (p<0.01). The former group was in poor preoperative state (cachexia, total bilirubin>2mg/dl, mean right atrial pressure>10mmHg and systolic pulmonary artery pressure >75mmHg), compared to the latter group. The cases of re-replacement of the prosthetic valve increased since 1985. The incidence of poor prognosis after operation, that included early death, late death and retire from society, was 47.1% in NYHA Class TV, and from 0 to 15.8% in NYHA Class I to Class III (p<0.01). 60 cases underwent valve replacement for infective endo-carditis, and 16 urgent operations were required in 23 active stage operations. Total early and late mortality was higher in active stage operation (30.0%) than in healed stage operation (2.7%) (p<0.01). In these way, the extension of the indications for operation was carried on the patients of advanced age, combined valve procedure for multiple valve disease, valve re-replacement and infective endocarditis. The operative risk was high in the patients older than 70 years old, the patients who had the risk factors of multiple organ failure after operation, valve re-replacement in NYHA Class IV, and the urgent operation at active stage of infective endocarditis.
9.Checklist and Guidance of Scientific Approach to Developing Pharmacovigilance Plan (PVP) in Japan: A Report from a Task Force of JSPE
Kiyoshi KUBOTA ; Kotonari AOKI ; Hisashi URUSHIHARA ; Tatsuo KAGIMURA ; Shigeru KAGEYAMA ; Daisuke KOIDE ; Akira KOKAN ; Tsugumichi SATO ; Toshiaki NAKAMURA ; Ken NAKAJIMA ; Naoya HATANAKA ; Takeshi HIRAKAWA ; Kou MIYAKAWA ; Mayumi MOCHIZUKI
Japanese Journal of Pharmacoepidemiology 2014;19(1):57-74
A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.
1.Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities
2.How to select Safety Specification (SS) and describe its characteristics
・Selection of SS
・Characterization of SS
・Association with Research Questions (RQ)
3.How to define and describe RQ
・What is RQ ?
・RQ interpretation in other relevant guidelines
・Methodology to develop RQ for PVP with examples
・Best approach to integrating PVP for whole aspects of safety concern
4.How to optimize PVP for specific RQ
・Routine PVP or additional PVP ?
・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)
・Checklist to help develop PVP
5.Epilogue:
・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.
・Significance of background incidence rate and needs for comparator group
・Infrastructure for the future PVP activities
6.Appendix: Checklist to help develop PVP activities in RMP
The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.
10.Clinical Study of Catamenial Pneumothorax
Mayumi KOBAYASHI ; Takuya ONUKI ; Masaharu INAGAKI ; Yasuko NISHIDA ; Kaori TAKAGI ; Yoshihide SAGAWA ; Reiko NAKAMURA ; Tamami ODAI ; Yoko FUJIOKA ; Maiko ICHIKAWA ; Seiichi ENDO ; Masae SAKAMOTO ; Koji SHIMABUKURO
Journal of the Japanese Association of Rural Medicine 2015;64(1):56-60
Catamenial pneumothorax (CP) is defined as a form of thoracic endometriosis syndrome (TES) and the clinical manifestations and management of this disease are not consensual. Successful treatment depends on how closely pulmonary specialists and gynecologists work together. Such being the circumstances, we reviewed our experience with CP in terms of treatment and follow-up. We treated surgically many patients with pneumothorax during the period from 1989 to 2014, of which eight cases had endometriosis on the diaphragm, lung or pleura histologically. The median age at the time of operation was 37 (range, 17 to 41). CP was right-sided in seven of the eight patients (87.5%). Six patients underwent an examination with diagnostic laparoscopy and five had positive findings. The median period of follow-up after surgery was 33.5 months (range, 4 to 129 months). Two patients had no recurrence without hormonal therapy. Six other patients experienced a recurrence of pneumothorax, although two patients received dienogest after surgery. The use of only dienogest or both GnRHa and dienogest prevented recurrence in all patients. CP is a critical condition that requires prompt action, so after surgical treatment, the choice of hormonal therapy with a high rate of patient compliance are needed. No recurrence occurred in young patients who had only surgical treatment, suggesting that there were some associations between age and recurrence. Since we succeeded in preventing recurrence after using GnRHa in all cases, we recommend GnRHa or dienogest following GnRHa for the first choice of hormonal therapy after surgery. However, treatment with only dienogest could achieve successful results with no recurrence, so more case studies need to be done to make the best treatment choice for each case.