Acupuncture sensations are considered essential in producing the treatment effect of acupuncture. The Massachusetts General Hospital Acupuncture Sensation Scale (MASS) is a frequently used scale in ...acupuncture research to measure acupuncture sensations. We translated the MASS into Japanese (Japanese MASS) based on Beaton’s guidelines. 30 acupuncturists evaluated the relevancy and meaning of the 12 descriptors included in the Japanese MASS. The content validity ratios for 10 of the 12 descriptors were 0.33 or greater. 42 healthy subjects then evaluated acupuncture sensations evoked by manual acupuncture at LI4 using the Japanese MASS. Cronbach’s alpha was 0.86. The correlation coefficient of total MASS scores and total Short Form McGill Pain Questionnaire scores and MASS indices and sensory visual analogue scores were 0.78 and 0.80, respectively. Factor analysis loaded the 12 descriptors onto two meaningful factors. This study demonstrated that the Japanese MASS has good reliability, content validity, criterion-related validity, and construct validity. Therefore, the Japanese MASS is a valid and reliable instrument for use with Japanese populations.
We collected HbA1c values and patient clinical information in the Hamamatsu area to investigate the state of diabetic treatment in October 2012. Since that time, several new drugs have been ...introduced, and target HbA1c values have been proposed. For comparison with 2012 another investigation was performed in October 2019. Study 1: HbA1c in outpatients. In comparison to 2012, the average HbA1c in general clinics was 6.87 % higher, while that in specialized clinics and hospitals was 7.15 % lower. Study 2: Clinical information of type 2 diabetes patients with HbA1c ≥8 %. In comparison to 2012, the average age was 4 years older in general clinics and 2 years older in specialized clinics and hospitals. In both institutions BMI decreased with aging. Similarly to 2012, patients in the higher HbA1c group were younger and had higher BMI values. In specialized clinics and hospitals, insulin therapy decreased. In both institutions the prescription of sulfonylurea decreased. Therapy with dipeptidyl-peptidase 4 inhibitors, sodium/glucose cotransporter 2 inhibitors, and glucagon-like peptide-1 receptor agonists increased in both institutions. These drug therapy changes can be expected to prevent vascular complications without increasing hypoglycemia or weight gain. The treatment of obese diabetes in younger patients, and the prevention of frailty in elderly patients are future issues.
Correspondence to Dr Nobuari Takakura, Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo ...135-0063, Japan; takakura@tau.ac.jp In acupuncture studies, it is necessary to expose blinded patients to control devices such as placebo/sham needles with a blunt tip, which allows the skin to be touched but not penetrated. Several recent systematic reviews have investigated the success of patient blinding with Streitberger, Park and Takakura placebo/sham needles in a series of validation and clinical trials using Bang’s blinding index (BI),1 2 which indicates the degree of potential unblinding beyond balance for each arm of real and placebo treatment.2 In a review papers, it was pointed out that the BIs for Takakura needles for double blinding were unavailable.1 Further, for study Ib (see table 1),3 Moroz et al reported the BIs of patients calculated from the number of subjects who did, or did not, experience the sensation of skin penetration,2 which differed from the BIs calculated from the number of correct and incorrect guesses, even though we reported that “none of the subjects commented in the questionnaire that they had received a non-penetrating needle”.3 The patient BIs for study Ib3 reported by Moroz et al were not appropriate. ...we report practitioner-sourced BIs, which have not been presented before, along with patient BIs from five validation studies3–7 (table 1).Table 1 Practitioner and patient blinding indices (BIs) and blinding scenarios for the use of Takakura needles in double blinding Study Study I3 Study II4 Study III5 Study IV6 Study V7 Total Takakura et al 2007 Takakura et al 2008a Takakura et al 2008b Takakura et al 2013 Vase et al 2015 Ia Ib Number of participants 10 practitioners, 1 subject 1 practitioner, 60 subjects 1 practitioner, 114 subjects 1 practitioner, 30 subjects 1 practitioner, 109 subjects 6 practitioners, 67 patients Practitioner blinding Penetrating real needles Number 170 needles 60 needles 114 needles 60 needles 109 needles 32 treatments BI −0.05 0.17 −0.22 −0.47 0.06 0.56 −0.05 95% CI −0.19 to 0.08 −0.08 to 0.42 −0.40 to −0.04 −0.69 to −0.24 −0.12 to 0.25 0.28 to 0.85 −0.13 to 0.03 Skin-touch placebo needles Number 230 needles 60 needles 114 needles – 109 needles 35 treatments BI 0.06 0.00 0.00 – −0.12 0.71 0.05 95%CI −0.06 to 0.18 −0.25 to 0.25 −0.18 to 0.18 – −0.31 to 0.07 0.48 to 0.95 −0.04 to 0.13 Blinding scenario Random/ random Random/ random Opposite/ random Opposite/- Random/ random Unblinded/ unblinded Random/ random Patient blinding Penetrating real needles Number – – 114 needles 60 needles 109 needles 32 treatments BI – – 0.37 0.33 0.56 0.38 0.43 95% CI – – 0.20 to 0.54 0.09 to 0.57 0.40 to 0.72 0.05 to 0.70 0.33 to 0.53 Skin-touch placebo needles Number – – 114 needles – 109 needles 35 treatments BI – – −0.12 – 0.19 0.20 0.05 95% CI – – −0.30 to 0.06 – 0.01 to 0.38 −0.12 to 0.52 −0.07 to 0.18 Blinding scenario – – Unblinded/ random Unblinded/- Unblinded/ random Unblinded/ unblinded Unblinded/ random The BI (ranging from −1 to 1) is a statistical tool that can be used to objectively assess the effectiveness of blinding and has been recently introduced into acupuncture studies.1 2 The BI is calculated based upon the number of correct guesses, incorrect guesses and don’t knows regarding treatment allocation.1 2 According to proposed criteria, a BI ≥0.2 indicates that the treatments have been correctly guessed (unblinded); a BI ranging from −0.2 to 0.2 indicates the treatments have been randomly guessed (random guess); and a BI ≤ −0.2 indicates the treatments have been incorrectly guessed (opposite guess).2 In total, nine blinding scenarios are possible when we consider all pairs created by ‘random guess’, ‘opposite guess’ and ‘unblinded’ options in real and sham/placebo arms.2 Table 1 shows the BIs derived from our studies3–7 employing pairs of penetrating real and skin-touch placebo needles3 4 6 7 or penetrating real needles only.5 The overall practitioner BIs for both penetrating real and skin-touch placebo needles indicate ‘random guesses’, which means that the effectiveness of practitioner blinding seems promising. For patient blinding scenarios in table 1, the ‘random guess’ for the skin-touch placebo arm appears promising because the patient BI of skin-touch placebo needles was 0.2 in study V,7 in which patients guessed the nature of the treatment with five needles, whilst ‘random guess’ was indicated by the BIs in study II4 and study IV.6 By contrast, the ‘random guess’ status for the penetrating real arm appears to be extremely difficult since the statuses in all studies were ‘unblinded’, as reported by a previous review.1 2 In addition to the ‘random guess’ status for both real and placebo arms, ‘unblinded’ in the real arm and ‘opposite guess’ in the placebo arm are also considered to reflect successful patient blinding as a ‘wishful thinking’ scenario, in which patients in both the real and placebo arms tend to believe that they received real treatment.2 If the latter scenario is acceptable, patient blinding appears to be more easily achievable than in the former scenario.
It's difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with ...stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.16 mm diameter DBNs found that the resistance felt by the acupuncturists during insertion successfully blinded them.
The study intended to compare the effects on an acupuncturist's blinding when the practitioner used penetrating DBNs with 0.14, 0.16, 0.18, and 0.20 mm diameters.
We conducted a double-blind randomized trial.
The study took place at the Japan School of Acupuncture, Moxibustion. and Physiotherapy in Tokyo, Japan.
The participant was one licensed acupuncturist who performed 320 needle insertions during acupuncture for 20 healthy students, who were familiar with acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy.
The acupuncturist was informed she would administer a penetrating or non-penetrating needle; however, only penetrating needles were used. She inserted the four sizes of needles in both of each student's dorsal forearms using an alternating twirling technique. This procedure was repeated once more on another day, with at least one day between sessions.
After the acupuncturist removed each needle, we asked her to guess: (1) the type of needle inserted, (2) her level of confidence in the guess, and (3) the clues that contributed to her guess. A chi-squared test was used to determine whether the ratio of correctly or incorrectly identified needles met an expected probability of 0.5 for each needle diameter.
Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions. The correct and incorrect ratios of identified needles were fitted with a probability of 0.5, with no significant differences in the acupuncturist's confidence (P = .16). In 99% of the tests, the cue that contributed to the acupuncturist's guess was the feeling of the needle insertion.
These findings indicate that the differences in the diameters of DBNs from 0.14 to 0.20 mm didn't significantly affect the acupuncturist's blinding.
To investigate the acupuncture sensations elicited by the Japanese style of acupuncture, penetrating acupuncture and skin-touch placebo needles were randomly administered at various insertion depths ...(5 and 10 mm for the penetrating needles and 1 and 2 mm for the placebo needles) at LI4 to 50 healthy subjects. Among the 12 acupuncture sensations in the Massachusetts General Hospital Acupuncture Sensation Scale (MASS), “heaviness” was the strongest and most frequently reported sensation with the 10 mm needles, but not with the 5 mm needles. There were no significant differences in number of sensations elicited, MASS index, range of spreading, and intensity of needle pain for 5 mm penetration versus 1 mm skin press and 10 mm penetration versus 2 mm skin press. The MASS index with 2 mm skin-touch needles was significantly larger than that with 1 mm skin-touch and 5 mm penetrating needles. The factor structures in the 12 acupuncture sensations between penetrating and skin-touch needles were different. The acupuncture sensations obtained in this study under satisfactorily performed double-blind (practitioner–patient) conditions suggest that a slight difference in insertion depth and skin press causes significant differences in quantity and quality of acupuncture sensations.
To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.
Forty healthy volunteers were enrolled as ...subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm: 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects.
The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was “random guess”, but “unblinded” for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters, the blinding status was “opposite guess” and the blinding status for penetrating needles of both diameters was “unblinded.” The percentages of “felt pain” with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters.
Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.
Magnetic resonance spectroscopy in situ was used to study changes in phosphorus 31 metabolism after photodynamic therapy (PDT) of transplanted HeLa cell tumours. Tumours were irradiated 2 h after ...administration of ATX-S10 (8-formyloximethylidene-7-hydroxy-3-ethenyl-2,7,12,18, tetramethyl-porphyrin-13,17-bispropionil aspartate), a new photosensitizer and chlorin derivative. Nuclear magnetic resonance spectra were measured prior to illumination and 1, 3, 7, 14, 21 and 28 days after PDT on each mouse. A drastic decrease in adenosine triphosphate (ATP) and a concomitant increase in inorganic phosphate (Pi) were evident on the first day after PDT in all cases. The beta-ATP/total phosphate (P) ratio was 0.64 +/- 0.29% (average +/- s.d.) in complete response, 0.67 +/- 0.30% in recurrence and 2.45 +/- 0.93% in partial response. Comparison of this ratio to the histological findings revealed that the beta-ATP/total P ratio reflects the HeLa cell tumours which survived PDT. In other words, partial response on the one hand was distinguished from complete response and recurrence on the other with this ratio 1 day after PDT (P < 0.05). In addition, the ratio of phosphomonoester (PME) to Pi rose beyond 1.0 when macroscopic recurrence occurred, while it stayed under 1.0 in complete response. This finding suggests that the recurrence of HeLa cell tumours can be detected by the PME/Pi ratio.
It is important to detect the near infrared emission of 1.27 IA in wavelength from the singlet oxygen, 1O2, to investigate and understand the mechanism of PDT. We detected this emission by means of a ...photon-counting system comprised with a high sensitive photomultiplier tube. For the efficient detection by this system, delayed detection time of 5μs from the onset of the laser irradiation and detection time duration of 5μs were necessary for the aqueous solution of photosensitizer PHE, and 8μs and 50μs were necessary for HeLa-tumor bearing mice injected with PHE (25mg/kg). The life time of the 1O2, was 5.3μs for the aqueous solution of PHE and 114μs for the HeLa-tumor bearing mice injected with PHE.
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