These results indicate that Shirodhara has anxiolytic and ASC-inducing effects, and it promotes a decrease of noradrenaline and exhibits a sympatholytic effect, resulting in the activation of peripheral foot skin circulation and immunopotentiation.

!Objectives : The objective of this study is to develop a Japanese version of the Constitution in Chinese Medicine Questionnaire (CCMQ) in Chinese, which is comprised of 60 items with 9 sub-scales, and evaluate its reliability and validity. Methods : We conducted a survey of 130 participants in the Toyama area of Japan from Dec. 2005, to Feb. 2006. A test-retest method was used. Feasibility was evaluated by the response times to the questionnaire, and the response rates of the CCMQ items. Internal consistency within the sub-scales was assessed by Cronbach's α coefficient. Reproducibility was confirmed between the first and second occasions using weighted kappa and Spearman correlation. Lastly, criterion validity was evaluated by correlation between CCMQ and SF-36 sub-scales. Results : Response time was 8 minutes on average and its rate was nearly 100%. Internal consistency was achieved for each of the 9 sub-scales with a 0.65 to 0.79 α coefficient. Reproducibility ranged from 0.41 to 0.81 for the items, and from 0.79 to 0.88 for the sub-scales. Regarding the criterion validity, the "Gentleness type" sub-scale was positively correlated with SF-36 (0.46, P<0.001), while other 8 pathological constitutional types of the CCMQ were negatively correlated with SF-36 (-0.35 to -0.50, P <0.001) as expected. Conclusions : We developed a Japanese version of the CCMQ and found acceptable levels of reliability and validity using a survey of 130 subjects in Japan. This suggests that the CCMQ could be a useful tool in comparing the constitution profiles between Chinese and Japanese.Constitution, CCMQ, Qi-deficiency type, Yang-deficiency type, reliability, validity

PurposeThe purpose of this study is to investigate the pharmacokinetics and deep tissue penetration capability of the newly developed S-flurbiprofen plaster (SFPP) in humans.MethodsStudy 1: SFPP tape-type patch (2–60 mg) was applied to the lower back for 24 h in healthy adult volunteers. S-flurbiprofen (SFP) plasma concentration was measured over time to examine SFP pharmacokinetics.Study 2: SFPP (20 mg) was applied for 12 h to the affected knee of osteoarthritis (OA) patients who were scheduled for total knee arthroplasty. Deep tissues (synovial tissue and synovial fluid) were collected during surgery to compare SFP concentrations after application of SFPP or a commercially available flurbiprofen (FP) gel-type patch.ResultsStudy 1: The plasma concentration of SFP was sustained during 24-h topical application of the SFPP, showing a high percutaneous absorption ratio of 51.4–72.2 %. Cmax and AUC0-∞ were dose-proportional.Study 2: After application of the SFPP for 12 h, SFP concentrations in the synovial tissue and synovial fluid were 14.8-fold (p = 0.002) and 32.7-fold (p < 0.001) higher, respectively, than those achieved by the FP patch.ConclusionsSustained plasma concentration of SFP and high percutaneous absorption ratio was observed after 24-h topical application of the SFPP. Compared to the FP patch, the SFPP showed superior percutaneous absorption and greater tissue penetration of SFP into the synovial tissue. Greater tissue penetration of the SFPP seemed to be primarily due to its formulation. Thus, SFPP is expected to show higher efficacy for the treatment of knee OA.Electronic supplementary materialThe online version of this article (doi:10.1007/s00228-015-1960-6) contains supplementary material, which is available to authorized users.

Ayurvedic oil-dripping treatment, Shirodhara, involves the use of medicated herbal sesame oils. In our previous reports, we found that Shirodhara with plain sesame oil induced anxiolysis and an altered state of consciousness (ASC) in healthy subjects. We studied the pharmaco-physio-psychologic effect of Shirodhara with medicated sesame oil including an essential oil from Lavendula angustifolia (lavender) in the present study. Sixteen (16) healthy females (38 +/- 8 years old) were assigned at random to three treatments applied by a robotic oil-dripping system: plain sesame oil (plain Shirodhara), medicated sesame oil with a 0.3 volume % of lavender essential oil (lavender Shirodhara), or the control supine position. Psychophysiologic parameters including the heart rate, skin temperature of the dorsum of hands and feet, as well as anxiety and ASC were monitored, and the rates of change of these items were calculated to assess the psychophysiologic changes brought about by Shirodhara. Lavender Shirodhara showed potent anxiolytic and ASC-inducing or promoting effects, and induced the largest increase in foot skin temperature. The correlation between anxiolysis and ASC, as well as the correlation between these psychologic effects and the elevated foot skin temperature were larger in the lavender Shirodhara than in the other two conditions. It was speculated that the psycho-physiologic effects of lavender Shirodhara would be brought about by three mechanisms: (1) the well-known relaxing action of essential oils from L. angustifolia mediated by olfactory nerves, (2) the pharmacologic action of substances absorbed through the skin or mucosa in the sesame oil or lavender essential oil, and (3) the physiologic effect of sesame oil dripped on the forehead induced by the somato-autonomic reflex through thermosensors or pressure sensors in the skin or hair follicles via the trigeminal cranial nerve. The complicated pharmaco-physio-psychologic action of Ayurvedic oil treatment may provide a useful model for future pharmaco-physio-psychotherapy.