A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial

Objective: xerostomia is a very common problem in the general population. The objective of this study was to determine the efficacy of a new gel and toothpaste in patients with xerostomia, analyze the role of salivary cytokines as biomarkers of xerostomia and assess the possible changes in salivary cytokines following treatment. Materials and methods: A randomized, controlled double-blind clinical study was carried out in 73 patients with xerostomia divided into two groups: placebo and active treatment (cymenol; tocopheryl acetate; D-panthenol; Aloe barbadensis; citrate tribasic dihydrate; fluoride) with oral gel and toothpaste three times a day for four consecutive weeks. The Thomson Xerostomia Inventory was applied, with the assessment of oral quality of life (OHIP-14) at baseline and after four weeks of application of the product. Sialometry was also performed in both groups, with analysis of the IL-1b, IL-6, IL-8 and TNFa levels in saliva. Results: In the active treatment group, the xerostomia scores decreased significantly at the end of the study versus baseline, from 33.47 to 27.93 (p < 0.001). No significant decrease was recorded in the placebo group (34.5 to 32.75; p = 0.190). There were no adverse effects in either group. Regarding the saliva samples, the active treatment group showed significant differences in IL-6 concentration versus the control group (18.55 pg/mL (8–38.28) and 5.83 pg/mL (1.19–12.04), respectively; p = 0.002). No significant differences in salivary cytokines were observed in either the treatment group or the control group. Conclusions: The use of a new toothpaste and gel developed for patients with xerostomia proved effective, with greater symptom relief than in the placebo group. Further clinical studies involving longer time periods and larger samples are advisable in order to confirm the benefits of the described treatment.

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Effectiveness of an app for perinatal home visitation by nurses in preventing infant abuse in Japan

European Journal of Public Health ◽

10.1093/eurpub/ckaa166.904 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

A Isumi ◽

S Doi ◽

T Fujiwara

Keyword(s):

Public Health ◽

Treatment Group ◽

Child Maltreatment ◽

Active Treatment ◽

Intervention Study ◽

Home Visitation ◽

Active Treatment Group ◽

Health Centers ◽

Public Health Nurses ◽

Control Group

Abstract Background In Japan, public health nurses provide home visitation with pregnant women who are at high risk for child maltreatment, but its effectiveness in preventing child maltreatment has not been evaluated because contents and quality of home visitation vary from municipality to municipality. This study aims to evaluate whether the tablet app developed to standardize and assist perinatal home visitation by public health nurses is effective in preventing child maltreatment. Methods An intervention study was conducted in 2018 in Adachi City, Tokyo, Japan. Public health nurses at two public health centers used the tablet app when they support high-risk pregnant women through home visitation and interviews, while public health nurses at the other three public health centers provided support as in the past. Because two public health centers were different in usage of the app, the treatment group was further divided into two groups: active and inactive. As fatal abuse among infants, frequency of shaking and smothering was assessed as an outcome through a self-reported questionnaire at the 4-month health check, and compared between the active treatment group, inactive treatment group, and control group, using multiple logistic regression (N = 5,651). Results Prevalence of infant abuse was 0.82% in the active treatment group, 1.34% in the inactive treatment group, and 1.50% in the control group. When adjusted for parental demographics and parenting situations, mothers in the active treatment group were less likely to shake or smother their baby than those in the control group (Odds ratio: 0.51, p = 0.093). Conclusions It possibly suggests that the tablet app developed to assist perinatal home visitation by public health nurses was effective in preventing infant abuse. Key messages An intervention study was conducted at public health centers in Adachi City, Tokyo, Japan, using the tablet app developed to standardize and assist perinatal home visitation by public health nurses. The finding suggested that the tablet app may be effective in preventing shaking and smothering among 4-month old infants.

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A Web-Based Transdiagnostic Intervention for Affective and Mood Disorders: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/mental.8901 ◽

2018 ◽

Vol 5 (2) ◽

pp. e36 ◽

Cited By ~ 7

Author(s):

Bogdan Tudor Tulbure ◽

Andrei Rusu ◽

Florin Alin Sava ◽

Nastasia Sălăgean ◽

Todd J Farchione

Keyword(s):

Treatment Group ◽

Emotional Disorders ◽

Active Treatment ◽

Active Treatment Group ◽

Self Report ◽

Control Group ◽

Obsessive Compulsive ◽

Web Based ◽

Transdiagnostic Treatment

Background Research increasingly supports a transdiagnostic conceptualization of emotional disorders (ie applying the same underlying treatment principles across mental disorders, without tailoring the protocol to specific diagnoses), and many international researchers are currently investigating this issue. Objective The aim of this study was to evaluate the efficacy and acceptability of a Web-based transdiagnostic program using a sample of Romanian adults diagnosed with anxiety and/or depression. Methods Volunteer participants registered for the study and completed a series of online self-report measures. Participants who fulfilled basic inclusion criteria on these measures were contacted for a telephone diagnostic interview using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Axis I Disorders (SCID-I). Enrolled participants were randomized to either the active treatment group (N=69) or the wait-list control group (N=36) using a 2:1 ratio. The transdiagnostic treatment was based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al, 2011) that addresses common underlying mechanisms of anxiety and depression. Participants randomized to the active treatment condition received 10 weeks of Web-based treatment based on the UP. Throughout treatment, graduate students in clinical psychology provided guidance that consisted of asynchronous written communication on a secure Web platform. After the intervention, participants in both study conditions were invited to complete a set of self-report measures and a postintervention SCID-I interview conducted by a different team of graduate students blinded to participants’ group and diagnostic status. Six months later, participants in the active treatment group were invited to complete an online follow-up assessment. Results During the intervention, active treatment participants completed on average 19 homework assignments (SD 12.10), and we collected data from 79.0% (83/105) at postintervention and 51% (35/69) at follow-up for self-report measures. Postintervention SCID-I interviews were collected from 77.1% (81/105) participants. Relative to the wait-list control group, the transdiagnostic intervention yielded overall medium to large effect sizes for the primary outcome measures (within-group Hedges g=0.52-1.34 and between-group g=0.39-0.86), and also for anxiety sensitivity (g=0.80), symptom interference (g=0.48), and quality of life (g=0.38). Significant within-groups effects only were reported for the active treatment group on Panic Disorder Severity Scale-Self Report (PDSS-SR, g=0.58-0.65) and Yale-Brown Obsessive Compulsive Scale (Y-BOCS, g=0.52-0.58). Conclusions Insignificant between-group differences for the Y-BOCS and PDSS-SR could be explained by the small number of participants with the associated primary diagnostic (eg, only 3 participants with obsessive compulsive disorder) by the choice of outcome measure (PDSS-SR was not rated among the evidence-based measures) and by the fact that these disorders may be more difficult to treat. However, the overall results suggest that the transdiagnostic intervention tested in this study represents an effective treatment option that may prove easier to disseminate through the use of Web-based delivery systems. Trial Registration ClinicalTrials.gov CT02739607; https://clinicaltrials.gov/ct2/show/study/NCT02739607 (Archived by WebCite at http://www.webcitation.org/6yY1VeYIZ)

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Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

10.21203/rs.3.rs-57313/v1 ◽

2020 ◽

Author(s):

Susanne Lynge ◽

Kristina Boe Dissing ◽

Werner Vach ◽

Henrik Wulf Christensen ◽

Lise Hestbaek

Keyword(s):

Clinical Trial ◽

Treatment Group ◽

Side Effects ◽

Pain Intensity ◽

Active Treatment ◽

Spinal Manipulation ◽

Active Treatment Group ◽

Text Messages ◽

Control Group ◽

Fixed Sequence

Abstract BackgroundTo investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.MethodsDesign: A two-arm randomised superiority single-blinded clinical trial.Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. The number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.ResultsChiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7) and better global perceived effect (2.63 vs. 3.24, p<0.001, NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.Trial registrationClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916

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Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

10.21203/rs.3.rs-57313/v3 ◽

2020 ◽

Author(s):

Susanne Lynge ◽

Kristina Boe Dissing ◽

Werner Vach ◽

Henrik Wulf Christensen ◽

Lise Hestbaek

Keyword(s):

Treatment Group ◽

Side Effects ◽

Pain Intensity ◽

Active Treatment ◽

Spinal Manipulation ◽

Controlled Trial ◽

Active Treatment Group ◽

Text Messages ◽

Control Group ◽

Fixed Sequence

Abstract Background: To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches. Methods: Design: A two-arm , single - blind, superiority randomised superiority single-blinded clinical controlled trial. Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants : 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. The n N umber and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period. Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. Results: Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement ) and better global perceived effect ( dichotomized into improved/not improved, OR= 2.8 (95% CI: 1.5-5.3) 2.63 vs. 3.24 , p<0.001 , NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. Conclusions: Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.

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Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7–14 years - a randomised clinical trial

Chiropractic & Manual Therapies ◽

10.1186/s12998-020-00360-3 ◽

2021 ◽

Vol 29 (1) ◽

Author(s):

Susanne Lynge ◽

Kristina Boe Dissing ◽

Werner Vach ◽

Henrik Wulff Christensen ◽

Lise Hestbaek

Keyword(s):

Treatment Group ◽

Side Effects ◽

Pain Intensity ◽

Active Treatment ◽

Spinal Manipulation ◽

Controlled Trial ◽

Active Treatment Group ◽

Text Messages ◽

Control Group ◽

Fixed Sequence

Abstract Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7–14 with recurrent headaches. Methods Design: A two-arm, single-blind, superiority randomised controlled trial. Setting: One chiropractic clinic and one paediatric specialty practice in Denmark, November 2015 to August 2020. Participants: 199 children aged 7 to 14 years, with at least one episode of headache per week for the previous 6 months and at least one musculoskeletal dysfunction identified. Interventions: All participants received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group; the children in the control group received approximately eight visits during the treatment period. Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p = 0.019, NNT = 7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR = 2.8 (95% CI: 1.5–5.3), NNT = 5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches. Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered.

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MODIFIED METHOD FOR PURULONECROTIC FOOT FLEGMON TREATMENT

Ulyanovsk Medico-biological Journal ◽

10.34014/2227-1848-2020-2-80-89 ◽

2020 ◽

pp. 80-89

Author(s):

E.Kh. Akramov ◽

A.A. Beysembaev ◽

V.Kh. Gabitov ◽

S.K. Sulaymankulova ◽

Omurbek uulu Ulukmyrza ◽

...

Keyword(s):

Hydrogen Peroxide ◽

Treatment Group ◽

Limb Salvage ◽

Active Treatment ◽

Active Treatment Group ◽

Limb Amputation ◽

Control Group ◽

Kyrgyz Republic ◽

Scientific Center ◽

Modified Method

Every 30 seconds somewhere in the world there occurs a lower limb amputation in a patient with foot phlegmon. Antibacterial agents are the basis of systemic pharmacotherapy of surgical infections. However, such treatment is rather difficult as it is associated with the loss of antibiotic sensitivity. The purpose of the study is to determine the antibacterial effects of innovative hydrogen peroxide and nanosilver composition combined with chitosan lymphostimulation in foot phlegmon treatment for limb salvage. Materials and Methods. The work is based on the analysis of 46 patients’ treatment outcomes. All the patients suffered from purulent-necrotic foot phlegmons and were treated at the Scientific Center for Reconstructive Surgery, the Ministry of Health of the Kyrgyz Republic and Chuy Regional Combined Hospital. The patients were divided into 2 groups: control group (n=22) – conventional treatments, and active treatment group (n=24) – additional administration of bactericidal-lymphotropic cocktail. The groups were comparable in sex, age, and soft tissue involvement. Results. In patients of active treatment group wound cleansing from wound detritus was observed in 5 days, while in patients undergoing conventional treatment it was detected only in 9 days. In the active treatment group, the granulation time was 1.8 times faster, and the normalization of the leukocyte intoxication index was 2.5 times earlier. The dynamics of the level of medium-weight molecules indicated that lymphostimulation accelerated the interstitium detoxification process in the affected limb by 3 times. Conclusion. The proposed modified method for foot phlegmon treatment with bactericidal-lymphostimulating technologies accelerates tissue regeneration and contributes to limb salvage. Keywords: foot phlegmon, hydrogen peroxide, nanosilver, chitosan. Каждые 30 с в мире пациенту с флегмоной стопы производится ампутация нижней конечности. Основу системной фармакотерапии хирургических инфекций составляют антибактериальные средства, но лечение представляет существенные трудности, связанные с потерей чувствительности к антибиотикам. Цель исследования. Определить эффективность применения инновационной антибактериальной композиции перекиси водорода с наносеребром в комплексе с лимфостимуляцией хитозаном при лечении флегмон стопы в целях сохранения конечности. Материалы и методы. Работа основана на анализе результатов лечения 46 больных с гнойно-некротическими флегмонами стопы, находившихся на лечении в Научном центре реконструктивно-восстановительной хирургии МЗ КР и Чуйской областной объединенной больнице. Все больные, разделенные на 2 группы (контрольная (n=22) – традиционное лечение; основная (n=24) – дополнительное применение бактерицидно-лимфотропного коктейля), были сопоставимы по характеру поражения мягких тканей, полу и возрасту. Результаты. Очищение ран от раневого детрита в основной группе наступало через 5 сут, тогда как при традиционном лечении – только через 9 дней. Появление грануляций в основной группе происходило в 1,8 раза быстрее, нормализация лейкоцитарного индекса интоксикации – в 2,5 раза раньше. Динамика уровня молекул средней массы свидетельствовала о том, что лимфостимуляция ускоряет процесс детоксикации интерстиция региона пораженной конечности в 3 раза. Выводы. Применение предложенного модифицированного способа при лечении флегмон стопы с использованием бактерицидно-лимфостимулирующих технологий ускоряет регенерацию региона и создает условия для сохранения конечности. Ключевые слова: флегмона стопы, перекись водорода, наносеребро, хитозан.

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The Efficacy of Fibrinolytic Enhancement with Stanozolol in the Treatment of Venous Insufficiency

Phlebology The Journal of Venous Disease ◽

10.1177/026835559100600406 ◽

1991 ◽

Vol 6 (4) ◽

pp. 233-239 ◽

Cited By ~ 5

Author(s):

G.M. McMullin ◽

G.T. Watkin ◽

P.D. Coleridge Smith ◽

J.H. Scurr

Keyword(s):

Treatment Group ◽

Confidence Interval ◽

Active Treatment ◽

Oxygen Diffusion ◽

Venous Insufficiency ◽

Active Treatment Group ◽

Control Group ◽

Double Blind ◽

Transcutaneous Oxygen ◽

Reduction In Area

Pericapillary fibrin cuffs have been demonstrated in patients with chronic venous insufficiency. It has been suggested that this fibrin deposition is responsible for an oxygen diffusion block, leading to local hypoxia and resulting in ulceration. Fibrinolysis is depressed in patients with venous insufficiency and therefore pharmacological enhancement of this factor might be expected to produce clinical improvement. A total of 60 patients with lipodermatosclerosis were entered into a prospective, double-blind, placebo-controlled, randomized trial. Stanozolol 5 mg or a placebo tablet was given twice daily for a period of 6 months. All patients were supplied with below knee German/Swiss specification class 2 compression stockings. The area of lipodermatosclerosis was measured at monthly intervals and transcutaneous oxygen tension within the liposclerotic area was measured at 3-monthly intervals. The control group showed a mean reduction in area of lipodermatosclerosis of 14% (95% confidence interval −2.6%−31%) compared with a 28% reduction in area in the active treatment group (95% confidence interval 5.3%–46%; P < 0.007). Transcutaneous oxygen measurements showed no change in either group. Side-effects were significantly more common in the active treatment group ( P < 0.002 χ2). Though fibrinolytic enhancement caused a reduction in the area of lipodermatosclerosis, no evidence of any effect on a possible oxygen diffusion block was demonstrated.

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Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

10.21203/rs.3.rs-57313/v2 ◽

2020 ◽

Author(s):

Susanne Lynge ◽

Kristina Boe Dissing ◽

Werner Vach ◽

Henrik Wulf Christensen ◽

Lise Hestbaek

Keyword(s):

Treatment Group ◽

Side Effects ◽

Pain Intensity ◽

Active Treatment ◽

Spinal Manipulation ◽

Controlled Trial ◽

Active Treatment Group ◽

Text Messages ◽

Control Group ◽

Fixed Sequence

Abstract Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.Methods Design: A two-arm, single-blind, superiority randomised controlled trial.Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR=2.8 (95% CI: 1.5-5.3), NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916

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Reduction of Pressure Pain Sensitivity as Novel Non-pharmacological Therapeutic Approach to Type 2 Diabetes: A Randomized Trial

Frontiers in Neuroscience ◽

10.3389/fnins.2021.613858 ◽

2021 ◽

Vol 15 ◽

Author(s):

Jens Faber ◽

Ebbe Eldrup ◽

Christian Selmer ◽

Caroline Pichat ◽

Sofie Korsgaard Hecquet ◽

...

Keyword(s):

Type 2 Diabetes ◽

Nervous System ◽

Treatment Group ◽

Glucose Metabolism ◽

Active Treatment ◽

Pain Sensitivity ◽

Active Treatment Group ◽

Control Group ◽

Pressure Pain

BackgroundAutonomic nervous system dysfunction (ANSD) is known to affect glucose metabolism in the mammalian body. Tradition holds that glucose homeostasis is regulated by the peripheral nervous system, and contemporary therapeutic intervention reflects this convention.ObjectivesThe present study tested the role of cerebral regulation of ANSD as consequence of novel understanding of glucose metabolism and treatment target in type 2 diabetes (T2D), suggested by the claim that the pressure pain sensitivity (PPS) of the chest bone periosteum may be a measure of cerebral ANSD.DesignIn a randomized controlled trial of 144 patients with T2D, we tested the claim that 6 months of this treatment would reduce PPS and improve peripheral glucose metabolism.ResultsIn the active treatment group, mean glycated hemoglobin A1c (HbA1c) declined from 53.8 to 50.5 mmol/mol (intragroup p = 0.001), compared with the change from 53.8 to 53.4 mmol/mol in the control group, with the same level of diabetes treatment but not receiving the active treatment (between group p = 0.036). Mean PPS declined from 76.6 to 56.1 units (p < 0.001) in the active treatment group and from 77.5 to 72.8 units (p = 0.02; between group p < 0.001) in the control group. Changes of PPS and HbA1c were correlated (r = 0.37; p < 0.001).ConclusionWe conclude that the proposed approach to treatment of T2D is a potential supplement to conventional therapy.Clinical Trial Registration:www.clinicaltrials.gov (NCT 03576430).

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