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Intervention | chronic pain, pain | CHRONIC PAIN | A novel application of VR for chronic pain management (Reducept) was used with an Oculus Go (Facebook Technologies, LLC) head-mounted display. This therapeutic application, still investigational, was designed in cocreation with patients, psychologists, educationalists, and software developers. It is based on the biopsychosocial model of pain, which describes the pain as the result of a combination of physical, psychological, and social factors. | PMC10205123 |
Study Procedures | pain | ADVERSE EVENTS | The treating physician (J.W.K.; anaesthesiologist and pain physician) identified eligible patients, provided verbal and written information, and subsequently obtained written informed consent. Patients were randomly assigned (1:1) to the VR or control group using computer-generated block randomization. Randomization was performed by the research staff, the treating physician was blinded for allocation at the moment of inclusion.All patients were approached by the research staff and asked to fill out questionnaires at baseline, at the end of treatment at 4 weeks, and at 4 months follow-up. Furthermore, patient characteristics were obtained at baseline for analysis of associations with VR effectiveness. Patients were asked to keep a diary of daily pain scores and analgesic use during the intervention period. On days 7 and 14, telephone interviews were carried out to monitor adherence, adverse events, and technical problems. The research staff was around the clock available for questions by telephone. | PMC10205123 |
Outcome Measures | CHRONIC PAIN | Outcome measures were chosen according to the core outcome measures for chronic pain as recommended in the IMMPACT guidelines. | PMC10205123 | |
Primary Outcome | The primary outcome was quality of life measured by the short form-12 (SF-12) at 4 weeks. | PMC10205123 | ||
Secondary Outcomes | Pain, pain | Secondary outcomes were SF-12 at 4 months, daily pain scores and analgesics use, and the questionnaires at 4 weeks and 4 months as described. Another outcome was feasibility in terms of acceptability, usability, and tolerability.Pain scores comprised pain scores (0 to 100 mm) on “worst pain experienced today” and “least pain experienced today” (0 = no pain, 10 = extreme pain), an 11-point visual analog scale (VAS) measuring the percentage of time having experienced severe pain (0% = none of the time, 100% = all the time), and an 11-point Likert scale measuring, to which extent pain has prevented the patient from moving in bed, taking a deep breath or coughing, and sleeping (0 = no influence, 10 = completely prevented).The Pain Catastrophizing Scale and the pain coping and cognition list were used to evaluate pain catastrophizing and pain coping strategies. | PMC10205123 | |
Feasibility | ADVERSE EVENT | Discontinuation of VR was registered as an acceptability outcome, together with reasons for withdrawal. Adherence was monitored through weekly telephone interviews. Adverse events were registered as a tolerability outcome through open-ended questions during the weekly telephone calls. | PMC10205123 | |
Statistical Analyses | Pain | ADVERSE EVENTS, SECONDARY | All analyses were done using IBM SPSS Statistics 25. Outcomes were analyzed following the intention-to-treat principle. Descriptive statistics were used for presenting baseline data, adverse events, and feasibility outcomes.For primary efficacy analyses, linear mixed models were used to analyze the effectiveness of the VR intervention at 4 weeks, with “treatment,” “time,” and “treatment time” as fixed effects. A within-person correlation was accounted for by using a repeated measure design. Baseline values were incorporated as a covariate. Possible other covariates were added on a rational basis and only retained when having a significant effect on the model. The best-fitting covariance structure was determined using likelihood ratio tests. Maximum likelihood estimation was used to be able to perform these likelihood ratio tests. For the final model, the restricted maximum likelihood was used, since this is recommended for smaller sample sizes. Residuals were checked for normality. An alpha of 0.05 was considered significant.All time points (postintervention at 4 wk and follow-up at 4 mo) were included in a linear mixed models analysis with repeated measure design. If a significant difference was detected, a pairwise comparison per time point was performed. Pain scores were analyzed using linear mixed models following the same methods. Other secondary outcomes were analyzed using descriptive statistics. When possible differences were observed, delta scores between baseline and at 4 weeks were assessed using | PMC10205123 |
RESULTS | pain | SECONDARY | A total of 207 patients were assessed for eligibility and 41 patients were included between January 2020 and January 2021 (Fig. Study flowchart. TENS indicates transcutaneous electrical nerve stimulation.Patient CharacteristicsISCED 0-1: early childhood to primary education.ISCED 2: lower secondary.ISCED 3-4: upper secondary to postsecondary nontertiary education.ISCED 5-7: short-cycle tertiary education, bachelor's, master's, or equivalent level.ISCED indicates International Standard Classification of Education; VR, virtual reality.In the VR group, 1 patient received pulsed radiofrequency stimulation and 2 patients received a transcutaneous electrical nerve stimulator within the 4-week intervention period. No patients in the control group received advanced pain treatment during the intervention period. Eleven patients in the VR group and 8 patients in the control group received advanced pain treatment between the end of the VR intervention at 4 weeks and 4 months follow-up (Fig. | PMC10205123 |
Primary Outcome | Physical and mental scores of the SF-12 are shown in Figure SF-12 physical (A) and mental (B) scores, mean and SD. SF-12 indicates short form-12.EMMs (95% CIs) of SF-12 Physical and SF-12 Mental at 4 Weeks and 4 MonthsEMM indicates estimated marginal mean; SF-12, short form-12; VR, virtual reality.No significant main treatment effect was found between groups over time for the SF-12 physical subscale ( | PMC10205123 | ||
Secondary Outcomes | pain | A significant main treatment effect of VR was seen on the daily worst experienced pain score (Mean and standard error of the mean of daily worst VAS pain score (A) and daily least VAS pain score (B) during the intervention period. In the intervention group, data were missing for 1 patient from day 8, for 1 patient from day 12, for 1 patient from day 13, for 2 patients from day 25, for 1 patient from day 26, and for 1 patient from day 27. VAS indicates visual analog scale.Number (%) of Participants Reported Have Used Analgesics at Least Once in Week 1 and in Week 4NSAID indicates nonsteroidal anti-inflammatory drug. | PMC10205123 | |
Feasibility | dizziness | ADVERSE EVENTS | Three out of 20 (15%) patients in the VR group reported mild and temporary symptoms of dizziness. No patients discontinued the intervention because of adverse events. During the weekly telephone calls, 1 patient reported not being motivated to adhere to the study protocol, 3 patients reported to have missed 2 out of 7 sessions per week, and 4 patients reported to have missed 1 session per week. | PMC10205123 |
DISCUSSION | PMC10205123 | |||
Main Findings | opioid dependence, low back pain, anxiety, chronic pain, pain, depression, disability, coronavirus disease 2019 | CHRONIC PAIN, COMPLEX REGIONAL PAIN SYNDROME, CORONAVIRUS DISEASE 2019, COMPLICATIONS | We did not find an effect of 4 weeks of VR behavioral therapy-based pain management and education intervention on the physical and mental function of patients with nonspecific CLBP referred to a pain clinic. VR seemed to positively affect daily worst and least experienced pain. Opioid use in the VR group was halved. VR was associated with good treatment adherence and minimal and mild side effects.The limited benefit of VR may be explained by the application itself, patient expectations, a mismatch between the design and evaluation of the VR application, and the execution of the study during the coronavirus disease 2019 (COVID-19) pandemic. This was the first properly designed comparative pilot study wherein this VR application was evaluated for an effect on patient-reported health-related quality of life, mental and physical function, and pain and disability outcomes. Despite a rigorous design together with stakeholders, the application might not yet fully match the needs of patients with CLBP who failed initial physical and pharmacological therapy. The outcomes in the VR group may have been affected by the patient’s expectations for benefit of the VR treatment considering the follow-up treatment they were waitlisted for. Patients with CLBP with a high expectation of improvement are 2.4 times more likely to report improvement in functional limitations, pain intensity, and work participation.Patients in our study had on average 4 to 5 years CLBP with pain scores more than 4 at inclusion, and 40% used opioids. A longer duration of low back pain has been associated with a less favorable prognosis in a meta-analysis with an average baseline pain duration varying from 6 to 12 weeks in the trials.We enrolled patients during the COVID-19 pandemic. It is unknown how the COVID pandemic has impacted the results of this study. Both increased and decreased pain, anxiety, and depression have been described in chronic pain patients.An interesting observation in this study is the reduction in opioid use. This reduction was by patient choice and has not been shown in previous studies with behavioral therapy-based VR for CLBP. Confirmation of this observation in larger well-powered studies could have large implications for clinical practice, reducing the need for opioids significantly and thus reducing opioid dependence, including its complications, and health care costs.Garcia et alComparing our study findings with other VR studies in chronic pain has limited value due to other than CLBP patients included, for example, with complex regional pain syndrome, | PMC10205123 |
Strengths and Limitations | chronic pain, pain | CHRONIC PAIN | This study has several strengths and limitations. This practice-based study was conducted in accordance with the IMMPACT guidelines, which are strongly recommended for chronic pain research.When compared with standard CBT, the total amount of VR treatment of <5 hours in 4 weeks is rather low. Behavioral therapy is given for a minimum of 6 weeks for 6 to 10 hours in total and is proven to be more effective on pain intensity when used even longer.It is known from a network meta-analysis of psychotherapy studies that a waiting list setting can induce a nocebo effect with larger effect sizes of treatment compared with no treatment groups outside this setting. | PMC10205123 |
Clinical Implications and Recommendations | chronic pain, pain | CHRONIC PAIN, MINOR, ADVERSE EFFECTS | A CBT-based VR intervention might offer a valuable contribution to the multidisciplinary biopsychosocial treatment of CLBP and possibly other chronic pain conditions. This study illustrates that VR pain treatment can be brought close to the patient’s personal environment allowing them to access the treatment at a time and place of their choice. This VR intervention might serve as a tool to narrow the “know-do” gap and help therapists and physicians to apply the psychosocial components of CLBP treatment. VR has the potential to enhance treatment effects through emotional engagement, sense of presence, and personal experiences and might, therefore, have added value over other home-based behavioral therapies.We hypothesize that the extension of the session and total duration of the intervention while avoiding repetitiveness, could contribute to the success of this VR application. Further intensifying VR use seems possible considering the low rate of minor adverse effects in the current study. Based on the results of this study, no claims can be made about the cost-effectiveness of this VR intervention. Establishing the cost-effectiveness of treatment for chronic pain proves very complex due to the multiple domains of life that chronic pain affects. | PMC10205123 |
CONCLUSION | pain | We conclude that 4 weeks of a novel self-administered behavioral therapy-based VR program for CLBP does not seem to improve quality of life, but is well tolerated and may positively affect daily pain experience. | PMC10205123 | |
Supplementary Material | PMC10205123 | |||
ACKNOWLEDGMENTS | The authors thank Petra Koopmans, PhD, Radboud University Medical Center, Department of Health Evidence, Section Biostatistics, biostatistician, for her support and review of the statistical analyses.The trial was registered at ClinicalTrials.gov (NCT04042090).This work was supported by the European Regional Development Fund (ERDF) [PROJ-00840, 2018]. The authors declare no conflict of interest.Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal’s | PMC10205123 | ||
REFERENCES | PMC10205123 | |||
Keywords | HEART | Spinal anesthesia induces sympatholysis and is usually combined with dexmedetomidine or propofol which induce different hemodynamic changes. The purpose of this study was to compare the effect on autonomic nervous system between dexmedetomidine and propofol combined with spinal anesthesia. Patients aged 20–65 undergoing elective surgery under spinal anesthesia were randomly assigned to dexmedetomidine or propofol group. Heart rate variability (HRV) and hemodynamic variables were measured at four time points: T0, baseline; T1, 10 min after spinal anesthesia; T2, 10 min after sedative administration; and T3, 20 min after sedative administration. In 59 patients, dexmedetomidine and propofol groups had significantly different hemodynamic changes over time (time × group effect P < 0.001). The dexmedetomidine group had slower heart rate at T2 (P = 0.001) and higher blood pressures at T2 and T3 (P < 0.001) than the propofol group. Overall HRV dynamics showed a significant change over time from T0 to T3, but both groups exhibited similar trends. Compared to the baseline data within the group, the low frequency (LF) decreased in both groups but the decrease occurred at T2 in the propofol group and at T3 in the dexmedetomidine group. The high frequency (HF) increased at T2 and T3 only in the dexmedetomidine group. The LF/HF ratio decreased in the dexmedetomidine group at T3. Dexmedetomidine showed slower heart rate and higher blood pressure than propofol when combined with spinal anesthesia, however, dexmedetomidine and propofol exhibited similar trends in HRV dynamics. Compared with the baseline within each group, both agents decreased LF, but only dexmedetomidine increased HF and decreased in the LF/HF ratio significantly. | PMC10651711 | |
Introduction | bradycardia, hypotension | Spinal anesthesia causes iatrogenic central sympatholysis by blocking the pre-ganglionic sympathetic fibers and cardiac sympathetic innervation. This iatrogenic sympathetic blockage causes hypotension and bradycardia, which occasionally require clinical intervention [In clinical practice, spinal anesthesia is usually combined with sedation, mainly using propofol or dexmedetomidine. In addition to spinal anesthesia, propofol and dexmedetomidine induce hemodynamic changes and alter the autonomic nervous system. Previous studies have reported that propofol induces bradycardia and hypotension [Spinal anesthesia is known to reduce sympathetic activity, and sometimes requires clinical intervention. Since dexmedetomidine and propofol have been shown to induce different hemodynamic changes, we hypothesized that they would also cause different changes in the autonomic nervous system additional to the effect of spinal anesthesia. Such information could be valuable in selecting a sedative for use in spinal anesthesia. The present preliminary study aimed to compare the differences in HRV dynamic during sedation with propofol or dexmedetomidine in patients who underwent spinal anesthesia. | PMC10651711 | |
Materials and methods | This study was approved by the Ajou Institutional Review Board on October 29, 2019 (AJIRB-MED-INT-19-350) and the Clinical Trial registration was done prior to the enrollment of the first patient ( | PMC10651711 | ||
Measurement of HRV | STARE, PHYSICAL STRESS | HRV was measured using an SA-3000P (Medicore Co., Ltd. Hanam, Gyeonggi-Do, Korea). Baseline HRV was measured on the morning of the day before surgery in a quiet room in the ward. The patient rested for 5 min before the measurement, and electrocardiogram (EKG) leads were applied. During the measurement, conversation was prohibited, and the patients were asked to open their eyes and stare at an empty wall in a supine position. Subsequent to the baseline measurement, three measurements were performed as follows: T1, 10 min after spinal anesthesia; T2, 10 min after the start of sedative administration; and T3, 20 min after the start of sedative administration. All measurements were conducted by collecting data for at least 3 min and while patients were in a supine position.The collected HRV parameters were calculated automatically by the SA-3000P as follows:
Time domain and complexity parameters.SDNN: standard deviation of the NN intervalRMS-SD: square root of the mean of the sum of the squares of the differences between adjacent NN interval
PSI: physical stress index or pressure indexApEn: approximate entropySRD: successive RR interval difference
Frequency domain parameters.Total powerVLF: very low frequency, 0.003–0.004 HzLF: low frequency, 0.04–0.15 HzHF: high frequency, 0.15–0.4 HzLF Norm (n.u.): Normalized LF = LF / LF + HFHF Norm (n.u.): Normalized HF = LF / LF + HFLF/HF ratio: low frequency / high frequency | PMC10651711 | |
Anesthesia | bradycardia, hypotension | Patients entered the operating room with no premedication. Standard monitoring of pulse oximetry, EKG, noninvasive blood pressure (BP), and bispectral index (BIS, Medtronic, Minneapolis, MN, USA) was performed. After measuring baseline hemodynamics, 5 L/min of oxygen was administered using a facial mask. The patient was placed in a lateral position with the operating leg facing down, and spinal anesthesia was administered at the lumbar 3/4 or 4/5 level with a 25G spinal needle. Hyperbaric bupivacaine (0.5%) was administered differentially according to the patient’s height with the aim of achieving an anesthesia level of T 10. Ten minutes after the induction of spinal anesthesia, the anesthesia level was checked using an alcohol swab. Hemodynamic parameters and T1 HRV were then measured.Thereafter, dexmedetomidine or propofol sedation was initiated according to group assignment. In the dexmedetomidine group, 0.6 mcg/kg was loaded for the first 10 min, followed by infusion at 0.5 mcg/kg/h. In the propofol group, the effect-site concentration of 0.3–1.0 ng/mL was adjusted using a target concentration infusion to maintain the BIS at 60–80. In both groups, T2 and T3 HRV were measured at 10 and 20 min, respectively, from the initial sedative administration. In cases of bradycardia (heart rate < 50 beats/min), atropine (0.5 mg) was administered, and ephedrine (8 mg) was administered for hypotension (systolic blood pressure < 90 mmHg). | PMC10651711 | |
Statistical analysis | All statistical analyses were performed using SPSS (version 26.0; IBM Corp., Armonk, NY, USA). For continuous data, normality was assessed using the Shapiro–Wilk test, and the independent | PMC10651711 | ||
Results | PMC10651711 | |||
Demography | Sixty patients completed the study (Fig.
Flow diagram
Patient characteristics and intraoperative dataValues are mean ± standard deviation and number (%)D group, dexmedetomidine group; P group, propofol group | PMC10651711 | ||
High baseline LF/HF ratio vs. low baseline LF/HF ratio | hypotension | A previous study reported that an preoperative LF/HF ratio > 2.3 was correlated with post-spinal anesthesia hypotension [ | PMC10651711 | |
All patients | Of the 59 patients, 45 were in the low LF/HF ratio group and 14 were in the high LF/HF ratio group. Vasoactive drugs were required in 10 patients (22.2%) in the low LF/HF ratio group and in five patients (35.7%) in the high LF/HF ratio group, and it was not statistically significant (P = 0.483). The hemodynamic data showed no significant differences between the two groups (Table
Subgroup analysis according to LF/HF ratio: Hemodynamic dataLow ratio(n = 24)High ratio(n = 6)Low ratio(n = 21)High ratio(n = 8)Values are median [interquartile range]Low ratio, LF/HF ratio ≤ 2.3; high ratio, LF/HF ratio > 2.3D group, dexmedetomidine group; P group, propofol groupHR, heart rate; SBP, systolic blood pressure; MBP, mean blood pressure; DBP, diastolic blood pressureT0, baseline; T1, 10 min after spinal anesthesia; T2, 10 min after sedation; T3, 20 min after sedation | PMC10651711 | ||
Dexmedetomidine group | Of the patients in the dexmedetomidine group, six were in the high LF/HF ratio group and 24 were in the low LF/HF group. Vasoactive drugs were required in two patients (33.3%) in the high LF/HF ratio group and in six patients (25.0%) in the low LF/HF ratio group. However, this difference was not statistically significant. The hemodynamic data showed no differences between the two groups (Table | PMC10651711 | ||
Propofol group | Of the patients in the propofol group, eight were assigned to the high LF/HF ratio group and 21 to the low LF/HF ratio group. Vasoactive drugs were required in three patients (37.5%) in the high LF/HF ratio group and in four patients (19.0%) in the low LF/HF ratio group. Although the difference was not statistically significant, the proportion of patients requiring vasoactive drugs in the high LF/HF group was approximately twice that of those in the low LF/HF group. This difference was larger than that between the low and high LF/HF groups in the dexmedetomidine group. In the hemodynamic data, none of the parameters showed a significant time × group effect (Table | PMC10651711 | ||
Discussion | Bradycardia, bradycardia, iatrogenic sympathetic block, hypotension, hypotensive | HYPOTENSIVE | This randomized controlled trial showed that HRV dynamics changed through spinal anesthesia and sedation, however, dexmedetomidine and propofol exhibited similar trends in HRV dynamics. Although dexmedetomidine and propofol did not result any significant difference in the HRV dynamic, the difference in hemodynamic change was obvious between the two groups. Dexmedetomidine induced more bradycardic and less hypotensive in hemodynamic changes compared to propofol. In intragroup analysis compared to each group’s baseline, the two sedatives showed distinctive features. Both sedatives decreased sympathetic activity, but dexmedetomidine did so at a later time, and only dexmedetomidine increased the parasympathetic activity. The LF/HF ratio was decreased only in dexmedetomidine.Spinal anesthesia has known to cause an iatrogenic sympathetic block, which leads to hypotension and bradycardia, requiring intervention. However, our data showed that spinal anesthesia itself had no effect on HRV dynamics. In this study, HRV data measured at T1 (10 min after spinal anesthesia) could be considered as the pure effect of spinal anesthesia, because it was measured prior to sedative administration, and the HRV data at T1 showed no statistically significant change compared to that at T0. A study by Hidaka et al. [Although no statistically significant difference was noted in the overall HRV dynamics between dexmedetomidine and propofol, we found variation in the patterns of HRV dynamics. Intragroup analysis of each group showed that LF, which represents sympathetic heart rate modulation, decreased with both sedatives, compared to that at baseline. In contrast, HF, which represents parasympathetic heart rate modulation, increased only with dexmedetomidine, compared to that at baseline (Fig. Another hypothesis could explain the increase in HF power with only dexmedetomidine. This may be related to the timing of HRV measurement. Tarvainen et al. [In this study, dexmedetomidine showed favorable hemodynamics compared with propofol in patients who underwent spinal anesthesia. Dexmedetomidine showed a delayed decrease in sympathetic activity compared with propofol (T3 in the dexmedetomidine group and T2 in the propofol group). If sympathetic activity correlates well with BP, it can provide useful information for cardiovascular high-risk patients. By adjusting the initiation timing of sedative administration, it is possible to achieve more favorable results for BP maintenance in high-risk patients under spinal anesthesia.In the second analysis, we examined whether the LF/HF ratio predicted spinal anesthesia-induced hypotension, as reported in previous studies [It is assumed that the prediction of hypotension using the LF/HF ratio cannot be applied to all anesthetics. Most of the anesthetics decreased the sympathetic heart rate modulation, but for the parasympathetic heart rate modulation, the change pattern varied (increased or decreased), and the degree of the decrease differed depending on the agent. Previous studies have shown that various anesthetics induce dynamic changes in HRV. With sevoflurane, LF decreased with a reduction in the BIS value, but HF decreased after induction, and no further decreases were observed despite the reduction in the BIS value [The current study, as a preliminary observational study, showed how the autonomic nervous system is altered under spinal anesthesia and sedation. The results of this study have the potential to be used as a reference in various fields. For example, a delayed decrease in sympathetic activity induced by dexmedetomidine could help determine the timing of sedation during spinal anesthesia. But at the same time, care must be taken when judging and applying the results from HRV measurement. This study showed that sympathetic activity and BP are not always correlated, as other compound factors such as peripheral vasoconstriction may play a role. Bradycardia is caused not only by an increase in parasympathetic tone but also by sympathetic withdrawal or sympathetic-parasympathetic interaction. HRV detects only information from the heart-brain interactions, interference from other components is not detected. Interpreting LF and HF component of HRV as sympathetic and parasympathetic tone is oversimplified and could lead to a wrong conclusion [This study had a few limitations. First, the individual variations in HRV values were larger than the sample size. In previous study, the challenges of conducting research due to inter-individual variation have been mentioned [ | PMC10651711 |
Authors’ contributions | IKY conceptualized the study. HBJ, YJC, and SHS performed data curation. HBJ, YJC, and IKY investigated references. YJC devised the research methodology. SHS performed visualization of the results. HBJ wrote original draft and IKY reviewed and edited. All authors reviewed the manuscript. | PMC10651711 | ||
Funding | None. | PMC10651711 | ||
Declarations | PMC10651711 | |||
Ethics approval and consent to participate | This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ajou Institutional Review Board on October 29, 2019 (AJIRB-MED-INT-19-350). | PMC10651711 | ||
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC10651711 | ||
Competing interests | The authors have no relevant financial or non-financial interests to disclose. | PMC10651711 | ||
References | PMC10651711 | |||
Keywords | Acne vulgaris | ACNE VULGARIS | Acne vulgaris is challenging to treat for several individuals. Laser therapy may be a desirable alternative to traditional therapies with limited success. This study aimed to assess efficacy of fractional COOpen access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10435603 |
Introduction | Acne vulgaris, acne | SCARRING, ACNE VULGARIS, ACNE, ACNE VULGARIS | Acne vulgaris is one of the main reasons for dermatological consultation with substantial physical and psychosocial burden [Numerous laser devices were proven successful in acne therapy, as they provide an efficient treatment of acne with a short recovery period and fewer drawbacks, notably the Nd:YAG laser, which has been documented with several studies [The mechanism of action of 1064-nm Nd:YAG laser relies on its action on the vascular element of inflammatory acne together with the alteration of cytokine release. While the improvement of non-inflammatory lesions can be attributed to the thermal damage to sebaceous glands causing sebum reduction [Fractional CO2 laser has been established as one of the best options of acne scarring therapy. Although, it can be hypothesized that fractional CO2 ablative laser can be a proper modality for inflammatory acne vulgaris, based on its effects on the various mechanisms of acne production [As, fractional COThere is limited evidence and few studies about benefits of fractional CO2 lasers for treating inflammatory acne. Consequently, the current trial aimed to asses efficacy and safety of fractional CO | PMC10435603 |
Material and methods | nodulocystic acne, hypertrophic scars, keloids, malignancy, infection, comedonal acne, acne, Acne, dermatitis | SYSTEMIC DISEASE, NODULOCYSTIC ACNE, HERPES INFECTION, INFECTION, ACNE, ACNE, DERMATITIS, PHOTOSENSITIVITY | This prospective randomized split-face comparative study was conducted with 30 patients with acne vulgaris. Patients were selected from the attendants of the Dermatology Outpatient Clinic of Al Zahraa University Hospital, Cairo, Egypt.The study was performed over a period from July 2021 to September 2022. The study was approved by the Research Ethics Committee of Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt with approval code (2021121145) and following the Helsinki Declaration. Written informed consent was obtained from all participating patients.Inclusion criteria included adult patients > 18 years old experiencing mild to severe acne according to the Global Acne Severity Scale (GEA Scale) [Exclusion criteria included age below 18, pregnancy or lactation, systemic diseases, a background of hypertrophic scars or keloids, photosensitivity, history of herpes infection, active infection, dermatitis, malignancy over the treatment area, hormone replacement therapy, patients taking contraceptive pills, topical acne therapies or systemic antibacterial agents 30 days preceding the study, or oral retinoid 6 months prior to enrollment; additionally, individuals with mild comedonal acne or nodulocystic acne were excluded from the trial.All patients provided a thorough medical history and had a comprehensive general and dermatological assessment and pretreatment photographs. Subjective clinical assessment, lesions counting [ | PMC10435603 |
Treatment sessions | INFLAMMATION | Each patient received four laser treatment sessions at 14 days of interval: Nd:YAG laser on half of the face and fractional COBefore the session, the face was washed with water, and an anesthetic cream (Pridocaine cream®; lidocaine 2.5% and prilocaine 2.5%) was left for 40 min. After removing it, skin was cleansed with 70% alcohol.On one side, a long-pulsed Nd:YAG 1064-nm laser (DEKA, Synchro FT, Italy) was utilized. Lesions were treated with three consecutive overlapped passes, while the perilesional region (approximately 2 cm around the lesion) and the unaffected region (approximately 10 cm around the lesion) were treated with one pass. The fluence was 35 J/cmOn the opposite side, fractional COIce packs were immediately applied to both sides after laser treatment. Texacort 0.1% (Hydrocortisone 17- butyrate 1 mg/gm) was advised for 3 days after the session to reduce post laser inflammation. Patients were instructed to avoid sun exposure and using cosmetics or any topical or systemic medications during the study period and to apply sunscreen with SPF 50 on their whole face every day. | PMC10435603 | |
Efficacy assessments | Erythema, hyperpigmentation, Acne lesions, Pain, hypopigmentation, erythema, pain, acne lesions, acne, Acne | ERYTHEMA, SCAR, HYPERPIGMENTATION, HYPOPIGMENTATION, ERYTHEMA, ADVERSE EFFECTS, ACNE, ACNE, SCARRING | Primary assessment was done by count of acne lesions at 1 month after the last session [Secondary assessment was performed through severity grading by the Global Acne Severity Scale (GEA Scale), acne lesions improvement percentage, and patient’s satisfaction [Clinical images were taken by an iPhone 6 s Plus (12 mega pixel, f/2.2 mm, LED flash, China) at baseline, each session, 1 month after the last session, and a 3-month follow-up after the last treatment.Acne lesions counting [Patient Global Impression of Change (PGIC), a 7-point scale representing a patient’s rating of overall improvement was conducted [Pain level was evaluated by the patients after each treatment via a 10-point visual analog scale (VAS 1 = no pain, 10 = worst pain ever felt).The degree of clinical improvement of facial pore size was recorded according to the Quartile improvement scale [Any changes in scar grading were documented using the Goodman and Baron qualitative and quantitative acne scarring grading system [The expected adverse effects are the following: (a) Erythema that lasts longer than 48 h which is graded on a three-point scale (at level of 0; “no erythema,” at level of 3; “severe erythema”). (b) Post laser hyperpigmentation (a score of 0 indicates no hyperpigmentation following laser therapy, whereas a score of 1 indicates the existence of hyperpigmentation). (c) Post laser hypopigmentation (a score of 0 shows the lack of hypopigmentation after laser treatment, whereas a value of 1 indicates the existence of hypopigmentation).Recurrence was defined as appearance of same lesions after the whole therapy or the development of novel lesions. Patients’ satisfaction levels were assessed through the VAS (0–10; 0: “not satisfied,” 10: “completely satisfied”). | PMC10435603 |
Statistical analysis | Data were managed through the Statistical Package for Social Science (IBM SPSS) version 23. The comparison between two modalities of treatment with qualitative data was done by using Chi-square test. The comparison between two modalities of treatment with quantitative data and non-parametric distribution was created by using Mann–Whitney test and Willcoxon test. For all previous tests, | PMC10435603 | ||
Discussion | sebaceous gland damage, tumor necrosis, shock, edema, erythema, acne scars, comedonal lesions, acne, comedonal acne lesion, AV lesions | ADVERSE EFFECTS, TUMOR NECROSIS, SHOCK, EDEMA, ERYTHEMA, ACNE, HEAT | Efficacy of Nd:YAG laser to treat acne has been established in multiple studies [The current study demonstrated improvement of AV lesions by both Nd:YAG laser and fractional COOn Nd:YAG side, inflammatory and comedonal acne lesion numbers decreased by 81.41% and 61.70%, respectively, from baseline to a month after the final session.Nd:YAG influences sebum output through sebaceous gland damage, normalizes follicular keratinization and corneocyte cohesion, upregulates TGF-β, and decreases the production of inflammatory cytokines, including interleukin-8, matrix metalloproteinase-9, nuclear factor kappa B, toll-like receptor (TLR)-2, and tumor necrosis factor-α [It is thoughted that, the damaging effect of 1064-nm Nd:YAG on the dilated superficial vessel of inflammatory acne and the changes of cytokine release, including the upregulation of TGF-β and the downregulation of IL-8 and TLR-2, were associated with the improvement of inflammatory acne lesions [The current results correlate with those of Chalermsuwiwattanakan et al. [Concerning the considerable improvement of the inflammatory lesions, these findings parallel our study findings with a substantial decline in noninflammatory lesions by 61.71%, which might be attributable to differences in patient demographics, number of sessions, and Nd:YAG parameters.Similar to the present results, long-pulsed Nd:YAG laser 1064 nm demonstrated improvement percentage of inflammatory acne lesions of 70.42% after the third session of a 1-month interval therapy and increased to 85.72% following a 3-month follow-up, while the improvement percentage of noninflammatory acne lesions was 41.8% after treatment sessions and increased to 49.05% after 3 months of follow-up [In addition, Monib et al. [It was evident that, similar to the present study, these trials demonstrated a more significant improvement in inflammatory lesions than in comedonal lesions. However, in the present study, the response rates were higher, which could be due to variations in participant features, device parameters and manufacturer, therapy session number, and time between sessions.On the fractional COThe high improvement percentage regarding noninflammatory and inflammatory lesions on the fractional COA few studies have considered fractional COPestoni Porvén et al. [In addition, Shin et al. [Adverse effects in this study such as erythema and edema were transient and progressively reduced immediately after treatment with the Nd:YAG laser and approximately 24 h following fractional COFractional COOur findings were marginally inferior to those of Eldeeb et al. [Nd:YAG laser treatment resulted in moderate to significant enhancement of wide pores in 19 cases (63.3%). This can be attributed to the thermal or mechanical impacts of 1064-nm laser on fibroblasts, resulting in the production of novel elastin and collagen as well as collagen remodeling [The present study involved six cases with acne scars in addition to active lesions; fractional COIt is recognized that Nd:YAG lasers generate heat shock protein 70 and procollagen I from dispersed dendritic cells in the papillary and upper reticular dermis, resulting in collagen deposition in the papillary dermis [In the present study, the percent of improvement of acne scars was 68.67% after fractional CO | PMC10435603 |
Conclusion | acne | ACNE | Fractional CO2 and Nd:YAG 1064-nm lasers are safe, tolerable, and highly effective therapeutic options for acne. However, fractional CO2 laser had a higher percent of improvement and patient’s satisfaction compared with long pulsed Nd:YAG. To our knowledge, this seems to be the first comparison between fractional CO2 laser and Nd:YAG laser in AV. | PMC10435603 |
Limitations | The small number of participants ( | PMC10435603 | ||
Acknowledgements | This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. | PMC10435603 | ||
Author contribution | Mervat Hamdino: contributed to the design and conception, and performed the procedures and revision of the manuscript.Tasneem Muhammad Hammoda: contributed in acquisition of data, analysis and interpretation of data, and drafting of the manuscript.Naglaa Abdallah Ahmed: contributed to the conception and revision of the manuscript. All authors have read and approved the final manuscript. | PMC10435603 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10435603 | ||
Data Availability | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10435603 | ||
Declarations | PMC10435603 | |||
Ethical approval | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and with the 1964 Helsinki declaration. The study was approved by the Research Ethics Committee of Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt with approval code (2021101036). The study was following the Helsinki Declaration. | PMC10435603 | ||
Conflict of interest | The authors declare no competing interests. | PMC10435603 | ||
Informed consent | All study participants provided written informed consent to the study. | PMC10435603 | ||
References | PMC10435603 | |||
1. Introduction | Obesity, intestinal behavior, weight gain, satiety, overweight, adiposity, intestinal dysbiosis, weight loss | OBESITY, DISEASE, ADIPOSITY | These authors contributed equally to this work.Background: Sorghum is a cereal source of energy, carbohydrates, resistant starch, proanthocyanidins, and 3-deoxyanthocyanins; it promotes satiety by slowing digestion and benefits intestinal health. Objective: This study investigated the effects of extruded sorghum SC319 consumption on intestinal health, weight loss, and inflammatory markers in men with overweight. Methods: This was a randomized, controlled, single-blind clinical trial. Twenty-one men were randomly allocated into one of two groups: the sorghum group (test), which received 40 g of extruded SC319 whole sorghum (Obesity is a disease related to complex interactions among genetic, socioeconomic, cultural, and environmental influences. It is a disease with multifactorial causes [The inflammatory environment caused by lipid accumulation results in a non-specific activation of the immune system, contributing to a large extent to the development of alterations in intestinal behavior, altering the functionality of enterocytes and other structures, and favoring the development of intestinal dysbiosis [Studies have shown that the intestinal microbiota can influence adiposity and weight gain [Sorghum grains ( | PMC10490362 |
2. Materials and Methods | PMC10490362 | |||
2.1. Raw Materials and Processing | ± | SCHENCK | Whole-grain sorghum (SC319 genotype) was grown in Nova Porteirinha, MG, Brazil, by Embrapa Milho e Sorgo. The grains were harvested in September 2013. They were milled into flour using a disc mill (Perten Instruments, Huddinge, Sweden) at position 2. The sorghum flour was combined with 10% fine granulated sugar (sucrose) and 0.5% iodized salt (NaCl). The mixture was processed using a twin-screw extruder (Clextral, Firminy, France) with a screw speed of 600 rpm and temperature ranging from 30 to 140 °C. The extruder had a screw diameter of 25 mm and a length of 1000 mm, resulting in an L/D ratio of 40. The die had four round openings measuring 2.0 mm in diameter and 9 mm in length. A gravimetric feeder (Schenck Process, Darmstadt, Germany) delivered the formulation to the extruder, while distilled water was added to adjust the moisture content to 12%. The extruded sorghum breakfast cereal was stored in polyethylene bags at 10 ± 2 °C.Similarly, whole-grain wheat flour from SL Alimentos in Mauá da Serra, PR, Brazil, was processed with the addition of 10% sucrose and 0.5% iodized salt. The wheat flour mixture was extruded using a twin-screw extruder (Clextral, Firminy, France) at a screw speed of 200 rpm and temperature ranging from 50 to 143 °C. The processing conditions were comparable to those used for sorghum. The resulting whole-grain wheat breakfast cereal was also stored in polyethylene bags at 10 ± 2 °C until it was ready for consumption. | PMC10490362 |
2.2. Trial Design | overweight | This was an 8-week, single-blind, controlled, randomized nutritional intervention study conducted in men with overweight. This study was conducted using data from the second phase of a crossover study previously conducted by our research group [The study was approved by the Human Research Ethics Committee of the Federal University of Viçosa, Brazil (CAAE: 13630513.0.0000.5153). All participants were informed about the objectives of the study and provided written informed consent. | PMC10490362 | |
2.3. Participants | obesity, overweight | OBESITY, DISEASES | Volunteers were recruited in Viçosa-MG, Brazil, through advertisements on social networks, pamphlets, and posters. An email address and a telephone number were made available to individuals who were interested in participating in the study. In the first contact, the objectives and conditions of the study were informed to the potential volunteers. Then, screening was conducted for those who chose to participate in the study. During screening, a selection form was completed and, when they met the eligibility criteria, respecting the inclusion and non-inclusion criteria, a nutritional assessment was performed.Eligibility criteria were male; age 18–40 years; body mass index (BMI) 27.0–34.9 kg/mOnly men were included in the study for two main reasons: the first is that males do not have as many hormonal changes as females, especially related to the menstrual period, considering that the woman’s reproductive status linked to the ovarian cycle is imperative while examining disparities between sexes in terms of health and vulnerability to diseases, scrutinizing the impacts of drugs, and exploring behavior. In addition, men suffer fewer changes in hormones associated with body composition compared to women, which meant that, in this case, male subjects were recruited for the study. The second reason is the fact that a previous experimental study investigated the consumption of sorghum in male Wistar rats fed a diet high in saturated fat (SFA) to induce overweight, since the consumption of this type of diet is associated with the development of obesity, so this study can be considered a sequel [ | PMC10490362 |
2.4. Interventions and Test Meals | Volunteers attended the laboratory daily to consume the test preparations (breakfast cereal with milk or dairy product, or a drink) at breakfast and guided to follow a 500 kcal/day caloric restriction diet. On the weekends, the volunteers consumed the meals at home. The volunteers were instructed to consume the entire amount of test food provided. Thus, meals were offered to both groups in the form of breakfast cereal (extruded sorghum × wheat) added with whole milk or light whole yogurt, or a drink (extruded flours were mixed with skimmed milk powder, powdered juice, and sweetener) ( | PMC10490362 | ||
2.5. Outcomes | tumor necrosis | TUMOR NECROSIS | The primary outcome of this study was the effect on anthropometric measurements such as body weight, waist circumference, sagittal abdominal diameter, waist-to-height ratio, and body fat percentage. The second outcome was the effect of the interventions on intestinal health, including short-chain fatty acid synthesis, fecal pH, gut microbiota composition, and inflammatory markers, such as interleukin 6, interleukin 10, and tumor necrosis factor-α. | PMC10490362 |
2.6. Randomization, Allocation, and Sample Power | Participants were randomized using a random sequence, according to the corresponding numbers received prior to the intervention, using a Microsoft Excel 365 software spreadsheet for distribution between groups. Allocation concealment occurred so that investigators or research participants did not know whether the next eligible participant would receive a treatment or control intervention. This was masked until such time as the intervention was initiated.A power of 94.54% was obtained considering the mean difference in body fat percentage between the groups (effect size = 1.64), bilateral α of 5%, and sample size of the groups. Calculations were performed using the GPower software version 3.1.9.7. | PMC10490362 | ||
2.7. Assessment of Anthropometry and Body Composition Markers | overweight [ | Anthropometric and body composition evaluations were performed by a single trained researcher. Body weight was assessed using an electronic platform scale (Model 2096 PP, Toledo, Brazil), with a capacity of 150 kg and precision of 50 g. Height was measured using a stadiometer (AlturexataBody composition was assessed by dual-energy X-ray absorptiometry (DXA) (GE Healthcare, Lunar Prodigy Advance), and the results were expressed as total body fat (%). Body fat % higher than 25% was used to classify individuals with overweight [ | PMC10490362 | |
2.8. Inflammatory Markers | tumor necrosis | TUMOR NECROSIS | All participants underwent overnight fasting, and blood samples were collected at baseline and endpoint. Enzyme-linked immunosorbent assay (ELISA) was utilized to analyze the levels of inflammatory markers, including interleukin 6, interleukin 10, and tumor necrosis factor-α. The Milliplex Map Human Cytokine/Chemokine Magnetic Bead kit (HCYTOMAG-code 60K, Millipore, Darmstadt, Germany) was employed for the accurate measurement of these markers in the blood samples. | PMC10490362 |
2.9. Fecal Samples | At baseline and endpoint (8 weeks after) of the intervention, study participants were instructed to provide a fecal sample as close to the collection time as possible. If immediate processing was not feasible, the samples were refrigerated at 4 °C for a maximum of 12 h. Participants transported the fecal samples to the laboratory in polystyrene containers along with ice cubes to ensure temperature preservation. Upon arrival, the samples were weighed and transferred into micro tubes, then subsequently stored at −80 °C until analysis. | PMC10490362 | ||
2.10. Fecal pH | The fecal pH level was assessed using a digital pH meter T-1000 (Tekna, São Paulo, Brazil). To perform the measurement, one gram of feces was transferred into a 15 mL falcon-type tube, and then 10 mL of ultrapure water was introduced. The mixture was thoroughly homogenized by vortexing, and the pH reading was obtained using a digital pH meter. | PMC10490362 | ||
2.11. Organic Acid Analysis | To extract and identify organic acids from fecal samples, 500 mg of feces was weighed in duplicate and stored at −80 °C until further analysis. The frozen feces were thawed at room temperature (23 ± 2 °C) and homogenized with 1 mL of ultrapure water. Subsequently, the samples underwent centrifugation at 12,000× | PMC10490362 | ||
2.12. Fecal Sample DNA Extraction | The extraction of DNA from fecal samples was performed using the QIAamp Fast DNA Stool Mini kit (Qiagen, Hilden, Germany) in accordance with the manufacturer’s guidelines. Each extraction involved 200 ± 20 mg of feces as the starting material. Following purification, the isolated DNA was preserved at −80 °C until it was ready for subsequent analysis. | PMC10490362 | ||
2.13. Quantitative Real-Time Polymerase Chain Reaction (qPCR) Analysis of Gut Microbiota DNA Concentration | In this study, the researchers aimed to quantify the concentration of gut microbiota DNA through quantitative real-time polymerase chain reaction (qPCR) analysis. The DNA concentration was determined by measuring the absorbance at 260 nm (A260), while its purity was assessed by calculating the A260/A280 ratio using a Multiskan™ 1500 spectrophotometer (Thermo Fisher Scientifics; Waltham, MA, USA). For PCR analysis, group-specific primers ( | PMC10490362 | ||
2.14. Analysis of Gut Microbiota | The sequencing of variable regions of the 16S rRNA gene of members of the Bacteria domains (V3–V4) was carried out by the company Argonne National LaboratoryFor alpha diversity analysis, the indices Chao1, Shannon, and Simpson were applied. Beta diversity was assessed by Principal Coordinate Analysis (PCoA) based on the Bray–Curtis dissimilarity index and a similarity test for non-parametric data (ANOSIM, permutation number = 1000) [Metagenome functional predictive analysis was carried out using PICRUSt2 software version 2.3.0. Normalized OTU abundance was identified, and the assigned functional traits were predicted based on reference genomes using the Kyoto Encyclopedia of Genes and Genomes (KEGG). The most abundant metabolic processes and significant fold-change differences in functional pathways between groups adopting an unpaired | PMC10490362 | ||
2.15. Statistical Analysis | For body composition, inflammatory markers, organic acids, fecal pH, and PCR, statistical analysis was performed using SPSS 20.0 software. The normality of the data was assessed by Shapiro–Wilk test. The average of each variable at the beginning and end of the intervention was compared using paired For analysis related to gut microbiota composition the normality of the data was assessed by Kolmogorov–Smirnov test. The α diversity index and Firmicutes/Bacteroidetes ratio statistical analysis was performed using GraphPad version 9.0. Principal Coordinate Analysis (PCoA) based on the Bray–Curtis dissimilarity index was accessed using Past software version 4.0.5. Metagenome functional predictive analysis was carried out using PICRUSt2 software version 2.3.0. Differences between averages were analyzed using STAMP software version 2.1.3. White’s non-parametric | PMC10490362 | ||
3. Results | overweight | Thirty-six men with overweight were recruited to the study. However, 12 did not meet the inclusion criteria; therefore, a total of 24 participants were included in study. Three participants left the study for personal reasons and twenty-one individuals finished the study ( | PMC10490362 | |
3.1. Anthropometric Measures and Inflammatory Markers | weight loss | Significant weight loss (−1.25 ± 0.84 kg, | PMC10490362 | |
3.2. SCFA Synthesis and Gut Microbiota PCR | We did not observe significant changes in fecal concentrations of acetic, propionic, and butyric acids after sorghum or wheat consumption for 8 weeks ( | PMC10490362 | ||
3.3. Gut Microbiota Analysis | ± | Sequencing the 16S rRNA gene from stool samples generated 1,383,378 raw sequences. After filtering and cleaning the sequences, 1,001,142 good-quality sequences were obtained. The Good’s coverage obtained in samples was >99%, indicating good sequencing coverage. Raw filtered reads and normalized read counts per group are shown in The α diversity, microbial richness, and diversity were not different for the Chao1 (Intervention groups presented 21 phyla, 35 classes, 77 orders, 134 families, and 302 genera. All groups had eight predominant phylum: Firmicutes (sorghum group: 61.45 ± 4.92%; wheat group: 62.81 ± 7.55%), followed by Bacteroidetes (sorghum group: 29.35 ± 4.67%; wheat group: 26.17 ± 6.92%), Proteobacteria (sorghum group: 3.87 ± 1.09%; wheat group: 4.34 ± 2.18%), Actinobacteria (sorghum group: 2.75 ± 1.18%; wheat group: 3.10 ± 1.02%), and Desulfobacterium (sorghum group: 1.04 ± 0.47%; wheat group: 1.06 ± 0.42%) ( | PMC10490362 | |
3.4. Functional Prediction Analysis (KEGG Analysis) | According to the intragroup KEGG metabolic pathway analysis, extruded sorghum SC319 consumption increased methyl ketone biosynthesis (By comparing the extruded sorghum and wheat group metabolic pathways using a KEGG intergroup analysis at the endpoint, it was found that sorghum consumption increased S-adenosyl-L-methionine cycle I ( | PMC10490362 | ||
3.5. LEfSe Analysis | All OTUs were analyzed by a Linear Discriminant Analysis of Effect Size (LEfSe) to identify the dominant cecal microbiota and intestinal biomarkers using taxonomy ( | PMC10490362 | ||
4. Discussion | inflammation, overweight, weight loss | CELIAC DISEASE, INFLAMMATION | This study investigated the effects of the consumption of extruded SC319 whole sorghum or extruded whole wheat associated with an 8-week daily 500 kcal energy restriction diet on the modulation of intestinal health with a focus on gut microbiota, short-chain fatty acid production, fecal pH, and weight loss and inflammation markers. Extruded sorghum and whole wheat did not show differences in α and β diversity indexes, short-chain fatty acid synthesis, and fecal pH. However, sorghum consumption promoted alterations at the genus level compared to baseline, reducing Extruded whole wheat and sorghum have a similar concentration of total dietary fiber, promoting a similar dietary fiber intake when consumed for eight weeks. This resulted in similar effects on fecal pH, short-chain fatty acid synthesis, and microbial diversity. However, sorghum SC319 promoted a weight loss intragroup, probably due to its unique phenolic compounds, 3-deoxyanthocianins, and proanthocyanins, which complex with starch, thereby reducing their digestibility [The extruded SC319 sorghum consumption tended to reduce the proteobacteria phylum, most of which is pathogenic. At the genus level, We observed that overweight male individuals intaking 40 g/day of extruded whole sorghum SC319, rich in 3-deoxyanthocyanidins and proanthocyanidins, for eight weeks, did not change the anti-inflammatory markers. A previous study with these individuals also showed no effects on the antioxidant response [The intake of extruded sorghum is an alternative to wheat consumption, which can improve the life quality of populations, especially individuals with celiac disease. Thus, sorghum is an excellent substitute for wheat intake since it does not have allergen compounds and, when combined with other ingredients, can be used to produce beverages, pasta, bread, cakes, and biscuits, among other bakery products. The unique techno-functional and biofunctional properties of kafirins, such as non-allergenic features and slow digestibility by mammalian proteases, amplify the applications of sorghum flour in food production [Although no effects were observed regarding the composition of the intestinal microbiota in the extruded whole sorghum and wheat groups, sorghum can be an alternative to wheat since it is a non-allergenic cereal and has been demonstrated to enhance weight loss, in addition to showing similar results to wheat on SCFA synthesis and fecal pH.The strength of the present study is to associate two interventions, namely the use of extruded whole sorghum, a prebiotic, with a caloric restriction diet, to investigate the systemic effects on body composition, inflammatory markers, and intestinal health, encouraging the consumption of this cereal in the human population. The limitations of this study are as follows: the small number of volunteers in each group; the unusual consumption of sorghum by most of the world population, besides being considered a whole ingredient by Brazilian Official Institutions; the duration of the intervention, because eight weeks may not be a sufficient amount of time to find effects on intestinal health; gut microbiota composition; and the data collection, due to it being in the second phase of a crossover study, as weight loss is more effective in the first weeks with a caloric restriction diet [ | PMC10490362 |
5. Conclusions | overweight, weight loss | Consuming SC319 extruded sorghum allied to an energy restriction diet reduced body fat percentage in Brazilian men with overweight compared to control, with no differences in SCFA synthesis, fecal pH, α and β diversity, and inflammatory markers. In addition to this, considering gut microbiota functional prediction, the extruded SC319 consumption for eight weeks improved metabolic pathways related to carbohydrate metabolism compared to extruded wheat consumption. The sorghum consumption intragroup had improved weight loss, decreased anthropometric measures, and a relative abundance of harmful microorganisms at the genus level. | PMC10490362 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10490362 | ||
Author Contributions | Conceptualization, H.L., P.A., B.d.S. and H.M.; data curation, H.L., P.A., B.d.S., A.d.S., H.P.-S. and H.M.; formal analysis, H.L. and P.A.; funding acquisition, C.d.C., V.Q. and H.M.; investigation, H.L., P.A., B.d.S., A.d.S., H.P.-S. and H.M.; methodology, B.d.S., A.d.S., C.d.C., V.Q., H.P.-S. and H.M.; project administration, B.d.S. and H.M.; resources, C.d.C., V.Q. and H.M.; software, H.L.; supervision, H.M.; validation, H.P.-S. and H.M.; visualization, H.M.; writing—original draft, H.L.; writing—review and editing, H.P.-S. and H.M. All authors have read and agreed to the published version of the manuscript. | PMC10490362 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Human Research Ethics Committee of the Federal University of Viçosa, Brazil (CAAE: 13630513.0.0000.5153), on 13 October 2014. | PMC10490362 | ||
Informed Consent Statement | All participants were informed about the objectives of the study and provided written informed consent. | PMC10490362 | ||
Data Availability Statement | Data presented in this study are available upon request to the corresponding author. The data are not publicly available due to the fact that they are available within an internal database of the research institution, therefore, they cannot be made publicly available. | PMC10490362 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10490362 | ||
Background | T2DM | HEART FAILURE, TYPE 2 DIABETES MELLITUS | The sodium-glucose co-transporter 2 inhibitor empagliflozin improves cardiovascular outcome in patients with type 2 diabetes mellitus (T2DM) and heart failure. Experimental studies suggest a direct cardiac effect of empagliflozin associated with an improvement in left ventricular diastolic function. | PMC10293456 |
Methods | T2DM | In the randomized, double-blind, two-armed, placebo-controlled, parallel group trial EmDia, patients with T2DM and elevated left ventricular | PMC10293456 | |
Results | T2DM | A total of 144 patients with T2DM and an elevated left ventricular | PMC10293456 | |
Conclusions | heart failure, T2DM | HEART FAILURE | Empagliflozin improves diastolic function in patients with T2DM and elevated end-diastolic pressure. Since the positive effects were consistent in patients with and without heart failure with preserved ejection fraction, the data add a mechanistic insight for the beneficial cardiovascular effect of empagliflozin. | PMC10293456 |
Trial registration | NCT02932436 | Clinicaltrials.gov, unique identifier: NCT02932436. | PMC10293456 | |
Graphical abstract | PMC10293456 | |||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00392-023-02164-w. | PMC10293456 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10293456 | ||
Introduction | type 2 diabetes mellitus, Diabetes mellitus | EPIDEMIC DISEASE, TYPE 2 DIABETES MELLITUS, DIABETES MELLITUS | Diabetes mellitus is an epidemic disease affecting more than 460 million people worldwide [The specific mechanisms mediating the beneficial effects of empagliflozin on cardiovascular outcome remain controversial [The EmDia trial was designed to evaluate the effect of empagliflozin compared to placebo on left ventricular diastolic function in subjects with type 2 diabetes mellitus and elevated left ventricular end-diastolic pressure in a randomized, double-blind controlled clinical trial combined with comprehensive clinical and molecular phenotyping. | PMC10293456 |
Methods | PMC10293456 | |||
Trial design | NCT02932436 | -11 | The EmDia trial is a randomized, double-blind, two-armed, placebo-controlled, parallel group, investigator-initiated study of phase IV. The University Medical Center of the Johannes Gutenberg-University Mainz conducted the single-center trial as study sponsor. All study documents were approved by the local ethics committee and the data protection officer prior to study initiation. All study participants provided informed written consent, and study procedures have been performed in line with the principles outlined in the Declaration of Helsinki and the recommendations for Good Clinical Practice. The trial was registered at clinicaltrials.gov with the unique identifier: NCT02932436 (EudraCT number: 2016-001264-11). The rationale and design of the trial have been described in detail recently [ | PMC10293456 |
Patient enrolment and randomization | type 2 diabetes mellitus, left ventricular diastolic dysfunction | TYPE 2 DIABETES MELLITUS, LEFT VENTRICULAR DIASTOLIC DYSFUNCTION | The main inclusion criteria of the EmDia trial were: (i) age from 18 to 84 years, (ii) diagnosis of type 2 diabetes mellitus with stable glucose-lowering background therapy and/or dietary treatment for at least 12 weeks, (iii) HbA1c ≥ 6.5% and ≤ 10.0% in subjects on antidiabetic background therapy or HbA1c ≥ 6.5% and ≤ 9.0% for drug-naïve subjects with dietary treatment, and (iv) prevalent left ventricular diastolic dysfunction defined as left ventricular lateral Patients who met all inclusion criteria and none of the exclusion criteria were randomized 1:1 to the intervention or control group at the baseline visit. Block-randomization including sex-stratification was performed by an independent institution (Interdisciplinary Center for Clinical Trials (IZKS), Mainz, Germany). During the 12-week trial period after randomization, patients received empagliflozin at a dose of 10 mg per day or an identical placebo in addition to the concomitant medication. | PMC10293456 |
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