[Functional gastrointestinal disorders].
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Abdominal Pain↗
Biomedical subjects
S Bertram
Publications and source records attributed to S Bertram.
Laser Doppler flow investigation of fractured permanent maxillary incisors.
Laser Doppler flowmetry (LDF) is a non-invasive method to assess pulpal blood-flow (PBF). Dental injury has been associated with losses of pulpal sensibility. The purpose of this study was to assess the outcome of splint therapy on tooth fracture type-related PBF values. In 15 trauma patients, a single maxillary incisor treated by repositioning and splinting was investigated by LDF to assess local PBF values. Perfusion units were taken in four sessions, on the day of splint removel, and 12, 24 and 36 weeks after splint removal. Analysis of the tooth fracture type-related PBF measurements revealed root fractures to be associated with a significant decrease (P < 0.05) and uncomplicated crown fractures to be associated with a significant increase in PBF values (P < 0.05), while complicated crown fractures showed no significant difference between the session-related values (P > 0.05). The main findings of this study suggest splint therapy of root fractures of the central maxillary incisor to be associated with a short- and long-term decrease in PBF values. The LDF may become useful in the detection of transient ischaemic episodes and the identification of teeth at risk for adverse sequelae such as avascular necrosis and tissue loss.
Adolescent↗
Validation of the clinical diagnostic criteria for temporomandibular disorders for the diagnostic subgroup of degenerative joint disease.
Research is needed to assess the validity of the Clinical Diagnostic Criteria for Temporomandibular Disorders (CDC/TMD). The purpose of this study was to test the reliability of the clinical diagnosis of temporomandibular joint (TMJ) degenerative joint disease (DJD) as compared with the magnetic resonance imaging (MRI) 'gold standard'. The TMJ DJD group comprised 48 joints in 24 consecutive patients who were assigned a clinical bilateral diagnosis of TMJ DJD. The TMJ non-DJD group consisted of 82 joints in 41 consecutive patients without a TMJ-related diagnosis of TMD. Bilateral sagittal and coronal MR images were obtained subsequently to establish the corresponding diagnosis of degenerative joint changes. An MRI diagnosis of osteoarthrosis (OA) was defined by the presence of flattening, subchondral sclerosis, surface irregularities, and erosion of the condyle or presence of condylar deformities associated with flattening, subchondral sclerosis, surface irregularities, erosion and osteophyte. For the CDC/TMD interpretations, the positive predictive of DJD for OA was 67%, and for the presence of degenerative joint changes 88%. The overall diagnostic agreement for DJD was 44.6% with a corresponding K-value of 0.01. Most of the disagreement was due to false-negative interpretations of asymptomatic joints. The results suggest CDC/TMD to be predictive for degenerative joint changes but insufficient for determination of OA. Patients assigned a clinical TMJ-related diagnosis of DJD may need to be supplemented by evidence from MRI to determine the presence or absence of OA.
Adult↗
Effect of scanning level and muscle condition on ultrasonographic cross-sectional measurements of the anterior masseter muscle.
With the disadvantage of computed tomography showing cumulative biological effects and magnetic resonance imaging posing a problem in clinical availability and cost, several authors described the technique of ultrasonography to measure non-invasively local cross-sectional dimensions (LCSDs) of masseter muscle sites. However only few studies addressed the issue of 'technique-related factors for intra- and inter-observer reliability' to gain more consistent testing and diagnosis. The purpose of the present study was to determine (1) whether the scanning level and/or the muscle condition may affect LCSD measurements and (2) whether measurements made at identical levels may be reproducible. The study included 35 subjects with signs and symptoms of temporomandibular disorders. Bilateral ultrasonographic investigation was performed with a linear (B-scan) 7.5 Mhz small-part transducer to register LCSDs of the anterior masseter muscle on three different levels. Scans were made on the relaxed and contracted muscle. Measurements were made in two sessions with a time interval of at least 5 min. Data were analysed for reproducibility by using the intra-class correlation coefficient (ICC) and the method error (ME). Scanning level and muscle condition had a significant effect on muscle measurements (P = 0.000). There was no difference in LCSD between the right and left muscle (P = 0.531). Measurements recorded at a given site were consistent across the testing sessions (P = 0.058). The scanning level with highest reproducibility was halfway between the origin and insertion (ICC = 0.92; ME = 6.2%). The data suggest that ultrasonography is a reliable method for measuring LSCDs of the anterior masseter muscle.
Adult↗
Temporomandibular joint internal derangement: detection with 12.5 MHz ultrasonography.
The purpose of this study was to determine whether 12.5 MHz ultrasonography (US) could be used to assess the presence or absence of temporomandibular joint (TMJ) internal derangement (ID). In 48 consecutive patients with TMJ disorders 192 TMJ positions were investigated by US to analyse the functional disc-condyle relationship (DCR). In order to compare the respective findings with those of a diagnostic method offering a high accuracy, coronal and sagittal magnetic resonance imaging was carried out immediately afterwards. With US showing a sensitivity of 0.58 and 0.75, and a specificity of 0.92 and 0.84 for disc displacement with and without reduction, the data revealed US to be marginal in detecting the presence, but sensitive in detecting the absence of the respective types of a TMJ ID. In addition, with a positive predictive value of 0.83 and 0.71, and a negative predictive value of 0.81 and 0.87 for disc displacement with and without reduction, the results indicate that US may be insufficient in establishing a correct diagnosis for the presence or absence of the respective types of TMJ ID. Regarding the diagnosis of absence or presence of TMJ ID, the results demonstrate high-resolution (HR)-US to be sensitive in detecting the absence, and reliable in predicting the presence of TMJ ID. In view of the fact that the 12.5 MHz US technique proved to be a reliable diagnostic aid for the detection of normal, and the prediction of abnormal DCR, the results of this study should be of further interest and encourage research in its potential uses and diagnostic capabilities.
Adolescent↗
Risk factors for temporomandibular joint pain in patients with disc displacement without reduction - a magnetic resonance imaging study.
The purpose of this study was to evaluate whether the magnetic resonance (MR) imaging variables of temporomandibular joint (TMJ) internal derangement, osteoarthrosis and/or effusion may predict the presence of pain in patients with a clinical disorder of an internal derangement type (ID)-III. The relationship between TMJ ID-III pain and TMJ internal derangement, osteoarthrosis and effusion was analysed in MR images of 84 TMJs in 42 patients with a clinical unilateral diagnosis of TMJ ID-III pain. Criteria for including a TMJ ID-III pain patient were report of orofacial pain referred to the TMJ, with the presence of unilateral TMJ pain during palpation, function and/or unassisted or assisted mandibular opening. Bilateral sagittal and coronal MR images were obtained to establish the presence or absence of TMJ internal derangement, osteoarthrosis and effusion. Using chi-square analysis for pair-wise comparison, the data showed a significant relationship between the MR imaging findings of TMJ ID-III pain and those of internal derangement (P=0.01) and effusion (P=0.00). Of the MR imaging variables considered simultaneously in the multiple logistic regression analysis, osteoarthrosis (P=0.82) and effusion (P=0.08) dropped out as non-significant in the diagnostic TMJ pain group when compared with the TMJ non-pain group. The odds ratio that a TMJ with an internal derangement type of disk displacement without reduction might belong to the pain group was strong (2.7:1) and highly significant (P=0.00). Significant increases in risk of TMJ pain occurred with 'disk displacement without reduction in combination with osteoarthrosis' (5.2:1) (P=0.00) and/or 'disk displacement without reduction in combination with osteoarthrosis and effusion' (6.6:1) (P=0.00). The results suggest that TMJ pain is related to internal derangement, osteoarthrosis and effusion. However, the data re-emphasize the aspect that these MR imaging variables may not be regarded as the unique and dominant factors in defining TMJ pain instances.
Adolescent↗
Temporomandibular joint osteoarthrosis diagnosed with high resolution ultrasonography versus magnetic resonance imaging: how reliable is high resolution ultrasonography?
The purpose of this study was to determine whether 12.5 MHz ultrasonography (US) could be used to assess the presence or absence of temporomandibular joint (TMJ) condylar osteoarthrosis. In 40 consecutive patients with TMJ disorders, 80 TMJs were investigated by US to analyse the condylar morphology. In order to compare the respective findings with those of a diagnostic method offering a high accuracy, coronal and sagittal magnetic resonance imaging was carried out immediately afterwards. With US showing a sensitivity of 87%, and a specificity of 20%, the data revealed US to be sensitive in detecting the presence, but insufficient in detecting the absence of osteoarthrosis. In addition, with a positive predictive value of 88%, and a negative predictive value of 18%, the results indicate that US may be valuable in diagnosing the presence, but insufficient in diagnosing the absence of osteoarthrosis. In view of the fact that the 12.5 MHz US technique proved to be a valuable diagnostic aid for the detection and prediction of abnormal condylar morphology, the results of this study should be of further interest and encourage research in its potential uses and diagnostic capabilities.
Adolescent↗
Cross-sectional characteristics of the masseter muscle: an ultrasonographic study.
Cross-sections of the masseter muscle may now be measured non-invasively using ultrasonography. The purpose of the present study was to determine (1) whether the scanning level may affect cross-sectional measurements and (2) whether measurements made at identical levels may be reproducible. The study included 42 asymptomatic volunteers. Unilateral ultrasonographic investigation was performed with a linear (B-scan) 7.5 Mhz small-part transducer to register cross-sections of the masseter muscle on five different levels. Scans were made on the relaxed and contracted muscle. Measurements were made in two sessions with a time interval of at least 5 min. Statistical analysis consisted of univariate analysis of variance for repeated measurements. Data were analysed for reproducibility by using the method error and measurement error. For the ultrsonographic measurements the main effects of the variables 'session' (P=0.0001), 'level' (P=0.0001), and 'condition' (P=0.0001) were significant. Analysis of simple session-within-level effects revealed a significant difference between the repeated measurements for the most upper level (P=0.022), the upper level (P=0.012), and the most lower level (P=0.0001) of the relaxed muscle. An additional significant effect was found for the most lower level of the contracted muscle (P=0.015). Cross-sections evaluated at the middle (method error=0.31 mm; measurement error=2.0%) and lower level (method error=0.32 mm; measurement error=2.4%) of the contracted muscle were the most reproducible. The conclusion is that ultrasonography is a reproducible method for measuring cross-sections at the middle and lower level of the contracted masseter muscle.
Adolescent↗
Reliability and temporal variation of masseter muscle thickness measurements utilizing ultrasonography.
Muscle thickness may now be measured in the clinic by ultrasonography. The purpose of this study was to test (i) whether the position of the transducer on the muscle affects muscle thickness measurements and (ii) whether measurements from identical locations vary over time. Muscle thickness of one masseter muscle side was measured in each of 30 volunteers. Measurements were recorded at five different locations on the lateral surface of each muscle. Four measurement sessions were performed, and two sets of measurements were recorded at each session. Spatial position of the transducer had a clear effect on the muscle thickness measurements (P < 0.0001). Measurements made at the most upper and middle level were less and greater (P < 0.0001), respectively, than those made at the upper, lower, and most lower levels. Measurements from various positions did not differ (P > 0.05) when made at the same level. Masseter thickness measurements recorded at a given site were consistent across all of the testing sessions (P=0.575). The data suggest that reliable interpretation of longitudinal measurements of masseter thickness obtained with ultrasonography requires accurate repositioning of the transducer. Ultrasonography may be used to investigate the effect of specific treatment modalities on masseter thickness measurements.
Adult↗
Effect of stabilization-type splints on the asymmetry of masseter muscle sites during maximal clenching.
Patients with temporomandibular disorders may present with a cluster of joint and muscle disorders characterized primarily by pain, joint sounds and irregular or deviating jaw function. Maxillary stabilization-type splints represent the best standard therapy, so the purpose of this study was to evaluate changes in local maximal clenching-related asymmetry patterns of masseter muscle sites associated with the immediate 'application of splint therapy' using the diagnostic approach of high-resolution gray-scale ultrasonography. The study included 24 patients who had signs and symptoms of temporomandibular disorders. Ultrasonographic investigation was performed with a linear (B-scan) 7.5 Mhz small-part transducer to visualize the antero-superior, antero-inferior, medio-superior, medio-inferior, postero-superior, and postero-inferior sites of the masseter muscle. To assess local maximal clenching-related muscle asymmetry patterns and to evaluate the respective effect of occluding splints, the 'absolute asymmetry index' was used, with the mean maximum muscle diameter of the respective right and left sides calculated from three consecutive measurements before and after splint insertion. Comparing the values assessed before splint insertion with those after splint insertion revealed a significant decrease in local maximal clenching-related muscle asymmetry values for the antero-inferior masseter muscle site (P < 0.05). The results of this study suggest stabilization-type splints to have a site-specific effect in the immediate reduction of local maximal clenching-related muscle asymmetries. Further studies are warranted to evaluate muscle-site specific effects in patient and non-patient groups and to relate these effects to pre-treatment variables like bite force, preferred chewing side, facial morphology and occlusion.
Adult↗
Magnetic resonance imaging findings of internal derangement in temporomandibular joints without a clinical diagnosis of temporomandibular disorder.
The purpose of this study was to assess the prevalences of magnetic resonance (MR) imaging findings of internal derangement (ID) in temporomandibular joints (TMJs) without a specific clinical diagnosis of temporomandibular disorder (TMD), and to investigate whether in this TMJ group the variable of pain may be linked to MR imaging findings of ID. The study comprised 109 patients, who were assigned a clinical uni- or bilateral TMJ-related diagnosis of 'absence of TMD'. Bilateral sagittal and coronal MR images were obtained subsequently to establish the prevalence of TMJ ID. An MR imaging diagnosis of ID was found in 99 (55.9%) of the 177 TMJs investigated. About 30.3% of the closed mouth-related TMJ positions characterized by disc displacement presented with anterior disc displacement, while 27.3% had anterolateral and 25.3% anteromedial disc displacement. Analysis of the data revealed the presence of TMJ pain to be associated with significantly more MR imaging diagnoses of disc displacement without reduction than disc displacement with reduction (P < 0.05), while there was no significant difference in the prevalences of ID and those of absence of ID (P > 0.05). Using chi-square analysis, no significant relationship was found between the presence of TMJ pain and the MR imaging diagnosis of TMJ ID (P=0.93). Use of the kappa statistical test indicated poor diagnostic agreement between the presence of TMJ pain and the MR imaging diagnosis of ID (kappa=0.01). The results suggest TMJs with a clinical diagnosis of 'absence of TMD' to be associated with a high rate of IDs, while in these instances the clinical variable of TMJ pain may have no effect on prevalences of MR imaging diagnoses TMJ ID. The data confirm the aspect of clinical diagnostic criteria as an unreliable instrument in predicting MR imaging diagnoses of TMJ ID.
Adolescent↗
Ultrasonographic assessment of local cross-sectional dimensions of masseter muscle sites: a reproducible technique?
Local cross-sectional dimensions (LCSDs) of masseter muscle sites may now be measured non-invasively using ultrasonography. The purpose of the present study was to determine (i) whether the muscle site may affect LCSD measurements and (ii) whether measurements made at identical sites may be reproducible. The study included 17 patients who had signs and symptoms of temporomandibular disorders (TMD). Bilateral ultrasonographic investigation was performed with a linear (B-scan) 7.5 MHz small-part transducer to visualize the antero-superior, antero-inferior, medio-superior, medio-inferior, postero-superior, and postero-inferior sites of the masseter muscle. Measurements were made in two sessions with a time interval of at least five minutes. Data were analysed for reproducibility by using the intraclass correlation coefficient (ICC) and the method error (ME). Muscle site had no significant effect on muscle measurements (P = 0.090). Measurements from the various side-related sites did not differ significantly (P = 0.425). Measurements recorded at a given site were consistent across the testing sessions (P = 0.605). The muscle site with highest reproducibility was the medio-inferior site (ICC = 0.92; ME = 6.4%). The data suggest that ultrasonography is a reproducible method for measuring LSCDs of the masseter muscle.
Adolescent↗
Validation of the clinical diagnostic criteria for temporomandibular disorders for the diagnostic subgroup - disc derangement with reduction.
Research is needed to assess the validity of the clinical diagnostic criteria for temporomandibular disorders (CDC/TMD). The purpose of this study was to test the reliability of the clinical diagnosis of temporomandibular joint (TMJ) internal derangement type (ID)-I as compared with the magnetic resonance imaging (MRI) 'gold standard'. The study comprised 168 TMJs in 84 patients, who were assigned a clinical TMJ-related diagnosis of ID-I (disc displacement with reduction) in at least one TMJ. Bilateral sagittal and coronal MR images were obtained subsequently to establish the corresponding diagnosis of the disc-condyle relationship. For the CDC/TMD interpretations, the positive predictive value (PPV) of ID-I for disc displacement with reduction (DDR) was 44%, and for the presence of an ID 69%. The overall diagnostic agreement for ID-I was 47.6% with a corresponding K-value of 0.05. Most of the disagreement was the result of the false-positive interpretations of ID-I, and false-negative interpretations of an 'absence of ID'. The results suggest CDC/TMD for ID-I to be insufficient reliable for determination of ID and/or DDR. Patients assigned a clinical TMJ-related diagnosis of ID-I may need to be supplemented by evidence from MRI to determine the functional 'disc-condyle relationship'.
Adolescent↗
Magnetic resonance imaging findings of osteoarthrosis and effusion in patients with unilateral temporomandibular joint pain.
The purpose of this study was to investigate the relationship between the presence of temporomandibular joint (TMJ) pain and the magnetic resonance (MR) imaging findings of osteoarthrosis (OA), and effusion. The study comprised 112 consecutive TMJ pain patients. Criteria for including a patient were report of unilateral pain near the TMJ, with the presence of unilateral TMJ pain during palpation, function, and/or unassisted or assisted mandibular opening. Bilateral sagittal and coronal MR images were obtained to establish the presence or absence of TMJ OA, and/or effusion. Comparison of the TMJ side-related data showed a significant relationship between the clinical finding of TMJ pain and the MR imaging diagnoses of TMJ OA (P=0.000), and TMJ effusion (P=0.000). Further, there was a significant relationship between the MR imaging diagnosis of TMJ OA and TMJ effusion (P=0.000). Use of the Kappa statistical test indicated poor diagnostic agreement between the presence of TMJ pain and the MR imaging diagnosis of TMJ OA (K=0.22), TMJ effusion (K=0.29), and TMJ 'OA and effusion' (K=0.30). The study's findings suggest that while clinical pain is correlated to TMJ-related MR imaging findings, clinical pain in and of itself, is not reliable for predicting the presence of TMJ OA and/or effusion. Validation of MR imaging diagnoses would involve the investigation of cross-sectional and longitudinal evidence to assess decisive differences in terms of prognosis and/or treatment outcome.
Adolescent↗
The short-term effect of stabilization-type splints on the local asymmetry of masseter muscle sites.
Patients with temporomandibular disorders (TMD) may present with a cluster of joint and muscle disorders characterized primarily by pain, joint sounds and irregular or deviating jaw function. Maxillary stabilization-type splints represent the best standard therapy, so the purpose of this study was to evaluate changes in local cross-sectional dimensions (LCSD) of masseter muscle sites associated with short-term application of 'splint therapy' using the diagnostic approach of high-resolution gray-scale ultrasonography. The study included 29 patients who had signs and symptoms of temporomandibular disorders. Ultrasonographic investigation was performed with a linear (B-scan) 7.5 MHz small-part transducer to visualize the antero-superior, antero-inferior, medio-superior, medio-inferior, postero-superior and postero-inferior sites of the masseter muscle. To assess local muscle asymmetry patterns and to evaluate the respective effect of occluding splints, the 'absolute asymmetry index (AAI)' was used, with the mean maximum muscle diameter of the respective right and left sides calculated from three consecutive measurements before and after splint therapy. Comparing the pre-treatment with the 2-month follow-up values revealed a significant decrease in the overall mean asymmetry indices at the anterior (P < 0.01), medial (P < 0.05) and posterior (P < 0.05) muscle sites. There was no significant change in LCSDs at the various muscle sites (P > 0.05). The results of this study suggest stabilization-type splints to be effective in reducing local muscle asymmetries. Further studies are warranted to evaluate muscle-site specific effects in patient and non-patient groups and to relate these effects to pre-treatment variables like bite force, preferred chewing side, facial morphology and occlusion.
Adult↗
Relationship between temporomandibular joint pain and magnetic resonance imaging findings of internal derangement.
In terms of clinical decision-making in instances of temporomandibular disorders (TMD) and orofacial pain, there is controversy in the literature over the diagnostic significance of the temporomandibular joint (TMJ)-related variable disk-condyle relationship (DCR). The purpose of this study was to investigate whether in patients with TMJ-related pain, the variable of TMJ pain may be linked to magnetic resonance (MR) imaging findings of internal derangement (ID). The study comprised 163 consecutive TMJ pain patients. Criteria for including a patient were report of orofacial pain referred to the TMJ, and the presence of uni- or bilateral TMJ pain during palpation, during function, and/or during unassisted or assisted mandibular opening. Bilateral sagittal and coronal MR images were obtained to establish the prevalence of TMJ ID types. Analysis of the data revealed the presence of TMJ pain to be associated with significantly more MR imaging diagnoses of ID than an absence of ID (P<0.001), and disk displacement without reduction than disk displacement with reduction (P<0.001). Using chi-square analysis, the results showed a significant relationship between the presence of TMJ-related pain and the MR imaging diagnosis of TMJ ID (P=0.001), and TMJ ID type (P=0.000). Use of the Kappa statistical test indicated poor diagnostic agreement between the presence of TMJ pain and the MR imaging diagnosis of ID (K=0.16). The results suggest that the clinical variable of TMJ pain may have a significant effect on the prevalences of MR imaging diagnoses of TMJ ID. The data confirm the biological concept of DCR as a diagnostic approach in patients with signs and symptoms of TMJ-related pain.
Adolescent↗
Temporomandibular joint internal derangement type III: relationship to magnetic resonance imaging findings of internal derangement and osteoarthrosis. An intraindividual approach.
The purpose of this study was to investigate whether in patients with a clinical unilateral temporomandibular joint (TMJ)-related finding of internal derangement type (ID)-III (disk displacement without reduction) in combination with TMJ-related pain, the intraindividual variable of 'unilateral TMJ ID-III pain' may be linked to subject-related magnetic resonance (MR) imaging findings of TMJ ID, and TMJ osteoarthrosis (OA). The study comprised 48 consecutive TMJ pain patients, who were assigned a clinical unilateral TMJ pain side-related diagnosis of ID-III. Bilateral sagittal and coronal MR images were obtained to establish the presence or absence of TMJ ID and/or OA. Comparison of the TMJ side-related data showed a significant relationship between the clinical finding of TMJ ID-III pain and the MR imaging diagnoses of TMJ ID (P=0.000) and TMJ ID type (P=0.000). There was no correlation between the clinical finding of TMJ ID-III pain and the MR imaging diagnosis of TMJ OA (P=0.217), nor between the MR imaging diagnosis of TMJ OA and that of TMJ ID (P=0.350). Regarding the diagnostic subgroups of TMJ ID, a significant relationship was found between the presence of TMJ OA and the MR imaging diagnoses of TMJ ID type(P=0.002). Use of the Kappa statistical test indicated a fair diagnostic agreement between the presence of TMJ ID-III pain and the MR imaging diagnosis of disk displacement without reduction (DDNR) (K=0.42). The results suggest that TMJ ID-III pain is related to TMJ-related MR imaging diagnoses of ID. Further, the data confirm the biological concept of 'DDNR and OA' as an underlying mechanism in the etiology of TMJ-related pain and dysfunction.
Adolescent↗
Efficacy and tolerability of escin/diethylamine salicylate combination gels in patients with blunt injuries of the extremities.
The aim of this confirmative, monocentre, double-blind, controlled clinical trial was to investigate whether different escin combinations show differences in comparison to placebo with regard to pain reactions in the topical treatment of sports injuries. A total of 126 patients with blunt injuries of the extremities were randomly allocated to four parallel groups: Reparil-Gel N (n = 32), Reparil-Gel (n = 31), Reparil-Sportgel (n = 32) and a placebo gel (n = 31). All patients were evaluated for efficacy (intention to treat) and tolerability. A per-protocol analysis was also carried out, in which 12 of the 126 patients were excluded due to protocol violations. The intention-to-treat and per-protocol analyses produced similar results. The patients had suffered contusions while participating in soccer, hockey, karate, tae-kwon-do, handball, American football, rugby or tennis. The measured variable was the pressure required at the centre of the lesion to elicit the first pain reaction (tenderness reaction) at measuring time 0 (baseline) and then 1, 2, 3, 4, 6 and 24 h after the injury. The primary variable was the area under the curve (AUC) for tenderness over a six-hour period. The mean AUC differed significantly in the four groups (Kruskal-Wallis test p = 0.0001). Then six pairwise comparisons of two treatment groups each were carried out using the Mann-Whitney test. To control the multiple significance level of 5%, the adjusted p-values according to the Holm-Shaffer method were used in these tests. The three active gels were significantly superior to the placebo gel (Mann-Whitney test, p = 0.0004 in each case) in terms of the AUC. There were no significant differences between the active test substances in terms of the primary variable. The intensity of the pain was also measured on a visual analogue scale (VAS). The pain diminished more rapidly with the Reparil gels than with the placebo. The tolerability of all test substances was good. No adverse events were observed in any of the 126 patients. Escin combination gels are more effective than a placebo and are also well tolerated. Therefore, they can be recommended for the treatment of blunt injuries caused during sports and leisure activities.
Administration, Topical↗