. Effectiveness and safety of topical capsaicin cream in the treatment of chronic soft tissue pain. Phytotherapy Research, Wiley, 2010, 24 (12) AbstractTopical capsaicin is an established treatment option for various pain conditions. In a randomised double-blind multi-center study, 281 patients suffering from chronic soft tissue pain were treated either with a cream containing capsaicin 0.05% ("Finalgon® CPD Wärmecreme", n= 140) or placebo (n= 141). Of these, 151 were excluded from the ITT analysis, as they had in addition to their soft-tissue pain, pain of other origin.The primary outcome measure was a positive treatment response, defined as a pain sum score reduction of 30% or more. After 3 weeks of treatment, the median pain sum score had decreased by 49% (capsicum) group and 23% (placebo) (ITT analysis, p=0.0006). The odds ratio of the responders in favour for capsaicin was 4.3 (CI 97.5% lower limit 1.9, p < 0.0001).Improvements in the secondary efficacy measures confirmed the results. Likewise, all outcome measures had significantly more improved in the capsaicin-treated compared to the placebo-treated chronic back pain sufferers. All patients were included in the safety assessments. More adverse events occurred in the capsicum group (n=13) than in the placebo group (n=6). The capsaicin cream was generally well tolerated.Our results indicate that capsaicin cream is useful in patients with chronic soft tissue pain and is also efficacious in patients with chronic back pain for which effectiveness was already demonstrated in earlier clinical trials.

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

The Omron RS6 position sensor is an important function for a wrist device that improves measurement accuracy by decreasing variations in wrist height.

ObjectiveThe aim of the present study was to validate the custo screen 400 ambulatory blood pressure-monitoring (ABPM) device according to the 2010 International Protocol revision of the European Society of Hypertension (ESH-IP). The device can be used for ABPM for up to 72 hours.Materials and methodsSystolic and diastolic blood pressure (SBP and DBP, respectively) were sequentially measured in 33 adult subjects (13 males and 20 females) and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained.ResultsThe custo screen 400 met the requirements of parts 1 and 2 of the ESH-IP revision 2010. The mean difference between the device and reference sphygmomanometer readings was −0.5±4.5 mmHg for SBP and −0.1±3.3 mmHg for DBP. All but one measurement were within the absolute difference of 10 mmHg between the device and the observers for SBP and DBP. The number of absolute differences between the device and the observers within a range of 5 mmHg was 84 of 99 readings for SBP, and 93 of 99 readings for DBP.ConclusionThe custo screen 400 ABPM device met the requirements of the 2010 ESH-IP revision, and hence can be recommended for ABPM in adults. To our knowledge, the custo screen 400 is the first device to pass the revised ESH-IP 2010.

Benzocaine lozenges are popular in symptomatic treatment of acute sore throat. The aim of this study was to evaluate if sucking a benzocaine lozenge was superior to a placebo lozenge in patients with pain while swallowing. Volunteers with acute, uncomplicated sore throat received randomly and double-blind either a benzocaine 8 mg or a placebo lozenge. Pain was assessed on a numerical visual rating scale. The primary outcome measure was the sum of the pain intensity differences (SPID) over 2 h. Secondary outcome measures included the number of patients who reported 50% or more of their baseline pain score (responders) and those with worthwhile and complete pain relief, the times to worthwhile/complete pain relief and to pain recurrence and the occurrence of any adverse effects. A predefined interim analysis after including 50 patients revealed the superiority of benzocaine versus placebo in the SPID (p = 0.0086). At this time, a total of 165 patients had been recruited (full analysis set, FAS) and underwent statistical analysis. In the FAS, median SPID had significantly more decreased in patients receiving benzocaine compared to placebo (-12 vs. - 5, p = 0.001). There were significantly more responders and patients with worthwhile pain relief in group benzocaine. The number of patients with complete pain relief was very small. Median time to worthwhile pain relief was 20 min (benzocaine) and >45 min (placebo). Adverse events were not observed. Benzocaine lozenges are superior to placebo lozenges and a useful, well-tolerated treatment option to reduce painful pharyngeal discomfort.