This single-blind, placebo-controlled study assesses the efficacy of synergic administration of intravenous laser blood irradiation (ILBI) and etanercept in selected subtypes of juvenile idiopathic arthritis (JIA). Etanercept is a tumor necrosis factor alpha blocking agent with recognized importance in JIA. Laser radiation has immunomodulatory effects in animal and human studies. Fourteen patients (Group I) received ILBI and 9 patients (Group II) received placebo laser. ILBI was performed in addition to ongoing JIA medication, including etanercept. ILBI was administrated in 3 sets of 5 consecutive daily sessions, with a 7-week interval between every set of sessions. Evaluation was performed using ACR (American College of Rheumatology) Pediatric Criteria (ACR Pedi) at study enrollment and at 10 and 20 weeks, respectively. After 10 weeks, 85.7% of the patients in Group I fulfilled Pedi 30 criteria, compared to only 55.6% of the patients in Group II. After 20 weeks, all patients in both groups had a Pedi 30 response. In Group I, 92.8% of the subjects met the Pedi 50 response, compared to only 55.6% in the placebo group. One patient in Group I responded best, fulfilling Pedi 70 criteria. If applied synergistically, ILBI and etanercept would have an increased efficacy in promoting JIA remission.
Sublingual laser blood irradiation (SLBI) was applied into a randomized, single-blind, placebo-controlled study in juvenile idiopathic arthritis (JIA), aimed at inducing disease remission. 105 children with JIA, without an adequate response to classical treatment, were administrated a disease modifying drug (Methotrexate) and were randomly assigned to three groups. Group I (36 patients) received SLBI with the Weberneedle Lasershower Mouth Applicator with three wavelengths (635 nm, 536 nm, and 405 nm), 5 mW maximum output power each, in continuous mode, simultaneously, for 20 minutes daily, 7 successive sessions per month, repeated every 7 weeks, for three times. Group II (36 patients) received placebo SLBI. Group III (33 patients) received only treatment with Methotrexate. Evaluation was performed using American College of Rheumatology Pediatric criteria (ACR Pedi) at study enrollment and at 8, 16, 24, and 48 weeks. At the end of study, there was an improvement of the ACR Pedi 30 by 86.11% in SLBI group compared to only 61.11% in Group II, respectively, and 60.6% in Group III (P=0.001), with significant statistical differences. SLBI has reduced the pain, lowered the number of articulations with movement limitation, increased the quality of life, and made it possible to avoid the administration of biological agents.
This study presents effects of intravenous laser blood irradiation (ILBI) in a transient immunodeficiency patient with juvenile idiopathic arthritis (JIA) treated with an interleukin-6 receptor inhibitor (Tocilizumab). Biological agents induce JIA remission, but some patients do not respond favorably to this final therapeutic line of defense. ILBI was performed in a 16-year-old male patient, with JIA and transient immunodeficiency. When ILBI was introduced, the patient was receiving disease-modifying drugs, steroids, tocilizumab, and physical therapy. Because the disease was not well controlled, ILBI was applied in addition to other ongoing therapies. The patient underwent 1 session daily, and 10 successive sessions per month, repeated every 3 months, for 7 months. Patient evaluation was performed before ILBI was started and at 3, 6, 9, and 12 months after ILBI initiation, using the ACR Pediatric response. The outcome was evaluated using Pediatric 50, 70, and 90 responses and compared to initial status, after 3, 6, 9, and 12 months. At the end of study, the titre of IgA and IgG levels returned to normal. Synergistic anti-inflammatory effect of ILBI was evident, if applied additionally in combination with tocilizumab, in a patient with a therapy-resistant severe form of JIA and related subacute transient immunodeficiency.
, the angiotensin-converting enzyme [ACE] inhibitors, the calcium channel blockers [CCBs], and the α blockers (because they had some positive effects on different metabolic aspects) were any more effective in reducing cardiovascular events than a diuretic-in this case, chlorthalidone.There were data over many decades regarding the benefits of diuretic-based therapy in preventing both cerebrovascular as well as cardiovascular events in hypertension. Meta-analyses had also reported a decrease in all-cause mortality with these agents. There were no placebo-controlled hypertension morbidity trials with CCBs or ACE inhibitors when ALLHAT was planned and initiated and there has been only one placebo-controlled study with a CCB and no placebocontrolled studies with ACE inhibitors to demonstrate a reduction of cardiovascular events in hypertensive patients since then. We believed they were likely to be beneficial, but we had no data. Physicians were, however, using the newer classes of drugs more frequently while using fewer and fewer diuretics and β blockers.It was decided to determine how these newer drugs compared with a diuretic. The primary purpose of ALLHAT was to determine whether amlodipine (a CCB), lisinopril (an ACE inhibitor), or doxazosin (an α blocker) were better than a diuretic at preventing coronary events and other cardiovascular events.DR. MOSER: OK, but why did the ALLHAT investigators confine the study to an elderly population and choose to have more than 35% black patients? I understand that it is important to include these particular populations because hypertension is more common and may be more serious in these groups, but didn't you concern yourselves with the fact that this might skew the results in some way, and not be able to be generalized to the population at large? DR. CUSHMAN: No, we thought it was very important to get the answer in different age and racial groups, and the only way to do this was to have a fairly sizable representation. Black individuals have been underrepresented in many other hypertension trials except for a few in the United States; there also was very little likelihood that we would have much information about ACE inhibitors or calcium blockers in African Americans in other studies. So we selectively wanted to recruit more African Americans and to analyze them as a subgroup separately. The age group of ALLHAT is also representative of most hypertensives.
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