A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs dexamethasone injection in rotator cuff syndrome: the TRAumeel in ROtator cuff syndrome (TRARO) study protocol.

BACKGROUND: Shoulder pain is a common musculoskeletal symptom with a wide range of potential causes; however, the majority of conditions can be managed with conservative treatment. The aim of this study is to assess the efficacy and safety of Traumeel injections versus corticosteroid injections and placebo in the treatment of rotator cuff syndrome and bursitis and expand the current evidence base for the conservative treatment of rotator cuff syndrome. METHODS/DESIGN: This is a multi-center, randomized, double-blind, 16-week, three-arm, parallel-group, active- and placebo-controlled trial to assess the efficacy and safety of Traumeel 2 ml injection versus dexamethasone 8 mg injection versus placebo (saline solution). Patients will be randomly allocated to Traumeel, dexamethasone or placebo in a 2:2:1 randomization. After 1 week screening, patients will receive 3 injections at weekly intervals (days 1, 8 and 15) with additional follow-up assessments on day 22, a telephone consultation in week 9 and a final visit at week 15. Male and female patients aged 40 to 65 years, inclusive, will be recruited if they have acute episodes of chronic rotator cuff syndrome and/or bursitis. Patients with calcifications in the shoulder joint or a complete rotator cuff tear will be excluded. At least 160 patients will be recruited. All subacromial injections will be performed under ultrasound guidance utilizing a common technique. The only rescue medication permitted will be paracetamol (acetaminophen), with usage recorded. The primary endpoint is change from baseline in abduction-rotation pain visual analog scale (0-100 mm scale, 0 corresponds to no pain and 100 to extreme pain) at day 22 (Traumeel injections versus dexamethasone injections) for active external rotation. Secondary efficacy parameters include range of motion, disability of arm, shoulder, hand score and patient's/investigator's global assessment. Clinical efficacy will be assessed as non-inferiority of Traumeel with respect to dexamethasone regarding the primary efficacy parameter. DISCUSSION: It is hoped that the results of this trial will expand the treatment options and evidence base available for the management of rotator cuff disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01702233 . EudraCT number: 2012-003393-12.

Topical steroids: Awareness and misuse among patients, pharmacists and general medical practitioner.

AIMS AND OBJECTIVES: (1) To determine the level of awareness among patients, pharmacists and general practitioners about commonly available topical steroids and its combinations.(2) To determine the source of recommendation/prescription of topical steroids and its combination creams.(3) To know and create awareness about the side effects of topical steroids in all the study groups. METHODS: This was a prospective questionnaire-based study where three study groups, namely patients, pharmacists and general practitioners, were included. This study was approved by the institutional ethics committee. after ethical clearance. The patients who used topical steroids for dermatoses where it is an absolute contraindication, as well as those who developed side effects, were included in the study. ThoroughComplete cutaneous examination was done specifically to detect the side effects of steroids. Seminars were conducted and questionnaires were given to both the pharmacists and general practitioners of nearby areas. The questionnaire consisted of questions regarding their prescription and dispensing practices of topical steroids and its combinations. RESULTS: Out of 95 patients seen, the most commonly used steroid molecule was clobetasol propionate 0.05% in 44 (46.3%) patients, the common source of recommendation was general practitioners in 36 (37.8%), the common indication was superficial dermatophytosis in 85 (89%) and the most common adverse effect was recurrence/increase in the extent of the infection in 72 (75.78%) patients. Out of total 44 general practitioners enrolled in the study, 22 (50%) were qualified allopathic medical practitioners and22 (50%) were homeopathic/ayurvedic doctors. Superficial dermatophytosis [19 (43.18%)] was the common dermatosis seen by them. While 29 (65.90%) preferred prescribing topical steroids or its combination, rest of them preferred plain steroid creams. Out of 179 pharmacists, 74 (41.34%) did not have appropriate knowledge of topical steroids, 35 (19.55%) were not aware that steroids are isschedule "H" drugs. Commonest molecule sold over the counterwas clobetasol propionate 0.05% by 74 (41.89%). The limitations of our study were small study group and short duration. CONCLUSION: As dermatologists, it is our responsibility, to correctly educate the society, particularly the non-dermatologist medical fraternity, about ethical and rational use of topical steroids.

Treatment of instability and spondylolisthesis: surgical versus nonsurgical treatment.

UNLABELLED: Spondylolisthesis is a common cause of lower-back pain, radiculopathy, and neurogenic claudication among the adult population. Treatment should begin with nonoperative measures that may include physical therapy, aerobic exercise, epidural steroid injections, and homeopathic remedies. If these treatments fail, surgical intervention may provide the patient pain relief and improvement in neurologic symptoms. The use of instrumentation for posterolateral fusions as well as interbody fusion may improve clinical outcomes for those having surgical intervention. We discuss the current nonoperative modalities and surgical techniques treating degenerative spondylolisthesis. LEVEL OF EVIDENCE: Level V: Expert Opinion. See the Guidelines for Authors for a complete description of the levels of evidence.

Evidence-based veterinary dermatology: a systematic review of the pharmacotherapy of canine atopic dermatitis.

The efficacy of pharmacological interventions used to treat canine atopic dermatitis, excluding fatty acid supplementation and allergen-specific immunotherapy, was evaluated based on the systematic review of prospective clinical trials published between 1980 and 2002. Studies were compared with regard to design characteristics (randomization generation and concealment, masking, intention-to-treat analyses and quality of enrolment of study subjects), benefit (improvement in skin lesions or pruritus scores) and harm (type, severity and frequency of adverse drug events) of the various interventions. Meta-analysis of pooled results was not possible because of heterogeneity of the drugs evaluated. Forty trials enrolling 1607 dogs were identified. There is good evidence for recommending the use of oral glucocorticoids and cyclosporin for the treatment of canine atopic dermatitis, and fair evidence for using topical triamcinolone spray, topical tacrolimus lotion, oral pentoxifylline or oral misoprostol. Insufficient evidence is available for or against recommending the prescription of oral first- and second-generation type-1 histamine receptor antagonists, tricyclic antidepressants, cyproheptadine, aspirin, Chinese herbal therapy, an homeopathic complex remedy, ascorbic acid, AHR-13268, papaverine, immune-modulating antibiotics or tranilast and topical pramoxine or capsaicin. Finally, there is fair evidence against recommending the use of oral arofylline, leukotriene synthesis inhibitors and cysteinyl leukotriene receptor antagonists.