RESUMO
BACKGROUND: Major Depressive Disorder (MDD) is one of the common depressive disorder. MDD has high comorbidity and has greater implications on quality of life. Whole system Ayurveda management protocol (WSAP) is explored for it's possible role in management of MDD. OBJECTIVE: To evaluate the efficacy of Whole system Ayurveda management protocol on Major Depressive Disorder. MATERIAL AND METHODS: Study was a randomized controlled trial. Total 50 patients of MDD meeting the DSM V criteria, age group 20-70 years of either sex participated in the study. They were randomly divided into two groups, control group received Escitalopram 10 mg twice a day and Ayurveda group was on WSAP. Interventions were for 60 days. Assessments were done through various clinical parameters like Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (HARS), Brief psychiatric rating scale (BPRS), Pittsburgh Sleep Quality Index (PSQI), WHO Quality of Life- BREF (WHOQOL-BREF), Clinical Global Improvement scale (CGI), UKU Side effect scale. Assessments during intervention was on every 15th day. RESULTS: Study showed that Ayurveda group produced significant outcome improvement compared to control group in HDRS (p = 0.01), HARS (p = 0.03), PSQI (p = 0.03), WHOQOL-Bref (p < 0.001) and UKU side effect scale (p = 0.02). Both the group showed improvements in all the parameters except in WHOQOL-Bref where Ayurveda group only showed improvements (p < 0.001). Effect size showed large effect in WHOQOL-Bref. Mild side effects were reported in control group and none in Ayurveda group. CONCLUSION: WSAP was effective in management of MDD and had better side effect profile. Further studies needed.
RESUMO
BACKGROUND: Oral mucositis related pain during CTRT in head and neck cancers is a common problem. Unfortunately, in spite of it being common, there is limited evidence for selection of systemic analgesic in this situation. Hence, this study was designed to compare the analgesic effect of a non-steroidal anti-inflammatory drug (diclofenac) versus a weak opioid (tramadol). PATIENTS AND METHODS: This was an open-label, parallel design, superiority randomised controlled study. In this study, head and neck cancer patients undergoing radical or adjuvant chemoradiation, who had grade 1 or above mucositis (in accordance with Common Terminology Criteria for Adverse Events version 4.03) and had pain related to it were randomly assigned to either diclofenac or tramadol for mucositis related pain control. The primary endpoint was analgesia after the first dose. The secondary endpoints were the rate of change in analgesic within 1 week, adverse events and quality of life. RESULTS: One hundred and twenty-eight patients were randomised, 66 in diclofenac and 62 in tramadol arm. The median area under the curve for graph of pain across time after first dose of pain medication for the diclofenac arm and the tramadol arm was 348.936 units (range: 113.64-1,969.23) and 420.87 (101.97-1,465.96), respectively, (p = 0.05619). Five patients (8.1%) in the tramadol arm and 11 patients (16.7%) in the diclofenac arm required a change in analgesic within 1 week of starting the analgesic (p = 0.184). There was no statistically significant difference in any adverse events between the two arms. However, the rate of any grade of renal dysfunction was numerically higher in the diclofenac arm (10.6% versus 4.8%, p = 0.326). CONCLUSION: In this phase 3 study, evaluating diclofenac and tramadol for chemoradiation induced mucositis pain, there was no statistical difference in analgesic activity of these two drugs.
