Evaluation of efficacy of Valsalva for attenuating needle puncture pain in first time nonremunerated voluntary plateletpheresis donors: A prospective, randomized controlled trial
Asian journal of transfusion science. 2021;15(1):68-74
BACKGROUND Plateletpheresis is generally safe but may have adverse reactions. Adverse reactions can negatively influence donor recruitment and retention. Valsalva is a proven method of attenuating pain caused by venipuncture. AIMS The aim was to evaluate the efficacy of the Valsalva maneuver on the attenuation of needle pain and donor anxiety. SETTINGS AND DESIGN This prospective randomized controlled trial was conducted between November 2015 and April 2016 at the Department of Transfusion Medicine. SUBJECTS AND METHODS One-hundred and sixty consecutive donors were grouped into control group (C) and Valsalva group (V) each of sample size 80. The Valsalva group performed a Valsalva maneuver and control did nothing before the venipuncture. Anxiety and pain were scored using a 10 cm visual analog scale (VAS). Severity was graded as VAS = 0 defines no pain and anxiety, VAS = 1-3 as mild pain and anxiety, VAS = 4-6 as moderate pain and anxiety, VAS = 7-9 as severe pain and anxiety, whereas VAS = 10 denotes extreme pain and anxiety. STATISTICAL ANALYSIS Statistical Package for Social Sciences, version 23 was used for analysis. Independent samples t-test/Mann-Whitney U-test was used to compare between treatment and control group, whereas the Wilcoxon signed-rank test was used to test the difference between pre- and postobservations. RESULTS In the Valsalva group, post-Valsalva anxiety levels were significantly reduced to (1 [0-2]) from their pre-Valsalva values of (2 [0-3]); (P < 0.001). Pain was significantly lower (2[1-2]) in Valsalva group compared to control (4[2-5]); (P < 0.001). CONCLUSIONS Valsalva reduced both severity of venipuncture pain and anxiety. Valsalva can be performed by donors as it is an easy, painless, and nonpharmacological method of pain and anxiety attenuation.
A randomized phase II study of thalidomide with or without erythropoietin (EPO) in metastatic renal cell carcinoma (RCC)
Journal of Clinical Oncology. 2004;22((14_suppl)):4747.
4747 Background: Thalidomide (thal) (Celgene) produces tumor responses in some pts with mRCC, but also causes dose dependent fatigue. EPO (Ortho Biotech Products) improves overall quality of life [QOL] in cancer pts by raising hemoglobin (hgb) and reducing fatigue. We added EPO to thal in an effort to enhance its tolerability and efficacy. METHODS Pts with mRCC refractory to immune Rx were randomized to thal (100mg/d) or thal (100mg/d) + EPO (40,000 IU/wk). The dose of thal was escalated by 100mg/wk to 1g or MTD and EPO to 60,000 IU/wk in pts who failed to develop an hgb increase of 1g/dl after 4 wks. Tumor response was assessed by CT scan every 12 wks and QOL (FACT-An and Linear Analog scale) at baseline and q 4 wks for 24 wks. RESULTS To date, 25 patients (16 M, 9 F); median age 60 yrs (range 36-78); median prior Rx 2 (range 0-4); median number of metastatic sites 3.5 (range 1-7); median Motzer prognostic score 1 (range 0-3) have been enrolled since 4/11/01. 13 have received thal and 12 thal + EPO. Pts on thal had an MTD range from 100-700 (median 200), duration of Rx 2-59 wks (median 8 wks), mean baseline hgb (11.47 g/dl) and hgb variation from baseline range -3.3 to +1.8 (median -1.1 g/dl). Pts on thal + EPO had an MTD range from 100-800 (median 350), duration of Rx 1-119 wks (median 9 wks), mean baseline hgb (10.68 g/dl) and hgb variation from baseline -1.8 to +3.9 (median +0.95 g/dl). The mean change in hgb has been greater for pts on the thal + EPO arm (P=0.08, CI 1.062) Side effects (grade 1-2) including fatigue (80%), constipation (72%), N/V (52%), and neuropathy (40%) have occurred equally between arms. No responses (CR/PR) have been seen in either arm but 3 pts (thal [1pt], thal + EPO [2pts]) had SD lasting 24-119+ wks. So far, 21 of 25 pts have come off the study at or before wk 12 due to disease progression. CONCLUSIONS Addition of EPO to thal produced an improvement in baseline hgb. However, this improvement has not reached statistical significance. The effect of this rise in hgb on QOL will be analyzed at the completion of the study. Rapid disease progression in this poor prognosis pt population limits the ability to determine the impact of EPO on the clinical efficacy of thal at present. [Table: see text].