I read with great interest an article titled “Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial” by Zheng et al. [1] published in the May 2020 issue of the journal and would like to congratulate the authors for their study. Although they have touched a highly pertinent topic in a scientific manner, the study has brought an important issue that I would like to communicate with the authors.
Hip fractures are a well-known risk factor for deep vein thrombosis (DVT) and has been reported in 62% of all patients with hip fracture [2]. Guidelines [3,4,5] recommend use of some precautions against DVT. However, in this study, the authors used a placebo for the control group. The Declaration of Helsinki [6] defines how to use placebo as follows: “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: Where no proven intervention exists, ….”
I think the design of this study is ethically questionable.
References
Zheng X, Jia R, Li Y, Liu T, Wang Z (2020) Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial. Int Orthop. https://doi.org/10.1007/s00264-020-04610-0
Zahn HR, Skinner JA, Porteous MJ (1999) The preoperative prevalence of deep vein thrombosis in patients with femoral neck fractures and delayed operation injury. Injury 30(9):605–607. https://doi.org/10.1016/s0020-1383(99)00163-1
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW (2008) Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest 133(6 Suppl):381S–453S. https://doi.org/10.1378/chest.08-0656
Cardiovascular Disease Educational and Research Trust; Cyprus Cardiovascular Disease Educational and Research Trust; European Venous Forum; International Surgical Thrombosis Forum; International Union of Angiology; Union Internationale de Phlébologie (2006) Prevention and treatment of venous thromboembolism. International consensus statement (guidelines according to scientific evidence). Int Angiol. 25(2):101–161
Hill J, Treasure T (2007) Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients having surgery: summary of NICE guidance. BMJ. 334(7602):1053–1054. https://doi.org/10.1136/bmj.39174.678032.AD
WMA declaration of Helsinki—ethical principles for medical research involving human subjects. Available: https://www.wma.net/policiespost/wma-declaration-of-helsinki-ethical-principles-for-medicalresearch-involving-human-subjects/
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Shigemura, T. Letter to the editor regarding “Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial” by Zheng et al. International Orthopaedics (SICOT) 44, 2809 (2020). https://doi.org/10.1007/s00264-020-04776-7
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DOI: https://doi.org/10.1007/s00264-020-04776-7