История контролируемых испытаний в медицине: реальные приоритеты малоизвестны. Сообщение 2. От ранних экспериментов до наших дней: без чередования и рандомизации

Обзор из трех сообщений посвящен историческому развитию клинических испытаний, контролируемых испытаний (англ. controlled trials, CT) и рандомизированных контролируемых испытаний (англ. randomized controlled trials, RCT), а также включению этих подходов в дисциплины, связанные со здоровьем (медицина и эпидемиология). В Сообщении 2 представлена характеристика известной библиотеки James Lind Library (JLL) и сформированной базы источников по теме. Отмечена интернациональность JLL, хотя большинство работ и принадлежит авторам из Великобритании. Многие исследования по теме истории CT и RCT отражены в публикациях JLL, но остаются невостребованными, не меняя общепринятых вех и приоритетов. Кроме того, в сформированную базу работ вошли 9 исследований, не отраженных в JLL, из которых 3 принципиальны. Шесть из них приведены в Сообщении 2.

Половина исторических вех по теме (всего 168) принадлежит Великобритании, 23% – США, 4% – Италии. Остальные 19 стран (древних, средневековых и современных) вносят вклады в 0,6–3,6% (Россия – 1,2% к XX в.). Самым ранним источником по теме истории CT является диссертация J.P. Bull (1951 г.). В сформированной базе на июль 2020 г. находилось более 260 публикаций, и только 9 из них – русскоязычные (2005–2018 гг.). В базу вошли 7 западных диссертаций по истории CT.

Объектом исследования Сообщения 2 являлись CT как таковые, без попыток рандомизации и даже квазирандомизации путем чередования (англ. alternate allocation). Сформирована наиболее полная тематическая таблица по нерандомизированным CT, включившая исследования от китайского императора Shen Nung (2373 г. до н.э.) и пророка Даниила (VI в. до н.э.) до прививки БЦЖ детям канадских индейцев (1941–1949 гг.). Выполнен поиск в PubMed на ‘non-randomized controlled trial’. Для периода 1990–2020 гг. обнаружено 303 публикации (до 32 статей в 2020 г.). Сравнительно с RCT число таких исследований мало (оценено в 0,08%), но важно наличие соответствующей конъюнктуры в современный период. Поскольку большинство используемых ныне препаратов и средств терапии разработаны без RCT, выявленная «бессмертность» CT даже без квазирандомизации может иметь социальное значение в тех случаях, когда ни RCT, ни даже квази-RCT провести невозможно, однако общественно-социальная необходимость требует получения хотя бы приблизительного ответа на острые вопросы из области здравоохранения (например, в 2020 г.).

1. Bull J.P. A study of the history and principles of clinical therapeutic trials. M.D. thesis, University of Cambridge; 1951: 80 p. URL: https://www.jameslindlibrary.org/wp-data/uploads/2014/05/bull-19511.pdf (дата обращения 21.06.2020).

2. Le Clerc D. Histoire de la medecine. Geneve: J.A. Chouet, D. Ritter;1696: 694 p.

3. The James Lind Library. Building the Library. URL: https://www.jameslindlibrary.org/about-the-library/building-the-library/ (дата обращения 23.06.2020).

4. Chalmers I., Milne I., Tröhler U., et al. The James Lind Library: explaining and illustrating the evolution of fair tests of medical treatments. J R Coll Physicians Edinb. 2008; 38 (3): 259–64.

5. Medical Research Council. Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. Brit Med J. 1948; 2 (4582): 769–82. https://doi.org/10.1136/bmj.2.4582.769.

6. Lock S. The randomised controlled trial – a British invention. In: Lawrence G. (Ed.) Technologies of modern medicine. London: Science Museum; 1994: 81–7.

7. Jadad A.R., Enkin M.W. Randomized controlled trials. Questions, answers, and musings. 2nd ed. Malden, Oxford, Carlton: BMJ Books; 2007: 136 p.

8. Котеров А.Н., Тихонова О.А., Ушенкова Л.Н., Бирюков А.П. История контролируемых испытаний в медицине: реальные приоритеты малоизвестны. Сообщение 1. Основные понятия, термины и дисциплины, использующие медицинский эксперимент: исторические и философские истоки. ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология. 2021; 14 (1): 72–98. https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.059.

9. Lind J. A treatise of the scurvy. In three parts. Containing an inquiry into the nature, causes and cure, of that disease. Together with a critical and chronological view of what has been published on the subject. Edinburgh: A Kincaid and A Donaldson; 1753. Classic Reprint. Forgotten Books; 2018: 508 p.

10. Watts G. Iain Chalmers: maverick master of medical evidence. Lancet. 2006; 368 (9554): 2203. https://doi.org/10.1016/S0140-6736(06)69879-6.

11. Gaddum J.H. Discoveries in therapeutics. J Pharm Pharmacol. 1954; 6 (8): 497–512. https://doi.org/10.1111/j.2042-7158.1954.tb10979.x.

12. Hansen E.V. The Attalids of Pergamon. Ithaca, New York: Cornell University Press; 1971: 500 p.

13. McCallum R.I. President's address. Observations upon antimony. Proc R Soc Med. 1977; 70 (11): 756–63.

14. Gurunluoglu A., Gurunluoglu R., Hakobyan T. A medieval physician: Amirdovlat Amasiatsi (1420–1495). J Med Biogr. 2019; 27 (2): 76–85. https://doi.org/10.1177/0967772016682726.

15. Junod S.W. FDA and clinical drug trials: a short history. In: Davies M., Kerimani F. (Eds.) A quick quide to clinical trial. Washington: DC Bioplan Inc.; 2008: 25–5.

16. Van den Broeck J., Brestoff J.R. (Eds.) Epidemiology: principles and practical guidelines. Dordrecht: Springer; 2013: 621 p.

17. McCord J. A thirty year follow-up of treatment effects. Am Psychol. 1978; 33 (3): 284–9. https://doi.org/10.1037//0003-066x.33.3.284.

18. Paterson R., Russell M.J. Clinical trials in malignant disease. Part III. J Fac Radiol. 1959; 10 (4): 175–80. https://doi.org/10.1016/S0368-2242(59)80048-8.

19. Hemminki E. Commentary on an early placebo controlled trial in Finland. In: JLL Bulletin: Commentaries on the history of treatment evaluation; 2005. URL: https://www.jameslindlibrary.org/articles/commentary-on-an-early-placebo-controlled-trial-in-finland/ (дата обращения 25.06.2020).

20. Garattini S. Italian controlled trials to assess prevention and treatment of malaria, 1900–1930s. J R Soc Med. 2019; 112 (8): 349–53. https://doi.org/10.1177/0141076819863289.

21. Hrobjartsson B., Gotzsche P.C., Gluud C. The controlled clinical trial turns 100 years: Fibiger’s trial of serum treatment of diphtheria. Brit Med J. 1998; 317 (7167): 1243–5. https://doi.org/10.1136/bmj.317.7167.1243.

22. Toth B. Pioneering controlled trials of treatments for erysipelas and pneumonia in Glasgow, 1936–1947. J R Soc Med. 2019; 112 (7): 304–12. https://doi.org/10.1177/0141076819856278.

23. Ramanna M. Nasarwanji Hormusji Choksy (1861–1939): a pioneer of controlled clinical trials. J R Soc Med. 2014; 107 (3): 120–2. https://doi.org/10.1177/0141076814523901.

24. Choksy N.H. Letter to the Editor: Professor Lustig’s plague serum. Lancet. 1900; 2: 291–92.

25. Van der Wijden C.L., Overbeke J.A. Audit of reports of randomised clinical trials published in one journal over 45 years. Brit Med J. 1995; 311 (7010): 918. https://doi.org/10.1136/bmj.311.7010.918.

26. Haffkine W.M. On preventive inoculation. Proc R Soc. 1900; 65 (1): 252–71. https://doi.org/10.1098/rspl.1899.0031.

27. Hawgood B.J. Waldemar Mordecai Haffkine, CIE (1860–1930): prophylactic vaccination against cholera in bubonic plague in British India. J Med Biogr. 2007; 15 (1): 9–19. https://doi.org/10.1258/j.jmb.2007.05-59.

28. Gachelin G., Garner P., Ferroni E., et al. Evaluating Cinchona bark and quinine for treating and preventing malaria. J R Soc Med. 2017; 110 (1): 31–40. https://doi.org/10.1177/0141076816681421.

29. Dean M.E. ‘An innocent deception’: placebo controls in the St. Petersburg homeopathy trial, 1829–1830. J R Soc Med. 2006; 99 (7): 375–6. https://doi.org/10.1258/jrsm.99.7.375.

30. Авксентьева М.В. Контролируемый эксперимент в медицине. История вопроса. Медицинские технологии. Оценка и выбор. 2011; 3: 88–93.

31. Двойрин В.В. Рандомизированные клинические испытания. Вопросы онкологии. 1982; 28 (4): 70–2.

32. Kiseleva E.S., Pitskhelauri V.G., Trakhtenberg A.K., et al. Results of radiotherapy and combined radiotherapy and chemotherapy of inoperable lung cancer. Neoplasma. 1983; 30 (5): 573–80.

33. Tröhler U. Quantification in British Medicine and Surgery 1750–1830, with special Reference to its Introduction into Therapeutics. PhD thesis: University of London; 1978: 552 p. URL: https://www.jameslindlibrary.org/wp-data/uploads/2014/05/troehler-1978.pdf (дата обращения 28.06.2020).

34. Cox-Maximov D. The making of the clinical trial in Britain, 1910–1945: expertise, the state and the public. PhD thesis: University of Cambridge; 1997: 395 p. URL: https://www.jameslindlibrary.org/wp/data/uploads/2014/05/cox-maksimov-1997.pdf (дата обращения 28.06.2020).

35. Toth B. Clinical trials in British medicine 1848–1948, with special reference to the development of the Randomised Controlled Trial. PhD thesis: University of Bristol, Department of Social Medicine; 1998: 371 p. URL: https://www.jameslindlibrary.org/wp-data/uploads/2014/05/toth-1998.pdf (дата обращения 28.06.2020).

36. Edwards M.V. Control and the therapeutic trial, 1918–1948. MD thesis: University of London; 2004: 142 p. URL: https://www.jameslindlibrary.org/wp-data/uploads/2014/05/edwards-2004.pdf (дата обращения 28.06.2020).

37. Williams K.J. British pharmaceutical industry, synthetic drug manufacture and the clinical testing of novel drugs 1895–1939. PhD thesis: University of Manchester; 2005: 484 p. URL: https://www.jameslindlibrary.org/wp-data/uploads/2014/05/williams-2005.pdf (дата обращения 28.06.2020).

38. Bothwell L. The emergence of the randomized controlled trial: origins to 1980. PhD. thesis: New York, Columbia University Academic Commons; 2014. URL: https://academiccommons.columbia.edu/doi/10.7916/D8K072V0 (дата обращения 28.06.2020).

39. Chalmers I., Dukan E., Podolsky S., Davey Smith G. The advent of fair treatment allocation schedules in clinical trials during the 19th and early 20th centuries. J R Soc Med. 2012; 105 (5): 221–7. https://doi.org/10.1258/jrsm.2012.12k029.

40. Feinstein A.R. Clinical epidemiology: the architecture of clinical research. Philadelphia: W.B. Saunders Company; 1985: 812 p.

41. Green F.H. The clinical evaluation of remedies. Lancet. 1954; 267 (6848): 1085–90. https://doi.org/10.1016/s0140-6736(54)90649-2.

42. Bull J.P. The historical development of clinical therapeutic trials. J Chronic Dis. 1959; 10 (3): 218–48. https://doi.org/10.1016/0021-9681(59)90004-9.

43. Lilienfeld A.M. The Fielding H. Garrison lecture: Ceteris paribus: the evolution of the clinical trial. Bull Hist Med. 1982; 56 (1): 1–18.

44. Morabia A. The controversial controversy of a passionate controversialist. J Clin Epidemiol. 2002; 55 (12): 1207–13. https://doi.org/10.1016/s0895-4356(02)00526-7.

45. Feinstein A.R. Meta-analysis: statistical alchemy for the 21st century. J Clin Epidemiol. 1995; 48 (1): 71–9. https://doi.org/10.1016/0895-4356(94)00110-c.

46. Брико Н.И., Полибин Р.В., Миндлина А.Я. Клиническая эпидемиология: история становления и перспективы развития. Медицинский альманах. 2012; 3: 28–31.

47. Власов В.В. О доказательной медицине, демографии, эпидемиологии и многом другом. Как эпидемиология добывает знания. URL: http://vechnayamolodost.ru/articles/vashe-zdorove/odokmeddem2aca/http://vechnayamolodost.ru/articles/vashe-zdorove/odokmeddem2aca/ (дата обращения 28.06.2020).

48. Варшавский С.Ю. Кто был первым? Международный журнал медицинской практики. 2005; 4: 12–3.

49. Петренко А. С миру по нитке: как соединились компоненты клинического исследования. URL: https://biomolecula.ru/articles/s-miru-po-nitke-kak-soedinilis-komponenty-klinicheskogo-issledovaniia (дата обращения 28.06.2020).

50. Всемирная история клинических исследований. Ветхозаветные исследования, 6 век до н.э. URL: http://clinical-trials.ru/8.html (дата обращения 28.06.2020).

51. Спасов А.А., Черников М.В. Основы доказательной медицины. Лекарственный вестник. 2007; 4 (1): 4–12.

52. Сергиенко В.И., Бондарева И.Б. Математическая статистика в клинических исследованиях. М.: ГЭОТАР-Медиа. 2006; 304 с.

53. Василенко В.В. Предыстория пустышки. Русский медицинский журнал. 2012; 20: 1058–61.

54. Талантов П. 0,05. Доказательная медицина от магии до поисков бессмертия. М.: АСТ; 2019: 769 с.

55. Мелихов О.Г. Клинические исследования. 3-е изд. М.: Атмосфера; 2013: 200 с.

56. Sigerist H.E. A history of medicine. Vol. 1. New York: Oxford University Press; 1951: 564 p.

57. Modjarrad K. A changing paradigm for medical research: the evolution of the clinical trial. Hektoen International Journal (A Journal of Medical Humanities). 2013; 5 (4). URL: https://hekint.org/2017/02/01/a-changing-paradigm-for-medical-research-the-evolution-of-the-clinical-trial/ (дата обращения 28.06.2020).

58. Nellhaus E.M., Davies T.H. Evolution of clinical trials throughout history. Marshall J Med. 2017; 3 (1): 41–8. http://dx.doi.org/10.18590/mjm.2017.vol3.iss1.9.

59. Mathews J.N. Introduction to randomized controlled clinical trials. Texts in statistical science. 2nd ed. Charman & Hall/CRC; 2006: 272 p.

60. Gallin J.I., Ognibene F.P. (Eds.) Principles and practice of clinical research. 3rd ed. Elsevier, Academic Press; 2018: 806 p. https://doi.org/10.1016/C2009-0-62909-3.

61. Fregni F., Illigens B.M. (Eds.) Critical thinking in clinical research: applied theory and practice using case studies. New York: Oxford University Press; 2018: 536 p.

62. Castiglioni A. A history of medicine. 2nd ed. New York: Alfred A. Knopf; 1947: 646 p.

63. Machin D., Day S., Green S. (Eds.) Textbook of clinical trials. 2nd ed. Chichester: John Wiley & Sons Ltd.; 2006: 763 p.

64. Ostbye T., Rochon J. An early ‘clinical trial’ as a teaching exercise: the Book of Daniel 1.1-15 (1.1-20). Med Educ. 1993; 27 (1): 97–101. https://doi.org/10.1111/j.1365-2923.1993.tb00236.x.

65. Grimes D.A. Clinical research in ancient Babylon: methodologic insights from the book of Daniel. Obstet Gynecol. 1995; 86 (6): 1031–4. https://doi.org/10.1016/0029-7844(95)00276-W.

66. Guyatt G., Sackett D., Adachi J., et al. A clinician's guide for conducting randomized trials in individual patients. CMAJ. 1988; 139 (6): 497–503.

67. Kulkarni K., Harrison J., Baguneid M., Prendergast B. (Eds.) Oxford handbook of key clinical evidence. 2nd ed. Oxford: Oxford University Press; 2016: 949 p.

68. Ibn Sina (c. 1012 CE; c. 402 AH). Kitab al-Qanun fi al-tibb (Avicenna’s The Canon of Medicine). URL: https://www.jameslindlibrary.org/ibn-sina-c-1012-ce-c-402-ah/ (дата обращения 29.06.2020).

69. Cingi C., Muluk N.B. Quick guide to good clinical practice: how to meet international quality. Springer International Publishing Switzerland; 2017: 255 p. https://doi.org/10.1007/978-3-319-44344-7.

70. Diggle G.E. Thalidomide: 40 years on. Int J Clin Pract. 2001; 55 (9):627–31.

71. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Perspect Clin Res. 2010; 1 (1): 6–10.

72. Chalmers I. Why the 1948 MRC trial of streptomycin used treatment allocation based on random numbers. J R Soc Med. 2011; 104 (9): 383–6. https://doi.org/10.1258/jrsm.2011.11k023.

73. Гашек Я. Камень жизни. В кн.: Рассказы и фельетоны. Прага: Лидове накладательстви; 1988: 37–41.

74. Read J. Prelude to chemistry; an outline of alchemy, its literature and relationships. London: G. Bell & Sons; 1936: 342 p.

75. Амасиаци А. Ненужное для неучей. М.: Наука; 1990: 880 с.

76. Oberbaum M., Lysy J., Gropp C. From Nebuchadnezzar to the randomized controlled trial – milestones in the development of clinical research. Harefuah. 2011; 150 (8): 668–71, 686 (in Hebrew).

77. Gordis L. Epidemiology. 5th ed. Philadelphia: Saunders, Elsevier Inc.; 2014: 392 p.

78. Baron J.H. Scurvy, Lancaster, Lind, Scott and Almroth Wright. J R Soc Med. 1997; 90 (7): 415. https://doi.org/10.1177/014107689709000726.

79. Tickner F.J., Medvei V.C. Scurvy and the health of European crews in the Indian Ocean in the seventeenth century. Med Hist. 1958; 2 (1): 36–46. https://doi.org/10.1017/s0025727300023255.

80. Baron J.H. Sailors' scurvy before and after James Lind – a reassessment. Nutr Rev. 2009; 67 (6): 315–32. https://doi.org/10.1111/j.1753-4887.2009.00205.x.

81. Mirza R.D., Punja S., Vohra S., Guyatt G. The history and development of N-of-1 trials. J R Soc Med. 2017; 110 (8): 330–40. https://doi.org/10.1177/0141076817721131.

82. Meldrum M.L. A brief history of the randomized controlled trial. From oranges and lemons to the gold standard. Hematol Oncol Clin North Am. 2000; 14 (4): 745–60. https://doi.org/10.1016/s0889-8588(05)70309-9.

83. Huth E.J. Benjamin Franklin's place in the history of medicine. J R Coll Physicians Edinb. 2007; 37 (4): 373–8.

84. Tröhler U. The introduction of numerical methods to assess the effects of medical interventions during the 18th century: a brief history. J R Soc Med. 2011; 104 (11): 465–74. https://doi.org/10.1258/jrsm.2011.11k025.

85. Bailey R., Howick J. Did John Stuart Mill influence the design of controlled clinical trials? J R Soc Med. 2019; 112 (6): 258–60. https://doi.org/10.1177/0141076819851759.

86. Lewis H.E. Medical aspects of polar exploration: sixtieth anniversary of Scott's last expedition. State of knowledge about scurvy in 1911. Proc R Soc Med. 1972; 65 (1): 39–42.

87. Susser M., Stein Z. Eras in epidemiology: the evolution of ideas. New York: Oxford University Press; 2009: 368 p.

88. Dodgson S. The evolution of clinical trials. EMWA. 2006; 15: 20–1.

89. Collier R. Legumes, lemons and streptomycin: a short history of the clinical trial. CMAJ. 2009; 180 (1): 23–4. https://doi.org/10.1503/cmaj.081879.

90. Mayer D. Essential evidence-based medicine. 2nd ed. Cambridge University Press; 2010: 442 p.

91. Tröhler U. Lind and scurvy: 1747 to 1795. J R Soc Med. 2005; 98 (11): 519–22. https://doi.org/10.1258/jrsm.98.11.519.

92. Louis-Courvoisier M. An 18th century controlled trial prompted by a potential shortage of hospital beds. J R Soc Med. 2007; 100 (10): 481–2. https://doi.org/10.1177/014107680710001020.

93. Short B. Dr Robert Robertson (1742–1829): fever specialist and philosopher-experimenter in the treatment of fevers with Peruvian bark in the latter eighteenth-century Royal Navy. Vesalius. 2015; 21 (2): 43–55.

94. Chick H., Dalyell E.J. Observations on the influence of foods in stimulating development in backward children. Brit Med J. 1921; 2 (3182): 1061–6. https://doi.org/10.1136/bmj.2.3182.1061.

95. Chick H., Dalyell E.J., Hume E.M., et al. Observations upon the prophylaxis and cure of rickets at the University Kinderklinik, Vienna. In: Medical Research Council. Studies of rickets in Vienna, 1919–22. Special Report Series No. 77. London: Her Majesty's Stationary Office: 19–94.

96. Carpenter K.J. Harriette Chick and the problem of rickets. J Nutr. 2008; 138 (5): 827–32. https://doi.org/10.1093/jn/138.5.827.

97. Minot G.R., Buckman T.E., Isaacs R. Chronic myelogenous leukemia: age, incidence, duration and benefit derived from irradiation. J Am Med Assoc. 1924; 82 (19): 1489–94. https://doi.org/10.1001/jama.1924.02650450001001.

98. Wayne E.J. Clinical observations on two pure glycosides of digitalis, digoxin and digitalinum verum. Clin. Sci. 1933; 1: 63–76.

99. Toth B. Why the MRC therapeutic trials committee did not introduce controlled clinical trials. J R Soc Med. 2015; 108 (12): 499–511. https://doi.org/10.1177/0141076815618891.

100. Bramwell J.C., Campbell M., Evans W. Harmol hydrochloride and o-n-propylharmol lactate in angina pectoris. Lancet. 1933; 222 (5732):69. https://doi.org/10.1016/S0140-6736(00)78542-4.

101. Spence J.C. Clinical tests of the antirachitic activity of calciferol. Lancet. 1933; 222 (5747): 911–5. https://doi.org/10.1016/S0140-6736(00)89131-X.

102. Kendrick P., Eldering G. A study in active immunization against pertussis. Am J Hyg. 1939; 29 (Sec. B): 133–53.

103. Marks H.M. The Kendrick-Eldering-(Frost) pertussis vaccine field trial. J R Soc Med. 2007; 100 (5): 242–7. https://doi.org/10.1177/014107680710000516.

104. Assinder E.W. Treatment of syphilis. Birmingham Med Rev. 1938; 13: 16–23.

105. Ferguson R.G., Simes A.B. BCG vaccination of indian Infants in Saskatchewan. Tubercle. 1949; 30 (1): 5–11. https://doi.org/10.1016/s0041-3879(49)80055-9.

106. Houston C.S. Ferguson's BCG research – Canada's first randomized clinical trial? Clin Invest Med. 1993; 16 (1): 89–91.

107. Quasi-randomised trial. European Patients' Academy (EUPATY). Glossary. URL: https://www.eupati.eu/glossary/quasi-randomised-trial/ (дата обращения 05.07.2020).

108. Власов В.В. Эпидемиология: учебное пособие. 2-е изд. М.: ГЭОТАР-Медиа; 2006: 464 с.

109. Hill A.B. The clinical trial. Br Med Bull. 1951; 7 (4): 278–82. https://doi.org/10.1093/oxfordjournals.bmb.a073919.

110. Chalmers I. Why transition from alternation to randomisation in clinical trials? Brit Med J. 1999; 319: (7221): 1372. https://doi.org/10.1136/bmj.319.7221.1372.

111. Davidson I., Hillier V.F. Comparison of four methods of allocation for clinical trials with small sample sizes. Physiotherapy. 2002; 88 (12): 722–9. https://doi.org/10.1016/S0031-9406(05)60715-8.

112. Papanastassiou I.D., Phillips F.M., Van Meirhaeghe J., et al. Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies. Eur Spine J. 2012; 21 (9): 1826–43. https://doi.org/10.1007/s00586-012-2314-z.

113. Moreira R.F., Foltran F.A., Albuquerque-Sendín F., et al. Comparison of randomized and non-randomized controlled trials evidence regarding the effectiveness of workplace exercise on musculoskeletal pain control. Work. 2012; 41 (Suppl. 1): 4782–9. https://doi.org/10.3233/WOR-2012-0764-4782.

114. Mueller D., Sauerland S., Neugebauer E.A., Immenroth M. Reported effects in randomized controlled trials were compared with those of nonrandomized trials in cholecystectomy. J Clin Epidemiol. 2010; 63 (10): 1082–90. https://doi.org/10.1016/j.jclinepi.2009.12.009.

115. Deeks J.J., Dinnes J., D’Amico R., et al. Evaluating non-randomised intervention studies. Health Technol Assess. 2003; 7 (27): iii–x, 1–173. https://doi.org/10.3310/hta7270.

116. Britton A., McKee M., Black N., et al. Choosing between randomised and non-randomised studies: a systematic review. Health Technol Assess. 1998; 2 (13): i–iv, 1–124. https://doi.org/10.1136/bmj.319.7205.312.

117. MacLehose R.R., Reeves B.C., Harvey I.M., et al. A systematic review of comparisons of effect sizes derived from randomised and non randomised studies. Health Technol Assess. 2000; 4 (34): 1–154. https://doi.org/10.3310/hta4340.

118. Schmoor C., Caputo A., Schumacher M. Evidence from nonrandomized studies: a case study on the estimation of causal effects. Am J Epidemiol. 2008; 167 (9): 1120–9. https://doi.org/10.1093/aje/kwn010.

119. Edwards J.P., Kelly E.J., Lin Y., et al. Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery. Can J Surg. 2012; 55 (3): 155–62. https://doi.org/10.1503/cjs.023410.

120. Weed D.L. Epidemiologic evidence and causal inference. Hematol Oncol Clin North Am. 2000; 14 (4): 797–807. https://doi.org/10.1016/S0889-8588(05)70312-9.

121. Worrall J. Why randomize? Evidence and ethics in clinical trials. In: Gonzalez W.J., Alcolea J. (Eds.) Contemporary perspectives in philosophy and methodology of science. A Coruna: Netbiblo; 2006: 65–82.

122. Vandenbroucke J.P. What is the best evidence for determining harms of medical treatment? CMAJ. 2006; 174 (5): 645–6. https://doi.org/10.1503/cmaj.051484.

123. Glasziou P., Chalmers I., Rawlins M., McCulloch P. When are randomised trials unnecessary? Picking signal from noise. Brit Med J. 2007; 334 (7589): 349–51. https://doi.org/10.1136/bmj.39070.527986.68.

124. Howick J. The philosophy of evidence-based medicine. Chichester: Wiley-Blackwell; 2011: 248 p.

125. Arditi C., Burnand B., Peytremann-Bridevaux I. Adding non randomised studies to a Cochrane review brings complementary information for healthcare stakeholders: an augmented systematic review and meta-analysis. BMC Health Serv Res. 2016; 16 (1): 598. https://doi.org/10.1186/s12913-016-1816-5.

126. Bothwell L.E., Podolsky S.H. The emergence of the randomized, controlled trial. N Engl J Med. 2016; 375 (6): 501–4. https://doi.org/10.1056/NEJMp1604635.