Placebo in the guise of evidence-based medications

Sergei Jargin

doi:10.17827/aktd.501826

TR

Placebo in the guise of evidence-based medications

Öz

Placebo therapy can be beneficial and ethically justifiable; but it is not a sufficient reason to publish biased information. Certain journals are selecting reliable reports but others are publishing biased materials and rejecting criticism. Publication series of questional reliability are sometimes continued without making references to published comments. Theories have been construed for promotion of some drugs and dietary supplements without proven effectiveness. This review is a collection of examples, when substances with unproven effects and unclear action mechanisms are directly or indirectly presented by professional publications as evidence-based medications. Some of the topics might be not completely clarified, so that arguments provided here can induce a constructive discussion.

Anahtar Kelimeler

placebo,hormesis,nutrition,phytoestrogens,soy,osteoarthritis

Kaynakça

1. Linde K, Fässler M, Meissner K. Placebo interventions, placebo effects and clinical practice. Philos Trans R Soc Lond B Biol Sci. 2011;366:1905–12.
2. Mattson MP, Calabrese EJ. Hormesis. A Revolution in Biology, Toxicology and Medicine. New York, Springer, 2010.
3 Jargin SV. Hormesis and homeopathy: The artificial twins. J Complement Med Res. 2015;4(1):74-77. doi: 10.5455/jice.20140929114417
4. Calabrese EJ, Calabrese V, Giordano J. The role of hormesis in the functional performance and protection of neural systems. Brain Circ. 2017;3(1):1–13.
5. Moffett JR. Miasmas, germs, homeopathy and hormesis: commentary on the relationship between homeopathy and hormesis. Hum Exp Toxicol. 2010;29:539–43.
6. Nebera SA. Homeopathic preparation for the treatment of myopia. Patent RU2203674C1, 2003.
7. Ostreikovskii IE. Treatment method of acute pneumonia. Patent RU2063224C1, 1996.
8. Chernozubov IE. The medications and method of tuberculosis treatment. Patent RU2119338C1, 1996.
9. Epshtein OI. The medications and treatment method of pathological syndrome. Patent RU2192888C1, 2002.
10. Luchkin VA. Method of treatment of degenerative - dystrophic diseases of locomotor system. Patent RU2015147929A, 2016.

11. Jargin SV. Hormetic use of stress in gerontological interventions requires a cautious approach. Biogerontology 2016;17:417–20.
12. Calabrese E, Iavicoli I, Calabrese V. Hormesis: Its impact on medicine and health. Hum Exp Toxicol. 2013;32:120–52.
13. Calabrese EJ, Iavicoli I, Calabrese V. Hormesis: why it is important to biogerontologists. Biogerontology 2012;13:215–35.
14. Patisaul HB. Endocrine disruption by dietary phyto-oestrogens: impact on dimorphic sexual systems and behaviours. Proc Nutr Soc. 2017;76(2):130–44.
15. Rietjens IMCM, Louisse J, Beekmann K. The potential health effects of dietary phytoestrogens. Br J Pharmacol. 2017;174(11):1263–80.
16. Messina M. Soy and health update: evaluation of the clinical and epidemiologic literature. Nutrients. 2016;8(12).
17. Cederroth CR, Zimmermann C, Nef S. Soy, phytoestrogens and their impact on reproductive health. Mol Cell Endocrinol. 2012;355:192–200.
18. Gencel VB, Benjamin MM, Bahou SN, Khalil RA. Vascular effects of phytoestrogens and alternative menopausal hormone therapy in cardiovascular disease. Mini Rev Med Chem. 2012;12:149–74.
19. Taku K, Melby MK, Kronenberg F, Kurzer MS, Messina M. Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials. Menopause 2012;19:776–90.
20. Baber R. Phytoestrogens and post reproductive health. Maturitas 2010;66:344–9.
21. Gold EB, Leung K, Crawford SL, Huang MH, Waetjen LE, Greendale GA. Phytoestrogen and fiber intakes in relation to incident vasomotor symptoms: results from the Study of Women's Health Across the Nation. Menopause 2013;20:305–14.
22. Lethaby AE, Brown J, Marjoribanks J, Kronenberg F, Roberts H, Eden J. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2007;(4):CD001395.
23. Krebs EE, Ensrud KE, MacDonald R, Wilt TJ. Phytoestrogens for treatment of menopausal symptoms: a systematic review. Obstet Gynecol. 2004;104:824–36.
24. Cheema D, Coomarasamy A, El-Toukhy T. Non-hormonal therapy of post-menopausal vasomotor symptoms: a structured evidence-based review. Arch Gynecol Obstet. 2007;276:463–9.
25. Al-Azzawi F, Wahab M. Effectiveness of phytoestrogens in climacteric medicine. Ann N Y Acad Sci. 2010;1205:262–7.
26. Villaseca P. Non-estrogen conventional and phytochemical treatments for vasomotor symptoms: what needs to be known for practice. Climacteric 2012;15:115–24.
27. Sirtori CR, Arnoldi A, Johnson SK. Phytoestrogens: end of a tale? Ann Med. 2005;37:423–38.
28. Davis SR. Phytoestrogen therapy for menopausal symptoms? BMJ 2001;323:354–5.
29. Coxam V. Phyto-oestrogens and bone health. Proc Nutr Soc. 2008;67:184–95.
30. This P, de Cremoux P, Leclercq G, Jacquot Y. A critical view of the effects of phytoestrogens on hot flashes and breast cancer risk. Maturitas 2011;70:222–6.
31. Haimov-Kochman R, Brzezinski A, Hochner-Celnikier D. Herbal remedies for menopausal symptoms: are we cautious enough? Eur J Contracept Reprod Health Care 2008;13:133–7.
32. Wilson S, Blaschek K, de Mejia E. Allergenic proteins in soybean: processing and reduction of P34 allergenicity. Nutr Rev. 2005;63:47–58.
33. de Villiers TJ, Bagratee JS, Dalmeyer JP, Davey MR, Davis CP, Guidozzi F et al. South African Menopause Society Council revised consensus position statement on menopausal hormone therapy. S Afr Med J. 2007;97:354–7.
34. Wuttke W, Jarry H, Seidlová-Wuttke D. Isoflavones - safe food additives or dangerous drugs? Ageing Res Rev. 2007;6:150–88.
35. Leclercq G, de Cremoux P, This P, Jacquot Y. Lack of sufficient information on the specificity and selectivity of commercial phytoestrogens preparations for therapeutic purposes. Maturitas 2011;68:56–64.
36. Usui T. Pharmaceutical prospects of phytoestrogens. Endocr J. 2006;53:7–20
37. Setchell KD, Clerici C. Equol: history, chemistry, and formation. J Nutr. 2010;140:1355S–62S.
38. Rizzo G, Baroni L. Soy, soy foods and their role in vegetarian diets. Nutrients 2018;10(1).
39. van Duursen MBM. Modulation of estrogen synthesis and metabolism by phytoestrogens in vitro and the implications for women's health. Toxicol Res (Camb) 2017;6(6):772–794.
40. Czuczwar P, Paszkowski T, Lisiecki M, Woźniak S, Stępniak A. The safety and tolerance of phytotherapies in menopausal medicine - a review of the literature. Prz Menopauzalny 2017;16(1):8–11.
41. Adgent MA, Daniels JL, Edwards LJ, Siega–Riz AM, Rogan WJ. Early-life soy exposure and gender - role play behavior in children. Environ Health Perspect. 2011;119:1811–16.
42. Martinez J, Lewi JE. An unusual case of gynecomastia associated with soy product consumption. Endocr Pract. 2008;14:415–8.
43. Jacobsen BK, Jaceldo–Siegl K, Knutsen SF, Fan J, Oda K, Fraser GE. Soy isoflavone intake and the likelihood of ever becoming a mother: the Adventist Health Study-2. Int J Womens Health 2014;6:377–84.
44. Adgent MA, Daniels JL, Rogan WJ, Adair L, Edwards LJ, Westreich D, Maisonet M, Marcus M. Early-life soy exposure and age at menarche. Paediatr Perinat Epidemiol. 2012;26(2):163–75.
45. Jefferson WN, Williams CJ. Circulating levels of genistein in the neonate, apart from dose and route, predict future adverse female reproductive outcomes. Reprod Toxicol. 2011;31:272–9.
46. Whitten PL, Lewis C, Russell E, Naftolin F. Potential adverse effects of phytoestrogens. J Nutr. 1995;125:771S–6S.
47. Dean M, Murphy BT, Burdette JE. Phytosteroids beyond estrogens: Regulators of reproductive and endocrine function in natural products. Mol Cell Endocrinol. 2017;442:98–105.
48. Jargin SV. Soy and phytoestrogens: possible side effects. Ger Med Sci. 2014;12:Doc18.
49. Saayman BD. The use of alternative lipid emulsions in paediatric and neonatal parenteral nutrition. S Afr J Clin Nutr. 2011;24:S32–4.
50. Messina M. Soybean isoflavone exposure does not have feminizing effects on men: a critical examination of the clinical evidence. Fertil Steril. 2010;93:2095–104.
51. Jargin SV. Replacement therapy in menopause: estrogens and phytoestrogens. Ukrainian Med J online 2012 https://www.umj.com.ua/article/43348 (accessed Dec 2018). (Russian)
52. Nikitina NA, Sobenin IA, Myasoedova VA, Korennaya VV, Mel'nichenko AA, Khalilov EM et al. Antiatherogenic effect of grape flavonoids in an ex vivo model. Bull Exp Biol Med. 2006;141:712–5.
53. Orekhov AN, Sobenin IA, Korneev NV, Kirichenko TV, Myasoedova VA, Melnichenko AA et al. Anti-Atherosclerotic Therapy Based on Botanicals. Recent Pat Cardiovasc Drug Discov. 2013;8:56–66.
54. Orekhov AN, Sobenin IA, Kirichenko TV, Myasoedova VA, Mel'nichenko AA, Orekhova VA. Method of atherosclerosis prevention and treatment. Patent RU2455016, 2011.
55. Jargin SV. Cell culture as a testing system for anti-atherogenic aubstances: a brief communication. Acta Pharmaceutica Sciencia 2008;50(3):237–40. http://www.actapharmsci.com/abstract.php?id=168 (accessed Dec 2018).
56. Kuznetsova IV, Kirpikov AS, Khovrina EA. Method of treating benign hyperplastic processes of female reproductive system. Patent RU2471485C1, 2013.
57. Bruyère O, Cooper C, Pelletier JP, Maheu E, Rannou F, Branco J, Luisa Brandi M, Kanis JA, Altman RD, Hochberg MC, Martel-Pelletier J, Reginster JY. A consensus statement on the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) algorithm for the management of knee osteoarthritis - From evidence-based medicine to the real-life setting. Semin Arthritis Rheum. 2016;45(4 Suppl):S3–11.
58. Vista ES, Lau CS. What about supplements for osteoarthritis? A critical and evidenced-based review. Int J Rheum Dis. 2011;14:152–8.
59. Wandel S, Jüni P, Tendal B, Nüesch E, Villiger PM, Welton NJ, Reichenbach S, Trelle S. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ. 2010;341:c4675.
60. Wood MJ. Conclusion not consistent with results. BMJ Rapid Response, 24 September 2010. https://www.bmj.com/rapid-response/2011/11/03/conclusion-not-consistent-results (accessed Dec 2018).
61. Black C, Clar C, Henderson R, MacEachern C, McNamee P, Quayyum Z, Royle P, Thomas S. The clinical effectiveness of glucosamine and chondroitin supplements in lowing or arresting progression of osteoarthritis of the knee: a systematic review and economic evaluation. Health echnol Assess (Rockv) 2009;13:1–148.
62. Volpi N. Quality of different chondroitin sulfate preparations in relation to their therapeutic activity. J Pharm Pharmacol. 2009;61:1271–80.
63. Wehling P, Evans C, Wehling J, Maixner W. Effectiveness of intra-articular therapies in osteoarthritis: a literature review. Ther Adv Musculoskelet Dis. 2017;9(8):183–196.
64. Arrich J, Piribauer F, Mad P, Schmid D, Klaushofer K, Mullner M. Intra-articular hyaluronic acid for the treatment of osteoarthritis of the knee: systematic review and meta-analysis. CMAJ 2005;172:1039–43.
65. Rutjes AW, Jüni P, da Costa BR, Trelle S, Nüesch E, Reichenbach S. Viscosupplementation for osteoarthritis of the knee: a systematic review and meta-analysis. Ann Intern Med. 2012;157(3):180–91.
66. Nguyen C, Lefèvre-Colau MM, Poiraudeau S, Rannou F. Evidence and recommendations for use of intra-articular injections for knee osteoarthritis. Ann Phys Rehabil Med. 2016;59(3):184–9.
67. Lohmander LS, Dalén N, Englund G, Hämäläinen M, Jensen EM, Karlsson K, Odensten M, Ryd L, Sernbo I, Suomalainen O, Tegnander A. Intra-articular hyaluronan injections in the treatment of osteo-arthritis of the knee: a randomised, double blind, placebo controlled multicentre trial. Hyaluronan Multicentre Trial Group. Ann Rheum Dis. 1996;55:424–31.
68. Brandt KD, Smith GN Jr, Simon LS. Intraarticular injection of hyaluronan as treatment for knee osteoarthritis: what is the evidence? Arthritis Rheum. 2000;43:1192–203.
69. Machado RC, Capela S, Rocha FAC. Polysaccharides as viscosupplementation agents: structural molecular characteristics but not rheology appear crucial to the therapeutic response. Front Med (Lausanne) 2017;4:82.
70. Uebelhart D. Clinical review of chondroitin sulfate in osteoarthritis. Osteoarthritis Cartilage 2008;16(Suppl 3):S19–21.
71. Leighton R, Fitzpatrick J, Smith H, Crandall D, Flannery CR, Conrozier T. Systematic clinical evidence review of NASHA (Durolane hyaluronic acid) for the treatment of knee osteoarthritis. Open Access Rheumatol. 2018;10:43–54.
72. Weihrauch TR. Placebo treatment is effective differently in different diseases – but is it also harmless? A brief synopsis. Sci Eng Ethics 2004;10:151–5.
73. Kulikov VG, Shusharin AG, Makhotin AA, Shevela AI. Method of treating coxarthrosis. Patent RU2396961C1, 2010.
74. Migliore A, Anichini S. Intra-articular therapy in hip osteoarthritis. Clin Cases Miner Bone Metab. 2017;14:179–81.
75. Altman R, Hackel J, Niazi F, Shaw P, Nicholls M. Efficacy and safety of repeated courses of hyaluronic acid injections for knee osteoarthritis: A systematic review. Semin Arthritis Rheum. 2018;48(2):168–175.
76. Xing D, Wang B, Liu Q, Ke Y, Xu Y, Li Z, Lin J. Intra-articular hyaluronic acid in treating knee osteoarthritis: a PRISMA–compliant systematic review of overlapping meta-analysis. Sci Rep. 2016;6:32790.
77. Jargin SV. Supplementation of glycosaminoglycans and their precursors in osteoarthritis versus diet modification. Int J Rheum Dis. 2012;15(3):e45–6.
78. Jargin SV. Glycosaminoglycans and their precursors in osteoarthritis. Open Vet J. 2018; https://www.openveterinaryjournal.com/letters-to-the-editor (accessed Dec 2018).
79. Tikhonov VP, Sidliarov DP, Zaveshchevskaia TL. Agent for care of peripheral joints and backbone area. Patent RU2376011C1, 2009.
80. Bhathal A, Spryszak M, Louizos C, Frankel G. Glucosamine and chondroitin use in canines for osteoarthritis: A review. Open Vet J. 2017;7(1):36–49.
81. Nicolaides AN, Cardiovascular Disease Educational and Research Trust, European Society of Vascular Surgery, The International Angiology Scientific Activity Congress Organization, International Union of Angiology et al. Investigation of chronic venous insufficiency: a consensus statement (France, March 5-9, 1997). Circulation 2000;102(20):E126–63.
82. Gattuso G, Barreca D, Gargiulli C, Leuzzi U, Caristi C. Flavonoid composition of Citrus juices. Molecules 2007;12(8):1641–73.
83. Brglez Mojzer E, Knez Hrnčič M, Škerget M, Knez Ž, Bren U. Polyphenols: extraction methods, antioxidative action, bioavailability and anticarcinogenic effects. Molecules 2016;21(7).
84. Mansilha A, Sousa J. Pathophysiological mechanisms of chronic venous disease and implications for venoactive drug therapy. Int J Mol Sci. 2018;19(6).
85. Katsenis K. Micronized purified flavonoid fraction (MPFF): a review of its pharmacological effects, therapeutic efficacy and benefits in the management of chronic venous insufficiency. Curr Vasc Pharmacol. 2005;3(1):1–9.
86. Danielsson G, Jungbeck C, Peterson K, Norgren L. A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease. Eur J Vasc Endovasc Surg. 2002;23:73–6.
87. Martinez-Zapata MJ, Vernooij RW, Uriona Tuma SM, Stein AT, Moreno RM, Vargas E et al. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2016;(4):CD003229.
88. Kharkevich DA. The principles of action and use of phlebotropic agents. Klin Med (Mosk) 2004;82(11):4–10.
89. Bevan JA. Some bases of differences in vascular response to sympathetic activity. Circ Res. 1979; 45:161–71.
90. Perrin M, Ramelet AA. Pharmacological treatment of primary chronic venous disease: rationale, results and unanswered questions. Eur J Vasc Endovasc Surg. 2011;41(1):117–25.
91. Duarte J, Peérez-Vizcaiíno F, Zarzuelo A, Jimeénez J, Tamargo J. Vasodilator effects of quercetin in isolated rat vascular smooth muscle. Eur J Pharmacol. 1993;239(1–3):1–7.
92. Schmitt M, Blackman DJ, Middleton GW, Cockcroft JR, Frenneaux MP. Assessment of venous capacitance. Radionuclide plethysmography: methodology and research applications. Br J Clin Pharmacol. 2002;54(6):565–76.
93. Aellig WH. Clinical pharmacology, physiology and pathophysiology of superficial veins - 2. Br J Clin Pharmacol. 1994;38:289–305.
94. Ivanov IS, Sidekhmenova AV, Nosarev AV, Tyukavkina NA, Plotnikov MB. Effect of dihydroquercetin on the tone of isolated rat veins. Bull Exp Biol Med. 2013;155(1):65–6.
95. Savineau JP, Marthan R. Diosmin–induced increase in sensitivity to Ca2+ of the smooth muscle contractile apparatus in the rat isolated femoral vein. Br J Pharmacol. 1994;111:978–80.
96. Testai L, Calderone V. Nutraceutical value of citrus flavanones and their implications in cardiovascular disease. Nutrients 2017;9(5):502.
97. Takumi H, Nakamura H, Simizu T, Harada R, Kometani T, Nadamoto T et al. Bioavailability of orally administered water-dispersible hesperetin and its effect on peripheral vasodilatation in human subjects: implication of endothelial functions of plasma conjugated metabolites. Food Funct. 2012;3(4):389–98.
98. Scallon C, Bell-Syer SE, Aziz Z. Flavonoids for treating venous leg ulcers. Cochrane Database Syst Rev. 2013;(5):CD006477.
99. Aziz Z, Tang WL, Chong NJ, Tho LY. A systematic review of the efficacy and tolerability of hydroxyethylrutosides for improvement of the signs and symptoms of chronic venous insufficiency. J Clin Pharm Ther. 2015;40:177–85.
100. Kakkos SK, Nicolaides AN. Efficacy of micronized purified flavonoid fraction (Daflon®) on improving individual symptoms, signs and quality of life in patients with chronic venous disease: a systematic review and meta-analysis of randomized double-blind placebo-controlled trials. Int Angiol. 2018;37(2):143–54.
101. Geroulakos G, Nicolaides AN. Controlled studies of Daflon 500 mg in chronic venous insufficiency. Angiology 1994;45(6 Pt 2):549–53.
102. Duchene Marullaz P, Amiel M, Barbe R. Evaluation of the clinical pharmacological activity of a phlebotonic agent. Application to the study of Daflon 500 mg. Int Angiol. 1988;7(2 Suppl):25–32.
103. Allaert FA. Meta-analysis of the impact of the principal venoactive drugs agents on malleolar venous edema. Int Angiol. 2012;31(4):310–5.
104. Rabe E, Agus GB, Roztocil K. Analysis of the effects of micronized purified flavonoid fraction versus placebo on symptoms and quality of life in patients suffering from chronic venous disease: from a prospective randomized trial. Int Angiol. 2015;34:428–36.
105. Giorgio M. Oxidative stress and the unfulfilled promises of antioxidant agents. Ecancermedicalscience 2015;9:556.
106. Abu Raihan SM. Effect of plant flavonoids on mosquito larvae. Nat Univ J Sci. 2014;1:27–30.
107. Lorent K, Gong W, Koo KA, Waisbourd-Zinman O, Karjoo S, Zhao X et al. Identification of a plant isoflavonoid that causes biliary atresia. Sci Transl Med. 2015;7(286):286ra67.
108. Goszcz K, Deakin SJ, Duthie GG, Stewart D, Leslie SJ, Megson IL. Antioxidants in cardiovascular therapy: panacea or false hope? Front Cardiovasc Med. 2015;2:29.
109. Duda-Chodak A. The inhibitory effect of polyphenols on human gut microbiota. J Physiol Pharmacol. 2012;63(5):497–503.
110. Sathe NA, Krishnaswami S, Andrews J, Ficzere C, McPheeters ML. Pharmacologic agents that promote airway clearance in hospitalized subjects: a systematic review. Respir Care 2015;60:1061–70.
111. Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respir Care 2007;52:1176–93.
112. Cazzola M, Calzetta L, Page C, Jardim J, Chuchalin AG, Rogliani P et al. Influence of N–acetylcysteine on chronic bronchitis or COPD exacerbations: a meta–analysis. Eur Respir Rev. 2015;24:451–61.
113. Decramer M, Rutten-van Mölken M, Dekhuijzen PN, Troosters T, van Herwaarden C, Pellegrino R et al. Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease (Bronchitis Randomized on NAC Cost-Utility Study, BRONCUS): a randomised placebo-controlled trial. Lancet 2005;365:1552–60.
114. Rubin BK. Aerosol medications for treatment of mucus clearance disorders. Respir Care 2015;60:825–9.
115. Tam J, Nash EF, Ratjen F, Tullis E, Stephenson A. Nebulized and oral thiol derivatives for pulmonary disease in cystic fibrosis. Cochrane Database Syst Rev. 2013;(7):CD007168.
116. Black PN, Morgan-Day A, McMillan TE, Poole PJ, Young RP. Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease ISRCTN21676344.. BMC Pulm Med. 2004;4:13.
117. Rubin BK. Mucolytics, expectorants, and mucokinetic medications. Respir Care 2007;52:859–65.
118. Poole PJ, Black PN. Oral mucolytic drugs for exacerbations of chronic obstructive pulmonary disease: systematic review. BMJ 2001;322:1271–4.
119. Gerrits CM, Herings RM, Leufkens HG, Lammers JW. N-acetylcysteine reduces the risk of re-hospitalisation among patients with chronic obstructive pulmonary disease. Eur Respir J. 2003;21:795–8.
120. Ernst P, Suissa S. N-acetylcysteine is unlikely to reduce hospitalisation for chronic obstructive pulmonary disease. Eur Respir J. 2003;22:865.
121. Sun T, Liu J, Zhao de W. Efficacy of N-Acetylcysteine in Idiopathic Pulmonary Fibrosis: A Systematic Review and Meta-Analysis. Medicine (Baltimore) 2016;95(19):e3629.
122. Otu A, Langridge P, Denning DW. Nebulised N-acetylcysteine for unresponsive bronchial obstruction in allergic brochopulmonary aspergillosis: a case series and review of the literature. J Fungi (Basel) 2018;4(4).
123. Rodenstein D, DeCoster A, Gazzaniga A. Pharmacokinetics of oral acetylcysteine: absorption, binding and metabolism in patients with respiratory disorders. Clin Pharmacokinet. 1978;3:247–54.
124. Bridgeman MM, Marsden M, MacNee W, Flenley DC, Ryle AP. Cysteine and glutathione concentrations in plasma and bronchoalveolar lavage fluid after treatment with N-acetylcysteine. Thorax 1991;46:39–42.
125. Cotgreave IA, Eklund A, Larsson K, Moldéus PW. No penetration of orally administered N-acetylcysteine into bronchoalveolar lavage fluid. Eur J Respir Dis. 1987;70:73–77.
126. Millar AB, Pavia D, Agnew JE, Lopez–Vidriero MT, Lauque D, Clarke SW. Effect of oral N-acetylcysteine on mucus clearance. Br J Dis Chest. 1985;79(3):262–6.
127. Holdiness MR. Clinical pharmacokinetics of N-acetylcysteine. Clin Pharmacokinet. 1991;20:123–34.
128. Dinicola S, De Grazia S, Carlomagno G, Pintucci JP. N-acetylcysteine as powerful molecule to destroy bacterial biofilms. A systematic review. Eur Rev Med Pharmacol Sci. 2014;18:2942–8.
129. Pintucci JP, Corno S, Garotta M. Biofilms and infections of the upper respiratory tract. Eur Rev Med Pharmacol Sci. 2010;14:683–90.
130. Smith A, Buchinsky FJ, Post JC. Eradicating chronic ear, nose, and throat infections: a systematically conducted literature review of advances in biofilm treatment. Otolaryngol Head Neck Surg. 2011;144:338–47.
131. Bulut F, Meric F, Yorgancilar E, Nergiz Y, Akkus M, Nergiz S et al. Effects of N-acetyl-cysteine and acetylsalicylic acid on the tonsil bacterial biofilm tissues by light and electron microscopy. Eur Rev Med Pharmacol Sci. 2014;18:3720–5.
132. Livingstone CR, Andrews MA, Jenkins SM, Marriott C. Model systems for the evaluation of mucolytic drugs: acetylcysteine and S-carboxymethylcysteine. J Pharm Pharmacol. 1990;42(2):73–8.
133. Johnson K, McEvoy CE, Naqvi S, Wendt C, Reilkoff RA, Kunisaki KM et al. High-dose oral N-acetylcysteine fails to improve respiratory health status in patients with chronic obstructive pulmonary disease and chronic bronchitis: a randomized, placebo-controlled trial. Int J Chron Obstruct Pulmon Dis. 2016;11:799–807.
134. Blasi F, Page C, Rossolini GM, Pallecchi L, Matera MG, Rogliani P et al. The effect of N-acetylcysteine on biofilms: Implications for the treatment of respiratory tract infections. Respir Med. 2016;117:190–7.
135. Moon JH, Choi YS, Lee HW, Heo JS, Chang SW, Lee JY. Antibacterial effects of N-acetylcysteine against endodontic pathogens. J Microbiol. 2016;54:322–9.
136. Onger ME, Gocer H, Emir D, Kaplan S. N-acetylcysteine eradicates Pseudomonas aeruginosa biofilms in bone cement. Scanning 2016;38(6):766–70.
137. Pei Y, Liu H, Yang Y, Yang Y, Jiao Y, Tay FR, Chen J. Biological activities and potential oral applications of N-acetylcysteine: progress and prospects. Oxid Med Cell Longev. 2018;2018:2835787.
138. Zheng JP, Wen FQ, Bai CX, Wan HY, Kang J, Chen P et al. Twice daily N–acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2:187–94.
139. Ziment I. Acetylcysteine: a drug that is much more than a mucokinetic. Biomed Pharmacother. 1988;42:513–9.
140. Tse HN, Tseng CZ. Update on the pathological processes, molecular biology, and clinical utility of N-acetylcysteine in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014;9:825–36.
141. Jargin SV. On the use of carnosine and antioxidants: a letter from Russia. J Complement Med Res. 2016;5:317–9.
142. Stelmakh A, Abrahamovych O, Cherkas A. Highly purified calf hemodialysate (Actovegin®) may improve endothelial function by activation of proteasomes: A hypothesis explaining the possible mechanisms of action. Med Hypotheses 2016;95:77–81.¬
143. Ziegler D, Edmundson S, Gurieva I, Mankovsky B, Papanas N, Strokov I. Predictors of response to treatment with actovegin for 6 months in patients with type 2 diabetes and symptomatic polyneuropathy. J Diabetes Complications 2017;31:1181–7.
144. Derev'yannykh EA, Bel'skaya GN, Knoll EA, Krylova LG, Popov DV. Experience in the use of Actovegin in the treatment of patients with cognitive disorders in the acute period of stroke. Neurosci Behav Physiol. 2008;38:873–5.
145. Skoog I, Korczyn AD, Guekht A. Neuroprotection in vascular dementia: a future path. J Neurol Sci. 2012;322:232–6.
146. Saletu B, Grünberger J, Linzmayer L, Stöhr H. Functional improvement of the aging brain: placebo controlled pharmaco-EEG and psychometric studies with a metabolically active hemoderivative (Actovegin). Z Gerontol. 1984;17:271–9.
147. Bugrova SG. Efficacy of actovegin in the treatment of cognitive disturbances in discirculatory encephalopathy. Zh Nevrol Psikhiatr Im S S Korsakova 2008;108(11):93–5.
148. Konoplya AI, Laskov VB, Shul'ginova AA. Immune and oxygen disturbances in patients with chronic cerebral ischemia and their correction. Zh Nevrol Psikhiatr Im S S Korsakova 2015;115(11):28–32.
149. Guekht A, Skoog I, Edmundson S, Zakharov V, Korczyn AD. ARTEMIDA trial (a randomized trial of efficacy, 12 months international double-blind actovegin): a randomized controlled trial to assess the efficacy of actovegin in poststroke cognitive impairment. Stroke 2017;48:1262–70.
150. Dutson TR, Orcutt MW. Chemical changes in proteins produced by thermal processing. Journal of Chemical Education 1984;61:303–8.
151. Budzen S, Rymaszewska J. The biological role of carnosine and its possible applications in medicine. Adv Clin Exp Med. 2013;22:739–44.
152. Lee P, Nokes L, Smith PM. No effect of intravenous Actovegin® on peak aerobic capacity. Int J Sports Med. 2012;33:305–9.
153. Beetz A, Machicao F, Ried C, Ruzicka T, Michel G. Radioprotective effects of a protein-free hemodialysate in human epidermis. Skin Pharmacol. 1996;9:197–202.
154. Wilmink JM, Stolk PW, van Weeren PR, Barneveld A. The effectiveness of the haemodialysate Solcoseryl for second-intention wound healing in horses and ponies. J Vet Med A Physiol Pathol Clin Med. 2000;47:311–20.
155. Isler H, Bauen A, Hubler M, Oberholzer M. Morphometric assessment of wound healing in rats treated with a protein - free haemodialysate. Burns 1991;17:99–103.
156. Meilin S, Machicao F, Elmlinger M. Treatment with Actovegin improves spatial learning and memory in rats following transient forebrain ischaemia. J Cell Mol Med. 2014;18:1623–30.
157. Elmlinger MW, Kriebel M, Ziegler D. Neuroprotective and anti-oxidative effects of the hemodialysate actovegin on primary rat neurons in vitro. Neuromolecular Med. 2011;13:266–74.
158. Gariballa SE, Sinclair AJ. Assessment and treatment of nutritional status in stroke patients. Postgrad Med J. 1998;74:395–9.
159. Safarova TP, Yakovleva OB, Sheshenin VS, Gavrilova SI. Methods of augmentation of antidepressant therapy (on the model of complex therapy with the inclusion of actovegin) in gerontopsychiatric hospital. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(6 Part 2):55–63.
160. Riobó Serván P, Sierra Poyatos R, Soldo Rodríguez J, Gómez-Candela C, García Luna PP, Serra-Majem L. Special considerations for nutritional studies in elderly. Nutr Hosp. 2015;31 Suppl 3:84–90.
161. Jargin SV. Invasive procedures with questionable indications. J Surg Open Access 2017;3(5). doi: 10.16966/2470-0991.158
162. Jargin SV. Scientific misconduct and related topics. Am J Exp Clin Res. 2017;4(1):197–201.
163. Smith R. Research misconduct: the poisoning of the well. J R Soc Med. 2006;99(5):232–7.
164. Foddy B. A duty to deceive: placebos in clinical practice. Am J Bioeth. 2009;9:4–12.165. Hróbjartsson A. Clinical placebo interventions are unethical, unnecessary, and unprofessional. J Clin Ethics 2008;19:66–9.

Ayrıntılar

Birincil Dil

İngilizce

Konular

-

Bölüm

Derleme

Yazarlar

Sergei Jargin ^*
0000-0003-4731-1853
Russian Federation

Yayımlanma Tarihi

31 Mart 2020

Gönderilme Tarihi

24 Aralık 2018

Kabul Tarihi

22 Mayıs 2019

Yayımlandığı Sayı

Yıl 2020 Cilt: 29 Sayı: 1

DOI

https://doi.org/10.17827/aktd.501826

IZ

https://izlik.org/JA97XX36CA

AMA

1.Jargin S. Placebo in the guise of evidence-based medications. aktd. 2020;29(1):75-88. doi:10.17827/aktd.501826

Placebo in the guise of evidence-based medications

Placebo in the guise of evidence-based medications

Öz

Anahtar Kelimeler

Abstract

Kaynakça

Ayrıntılar

Birincil Dil

Konular

Bölüm

Yazarlar

Yayımlanma Tarihi

Gönderilme Tarihi

Kabul Tarihi

Yayımlandığı Sayı

DOI

IZ

Kaynak Göster