How fragile the positive results of Chinese herbal medicine randomized controlled trials on irritable bowel syndrome are?

Expósito-Ruiz M, Pérez-Vicente S, Rivas-Ruiz F. Statistical inference: hypothesis testing. Allergol Immunopathol (Madr). 2010;38(5):266–77.

Article  Google Scholar 

Sarmukaddam SB. Interpreting statistical hypothesis testing results in clinical research. J Ayurveda Integr Med. 2012;3(2):65–9.

Article  PubMed  PubMed Central  Google Scholar 

Lew MJ. Principles: when there should be no difference–how to fail to reject the null hypothesis. Trends Pharmacol Sci. 2006;27(5):274–8.

Article  CAS  PubMed  Google Scholar 

Lieberman JA. Hypothesis and hypothesis testing in the clinical trial. J Clin Psychiatry. 2001;62:5–8. discussion 9–10.

CAS  PubMed  Google Scholar 

Luo J. Primary question and hypothesis testing in Randomized Controlled clinical trials. Shanghai Arch Psychiatry. 2016;28(3):177–80.

PubMed  PubMed Central  Google Scholar 

Graves N, Barnett AG, Burn E, Cook D. Smaller clinical trials for decision making; a case study to show p-values are costly. F1000Res. 2018;7:1176.

PubMed  PubMed Central  Google Scholar 

Tsushima E. Interpreting results from statistical hypothesis testing: understanding the appropriate P-value. Phys Ther Res. 2022;25(2):49–55.

Article  PubMed  PubMed Central  Google Scholar 

Walsh M, Srinathan SK, McAuley DF, et al. The statistical significance of randomized controlled trial results is frequently fragile: a case for a Fragility Index. J Clin Epidemiol. 2014;67(6):622–8.

Article  PubMed  Google Scholar 

Devereaux PJ, Yusuf S. The evolution of the randomized controlled trial and its role in evidence-based decision making. J Intern Med. 2003;254(2):105–13.

Article  CAS  PubMed  Google Scholar 

Evaniew N, Files C, Smith C, et al. The fragility of statistically significant findings from randomized trials in spine surgery: a systematic survey. Spine J. 2015;15(10):2188–97.

Article  PubMed  Google Scholar 

Ruzbarsky JJ, Khormaee S, Daluiski A. The Fragility Index in Hand Surgery Randomized Controlled Trials. J Hand Surg Am. 2019;44(8):698.e691-698.e697.

Ridgeon EE, Young PJ, Bellomo R, Mucchetti M, Lembo R, Landoni G. The Fragility Index in Multicenter Randomized controlled critical care trials. Crit Care Med. 2016;44(7):1278–84.

Article  PubMed  Google Scholar 

Desnoyers A, Wilson BE, Nadler MB, Amir E. Fragility index of trials supporting approval of anti-cancer drugs in common solid tumours. Cancer Treat Rev. 2021;94:102167.

Article  PubMed  Google Scholar 

Walter SD, Thabane L, Briel M. The fragility of trial results involves more than statistical significance alone. J Clin Epidemiol. 2020;124:34–41.

Article  PubMed  Google Scholar 

Ma Y, Zhou K, Fan J, Sun S. Traditional Chinese medicine: potential approaches from modern dynamical complexity theories. Front Med. 2016;10(1):28–32.

Article  PubMed  Google Scholar 

Lu AP, Jia HW, Xiao C, Lu QP. Theory of traditional Chinese medicine and therapeutic method of diseases. World J Gastroenterol. 2004;10(13):1854–6.

Article  PubMed  PubMed Central  Google Scholar 

Li Z, Xu C. The fundamental theory of traditional Chinese medicine and the consideration in its research strategy. Front Med. 2011;5(2):208–11.

Article  PubMed  Google Scholar 

Liu S, Zhu JJ, Li JC. The interpretation of human body in traditional Chinese medicine and its influence on the characteristics of TCM theory. Anat Rec (Hoboken). 2021;304(11):2559–65.

Article  PubMed  Google Scholar 

Ma Y, Sun S, Peng CK. Applications of dynamical complexity theory in traditional Chinese medicine. Front Med. 2014;8(3):279–84.

Article  PubMed  Google Scholar 

Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700.

Article  PubMed  PubMed Central  Google Scholar 

Drossman DA, Dumitrascu DL, Rome III. New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006;15(3):237–41.

PubMed  Google Scholar 

Alt F, Chong PW, Teng E, Uebelhack R. Evaluation of Benefit and Tolerability of IQP-CL-101 (Xanthofen) in the symptomatic improvement of irritable bowel syndrome: a Double-Blinded, randomised, placebo-controlled clinical trial. Phytother Res. 2017;31(7):1056–62.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Camilleri M. Editorial: is adequate relief fatally flawed or adequate as an end point in irritable bowel syndrome? Am J Gastroenterol. 2009;104(4):920–2.

Article  PubMed  PubMed Central  Google Scholar 

Portincasa P, Bonfrate L, Scribano ML, et al. Curcumin and fennel essential oil improve symptoms and quality of life in patients with irritable bowel syndrome. J Gastrointestin Liver Dis. 2016;25(2):151–7.

Article  PubMed  Google Scholar 

Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002;123(6):2108–31.

Article  PubMed  Google Scholar 

Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.

Article  PubMed  Google Scholar 

Lunt M. Introduction to statistical modelling: linear regression. Rheumatology (Oxford). 2015;54(7):1137–40.

Article  PubMed  Google Scholar 

Khan MS, Ochani RK, Shaikh A, et al. Fragility Index in Cardiovascular Randomized controlled trials. Circ Cardiovasc Qual Outcomes. 2019;12(12):e005755.

Article  PubMed  PubMed Central  Google Scholar 

Maldonado DR, Go CC, Huang BH, Domb BG. The Fragility Index of Hip Arthroscopy Randomized controlled trials: a systematic survey. Arthroscopy. 2021;37(6):1983–9.

Article  PubMed  Google Scholar 

Wang G, Li TQ, Wang L, et al. Tong-xie-ning, a Chinese herbal formula, in treatment of diarrhea-predominant irritable bowel syndrome: a prospective, randomized, double-blind, placebo-controlled trial[J]. Chin Med J (Engl).2006;119(24):2114–9.

Cappello G, Spezzaferro M, Grossi L, et al. Peppermint oil (Mintoil((R))) in the treatment of irritable bowel syndrome: A prospective double-blind placebo-controlled randomized trial[J]. Dig Liver Dis 2007;39(6):530–6.

Zhang SS, Xu WJ, Chen Z, et al. Short-term and medium-term clinical effect of liver dispersing with spleenstrengthening on irritable bowel syndrome dominated by diarrhea[J]. J Cap Med Uni 2009;30(4):436–40.

Saito YA, Rey E, Almazar-Elder AE, et al. A randomized, double-blind, placebo-controlled trial of St John’s Wort for treating irritable bowel syndrome[J]. Am J Gastroenterol. 2010;105(1):170–7.

Li YM, Zhang YN, Cai G, et al. A randomized, double-blinded and placebo-controlled trial of Chang Ji Tai Granule in treating diarrhea-predominant diarrhea[J]. ShangHai J Tradit Chin Med 2010;44(12):33–6.

Zhang SS, Wang HB, Li ZH, et al. A multi-center randomized controlled study on syndrome differentiation oftraditional Chinese medicine in the treatment of diarrhea-predominant irritable bowel syndrome[J]. Chin J Integr Med. 2010;30(1):9–12.

Tang XD, Li ZH, Li BS, et al. A randomized, double-blind, placebo-controlled clinical study of Chang’an prescription 1 in the treatment of diarrhea-predominant irritable bowel syndrome[D]. Beijing Uni Chin Med. 2011.

Zhang W, Zhang ZL, Li L. Clinical Research Irritable Bowel Syndrome with the Treatment of Liver-Softening andSpleen-Nourishing Decoction[J]. Hubei J Trad Chin Med. 2013;35(05):12–4.

Fu Q, Xu DS, Jiang SQ. Shugan Liqi Zhixie Tang in Treatment of 68 Patients with Diarrhea-predominant Irritable BowelSyndrome[J]. Chin J Exp Trad Med Form. 2013;19(16):301–4.

Li XL, Su ZZ, Gu XD. Observation on the efficacy of Changyiqing in the treatment of irritable bowel syndrome withspleen deficiency and dampness syndrome[J]. Chin J Inte Trad Chin West Med Dig. 2014;22(8):475–7.

Portincasa P, Bonfrate L, Scribano ML, et al. Curcumin and fennel essential oil improve symptoms and quality of life in patients with irritable bowel syndrome[J]. J Gast Liv Dis. 2016;25(2):151–7.

Liu ZW, Niu LJ, Su Q, et al. 100 cases of diarrhea-predominant irritable bowel syndrome treated with Anchangzhitongprescription combined with trimebutine[J]. Henan Trad chin Med. 2014;34(10):2015–16.

Hu QP. Self Beneficial Intestinal Side Spleen Dampness Type of Adjuvant Therapy Clinical Observation IrritableBowel[J]. Mod Diag Treat. 2015(1):42–3.

Cheng YY. Clinical study on the treatment of irritable bowel syndrome with liver stagnation and spleen deficiencywith Chaishao Tiaogan Decotion[D], Hebei Med Univ. 2015.

Alt F, Chong P-W, Teng E, et al. Evaluation of benefit and tolerability of IQP-CL-101 (Xanthofen) in the symptomaticimprovement of irritable bowel syndrome: a double-blinded, randomised, placebo-controlled clinical Trial[J].Phyto Res: PTR. 2017;31(7):1056–62.

Chen M, Tang TC, Wang Y, et al. Randomised clinical trial: tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome[J]. Ali Phar Thera. 2018;48(2):160–168.

Tang XD, Li B, Li ZH, et al. Therapeutic effect of chang’an I recipe on irritable bowel syndrome with diarrhea: a multicenter randomized double-blind placebo-controlled clinical Trial [J]. Chin J Int Med. 2018;24(09):645–652.

Weng MW, Chen YB, Cao J. Clinical Observation on 35 Cases of Treating Diarrheal Irritable Bowel Syndrome with LiverStagnation and Spleen Deficiency with Changning Prescription[J]. Journal of Traditional Chinese Medicine.2019;60(19):1663–1667.

Zeng P. Clinical study on the treatment of diarrhea-type irritable bowel syndrome with Shaoyang taiyin cold andheat benefit with Chaihu Guizhi Ganjiang Decoction[D]. Fujian Univ Trad Chin Med. 2019.

Chen X, Dai XT, Wu YL, et al. Clinical efficacy of An Chang Zhi Xie decotion in the treatment of diarrhea-type irritable bowel syndrome[J]. Inn Mongo J Trad Chin Med. 2020;39(9):8–9.

Zhao XY. Clinical study on the treatment of diarrhea-type irritable bowel syndrome by adding flavors to Wei GuanDecoction[D]. Yunn Univ Trad Chin Med. 2020.

Zheng HP, Zhang ZB, Wei XP, et al. Effect of Addition and Subtraction Therapy of Xiaoyaosan Combined withSimotang to Gut-brain Axis of Patients with Irritable Bowel Syndrome with Predominant Constipation and Syndromeof Stagnation of Liver Qi[J]. Chin J Exp Trad Med Form. 2020;26(22):53–58.

Bordbar G, Miri MB, Omidi M, et al. Efficacy and safety of a novel herbal medicine in the treatment of irritable bowel syndrome: a randomized double-blinded clinical Trial[J]. Gastro Res Prac. 2020.

Yu AP, Zhang HJ. Clinical study on the treatment of constipation-predominant irritable bowel syndrome with "yangmicro-knot" by Chaishao Zhizhu Decoction[D]. Fujian Univ Trad Chin Med. 2020.

Li YX. Clinical analysis of Liuwei Nengxiao capsule in the treatment of constipation-predominant irritable bowelsyndrome[J]. J Prac Trad Chin Med. 2021;37(12):2010–2011.

Kong WQ. Evaluation of the clinical efficacy of Changkang prescription in the treatment of constipation-predominantirritable bowel syndrome and research on its mechanism of action[D]. Nanj Univ Chin Med. 2021.

Jin YL. Clinical study on the treatment of diarrhea-predominant irritable bowel syndrome with Xingpi HuashiDecoction[D]. Zhejiang Univ Trad Chin Med. 2021.

Guo LX, Qin TT, Gao J, et al. Study on the regulatory effect of Shenbei Guchang Capsule on the brain-gut bacteriaaxis in the treatment of diarrhea-predominant irritable bowel syndrome[J]. J Chin Med Mat. 2022;45(10):2502–2506.

Zou JY, Tan HC, Wu C, et al. Analysis of the influencing factors of irritable bowel syndrome and the therapeutic effect of spleen-invigorating and astringent therapy in treating diarrhea od spleen-kidney yang deficiency syndrome[J].World J Inte Trad West Med. 2022;17(1):192–195.

Wang YR, Fu WB, Sun YQ, et al. Clinical efficacy of tongxie yaofang on diarrhea-predominant irritable bowelsyndrome (IBS-D) patients with liver depression and spleen deficiency[J]. Chin J Exp Trad Med Form. 2022;28(9):97–102.

Bertaggia L, Baiardo Redaelli M, Lembo R, et al. The Fragility Index in peri-operative randomised trials that reported significant mortality effects in adults. Anaesthesia. 2019;74(8):1057–60.

Article  CAS

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