Child's Nervous System

, Volume 35, Issue 12, pp 2261–2263 | Cite as

An experimental challenge to bring the empirical study design a step closer to evidence-based medicine and quit ethically problematic situations

  • Shinji IjichiEmail author
  • Naomi Ijichi
  • Chikako Imamura
  • Hisami Sameshima
  • Yoichi Kawaike
Letter to the Editor

Dear Editor:

Together with the authorized specialists in this field (Appendix), we would like to make some consideration concerning the use of decompressive cranioplasty in patients with mild trigonocephaly and psychomotor retardation aimed at favoring cognitive development as reported in your journal [1, 2, 3]. The efficacy of the procedure for developmental conditions is scientifically unproven [4], and mild cases of trigonocephaly are not candidates for surgery because of its mild morphological changes [5]. As an excuse for the long continuation of their non-controlled trial for the unproven intervention, it has been claimed for approximately 20 years that the deprivation of the chance to enjoy the promising intervention in the patients allocated to the control group is unethical and unacceptable [3]. This serious misunderstanding could not be corrected despite repeated explanation of the Declaration of Helsinki [6, 7, 8, 9]. The huge performance bias in the field of developmental...


Compliance with ethical standards

Conflict of interest

The authors declare no conflict of interest.


  1. 1.
    Shimoji T, Taira N (2019) Mild trigonocephaly associated with microcephaly: surgical outcomes for 15 cases. Childs Nerv Syst 35:645–655. CrossRefPubMedGoogle Scholar
  2. 2.
    Shimoji T, Tominaga D, Shimoji K, Miyajima M, Tasato K (2015) Analysis of pre- and post-operative symptoms of patients with mild trigonocephaly using several developmental and psychological tests. Childs Nerv Syst 31:433–440. CrossRefPubMedGoogle Scholar
  3. 3.
    Shimoji T (2015) Reply to Dr. Ijichi’s group letter. Childs Nerv Syst 31:1013–1015. CrossRefPubMedGoogle Scholar
  4. 4.
    Miyajima M (2014) Pathology, diagnosis, and treatment of trigonocephaly with clinical symptoms: the 2013 abstract report of a government-granted study (Ministry of Health, Labor and Welfare, National Bib. No.: 22431487, Ref. No.:201324159B). National Diet Library, Tokyo (in Japanese)Google Scholar
  5. 5.
    Shimoji T (2018) Shimoji’s cranioplasty yielding life-quality improvements in mild trigonocephaly (SCYLIMIT). J Stem Cells Regen Med 14:88Google Scholar
  6. 6.
    Ijichi S, Ijichi N (2002) Ignorance of Helsinki Declaration. Lancet 360:415. CrossRefPubMedGoogle Scholar
  7. 7.
    Ijichi S, Ijichi N (2002) Mild trigonocephaly with clinical symptoms. Childs Nerv Syst 18:659–660; author reply 661-662. CrossRefPubMedGoogle Scholar
  8. 8.
    Ijichi S, Ijichi N (2003) The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles. Childs Nerv Syst 19:711–715. CrossRefPubMedGoogle Scholar
  9. 9.
    Ijichi S, Ijichi N, Ishida A, Yotsumoto M, Nagata J, Tanuma R, Imamura C, Toki A, Sakajiri T, Hirotsune H, Nakadoi Y, Tanaka S, Kimura K, Tanaka K (2015) Ethical fallacies, tricky ambiguities, and the misinterpretation of the outcomes in the cranioplasty for mild trigonocephaly. Childs Nerv Syst 31:1009–1012. CrossRefPubMedGoogle Scholar
  10. 10.
    Shimoji T (2017) Reply to Dr. Ijichi’s group. Childs Nerv Syst 33:1433. CrossRefPubMedGoogle Scholar
  11. 11.
    Fok H, Jones BM, Gault DG, Andar U, Hayward R (1992) Relationship between intracranial pressure and intracranial volume in craniosynostosis. Br J Plast Surg 45:394–397CrossRefGoogle Scholar
  12. 12.
    Arnaud E, Renier D, Marchac D (1995) Prognosis for mental function in scaphocephaly. J Neurosurg 83:476–479. CrossRefPubMedGoogle Scholar
  13. 13.
    Collmann H, Sörensen N, Krauss J (1996) Consensus: trigonocephaly. Childs Nerv Syst 12:664–668CrossRefGoogle Scholar
  14. 14.
    Wall SA, Thomas GPL, Johnson D, Byren JC, Jayamohan J, Magdum SA, McAuley DJ, Richards PG (2014) The preoperative incidence of raised intracranial pressure in nonsyndromic sagittal craniosynostosis is underestimated in the literature. J Neurosurg Pediatr 14:674–681. CrossRefPubMedGoogle Scholar
  15. 15.
    Mendonca DA, White N, West E, Dover S, Solanki G, Nishikawa H (2009) Is there a relationship between the severity of metopic synostosis and speech and language impairments? J Craniofac Surg 20:85–88; discussion 89. CrossRefPubMedGoogle Scholar
  16. 16.
    Starr JR, Lin HJ, Ruiz-Correa S, Cunningham ML, Ellenbogen RG, Collett BR, Kapp-Simon KA, Speltz ML (2010) Little evidence of association between severity of trigonocephaly and cognitive development in infants with single-suture metopic synostosis. Neurosurgery 67:408–415; discussion 415-416. CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Cho SM, Park DH, Yoon SH (2019) Continuous intracranial pressure monitoring in 24 microcephalic children with developmental delay: a significant portion of microcephalic children with developmental delay have high intracranial pressure. World Neurosurg 123:e760–e765. CrossRefPubMedGoogle Scholar
  18. 18.
    Takahashi S, Shimoji T, Miyajima M, Inagaki T (2010) O4-4 Prospective multi-center trial for trigonocephaly: to elucidate natural history and indication of operation: registration in 2009. Shouni No Noshinkei 35:213 (in Japanese)Google Scholar
  19. 19.
    Oi S, Shimoji T, Miyajima M et al (2011) A prospective multi-center trial for trigonocephaly: COE-Big 4 Trigonocephaly Japan. Shouni No Noshinkei 36:528–534 (in Japanese)Google Scholar
  20. 20.
    Shimabukuro S, Shimoji T, Sugama S (2001) Cranioplasty for isolated trigonocephaly with developmental disorder. No To Hattatsu 33:487–493 (in Japanese)PubMedGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Health Service CenterKagoshima UniversityKagoshimaJapan
  2. 2.Institute for EGTKagoshimaJapan
  3. 3.Support Center for Students with DisabilitiesKagoshima UniversityKagoshimaJapan

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