Index de l'article

 

Conclusion

Challenges remain in the process to demonstrate the efficacy of acupuncture, despite the emergence of evidence-based medicine [25]. A more applicable and innovative research methodology that can reflect the effectiveness of acupuncture is needed, for improving future research into this integrative intervention, and CT’s based on OPC concept are worth developing.

To date, the gold standard for evaluation of a treatment is RCT with high methodological quality and high power, which can provides the highest level of scientific evidence. It would be interesting to add OPC methodology in the recommendations of grades, especially when blinding is difficult. A combined approach using a multidisciplinary team incorporating considerations of efficacy, effectiveness and qualitative measures, will strengthen the evidence base for acupuncture [26].

The OPC is a criteria based on published literature (meta-analyzes) and/or reliable registries OPC may be considered when disease natural history is well known, patient population well described, in case of extensive experience with acupuncture treatment, stable and well known standard of care, no significant new questions of safety and effectiveness, and expectation of significant positive treatment effect. The OPC use offers several advantages over randomized clinical trials: smaller sample size, standardized comparator for future trials, reduced cost, shortened time to completion, simpler logistic.

However the determination of an OPC is not a simple task. It requires rigorous and scientifically valid methodologies. An OPC should be established by a multidisciplinary team of Traditional Chinese Medicine (TCM) practitioners, and Western physicians in cooperation with statisticians.

OPC concept could represent an acceptable and scientifically valid alternative to determine effectiveness of acupuncture. Acupuncturists should consider this methodology when randomization and double-blindness are problematic.

 

Abbreviations 

CAM: complementary and alternative medicine

CI: confidence interval

CT: clinical trial

FDA: Food and Drug Administration

ICMART: International Council of Medical Acupuncture and Related Technique

OB: obstetric

OPC: objective performance criteria

RCT: randomized control trial

RR: relative risk

SMD: standardized mean difference

TCM: Traditional Chinese Medicine

US: the United States

 

Competing interests

The authors declare that they have no competing interests.

 

Acknowledgements

  • Anne-Sophie Piau, Sophie Broquet (Jeanne de Flandre Hospital, Lille, France): investigators of the trial on perineal relaxation during fetal expulsion.
  • Caroline Mollet, Sandra Dumortier (Paul Gellé Hospital Maternity, Roubaix, France): investigators of the trial on the third stage of labor.
  • Prof Véronique Houfflin-Debarge, Hélène Montaigne, MD: Lille 2 University, France.

 

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To cite: Brignol TN, Stéphan JM, Verta A. Acupuncture clinical trials without a control group in Obstetrics : a French experience alternative approach using OPC (objective performance criteria). Acupuncture & Moxibustion (online). Feb 2016. Available from: URL: https://meridiens.org/acuMoxi/Quinzeun/Brignol_OPC.pdf