Saam Acupuncture for Treating Functional Dyspepsia: A Feasibility Randomized Controlled Trial (3)

Boram Lee¹, O.-Jin Kwon¹, Joo-Hee Kim^2,3, Jung Won Kang⁴, Tae-Hun Kim⁵, Seunghoon Lee⁴, Jungeun Kim⁶, Ae-Ran Kim⁷, So Young Jung⁷, Hyo-Ju Park⁷  and Sun-Mi Choi ^{8,9 (Hindawi Evidence-Based Complementary and Alternative Medicine Volume 2022, Article ID 2581041, 11 pages}

• 1 KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
• 2 Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Sangji University, Wonju, Gangwon-do, Republic of Korea
• 3 Research Institute of Korean Medicine, Sangji University, Gangwon-do, Republic of Korea
• 4 Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea
• 5 Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, Republic of Korea
• 6 Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
• 7 Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, Republic of Korea
• 8 KM Data Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
• 9 Korean Convergence Medical Science, University of Science & Technology (UST), Daejeon, Republic of Korea

4. Discussion

In this preliminary clinical trial assessing the feasibility of confirmatory research, the recruitment rate was 60% (24/40), the completion rate was 79.2% (19/24), and the adherence rate of acupuncture was 83.3% (10/12). These results suggest that the compliance and study feasibility of this clinical trial were relatively high, given that adherence to long-term therapy for chronic illnesses in developed countries is typically 50% [28]. In our study, a mean of 1.14 participants was recruited per month in one center. This is is slightly higher than trials funded and published by the UK’s National Institute for Health Research, which recruited a median of 0.92 participants per center per month [29]. There were no missing values during data collection, except for those due to participant dropout, indicating that the participants understood and completed the questionnaire and other data collection measures. This indicates the preliminary feasibility of the data collection procedure.
In addition, we confirmed that Saam acupuncture improved dyspepsia as measured by GIS, VAS, and PGA and health-related quality of life as measured by FD-QoL and EQ-5D-3L. Although there was no significant difference in GIS scores between the two groups at Week 4, the difference increased over time, and there was a significant difference between them when measured at Weeks 8 and 12 for the follow-up assessments.
In our study, FD participants who met the ROME III criteria were recruited, but the ROME IV criteria are currently being applied. However, there is no significant change in the diagnostic criteria for FD between these two criteria, so the results of this study are applicable when applying the current criteria. According to the current ROME criteria, FD is divided into postprandial distress syndrome (PDS) with early satiety and postprandial fullness as the main symptoms and epigastric pain syndrome (EPS) with epigastric pain and burning as the main symptoms. Based on the prevalence studies of the existing FD subdivision, it has been reported that the prevalence of PDS is twice as high as that of EPS worldwide [30–33]. In our study, interestingly, Saam acupuncture significantly improved the early satiety subscores of the GIS compared to the control group at all evaluation points. .is may suggest the possibility of Saam acupuncture for improving PDS. We aimed to evaluate the feasibility and preliminary effectiveness of Saam acupuncture in a small sample of FD patients, and all included participants had PDS symptoms. .at is, there were no patients with only EPS symptoms without PDS symptoms in our study. Therefore, it would be meaningful to confirm the effect of Saam acupuncture according to the FD subdivisions in a future larger trial.
The quality of life measured by FD-QoL and EQ-5D-3L was only improved in the acupuncture group. It has been suggested that most diseases are caused by interruptions or imbalances in the meridian network [34]. The theory of Saam acupuncture is based on the regulation and harmonization of Qi and the blood among the organs and meridians, and it simultaneously modulates relative channels, which are selected based on the theory of nourishing or suppressing cycle relationships, to ensure whole-body balance [35]. Therefore, Saam acupuncture might have improved systemic function, and it might have led to a decrease in the FD-QoL’s liveliness status, psychological status, and role-functioning status scores and the EQ-5D-3L total scores in addition to the severity of the dyspeptic symptoms.
However, there was no statistically significant difference between the two groups in terms of these outcomes, so these results should be interpreted carefully. In our study, Saam acupuncture treatment was performed by a KM specialist with more than 5 years of clinical experience and more than 6 years of regular medical education. No AEs occurred during the trial period, and
therefore, we could confirm the preliminary safety of Saam acupuncture. .ese findings are consistent with previous studies indicating that acupuncture is relatively safe when performed by a qualified acupuncturist [36]. In addition, since the Saam acupuncture method stimulates acupuncture points at the ends of the limbs, there is practically no risk of internal organ damage. Saam acupuncture is frequently used for FD treatment in the KM clinical field, and we assessed its effect through a
pragmatic clinical trial design, selecting Saam acupuncture points based on FD symptoms and the systemic symptoms of each patient. .rough this, we aimed to increase the external validity of the study results by reducing the gap between the real-world clinical setting and the research. In addition, according to the existing studies, Saam acupuncture as an adjunctive or alternative therapy to body acupuncture improves back pain and sciatica or stroke patient’s dysarthria symptoms compared with body acupuncture alone [37, 38]. In situations where new treatment alternatives for FD are required due to the heterogeneous characteristics of FD and the side effects of conventional medications [6, 7], we confirmed the preliminary effect, safety, and potential of Saam acupuncture for treating FD through this study.
Various mechanisms have been proposed for acupuncture in patients with FD. In particular, a recent systematic review revealed that acupuncture improved dyspepsia by enhancing gastric motility and accommodation, regulating gastrointestinal hormones and mental status, and improving central and autonomic functions [39]. However, as far as we know, the specific mechanism of Saam acupuncture in FD treatment has not been studied. The acupuncture points of Saam acupuncture are located at the ends of the four limbs. .erefore, it would be interesting to conduct a mechanistic study of how Saam acupuncture stimulation of the extremities affects the upper gastrointestinal tract. Additional studies should be conducted in the future to elucidate the mechanism of how Saam acupuncture affects this heterogeneous disease. Our research has the following limitations. Since we did not set sham acupuncture as a control group, we could not evaluate the preliminary efficacy of Saam acupuncture, which is a major limitation of our study.

The purpose of this  study was to explore the preliminary effectiveness, safety, and feasibility of Saam acupuncture for treating FD patients, and usual care was set as the control group to reflect real world conditions. Therefore, blinding of the practitioner and participants was not possible. However, we attempted to minimize the risk of potential bias through blinding of the outcome assessors. In addition, according to the characteristics of a pragmatic clinical trial, we reflected the real world clinical setting by allowing communication between participants and the acupuncture therapists during treatment in the acupuncture group. However, nonspecific effects in this context may have affected the results of the trial.
Furthermore, the feasibility outcome of our study was not initially planned at the time of protocol development. However, we have reported this outcome to provide relevant information for performing future clinical trials. Through our study, to the best of our knowledge, we verified for the first time the preliminary effectiveness and safety of Saam acupuncture, which is widely used in KM clinical settings for FD patients, using a validated assessment questionnaire. In addition, we assessed the feasibility of conducting large confirmatory clinical trials. Based on the results of our study, conclusive evidence of the efficacy of Saam acupuncture in FD patients should be obtained through long-term, confirmatory clinical trials with formal sample size calculations.

5. Conclusions

Our study suggested the potential feasibility, preliminary effectiveness, and safety of Saam acupuncture for FD. Further high-quality confirmatory trials with a larger sample size and long-term follow-up are needed to demonstrate the exact effectiveness and safety of Saam acupuncture.

References

• [28] E. Sabat´e and E. Sabat´e, Adherence to Long-Term =erapies: Evidence for Action, World Health Organization, Geneva, Switzerland, 2003.
• [29] S. J. Walters, I. Bonacho Dos Anjos Henriques-Cadby, O. Bortolami et al., “Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme,” BMJ Open, vol. 7, 2017.
• [30] P. Aro, N. J. Talley, J. Ronkainen et al., “Anxiety is associated with uninvestigated and functional dyspepsia (Rome III
  criteria) in a Swedish population-based study,” Gastroenterology, vol. 137, no. 1, pp. 94–100, 2009.
• [31] J. Matsuzaki, H. Suzuki, K. Asakura et al., “Classification of functional dyspepsia based on concomitant bowel symptoms,” Neuro-Gastroenterology and Motility, vol. 24, no. 4, p. 325, 2012.
• [32] J. Matsuzaki, H. Suzuki, Y. Fukushima et al., “High frequency of overlap between functional dyspepsia and overactive
  bladder,” Neuro-Gastroenterology and Motility, vol. 24, no. 9, pp. 821–827, 2012.
• [33] R. M. Zagari, G. R. Law, L. Fuccio et al., “Epidemiology of functional dyspepsia and subgroups in the Italian general
  population: an endoscopic study,” Gastroenterology, vol. 138, no. 4, pp. 1302–1311, 2010.
• [34] C.-B. Ahn, K.-J. Jang, H.-M. Yoon et al., “Sa-Ahm five element acupuncture,” Journal of Acupuncture and Meridian Studies, vol. 3, no. 3, pp. 203–213, 2010.
• [35] H.-J. Kwon and Y.-S. Kim, “General guide for Korean acupuncture & moxibustion,” Open Journal of Immunology,
  vol. 05, no. 03, pp. 90–103, 2015.
• [36] M. W. C. Chan, X. Y. Wu, J. C. Y. Wu, S. Y. S. Wong, and V. C. H. Chung, “Safety of acupuncture: overview of systematic reviews,” Scientific Reports, vol. 7, 2017.
• [37] M. S. Song, Y. H. Kim, S. G. Jang et al., “Clinical comparison studies on 20 cases of stroke patients with dysarthria by Sa-Am & General acupuncture,” Journal of Acupuncture Research, vol. 20, pp. 160–167, 2003.
• [38] J. H. Kim, E. J. Park, C. H. Park, M.-R. Cho, C.-R. Ryu, and W.-S. Chae, “Comparision of the improvement of back pain and sciatica between common acupuncture treatment group and common acupuncture with Shin Jong Gyuk of Ohaeng acupuncture treatment group,” Journal of Acupuncture Research, vol. 19, pp. 84–91, 2002.
• [39] Y. Guo, W. Wei, and J. D. Chen, “Effects and mechanisms of acupuncture and electroacupuncture for functional dyspepsia: a systematic review,” World Journal of Gastroenterology, vol. 26, no. 19, pp. 2440–2457, 2020.