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Keywords
Retrospective analysis Acupuncture Functional dyspepsia subtype
Schlsselwrter
Retrospektive Analyse Akupunktur Subgruppe funktioneller Dyspepsie
Summary
Background: Whether subgroups of functional dyspepsia (FD) should be
treated with different approaches is controversially discussed in research. As our previous study has demonstrated the effect of acupuncture in FD treatment, we now further analyze the therapeutic effect of
acupuncture in the treatment of postprandial distress syndrome (PDS)
and epigastric pain syndrome (EPS). Methods: A retrospective analysis
was conducted in 465 eligible PDS patients and 241 EPS patients. 4 acupuncture groups (group A: specific acupoints along the stomach meridian; group B: non-specific acupoints along the stomach meridian; group
C: alarm and transport acupoints; group D: specific acupoints along the
gallbladder meridian) were compared with a non-acupoint sham acupuncture group and an itopride group. The patients were treated in 5
consecutive sessions per week for 4 weeks and were followed-up for 12
weeks afterwards. Primary outcome of the study was defined as response rate and symptom improvement as measured by the Symptom
Index of Dyspepsia, while secondary outcome was designated as improvement in quality of life (QoL) as determined by the Nepean Dyspepsia Index. Results: Symptoms of dyspepsia and QoL were improved
from baseline in all groups. In EPS patients, no statistically significant
differences could be observed in response rate (p = 0.239) and symptoms improvement (p = 0.344 for epigastric pain; p = 0.465 for epigastric
burning). In contrast, PDS patients of the acupuncture group A showed
higher response rate (53.2% vs. 19.7%, p<0.001; 53.2% vs. 35.1%, p =
0.025) and score change in postprandial fullness (1.01 vs. 0.27, p<0.001;
1.01 vs. 0.57, p<0.001), early satiation (0.81 vs. 0.21, p<0.001; 0.81 vs.
0.39, p=0.001), and QoL (14.5 vs. 4.33, p<0.001; 14.5 vs. 8.5, p<0.001)
compared to the sham acupuncture and itopride group. Conclusions: FD
patients with PDS responded better to the acupuncture therapies, especially at the specific acupoints along the stomach meridian. The positive
therapeutic effect of acupuncture on PDS was correlated with the improvement in postprandial fullness. Trial Registration: ClinicalTrial.gov
NCT00599677.
Zusammenfassung
Hintergrund: Ob bei der Behandlung von Subgruppen funktioneller Dyspepsie verschiedene therapeutische Anstze angewendet werden sollten, ist derzeit strittig. In einer im Vorfeld durchgefhrten Studie haben
wir die Wirkung von Akupunktur bei der Behandlung funktioneller Dyspepsie belegt. Daher prsentieren wir nun in der vorliegenden Studie
den therapeutischen Effekt von Akupunktur bei der Behandlung des
postprandiales Distresssyndroms (PDS) und epigastrischen Schmerzsyndroms (ESS). Methoden: Die retrospektive Analyse wurde an 465 geeigneten Patienten mit PDS sowie an 241 Patienten mit ESS durchgefhrt. 4
Akupunktur-Gruppen (Gruppe A: spezifische Punkte entlang des MagenMeridians; Gruppe B: nichtspezifische Punkte entlang des Magen-Meridians; Gruppe C: Alarm- und Transportpunkte; Gruppe D: spezifische
Punkte entlang des Meridians der Gallenblase) wurden mit einer ShamAkupunkturgruppe und einer Itoprid-Gruppe verglichen. Die Patienten
wurden in 5 aufeinanderfolgenden Sitzungen pro Woche ber 4 Wochen
behandelt, mit anschlieendem Follow-up ber 12 Wochen. Der Primrparameter der Studie wurde definiert als Rcklaufquote und Verbesserungen der Symptome, die mit dem Symptom Index of Dyspepsia erfasst wurden; der Sekundrparameter umfasste Verbesserungen in der
Lebensqualitt, die mit dem Nepean Dyspepsia Index erfasst wurden.
Ergebnisse: Die Dyspepsie-Symptome sowie die Lebensqualitt verbesserten sich in allen Gruppen im Vergleich zur Baseline. Zwischen den
ESS-Patienten der verschiedenen Gruppen konnten keine statistisch signifikanten Unterschiede bezglich der Rcklaufquote (p = 0,239) und der
Verbesserung der Symptome (p = 0,344 fr epigastrischen Schmerz; p =
0,465 fr epigastrisches Brennen) beobachtet werden. Demgegenber
konnte bei den PDS-Patienten der Akupunktur-Gruppe A im Vergleich zur
Sham-Akupunktur-Gruppe sowie der Itoprid-Gruppe eine hhere Rcklaufquote verzeichnet (53,2% vs. 19,7%, p<0,001; 53,2% vs. 35,1%, p =
0,025) und eine nderung der Scores bezglich des postprandialen Vllegefhls festgestellt werden (1,01 vs. 0,27, p<0,001; 1,01 vs. 0,57,
p<0,001). Zudem zeigte sich in dieser Gruppe eine frhere Sttigung
(0,81 vs. 0,21, p<0,001; 0,81 vs. 0,39, p = 0,001) und gesteigerte Lebensqualitt (14,5 vs. 4,33, p<0,001; 14,5 vs. 8,5, p<0,001). Schlussfolgerungen: Patienten mit funktioneller Dyspepsie, die an PDS leiden, reagierten
besser auf die Akupunktur-Behandlungen, insbesondere die entlang des
Magen-Meridians. Der positive therapeutische Effekt von Akupunktur auf
PDS wurde in Verbindung gebracht mit der Linderung des postprandialen Vllegefhls. Studienregistrierung: ClinicalTrial.gov NCT00599677.
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Methods
The study was conducted according to methods described in a previously
conducted RCT [15] which was performed at the outpatient departments of 8
hospitals in China between April 2008 and October 2009 in compliance with
the rules specified in the Declaration of Helsinki and the Good Clinical Practice
Guidelines. The study consisted of a 7-day run-in period prior to randomization, a treatment period of 4 weeks (5 consecutive sessions per week with an
interval of 2 days between 2 weeks), and a 12-week follow-up. FD patients were
randomly assigned to 1 of 4 acupuncture groups (groups AD), a sham acupuncture group (group E), or itopride group (group F) in a 1: 1:1: 1:1: 1 ratio by
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Introduction
Participants
All 706 patients were retrospectively divided in subgroups (465
PDS, 241 EPS), with an overlap between the subgroups of 71.1%.
The baseline characteristics of the subgroup population were similar (table1).
Efficacy
Response rates at the end of the 4-week treatment: For PDS, only
19.7% of the patients in group E were responders, which was significantly less than in the other groups (53.2% in group A, 39% in
group B, 36.5% in group C, and 35.1% in group F, p < 0.05). Significant difference in response rate was also observed between
group A and group F (p = 0.025), but not between group F and
groups B, C, and D (p = 0.15). On the contrary, no statistically significant differences were observed between the EPS groups (p =
0.239). The response rates of the groups were 54.1% for group A,
42.1% for group B, 35% for group C, 44.1% for group D, 27.7% for
group E, and 40% for group F (fig.2).
Symptom assessment in subgroups at the end of the 4-week treatment: For PDS, significant differences between groups were ob-
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Results
Table 1. Baseline
characteristics of patients in subgroups
Group A,
n = 116
Group B,
n = 120
Group C,
n = 114
Group D,
n = 119
Group E,
n = 118
Group F,
n = 119
84 (72.4)
76 (63.3)
84 (73.7)
92 (77.3)
74 (62.7)
84 (70.6)
79 (68.1)
38.8 13.8
52 (65.8)
75.7 74.5
82 (68.3)
34.9 13.9
55 (67.1)
59.3 52.2
74 (64.9)
35.5 11.6
52 (70.3)
63.6 60.1
85 (71.4)
38.5 13.5
61 (71.8)
70.4 60.7
71 (60.2)
36.0 13.0
52 (73.2)
67.3 80.3
74 (62.2)
36.2 14.0
56 (75.7)
65.9 71.2
4.38 1.50
4.48 1.77
4.59 1.39
4.54 1.52
4.35 1.67
4.05 1.57
Postprandial fullness
Early satiation
Nepean Dyspepsia Index
(mean SD)
1.96 0.49
1.29 0.75
73.3 11.8
1.89 0.63
1.41 0.74
75.6 10.7
1.92 0.57
1.38 0.70
73.5 12.1
1.93 0.65
1.44 0.78
73.0 8.28
1.92 0.60
1.28 0.74
76.7 9.65
1.81 0.49
1.14 0.82
76.2 10.6
37 (31.9)
35.3 12.6
31 (83.8)
71.0 73.6
38 (31.7)
34.5 14.1
24 (63.2)
69.6 58.4
40 (35.1)
39.8 15.3
30 (75)
84.8 67.7
34 (28.6)
34.9 12.6
27 (79.4)
62.8 45.8
47 (39.8)
37.0 13.5
32 (68.1)
60.1 68.7
45 (37.8)
35.0 14.0
26 (57.8)
65.8 57.5
4.00 1.60
4.47 1.80
4.00 1.91
5.06 1.56
4.15 1.86
4.56 2.05
Epigastric pain
Epigastric burning
Nepean Dyspepsia Index
(mean SD)
1.57 0.69
0.41 0.76
74.4 9.70
1.87 0.48
0.61 0.79
74.9 10.7
1.80 0.56
0.48 0.78
76.1 8.95
1.79 0.64
0.76 0.89
73.2 10.6
1.70 0.72
0.49 0.75
74.4 12.1
1.71 0.82
0.56 0.81
77.7 8.36
Variables
Overlap
Patients, n (%)
PDS
Patients, n (%)
Age, years (mean SD)
Female, n (%)
Duration of disease,
months (mean SD)
EPS
Patients, n (%)
Age, years (mean SD)
Female, n (%)
Duration of disease,
months (mean SD)
PDS = postprandial distress syndrome; EPS = epigastric pain syndrome; SD = standard deviation.
for group C, and 0.68 for group D vs. 0.37 for group E, p < 0.05)
and F (groups AC vs. 0.49 for group F, p < 0.05); and the highest
score change was again identified in group A. Meanwhile, groups
AC showed significantly higher score changes in early satiation
than groups E (0.8 vs. 0.38, p = 0.001, 0.67 vs. 0.38, p = 0.038, 0.69
vs. 0.38, p = 0.008) and F (0.8 vs. 0.32, p < 0.001, 0.67 vs. 0.32, p =
0.011, 0.69 vs. 0.32, p = 0.003); no significant difference was detected between groups AC (p = 0.528). Concerning NDI score,
PDS groups A (15.6 vs. 5.68, p < 0.001), C (12.2 vs. 5.68, p = 0.003),
and D (10.4 vs. 5.68, p = 0.003) and EPS group A (15.7 vs. 8.09, p =
0.001) yielded statistically significant differences as compared with
group E; the largest improvement was observed in group A for
both PDS and EPS.
Discussion
According to the Rome III consensus, FD may be subgrouped
into PDS and EPS based on the cause of the dyspeptic symptoms;
more specifically, PDS mostly exhibits meal-related symptoms
while EPS shows symptoms irrelevant to food intake. Due to the
heterogeneous pathophysiology of FD [21], treatment options for
PDS and EPS have been chosen based on only limited evidence
from clinical studies and guideline consensus [9]; the need for dif-
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Fig. 2. Improved response rate assessed with the Symptom Index of Dyspepsia at week 4: percentage of patients who were symptom-free or had shown
improvement in at least 2 scores at the end of the treatment. The differences in
response rate were statistically significant only among the groups with postprandial distress syndrome (PDS).
Group A
Group B
Group C
Group D
Group E
Group F
P value
1.010.78a,b
0.810.86a,b
14.512.3a,b
0.740.75a
0.660.76a,b
8.8911.5a
0.770.69a,b
0.570.72a
11.311.6a,
0.480.75a
0.390.71
9.019.64a
0.270.56b
0.210.58
4.337.46b
0.570.83a
0.390.83
8.5012.2a
<0.001
<0.001
<0.001
0.970.76
0.240.76
15.310.9a,b
1.050.84
0.110.45
10.77.86
0.830.64
0.280.60
13.210.2a,b
0.790.98
0.380.82
11.014.6
0.680.73
0.090.50
7.2512.1
0.871.12
0.220.67
7.810.6
0.344
0.465
0.03
PDS
Change from baseline in
Symptom Index of Dyspepsia
Postprandial fullness
Early satiation
Change from baseline in
Nepean Dyspepsia Index
EPS
Change from baseline in
Symptom Index of Dyspepsia
Epigastric pain
Epigastric burning
Change from baseline in
Nepean Dyspepsia Index
Conclusions
In this study, we found a significant difference in overall response rate and symptoms improvement among acupuncture,
sham acupuncture, and itopride in PDS but not in EPS, demonstrating that acupuncture was effective against meal-related FD
symptoms only. The observation that acupuncture was not more
effective in relieving epigastric pain and epigastric burning than
sham acupuncture, has also been reported by Park et al. [14]. The
distinct therapeutic effects of acupuncture on PDS and EPS may be
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ferent therapeutic approaches in treating EPS and PDS has remained controversial. Regarding our findings on the effect of acupuncture in treating PDS and EPS, more RCTs focusing on the
treatment responses are required to establish a standardized treatment guideline.
Fig. 4. Mean of score changes from baseline measured with Symptom Index
of Dyspepsia at the 12-week post-treatment follow-up: Bars represent the standard error. All symptoms consistently improved 12 weeks after treatment. The
difference between groups was not statistically significant for epigastric pain
syndrome (EPS). Change in postprandial distress syndrome (PDS) symptom
scores on was statistically significant between acupuncture and sham acupuncture groups. Group A showed the most significant improvement in postprandial fullness as compared to other groups. Groups A, B, and C showed significantly larger improvement in early satiation as compared to other groups.
Fig. 5. Mean of changes in quality of life (QoL) from baseline measured with
Nepean Dyspepsia Index (NDI) at the 12-week post-treatment follow-up: Bars
represent the standard error. QoL consistently improved in all groups 12 weeks
after treatment. Group A showed the largest improvement compared to other
groups in both epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS).
Acknowledgments
This work was supported by the National Basic Research Program of China
(973 Program; No.2006CB504501).
Disclosure Statement
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