By Traci Pantuso, ND, MS
Adjunct Faculty,
Bastyr University,
Seattle, WA;
Owner,
Naturopathic Doctor,
Harbor Integrative Medicine,
Bellingham, WA
Dr. Pantuso reports no financial relationships relevant to this field of study.
Synopsis: This randomized, placebo-controlled trial demonstrated that acupuncture and moxibustion treatment in patients with Crohn’s disease (CD) significantly improved the patient’s CD symptoms, quality of life, mucosal inflammation, serum hemoglobin, and C-reactive protein levels compared to the control group.
Source: Bao CH, et al. Randomized controlled trial: Moxibustion and acupuncture for the treatment of Crohn’s disease. World J Gastroenterol 2014;20:11000-11011.
Moxibustion is a treatment that uses a traditional Chinese medicine herbal formula that is placed on a patient’s acupuncture points, and a cone of moxa (mugwort) is then ignited on top of the herbal formula. This therapy is often used in conjunction with acupuncture.
Summary Points
- After 12 weeks of treatment, Crohn’s disease activity index scores were significantly decreased in patients receiving acupuncture and moxibustion compared to the control group.
- Quality-of-life measurements were also significantly improved in the Crohn’s disease patients receiving acupuncture and moxibustion compared to the control group.
This study used a randomized, placebo-controlled clinical trial design to investigate the effects of acupuncture and moxibustion treatment in patients with Crohn’s disease (CD) three times per week for 12 weeks, with a follow-up period of 12 weeks. CD patients were recruited between January 2010 and April 2013, at the acupuncture outpatient center for inflammatory bowel disease (IBD) of the Shanghai Institute of Acupuncture and Meridian. The primary outcome of the study was the CD activity index (CDAI), which measures the following eight factors over 7 days: number of liquid stools, abdominal pain, general well being, extraintestinal complications, antidiarrheal drugs, abdominal mass, hematocrit, and body weight.1 Secondary outcomes measured were quality of life (QoL) with the inflammatory bowel disease questionnaire (IBDQ), C-reactive protein and erythrocyte sedimentation rate (ESR) to evaluate inflammation, and hemoglobin (HGB) to assess anemia. In addition, 15 patients from each group were selected for enteroscopic exams and mucosal biopsies, which were evaluated by the CD endoscopic index of severity (CDEIS) and the D’Haens-Geboes intestinal histology scoring system.
Patients were included in the study if they had CDAI scores that were mild-to-moderate (151-350), had not been taking salicylic acid drugs and/or prednisone at a dose > 15 mg for at least 1 month, and had not been on immunosuppressants or used anti-TNF-α biological agents for 3 months prior to enrollment in the study. During the 12-week study period, patients maintained their CD medications at the same dosage. In the follow-up period, participants were allowed to adjust the dosage of their medication and were instructed to record such changes. Individuals with serious diseases of the heart, liver, brain, kidney or hematopoietic system, mental illness, and patients with other severe diseases were excluded. Pregnant and lactating women were also excluded.
A total of 146 patients were screened: 54 were excluded and 92 were included (see Table 1). Of that 92, 46 were assigned to the treatment group and 46 were assigned to the control group. The treatment group received moxibustion and acupuncture and the control group received a sham treatment of wheat bran moxibustion and superficial acupuncture for the 12 weeks. The sham treatments appear to the patient as the actual treatment, but have demonstrated significantly less treatment effects and are often used as a control arm in acupuncture studies. The treatment group received acupuncture with the acupoints selected from previous studies and herb-partitioned moxibustion, which contained Coptis chinensis, Radix Aconiti lateralis, Cortex cinnamomi, Radix Aucklandiae, Flos carthami, Salvia miltiorrhiza, and Angelica sinensis as the primary ingredients.
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Table 1: Exclusion Rationale |
|
|
Number Excluded |
Reason for Exclusion |
|
22 |
CDAI scores were too low |
|
4 |
CDAI scores were too high |
|
18 |
Refused to participate |
|
10 |
Use of immunosuppressive drugs or traditional Chinese drugs |
A total of 85 patients completed the study (43 patients in the treatment group and 42 in the control group). Three patients dropped out of the treatment group due to work and travel. Four patients in the control group did not complete the study for various reasons, including two who required prednisone > 15 mg/d, one who became pregnant, and the other due to unknown reasons. Seventy-seven patients completed follow-up: 37 in the control group and 40 in the treatment group.
There were no significant differences between groups at baseline with regard to gender or measurements of age, height, weight, Montreal classification, disease severity or duration, surgical history, CDAI, and QoL. Statistical analysis was performed using per-protocol (PP) and intention-to-treat (ITT) analysis for primary outcome of CDAI, and PP for subgroup and and secondary outcomes; the two-tailed t-test and Mann-Whitney test were also used to analyze secondary outcomes. P values < 0.05 were considered statistically significant.
Post-treatment CDAI scores were significantly reduced by PP analysis in both the treatment and control groups compared to baseline and to one another at 12 weeks (P = 0.000) (see Table 2). The treatment group demonstrated a significantly larger decrease in the CDAI scores compared to the control group (P = 0.000) (see Table 2). The CDAI scores remained significantly improved in the treatment group compared to the control group at follow up (see Table 2).
The ITT analysis demonstrated similar findings as the PP results except in the case of the CDAI score of the control group, as it was significantly improved during the follow-up period compared to baseline (see Table 2). The total treatment efficacy of the control and treatment groups was statistically significant and was 40.48% and 83.72%, respectively, through PP analysis (P = 0.000). The ITT analysis was also statistically significant, with a treatment efficacy of 78.26% and 36.96%, respectively, in the treatment and control groups, respectively (P = 0.000).
Seventy-four percent of patients in the treatment group and 36% patients in the control group were considered to be in remission, with a CDAI score of < 150 after treatment. After treatment, 70% of patients in the treatment group and 14% of patients in the control group showed CDAI score reductions > 100 points, and 79% of patients in the treatment group and 21% of patients of the control group demonstrated CDAI score reduction > 70 points.
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Table 2: PP and ITT analysis of CDAI scores in Control and Treatment Groups at Baseline, Post-Treatment, and Follow-up |
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Control |
Treatment |
P Value |
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|
Baseline to post-treatment |
PP = -35.68 ± 46.91 ITT = -32.58 ± 45.91 |
PP = -115.35 ± 55.05 ITT = -107.83 ± 60.47 |
PP = 0.000** ITT = 0.000** |
|
Baseline to follow up |
PP =-14.32 ± 52.09 ITT = -22.19 ± 55.31 |
PP =-128.93 ± 64.46 ITT =-117.85 ± 70.10 |
PP = 0.000** ITT = 0.000** |
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**= P < 0.01; *= P < 0.05 |
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The QoL measurement IBDQ scores were significantly improved in both the control and treatment groups compared to baseline. However, the treatment group demonstrated a larger increase in IBDQ scores than the control group (P = 0.017) (see Table 3). The HGB levels of the treatment group were significantly increased from both baseline (P = 0.026) and the control group at 12 weeks (P = 0.029) (see Table 3). CRP levels in the treatment group were significantly decreased from both baseline (P = 0.007) and the control group at 12 weeks (P = 0.008) (see Table 3). ESR levels were decreased in both the treatment and control groups from baseline levels, but were not statistically significant. No significant changes were found on endoscopy after treatment. However, the histology scores from the intestinal tissue biopsies were significantly reduced in the treatment group compared to baseline (P = 0.002), and were not significantly different in the control group at 12 weeks. There was also a significant improvement in the histology scores in the treatment group compared to the control group at 12 weeks (P = 0.029) (see Table 3).
Two adverse events also occurred during the study: a subcutaneous hematoma and pain during acupuncture and a mild burn during moxibustion.
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Table 3: Secondary Outcome Measurement Changes at Post-Treatment compared to Baseline |
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Outcome measure |
Control |
Treatment |
P Value |
|
IBDQ |
9.93 ± 19.13 |
24.56 ± 34.15 |
0.017* |
|
HGB (g/L) |
-0.93 ± 10.07 |
5.09 ± 14.45 |
0.029* |
|
CRP (mg/L) |
1 .16 ± 12.11 |
-8.67 ± 20.04 |
0.008** |
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Histology scores |
-0.53 ± 1.73 |
-2.2 ± 2.21 |
0.029* |
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**= P < 0.01; *= P < 0.05 |
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COMMENTARY
Both acupuncture and moxibustion are widely available in the United States and could be a potential treatment option for CD patients. Up to 60% of patients suffering from IBD are reported to use complementary and alternative medicine (CAM) therapies both to help treat their disease and also to treat side effects.2 In a German study investigating CAM use in 413 IBD patients, 52% reported using CAM therapies, with 33% reporting use of acupuncture/traditional Chinese medicine.3 In another study, acupuncture and moxibustion were reported to be 56% effective in the treatment of CD.4 In two recent meta-analyses investigating the role of CAM therapies in the treatment of inflammatory bowel disease, the authors of both studies concluded that the evidence for using TCM and acupuncture has yet to be proven, as the quality of the studies has overall been low.2,5
This particular study was not included in either meta-analysis and offers some important data, as it not only included CDAI scores and QoL measurements but also endoscopic, histology, HGB, CRP, and ESR information. The results of this study demonstrate that acupuncture and moxibustion treatment improve CD symptoms, QoL, and HGB levels and decrease CRP levels and histology scores on intestinal biopsy samples in CD patients. These results expand on previous studies that demonstrated acupuncture and moxibustion treatments reduce CRP but were not statistically significant.4
A limitation of this study was the placebo effect, which has been seen in numerous other studies where sham acupuncture and moxibustion are used and may interfere with the statistical analysis. Despite this limitation, clinicians could weave the results of this study into their treatment plans by recommending acupuncture and moxibustion because they may improve both QoL and disease severity. Definitive use of acupuncture and moxibustion for IBD patients remains to be clarified, which is an important next step since a large number of IBD patients use CAM therapies.
In conclusion, it seems reasonable that recommending acupuncture and moxibustion to patients wanting to prevent flares could benefit mild-to-moderate CD patients as demonstrated in this study. Severe CD patients also may benefit from acupuncture and moxibustion as an adjunctive therapy; however, more research is required to further assess the role of acupuncture and moxibustion treatments in this demographic.
REFERENCES
-
Best WR, et al. Rederived values of the eight coefficients of the Crohn’s Disease Activity Index (CDAI). Gastroenterology 1979;77:
843-846. - Langhorst J, et al. Systematic review of complementary and alternative medicine treatments in inflammatory bowel diseases. J Crohns Colitis 2015;9:86-106.
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Joos S, et al. Use of complementary and alternative medicine in
Germany — a survey of patients with inflammatory bowel disease. BMC Complement Altern Med 2006;6:19. - Joos S, et al. Acupuncture and moxibustion in the treatment of of active Crohn’s disease: A randomized controlled study. Digestion 2004;69:131-139.
- 50Ji J, et al. Acupuncture and moxibustion for inflammatory bowel diseases: A systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med 2013;2013:158352.
This randomized, placebo-controlled trial demonstrated that acupuncture and moxibustion treatment in patients with Crohn’s disease significantly improved the patient’s CD symptoms, quality of life, mucosal inflammation, serum hemoglobin, and C-reactive protein levels compared to the control group.
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