Table 1.
Characteristics of randomized controlled trials of acupuncture in irritable bowel syndrome (IBS)
| Study | N a | Country | Diagnosti c criteria used for IBS |
Criteria for improvement in overall IBS symptoms |
Criteria for improvement in IBS-related quality of life |
Time point for outcome assess- ment b |
Acupuncture treatment | Control treatment(s) |
|---|---|---|---|---|---|---|---|---|
| An 2010 (33) |
81 c | China | Rome II | Categoricald | -e | 4 wks EoT) |
Fixed formula with moxibustion at 2 fixed points; 24 sessions over 4 wks |
Combined Bifidobacterium, lactobacillus and Enterococcus faecium capsules (2 pills, 3×/d) |
| Anastasi 1999 (34) |
29 | USA | Rome II/III | CGI | - | 4 wks (EoT) |
Flexible formula with moxibustion at all points; 8 sessions over 4 wks |
Sham acupuncture -- superficial needling 2-3 cm from true acupoints |
| Chen 2009 (36) |
60c | China | Rome II | Categorical | FDG QoL scale |
4 wks (EoT) |
Flexible formula with moxibustion at 4 fixed pts; 12 sessions over 4 wks + Chinese herbal formula |
Chinese herbal formula alone (3 pills, 3×/d) |
| Chen 2011 (35) |
60 | China | Rome III – IBS-D |
Categorical | - | 3 wks (EoT) |
Flexible formula with moxibustion at 3-5 pts; 15 sessions over 3 wks |
Montmorillonite (1 bag, 2×/day) + loperamide (4mg, 3×/day) + pinaverium bromide (50mg, 3×/d)f |
| Forbes 2005 (37) |
59 | UK | Rome I and Manning |
Global symptom score based on patient diary g |
EuroQol | 13 wks (EoT) |
Individualized; 10 sessions over 10 wks |
Sham acupuncture -- penetrating needles at non- acupoints |
| Lembo 2009 (38) h |
230 | USA | Rome II | IBS-AR and IBS-SSS |
IBS-QoL | 3 wks (EoT) |
Flexible formula; 6 sessions over 3 wks |
|
| Li 2009 (39) |
186 | China | Rome III | Categorical | - | 10 wks (EoT) |
Flexible formula with moxibustion at all points; 60 sessions over 10 wks + Tuina spinal massage |
Tuina spinal massage alone (60 sessions over 10 wks) |
| Liu 1997 (40) |
150 | China | Not specified |
Categorical | - | 3-21 wks (EoT) |
Flexible formula with moxibustion at 1 acupoint; 10-60 sessions over 20- 120 days + psychotherapy |
|
| Liu 2010 (41) |
300 | China | Rome III – IBS-D |
Categorical | - | 4 wks (EoT) |
Fixed formula EA; 28 sessions over 4 wks + Chinese herbal formula |
|
| Lowe 2000 (42) |
50 | Canada | Rome (version not stated) |
Dichotomous measure of symptom relief |
IBS-36 | 4 wks (Eot) |
Fixed formula; 8 sessions over 4 wks | Sham acupuncture -- tapping blunt needle on the skin and then taping the needle in place |
| Reynolds 2008 (43) |
30 | UK | Rome II | IBS-SSS | - | 3 mos (EoT) |
Flexible formula; 8 sessions over 3 mos |
Usual care |
| Schneider 2006 (44) |
43 | Germ any |
Rome II | Not measured | FDDQL | 5 wks (EoT) |
Fixed formula; 10 sessions over 5 wks |
Sham acupuncture -- validated Streitberger placebo needles placed 2 cm from true acupoints |
| Shi 2010 (45) |
70 | China | Rome III – IBS-D |
Categorical | - | 5 wks (1 wk after (EoT)i |
Flexible formula EA; 28 sessions over 4 wks |
Pinaverium bromide (50mg, 3×/d) |
| Sun 2011 (46) |
63 | China | Rome III – IBS-D |
Categorical | - | 4 wks (EoT) |
Fixed formula; 20 sessions over 4 wks |
Pinaverium bromide (50mg, 3×/d) |
| Xiong 2008 (47) |
120 | China | Rome II | Categorical | - | 4 wks (EoT) |
Fixed formula with moxibustion at 2 pts; 28 sessions over 4 wks + Chinese herbal formula |
Chinese herbal formula alone |
| Xue 2009 (48) |
210 | China | Rome II | Categorical | - | 3-7 weeks (EoT) |
Fixed formula with moxibustion at 1 point; 20-40 sessions over 3-7 wks |
Sulfasalazine (10 mg, 1×/d) |
| Zeng 2010 (49) |
65 | China | Rome III – IBS-D |
Categorical | - | 30 d (EoT) | Flexible formula with moxibustion at 6 points; 30 sessions over 30 d |
Trimebutine maleate (100mg, 3×/d) |
IBS, irritable bowel syndrome; EoT, end of treatment; wks, weeks; d, day; CGI, Clinical Global Impression Scale (73); acupoints, acupuncture points; FDG QoL, Functional Digestive Diseases Quality of Life Scale, an IBS quality of life questionnaire which had been used in previous Chinese studies but that has not been validated; IBS-D, study restricted eligibility to IBS-D (IBS with diarrhea) subtype patients; EuroQol, EuroQol Group’s rating scale (74); IBS-AR, IBS-Adequate Relief question (19); IBS-SSS, IBS Severity Scoring System (20); IBS-QoL, IBS Quality of Life Measure (22); EA, electroacupuncture; IBS-36 (75); FDDQL, Functional Digestive Diseases Quality of Life Questionnaire (76).
Number randomized.
The time point listed is the number of weeks after randomization.
For these 2 trials, the author did not record nor recall the numbers randomized, nor the numbers of dropouts, and the numbers analyzed are reported here.
For all 11 trials conducted in China, a symptom scale was used to assess the severity of the patients’ overall IBS-related symptoms (e.g., abdominal pain, defecation difficulties, diarrhea) both at baseline and after treatment. For 8 of these trials (33,35,36,41,45-47,49), a percentage improvement from baseline scores was then calculated (i.e., (baseline symptom score – symptom score after treatment)/ baseline symptom score), and this percentage change from baseline was then grouped into 2 (45), 3 (33,49), or 4 (35,36,41,46,47) categories, which were then converted into 2 categories for the meta-analysis, as described in the Methods section. For the other 3 trials (39,40,48), it was not clear how the symptom scale scores were converted into the categorical data. For these 11 trials, the criteria for improvement is listed as “Categorical” in this table.
A dash (-) indicates that the outcome not measured.
The Montmorillonite was given to all patients and the loperamide and pinaverium bromide was added if the diarrhea did not stop.
This symptom diary is based on the Bristol scale (77).
In this trial, patients were randomized to five arms. The first arm was a wait-list control. Participants in the remaining 4 arms were randomized to sham or true acupuncture, with or without an augmented practitioner-patient interaction. There was no main effect of practitioner-patient interaction; therefore we combined the two acupuncture groups (augmented and limited encounter) and the two sham acupuncture groups (augmented and limited encounter) in order to compare the effects of acupuncture and sham acupuncture.
This trial also included an EoT measurement point, for which the results were very similar to the 1 wk post EoT measurement point.