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Flow of studies through selection process.
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Figure 1

Flow of studies through selection process.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Acupuncture versus sham acupuncture: Symptom severity
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Figure 3

Acupuncture versus sham acupuncture: Symptom severity

Acupuncture versus sham acupuncture: Quality of life
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Figure 4

Acupuncture versus sham acupuncture: Quality of life

Acupuncture versus another active treatment, as adjuvant to another active treatment, or compared to no specific treatment: Symptom severity
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Figure 5

Acupuncture versus another active treatment, as adjuvant to another active treatment, or compared to no specific treatment: Symptom severity

Comparison 1 Acupuncture versus sham acupuncture, Outcome 1 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 1.1

Comparison 1 Acupuncture versus sham acupuncture, Outcome 1 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).

Comparison 1 Acupuncture versus sham acupuncture, Outcome 2 Symptom severity (responders) (short‐term:up to 3 mons, closest to 8 wks).
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Analysis 1.2

Comparison 1 Acupuncture versus sham acupuncture, Outcome 2 Symptom severity (responders) (short‐term:up to 3 mons, closest to 8 wks).

Comparison 1 Acupuncture versus sham acupuncture, Outcome 3 Symptom severity (generic inverse variance) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 1.3

Comparison 1 Acupuncture versus sham acupuncture, Outcome 3 Symptom severity (generic inverse variance) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).

Comparison 1 Acupuncture versus sham acupuncture, Outcome 4 Quality of life (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 1.4

Comparison 1 Acupuncture versus sham acupuncture, Outcome 4 Quality of life (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).

Comparison 1 Acupuncture versus sham acupuncture, Outcome 5 Quality of life (responders) (short‐term:up to 3 mons, closest to 8 wks).
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Analysis 1.5

Comparison 1 Acupuncture versus sham acupuncture, Outcome 5 Quality of life (responders) (short‐term:up to 3 mons, closest to 8 wks).

Comparison 1 Acupuncture versus sham acupuncture, Outcome 6 Quality of life (mean outcomes) post‐treatment scores (long‐term: >3 mos, closest to 6 mos).
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Analysis 1.6

Comparison 1 Acupuncture versus sham acupuncture, Outcome 6 Quality of life (mean outcomes) post‐treatment scores (long‐term: >3 mos, closest to 6 mos).

Comparison 2 Acupuncture versus pharmacological medication, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).
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Analysis 2.1

Comparison 2 Acupuncture versus pharmacological medication, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).

Comparison 2 Acupuncture versus pharmacological medication, Outcome 2 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 2.2

Comparison 2 Acupuncture versus pharmacological medication, Outcome 2 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).

Comparison 3 Acupuncture versus Bifidobacterium, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).
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Analysis 3.1

Comparison 3 Acupuncture versus Bifidobacterium, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).

Comparison 4 Acupuncture versus psychotherapy, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).
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Analysis 4.1

Comparison 4 Acupuncture versus psychotherapy, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).

Comparison 5 Acupuncture plus psychotherapy versus psychotherapy alone, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).
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Analysis 5.1

Comparison 5 Acupuncture plus psychotherapy versus psychotherapy alone, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).

Comparison 6 Acupuncture plus another traditional Chinese medicine (TCM) treatment versus the other TCM treatment alone, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 6.1

Comparison 6 Acupuncture plus another traditional Chinese medicine (TCM) treatment versus the other TCM treatment alone, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mos, closest to 8 wks).

Comparison 6 Acupuncture plus another traditional Chinese medicine (TCM) treatment versus the other TCM treatment alone, Outcome 2 Quality of life (mean outcomes) (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 6.2

Comparison 6 Acupuncture plus another traditional Chinese medicine (TCM) treatment versus the other TCM treatment alone, Outcome 2 Quality of life (mean outcomes) (short‐term: up to 3 mos, closest to 8 wks).

Comparison 7 Acupuncture versus no specific treatment, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).
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Analysis 7.1

Comparison 7 Acupuncture versus no specific treatment, Outcome 1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks).

Comparison 7 Acupuncture versus no specific treatment, Outcome 2 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 7.2

Comparison 7 Acupuncture versus no specific treatment, Outcome 2 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).

Comparison 7 Acupuncture versus no specific treatment, Outcome 3 Quality of life (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).
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Analysis 7.3

Comparison 7 Acupuncture versus no specific treatment, Outcome 3 Quality of life (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks).

Comparison 7 Acupuncture versus no specific treatment, Outcome 4 Quality of life (responders) (short‐term: up to 3 mons, closest to 8 wks).
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Analysis 7.4

Comparison 7 Acupuncture versus no specific treatment, Outcome 4 Quality of life (responders) (short‐term: up to 3 mons, closest to 8 wks).

Summary of findings for the main comparison. Acupuncture versus sham acupuncture for irritable bowel syndrome

Acupuncture versus sham acupuncture for irritable bowel syndrome

Patient or population: patients with irritable bowel syndrome
Settings: Canada (1), Germany (1), UK (1), US (2)
Intervention: True acupuncture
Comparison: Sham acupuncture

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Sham acupuncture

True acupuncture

symptom severity (continuous outcome)
IBS Severity Scoring System (IBS‐SSS)1. Scale from: 0 to 500.
Follow‐up: 3‐13 weeks2

The mean symptom severity (continuous outcome) in the control groups was
193 points3

The mean symptom severity (continuous outcome) in the intervention groups was
9.2 lower
(29.2 lower to 10.8 higher)4(Better values are indicated by lower scores.) 

281
(4 studies)

⊕⊕⊕⊝
moderate5

SMD ‐0.11 (‐0.35 to 0.13)

quality of life (continuous outcome)
IBS Quality of Life (IBS‐QOL) Scale6. Scale from: 0 to 100.
Follow‐up: 3‐5 weeks2

The mean quality of life (continuous outcome) in the control groups was
73.8 points3

The mean quality of life (continuous outcome) in the intervention groups was
.53 lower
(4.8 lower to 3.9 higher)7(Better values are indicated by higher scores.) 

253
(3 studies)

⊕⊕⊕⊝
moderate5

SMD ‐0.03 (‐0.27 to 0.22)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 The IBS Severity Scoring System (IBS‐SSS) possesses responsiveness, face and construct validity (Francis 1997), and is one of the most widely used IBS symptom severity outcome measures. Better values are indicated by lower scores.
2 This outcome is for the short‐term follow‐up time point, defined as the time point closest to 8 weeks and less than or equal to 3 months after randomization. Outcomes were measured at the end of the treatment period in all studies, and because in all studies the end of treatment time point coincided with the time point closest to 8 weeks and less than or equal to 3 months, our short term outcome time points were the end of treatment for all trials.
3 We used the Lembo 2009 trial as the representative trial for the final value scores of symptom severity and quality of life in the control group because this trial was sufficiently large; the patient characteristics and the baseline means and SDs of symptom severity and quality of life in the control group of this trial were similar to and representative of the other trials; and this trial used the familiar IBS‐SSS scale for symptom severity and the well‐validated IBS‐QoL for quality of life.
4 The standardized mean difference (SMD) was re‐expressed into a mean difference by applying the calculated SMD back into the Lembo 2009 study and depicted on the IBS‐SSS scale used in that study. This calculation was made by multiplying the post‐treatment standard deviation of the IBS‐SSS score of the sham group in the Lembo trial by the pooled SMD.
5 Imprecision due to sparse data (less than 400 events ) and confidence intervals include possibility of benefit.
6 The IBS Quality of Life measure (IBS‐QoL) (Patrick 1998) is an extensively validated IBS quality of life scale (Bijkerk 2003; Irvine 2006). Better values are indicated by higher scores.
7 The standardized mean difference (SMD) was re‐expressed into a mean difference by applying the calculated SMD back into the Lembo 2009 study and depicted on the IBS‐QoL scale used in that study. This calculation was made by multiplying the post‐treatment standard deviation of the IBS‐QoL score of the sham group in the Lembo trial by the pooled SMD.

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Summary of findings for the main comparison. Acupuncture versus sham acupuncture for irritable bowel syndrome
Summary of findings 2. Acupuncture versus pharmaceutical medications for irritable bowel syndrome

Acupuncture versus pharmaceutical medications for irritable bowel syndrome

Patient or population: patients with irritable bowel syndrome
Settings: China (5)
Intervention: Acupuncture
Comparison: Pharmaceutical medications

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Pharmaceutical medications

Acupuncture

symptom severity (dichotomous outcome)
Dichotomous measure of overall symptom severity1
Follow‐up: 3‐7 weeks2

633 per 10003had improved overall symptom severity in the pharmaceutical medication group

810 per 1000 (709 to 918) had improved overall symptom severity in the acupuncture group

RR 1.28
(1.12 to 1.45)

449
(5 studies)

⊕⊕⊝⊝
low4,5

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 In cases where dichotomous outcomes such as improvement in IBS symptoms were presented in the form of multiple strata, such that we had the option of choosing cutpoints for the dichotomous outcome, we created a dichotomous measure in which all positive outcomes were combined into a single positive category (i.e., improvement) and the remaining strata constituted the negative category (i.e., no improvement). When investigators selected a cutpoint on a continuous scale to dichotomize between improvement and no improvement, we used the same cutpoint to define the dichotomous outcome.
2 This outcome is for the short‐term follow‐up time point, defined as the time point closest to 8 weeks and less than or equal to 3 months after randomization.
3 The assumed risk in the control group is based on the percentage of all participants in the control group who experienced improvement in symptom severity. There were a total of 229 control group participants, and 145 of these participants experienced improvement in symptom severity.
4 The primary limitation is that treatment in these studies was unblinded, and it is unclear whether or not the greater benefits of acupuncture reported by patients in these unblinded trials are due entirely to patients' greater expectations of improvement from acupuncture than drugs. Additionally, one study author (Xue Y 2009) explained that allocation to treatment was by means of a random number table and did not give further details.

5 Imprecision due to sparse data (less than 400 events).

Figuras y tablas -
Summary of findings 2. Acupuncture versus pharmaceutical medications for irritable bowel syndrome
Comparison 1. Acupuncture versus sham acupuncture

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

3

231

Std. Mean Difference (IV, Random, 95% CI)

‐0.09 [‐0.35, 0.17]

2 Symptom severity (responders) (short‐term:up to 3 mons, closest to 8 wks) Show forest plot

3

262

Risk Ratio (M‐H, Random, 95% CI)

1.09 [0.87, 1.37]

3 Symptom severity (generic inverse variance) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

4

281

Std. Mean Difference (Random, 95% CI)

‐0.11 [‐0.35, 0.13]

4 Quality of life (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

3

253

Std. Mean Difference (IV, Random, 95% CI)

‐0.03 [‐0.27, 0.22]

5 Quality of life (responders) (short‐term:up to 3 mons, closest to 8 wks) Show forest plot

1

153

Risk Ratio (M‐H, Random, 95% CI)

1.25 [0.58, 2.68]

6 Quality of life (mean outcomes) post‐treatment scores (long‐term: >3 mos, closest to 6 mos) Show forest plot

1

41

Std. Mean Difference (IV, Random, 95% CI)

0.07 [‐0.54, 0.69]

Figuras y tablas -
Comparison 1. Acupuncture versus sham acupuncture
Comparison 2. Acupuncture versus pharmacological medication

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks) Show forest plot

5

449

Risk Ratio (M‐H, Random, 95% CI)

1.28 [1.12, 1.45]

2 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

3

190

Std. Mean Difference (IV, Random, 95% CI)

‐0.72 [‐1.02, ‐0.43]

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Comparison 2. Acupuncture versus pharmacological medication
Comparison 3. Acupuncture versus Bifidobacterium

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks) Show forest plot

2

181

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.90, 1.27]

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Comparison 3. Acupuncture versus Bifidobacterium
Comparison 4. Acupuncture versus psychotherapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks) Show forest plot

1

100

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.87, 1.26]

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Comparison 4. Acupuncture versus psychotherapy
Comparison 5. Acupuncture plus psychotherapy versus psychotherapy alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks) Show forest plot

2

182

Risk Ratio (M‐H, Random, 95% CI)

1.16 [1.04, 1.29]

Figuras y tablas -
Comparison 5. Acupuncture plus psychotherapy versus psychotherapy alone
Comparison 6. Acupuncture plus another traditional Chinese medicine (TCM) treatment versus the other TCM treatment alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom severity (responders) (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

4

466

Risk Ratio (M‐H, Random, 95% CI)

1.17 [1.02, 1.33]

2 Quality of life (mean outcomes) (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

1

60

Std. Mean Difference (IV, Random, 95% CI)

0.48 [‐0.03, 0.99]

Figuras y tablas -
Comparison 6. Acupuncture plus another traditional Chinese medicine (TCM) treatment versus the other TCM treatment alone
Comparison 7. Acupuncture versus no specific treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Symptom severity (responders) (short‐term: up to 3 mons, closest to 8 wks) Show forest plot

2

181

Risk Ratio (M‐H, Random, 95% CI)

2.11 [1.18, 3.79]

2 Symptom severity (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

2

181

Std. Mean Difference (IV, Random, 95% CI)

‐1.29 [‐2.59, 0.01]

3 Quality of life (mean outcomes) post‐treatment scores (short‐term: up to 3 mos, closest to 8 wks) Show forest plot

1

155

Std. Mean Difference (IV, Random, 95% CI)

0.34 [0.02, 0.66]

4 Quality of life (responders) (short‐term: up to 3 mons, closest to 8 wks) Show forest plot

1

155

Risk Ratio (M‐H, Random, 95% CI)

1.43 [0.65, 3.14]

Figuras y tablas -
Comparison 7. Acupuncture versus no specific treatment