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. 2012 May 16;2012(5):CD005111. doi: 10.1002/14651858.CD005111.pub3

Lowe 2000.

Methods Design: Parallel 
 Blinding: Yes 
 Attempt to confirm patient blinding? Not reported 
 Dropouts/withdrawals: Not reported 
 Total duration: 3 months (from baseline) 
 Type of analysis reported: Not reported
Participants Setting: Canada. Not stated. 
 Mean age (+/‐Standard Deviation or Range): Range of 18 to 73 years for entire population; age not provided for each arm, text states "two groups were well‐matched for age" 
 Men/Women (number/number): 80% female in entire population; sex not provided for each arm
Recruitment method: Not reported
Minimum duration of IBS symptoms: Not reported
Actual duration of IBS symptoms before enrollment: Not reported
Diagnosis of IBS required for eligibility?  Not reported 
 Evaluation to rule out organic gastrointestinal disease: Not reported 
 Predominant symptoms or stool patterns of participants: Not reported
Hospital inpatients?  Not reportedWere people with a history of acupuncture treatment excluded?  Not reported
Interventions ACUPUNCTURE 
 Number allocated to acupuncture: 28 
 Style of acupuncture: Chinese 
 Points selection: Formula 
 Points stimulated: Names of points were not reported
Total length of treatment period (weeks): 4 
 Number of sessions target (mean): 8 
 Times per week: 2 
 Number of points used (mean): 6 (usually needled bilaterally) 
 Insertion depth: Not stated 
 Was De Qi reportedly sought? Not reported 
 Duration (minutes): 20 min 
 Method of stimulation: Not reported 
 
 CONTROL GROUP A INTERVENTION: Sham acupuncture with blunt needles 
 Number allocated to control group A: 22
Points selection: Formula
Points stimulated: Names of points were not stated 
 Total length of treatment period: 4 weeks 
 Number of sessions target (mean): 8 
 Times per week: 2
Number of points used: 9 
 Insertion depth: 0 
 Was De Qi sought? No 
 Duration (minutes): 20 
 Method of stimulation: None
Any co‐interventions in all groups? No
Total follow‐up period: 8 weeks
Outcomes Symptom severity: Individual patient‐determined treatment success rate 
 Time points of symptom measurement: At the end of treatment: Acupuncture group: 57%, Sham group: 45% (P = 0.57)
Quality of life: IBS‐36 
 Time points of symptom measurement: (P value for pre‐post treatment change); Acupuncture group; P < 0.0001, Sham; P = 0.0005 
 Type of outcome data reported: Difference post treatment value between acupuncture and control groups. Change from baseline reported in publication
Author's conclusion:
Acupuncture has no method‐specific therapeutic benefit for the treatment of IBS
Additional outcomes reported in the trial but not extracted: Barostat rectal thresholds, McGill pain score. 
 
 Adverse effects: Not reported
Notes Weak points: small sample size, lack of described information
Improvement in pain scores and quality of life in both the treatment and control groups suggests that aspects of sham and true acupuncture may positively influence these measures ‐ or that these are the effects of enrollment in the clinical trial 
 In the patients who did not attain their individual "success goals" there is no data presentation to indicate whether they experienced worsening of symptoms or adverse effects during the trial
Funding sources: Not reported
Additional information provided by William Depew on September 20, 2011
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “This randomized double‐blind study compared acupuncture to a validated placebo acupuncture technique in 50 patients with ROME positive IBS”
Comment: No specific description of sequence generation in the abstract text
[The study employed computer generated random number sequencing to determine assignment. The sequence and codes were held by a third party unassociated with the clinical conduct of the trial. The code was revealed only after the final consecutive case was finished the entire trial observation period]
Allocation concealment (selection bias) Low risk Quote: “This randomized double‐blind study compared acupuncture to a validated placebo acupuncture technique in 50 patients with ROME positive IBS”
Comment: No specific description of allocation concealment in the abstract text.
[The study employed computer generated random number sequencing to determine assignment. The sequence and codes were held by a third party unassociated with the clinical conduct of the trial. The code was revealed only after the final consecutive case was finished the entire trial observation period]
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Quote: “This randomized double‐blind study compared acupuncture to a validated placebo acupuncture technique (tapping a blunt needle on the skin and taping in place at the same points)....”
Comment: There’s no description about whether the patients in this trial were required to have never used acupuncture (i.e. to be acupuncture naive) or not. There were no tests for checking the success of the blinding either. In addition, there was no reference for a study of the validation of this sham procedure, and we are unfamiliar with any study that has validated this procedure
Incomplete outcome data (attrition bias) 
 Short term Unclear risk Comment: Dropouts/withdrawals were not reported or described
Selective reporting (reporting bias) Low risk This trial reported outcomes for individual patient‐determined treatment success and IBS‐36 (only P value) at the completion of the 4 week treatment period, together with results for each outcome measured, according to the Abstract
Other bias Unclear risk Quote: “The two groups were well matched for age, symptom scores, Beck depression and State‐Trait anxiety scores.” However, there were no statistical tests or P values reported for these comparisons, probably because of the abstract format.
Comment: ITT analysis was not reported and the drop‐outs were not reported either, so we couldn't know the degree of “missingness” and whether it would be to affect the estimate of the treatment effect in this trial.
Comment: It’s an abstract and the reporting about methods and outcomes was unclear and incomplete.