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 |
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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 |
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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 |
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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 |
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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. |