Explanations and examples for Item 3: Treatment regimen

Item 3a: Number of treatment sessions.


The planned number of sessions and frequency of treatment should be clearly documented. The actual number of treatments received by participants should be reported in the Results section. If there is variation between patients, then the mean and range should be reported.


(i) The true acupuncture (experimental) group underwent 26 weeks of gradually tapering treatment according to the following schedule: 8 weeks of 2 treatments per week followed by 2 weeks of 1 treatment per week, 4 weeks of 1 treatment every other week, and 12 weeks of 1 treatment per month.

(ii) In all groups, participants were asked to attend treatment sessions twice weekly for 12 weeks (24 treatments). We considered participants who attended 80% or more ($19 of 24) of acupuncture sessions to have completed a full course of treatment.

Item 3b Frequency and duration of treatment sessions.


The frequency and duration of sessions should be documented, with mean and range to be reported where there is variation across patients. Any variation in frequency of treatment (for example if subjects are to be treated twice weekly in the first two weeks then once a week for the next six weeks) should be clearly reported.


(i) Acupuncture was administered a maximum of eight times, twice during each of the first three weeks and once during each of the following two weeks, for 30 minutes at each session. One month after this series of treatments had been completed and evaluated, the patients were offered a maximum of two follow up treatments of the same kind, one week apart. 

(ii) The VA (verum acupuncture) group received acupuncture with a 0.25640-mm stainless steel needle (Asia Med, Munich, Germany) at LI4.

For a fully-referenced version of these explanations and examples for this item, please refer to the following paper:

MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement. PLoS Medicine 2010; 7(6): e1000261. doi:10.1371/journal.pmed.1000261. [full text]