Item 4a: Details of other interventions administered to the acupuncture group (e.g. moxibustion, cupping, herbs, exercises, lifestyle advice)
Additional components of treatment refer to the auxiliary techniques, prescribed self-treatment and lifestyle advice provided by the practitioner. All additional components, whether carried out by the practitioner or patient and whether integral or adjunctive to the acupuncture needling, should be described clearly. For acupuncture related interventions, such as moxibustion or cupping, detail should be provided equivalent to that recommended for acupuncture needling. If the protocol specifies the options of prescribed self-help treatments such as qigong or muscle stretching exercises, and/or lifestyle advice such as dietary changes based on acupuncture-related diagnostic criteria, then these too must be reported. The frequency with which the advice was given, and participants’ compliance with this advice, should be reported. ‘‘Other components of treatment’’ should be distinguished from ‘‘co-interventions’’, that is interventions that are provided additionally to both groups, which should be fully reported as described in STRICTA Item (6b).
(i) In addition to needling, moxibustion or thermal stimulation of the acupoints was used forming very fine wool of mugwort (Artemisa vulgaris) into minute, thread-size punks (okyu) and placing them on a thin layer of an herbal cream (shiunko). The moxa was lit with an incense stick and the process was repeated several times until warmth was felt by the patient.
(ii) Following application of the studs, patients were instructed to apply pressure to the stud by making small circular movements with the fingers of the opposite hand, 2–3 cycles per second for 1– 2 minutes per point. As is typical for self-administered acupressure, patients were encouraged to apply acupressure this way on waking, in the early afternoon and during any exacerbation of symptoms. Initial instruction was provided verbally, at which time patients were asked to confirm their understanding by demonstrating the procedure. Patients also were given easy-to-read written materials describing the acupressure procedure.
(iii) Chinese herbal medicine was to be taken three times per day over a period of 6 weeks and parallel to acupuncture treatment… All herbs used in the present study were imported from China by a single TCM herbal medicine import company (Sinores, Lueneberg, Germany)… All herbs were prepared in dried, minced pieces and then sealed in generic paper sachets by a pharmacist in order to render the herbal formulation non-identifiable for patients… In addition to the basic formula, every patient received a second additional formula tailored to his or her individual TCM diagnosis.
Item 4b: Setting and context of treatment, including instructions to practitioners and information and explanations to patients.
The setting and context of treatment can also provide important additional components to treatment. Context includes instructions to practitioners that might modify their normal practice, for example, prescribing or proscribing explanations to patients about their diagnosis. For patients, the context includes the information they have been given about the trial that might be expected to modify outcomes. Therefore, the information that the patient receives regarding the treatment and control intervention should be reported, including any relevant wording on consent forms and information leaflets designed to influence beliefs or expectations. For example, describing a sham acupuncture control as ‘‘a type of acupuncture’’ may have a different effect on outcome than saying it is ‘‘not acupuncture, but will involve a similar experience to acupuncture.’’
(i) The first acupuncturist was the ‘‘diagnosing acupuncturist’’ (DA), whom the patient saw for the initial consultation, and before and after each treatment. A full case history was taken by the DA, together with tongue and pulse examination, to arrive at an individual diagnosis in accordance with the principles of TCM, with an additional lesser emphasis on Five Element Acupuncture (refs). Although all patients in the study had IBS, this corresponded to a wide range of TCM patterns, making individual diagnosis essential. Dietary and lifestyle advice (important in treatment according to TCM principles) was given to all patients by the DA, who then selected acupuncture points.
The second ‘‘treating acupuncturist’’ (TA) opened the randomization envelope, and for the duration of the study remained the only individual aware of treatment allocation. The TA carried out the treatment – either according to instructions issued by the DA or using sham points, depending on the randomization.
(ii) Patients were informed about acupuncture and minimal acupuncture in the study as follows: ‘‘In this study, different types of acupuncture will be compared. One type is similar to the acupuncture treatment used in China. The other type does not follow these principles, but has also been associated with positive outcomes in clinical studies’’.
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]