1 Intervention
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1a)
Style of acupuncture: Traditional Chinese Medicine; Chinese Acupuncture
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1b)
Rationale for treatment (e.g. syndrome patterns): expert panel review of protocol; grouping of TCM diagnoses, syndrome analyses and preliminary studies. TCM diagnoses: liver qi stagnation, liver yin deficiency, liver blood deficiency, spleen qi deficiency, spleen yang deficiency, kidney qi deficiency, kidney yin deficiency, kidney yang deficiency, qi & blood deficiency, qi & blood stagnation, dampness. Based on the grouping of TCM diagnoses and expert counsel we arrived at a specific set of acupuncture points for needling and moxa administration.
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2 Needling details
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2a)
Needle type (gauge, length, and manufacturer or material):
All acupuncture procedures were performed with sterile disposable needles Seirin, J-type, 30 mm, 38 gauge.
Acupuncture points: LI 11, SP 10, GB 34, ST 36, SP 6, KI 3, LV 8, GB 39.
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3 Treatment regimen
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4 Co-interventions
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4a)
Other interventions (e.g. moxibustion, cupping):
Moxibustion: All moxibustion procedures were performed with moxa sticks made of Artemisia Vulgaris
Active moxibustion – moxa stick was held approximately one inch over points.
Indirect pole moxa on UB 17, UB 18, UB 20, KI 1. Additional details in manuscript.
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5 Practitioner background
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5a)
Practitioner background:
Research Acupuncturists: Criteria for serving as a Research Acupuncturist
completed training from an accredited acupuncture programme which has received certification from the Accreditation Commission for Acupuncture and Oriental Medicine State Acupuncture license current certification from the National Commission for the Certification of Acupuncture and Oriental Medicine (which includes ‘Clean Needle Technique’ certification) have a minimum of two years experience have experience in serving as a Research Acupuncturist (following the research treatment protocol precisely as instructed).
In addition, prior to the implementation of the RCT all Research Acupuncturists:
attended an acupuncture point location training session conducted by Research Acupuncture Consultant and PI pass a written and practical exam on point locations* (both traditional [true] and sham points) Research Acupuncturist and subject interaction – There was no discussion between the Research Acupuncturist and the subject. This was to maintain a research milieu and to ensure consistency and uniformity of protocol application.
All questions and/or comments were directed to the Study Facilitator (SF) who was present during all treatment sessions. Subjects were informed of this procedure at the time of consent. The SF role was otherwise scripted so that all subjects receive the same level of interaction.
receive detailed instructions regarding the implementation of acupuncture procedures/techniques for all conditions from acupuncture consultant and PI -
reviewed current standards of practice including cleansing the site and proper disposal of needles.
Study Facilitator (SF) (Monitor Protocol Fidelity): The SF underwent training by an acupuncture consultant and the PI. SF training emphasis involved subject safety, methodical facilitation of all conditions, monitoring of protocols, timing and sequencing of points, structured elicitation of adverse events, recording/documenting sessions, blinding procedures, unblinding subjects at final session and scheduling of post-study control subjects for active Acu/Moxa sessions.
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5b)
Length of clinical experience: Acupuncturists completed a 3 year, full-time (2,835 hours) programme, at a Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) accredited institution. Acupuncturists were nationally certified by NCCAOM and New York State licensed.
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5c)
Expertise in specific condition: Study team has extensive experience in HIV-related conditions and symptom management.
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6 Control intervention(s)
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6a)
Intended effect of control intervention and its appropriateness to research question and, if appropriate, blinding of participants (e.g. active comparison, minimally active penetrating or non-penetrating sham, inert):
Control interventions, sham acupuncture and placebo moxibustion, were designed specifically for two purposes:
to minimize the non-physiological effects (Birch et al., 2002), and 2) to maintain the psychological impact.
Sham acupuncture:
void of treatment effect by specifying the exact anatomical location of sham points at 2–3 cm away from the classic/traditional true point location and not on the channel/meridian minimally stimulating by ensuring an insertion depth of only 2 mm, which was just sufficient to make the needle stand vertically with very light [minimal] stimulation specifically void of manipulation of the needle so that no qi would be elicited applied a, b, and c (above) to sham acupuncture points.
Placebo moxibustion:
void of treatment effect by specifying the exact anatomical location of control moxa 8 inches above and 2–3 cm away from the traditional location subjects were exposed to the moxibustion procedure by the lighting and administration of a moxa stick which emits smoke and a floral aroma, as in the true moxibustion specifically void of stimulation from the moxa stick so that no heat would be generated applied a, b, and c (above) to Placebo moxa points.
As an added measure to ensure blinding, all subjects were blindfolded during their treatments.
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6b)
Explanations given to patients of treatment and control interventions: All potential subjects are informed during consent procedures that: all subjects are randomised to either Active (true) Acu/Moxa or Sham/Placebo Acu/Moxa which is not an active treatment (non-treatment); all subjects are blinded treatment assignment and blind-folded during their treatments and that those subjects who were assigned to Sham/Placebo Acu/Moxa are offered 12 true Acu/Moxa treatments at no cost.
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6c)
Details of control intervention (precise description, as for Item 2 above): Details for control condition are as specific as the active treatment condition. All sham points are illustrated in our study procedure manual. All acupuncturists receive training and are tested on these points as well as the active points (written and practical exam).
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6d)
Sources that justify choice of control: (Birch et al., 2002; Hammerschlag, 1997; Stux & Hammerschlag, 2001, MacPherson et al., 2002; Vincent & Lewith, 1995; Vincent, 1989)
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