| | Issue | Comments |
| | (1) Plurality of forms | (i) Qigong has a long history and is part of traditional Chinese medicine; many forms have evolved; different contexts (martial arts, health benefits, and spiritual development) emphasize different elements.
(ii) Qigong is used either generically to refer to collective practices with common elements or specifically to refer to a particular form of practice. |
| | (2) Components of practice | (i) Qigong consists of movement, breath instruction, and mental/mind components.
(ii) Qigong is now characterized as “meditative movement” and “mindful exercise,” recognizing a unique form of movement.
(iii) Qigong movements emphasize softness, looseness, flowing, and relaxation; this differs from the emphasis on muscular strength or flexibility or aerobic capacity that is part of other exercise regimens. |
| | (3) Amount of practice | (i) Internal qigong involves self-practice, while external qigong involves highly skilled practitioners; most FM studies use self-practice.
(ii) Minimal amounts of practice required (threshold for effect) and relationship of amount of practice to outcomes (practice-response relationship) are important.
(iii) Threshold requirements can be explored in RCTs where the amount of practice is specified, and adherence to practice is monitored.
(iv) The practice-response relationship can be explored in a prospective or retrospective manner within RCTs. However, as the amount of practice increases, there is increased attrition, and retrospective analyses are limited by self-selection.
(v) Observational studies of those who engage in extended practice in a controlled setting, or voluntarily in a community setting, provide important information relating to the health potential of qigong. |
| | (4) Effectiveness of practice | Not all practice time is equally effective. Movements can take time to learn, and nuances of execution can matter. With mental instructions, it can be a challenge to determine parameters that reflect effective engagement. |
| | (5) Control/comparator group | (i) Some trials strive to isolate an active component of an intervention, to delineate “specific” from “nonspecific” factors.
(ii) With complex interventions, many elements (specific, nonspecific) can be contributive, and isolating specific components can be a challenge.
(iii) Control/comparison groups for FM trials can consist of (1) wait-list subjects; (2) sham group (some elements of practice engaged, e.g., movement without mental instruction); (3) education/social support group; (4) active comparator group (e.g., qigong compared to exercise or meditation). |
| | (6) Multiple trial designs | (i) RCTs involve controlled settings, defined inclusion-exclusion criteria, predetermined primary and secondary outcomes, and comparison to placebo or comparator groups, and provide information that is relevant to the regulatory approval process.
(ii) Pragmatic trials provide “in situ” information, include more heterogeneous patient groups, compare outcomes to usual care or standards of care, include long-term follow-ups, and provide information that is relevant to clinical practice.
(iii) Qualitative research provides further valuable insights.
(iv) It is impossible to blind qigong practice, and multiple trial designs are needed to explore efficacy. |
| | (7) Participants, subgroups | (i) FM involves widespread pain and multiple somatic symptoms (disturbances in sleep, mood, and other functions) and can differ in terms of chronicity (duration) and additional symptomology (part of FM or comorbidity).
(ii) Post hoc analyses based on demographics or chronicity are possible in larger trials.
(iii) Prospective subgroups based on psychological characteristics, motivation, locus of control, and attitudes towards complementary and alternative therapies need to be considered. |
| | (8) Outcomes | (i) FM outcomes can be considered in the context of chronic pain or as condition-specific outcomes.
(ii) Comparisons can be between groups (compared to control or comparator) or within groups (compared to baseline).
(iii) With the latter approach, it is possible to consider outcomes in relation to those considered to be clinically significant, which have been defined by clinicians and patients.
(iv) For a condition with multiple symptoms, an intervention that provides benefits in multiple core domains (pain, sleep, mood, impact, and quality of life) will be of particular relevance for clinical practice. |
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