Baseline characteristics of participants
Table shows baseline characteristics of participants assigned to the immediate practice and wait-list/delayed practice groups. Most participants (94 to 98%) were female. The mean age at enrollment was 52 years, and the mean duration of fibromyalgia was 9.6 years. Several additional pain diagnoses were involved (Table ); the incidence of these did not differ between groups, except for orofacial pain which was higher in the wait-list/delayed practice group (P < 0.007). Participants had previously been treated with several drugs from major analgesic and adjuvant drug groups, and had also tried a variety of complementary and alternative therapies. There was no difference in the analgesic pharmacological profile between groups.
Study participants and baseline characteristics
Figure shows the flowchart for disposition of subjects throughout the study. Randomization resulted in assignment of N = 53 to the immediate, and N = 47 to the delayed group. N = 43/53 (81.1%) completed the immediate qigong training protocol for six months, and N = 30/37 (81.1%) completed the delayed qigong protocol for six months. N = 30/47 (63.8%) completed the wait-list protocol for six months and then the training protocol for six months.
Screening, randomization and disposition of participants.
Pain and impact of fibromyalgia
Table shows baseline values for all outcomes in the immediate practice group, the wait-list group and then the delayed practice group. There were no differences in baseline values in any measure between groups. NRS-PI scores remained relatively stable during the six-month interval in the wait-list group (Figure ). There were statistically significant reductions in pain at all times compared to the wait-list/usual care group in both immediate and delayed CFQ practice groups (Figure ). Both groups showed similar results despite the six-month delay in training for one group, and this indicates the reproducibility of outcomes in two cohorts. Figure indicates change in FIQ scores from baseline. FIQ scores were reduced by 17 to 18 units from baseline at eight weeks in both the immediate and delayed CFQ practice groups; in both instances this was significantly reduced compared to the control group (P < 0.001). While there was a slight rebound in FIQ scores at four and six months, significant differences were maintained in both individual CFQ groups compared to the control group (Figure ).
Baseline values for outcome measures
Figure 2 Effects of CFQ practice on pain, function and sleep. Change from baseline in (A) numerical rating scale-pain intensity (NRS-PI) score, (B) fibromyalgia impact questionnaire (FIQ) score, and (C) Pittsburgh Sleep Quality Index (PSQI) scores in immediate (more ...)
Sleep and physical and mental function
Sleep scores showed downward drift over six months in the wait-list group (Figure ). PSQI scores were significantly improved in both immediate and delayed CFQ groups at eight weeks; improvements were maintained in the immediate training group, but exhibited rebound in the delayed group. Physical and mental function scores remained relatively stable over six months in the wait-list group (Figure ). Following CFQ practice, SF-36 physical scores were significantly improved at eight weeks and this was maintained at four and six months in both individual groups (Figure ). SF-36 mental scores were also significantly improved in individual CFQ groups at eight weeks, but did not differ from controls at later times (Figure ).
Figure 3 Effects of CFQ practice on physical and mental function. Changes from baseline in (A) SF- physical, and (B) SF-mental scores in immediate and delayed qigong practice groups compared to the wait-list/usual care control. Values are means for the (•) (more ...)
Combined outcomes in two CFQ groups
When data for the immediate and delayed practice groups were combined, the significant reductions in pain reported at the end of the eight-week training/practice interval (P < 0.001) were sustained in the longer term to four months (P < 0.001) and six months (P = 0.003) (Figure ). With respect to FIQ scores, the combination group exhibited significant improvements compared to the control group at all times (two, four and six months) (Figure ). There was also a significant improvement in sleep (Figure ) and in physical function (Figure ) at all times over the six-month interval in the combination group. Mental function was significantly improved at two and six months, but not at four months (Figure ).
Figure 4 Mean differences from baseline for all participants who completed CFQ training and practice. (A) NRS-PI, (B) FIQ, (C) PSQI, (D) SF- physical, (E) SF-mental scores. Numbers at bottom of panels indicate mean(SD) values for respective groups. Between-group (more ...)
The median duration of fibromyalgia in this study was nine years. A post-hoc analysis of those above and below the median in the combination CFQ group indicated similar changes in pain in both cohorts (mean NRS-PI reductions of 1.38, 1.52 and 1.35 for < 9 years and 1.49, 1.35 and 1.26 for ≥ 9 years at eight weeks and four and six months, P = 0.82, 0.77 and 0.85, respectively). Post-hoc analysis of those with fibromyalgia for < 9 or ≥ 9 years indicated no difference in FIQ reductions in relation to duration of the condition (mean reduction of 16.72, 16.00 and 16.12 for < 9 years, and 19.38, 12.09 and 14.50 for ≥ 9 years at eight weeks and four and six months, P = 0.52, 0.38 and 0.73, respectively).
Clinically meaningful outcomes
Minimal clinical differences for pain (30% reduction from baseline) [21
] and FIQ (14% reduction from baseline) [25
] have been established. The number of individuals with a ≥ 2 point reduction in NRS-PI ranged from 38 to 51% in the combined CFQ group, and this was significantly higher than in the usual care group (9 to 18%) at all times (Table ). Those with a ≥ 8.8 unit reduction in FIQ scores ranged from 56 to 71% in the combined CFQ group, and this was also significantly higher than in the usual care group (20 to 34%) at all times (Table ). A reduction in PSQI of ≥ 3 is considered a treatment effect [26
]. In the combined CFQ group, 48 to 51% attained this, compared to 22 to 25% in the control group (Table ). In the CFQ group, 33 to 36% attained an increase of ≥ 6.5 points in SF-physical scores compared to 9 to 14% in the control group; for SF-mental scores, 30 to 38% in the CFQ group attained an increase of ≥ 7.9 points compared to 11 to 27% in the control group (Table ). These latter differences are considered clinically meaningful in fibromyalgia [12
Individuals with clinically meaningful improvements
Relationship of outcomes to extent of practice
The design of this trial included CFQ instruction and a commitment to a minimum of 45 minutes daily practice for eight weeks. We recognize this was a significant commitment and that not all would be able to meet this goal, despite best intentions. Self-reports of weekly practice times indicated 38/73 (52%) practiced for ≥ 5 h per week for this interval, which represents per protocol practice. There was also a cohort who completed training but then practiced minimally (≤ 3 h/week) (N = 11/73; 15%). Figure presents a comparison of outcomes for those who adhered to the protocol and those who practiced minimally. There were significantly greater improvements in pain (six months, Figure ), FIQ (two months, Figure ), PSQI (two and four months, Figure ), physical function (four and six months, Figure ) and mental function (two months, Figure ) in the per protocol group. Within the per protocol group, 53 to 57% had a ≥ 2 point reduction in NRS-PI, 60 to 82% had a reduction of ≥ 8.8 units in FIQ, and 55 to 65% had a drop of ≥ 3 units in PSQI scores; furthermore, 37 to 43% had increased SF-physical scores of ≥ 6.5 and 32 to 42% had increased SF-mental scores of ≥ 7.9 over the six-month duration of the study.
Figure 5 Comparison of outcomes in the per protocol practice group and those who practiced minimally. Values are means for those who practiced minimally (≤ 3 h/week, N = 11), and those who practiced as per protocol (≥ 5 h/week, N = 38). Numbers (more ...)
Two participants experienced adverse events judged to be possibly related to the CFQ practice. One patient experienced an increase in right-sided shoulder pain, and another participant experienced an episode of plantar fasciitis. In both cases, patients were able to continue with the study and the pain settled over time.