Medici 2002.
Methods | Design: parallel group Drop‐outs/withdrawals: 1 in treatment group and 1 in sham group. Jadad score: 1‐1‐1 Duration: 8 weeks treatment., 8 week break, 8 weeks treatment, then follow‐up at 40 weeks. | |
Participants | N = 66 (32 female, 34 male) with 23 in acupuncture group, 23 in sham acupuncture group and 20 in no treatment control). Mean age in acupuncture group 39.3+/‐11.4; sham group 38.4+/‐11.8; no treatment group 40.6+/‐13.5. Mean and range of nocturnal attacks per week in acupuncture group/sham group/no treatment control were 1.2(0‐6) / 2.1(0‐11) / 2.0(0‐8) and for diurnal attacks per week 4.1(0‐14) / 5.5(0‐38) / 2.1(0‐12). Mean and SD FEV1%predicted in acupuncture group/sham group/no treatment control were 91.1(+/‐17.2) / 87.0(+/‐16.1) / 85.7(+/‐18.4). Median and range of eosinophils in blood (cells*10E6/L) in acupuncture group/sham group/no treatment control were 365 (120‐1390) / 383 (50‐950) / 405 (105‐1075) and in sputum (%) were 21.6 (2.0‐76.1) / 15.3(3.6‐65.6) / 18.7(1.4‐60.3). Source of patients not reported. Diagnosis according to GINA guidelines, mild‐moderate asthma. Inclusion criteria: this asthma severity < 10 years; daily use of asthma drugs; excess type asthma according to TCM diagnosis; PEF > 60% predicted; eosinophils present in induced sputum>= 5%. Exclusion criteria: acupuncture treatment in proceeding 5 months; immunotherapy in last year; oral steroids at any time>=8 weeks in a year; high dose inhaled steroids > 1000µg BDP or > 800µg BUD; blood‐clotting disorder; >= 10 cigarettes/day; poor compliance. | |
Interventions | Acupuncture group: Standardized acupuncture formula (n=23) with 11 points in total, chosen for
antiasthmatic effect
(DU‐14, EX‐BW1, BL‐13, KID‐3, LU‐10, SP‐6),
anti‐inflammatory effect
(LI‐4, LI‐11, DU‐14, St‐36),
and anti‐allergic as well as anti‐histaminic effect
(St‐36, LIV‐13, P‐6).
Using 1,5 inch, 30 gauge stainless steel needles.
Insertion depth 13‐40 mm at angle of 45‐90 degrees. Manually manipulated 30 times every 5 min for each session.
Laterality not stated. Control group: Sham acupuncture (n = 23) at 11 non‐acupuncture points close to real acupuncture points (not defined exact). Same needles, depth of maximal 10 mm at an angle of 10 degrees, same manipulation. Laterality not stated. Non treatment control group (n = 20). Treatment duration: 16 treatments (each 20 min) altogether. Twice weekly for 4 weeks, followed by 8 weeks without treatment and then ongoing twice weekly for 4 weeks. Acupuncturist: Well trained, experienced physician. TCM‐Diagnosis done/applied to intervention: (+/‐) Patients had to have symptoms of excess (Shi)‐type asthma. |
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Outcomes | Pulmonary function, subjective symptoms, drug use, immunologic parameters. | |
Notes | Significant results in favour of acupuncture in PEF variability; by 10 months the differences between the groups had disappeared. Asthma attacks decreased slightly in all three groups (not significant between groups). Use of inhaled beta‐agonists not statistically significant between all three groups. Quality of life not effected by real or placebo acupuncture. Eosiniphils: statistical results observed sporadically. No serious adverse events reported, no reporting on non‐serious adverse events. Sham acupuncture may have effected asthma symptoms. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | No information available |
Allocation concealment? | Unclear risk | No information available |
Blinding? All outcomes | High risk | Therapist was aware as to the treatment given |
Incomplete outcome data addressed? All outcomes | Low risk | Low attrition rate |
Free of other bias? | Low risk | Experienced, qualified therapist |