Manzaneque 2004.
Methods | Study design: parallel‐group randomised controlled trial Location, number of centres: psychology students at the University of Malaga Country: Spain Study period: 1‐month training period, Monday to Friday for 30 minutes Methods of analysis: "the day before the study commenced, blood samples were taken from all participants, in both the control and experimental group, at 9:30 in the morning and again 1 month later, at the end of the study, when qigong training was concluded for the experimental participants. The immunological parameters investigated included the number of leukocytes (total leukocytes, monocytes, neutrophils, eosinophils, basophils, lymphocytes, T lymphocytes and T helper lymphocytes), the percentages of leukocytes (monocytes, neutrophils, eosinophils, basophils, lymphocytes and T helper lymphocytes), as well as the concentrations of immunoglobulins (IgA, IgG and IgM) and complement (C3 and C4). Total blood count ‐ Pentra 120 ABX analyser. Serum immunoglobulins and complement Immage, Immunochemistry System (Beckman Coulter)" Statistical analysis: "a between‐group analysis of covariance (ANCOVA) was performed on several dependent variables: the numbers of total leukocytes, monocytes, neutrophils, eosinophils, basophils, lymphocytes, T lymphocytes and T helper lymphocytes; the percentages of lymphocytes, T helper lymphocytes, monocytes, neutrophils, eosinophils and basophils; as well as the concentrations of IgG, IgA, IgM and the complements C3 and C4. The qigong training was considered as an independent variable with 2 levels (absence or control group and presence or experimental group) and the respective pretest scores of each dependent variable as covariates. Thus, the differences between groups were estimated with the differences in pretest scores removed. P < 0.05 was considered to be significant, while P < 0.1 was considered a trend towards significance. Lymphocytes subsets: FACScan (Becton Dickinson)" |
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Participants | Recruitment means: psychology student volunteers Target participants: adults N screened: 29 adults N randomised: 29 adults randomised N completed: 26 adults completed: 13 (Qigong) and 13 (control) Gender: M = 12; F = 14 Age: 18 to 21 years old Baseline details: age, gender |
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Interventions | Setting of intervention: a room adjoining the laboratory where the practice sessions were conducted Description of intervention: "the form of qigong taught is known as the 'eight pieces of brocade' (Ba Duan Jin in Chinese pinyin transliteration). It is a simple qigong method that contains 8 distinct movements and integrates them with breathing and a relaxed state of the mind. The whole physical sequence contains 8 discrete movements each, making a total of 64 physical movements to complete the entire set. Throughout the practice, natural, relaxed and rhythmic breathing is required. This method of qigong reportedly dates back hundreds of years and a number of physical and psychological benefits ts has traditionally been attributed to it. More recently, 2 reports published in important international journals focused on this qigong style and its health‐promoting features. 30 minutes per session, 5 days per week for the month‐long intervention with instructor. Encouraged to do extra on weekends. No data reported on this extra practice" Delivered by: qualified Qigong instructor of this discipline Intervention period: 1 month Follow‐up period: 1 month Co‐interventions: medication was kept constant during the study period |
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Outcomes | Leucocytes (× 103 cells/μL and %); monocytes (× 103 cells/μL and %); neutrophils (× 103 cells/μL and %); eosinophils (× 103 cells/μL and %); basophils (× 103 cells/μL and %); lymphocytes (× 103 cells/μL and %); T lymphocytes (cells/μL and %); T helper lymphocytes (cells/μL and %); IgA (mg/dL); IgG (mg/dL); IgM (mg/dL); C3 (mg/dL); C4 (mg/dL) Follow‐up period: blood sample at 9:30 a.m. the day before and again 1 month later, at the end of the study |
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Notes | Study funding: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The authors do not explain how the random sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | "16 subjects were randomly allocated to the experimental group and 13 to the control group, balancing the number of males and females in each case". Insufficient information provided to permit an assessment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The participants could not be blinded due to the characteristics of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes measured by participant self‐report. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "One experimental subject (male) decided to abandon the experiment without reasons given within the first few days of onset and a further two (one male and one female) were excluded from the sample for non‐attendance at the qigong sessions on more than two occasions" |
Selective reporting (reporting bias) | Low risk | The outcomes prespecified in the methods were reported in the results. |
Other bias | Low risk | The study seems to be free of other sources of bias. |