Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

Table 4

Descriptive of clinical trials of choice of care (multidimensional) integrative healthcare interventions (𝑛=7).

Reference	Design	Sample	Trial duration	Intervention	Control	Primary measures	Evidence direction on primary^#	SIGN score*	Adverse events score
Krucoff et al. 2001 [16]	RCT	150	6 months	MANTRA	UC	DUREL, SSTA, Risk Stratification, and post-PCI ischemia	Weak	++	100
		Gender: 1 F
		Mean Age: 63
Krucoff et al. 2005 [17]	RCT	748	6 months	MANTRA: MIT or MIT plus prayer	UC or Prayer	DUREL, SSTA, and mood assessed by VAS before PCI for unstable coronary syndromes	Weak	++	100
		Gender: 214 F
		Mean Age: 65
Seskevich et al. 2004 [18]	RCT	150	15 months	MANTRA	UC	Mood assessed by VAS before PCI for unstable coronary syndromes	Mixed	++	0
		Gender: 1 F
		Mean Age: 64
Edelman et al. 2006 [19]	RCT	154	10 months	PHP	UC	10-year risk of CHD (FRS)	Strong	+	0
		Gender: 81 F
		Mean Age: 53
Carlsson et al. 2001 [20]	CCT	120	1 year	ABCW	CBCW	Life satisfaction (EORTC QLQ-C30, LSQ & MAC)	Weak	NA	100
		Gender: F
		Mean Age: 49
Carlsson et al. 2004 [21]	CCT	60	6 months plus follow-up	ABCW	CBCW	Life satisfaction (EORTC QLQ-C30 & LSQ)	Strong	NA	100
		Gender: F
		Mean Age: 49

Abbreviations: ABCW: Women with breast cancer, anthroposophic therapy; CBCW: Women with breast cancer, conventional therapy; CHC: Coronary heart disease; DUREL: Duke University religion index; EORTC QLQ-C30: European organization for research and treatment of cancer, quality of life questionnaire core 30; FRS: Framingham risk score; LSQ: Life satisfaction questionnaire; MAC: Mental adjustment to cancer scale; MANTRA: Monitoring & actualization of noetic training; MIT: Music, imagery, and touch; PCI: percutaneous coronary intervention; PHP: Personalized health planning; SMT: Spinal manipulative therapy; SSTA: Spielberger state-trait anxiety inventory; U: Unknown; UC: Usual care; and VAS: Visual analog scale.
^#Evidence direction on primary measures. Weak: no outcome measures positive despite sufficient statistical power to do so, Mixed: at least one primary outcome measure positive at the level of 𝑃<.05, Strong ≥ 50% of measures positive at the level of 𝑃<.05, and Inconclusive: study failed to demonstrate a change but lacked the statistical power to demonstrate.
*SIGN checklist for RCTs and controlled clinical trials
++: Strong. All or most of the criteria have been fulfilled.
+: Article is neither exceptionally strong nor exceptionally weak.
−: Weak. Few or no criteria fulfilled.