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

Table 5

Items on internal validity*.

Reference	1.1	1.2	1.3	1.4	1.5	1.6	1.7	1.8	1.9	1.10
	Study addresses appropriate, clearly focused question.	Treatment group assignment is randomized	Adequate concealment method is used.	Subjects and investigators are kept “blind” about treatment allocation.	Treatment and control groups are similar at the start of the trial.	Only difference between groups is the treatment under investigation	Outcomes are measured in a standard, valid and reliable way.	What % of subjects in each treatment arm dropped out before the study was completed	All subjects are analyzed in the groups to which they were randomly allocated (intention to treat analysis).	If the study is multi-site, results are comparable for all sites.
Krucoff et al. 2001 [16]	Well Covered	Well Covered	Well Covered	Adequately Addressed	Well Covered	Well Covered	Well Covered	(1) MANTRA =    2%	Well Covered	Not Applicable
Krucoff et al. 2005 [17]	Well Covered	Well Covered	Well Covered	Adequately Addressed	Well Covered	Well Covered	Well Covered	(1) MIT +    Prayer = 2%	Well Covered	Poorly Addressed
								(2) Prayer = 4%
								(3) MIT = 6%
								(4) UC = 5%
Seskevich et al. [18]	Well Covered	Well Covered	Well Covered	Adequately Addressed	Well Covered	Well Covered	Well Covered	(1) MANTRA =    2%	Well Covered	Poorly Addressed
Edelman et al. [19]	Well Covered	Well Covered	Poorly Addressed	Poorly Addressed	Adequately Addressed	Adequately Addressed	Well Covered	(1) PHP = 27%	Well Covered	Not Applicable
								(2) UC = 14%

Abbreviations: CMA: Conventional medical analgesia; EA: Electro-acupuncture technique; PCB: Paracervical block; MIT: Music, imagery, and touch; PHP: Personalized health planning; SMT: Spinal manipulative therapy; TMS: transcranial magnetic stimulation; and UC: Usual care.
*Each item in Section  1 is to be evaluated using these criteria:
(i) well covered,
(ii) adequately addressed,
(iii) poorly addressed,
(iv) not addressed (i.e., not mentioned, or indicates that this aspect was ignored),
(v) not reported (i.e., mentioned, but insufficient detail to allow assessment),
(vi) not applicable.