Yoga versus non‐standard care for schizophrenia

Julie Broderick; Niall Crumlish; Alice Waugh; Davy Vancampfort

doi:10.1002/14651858.CD012052.pub2

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Figure 1

37Study flow diagram for 2015 searches

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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 1 Mental state: 1. Clinically important change (PANSS ‐ not improved) short term.

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Analysis 1.2

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 2 Mental state: 2. Average endpoint score (various scales) short term.

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Analysis 1.3

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 3 Global state: Average endpoint score (CGIS, low score=good) short term.

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Analysis 1.4

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 4 Social functioning: 1. Clinically important change (SOFS ‐ not improved) short term.

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Analysis 1.5

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 5 Social functioning: 2. Average score at endpoint (two scales).

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Analysis 1.6

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 6 Quality of life: Average endpoint scores (various scales) short term.

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Analysis 1.7

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 7 Adverse effects.

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Analysis 1.8

Comparison 1 YOGA versus NON‐STANDARD CARE, Outcome 8 Leaving the study early ‐ short term.

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Table 2. Comparisons relevant to other reviews suggested by excluded and included studies

Intervention	plus	Control	Participants	Reference tag	Relevant Cochrane review
Yoga	nil	standard care	people with schizophrenia	Behere 2011; Ikai 2013; Ikai 2014; Jayaram 2013; Lin 2006;Lin 2015;Varambally 2012a; Visceglia 2011	Yoga versus standard care for schizophrenia
	counselling	standard care
	motivational and feedback session
	nil		caregivers of people with schizophrenia	Varambally 2013
Yoga	non‐standard care		people with schizophrenia	SLCTR‐2013‐008*; Paikkatt 2012; Xie 2006;	Yoga as part of a package of care versus non‐standard care
Chlorpromazine	nil	placebo		Mahal 1976; Ramu 1999	Chlorpromazine versus placebo for schizophrenia
'Tagara' (local drug with anti‐psychotic properties) and 'Brahmyadiyoga' (a herbal compound)	nil				Chlorpromazine versus herbal compounds for schizophrenia
		chlorpromazine
* This particular study used yoga combined with relaxation exercises, breathing exercises, body movement exercises, basic acting exercises, the Alexander technique, theatre games, exercise ''to build self confidence'', creative work using props, use of music to enhance creativity and moods.

Table 2. Comparisons relevant to other reviews suggested by excluded and included studies

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Table 3. Design of a future study

Methods	Allocation: randomised (clearly described). Blinding: single‐blind (outcomes assessor). Duration: minimum 1 year. Design: parallel. Setting: outpatient and inpatient settings.
Participants	Diagnosis: people with a clinical diagnosis of schizophrenia. History: from waiting list and referred to research staff. N=300. Age: > 18 years. Sex: males and females. Inclusion criteria: .age 18 years or greater. Exclusion criteria: presence of physical disability or illness which precludes participation in yoga intervention.
Interventions	1. Yoga: the yoga intervention should be clearly described and consist of the following components; (i) shithileekarana vyayama (loosening exercises) for approximately 10 minutes (ii) yoga postures (asanas) for approximately 20 minutes (iii) breathing exercises and relaxation techniques for approximately 20 minutes using a manualised protocol, yoga programme for 12 weeks, 3 times weekly, follow‐up at 6 months and 1 year, yoga delivered by a trained yoga instructor, meditation not included. 2. Standard care control*. All groups stable pharmacotherapy.
Outcomes	Mental state (binary outcomes). Relapses (binary outcomes). QOL (binary outcomes). Disability (binary outcomes). Activities of daily living (binary outcomes). Costs: cost of services, cost of care. Adverse events related to yoga (number and type of injuries). Service outcomes: days in hospital, time attending outpatient psychiatric clinic.
Notes	Adherence should be logged with patients expected to adhere to 70% to 75% of scheduled sessions. * Regarding design of a future study, readers are directed to the first yoga review in this series (Broderick 2015) ‐ as a comprehensive yoga versus standard care study has not yet been published, this would be the initial priority. When this is conducted, many legitimate active comparators to yoga could be suggested; such as, but not limited to the following; yoga versus talking therapy, yoga versus expressive therapies, yoga versus other forms of exercise such as Tai'chi.

Table 3. Design of a future study

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Table 4. Possible active comparators to yoga for the design of future trials

Intervention	plus	Active Comparator Broad Group	Specific interventions*
Yoga	nil	expressive therapy	art therapy
			drama therapy
			music therapy
			dance therapy
			writing therapy
		talking therapies	cognitive behavioural therapy
			dialectic behaviour therapy
			humanistic therapies
		exercise	aerobic‐based interventions
			combined aerobic and resistance programme
			resistance‐based interventions
			Tai'chi
			qi'gong
*This list of specific interventions is not exhaustive and merely provides some examples of legitimate active comparators to yoga which are not currently available. These interventions could also be considered alternatively. For instance, exercise consists of heterogeneous interventions, it is accepted there could be other equally justifiable intervention titles such as 'supervised' exercise, 'non‐supervised exercise', or 'group‐based exercise', 'individual exercise', or exercise could be considered in terms of intensity such as 'high intensity', 'moderate intensity' and 'low intensity'. Note the specific intervention should be delivered by suitably qualified personnel.

Table 4. Possible active comparators to yoga for the design of future trials

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Summary of findings for the main comparison. YOGA versus NON‐STANDARD CARE for schizophrenia

YOGA versus NON‐STANDARD CARE for schizophrenia
Patient or population: people with schizophrenia Settings: hospitals, in India and China Intervention: YOGA versus NON‐STANDARD CARE
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	YOGA versus NON‐STANDARD CARE
Mental state: clinically important change PANSS ‐ not improved Follow‐up: 4 months	Low¹		RR 0.81 (0.62 to 1.07)	84 (1 study)	⊕⊕⊝⊝ low²
	800 per 1000	648 per 1000 (496 to 856)
	Moderate¹
	900 per 1000	729 per 1000 (558 to 963)
	High¹
	1000 per 1000	810 per 1000 (620 to 1000)
Global state: relapse	No trial reported this outcome.
Social functioning: clinically important change SOFS ‐ overall, not improved Follow‐up: 4 months	Low¹		RR 0.90 (0.78 to 1.04)	84 (1 study)	⊕⊕⊝⊝ low²
	700 per 1000	630 per 1000 (546 to 728)
	Moderate¹
	900 per 1000	810 per 1000 (702 to 936)
Adverse effects ‐ any	See comment	See comment	Not estimable	85 (1 study)	⊕⊕⊕⊝ medium⁷	Risks were calculated from pooled risk differences. The study reported no adverse effects.
Quality of life: clinically important change SF‐36 average change score mental health * Follow‐up: 12 weeks		The mean quality of life: average change ‐ mental health in the intervention (yoga) groups was ‐5.30 lower (17.78 lower to 7.18 higher)		69 (1 study)	⊕⊕⊝⊝ low^3,4,5	* no trial reported binary data; we chose 1 of 2 QOL measures as proxy measure
Physical health: clinically important change WHQOL‐BREF ‐ average change score * Follow‐up: 12 weeks		The mean physical health: average change in the intervention (yoga) groups was 9.22 higher (0.42 lower to 18.86 higher)		41 (1 study)	⊕⊕⊝⊝ low^3,4,6	* no trial reported binary data; we chose physical health dimension of QOL measure as proxy measure.
Costs: direct and indirect costs of care	No trial reported this outcome.
Leaving the study early: short term	Low¹		RR 0.64 (0.49 to 0.83)	586 (6 studies)	⊕⊕⊕⊝ medium⁸
	200 per 1000	120 per 1000 (88 to 166)
	Moderate¹
	400 per 1000	240 per 1000 (176 to 332)
	High¹
	600 per 1000	360 per 1000 (264 to 498)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. CI: confidence interval; RR: risk ratio
¹ Moderate risk approximates to that of non‐standard care in trial(s). ² Imprecision: Downgraded two levels due to small sample size and substantial loss to follow‐up which was uneven between groups (40.5% non‐standard care, 17% yoga) ³ Imprecision: Downgraded one level due to small sample size ⁴ Indirect: Downgraded one level as no trial reported binary data and review authors had to use one of 2 sub‐measures. ⁵ Indirect:Downgraded one level as unclear of clinical meaning of scores from 4 to 26. ⁶ Indirect:Downgraded two levels as no trial reported binary data and reviewers had to use one of 2 sub‐sets. ⁷ Imprecision: Downgraded one level as based on one study with no reported adverse events. ⁸ Risk of bias: Downgraded one level as a number of participants withdrew from one trial and it was not clear to which group they were randomised.

Summary of findings for the main comparison. YOGA versus NON‐STANDARD CARE for schizophrenia

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Table 1. Yoga titles ‐ relevant to people with schizophrenia

Review title	Status
Yoga versus standard care for schizophrenia	Full review: Broderick 2015
Yoga versus non‐standard care for schizophrenia	This review.
Yoga as part of a package of care versus standard care	Protocol: Broderick 2016b
Yoga as part of a package of care versus non‐standard care	Broderick 2017

Table 1. Yoga titles ‐ relevant to people with schizophrenia

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Comparison 1. YOGA versus NON‐STANDARD CARE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mental state: 1. Clinically important change (PANSS ‐ not improved) short term Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 overall	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.07]
1.2 specific ‐ negative symptoms	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.57, 0.90]
1.3 specific ‐ positive symptoms	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.84, 1.38]
2 Mental state: 2. Average endpoint score (various scales) short term Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 overall (PANSS)	3	170	Mean Difference (IV, Fixed, 95% CI)	‐4.69 [‐8.35, ‐1.03]
2.2 specific ‐ depressive symptoms (CDS)	1	69	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐1.01, 1.21]
2.3 specific ‐ depressive symptoms (HDRS)	1	60	Mean Difference (IV, Fixed, 95% CI)	‐1.41 [‐2.40, ‐0.42]
2.4 specific ‐ negative symptoms (PANSS)	4	214	Mean Difference (IV, Fixed, 95% CI)	‐1.15 [‐2.30, 0.01]
2.5 specific ‐ positive symptoms (PANSS)	4	214	Mean Difference (IV, Fixed, 95% CI)	‐0.36 [‐1.35, 0.63]
3 Global state: Average endpoint score (CGIS, low score=good) short term Show forest plot	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.85 [‐1.21, ‐0.49]

4 Social functioning: 1. Clinically important change (SOFS ‐ not improved) short term Show forest plot	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.78, 1.04]

5 Social functioning: 2. Average score at endpoint (two scales) Show forest plot	1	88	Mean Difference (IV, Fixed, 95% CI)	3.20 [‐0.57, 6.97]

5.1 SOFS, high score=good	1	44	Mean Difference (IV, Fixed, 95% CI)	3.70 [‐0.70, 8.10]
5.2 Emotional recognition, TRACS, high score=good	1	44	Mean Difference (IV, Fixed, 95% CI)	1.80 [‐5.54, 9.14]
6 Quality of life: Average endpoint scores (various scales) short term Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 mental health (SF‐36, average summary score, high score=good))	1	69	Mean Difference (IV, Fixed, 95% CI)	‐5.30 [‐17.78, 7.18]
6.2 physical health (WHOQOL‐BREF, high score=good)	1	41	Mean Difference (IV, Fixed, 95% CI)	9.22 [‐0.42, 18.86]
6.3 physical health (SF‐36, average summary score, high score=good) )	1	69	Mean Difference (IV, Fixed, 95% CI)	‐3.60 [‐11.98, 4.78]
6.4 psychological health (WHOQOL‐BREF, high score=good)	1	41	Mean Difference (IV, Fixed, 95% CI)	17.70 [6.50, 28.90]
6.5 social well being (WHOQOL‐BREF, high score=good)	1	41	Mean Difference (IV, Fixed, 95% CI)	20.75 [7.42, 34.08]
7 Adverse effects Show forest plot	1		Risk Difference (M‐H, Fixed, 95% CI)	Subtotals only

7.1 any serious	1	85	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.05, 0.05]
7.2 others	1	85	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.05, 0.05]
8 Leaving the study early ‐ short term Show forest plot	6	586	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.51, 0.86]

Comparison 1. YOGA versus NON‐STANDARD CARE

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