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Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 1 Leaving the study early.
Figures and Tables -
Analysis 1.1

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 1 Leaving the study early.

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 2 Mental state: 1. Not improved.
Figures and Tables -
Analysis 1.2

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 2 Mental state: 1. Not improved.

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 3 Mental state: 2. Unco‐operative or did not comprehend.
Figures and Tables -
Analysis 1.3

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 3 Mental state: 2. Unco‐operative or did not comprehend.

Study

Intervention

Mean

SD

N

Notes

brahmyadiyoga

Mahal 1976

brahmyadiyoga

7.93

9.56

27

F test undertaken.
p<0.05 in favour of brahmyadiyoga.

Mahal 1976

placebo

1.48

7.70

27

Ramu 1999

brahmyadiyoga

17.4

8.97

here high=poor

Ramu 1999

placebo

22.5

15.2

tagara

Mahal 1976

tagara

2.74

8.09

27

F test undertaken.
p<0.05 not significant.

Mahal 1976

placebo

1.48

7.70

27

Figures and Tables -
Analysis 1.4

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 4 Mental state: 3a. Average improvement ‐ positive symptoms (PSRS, high=good, skewed data).

Study

Intervention

Mean

SD

N

Notes

brahmyadiyoga

Mahal 1976

brahmyadiyoga

3.26

5.69

27

F test undertaken.
p<0.05 in favour of brahmyadiyoga.

Mahal 1976

placebo

‐0.48

8.54

27

Ramu 1999

brahmyadiyoga

20.8

11.8

here high=poor

Ramu 1999

brahmyadiyoga

17.6

13.7

tagara

Mahal 1976

tagara

‐2.81

7.69

27

F test undertaken.
p<0.05 not significant.

Mahal 1976

placebo

‐0.48

8.54

27

Figures and Tables -
Analysis 1.5

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 5 Mental state: 3b. Average improvement ‐ negative symptoms (PSRS, high=good, skewed data).

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 6 Behavioiur: Average score (Fergus Falls, high score = poor).
Figures and Tables -
Analysis 1.6

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 6 Behavioiur: Average score (Fergus Falls, high score = poor).

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 7 Psychological assessment: 1. Critical flicker fusion threshold (simple).
Figures and Tables -
Analysis 1.7

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 7 Psychological assessment: 1. Critical flicker fusion threshold (simple).

Study

Intervention

Mean

S.D

N

Notes

Order

Reaction time (simple)

Ramu 1999

Brahmyadiyoga

3.62

3.75

23

Ramu 1999

Placebo

3.94

3.49

20

Vigilance

Ramu 1999

Brahmyadiyoga

28.76

21.37

23

Ramu 1999

Placebo

24.88

16.01

20

Figures and Tables -
Analysis 1.8

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 8 Psychological assessment: 2. Reaction and vigilance (skewed data).

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 9 Adverse effects.
Figures and Tables -
Analysis 1.9

Comparison 1 AYURVEDIC HERBS versus PLACEBO (all short term), Outcome 9 Adverse effects.

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 1 Leaving the study early.
Figures and Tables -
Analysis 2.1

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 1 Leaving the study early.

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 2 Mental state: 1. Not improved.
Figures and Tables -
Analysis 2.2

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 2 Mental state: 1. Not improved.

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 3 Mental state: 2. Unco‐operative or did not comprehend.
Figures and Tables -
Analysis 2.3

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 3 Mental state: 2. Unco‐operative or did not comprehend.

Study

Intervention

Mean

SD

N

Notes

brahmyadiyoga

Mahal 1976

brahmyadiyoga

7.93

9.56

27

F test undertaken.
p<0.05 in not significant.

Mahal 1976

chlorpromazine

12.33

10.96

27

tagara

Mahal 1976

tagara

2.74

8.09

27

F test undertaken.
p<0.05 in favour of chlorpromazine.

Mahal 1976

chlorpromazine

12.33

10.96

27

Figures and Tables -
Analysis 2.4

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 4 Mental state: 3a.i. Average improvement ‐ positive symptoms (PSRS, zero =good, skewed data).

Study

Intervention

Mean

S.D

N

Notes

Ramu 1999

brahmyadiyoga

17.4

8.97

here high= poor

Ramu 1999

chlorpromazine

8.14

9.56

Figures and Tables -
Analysis 2.5

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 5 Mental state: 3a.ii. Average endpoint score ‐ postive symptoms (PSRS, zero = good, skewed data).

Study

Intervention

Mean

SD

N

Notes

brahmyadiyoga

Mahal 1976

brahmyadiyoga

3.26

5.69

27

F test undertaken.
p<0.05 is not significant.

Mahal 1976

chlorpromazine

5.52

5.37

27

tagara

Mahal 1976

tagara

‐2.81

7.69

27

F test undertaken.
p<0.05 in favour of chlorpromazine.

Mahal 1976

chlorpromazine

5.52

5.37

27

Figures and Tables -
Analysis 2.6

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 6 Mental state: 3b.i. Average improvement ‐ negative symptoms (PSRS, zero =good, skewed data).

Study

Intervention

Mean

S.D

N

Notes

Ramu 1999

brahmyadiyoga

20.8

11.8

here high=poor

Ramu 1999

chlorpromazine

10.5

8.7

Figures and Tables -
Analysis 2.7

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 7 Mental state: 3b.ii. Average endpoint score ‐ negative symptoms (PSRS, zero =good, skewed data).

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 8 Behavioiur: Average score (Fergus Falls, high score = poor).
Figures and Tables -
Analysis 2.8

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 8 Behavioiur: Average score (Fergus Falls, high score = poor).

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 9 Psychological assessment: 1. Critical flicker fusion threshold (simple).
Figures and Tables -
Analysis 2.9

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 9 Psychological assessment: 1. Critical flicker fusion threshold (simple).

Study

Intervention

Mean

S.D

N

Notes

Order

reaction time (simple)

Ramu 1999

Brahmyadiyoga

3.62

3.75

23

Ramu 1999

Chlorpromazine

4.40

4.57

22

vigilance

Ramu 1999

Brahmyadiyoga

28.76

21.37

23

Ramu 1999

Chlorpromazine

24.88

16.01

22

Figures and Tables -
Analysis 2.10

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 10 Psychological assessment: 2. Reaction and vigilance (skewed data).

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 11 Adverse effects.
Figures and Tables -
Analysis 2.11

Comparison 2 AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term), Outcome 11 Adverse effects.

Comparison 3 AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term), Outcome 1 Leaving the study early.
Figures and Tables -
Analysis 3.1

Comparison 3 AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term), Outcome 1 Leaving the study early.

Study

Intervention

Mean

SD

N

Notes

Ramu 1992

Ayurvedic treatment

11.5

7.9

18

Ramu 1992

Chlorpromazine

12.7

9.9

18

Figures and Tables -
Analysis 3.2

Comparison 3 AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term), Outcome 2 Mental state: 1a.i. Average endpoint score ‐ by 4 weeks (BPRS, high=poor, skewed data).

Study

Intervention

Mean

SD

N

Notes

manas

Ramu 1992

Ayurvedic treatment

4.9

4.2

18

Ramu 1992

Chlorpromazine

4.8

5.0

18

symptoms

Ramu 1992

Ayurvedic treatment

22.5

15.2

18

Ramu 1992

Chlorpromazine

21.6

20.3

18

Figures and Tables -
Analysis 3.3

Comparison 3 AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term), Outcome 3 Mental state: 1a.ii. Average endpoint score ‐ by 4 weeks (Ayurvedic Assessment, high=poor, skewed data).

Study

Intervention

Mean

SD

N

Notes

Ramu 1992

Ayurvedic treatment

‐11.9

7.2

18

Ramu 1992

Chlorpromazine

‐17.3

14.2

18

Figures and Tables -
Analysis 3.4

Comparison 3 AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term), Outcome 4 Mental state: 1b.i. Average change score ‐ by 4 weeks (BPRS, high=poor, skewed data).

Study

Intervention

Mean

SD

N

Notes

manas

Ramu 1992

Ayurvedic treatment

‐6.5

2.9

18

Ramu 1992

Chlorpromazine

‐9.4

5.6

18

symptoms

Ramu 1992

Ayurvedic treatment

‐32

20.4

18

Ramu 1992

Chlorpromazine

‐36.2

26.3

18

Figures and Tables -
Analysis 3.5

Comparison 3 AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term), Outcome 5 Mental state: 1b.ii. Average change score ‐ by 4 weeks (Ayurvedic Assessment, high=poor, skewed data).

Table 1. Suggested design of study

Methods

Participants

Interventions

Outcomes

Notes

Allocation: centralised sequence generation with table of random numbers or computer generated code, stratified by severity of illness, sequence concealed till interventions assigned. In the context of limited provision, randomisation may be the only equitable way of distributing care.
Blindness: double ‐ tested.
Duration: 1 year.
Design: parallel groups.

Diagnosis: it may be preferred not to use diagnostic categories such as DSM IV and just to include those whose mental health problem is designated as schizophrenia or psychosis and unmada.
N=300.
Age˜any.
Sex: either.
Setting: anywhere (preferably hospital setting ).
History: non‐acute.

1a. Ayurvedic herbs: dose and choice at clinician's and patient's discretion + chlorpromazine: dose ‐ clinician's and patient's discretion. N=150 OR
1b. Ayurvedic treatment (as a holistic package). + chlorpromazine: dose ‐ clinician's and patient's discretion. N=150.
2. Chlorpromazine: dose ‐ clinician's and patient's discretion. N=150.

Qualtiy of life: healthy days.
Service outcomes: days in hospital, time attending psychiatric outpatient clinic.
Satisfaction with care: patients/carers.
Global state: CGI.***
Mental state: CGI, relapse.**
Functioning: engagement with services, leaving the study early, living independently.
Adverse effects: including mortality.
Economic outcomes: cost‐effectiveness and cost‐benefit.

* size of study to detect a 10% difference in improvement with 80% certainity.

*** Primary outcome.

If scales are used to measure outcome then there should be binary cut off points, defined before study start, of clinically important improvement.

Figures and Tables -
Table 1. Suggested design of study
Comparison 1. AYURVEDIC HERBS versus PLACEBO (all short term)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Leaving the study early Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 brahmyadiyoga

2

120

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.37, 1.62]

1.2 tagara

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.39, 2.54]

2 Mental state: 1. Not improved Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 brahmyadiyoga (Ayurvedic assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

0.56 [0.36, 0.88]

2.2 brahmyadiyoga (MPQ assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

0.84 [0.60, 1.17]

2.3 brahmyadiyoga (assessment tool not clear)

1

43

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.72, 1.16]

2.4 tagara (Ayurvedic assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.49, 1.05]

2.5 tagara (MPQ assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.79, 1.37]

3 Mental state: 2. Unco‐operative or did not comprehend Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 brahmyadiyoga

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [0.39, 10.20]

3.2 tagara

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.5 [0.27, 8.42]

4 Mental state: 3a. Average improvement ‐ positive symptoms (PSRS, high=good, skewed data) Show forest plot

Other data

No numeric data

4.1 brahmyadiyoga

Other data

No numeric data

4.2 tagara

Other data

No numeric data

5 Mental state: 3b. Average improvement ‐ negative symptoms (PSRS, high=good, skewed data) Show forest plot

Other data

No numeric data

5.1 brahmyadiyoga

Other data

No numeric data

5.2 tagara

Other data

No numeric data

6 Behavioiur: Average score (Fergus Falls, high score = poor) Show forest plot

1

43

Mean Difference (IV, Fixed, 95% CI)

1.14 [‐1.63, 3.91]

7 Psychological assessment: 1. Critical flicker fusion threshold (simple) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

8 Psychological assessment: 2. Reaction and vigilance (skewed data) Show forest plot

Other data

No numeric data

8.1 Reaction time (simple)

Other data

No numeric data

8.2 Vigilance

Other data

No numeric data

9 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

9.1 drowsiness

1

43

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 giddiness

1

43

Risk Ratio (M‐H, Fixed, 95% CI)

2.63 [0.11, 61.05]

9.3 nausea and vomiting

1

43

Risk Ratio (M‐H, Fixed, 95% CI)

13.13 [0.80, 216.30]

9.4 somnolence

1

43

Risk Ratio (M‐H, Fixed, 95% CI)

2.63 [0.11, 61.05]

Figures and Tables -
Comparison 1. AYURVEDIC HERBS versus PLACEBO (all short term)
Comparison 2. AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Leaving the study early Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 brahmyadiyoga

2

120

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.42, 1.97]

1.2 tagara

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.39, 2.54]

2 Mental state: 1. Not improved Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 brahmyadiyoga (Ayurvedic assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.60, 1.94]

2.2 brahmyadiyoga (MPQ assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.62 [0.98, 2.67]

2.3 brahmyadiyoga (assessment tool not clear)

1

45

Risk Ratio (M‐H, Fixed, 95% CI)

1.82 [1.11, 2.98]

2.4 tagara (Ayurvedic assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [0.81, 2.36]

2.5 tagara (MPQ assessment)

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [1.25, 3.19]

3 Mental state: 2. Unco‐operative or did not comprehend Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 brahmyadiyoga

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.27, 3.68]

3.2 tagara

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.18, 3.10]

4 Mental state: 3a.i. Average improvement ‐ positive symptoms (PSRS, zero =good, skewed data) Show forest plot

Other data

No numeric data

4.1 brahmyadiyoga

Other data

No numeric data

4.2 tagara

Other data

No numeric data

5 Mental state: 3a.ii. Average endpoint score ‐ postive symptoms (PSRS, zero = good, skewed data) Show forest plot

Other data

No numeric data

6 Mental state: 3b.i. Average improvement ‐ negative symptoms (PSRS, zero =good, skewed data) Show forest plot

Other data

No numeric data

6.1 brahmyadiyoga

Other data

No numeric data

6.2 tagara

Other data

No numeric data

7 Mental state: 3b.ii. Average endpoint score ‐ negative symptoms (PSRS, zero =good, skewed data) Show forest plot

Other data

No numeric data

8 Behavioiur: Average score (Fergus Falls, high score = poor) Show forest plot

1

45

Mean Difference (IV, Fixed, 95% CI)

3.5 [‐0.18, 7.18]

9 Psychological assessment: 1. Critical flicker fusion threshold (simple) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

10 Psychological assessment: 2. Reaction and vigilance (skewed data) Show forest plot

Other data

No numeric data

10.1 reaction time (simple)

Other data

No numeric data

10.2 vigilance

Other data

No numeric data

11 Adverse effects Show forest plot

2

180

Risk Ratio (M‐H, Fixed, 95% CI)

1.20 [0.48, 2.97]

11.1 drowsiness

1

45

Risk Ratio (M‐H, Fixed, 95% CI)

0.11 [0.01, 1.87]

11.2 giddiness

1

45

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.05, 4.91]

11.3 somnolence

1

45

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.06, 14.37]

11.4 nausea and vomiting

1

45

Risk Ratio (M‐H, Fixed, 95% CI)

14.38 [0.87, 237.58]

Figures and Tables -
Comparison 2. AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term)
Comparison 3. AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Leaving the study early Show forest plot

1

36

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.13, 3.53]

2 Mental state: 1a.i. Average endpoint score ‐ by 4 weeks (BPRS, high=poor, skewed data) Show forest plot

Other data

No numeric data

3 Mental state: 1a.ii. Average endpoint score ‐ by 4 weeks (Ayurvedic Assessment, high=poor, skewed data) Show forest plot

Other data

No numeric data

3.1 manas

Other data

No numeric data

3.2 symptoms

Other data

No numeric data

4 Mental state: 1b.i. Average change score ‐ by 4 weeks (BPRS, high=poor, skewed data) Show forest plot

Other data

No numeric data

5 Mental state: 1b.ii. Average change score ‐ by 4 weeks (Ayurvedic Assessment, high=poor, skewed data) Show forest plot

Other data

No numeric data

5.1 manas

Other data

No numeric data

5.2 symptoms

Other data

No numeric data

Figures and Tables -
Comparison 3. AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term)