Ayurvedic medicine for schizophrenia

Vishesh Agarwal; Akhil Abhijnhan; Prakash Raviraj

doi:10.1002/14651858.CD006867

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Analysis 1.1

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

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Analysis 1.2

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

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Analysis 1.3

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

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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

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).

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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

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).

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Analysis 1.6

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

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Analysis 1.7

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

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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

Analysis 1.8

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

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Analysis 1.9

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

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Analysis 2.1

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

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Analysis 2.2

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

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Analysis 2.3

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

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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

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).

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Study	Intervention	Mean	S.D	N	Notes
Ramu 1999	brahmyadiyoga	17.4	8.97		here high= poor
Ramu 1999	chlorpromazine	8.14	9.56

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).

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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

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).

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Study	Intervention	Mean	S.D	N	Notes
Ramu 1999	brahmyadiyoga	20.8	11.8		here high=poor
Ramu 1999	chlorpromazine	10.5	8.7

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).

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Analysis 2.8

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

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Analysis 2.9

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

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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

Analysis 2.10

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

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Analysis 2.11

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

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Analysis 3.1

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

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Study	Intervention	Mean	SD	N	Notes
Ramu 1992	Ayurvedic treatment	11.5	7.9	18
Ramu 1992	Chlorpromazine	12.7	9.9	18

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).

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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

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).

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Study	Intervention	Mean	SD	N	Notes
Ramu 1992	Ayurvedic treatment	‐11.9	7.2	18
Ramu 1992	Chlorpromazine	‐17.3	14.2	18

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).

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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

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).

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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.

Table 1. Suggested design of study

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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]

Comparison 1. AYURVEDIC HERBS versus PLACEBO (all short term)

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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]

Comparison 2. AYURVEDIC HERBS versus ANTIPSYCHOTIC (all short term)

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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

Comparison 3. AYURVEDIC TREATMENT versus ANTIPSYCHOTIC (all short term)

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