Chinese herbal medicine for primary dysmenorrhoea

Xiaoshu Zhu; Michelle Proctor; Alan Bensoussan; Emily Wu; Caroline A Smith

doi:10.1002/14651858.CD005288.pub3

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Figure 1

Funnel plot of trials comparing CHM with conventional therapy for the outcome of reduction of pain

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Figure 2

Funnel plot of trials comparing CHM with conventional therapy for the outcome of overall symptoms

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Figure 3

Funnel plot of trials comparing CHM (self‐desogned) with CHM (over‐the‐counter) for the outcome of reduction of pain

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Figure 4

Funnel plot of trials comparing CHM (self‐desogned) with CHM (over‐the‐counter) for the outcome of overall symptoms

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Analysis 1.1

Comparison 1 Chinese herbal medicine versus placebo, Outcome 1 Reduction of pain.

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Analysis 1.2

Comparison 1 Chinese herbal medicine versus placebo, Outcome 2 Reduction of pain.

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Analysis 1.3

Comparison 1 Chinese herbal medicine versus placebo, Outcome 3 Overall symptoms.

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Analysis 1.4

Comparison 1 Chinese herbal medicine versus placebo, Outcome 4 Adverse effects.

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Analysis 1.5

Comparison 1 Chinese herbal medicine versus placebo, Outcome 5 Use of additional medication.

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Analysis 2.1

Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 1 Reduction of pain.

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Analysis 2.2

Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 2 Overall symptoms.

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Analysis 2.3

Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 3 Adverse effects.

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Analysis 2.4

Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 4 Use of additional medication.

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Analysis 3.1

Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 1 Reduction of pain.

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Analysis 3.2

Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 2 Overall symptoms.

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Analysis 3.3

Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 3 Adverse effects.

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Analysis 3.4

Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 4 Use of additional medication.

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Analysis 4.1

Comparison 4 Chinese herbal medicine versus acupuncture, Outcome 1 Reduction of pain.

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Analysis 5.1

Comparison 5 Chinese versus heat compression, Outcome 1 Reduction of pain.

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Analysis 5.2

Comparison 5 Chinese versus heat compression, Outcome 2 Adverse effects.

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Table 1. Rose tea for relief of primary dysmenorrhoea

Study ID	Outcome measures	Exp group (SD)	Control group (SD)	P value
Tseng 2005	The Sort‐form McGill Pain Questionnaire (SF‐MPQ) ‐ means (SD)	1 month ‐ 8.64 (8.35) 3 months ‐ 7.02 (6.24) 6 months ‐ 6.82 (7.07)	1 month ‐ 11.86 (8.34) 3 months ‐ 11.41 (7.72) 6 months ‐ 9.52 (7.76)	P = 0.0443 P = 0.0010 P = 0.0629
	The Menstrual Distress Questionnaire Short Form, mean (sd)	1 month ‐ 24.23 (5.42) 3 months ‐ 23.44 (5.78) 6 months ‐ 22.75 (5.25)	1 month ‐ 26.86 (5.78) 3 months ‐ 26.02 (5.21) 6 months ‐ 25.94 (6.26)	P = 0.0191 P = 0.0144 P = 0.0040
	Visual analogue scale for Anxiety (VASA), mean (sd)	1 month ‐ 3.64 (1.74) 3 months ‐ 3.14 (1.84) 6 months ‐ 3.09 (1.88)	1 month ‐ 4.04 (2.15) 3 months ‐ 4.16 (1.82) 6 months ‐ 3.65 (2.20)	P = 0.2546 P = 0.0037 P = 0.1537
	Received Stress scale (PSS), mean (sd)	1 month ‐ 20.83 (5.69) 3 months ‐ 20.81 (5.22) 6 months ‐ 20.84 (4.61)	1 month ‐ 17.76 (5.82) 3 months ‐ 18.51 (5.12) 6 months ‐ 19.12 (5.59)	P = 0.0063 P = 0.0195 P = 0.0817
	The Psychophysiologic Life Adaptation scale (PLAS), means (sd)	3 months ‐ 94.08 (15.00) 6 months ‐ 95.25 (13.43)	3 months ‐ 94.76 (13.13) 6 months ‐ 95.64 (13.20)	P = 0.7972 P = 0.8789

Table 1. Rose tea for relief of primary dysmenorrhoea

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Table 2. Analgesic effect of a herbal medicine for treatment of primary dysmenorrhoea

Study ID	Outcome measures	Experimental group	Control group	Conclusion
Naoki 1997	Visual analogue scale (VAS)	Data not available	Data not available	Compared to placebo, herbs significantly reduced pain through 2 intervention cycles and 2 follow‐up cycles (P<0.05 for the 1st intervention cycle, P<0.005 for subsequence cycles)
	Pain relieving medication	Data not available	Data not available	Significant reduction in pain relieving medication through intervention and follow‐up in herbal group (P<0.05, P<0.01). Significant reduction in pain relieving medication only in 1st cycle of intervention in placebo group (P<0.01), then faded out.
	Zung self‐rating depression Scale	Data not available	Data not available	No significant difference between groups, nor within groups in Zung self‐rating depression scale
	Improved biomedical parameters (FSH, LH, Prolactin, Esrtadiol, Blood count, Hepatic and renal function tests at each cycle)	Data not available	Data not available	Plasma levels of various hormones and chemical mediators changed during and after treatment.

Table 2. Analgesic effect of a herbal medicine for treatment of primary dysmenorrhoea

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Table 3. Quality features of included studies

Study	Allocation concealme	Randomisation	Blinding	ITT	Follow‐up
Deng 2003a	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Deng 2003a	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Fan 1999	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Guo 1997	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Huang 2000	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	2 cycles
Jiang 2000	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Kotani 1997	Unclear/Not stated	Unclear/Not stated	Double blinded	Unclear/Not stated	2 cycles
Li 1999	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Li 2001	Unclear/Not stated	Unclear/Not stated	Single blinded	Unclear/Not stated	3 cycles
Li 2004	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Liu 2000	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Liu 2002	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Liu 2003	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Liu 2004	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Liu 2005	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Lu 2002	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Luo 2001	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Miao 2001	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Niu 1996	Unclear/Not stated	Unclear/Not stated	Single blinded	Unclear/Not stated	3 cycles
Qin 2003	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Shen 2001	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Song 2003	Unclear/Not stated	Unclear/Not stated	Single blinded	Unclear/Not stated	3 cycles
Sun 2006	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Sun 2004	Unclear/Not stated	Random number table	Double blinded	Unclear/Not stated	3 cycles
Sun 2004‐2	Unclear/Not stated	Random number table	Double blinded	Unclear/Not stated	3 cycles
Tseng 2005	Unclear/Not stated	Unclear/Not stated	Open trial	Unclear/Not stated	None
Wang 1996	Unclear/Not stated	Random number table	Single blinded	Unclear/Not stated	3 cycles
Wang 2000b	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Wang 2003	Unclear/Not stated	Unclear/Not stated	Open labelled	Unclear/Not stated	3 cycles
Wang 2006a	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	None
Wang 2006b	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Wu 2006	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Ye 2004	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Yu 2003	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Zhang 2000	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Zhang 2001	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Zhu 2001	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Zhu 2002	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles
Zhu 2003	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	Unclear/Not stated	3 cycles

Table 3. Quality features of included studies

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Table 4. RCT assessing a traditional Chinese medicine remedy in primay dysmenorrhoea

Study ID	Outcome	Group	Observation cycle SD	Treatment cycle 1 SD	Treatment cycle 2 SD	Treatment cycle 3 SD	Follow‐up cycle SD
Kennedy 2006	The maximal pain scores (Cmax)	Placebo	76 (14)	67 (27)	57 (28)	61(31)	60 (30)
		Herbs	77 (19)	59 (28)	58 (36)	51 (36)	61 (28)
	Total pain area under the curve (AUC)	Placebo	186 (73)	123 (69)	115 (84)	134 (102)	138 (119)
		Herbs	207 (84)	128 (83)	130 (97)	112 (88)	150 (84)
	Duration of pain (data not shown)
	Total amount of rescure medication used (data not shown)
	Global assessment of treatment (data not shown)
	Safety	Placebo (18 adverse events)
		Herbs (13 adverse events)

Table 4. RCT assessing a traditional Chinese medicine remedy in primay dysmenorrhoea

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Comparison 1. Chinese herbal medicine versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Reduction of pain Show forest plot	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	5.59 [0.32, 97.87]

1.1 Methodological quality A ‐ standard formula ‐ up to 3 month follow up	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	5.59 [0.32, 97.87]
2 Reduction of pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 Intensity of pain Cmax	1	36	Mean Difference (IV, Fixed, 95% CI)	1.0 [‐17.95, 19.95]
2.2 Intensity of pain AUCt	1	36	Mean Difference (IV, Fixed, 95% CI)	12.0 [‐54.76, 78.76]
3 Overall symptoms Show forest plot	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	5.59 [0.32, 97.87]

3.1 Methodology quality A ‐ standard formula ‐ up to 3 month follow up	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	5.59 [0.32, 97.87]
4 Adverse effects Show forest plot	3	166	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.61, 1.07]

4.1 Methodology quality A ‐ standard formua	3	166	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.61, 1.07]
5 Use of additional medication Show forest plot	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	12.0 [1.70, 84.49]

5.1 Methodology quality A ‐standard formula	1	90	Risk Ratio (M‐H, Fixed, 95% CI)	12.0 [1.70, 84.49]

Comparison 1. Chinese herbal medicine versus placebo

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Comparison 2. Chinese herbal medicine versus conventional therapy (NSAIDs or OCP)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Reduction of pain Show forest plot	14	1441	Risk Ratio (M‐H, Random, 95% CI)	1.99 [1.52, 2.60]

1.1 Methodological quality B ‐ standard formula ‐ up to 3 month's follow‐up	4	312	Risk Ratio (M‐H, Random, 95% CI)	2.28 [0.88, 5.94]
1.2 Methodological quality B ‐ tailored formula ‐ up to 3 month follow up	9	789	Risk Ratio (M‐H, Random, 95% CI)	2.13 [1.70, 2.66]
1.3 Methodological quality B ‐ standard formula ‐ immediate efficacy	1	340	Risk Ratio (M‐H, Random, 95% CI)	1.67 [1.42, 1.97]
2 Overall symptoms Show forest plot	6	482	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [1.73, 2.73]

2.1 Methodological quality B ‐ standard formula ‐ up to 3month follow up	1	58	Risk Ratio (M‐H, Fixed, 95% CI)	23.39 [1.45, 377.35]
2.2 Methodology quality B ‐ tailored formula ‐ up to 3month follow up	5	424	Risk Ratio (M‐H, Fixed, 95% CI)	2.00 [1.59, 2.52]
3 Adverse effects Show forest plot	2	418	Risk Ratio (M‐H, Fixed, 95% CI)	0.01 [0.00, 0.15]

3.1 Methodology quality B	2	418	Risk Ratio (M‐H, Fixed, 95% CI)	0.01 [0.00, 0.15]
4 Use of additional medication Show forest plot	2	194	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [1.30, 1.93]

4.1 Methodological quality B ‐ standard formula ‐ up to 3‐month follow up	1	62	Risk Ratio (M‐H, Fixed, 95% CI)	1.73 [1.17, 2.57]
4.2 Methodological quality B ‐ tailored followup ‐ up to 3 month follow up	1	132	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.21, 1.92]

Comparison 2. Chinese herbal medicine versus conventional therapy (NSAIDs or OCP)

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Comparison 3. Experimental Chinese herbal formula versus OTC Chinese herbal formula

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Reduction of pain Show forest plot	18	1527	Risk Ratio (M‐H, Fixed, 95% CI)	2.06 [1.80, 2.36]

1.1 Methodological quality B ‐ standard formula ‐ up to 3 month follow up	5	380	Risk Ratio (M‐H, Fixed, 95% CI)	2.09 [1.62, 2.70]
1.2 Methodological quality B ‐ tailored formula ‐ up to 3 month follow up	12	1087	Risk Ratio (M‐H, Fixed, 95% CI)	2.13 [1.80, 2.51]
1.3 Methodological quality C ‐ tailored formula ‐ up to 3 month follow up	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.43, 1.99]
2 Overall symptoms Show forest plot	14	1167	Risk Ratio (M‐H, Fixed, 95% CI)	2.04 [1.74, 2.39]

2.1 Methodological quality B ‐ standard formula ‐ up to 3 month' follow up	4	320	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [1.61, 2.92]
2.2 Methodological quality B ‐ tailored formula ‐ up to 3 month follow up	10	847	Risk Ratio (M‐H, Fixed, 95% CI)	1.99 [1.65, 2.40]
3 Adverse effects Show forest plot	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3.1 Completed data	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Use of additional medication Show forest plot	5	402	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [1.34, 1.87]

4.1 Methodological quality B ‐ standard formula ‐ up to 3 month follow up	2	116	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [1.21, 2.43]
4.2 Methodological quality B ‐ tailored formula ‐ up to 3month follow up	3	286	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.27, 1.85]

Comparison 3. Experimental Chinese herbal formula versus OTC Chinese herbal formula

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Comparison 4. Chinese herbal medicine versus acupuncture

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Reduction of pain Show forest plot	2	156	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [1.09, 2.82]

1.1 Methodological quality B ‐ standard formula with 3 month follow up	1	53	Risk Ratio (M‐H, Fixed, 95% CI)	2.68 [0.91, 7.91]
1.2 Methodological quality B ‐ tailored formula ‐ up to 3 month follow up	1	103	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [0.89, 2.54]

Comparison 4. Chinese herbal medicine versus acupuncture

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Comparison 5. Chinese versus heat compression

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Reduction of pain Show forest plot	1	55	Risk Ratio (M‐H, Fixed, 95% CI)	32.08 [2.06, 499.18]

1.1 Methodological quality B ‐ standard formula ‐ up to 3 month follow up	1	55	Risk Ratio (M‐H, Fixed, 95% CI)	32.08 [2.06, 499.18]
2 Adverse effects Show forest plot	1	55	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

2.1 Methodology quality B ‐ standard formula	1	55	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 5. Chinese versus heat compression

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