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Xiaoshu Zhu1 , Michelle Proctor2 , Alan Bensoussan3 , Emily Wu4 , Caroline A Smith5
1 Center for Complementary Medicine Research, School of Biomedical and Health Science, University of Western Sydney, Sydney,
Australia. 2 Psychological Service, Department of Corrections, Auckland, New Zealand. 3 Center for Complementary Medicine Research,
University of Western Sydney, Sydney, Australia. 4 Traditional Chinese Medicine, Emily Wu Traditional Chinese Medicine Clinic,
Lindfield, Australia. 5 Centre for Complementary Medicine Research, The University of Western Sydney, Penrith South DC, Australia
Contact address: Xiaoshu Zhu, Center for Complementary Medicine Research, School of Biomedical and Health Science, University
of Western Sydney, Building 24, Campbelltown Campus, Locked Bag 1797, Penrith South DC, Sydney, New South Wales, 1797,
Australia. x.zhu@uws.edu.au, mszhuxiaoshu@yahoo.com.
Citation: Zhu X, Proctor M, Bensoussan A, Wu E, Smith CA. Chinese herbal medicine for primary dysmenorrhoea. Cochrane Database
of Systematic Reviews 2008, Issue 2. Art. No.: CD005288. DOI: 10.1002/14651858.CD005288.pub3.
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by
some women. Chinese herbal medicine may be a suitable alternative.
Objectives
To determine the efficacy and safety of Chinese herbal medicine for primary dysmenorrhoea when compared with placebo, no treatment,
and other treatment.
Search methods
The Cochrane Menstrual Disorders and Subfertility Group Trials Register (to 2006), MEDLINE (1950 to January 2007), EMBASE
(1980 to January 2007), CINAHL (1982 to January 2007), AMED (1985 to January 2007), CENTRAL (The Cochrane Library issue
4, 2006), China National Knowledge Infrastructure (CNKI, 1990 to January 2007), Traditional Chinese Medicine Database System
(TCMDS, 1990 to December 2006), and the Chinese BioMedicine Database (CBM, 1990 to December 2006) were searched. Citation
lists of included trials were also reviewed.
Selection criteria
Any randomised controlled trials involving Chinese herbal medicine versus placebo, no treatment, conventional therapy, heat com-
pression, another type of Chinese herbal medicine, acupuncture or massage. Exclusion criteria were identifiable pelvic pathology and
dysmenorrhoea resulting from the use of an intra-uterine contraceptive device.
Data collection and analysis
Quality assessment, data extraction and data translation were performed independently by two review authors. Attempts were made
to contact study authors for additional information and data. Data were combined for meta-analysis using either Peto odds ratios or
relative risk (RR) for dichotomous data or weighted mean difference for continuous data. A fixed-effect statistical model was used,
where suitable. If data were not suitable for meta-analysis, any available data from the trial were extracted and presented as descriptive
data.
Chinese herbal medicine for primary dysmenorrhoea (Review) 1
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results
Thirty-nine randomised controlled trials involving a total of 3475 women were included in the review. A number of the trials were
of small sample size and poor methodological quality. Results for Chinese herbal medicine compared to placebo were unclear as data
could not be combined (3 RCTs). Chinese herbal medicine resulted in significant improvements in pain relief (14 RCTs; RR 1.99,
95% CI 1.52 to 2.60), overall symptoms (6 RCTs; RR 2.17, 95% CI 1.73 to 2.73) and use of additional medication (2 RCTs; RR 1.58,
95% CI 1.30 to 1.93) when compared to use of pharmaceutical drugs. Self-designed Chinese herbal formulae resulted in significant
improvements in pain relief (18 RCTs; RR 2.06, 95% CI 1.80 to 2.36), overall symptoms (14 RCTs; RR 1.99, 95% CI 1.65 to 2.40)
and use of additional medication (5 RCTs; RR 1.58, 95% CI 1.34 to 1.87) after up to three months of follow-up when compared to
commonly used Chinese herbal health products. Chinese herbal medicine also resulted in better pain relief than acupuncture (2 RCTs;
RR 1.75, 95% CI 1.09 to 2.82) and heat compression (1 RCT; RR 2.08, 95% CI 2.06 to 499.18).
Authors’ conclusions
The review found promising evidence supporting the use of Chinese herbal medicine for primary dysmenorrhoea; however, results are
limited by the poor methodological quality of the included trials.
Dysmenorrhoea is a very common complaint that refers to painful menstrual cramps in abdomen. Primary dysmenorrhoea refers to pain
of an unknown cause (i.e. no medical condition is identified). Nonsteroidal anti-inflammatory drugs or the contraceptive pill have been
used successfully for treatment but more women are looking for non-drug therapies. Chinese herbal medicine has been used for centuries
in China and it is currently used in public hospitals in China for the treatment of primary dysmenorrhoea. The review found promising
evidence for the use of Chinese herbal medicine in reducing menstrual pain in the treatment of primary dysmenorrhoea, compared
to conventional medicine such as NSAIDs and the oral contraceptive pill, acupuncture and heat compression. No significant adverse
effects were identified in this review. However the findings should be interpreted with caution due to the generally low methodological
quality of the included studies.
No data were available for this comparison Three trials (166 women) compared CHM against placebo. One
7) Overall reduction in symptoms - Chinese herbal medicine trial (90 women) (Sun2004) that set up two experimental herbal
versus heat compression groups with slightly different formulae (30 women in each group)
was included in meta-analysis, the results showed a statistically
No data were available for this comparison significant difference between the herbal intervention and placebo
Adverse effects (RR 12.00, 95% CI 1.70 to 84.49).
Another included trial (40 women) reported results on this out-
1) Adverse effects - Chinese herbal medicine versus placebo come in such a form that no numerical data could be extracted,
nor were the data suitable for meta-analysis (see Table 2). Signif-
Three included trials (166 women) reported no serious adverse icant reduction in the use of pain-relieving medication while on
events in either the experimental or control groups. the intervention and at follow-up was found in the herbal group
Trial data were extracted and suitable for meta-analysis (Kennedy (P < 0.05; P < 0.01, respectively). Significant reduction in the use
2006; Kotani 1997; Sun2004). One of the trials (36 women) re- of pain-relieving medication was found in the placebo group in
ported that headache was the most frequently reported side ef- the first intervention cycle only (P < 0.01) (Kotani 1997).
fect and that there was no difference between the groups. How- One trial (36 women) reported that it had assessed the amount of
ever, meta-analysis showed a small statistical difference between additional medication used; however, this trial did not report any
the groups with more incidents occurring in the placebo group detail for undertaking meta-analysis (Kennedy 2006).
than in the herbal group (RR 0.81, 95% CI 0.61 to 1.07). There 2) Use of additional medicine - Chinese herbal medicine versus
were no serious adverse events and no clinically relevant changes no treatment
in laboratory values (Kennedy 2006).
2) Adverse effects - Chinese herbal medicine versus no treat- No data were available for this comparison.
ment 3) Use of additional medicine - Chinese herbal medicine versus
conventional therapy
No data were available for this comparison Two trials (194 women) measured this outcome. One (132
3) Adverse effects - Chinese herbal medicine versus conventional women) used a tailored formula with up to three months of fol-
therapy low-up, and the other trial (62 women) used a standard formula
with no follow-up. Overall results showed that the use of CHM
Only two included trials (418 women) mentioned that adverse resulted in a reduction in the use of additional pain-relieving med-
effects were monitored, with no incident reported in either the ication (RR 1.58, 95% CI 1.30 to 1.93).
experimental or the control groups. 4) Use of additional medicine - Chinese herbal medicine (ex-
4) Adverse effects - Chinese herbal medicine (experiment) versus periment) versus Chinese herbal medicine (OTC)
Chinese herbal medicine (OTC) Five trials (402 women) including two trials (116 women) with
standardised formulae, and three trials (286 women), used tailored
Two included trials (183 women) reported no adverse effects. Only formulae, all were with three months of follow-up. The results
one of the trials (120 women) had data that could be extracted showed significant improvements - numbers of women did not
(Shen 2001) for meta-analysis; the data were incomplete in the require analgesics after the herbal intervention (RR 1.58, 95% CI
other trial, since the information on the control group was not 1.34 to 1.87).
provided (Deng 2003). 5) Use of additional medicine - Chinese herbal medicine versus
5) Adverse effects - Chinese herbal medicine versus acupuncture massage
No data were available for this comparison No data were available for this comparison.
6) Adverse effects - Chinese herbal medicine versus massage 6) Use of additional medicine - Chinese herbal medicine versus
No data were available for this comparison heat compress
7) Adverse effects - Chinese herbal medicine versus heat com- No data were available for this comparison.
pression Laboratory tests
One trial (55 women) reported no adverse effects in either the Omitted from this review
A possible publication bias has not excluded for this review as the
Further effort for understanding aetiology of primary dysmen-
majority of trials reported positive effects of CHM in the treatment
orrhoea
of primary dysmenorrhoea. Funnel plots were used to investigate
the possibility of publication bias, for the trials comparing CHM
with conventional medicine. For the outcomes of pain reduction
In China, CHM has been used to treat dysmenorrhoea for cen-
and overall symptom assessment (outcomes that are highly corre-
turies, with positive clinical responses. Clinical success is likely to
lated), the funnel plots appear to be asymmetrical, which suggests a
be related to one of the TCM fundamental theories - ’stagnation of
bias towards positive studies (see Figure 1 and Figure 2). However,
Blood’ is the main pathological condition in primary dysmenor-
it remains unclear whether this bias is related solely to publication
rhoea. To draw relevant parallels between contemporary medical
bias or whether it is an effect of poor methodological quality of
sciences and TCM, four included trials attempted to reveal and
the smaller trials. Conversely, funnel plots of the trials comparing
explore the aetiology of primary dysmenorrhoea in the fields of
CHM (experimental) with other CHM (OTC) appeared roughly
endocrinology and neurology.
symmetrical indicated less chance of publication bias in this group
General haemorheology and vascular microcirculation effects were of trials (Figure 3 and Figure 4). Therefore, the existence of pub-
also investigated. Some studies stated that abnormalities were lication bias in the reviewed trials remains unclear.
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Chinese herbal medicine for primary dysmenorrhoea (Review) 18
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Zhong Guo Yi Yao Xue Bao [China Journal of Chinese Wang 2006a {published data only}
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treatment of 90 cases of primary dysmenorrhoea. Zhong primary dysmenorrhoea. Shi Yong Zhong Yi Yao Za Zhi
Guo Zhong Xi Yi Jie He Za Zhi [CJITWM] 2004;24(12): [Journal of Practical Traditional Chinese Medicine] 2001;17
1121–3. (5):11.
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Chinese herbal medicine for primary dysmenorrhoea (Review) 20
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Deng 2003
Participants Number
Experimental: 33 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 16-33,
Control: 15-33
History: stated
TCM Pattern: unstated
Interventions Self-designed formula (Jia Wei Muo Jie Pian) vs OTC (Yue Yue Shu)
Jia Wei Muo Jie Pian: Xue Jie (Sanguis Draconis), Mo Yao (Myrrha), Pu Huang (Pollen Typhae), Wu
Ling Zhi (Excrementum Trogopteri Seu Pteromi), San Leng (Rhizoma Sparganii Stoloniferi), Er Zhu
(Rhizoma Curcumae Ezhu) etc. 4 tablets, tid. 2 weeks prior to bleeding till 1st day of cycle
Yue Yue Shu: 1 sachet (10g), bid. 1 week prior to bleeding till 1st day of cycle
Outcomes 1. Pain
Experimentalerimental :
Casess of cure: 19/33
Casess of improvement: 7/33
Casess of response: 5/33
Casess of no response: 2/33
Total effectiveness: 93.94%
Controlrol
Cases of cure: 7/30
Cases of improvement: 8/30
Cases of response: 9/30
Cases of no response: 6/30
Total effectiveness: 80.00%
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Cases of cure: 19/33
Cases of improvement: 7/33
Cases of response: 5/33
Cases of no response: 2/33
Total effectiveness: 93.94%
Control:
Cases of cure: 7/30
Notes
Risk of bias
Deng 2005
Participants Number:
Experimental: 70 women
Control: 70 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-37 ys.
History: stated
TCM Pattern: both groups were diagnosed as ’retention of cold’, ’stagnation of Qi and blood’, ’deficiency
of liver and kidney’, ’retention of dampness and heat’
Interventions Folker formula (Jiang Ji Jiu) vs OTC ( Tian Qi Tong Jing Jiao Nang)
Jiang Ji Jiu: rice wine 200ml, Sheng Jiang (Rhizoma Zingiberis Officinalis Recens) 200 g, Ai Ye (Folium
Artemisiae Argyri) 200 g, Yi Mu Cao (Herba Leonuri Herterophylli) 50 g, Hen 1000 g, modification of
formula may be required. Stewing all ingredients, taking the soup and the chicken meat, one dose for 3
days. 3 days prior to bleeding, no chicken soup during menstruation, then started it again on day 2 of
cycle for 6 days
Tian Qi Tong Jing Jiao Nang: 6 pills, tid. 2 days prior to bleeding for 6 days
Outcomes 1. Pain:
Experimental:
Rate & Casess of cure: 44.3%, 31/70
Rate & Casess of improvement: 51.4%, 36/70
Rate & Casess of no response: 4.3%, 3/70
Cont:
Rate & Cases of cure: 21.4%, 15/70
Rate & Cases of improvement: 67.1%, 47/70
Rate & Cases of no response: 11.4%, 8/70
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, but relapse during 3 cycles of follow up
No response: abdominal pain and other symptoms not changed at all
2. Overall symptoms:
unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Fan 1999
Participants Number:
Experimental: 50 women
Control: 48 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-26 y
History: stated
Chinese herbal medicine for primary dysmenorrhoea (Review) 25
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Fan 1999 (Continued)
TCM Pattern: specified, ’stagnation of blood Qi and blood, ’,’retention of cold’, ’deficiency of kidney
deficiency’
Interventions Self-designed formula (Huo Xue Zhen Tong Tang) vs indomethacin + Atropome
Huo Xue Zhen Tong Tang:
Pu Huang (Pollen Typhae) 15 g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 15 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 30 g, Dan Shen (Radix Salviae Miltrorrhizae) 12 g,
Hong Hua (Flos Carthami Tinctorii) 12 g, Bai Shao (Radix Paeoniae Latiflorae) 30-45 g,
Chai Hu (Radix Bupleuri) 12 g.
Modification might be required. Herbal decoction, one dose/day, 5 days prior to bleeding for a period of
7 days
Indomethacin: 25mg, tid. Atropome: 0.3 mg, tid. 20 th days of cycle for a period of 7 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 58.00%, 29/50
Rate and Cases of improvement: 42.00%, 21/50
Rate and Cases of no response: 0%, 0/50
Total effectiveness: 100%
Control:
Rate and Cases of cure: 35.42%, 17/48
Rate and Cases of improvement: 43.75%, 21/48
Rate and Cases of no response:0%, 0/48
Total effectiveness: 79.17%
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 58.00%, 29/50
Rate and Cases of improvement: 42.00%, 21/50
Rate and Cases of no response: 0%, 0/50
Total effectiveness: 100%
Control:
Rate and Cases of cure: 35.42%, 17/48
Rate and Cases of improvement: 43.75%, 21/48
Rate and Cases of no response:0%, 0/48
Total effectiveness: 79.17%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, but relapse during 3 cycles of follow up
No response: abdominal pain and and other symptoms changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Guo 1997
Participants Number:
Experimental: 35 women
Control: 31 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-26 years
History: stated
TCM Pattern: unspecified, but mentioned the common reasons as ’stagnation of blood Qi and blood,
retention of cold’ etc
Interventions Self-designed formula (Tong Jing San) vs OTC formula (Yue Yue Shu)
Tong Jing San: Xue Jie (Sanguis Draconis), Rou Gui (Cortex Cinnamomi Cassiae), in a ratio of 3:1 and
a form of powder, 3 g, bid. Mixed and dissolve with warm water. starting 24 hours prior to bleeding till
3rd day of cycle
Yue Yue Shu (powder): 10g, bid. 1 week prior to bleeding till day 3 of cycle
Outcomes 1. Pain:
Experimental:
Cases of cure: 24/35
Cases of improvement: 7/35
Cases of response: 3/35
Cases of no response: 1/35
Total effectiveness: 97.14%
Control:
Cases of cure: 9/31
Cases of improvement: 9/31
Cases of response: 11/31
Cases of no response: 1/31
Total effectiveness: 93.55%
Significant difference between the two groups in the total efficacy P<0.01
2. Overall symptoms:
Experimental:
Cases of cure: 24/35
Cases of improvement: 7/35
Cases of response: 3/35
Cases of no response: 1/35
Total effectiveness: 97.14%
Control:
Cases of cure: 9/31
Cases of improvement: 9/31
Cases of response: 11/31
Cases of no response: 1/31
Total effectiveness: 93.55%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, and other symptoms disappeared or reduced, capable
of working without pain relieving medication
Response: abdominal pain reduced, and other symptoms improved, capable of working with pain relieving
medication
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: stated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Huang 2000
Participants Number:
Experimental: 33 women
Control: 25 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-33 ys
History: unstated
TCM Pattern: unspecified, only common patters were ’stagnation of Qi and blood in the channels’ and
’retention of cold in the channels’
Outcomes 1. Pain:
Experimental:
Cases of cure: 10/33
Cases of improvement: 18/33
Cases of no response: 5/33
Total effectiveness: 92.4%
Control:
Cases of cure: 2/25
Cases of improvement: 17/25
Cases of no response: 6/25
Total effectiveness: 76%
Criteria
Cure: abdominal pain disappeared. no relapse during 2 cycles of follow up
Improvement: abdominal pain reduced, but relapse during 2 cycles of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms:
unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Participants Number:
Experimental: 40 women
Control: 36 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-25 years
History: stated
TCM Pattern: unspecified, but the common pattern was ’stagnation of Qi and blood with retention of
cold’
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 37.5%, 15/40
Rate and Cases of improvement: 52.5%, 21/40
Rate and Cases of no response: 10%, 4/40
Total effectiveness: 90.0%
Control:
Rate and Cases of cure: 30.5%, 11/36
Rate and Cases of improvement: 41.7%, 15/36
Rate and Cases of no response: 27.8%, 10/36
Total effectiveness: 72.2%%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 37.5%, 15/40
Rate and Cases of improvement: 52.5%, 21/40
Rate and Cases of no response: 10%, 4/40
Total effectiveness: 90.0%
Control:
Rate and Cases of cure: 30.5%, 11/36
Notes
Risk of bias
Kennedy 2006
Methods Allocation concealment and randomisation: Randomised - method stated (computer-generated opaque
sealed envelope)
Blinding: double blinded
Trial design: parallel
Duration: 3 cycles of intervention + 1 cycles of follow up
Participants Number:
Experimental: 17 women
Control: 19 women
Drop-outs/withdrawals: stated 3 dropped out before randomisation, 2 dropped out after randomisation
due to either irregular menstruation or personal reasons. Their data were excluded (no intention-to-
treatment performed)
Diagnosis of dysmenorrhoea: stated
Age: 18-45 years
History: unstated
TCM Pattern: unspecified
Outcomes 1. Pain:
VAS, more details in the additional table
2. Overall symptoms: unstated
3. Adverse effect: stated, measured by hematological and biochemical tests. No details provided
4. Lab tests: unstated
5. Use of additional medication: stated, no details provided
6. Satisfaction from patients: stated, no details provided.
7. Quality of life: unstated
Risk of bias
Kotani 1997
Participants Number:
Experimental: 20 women
Control: 20 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: unstated
Age: 14-45
History: unstated
TCM Pattern: stated, only included ’stagnation blood’, ’deficiency’, ’yin’, and ’cold’
Risk of bias
Li 1999
Participants Number:
Experimental: 44 women
Control: 36 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-45
History: stated
TCM Pattern: stated, ’stagnation of Qi and Blood’
Interventions Self designed formula (Fu Ke Qian Jin Pian) vs OTC Chinese herbal formula (Tian Qi Jiao Nang)
Fu Ke Qian Jin Pian: no details stated
Tian Qi Jiao Nang: no details stated
Both group took 5 tablets of each study material, tid. 4-5 days prior to bleeding till day 2 of cycle
Outcomes 1. Pain:
Experimental:
Cases of cure: 13/44
Cases of improvement: 23/44
Cases of response: 5/44
Cases of no response: 3/44
Total effectiveness: 93.2%
Control:
Risk of bias
Participants Number:
Experimental: 50 women
Control: 50 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental:15-35,
Control: 15-33
History: stated
TCM Pattern: unstated
Interventions Self designed formula (Tong Jing Wan) vs OTC Chinese herbal formula (Yuan Hu Zhi Tong Pian)
Tong Jing Wan: Xiao Hui Xiang (Fructus Foeniculi Vulgaris), Rou Gui (Cortex Cinnamomi Cassiae),
San Qi (Radix Notoginseng), Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi), Pu Huang (Pollen
Typhae), Chen Xiang (Lignum Aquitariae), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Mu Xiang (Radix
Aucklandiae Lappae), Bai Zhu (Rhizoma Atractylodis Macrocephalae), made as a form of pills in certain
ratio. 2g, tid
Yuan Hu Zhi Tong Pian: 5 tablets, tid
Both groups started from 5 days prior to bleeding till day 2 of cycle
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 68.0%, 34/50
Rate and Cases of improvement: 10%, 5/50
Rate and Cases of response: 12%, 6/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 90%
Control:
Rate and Cases of cure: 20%, 10/50
Rate and Cases of improvement: 30%, 15/50
Rate and Cases of response: 22%, 11/50
Rate and Cases of no response: 28%, 14/50
Total effectiveness: 72%
Significant difference between the two groups in the rate of cure P<0.001
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 68.0%, 34/50
Rate and Cases of improvement: 10%, 5/50
Rate and Cases of response: 12%, 6/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 90%
Control:
Rate and Cases of cure: 20%, 10/50
Rate and Cases of improvement: 30%, 15/50
Notes
Risk of bias
Li 2004
Participants Number:
Experimental: 40 women
Control: 40 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 12-33 y
Control: 13-32 y
History: unstated
TCM Pattern: stated, only the pattern of ’retention of cold and blood stasis’
Interventions Self-designed formula (Nuan Gong ZHi Tong Tang) vs OTC (Yue Yue Shu)
Nuan Gong ZHi Tong Tang:
Rou Gui (Cortex Cinnamomi Cassiae) 5 g,
Zhi Fu Zi (Radix Lateralis Aconiti Carmichaeli Praeparata) 3 g,
Chinese herbal medicine for primary dysmenorrhoea (Review) 36
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Li 2004 (Continued)
Outcomes 1. Pain:
Experimental:
Casess of cure: 21/40
Casess of improvement: 11/40
Casess of response: 5/40
Casess of no response: 3/40
Total effectiveness: 92.5%
Control:
Casess of cure: 14/40
Casess of improvement: 10/40
Casess of response: 7/40
Casess of no response: 9/40
Total effectiveness: 77.5%
Significant difference between the two groups in the rate of cure P<0.05
2. Overall symptoms:
Experimental:
Casess of cure: 21/40
Casess of improvement: 11/40
Casess of response: 5/40
Casess of no response: 3/40
Total effectiveness: 92.5%
Control:
Casess of cure: 14/40
Casess of improvement: 10/40
Casess of response: 7/40
Casess of no response: 9/40
Total effectiveness: 77.5%
Significant difference between the two groups in the rate of cure P<0.05
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapsed during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, and other symptoms disappeared or reduced, remained
the efficacy during 3 cycles of follow up
Response: abdominal pain reduced, and other symptoms improved, relapsed but less severe
No response: abdominal pain, other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Liu 2000
Participants Number:
Experimental: 40 women
Control: 38 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-31
History: stated
TCM Pattern: unspecified
Interventions OCT Chinese herbal formula (Xiao Yao Wan) + Piroxicam vs Prioxicam
Xiao Yao Wan: Dang Gui (Radix Angelicae Sinensis), Bai Shao (Radix Paeoniae Latiflorae), Chai Hu
(Radix Bupleuri), Fu Ling (Sclerotium Poriae Cocos), Bai Zhu (Rhizoma Atractylodis Macrocephalae)
, Gan Cao (Radix Glycyrrhizae Uralensis), Wei Jiang (Rhizoma Phragmitis Communis), Bo He (Herba
Menthae Haplocalcis), 9g, bid. in combination with Piroxicam: 20mg, once daily
Piroxicam: 20 mg, once daily
Both groups started from 2 days prior to bleed for a period of 3 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 70%, 28/40
Rate and Cases of improvement: 22.5%, 9/40
Rate and Cases of no response: 7.5%, 3/40
Total effectiveness: 92.5%
Control:
Rate and Cases of cure: 31.6%, 12/38
Rate and Cases of improvement: 52.6%, 20/38
Rate and Cases of no response: 15.8%, 6/38
Total effectiveness:84.2%
No significant difference between the Experimentalerimental and Controlrol groups in total efficacy P>0.
05. but different in rate of cure P<0.001
Criteria
Cure: abdominal pain disappeared, no relapse during 10 cycles of follow up
Improvement: abdominal pain reduced or disappeared, no relapse during 3 cycles of follow up
Notes
Risk of bias
Liu 2002
Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 12-36
History: stated
TCM Pattern: unspecified
Interventions Self designed formula (Wen Tong Tang) vs OTC Chinese herbal formula (Gu Zhi Wan)
Wen Tong Tang:
Dang Gui (Radix Angelicae Sinensis) 10 g,
Chuan Xiong (Radix Ligustici Chuanxiong) 10 g,
Chi Shao (Radix Paeoniae Rubrae) 10 g,
Chuan Niu Xi (Radix Cyathulae Officinalis) 15 g,
Pu Huang (Pollen Typhae) 10g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 10 g,
Rou Gui (Cortex Cinnamomi Cassiae) 5 g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 5 g,
Pao Jiang (Quick-Fried Rhizoma Zingiberis Officinalis) 5 g,
Lu Jiao Shuang (Cornu Cerri Degelatinatium) 10 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 10 g, Xiang Fu (Rhizoma Cypri Rotundi) 10 g.
Herbal decoction, one dose, bid
Gu Zhi Wan: 9g, bid
Both group started study material from the first day of cycle (bleeding) to the end of bleeding
Outcomes 1. Pain:
Experimental:
Cases of cure: 22/30
Cases of improvement: 6/30
Cases of no response: 2/30
Total effectiveness: 93.3%
Control:
Cases of cure: 12/30
Cases of improvement: 10/30
Cases of no response: 8/30
Total effectiveness: 73.3%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced or disappeared, but relapse during 3 cycles of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: stated but doesn’t fit the criteria of outcomes
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Liu 2003
Participants Number:
Experimental: 52 women
Control: 38 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-30
History: stated
Interventions Self designed formula (Wen Jing Tang -> oral administration +
Xin Jie San -> external administration ) vs Indomethacin + Vit B6 + Hot water bottle
Wen Jing Tang:
Rou Gui (Cortex Cinnamomi Cassiae) 3 g,
Chuan Xiong (Radix Ligustici Chuanxiong) 8 g,
Dangshen (Codonopsis Radix) 20 g,
Dang Gui (Radix Angelicae Sinensis) 10 g, Er Zhu (Rhizoma Curcumae Ezhu) 10 g, Dan Shen (Radix
Salviae Miltrorrhizae) 15 g, Chuan Niu Xi (Radix Cyathulae Officinalis) 10 g,
Bai Shao (Radix Paeoniae Latiflorae) 10 g, Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 10 g,
Gan Cao (Radix Glycyrrhizae Uralensis) 6 g. Herbal decoction, one dose daily
Xin Jie San: Xi Xin (Asari Herba) 30 g,
Bai Jie Zi (Sinapis Semen) 30 g,
Mang Xiao (Natrii Sulfas) 30g. All ingredients were mixed, ground into powder and packed into a bag
sized as 20x30cm, then sealed. Warmed up in microwave oven before applied on the lower abdominal
region
Indomethacin: 25 mg, tid. Vit B6 20 mg, tid. Hot water bottle in the lower abdominal region
Both groups started from 2-3 days prior to bleeding or 1st day of bleeding for a period of 7 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure:90.4%, 47/52
Rate and Cases of improvement: 7.7%, 4/52
Rate and Cases of no response: 1.9%, 1/52
Total effectiveness: 98.1%
Control:
Rate and Cases of cure: 44.7%, 17/38
Rate and Cases of improvement: 31.6%, 12/38
Rate and Cases of no response: 23.7%, 9/38
Total effectiveness: 76.3%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced.
No response: abdominal pain not changed at all.
2. Improved other symptoms: unstated
3. Adverse effect: unstated
4. Improvement in lab tests: unstated
5. Reduced additional medication: unstated
6. Satisfaction from patients: unstated
7. improvement in quality of life: unstated
Risk of bias
Liu 2004
Participants Number:
Experimental: 45 women
Control: 40 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-18
History: stated
TCM Pattern: retention of coldness and stagnation of blood
Interventions Self-designed formula administrated externally vs classic formula (Wen Jing Tang) administrated orally
Zi Ni Wai Fu Tong Jing Zhi Tong Fan:
Rou Gui (Cortex Cinnamomi Cassiae) 30 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 30 g, Ru Xiang (Gummi Olibanum) 30 g,
Mo Yao (Myrrha) 30 g,
Di Bie Chong (Eupolyphaga Seu Opisthaplatia) 30 g,
Wu Yao (Radix Linderae Strychnifoliae) 30 g.
All ingredients were dried and granted into powder, 20g each time, mixed with rice wine as paste for
external use on navel. Change once daily
Wen Jing Tang: no details. One dose daily.
Both groups started from 3 days prior to bleeding for a period of 5 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 88.89%, 40/45
Rate and Cases of improvement: 6.67%, 3/45
Rate and Cases of response: 2.22%, 1/45
Rate and Cases of response: 2.22%, 1/45
Total effectiveness: 97.78%
Control:
Rate and Cases of cure: 47.50%, 19/40
Rate and Cases of improvement: 10.00%, 4/40
Rate and Cases of response: 15.00%, 6/40
Rate and Cases of no response: 27.50%, 11/40
Total effectiveness: 72.50%
Significant difference between the two groups in the rate of cure P<0.05
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 88.89%, 40/45
Rate and Cases of improvement: 6.67%, 3/45
Notes
Risk of bias
Liu 2005
Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-30
History: stated
TCM Pattern: stated, retention of coldness and stagnation of blood
Interventions Self-designed formula (Wen Jing Zhi Tong Yin) vs OTC Chinese herbal formula (Ai Fu Nuan Gong
Tang)
Wen Jing Zhi Tong Yin: Pao Jiang (Quick-Fried Rhizoma Zingiberis Officinalis), Rou Gui (Cortex
Cinnamomi Cassiae), Dang Gui (Radix Angelicae Sinensis), Chuan Xiong (Radix Ligustici Chuanxiong)
, Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi), Pu Huang (Pollen Typhae), Bai Shao (Radix
Paeoniae Latiflorae), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Huai Niu Xi (Radix Achyranthis
Bidentatae), Xiao Hui Xiang (Fructus Foeniculi Vulgaris), Xiang Fu (Rhizoma Cypri Rotundi), Gan Cao
(Radix Glycyrrhizae Uralensis) etc. No dosage in detail stated. Herbal decoction. 5 days prior to bleeding
for a period of 7 days
Ai Fu Nuan Gong Tang: No dosage in detail stated. 3 days prior to bleeding for a period of 6 days
Outcomes 1. Pain:
Experimental:
Casess of cure: 7/30
Casess of improvement: 15/30
Casess of response: 6/30
Casess of no response: 2/30
Total effectiveness: 93.33%
Control:
Casess of cure: 6/30
Casess of improvement: 6/30
Casess of response: 11/30
Casess of no response: 7/30
Total effectiveness: 76.67%
Significant difference between the two groups in the rate of cure P<0.05
2. Overall symptoms: Experimental:
Casess of cure: 7/30
Casess of improvement: 15/30
Casess of response: 6/30
Casess of no response: 2/30
Total effectiveness: 93.33%
Control:
Casess of cure: 6/30
Casess of improvement: 6/30
Casess of response: 11/30
Casess of no response: 7/30
Total effectiveness: 76.67%
Significant difference between the two groups in the rate of cure P<0.05
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, other symptoms disappeared or reduced, the pain scores
after intervention reduced as low as 1/2 of the scores before intervention
Response: abdominal pain reduced, other symptoms improved, the pain scores after intervention reduced
as low as between 1/2 to 3/4 of the scores before intervention
No response: abdominal pain, or other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
Notes
Risk of bias
Lu 2002
Participants Number:
Experimental: 45 women
Control: 41 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-32
History: stated
TCM Pattern: unspecified
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 66.7%, 30/45
Rate and Cases of improvement: 28.8%, 13/45
Rate and Cases of no response: 4.4%, 2/45
Total effectiveness: 95.6%
Control:
Rate and Cases of cure: 42.5%, 20/41
Rate and Cases of improvement: 26.8%, 11/41
Rate and Cases of no response: 24.3%, 10/41
Total effectiveness: 75.6%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Notes
Risk of bias
Luo 2001
Participants Number:
Experimental: 31 women
Control: 31 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 13-40
History: stated
TCM Pattern: Stagnation of Qi and Blood
Outcomes 1. Pain:
Experimental:
Cases of improvement: 26/31
Cases of response: 5/31
Cases of no response: 0/31
Chinese herbal medicine for primary dysmenorrhoea (Review) 46
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Luo 2001 (Continued)
Notes
Risk of bias
Participants Number:
Experimental: 36 women
Control: 27 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 12-20 y
History: stated
TCM Pattern: believed all clinical patterns related to ’deficiency of kidney and liver’
Interventions Self designed formula (Niu Xi San) vs Acupuncture (LI 4, and SP 6 only)
Niu Xi San: Niu Xi (Chuan Niu Xi (Radix Cyathulae Officinalis) or Huai Niu Xi (Radix Achyranthis
Bidentatae) (not clear), Rou Gui (Cortex Cinnamomi Cassiae), Chi Shao (Radix Paeoniae Rubrae), Tao
Ren (Semen Persicae), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Dang Gui (Radix Angelicae Sinensis)
, Mu Xiang (Radix Aucklandiae Lappae), Dan Pi (Cortex Mouten Radicis) in a ration of 3:1:1:1:1:1:1:1:
1, in a form of powder, 9g, mixed with warm water or wine, for a period of 5 days (unclear when started
the intervention)
Acupuncture: needles remained for 30 minutes of each point, for a period of 5 days (unclear when started
the intervention)
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 47.3%, 17/36
Rate and Cases of improvement: 41.3%, 15/36
Rate and Cases of no response: 11.4%, 4/36
Total effectiveness: 88.6%
Control:
Rate and Cases of cure: 17.1%, 3/17
Rate and Cases of improvement: 47.1%, 8/17
Rate and Cases of no response: 34.8%, 6/17
Total effectiveness: 65.2%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
Criteria:
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced or disappeared, but relapse during 3 cycle of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Niu 1996
Participants Number:
Experimental: 32 women
Control: 21 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 17-47 ys
Control: 18-42yrs
History: stated
TCM Pattern: unstated
Interventions Single herb (Glycyrrhiza uralensis Fisch) vs OTC (Yuan Hu Zhi Tong Pian)
Glycyrrhiza uralensis Fisch: no dosage of details stated
Yuan Hu Zhi Tong Pian: 6 tablets, tid
Both group took herb as soon as pain started for 3 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 28.1%, 9/32
Rate and Cases of improvement: 40.6%, 13/32
Rate and Cases of response: 25.0%, 8/32
Rate and Cases of no response: 6.3%, 2/32
Total effectiveness: 93.8%
Control:
Rate and Cases of cure: 9.5%, 2/21
Rate and Cases of improvement: 23.8%, 5/21
Rate and Cases of response: 23.8%, 5/21
Rate and Cases of no response: 42.9%, 9/21
Total effectiveness: 57.1%
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 28.1%, 9/32
Rate and Cases of improvement: 40.6%, 13/32
Rate and Cases of response: 25.0%, 8/32
Notes
Risk of bias
Qin 2003
Participants Number:
Experimental: 60 women
Control: 60 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
average 14-40 y
History: unstated
TCM Pattern: unstated
Interventions Self designed formula (Du Yi Wei Jiao Nang) vs OTC Formua (Yuan Hu Zhi Tong Jiao Nang) or added
pain relieving medication if required
Du Yi Wei Jiao Nang: no details given. 3 pills, tid.
Yuan Hu Zhi Tong Jiao Nang: no details given.
Both group started herb from 1st day of cycle/bleeding for 7 days
Outcomes 1. Pain:
Experimental:
Rate of cure: 81.67%, 49/60
Rate of improvement: 15.00%, 9/60
Rate of no response: 3.33%, 2/60
Total effectiveness: 96.66%
Control:
Rate of cure: 35.00%, 21/60
Rate of improvement: 48.33%, 29/60
Rate of no response: 16.66%, 10/60
Total effectiveness: 83.33%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, but relapsed during 3 cycle of follow up
No response: abdominal pain and other symptoms not changed at all
2. Overall symptoms:
Experimental:
Rate of cure: 81.67%, 49/60
Rate of improvement: 15.00%, 9/60
Rate of no response: 3.33%, 2/60
Total effectiveness: 96.66%
Control:
Rate of cure: 35.00%, 21/60
Rate of improvement: 48.33%, 29/60
Rate of no response: 16.66%, 10/60
Total effectiveness: 83.33%
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Participants Number:
Experimental: 60 women
Control: 60 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 26.63 y
Control: 25.1 y
History: stated
TCM Pattern: stated, ’the retention of cold and stagnation of blood’
Interventions Self designed formula (Wen Jing Jian Tong Jiao Nang) vs OCT Formua (Jiu Qi Jian Tong Wan)
Wen Jing Jian Tong Jiao Nang: Rou Gui (Cortex Cinnamomi Cassiae), Jiu Xiang Chong (Aspongopus)
, Xiao Hui Xiang (Fructus Foeniculi Vulgaris), Dang Gui (Radix Angelicae Sinensis), Wu Ling Zhi
(Excrementum Trogopteri Seu Pteromi), Xiang Fu (Rhizoma Cypri Rotundi), Yan Hu Suo (Rhizoma
Corydalis Yanhusuo), Bing Pian (Borneol), dosage of herbal ingredients unstated. 4 pills, bid
Jiu Qi Jian Tong Wan: no detail of dosage of herbal ingredient stated. 9g, bid
Both groups started herbs 7 days prior to period for a period of 5 days
Outcomes 1. Pain:
Experimental:
Cases of cure: 14/60
Cases of improvement: 27/60
Cases of response: 16/60
Cases of no response: 3/60
Total effectiveness: 57 (95.00%)
Control:
Cases of cure: 8/60
Cases of improvement: 19/60
Cases of response: 28/60
Cases of no response: 5/60
Total effectiveness: 55 (91.67%)
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Cases of cure: 14/60
Cases of improvement: 27/60
Cases of response: 16/60
Cases of no response: 3/60
Total effectiveness: 57 (95.00%)
Control:
Cases of cure: 8/60
Cases of improvement: 19/60
Cases of response: 28/60
Notes
Risk of bias
Song 2003
Participants Number:
Experimental: 50 women
Control: 50 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 15-35,
Control: 14-36
History: stated
TCM Pattern: stated, only the pattern of ’stagnation of Qi and Blood” was included
Trogopteri Seu Pteromi), Chuan Niu Xi (Radix Cyathulae Officinalis), Xiang Fu (Rhizoma Cypri Rotundi)
, Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Dang Gui (Radix Angelicae Sinensis), Bai Shao (Radix
Paeoniae Latiflorae), Xi Xin (Herba cum Radice Asari), etc. in a form of capsule (no detailed dosage), 4
capsules, tid. 5 days prior to period for a period of 7 days
Indomethacin: 25 mg, tid. 3 days prior to period for a period of 6 days
Outcomes 1. Pain:
Experimental:
Rate of cure: 70%, 35/50
Rate of improvement: 20%, 10/50
Rate of no response: 10%, 5/50
Total effectiveness: 90%
Control:
Rate of cure: 20%, 10/50
Rate of improvement: 52%, 26/50
Rate of no response: 28%, 14/50
Total effectiveness: 72%
significant difference between the Experimentalerimental and Controlrol groups P<0.005
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, but relapsed during 3 cycles of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Sun 2006
Participants Number:
Experimental: 46 women
Control: 45 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Chinese herbal medicine for primary dysmenorrhoea (Review) 54
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sun 2006 (Continued)
Age:
Experimental: 13-35
Control: 12-35
History: stated
TCM Pattern: specified, only the pattern of “stagnation of blood and retention of cold”
Interventions Self-designed formula (Tao Jing Ding Tong Tang) vs OTC Chinese herbal formula (Tian Qi Tong Jing
Jiao Nang)
Tao Jing Ding Tong Tang:
Gui Zhi (Ramulus Cinnamomi Cassiae) 15 g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 10 g, Dang Gui (Radix Angelicae Sinensis) 10 g, Chuan
Xiong (Radix Ligustici Chuanxiong) 15 g, Xiang Fu (Rhizoma Cypri Rotundi) 15 g,
Chai Hu (Radix Bupleuri) 10 g,
Yi Mu Cao (Herba Leonuri Herterophylli) 15 g,
Ze Lan (Herba Lycopi Lucidi) 15 g,
Wang Bu Liu Xing (Semen Vaccariae Segetalis) 20 g,
Lu Lu Tong (Fructus Liquidambaris Taiwanianae) 15 g,
Bai Shao (Radix Paeoniae Latiflorae) 15 g,
Gan Cao (Radix Glycyrrhizae Uralensis) 5 g. Herbal decoction, bid
Tian Qi Tong Jing Jiao Nang: 4 pills, tid, a half hour before meals
Both groups took herbs from 5 days prior to period for a period of 6 days
Outcomes 1. Pain:
Experimental:
Cases of cure: 27/46
Cases of improvement: 12/46
Cases of response: 5/46
Cases of no response: 2/46
Total effectiveness: 95.65%
Control:
Cases of cure: 7/45
Cases of improvement: 18/45
Cases of response: 8/45
Cases of no response: 12/45
Total effectiveness: 73.33%
Significant difference in rate of cure between the two groups: P<0.05
2. Overall symptoms:
Experimental:
Cases of cure: 27/46
Cases of improvement: 12/46
Cases of response: 5/46
Cases of no response: 2/46
Total effectiveness: 95.65%
Control:
Cases of cure: 7/45
Cases of improvement: 18/45
Cases of response: 8/45
Cases of no response: 12/45
Total effectiveness: 73.33%
Notes
Risk of bias
Sun2004
Methods Allocation concealment and randomisation: randomised based on a random number table
Blinding: double-blinding
Trial design: parallel
Parallel performance: may not
Duration: 3 cycles of intervention + 3 cycles of follow up
Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-23
History: stated
TCM Pattern: unstated
Outcomes 1. Pain:
Experimental 1:
Rate and Cases of cure: 10%, 3/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 46.7%, 14/30
Rate and Cases of no response: 10%, 3/30
Total effectiveness: 90.0%
Experimental 2:
Rate and Cases of cure: 6.7%, 2/30
Rate and Cases of improvement: 30.0%, 9/30
Rate and Cases of response: 50.0%, 15/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Control:
Rate and Cases of cure: 0%, 0/30
Rate and Cases of improvement: 3.3%, 1/30
Rate and Cases of response: 36.7%, 11/30
Rate and Cases of no response: 60%, 18/30
Total effectiveness: 60.0%
2. Overall symptoms:
Experimental 1:
Rate and Cases of cure: 10%, 3/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 46.7%, 14/30
Rate and Cases of no response: 10%, 3/30
Total effectiveness: 90.0%
Experimental 2:
Rate and Cases of cure: 6.7%, 2/30
Rate and Cases of improvement: 30.0%, 9/30
Rate and Cases of response: 50.0%, 15/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Control:
Rate and Cases of cure: 0%, 0/30
Rate and Cases of improvement: 3.3%, 1/30
Rate and Cases of response: 36.7%, 11/30
Rate and Cases of no response: 60%, 18/30
Total effectiveness: 60.0%
Criteria
Cure: abdominal pain and other symptoms disappeared, scores reduced to 0, no relapse during 3 cycles
of follow up, lab tests within normal range
Improvement: abdominal pain and other symptoms significantly reduced, after intervention, scores re-
duced as 1/2 below as before, maintain daily activities with pain relieving medication, lab tests significantly
improved, closed to normal range
Response: abdominal pain and reduced, after intervention, scores reduced as 1/2 to 3/4 below as before,
pain relieving medication needed, lab tests improved
No response: abdominal pain, other symptoms, lab tests not changed at all
Notes This trial had two Experimental groups,which is tabled separately, however the numbers of women in
placebo group was only entered into analysis once
Risk of bias
Sun2004 -2
Methods Allocation concealment and randomisation: randomised based on a random number table
Blinding: double-blinding
Trial design: parallel
Parallel performance: may not
Duration: 3 cycles of intervention + 3 cycles of follow up
Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-23
History: stated
TCM Pattern: unstated
Outcomes 1. Pain:
Experimental 1:
Rate and Cases of cure: 10%, 3/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 46.7%, 14/30
Rate and Cases of no response: 10%, 3/30
Total effectiveness: 90.0%
Experimental 2:
Notes
Risk of bias
Tseng 2005
Participants Number:
Experimental: 70 adolescents
Control: 60 adolescents
Drop-outs/withdrawals: stated
21 out of 130 dropped out because of irregular course of menstruation, failure of compliance, withdrawal
of school. 59 Experimental and 50 Control subjects completed the assessment
Diagnosis of dysmenorrhoea: unstated
Age: adolescents/boarding school girls, age unspecified
History: stated
TCM Pattern: unstated, only mentioned stagnation Qi and blood as general condition
Risk of bias
Methods Allocation concealment and randomisation: randomised based on random number table
Blinding: stated, single blinded
Trial design: parallel
Duration: 3 cycles + 3 cycles of follow up
Participants Number:
Experimental: 23 women
Control 1: 21 women
Control 2: 16 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
high school girls
History: stated
TCM Pattern: specified, ’retention of cold and stagnation of Qi’
Interventions Self-designed formula (Tong Jing Ling) rectal administration vs 1 OCT Chinese herbal formula (Tian Qi
Tong Jing Jiao Nang) oral administration vs 2 Self-designed formula (Tong Jing Ling) oral administration
Tong Jing Ling: Gui Zhi (Ramulus Cinnamomi Cassiae), Wu Yao (Radix Linderae Strychnifoliae), Xiang
Fu (Rhizoma Cypri Rotundi), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Mu Xiang (Radix Aucklandiae
Lappae), Kun Cao, Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi), Chuan Xiong (Radix Ligustici
Chuanxiong), etc. Either in suppository administration, 1 piece, rectal administration, bid. or in oral
administration in capsule form, 5 pills, tid
Tian Qi Tong Jing Jiao Nang: 5 pills, tid
All groups started from 4-5 days prior to bleeding till day 2 of cycle (appx 7 days)
Outcomes 1. Pain:
Experimental:
Cases of cure: 8/23
Cases of improvement: 11/23
Cases of response: 2/23
Cases of no response: 2/23
Total effectiveness: 91.3%
Control 1:
Cases of cure: 7/21
Cases of improvement: 8/21
Cases of response: 2/21
Cases of no response: 4/21
Total effectiveness: 81.0%
Control 2:
Cases of cure: 4/16
Cases of improvement: 6/16
Cases of response: 3/16
Cases of no response: 3/16
Total effectiveness: 81.3%
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
2. Overall symptoms:
unstated
Criteria:
Notes
Risk of bias
Wang 2000b
Interventions Self designed formula (Bu Shen Hua Yu Tang) vs OCT formula (Yue Yue Shu)
Bu Shen Hua Yu Tang:
Ba Jie Tian (Radix Morindae Officinalis) 15g,
Gou Qi Zi (Fructus Lycii) 15g,
Xian Ling Pi (Herba Epimedii) 15g,
Shu Di (Radix Rehmanntae Glutinosae Conquitae) 15g,
Bai Shao (Radix Paeoniae Latiflorae) 20g,
Dang Gui (Radix Angelicae Sinensis) 12g,
Hong Hua (Flos Carthami Tinctorii) 12g,
Pu Huang (Pollen Typhae) 12g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 12g,
Chuan Xiong (Radix Ligustici Chuanxiong) 6g, Xiang Fu (Rhizoma Cypri Rotundi) 9g,
Zhi Qiao (Fructus Aurantii) 9g,
Gan Cao (Radix Glycyrrhizae Uralensis)6g. Modification of formulation might be required. Herbal de-
coction, one dose daily, starting from 5 days prior to bleeding for a period of 7 days
Yue Yue Shu: no details of formula stated. 10g, bid, started from 7 days prior to bleeding for a period of
10 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 38%, 19/50
Rate and Cases of improvement: 50%, 25/50
Rate and Cases of response: 8%, 4/50
Rate and Cases of no response: 4%, 2/50
Total effectiveness: 48/50
Control:
Rate and Cases of cure: 16%, 8/50
Rate and Cases of improvement: 24%, 12/50
Rate and Cases of response: 50%, 25/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 45/50
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 38%, 19/50
Rate and Cases of improvement: 50%, 25/50
Rate and Cases of response: 8%, 4/50
Rate and Cases of no response: 4%, 2/50
Total effectiveness: 48/50
Control:
Rate and Cases of cure: 16%, 8/50
Rate and Cases of improvement: 24%, 12/50
Rate and Cases of response: 50%, 25/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 45/50
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
Significant difference between the two groups in the rate of cure P<0.01
Criteria:
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, capable of working, no relapse during 3 cycles
Response: abdominal pain reduced, capable of working, but relapse
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Wang 2003
Participants Number:
Experimental: 52 women
Control: 51 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental 14-35 y
Control 15-32 y
History: stated
TCM Pattern: specified
Outcomes 1. Pain:
Experimental:
Cases of cure: 23/52
Cases of improvement: 25/52
Cases of no response: 4/52
Control:
Cases of cure: 15/51
Cases of improvement: 21/51
Cases of no response: 14/51
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, but relapse during 3 cycle of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes Author stated the selected point might not be suitable for two of four patterns based on Chinese medicine
diagnostic approach which might influence the outcome for women diagnosed with these two patterns
Risk of bias
Wang 2006a
Participants Number:
Experimental: 172 women
Control: 168 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-23 y
History: stated
TCM Pattern: unspecified
Interventions OCT Chinese herbal formula (Su Xiao Jiu Xin Wan) vs Indomethacin
Su Xiao Jiu Xin Wan: sublingual adminstration, 2-5 pills, tid, as soon as pain started for 4 days
Indomethacin: 25mg, tid, as soon as pain started for 4 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 83.7%, 144/172
Rate and Cases of improvement: 14.0%, 24/172
Total effectiveness: 97.7%
Control:
Rate and Cases of cure: 50.0%, 84/168
Rate and Cases of improvement: 42.9%, 72/168
Total effectiveness: 92.7%
Criteria
Cure: abdominal pain disappeared within 15-30 mins
Improvement: abdominal pain reduced within 15-30 mins
No response: abdominal pain not changed at all.
2. Overall symptoms:
unstated
3. Adverse effect: stated
4. Lab tests: unstated
5. Use of additional medication: unstated
Notes
Risk of bias
Wang 2006b
Participants Number:
Experimental: 32 women
Control: 24 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 14-29 y
Control: 15-30 y
History: stated
TCM Pattern: unspecified
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 62.50%, 20/32
Rate and Cases of improvement: 31.25%, 10/32
Rate and Cases of no response: 6.25%, 2/32
Total effectiveness: 93.75%
Control:
Notes
Risk of bias
Wu 2006
Participants Number:
Experimental: 45 women
Control: 45 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 13-27 ys
Control: 14-29 ys
History: stated
TCM Pattern: no specific statement
Interventions Self-designed formula (Jia Wei Dang Gui Shao Yao San) vs Ibuprofen
Jia Wei Dang Gui Shao Yao San:
Dang Gui (Radix Angelicae Sinensis) 10-20g,
Chuan Xiong (Radix Ligustici Chuanxiong) 30g, Bai Shao (Radix Paeoniae Latiflorae) 15-30g,
Chi Shao (Radix Paeoniae Rubrae) 10-20g,
Fu Ling (Sclerotium Poriae Cocos) 10-20g,
Ze Xie (Rhizoma Alismatis Orientalis) 10-20g, Bai Zhu (Rhizoma Atractylodis Macrocephalae) 10-20g,
Wu Yao (Radix Linderae Strychnifoliae) 10-20g, Xiang Fu (Rhizoma Cypri Rotundi) 10-20g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 10-20g,
Gan Cao (Radix Glycyrrhizae Uralensis) 5-10g. Herbal decoction, 300ml daily, 150ml bid
Ibuprofen: 200mg, tid
Both groups started from 3 days prior to bleeding for a period of 5 days
Outcomes 1. Pain:
Experimental:
Cases of cure: 14/45
Cases of improvement: 27/45
Cases of no response: 4/45
Total effectiveness: 91.1%
Control:
Cases of cure: 1/45
Cases of improvement: 27/45
Cases of no response: 17/45
Total effectiveness: 60.2%
Significant difference between the two groups in the rate of cure P<0.05
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain almost disappeared or reduced.
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Participants Number:
Experimental: 30 women
Control: 28 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 15-27 ys
Control: 14-28y
History: unstated
TCM Pattern: unstated
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 40%, 12/30
Rate and Cases of improvement: 56.67%, 17/30
Rate and Cases of no response: 3.33%, 1/30
Total effectiveness: 96.67%
Control:
Rate and Cases of cure: 0%, 0/28
Rate and Cases of improvement: 57.14%, 16/28
Rate and Cases of no response: 42.86%, 12/28
Total effectiveness: 57.14%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 40%, 12/30
Rate and Cases of improvement: 56.67%, 17/30
Rate and Cases of no response: 3.33%, 1/30
Total effectiveness: 96.67%
Control:
Rate and Cases of cure: 0%, 0/28
Rate and Cases of improvement: 57.14%, 16/28
Rate and Cases of no response: 42.86%, 12/28
Total effectiveness: 57.14%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Notes
Risk of bias
Yu 2003
Participants Number:
Experimental: 35 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 12-32 ys
Control: 13-30 ys
History: stated
TCM Pattern: both groups were diagnosed as ’retention of cold with blood stasis’
Interventions Self designed formula (Fu Mei Tong Jing Fang) vs OTC formula (Tian Qi Tong Jing Jiao Nang)
Fu Mei Tong Jing Fang:
Zhi Fu Zi (Radix Lateralis Aconiti Carmichaeli Praeparata) 6g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 12g, Dang Gui (Radix Angelicae Sinensis) 12g,
Mo Yao (Myrrha) 9g,
E Zhu (Rhizoma Curcumae Ezhu) 9g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 9g,
Pu Huang (Pollen Typhae) 9g,
Rou Gui (Cortex Cinnamomi Cassiae) 5g. Herbal decoction, extracted as 400 ml daily, 200 ml, bid
Tian Qi Tong Jing Jiao Nang: no details of formulation provided, 4 pills, tid
Both groups started from 3 days prior to bleeding for a period of 5 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 51.4%, 18/35
Chinese herbal medicine for primary dysmenorrhoea (Review) 71
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Yu 2003 (Continued)
Notes
Risk of bias
Participants Number:
Experimental: 35 women
Control: 20 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 16-22 ys
Control: 15-23
History: stated
TCM Pattern: unspecified, common patterns mentioned were ’deficiency of blood, blood stasis’
Outcomes 1. Pain:
Experimental:
Rate of cure: 77.14%, 27/35
Rate of improvement: 11.43, 4/35
Rate of response: 8.57%, 3/35
Rate of no response: 2.86%, 1/35
Total effectiveness: 97.14%
Control:
Rate of cure: 0%, 0/20
Rate of improvement: 0%, 0/20
Rate of response: 10%, 2/20
Rate of no response: 90%, 18/20
Total effectiveness: 10%
Significant difference between the two groups in the rate of cure P<0.001
2. Overall symptoms: unstated
Criteria:
Cure: abdominal pain symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain symptoms reduced obviously, but relapsed
Response: abdominal pain reduced.
No response: abdominal pain not changed at all.
3. Adverse effect: stated. no incidence
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Zhang 2001
Participants Number:
Experimental: 60 women
Control: 40 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-26 y
History: stated
TCM Pattern: unstated
Interventions Self-designed formula (oral administration) + self-designed formula (external administration) vs 2 different
OTC formulae (Yuan Hu Zhi Tong Pian and Tong Jing Wan, oral administration)
Self-designed formula (oral administration):
Gui Zhi (Ramulus Cinnamomi Cassiae) 9g,
Ru Xiang (Gummi Olibanum) 9g,
Chi Shao (Radix Paeoniae Rubrae) 9g,
Ze Lan (Herba Lycopi Lucidi) 9g,
Gan Cao (Radix Glycyrrhizae Uralensis) 9g,
Xi Xin (Herba cum Radice Asari) 6g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 6g, Chuan Xiong (Radix Ligustici Chuanxiong) 6g, Yan Hu
Suo (Rhizoma Corydalis Yanhusuo) 6g, Yi Mu Cao (Herba Leonuri Herterophylli) 15g, Dang Gui (Radix
Angelicae Sinensis) 15g,
Xiang Fu (Rhizoma Cypri Rotundi) 15g. Herbal decoction, one dose daily, 7 days prior to period till
postal menstruation
Self-designed formula (external administration): Bai Zhi (Radix Angelicae) 6g,
Dang Gui (Radix Angelicae Sinensis) 6g,
Chi Shao (Radix Paeoniae Rubrae) 6g,
Da Huang (Radix et Rhizoma Rhei) 6g,
Huang Dan (Minium) mixed with sesame oil, in a form of paste, applied on ’Guan Yuan’ outpoint during
menstruation
Yuan Hu Zhi Tong Pian: 4 tablets, bid, 1st OCT herbs started from 7 days prior to period for 7 days
Tong Jing Wan: 10 pills, bid, 2nd OCT herbs in menstruation period for 3-5 days
Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 85%, 51/60
Notes
Risk of bias
Zhu 2001
Participants Number:
Experimental: 78 women
Control: 39 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 12-30,
Control: 12.5-28
History: stated
TCM Pattern: stated,
’stagnation of Qi and Blood, retention of cold, deficiency of Qi and Blood, deficiency of Liver and Kindey’
Outcomes 1. Pain:
Experimental:
Rate of cure: 71/78
Rate of improvement: 5/78
Rate of no response: 2/78
Total effectiveness: 97.4%
Control:
Rate of cure: 15/39
Rate of improvement: 16/39
Rate of no response: 8/39
Total effectiveness: 79.5%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, but relapse during 3 cycle of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Participants Number:
Experimental: 70 women
Control: 62 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 16-32,
History: stated
TCM Pattern: unstated
Outcomes 1. Pain:
Experimental:
Cases of cure: 48/70
Cases of improvement: 14/70
Cases of response: 6/70
Cases of no response: 2/70
Total effectiveness: 97.14%
Control:
Cases of cure: 18/62
Cases of improvement: 18/62
Cases of response: 2/62
Cases of no response: 2/62
Total effectiveness: 93.55
Significant difference in rate of cure between the two groups: P<0.01
2. Overall symptoms:
Cases of cure: 48/70
Cases of improvement: 14/70
Cases of response: 6/70
Cases of no response: 2/70
Total effectiveness: 97.14%
Control:
Cases of cure: 18/62
Cases of improvement: 18/62
Cases of response: 2/62
Cases of no response: 2/62
Notes
Risk of bias
Zhu 2003
Participants Number:
Experimental: 42 women
Control: 42 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-32,
History: stated
TCM Pattern: unspecific, but mentioned ’stagnation of blood in the medians’ was most common pattern
Interventions Self-designed formula (Hua Yu Tong Mai Zhi Tong Tang) vs OCT (Yuan Hu Zhi Tong Jiao Nang)
Hua Yu Tong Mai Zhi Tong Tang:
Dang Gui (Radix Angelicae Sinensis) 10g,
Shi Shao 12g, Bai Shao (Radix Paeoniae Latiflorae) 12g,
Tao Ren (Semen Persicae) 10g,
Chuan Xiong (Radix Ligustici Chuanxiong) 10g, Hong Hua (Flos Carthami Tinctorii) 10g,
Xiang Fu (Rhizoma Cypri Rotundi) 12g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 15g, Yi Mu Cao (Herba Leonuri Herterophylli) 20g,
Ze Lan (Herba Lycopi Lucidi) 15g,
Outcomes 1. Pain:
Experimental:
Cases and rate of cure: 12/42, 28.6%
Casess and rate of improvement: 23/42, 54.8%
Cases and rate of response: 4/42, 9.5%
Cases and rate of no response: 3/42, 7.1%
Total effectiveness: 92.9%
Control:
Cases and rate of cure: 9/42, 21.4%
Cases and rate of improvement: 18/42, 42.9%
Cases and rate of response: 8/42, 19.0%
Cases and rate of no response: 7/42, 16.7%
Total effectiveness: 83.3%
2. Overall symptoms:
Experimental:
Cases and rate of cure: 12/42, 28.6%
Cases and rate of improvement: 23/42, 54.8%
Cases and rate of response: 4/42, 9.5%
Cases and rate of no response: 3/42, 7.1%
Total effectiveness: 92.9%
Control:
Cases and rate of cure: 9/42, 21.4%
Cases and rate of improvement: 18/42, 42.9%
Cases and rate of response: 8/42, 19.0%
Casess and rate of no response: 7/42, 16.7%
Total effectiveness: 83.3%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, other symptoms disappeared or reduced, relapse during
3 cycles of follow up
Response: Response: abdominal pain reduced, other symptoms improved
No response: abdominal pain, or other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication:
unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated
Notes
Risk of bias
Huang 2005 Trial not randomised (the numbers of women in each treatment arm were very different, 56 women in herbal group
vs 32 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Ji 2001 Trial not randomised (the numbers of women in each treatment arm are very different, 273 women in herbal group
vs 70 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Li 2005 Mixed cases of primary and secondary dysmenorrhoea in the trial, review is limited to primary dysmenorrhoea only
Liao 2002 Trial not randomised (the numbers of women in each treatment arm were very different, 79 women in herbal group
vs 24 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was receieved
Lin 2004 Mixed cases of primary and secondary dysmenorrhoea in data, Review is limited to primary dysmenorrhoea only
Liu 2006 Trial not randomised (the numbers of women in each treatment arm were very different, 60 women in herbal group
vs 30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was receieved
Miao 2006 Trial not randomised (the numbers of women in each treatment arm were very different, 58 women in herbal group
vs 40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment
Ni 2004 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Pan 2003 Trial not randomised (the numbers of women in each group were very different, 76 women in herbal group vs
50 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Shi 2003 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Song 2005 Trial not randomised (the numbers of women in each group were very different, 120 women in herbal group vs
40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Sun 2005 Trial not randomised (’randomisation’ based on hospital number allocation)
Wang 2000a Trial not randomised (the numbers of women in each group were very different, 150 women in herbal group vs
50 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Wang 2002 Trial not randomised (the numbers of women in each group were very different, 150 women in herbal group vs
50 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Wu 2005 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Xu 2000 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Yang 2005 Trial not randomised (’randomisation’ based on odd and even day)
Zhang 2003 Trial not randomised (the numbers of women in each group were very different, 50 women in herbal group vs
30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received
Zhang Y 2003 The experimental group was mixed herbs and acupuncture - contaminated data, which is not one of the interventions
considered by this review
Zhao 2006 Trial not randomised (the numbers of women in each group were very different, 318 women in herbal group vs
132 women in control group 1 vs 116 women in control group 2). Attempts were made to contact the authors to
clarify randomisation and allocation concealment however no response was recieved
Zhen 2002 Mixed cases of primary and secondary dysmenorrhoea in the trial, review is limited to primary dysmenorrhoea only
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Reduction of pain 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
1.1 Methodological quality A 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
- standard formula - up to 3
month follow up
2 Reduction of pain 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 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
3.1 Methodology quality A 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
- standard formula - up to 3
month follow up
4 Adverse effects 3 166 Risk Ratio (M-H, Fixed, 95% CI) 0.81 [0.61, 1.07]
4.1 Methodology quality A - 3 166 Risk Ratio (M-H, Fixed, 95% CI) 0.81 [0.61, 1.07]
standard formua
5 Use of additional medication 1 90 Risk Ratio (M-H, Fixed, 95% CI) 12.0 [1.70, 84.49]
5.1 Methodology quality A - 1 90 Risk Ratio (M-H, Fixed, 95% CI) 12.0 [1.70, 84.49]
standard formula
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Reduction of pain 14 1441 Risk Ratio (M-H, Random, 95% CI) 1.99 [1.52, 2.60]
1.1 Methodological quality B 4 312 Risk Ratio (M-H, Random, 95% CI) 2.28 [0.88, 5.94]
- standard formula - up to 3
month’s follow-up
1.2 Methodological quality B 9 789 Risk Ratio (M-H, Random, 95% CI) 2.13 [1.70, 2.66]
- tailored formula - up to 3
month follow up
1.3 Methodological quality B 1 340 Risk Ratio (M-H, Random, 95% CI) 1.67 [1.42, 1.97]
- standard formula - immediate
efficacy
2 Overall symptoms 6 482 Risk Ratio (M-H, Fixed, 95% CI) 2.17 [1.73, 2.73]
2.1 Methodological quality 1 58 Risk Ratio (M-H, Fixed, 95% CI) 23.39 [1.45, 377.35]
B - standard formula - up to
3month follow up
2.2 Methodology quality 5 424 Risk Ratio (M-H, Fixed, 95% CI) 2.00 [1.59, 2.52]
B - tailored formula - up to
3month follow up
Chinese herbal medicine for primary dysmenorrhoea (Review) 82
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
3 Adverse effects 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 2 194 Risk Ratio (M-H, Fixed, 95% CI) 1.58 [1.30, 1.93]
4.1 Methodological quality B 1 62 Risk Ratio (M-H, Fixed, 95% CI) 1.73 [1.17, 2.57]
- standard formula - up to 3-
month follow up
4.2 Methodological quality B 1 132 Risk Ratio (M-H, Fixed, 95% CI) 1.53 [1.21, 1.92]
- tailored followup - up to 3
month follow up
Comparison 3. Experimental Chinese herbal formula versus OTC Chinese herbal formula
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Reduction of pain 18 1527 Risk Ratio (M-H, Fixed, 95% CI) 2.06 [1.80, 2.36]
1.1 Methodological quality B 5 380 Risk Ratio (M-H, Fixed, 95% CI) 2.09 [1.62, 2.70]
- standard formula - up to 3
month follow up
1.2 Methodological quality B 12 1087 Risk Ratio (M-H, Fixed, 95% CI) 2.13 [1.80, 2.51]
- tailored formula - up to 3
month follow up
1.3 Methodological quality C 1 60 Risk Ratio (M-H, Fixed, 95% CI) 0.92 [0.43, 1.99]
- tailored formula - up to 3
month follow up
2 Overall symptoms 14 1167 Risk Ratio (M-H, Fixed, 95% CI) 2.04 [1.74, 2.39]
2.1 Methodological quality B 4 320 Risk Ratio (M-H, Fixed, 95% CI) 2.17 [1.61, 2.92]
- standard formula - up to 3
month’ follow up
2.2 Methodological quality B 10 847 Risk Ratio (M-H, Fixed, 95% CI) 1.99 [1.65, 2.40]
- tailored formula - up to 3
month follow up
3 Adverse effects 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 5 402 Risk Ratio (M-H, Fixed, 95% CI) 1.58 [1.34, 1.87]
4.1 Methodological quality B 2 116 Risk Ratio (M-H, Fixed, 95% CI) 1.71 [1.21, 2.43]
- standard formula - up to 3
month follow up
4.2 Methodological quality 3 286 Risk Ratio (M-H, Fixed, 95% CI) 1.53 [1.27, 1.85]
B - tailored formula - up to
3month follow up
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Reduction of pain 2 156 Risk Ratio (M-H, Fixed, 95% CI) 1.75 [1.09, 2.82]
1.1 Methodological quality 1 53 Risk Ratio (M-H, Fixed, 95% CI) 2.68 [0.91, 7.91]
B - standard formula with 3
month follow up
1.2 Methodological quality B 1 103 Risk Ratio (M-H, Fixed, 95% CI) 1.50 [0.89, 2.54]
- tailored formula - up to 3
month follow up
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Reduction of pain 1 55 Risk Ratio (M-H, Fixed, 95% CI) 32.08 [2.06, 499.18]
1.1 Methodological quality B 1 55 Risk Ratio (M-H, Fixed, 95% CI) 32.08 [2.06, 499.18]
- standard formula - up to 3
month follow up
2 Adverse effects 1 55 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
2.1 Methodology quality B - 1 55 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
standard formula
ADDITIONAL TABLES
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 1 month - 8.64 (8.35) 1 month - 11.86 (8.34) P = 0.0443
Questionnaire (SF-MPQ) - 3 months - 7.02 (6.24) 3 months - 11.41 (7.72) P = 0.0010
means (SD) 6 months - 6.82 (7.07) 6 months - 9.52 (7.76) P = 0.0629
The Menstrual Distress 1 month - 24.23 (5.42) 1 month - 26.86 (5.78) P = 0.0191
Questionnaire Short Form, 3 months - 23.44 (5.78) 3 months - 26.02 (5.21) P = 0.0144
mean (sd) 6 months - 22.75 (5.25) 6 months - 25.94 (6.26) P = 0.0040
Visual analogue scale for 1 month - 3.64 (1.74) 1 month - 4.04 (2.15) P = 0.2546
Anxiety (VASA), mean (sd) 3 months - 3.14 (1.84) 3 months - 4.16 (1.82) P = 0.0037
6 months - 3.09 (1.88) 6 months - 3.65 (2.20) P = 0.1537
Received Stress scale (PSS), 1 month - 20.83 (5.69) 1 month - 17.76 (5.82) P = 0.0063
mean (sd) 3 months - 20.81 (5.22) 3 months - 18.51 (5.12) P = 0.0195
6 months - 20.84 (4.61) 6 months - 19.12 (5.59) P = 0.0817
The Psychophysiologic Life 3 months - 94.08 (15.00) 3 months - 94.76 (13.13) P = 0.7972
Adaptation scale (PLAS), 6 months - 95.25 (13.43) 6 months - 95.64 (13.20) P = 0.8789
means (sd)
Naoki 1997 Visual analogue scale (VAS) Data not available Data not available Compared to placebo, herbs significantly
reduced pain through 2 intervention cy-
cles and 2 follow-up cycles (P<0.05 for the
1st intervention cycle, P<0.005 for subse-
quence cycles)
Pain relieving medication Data not available Data not available Significant reduction in pain relieving
medication through intervention and fol-
low-up in herbal group (P<0.05, P<0.01)
. Significant reduction in pain relieving
medication only in 1st cycle of interven-
tion in placebo group (P<0.01), then faded
out
Zung self-rating depression Data not available Data not available No significant difference between groups,
Scale nor within groups in Zung self-rating de-
pression scale
Improved biomed- Data not available Data not available Plasma levels of various hormones and
ical parameters (FSH, LH, chemical mediators changed during and
Prolactin, Esrtadiol, Blood after treatment
count, Hepatic and renal
function tests at each cycle)
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 ta- Double blinded Unclear/Not stated 3 cycles
ble
Sun 2004-2 Unclear/Not stated Random number ta- Double blinded Unclear/Not stated 3 cycles
ble
Tseng 2005 Unclear/Not stated Unclear/Not stated Open trial Unclear/Not stated None
Wang 1996 Unclear/Not stated Random number ta- Single blinded Unclear/Not stated 3 cycles
ble
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
Study ID Outcome Group Observation Treatment cy- Treatment cy- Treatment cy- Follow-up cy-
cycle SD cle 1 SD cle 2 SD cle 3 SD cle SD
Total pain Placebo 186 (73) 123 (69) 115 (84) 134 (102) 138 (119)
area under the
curve (AUC)
Herbs 207 (84) 128 (83) 130 (97) 112 (88) 150 (84)
Duration of
pain (data not
shown)
Total
amount of res-
cure medica-
tion used (data
not shown)
Global assess-
ment of treat-
ment (data not
shown)
WHAT’S NEW
Last assessed as up-to-date: 13 December 2007.
HISTORY
Protocol first published: Issue 2, 2005
Review first published: Issue 4, 2007
14 December 2007 New citation required and conclusions have changed Substantive amendment
DECLARATIONS OF INTEREST
Xiaoshu Zhu recently completed a randomised controlled trial of CHM for primary dysmenorrhoea. There are no other known
potential conflicts of interest.
SOURCES OF SUPPORT
Internal sources
• Cochrane Menstrual Disorders and Subfertility Group, New Zealand.
External sources
• University of Western Sydney, Australia.
INDEX TERMS