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Original Article

Comparative efficacy trial of cupping


and serkangabin versus conventional therapy
of migraine headaches: A randomized,
open-label, comparative efficacy trial
Mohammad Dehghani Firoozabadi, Maryam Navabzadeh1, Mohammad Khodashenas Roudsari, Mohsen Zahmatkash2
Division of Neurology, Birjand University of Medical Sciences, Complementary Alternative Medicine Research Center, Valiasr Hospital,
1
Birjand University of Medical Sciences, Complementary Alternative Medicine Research Center, Towhid Square, Birjand, 2Farateb Research
Institute, Yazd, Iran

Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine
headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative
medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches.
Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned
patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients).
An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits
(at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures
data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group
were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity
of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in
conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). Conclusion:
There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment
and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and
in primary care.

Key words: Cupping therapy, migraine, prophylaxis, serkangabin, treatment

How to cite this article: Firoozabadi MD, Navabzadeh M, Roudsari MK, Zahmatkash M. Comparative efficacy trial of cupping and serkangabin versus
conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial. J Res Med Sci 2014;19:1134-9.

INTRODUCTION Many diseases especially chronic ones are neither


curable nor well palliated. Existing treatments can
Millions of people worldwide suffer from migraine. impose serious adverse reactions and provision of
Migraine is one of the top 20 causes of disability in the care is fragmented and impersonal.[9] Complementary
world.[1,2] Migraine causes morbidity and bed rest in alternative medicine (CAM) approach is frequently
more than half of affected people. It causes a decrease used today. More than 30% of Americans use CAM.[10]
in the quality of life, increased absenteeism and reduced Over the past few decades, thousands of studies have
productivity at work. It also increases healthcare costs.[2] been performed via various CAM approaches. Migraine
Migraine attack is usually managed by nonsteroidal patients seek and explore both conventional and CAM
antiinflammatory drugs, acetaminophen, 5HT 1 approaches.[11]
agonists including ergots and triptans, dopamine
antagonists and sometimes opioid analgesics. [3-7] Wet cupping is an ancient medical technique used in
Different medications such as β-blockers, flunarizine, several contemporary societies in East Asia and the
valproic acid, topiramate, amitriptyline, venlafaxine, Middle East[12] and it is frequently used for controlling
gabapentin, naproxen, butterbur root, Vitamin B 2 pain.[13] Types of cupping include retained cupping,
and magnesium are recommended for migraine flash cupping, moving cupping, wet cupping, medicinal
prophylaxis; however, efficacy and adverse effects are cupping, and needling cupping.[14] Wet cupping is a
still controversial.[8] common method. In order to perform this procedure,

Address for correspondence: Dr. Mohammad Khodashenas Roudsari, Division of Neurology, Birjand University of Medical Sciences,
Complementary Alternative Medicine Research Center, Valiasr Hospital, Birjand, Iran. E-mail: [email protected]
Received: 11-01-2014; Revised: 02-07-2014; Accepted: 19-11-2014

| December 2014 | Journal of Research in Medical Sciences 1134


Firoozabadi, et al.: Effect of cupping therapy plus serkangabin on migraine

a glass cup is placed on the skin and a vacuum is created 4. Previous stroke or transient ischemic attack.
inside it. After a few minutes, a superficial incision is placed 5. Severe liver or renal impairment.
in the area to suck the blood into the cup. This is repeated 6. Any other severe or disabling medical condition.
several times.[15] 7. History of alcohol or analgesic or psychotropic drug
abuse.
It is being used in the management of hypertension, diabetes 8. Contraindication to or known hypersensitivity to drugs.
mellitus, headaches, renal, and biliary stones and for 9. Current use or use in the previous 2 weeks of
maintaining health. Little experimental studies have been monoamine oxidase-inhibitors and other migraine
devoted to test its efficacy to treat migraine headache. Some related medication.
studies stated that wet cupping have clinical benefits on pain 10. A pain disorder other than migraine as the primary
conditions.[12,15,16] Some studies have assessed the pain killing presenting problem.
effect of wet cup and have found some advantages;[16-19] 11. Current psychological treatment, psychiatric disorder
nevertheless, there are few studies about the effects of needing immediate or priority treatment.
cupping on migraine.[12] 12. For women, current or planned breastfeeding or
pregnancy or unwillingness to use an established
Serkangabin is a traditional drink which is frequently used contraceptive method.
for headache in Iran. In traditional Iranian medicine (TIM)
it is believed that serkangabin has therapeutic effects in Written informed consent was obtained from all patients
many diseases such as diabetes mellitus, hypertension, before their inclusion into the study.
hyperlipidemia, ischemic heart disease, migraine and
cerebrovascular diseases. According to the Iranian A pilot study was done for gathering some assumptions for
traditional literature, serkangabin can cause blood dilution calculating the study sample size. Sample size was calculated
and is easier to make compared with cupping procedure.[20] 29 patients in each groups according these assumptions:
Alpha error of 5%, power of 85%, mean of headache severity
Serkangabin from the words (serke, “vinegar ”) and after 2 weeks treatment in the conventional methods equal
(angobin, “honey”) is a drink which is traditionally to 5.1 (±1.1) and in the serkangabin group 4.2 (±1.4). Then
produced in Iran. We did not find any studies on the 391 headache patients were examined, and 76 confirmed
effect of serkangabin in the literature. The mixture of these migraine cases were divided into two study groups by
two methods (wet cupping plus serkangabin) may lead simple randomization using random number table. Totally,
to therapeutic synergy. Therefore, this study evaluated 16 cases were excluded, and finally 60 cases were included
therapeutic and prophylactic effects of cupping and in the study (41 were women and 19 men).
serkangabin and compares it with conventional migraine
therapy. Then the study group completed a 6 months study program.
30 patients were treated with cupping and serkangabin and
MATERIALS AND METHODS 30 patients with conventional migraine treatment protocols.

Study design and participants Instruments and drugs


Researchers of the CAM Research Center of Birjand All patients examined by a neurologist to confirm the
University of Medical Sciences (BUMS) designed and diagnosis of a migraine headache. The study involved
conducted this randomized, controlled, open-label, 5 visits (at the end of 2 weeks, 1, 3 and 6 months after
comparative efficacy trial of cupping therapy and treatment). The patients provided either conventional
serkangabin versus conventional therapy in 2012. This medical treatment or cupping therapy plus serkangabin.
study was approved by medical ethics committee of BUMS, History and physical examination were done by one
and it was registered at ClinicalTrials.gov by number of physician. A researcher assessed severity of headache by
NCT01476930. visual analog scale (0 = no pain to 10 = very severe pain)
and frequency of attacks in a weak and duration of attacks
Population of study included patients aged 15-50 years, per hour. The history was taken from patients by one
with a current history of migraine with or without aura medical doctor investigator. In conventional treatment
and according to international headache society criteria, group, standard treatment conducted by a neurologist that
2004.[17] Patients with following criteria were not included: lasted for 6 months including migraine attack control and
1. Uncontrolled hypertension. prophylactic medications. Medications used for a migraine
2. Ischemic heart disease. attack were as follows:
3. Cardiac arrhythmia or symptomatic Wolff-Parkinson- 1. Ergotamine tartrate USP (Tolidarou Pharmaceutical Co.,
White syndrome. Tehran, Iran) 2 mg tablet (DAROU PAKHSH PHARMA.

1135 Journal of Research in Medical Sciences | December 2014 |


Firoozabadi, et al.: Effect of cupping therapy plus serkangabin on migraine

CHEM. Co) in the beginning of attack and every 30-min 10 years of experience in TIM. Wet cupping (hijama with
if necessary for control of pain with a maximum dose of bloodletting) was done monthly for 3 times, beginning
6 mg. 2 weeks after the first appearance according to “Aam”
2. In case of no medication response or ergotamine protocol Figure 1 (Midline interscapular area at the level
intolerance the drug was replaced by sumatriptan of third to fifth thoracic vertebrae, T3-T5) with single use
succinate USP (Hakim Pharmaceutical Company) only, 100 ml plastic cups [Figure 2a and b].
50 mg tablet early in the attack and repeated every
2 h if necessary, with a maximum dose of 200 mg. In order to produce serkangabin, some honey should be
The prophylactic treatments were nortriptyline or boiled in a large pot of water for 2-3 min. Then the content
propranolol. of Pan is mixed with vinegar. Then it is cooled at room’s
temperature and the peppermint water (Peppermint Water)
We tried to maximize the efficacy and tolerability of is added to the mixture. In order to make serkangabin-drink,
β-blocker and tricyclic antidepressant treatment by using a cup of this syrup is mixed with 4-5 cups of water. A full
a flexible target dose. Treatment was started with one glass of syrup serkangabin (200 ml) will be taken every
10 mg tablet of propranolol hydrochloride USP (Tolidarou night for 60 days from the first appearance. Each 200 ml of
Pharmaceutical Co., Tehran, Iran) 3 times daily which serkangabin syrup consists of 15 ml of multifloral honey,
increased as tolerated to 40 mg 3 times daily at week 4. 15 ml of distilled peppermint water (distillate of peppermint
leaf-mentha piperita-soaked in purified water) and 7 ml of
Participants, who did not tolerate 3 times daily dose of
grape (Vitis vinefera) vinegar, made from fermented grape.
20 mg and were unimproved according to the neurologist
view, were switched to nortriptyline hydrochloride USP
Data analysis
(Loghman Pharmaceutical and Hygienic Co.) 25 mg
Study outcomes were (1) frequency of attacks in a week,
nightly, which increased to 50 mg nightly at week 2. Then
(2) duration of attacks and (3) severity of headache. The
medical treatment continued for the rest of the 6 months
outcome trends were compared between the cupping
of study.
therapy and conventional treatment groups during the 6
months period.
In cupping therapy group, cupping and serkangabin
therapy was conducted by TIM specialist who had
Data analysis was done by SAS software version 9.1 (SAS
Institute, Cary, NC, USA). Chi-square and Fisher exact
test were used to compare categorical variable between
the two groups. The quantitative variable was compared
between the two groups by independent t-test. Repeated
Measurement by generalized estimation equation method
was used to assess the main effect and interactions between
time and treatment groups. Also, adjustment for age and
sex was considered in the models.

b
Figure 2: Superficial incisions are made on the skin using 15-22 gauge surgical
Figure 1: Design and profile of participants at baseline. Several participants blade in Midline interscapular area at the level of third to fifth thoracic vertebrae,
were excluded from the study because of not showing up on time despite several T3-T5 (a) then sucking with single use 100 ml plastic cups (b) until it is filled with
reminder calls blood. The cup is removed, and the process is repeated 3 times

| December 2014 | Journal of Research in Medical Sciences 1136


Firoozabadi, et al.: Effect of cupping therapy plus serkangabin on migraine

RESULTS

Mean and standard deviation of age for cupping therapy


group and conventional treatment group were 31.7 ± 7.6
and 32.6 ± 12.7 years, respectively (P = 0.45). There were
no statistically significant difference between two groups
in relation to sex, marital status, oral contraceptive (OCP)
consumption, residence, family history of headache and
age [Table 1]. Treatment was accompanied by no relevant
changes in vital signs, electrocardiogram or results of
Figure 3: Comparison of severity of headaches between study groups during
cardiovascular examination. the study

Figure 3 shows that the severity of headaches 2 weeks; and


1, 3 and 6 months after treatment were not different between
conventional and cupping groups (P = 0.80). According to
Table 2, frequency of attacks in a week, after 2 weeks; and
1, 3 and 6 months of treatment were indistinguishable as
well (P = 0.63). Also duration of the attacks per hours after
2 weeks, 1, 3 and 6 months after the treatment were not
different in conventional and cupping groups which is
presented in the Figures 4, 5 and Table 2 (P = 0.48). According
to the result, both treatments were effective in reducing the
severity, frequency and duration of headache during the
Figure 4: Comparison of duration of attacks per hours between first and next
different period of follow-up [Table 2]. presentations and the end of the study in two study groups

DISCUSSION

To our knowledge, this is the first controlled trial that


compared serkangabin syrup and cupping in patients
with migraine. In this trial, treatment of migraine with

Table 1: Demographic and clinical data of the cases


Variables Conventional Cupping plus P
(%) serkangabin (%)
Sex
Male 7 (23.3) 12 (40) 0.165
Figure 5: Comparison of frequency of attacks in a week between first and next
Female 23 (76.7) 18 (60) presentations and the end of study in two study groups
Marital status
Single 8 (26.7) 7 (23.3) 0.766 either cupping plus serkangabin or conventional treatment
Married 22 (73.3) 23 (76.7)
resulted in similar outcomes. Severity of headaches,
OCP consumption
duration and frequency of attacks were similar in two
Yes 2 (6.7) 0 0.492†
treatment groups during 6 months of study. The results of
No 28 (93.3) 30 (100)
Residence
our study showed that an alternative therapy by cupping
Urban 27 (90) 29 (96.7) 0.612† plus serkangabin was an effective approach to headache
Rural 3 (10) 1 (3.3) treatment and prophylaxis in patients with migraine.
Family history of headache
Yes 17 (56.7) 15 (50) 0.605 The findings of our study is congruent with those of other
No 13 (43.3) 15 (50) studies and indicate that cupping therapy is a promising
Smoking CAM treatment method for migraine headache and other
Yes 2 (6.7) 0 0.492† painful conditions such as carpal tunnel syndrome (CTS),
No 28 (93.3) 30 (100) low back pain, and fibromyalgia.[12,16,18-23] Ahmadi, et al.
Age (mean) 32.6 (±12.7) 31.7 (±7.6) 0.459†† in their study on cupping therapy in chronic headaches
There were no statistically differences between two groups according to sex, marital
status, OCP consumption, residence, family history of headache and age; †Analyzed
compared headache severity, frequency of headache days
by Fisher exact test; ††Analyzed by independent t-test; OCP = Oral contraceptive in month and medication consumption before and 3 months

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Firoozabadi, et al.: Effect of cupping therapy plus serkangabin on migraine

Table 2: Comparison of severity, frequency and duration system and increases the level of immune products.[12]
of headache between study groups during the study However, the mechanism is still unknown[18] and needs
following sex and age control further studies.
Outcome Parameter Estimate SE 95% CI P
Lower Upper Serkangabin is made from honey, peppermint water, and
limit limit vinegar. Therefore, some pain relief effects of this drink
Severity Time −0.5729 0.1656 −0.8975 −0.2484 0.0005 may be originated from the therapeutic effects of these
of Group −0.1296 0.1453 −0.4144 0.1553 0.3725
headache Time*group herbal drugs.
0.0275 0.1089 −0.1860 0.2409 0.8009
Age −0.0042 0.0025 −0.0091 0.0007 0.0926
Limitations in our study include: For the reason that it was
Sex 0.0036 0.552 −0.1047 0.1118 0.9483
a new treatment protocol, there were no similar studies
Frequency Time −0.7310 0.1902 −1.1037 −0.3583 0.0001
of Group 0.2546 0.2357 −0.2073 0.7166 0.2800
to assist us with the study sample size. The study had
headache Time*group 0.0646 0.1344 −0.1978 0.3280 0.6306 longer follow-ups and includes other factors like cost, side
Age 0.0089 0.0048 −0.0006 0.0184 0.0657 effects, patient’s preference and compliance. However,
Sex −0.2063 0.1675 −0.5346 0.1220 0.2182 relapse after treatment may suggest revised approaches.
Duration Time 1.1479 0.2901 0.5793 1.7165 <0.001 Moreover, in our study the advantages are due to both wet
of Group 0.9359 0.5696 −0.1805 2.0523 0.1004 cupping plus serkangabin and further studies are required
headache Time*group −0.1299 0.1841 −0.4908 0.2309 0.4804 to distinguish the effects. The other limitation was the open-
Age −0.0179 0.0203 −0.0577 0.0219 0.3791 labeled design of our study. There might be a supposed
Sex −0.2400 0.4130 −1.0495 0.5695 0.5612 psychological effects related to cupping that is effective in
SE = Standard error; CI = Confidence interval
reducing pain by itself. This effect, in case of being accurate,
could be considered as an advantage of cupping procedure.
after cupping. It revealed statistically significant decrease Consequently, authors recommend re-evaluation of
(86%) in the frequency of days with headache, medication periodic wet cupping biannually in prevention of migraine
consumption (80%) and severity of headache (66%). In 93% of relapse after prophylactic treatment.
patients, it had positive therapeutic effects.[12] Lauche et al. in
their study of cupping in neck pain concluded that cupping CONCLUSION
appeared to be effective in relieving chronic nonspecific
pain which had an influence on pain processing.[19] Cao, et al. Our study suggests that cupping plus serkangabin therapy
showed reduction in fibromyalgia pain and number of tender is effective parallel to that of conventional therapy in
points in their study of cupping therapy.[22] Lee, et al. in their management and prophylaxis of migraine headaches.
assessment of systematic reviews of cupping effectiveness, However, this may be used in cases of medication
stated that it was effective in reducing pain.[15] Cao, et al. in intolerance, nonresponsive medication, and primary care.
their systematic review stated that the majority of studies
on cupping show potential benefit on pain conditions.[16] ACKNOWLEDGMENTS
Michalsen, et al. in a randomized clinical trial on effects of
cupping in CTS concluded that it may be effective in relieving The present study was supported by a grant (no. 231) from BUMS.
pain and other symptoms related to CTS.[23] Farhadi et al. We thank the following people for their assistance in preparing
and revising the manuscript: Asghar Zarban, Ph.D., Seyed Hossein
in their randomized controlled study on wet cupping for
Hosseini Moghaddam, Ph.D., Mohammadreza Abedini, Ph.D.,
nonspecific low back pain concluded that it was safe and Mohaddeseh Rouhani, Masumeh Rouhani, Motahareh Rouhani.
acceptable to patients and more effective than usual care.[21]
AUTHOR’S CONTRIBUTIONS
There are very few studies in the literature that might
provide clues about mechanism of wet-cupping.[21] It has MN, MDF and JH were responsible for the study concept and
been suggested that wet-cupping analgesia is similar to design. Literature search done by MN,MDF and MKhR.MN
the effect of acupuncture and occurs via segmental, extra- and MDF obtained funding from BUMS. Cupping done by
segmental and central regulatory action.[24] MN and JH. Neurologic evaluation and confirming migraine
diagnosis and conventional treatment, performed by MDF.
Cupping and serkangabin can adjust some neurotransmitter NS, JH and MDF were involved in acquisition of data. GhSh
like serotonin, dopamine, endorphin, calcitonin-gene analyzed and interpreted the data and did the statistical
related peptide and acetylcholine which are connected to analysis. MKhR and MN drafted the manuscript, and all
headaches. In addition, they can adjust hematocrit and authors critically revised it for important intellectual content.
immune system through bleeding and local inflammation. MN, MDF, JH and MKhR provided administrative, technical,
Local inflammation activates complementary immune or material support. MN and MDF supervised the study.

| December 2014 | Journal of Research in Medical Sciences 1138


Firoozabadi, et al.: Effect of cupping therapy plus serkangabin on migraine

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