JRMS 19 1134
JRMS 19 1134
JRMS 19 1134
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.
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.
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
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.
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
RESULTS
DISCUSSION
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.
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