MD, PhD, FMedSci, FSB, FRCP, FRCPEd

This website tells us that ‘Stopain Migraine’ is the first topical product to effectively relieve migraine pain. It is a safe alternative to other migraine relief products that begins to work as soon as it’s applied. And the press release informs us that Troy Healthcare extended its Stopain line with a Stopain Migraine offering – a topical pain relieving gel that is massaged onto the back of the neck and behind each ear.

“Many of the women we shopped with told us they like that Stopain Migraine lacks systemic side effects and can be used in conjunction with other products – whether that’s natural remedies like peppermint essential oil, Epsom salts and ginger tea, or even prescription drugs or other over-the-counter products,” stated Anthony Cicini, VP Troy Healthcare.

Stopain Migraine begins to work as soon as it’s applied, can be reapplied after 30 minutes, and can be used up to four times daily, the company noted. It’s unique in that it can be used alone, or in addition to other ingestible migraine products to relieve migraine pain.

The homeopathic blend of ingredients follow the guidelines of The Homeopathic Pharmacopoeia of the United State and is recommended by both by primary care physicians and OBGYNs, the company stated.

In addition to providing effective relief quickly, Stopain Migraine offers peace of mind for migraine sufferers, knowing the product is free from aspirin, acetaminophen and caffeine, has no known drug interactions and contains no dyes or preservatives.

Consumers can now find Stopain Migraine nationwide for the suggested retail price of $11.99

END OF PRESS RELEASE

Any evidence, you’d probably ask. A quick Medline search located this abstract:

OBJECTIVE:

To determine whether topical menthol 6% gel will relieve a migraine attack.

MATERIALS AND METHODS:

A single-center, open-label pilot trial of 25 patients with at least 1 year of diagnosed episodic migraine and <15 headache days per month. Patients treated one migraine attack with STOPAIN topical menthol 6% gel to skull base within 2 h of headache onset. Headache pain severity was assessed prior to and after gel application.

RESULTS:

Thirty-two patients enrolled and 25 completed the study. Prior to treatment, 7 patients had mild pain, 13 moderate pain, and 5 severe pain. Two hours following gel application, 7 (28%) patients had no pain, 7 (28%) mild pain, 6 (25%) moderate pain, and 5 (20%) severe pain. The majority of patients had similar pain intensity (8; 32%) or improvement (13; 52%). At 24-h, only two non-rescued patients still had mild headache. Of the 25 completers, 2 patients took rescue medication prior to the 2-h period, and an additional 10 patients rescued between 2 and 24 h.

CONCLUSION:

Study results showed a significant improvement in headache intensity by 2 h after gel application. This pilot study shows STOPAIN gel may be effective in treating an acute migraine attack.

A pilot study! I thought pilots were for testing feasibility, not effectiveness!

No control group! The observed effect is therefore not attributable to ‘Stopain’ at all!

But there is more! Iranian researchers published this RCT:

OBJECTIVE:

To investigate the efficacy and safety of the cutaneous application of menthol 10% solution for the abortive treatment of migraine.

BACKGROUND:

Peppermint and its active ingredient menthol have long been used for the treatment of various pain conditions including headache.

METHODS:

This is a randomised, triple-blind, placebo-controlled, crossed-over study conducted in the neurology Clinic of Nemazee Hospital, affiliated with Shiraz University of Medical Sciences, Shiraz, southern Iran, from March 2007 to March 2008. The patients were recruited via local newspaper advertisements. Eligible patients were categorised into two groups and a 10% ethanol solution of menthol (as drug) and 0.5% ethanol solution of menthol (as placebo) were applied to the forehead and temporal area in a crossover design. Pain free, pain relief, sustained pain free and sustained pain relief end-points were measured by questionnaires using a visual analogue scale.

RESULTS:

The intent-to-treat population consisted of 35 patients (80% women, 20% men, mean age: 29.6 +/- 6.2) with 118 migraine attacks. In the intent-to-treat population, the menthol solution was statistically superior to the placebo on 2-h pain free (p = 0.001), 2-h pain relief (p = 0.000), sustained pain free and sustained pain relief end-points (p = 0.008). The menthol solution was also more efficacious in the alleviation of nausea and/or vomiting and phonophobia and/or photophobia (p = 0.02). In the per-protocol population, there was significantly higher number of patients who experienced at least one pain free/pain relief after the application of menthol rather than the placebo (p = 0.002). No significant difference was seen between the adverse effects of the drug and the placebo groups (p = 0.13).

CONCLUSION:

Menthol solution can be an efficacious, safe and tolerable therapeutic option for the abortive treatment of migraine.

Yes, you are quite right; this must be a different product. It contains just menthol and at a higher concentration than ‘Stopain’.

So what does ‘Stopain’ actually contain?  I must say that 6% menthol does not sound very homeopathic to me! The website of Troy Healthcare tells us that it has a total of 4 ingredients:

Mentholum 1X HPUS – 50.00%
Belladonna 3X HPUS – 1.33%
Iris Versicolor 6X HPUS – 1.33%
Sanguinaria Canadensis 6X HPUS – 1.33%

And what do the three homeopathically diluted ingredients do?

Is the term ‘homeopathic’ used here merely to attract a certain type of customer?

And why do they claim that ‘Stopain’ is effective when there is no evidence?

Or perhaps there is evidence and they haven’t published it?

And why do they claim that ‘Stopain’ is the first topical product?

Wasn’t a German topical menthol product marketed years ago?

Search me! I am not sure I know all the answers.

I hope someone from Troy Healthcare reads this and cares to explain.

7 Responses to A new homeopathic remedy for migraine “providing effective relief quickly”

  • Using ‘homeopathic’ to get out of FDA regulations?

    • As I understand it, it’s easy to get something new added to the HPUS. It’s run by homeopaths, after all.

    • Let’s face it; under current U.S. law, homeopathic preparations are grandfathered drugs. My argument is that if they are regulated as drugs, they should be subjected to the same laws governing all drugs, which is simply that until they are proven safe and effective, they can not be marketed to the public or prescribed by health care practitioners.

      For external use or any kind, drugs marketed or used with the intention of relieving pain must first be evaluated under the Tentative Final Monograph (TFM) for GTC External Analgesics or OTC (over-the-counter) drug review. For what it’s worth, not even Arnica montana is included in the TFM. In addition, according to the homeopathic compliance policy of the FDA, nonhomeopathic ingredients can not be combined with homeopathic drugs. Drugs marketed or used with the intention of relieving pain must first be evaluated under the Tentative Final Monograph (TFM) for GTC External Analgesics or OTC (over-the-counter) drug review for external use or any kind. For what it’s worth, not even Arnica montana is included in the TFM. In addition, according to the homeopathic compliance policy of the FDA, nonhomeopathic ingredients can not be combined with homeopathic drugs. About 5 years ago, Schwabe North America Inc. came under the ire of the FDA for just such an infraction.

      • Exactly Lighthorse! Lawmakers and pharmaceutical companies control health care based on ignorance and greed. All medicines, natural or synthetic,prescription or OTC, should be regulated and proven safe and effective.
        S. Cox, MD

        • As I see it, there are far too many loopholes in the laws. In order to protect the public from their own ignorance and both the greed and ignorance of manufacturers and purveyors of health care products of all kinds, these need to be firmly closed and the laws strictly and punitively enforced.

  • I hope that some chiropractors, acupuncturists, Reiki practitioners, et al. will explain to us whether this treatment for migraine is more effective than theirs or it is less effective than theirs, which would make a refreshing change from their tiresome insistence that we are just a bunch of pseudoskeptics and Big Pharma shills.

    Those who suffer migraine, including myself, really do want to know their consensus regarding this condition. I shan’t hold my breath while I wait for them to form a consensus; although doing so would be a 100% effective, permanent, cure.

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