Preference Trends for Antispasmodics Among Indian Healthcare Professionals: Results of a Cross Sectional Survey

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Original Article Preference trends for antispasmodics among Indian healthcare professionals: Results of a cross sectional survey

Gabhane M1, Braganza L2

Abstract Objective: Understanding antispasmodics usage pattern among Indian healthcare practitioners (HCPs).

Material and methods: HCPs were interviewed in person to understand preference of antispasmodics. The preference of formulation in acute/chronic pain, perceptions about attributes of antispasmodics, medicine recall and indications of different antispasmodics were noted.

Results: Acute spasmodic pain is more common than chronic pain (61% vs 39% pediatrics; 58% vs 42% other specialties). In mild acute spasmodic pain tablet is used by 58% and in severe acute spasmodic pain injection is preferred by 55% HCPs. In mild and moderate chronic spasmodic pain, almost half of HCPs use tablet. Injection is used by 53% of HCPs for severe acute / chronic spasmodic pain. Injection is preferred for better efficacy by 67% HCPs. 80% healthcare practitioners use injection for quick onset of action. Tablets provide prolonged relief and are easy to administer according to 46% and 58% HCPs respectively. Camylofin plus paracetamol was the most common antispasmodic preparation recalled (91% HCPs).

Conclusion: Spasmodic pain is common clinical condition. Antispasmodic injection is used in severe condition and quick onset of action while oral formulations are preferred for prolonged relief. Camylofin plus paracetamol is recalled by about nine out of ten HCPs.

Key words: Antispasmodic, Healthcare Practitioners, Survey.

1 Medical Advisor, Medical Dept., Abbott; 2 Chief Manager, Medical Dept., Abbott.

32 The Indian Practitioner q Vol.68 No.5. May 2015 Original Article

Introduction Pediatrician Consulting pasmodic conditions such as abdominal cramp and Physicians abdominal pain are often encountered in routine 20.47% clinical practice because of its common occurrence 34.50% S 34.50% and numerous etiologies affecting up to 30% adults in Gastro- western countries.1 The colic pain could be because of enterologist the spasm or obstruction of intestinal, biliary or uter- 2 ine smooth muscles. The clinical presentation of spasm 39.18% could be acute, subacute or chronic in nature. Untreated spasmodic pain is associated with patient discomfort and may result in complications, if untreated. Antispasmodic agents are commonly used in clinical practice for treat- General Practitioner ing various spasmodic conditions including abdominal Fig 1: Distribution of survey participants cramping pain3, renal colic4, acute abdominal spasm, spasm of biliary system or genito-urinary tract.5 In fe- ranking of preference on the scale of 1-3 (1-most pre- males, dysmenorrhea is another indication where anti- ferred; 3-less preferred) according to preference and indi- spasmodic analgesic agents are used for providing pain cations of different antispasmodic preparations and their relief.6 An analgesic antispasmodic can provide signifi- formulations (tablets, drops, injections and syrup) were cant pain relief to patients with spasmodic conditions.7 noted as reported by the HCPs. The severity of condition was graded into three categories: mild-no impairment of Different types of formulations of antispasmodic routine activities; moderate-slight impairment of activi- agents are available in Indian pharmaceutical market in- ties; severe-profound impairment of activities. cluding oral formulations and injection. However, there are no formal guidelines on the criteria for selecting anti- Results spasmodic agents for different spasmodic conditions seen A total of 171 HCPs were interviewed in this survey. during clinical practice. In the absence of clear guidelines, The distribution of HCPs is shown in figure 1. the choice of antispasmodic differs from physician to Pain, fever, cough and cold and acidity are the most physician. The preference pattern of antispasmodics and common ailments treated by HCPs. Pain is most com- attributes for selecting one agent over the other in spas- mon indication seen by all HCPs (100% HCPs). Similarly, modic conditions are largely unknown in India. patients with spasmodic pain are also encountered by all specialties surveyed. The HCPs reported that acute Objective spasmodic pain is more common type of presentation The objective of survey was to understand preference compared to chronic pain (61% vs 39% pediatrics; 58% vs of different antispasmodic formulations among Indian 42% other specialties). Oral formulations are the mostly healthcare practitioners (HCPs). recommended for mild to moderate cases of acute and Material and methods chronic pain while injections are mostly recommended In this cross sectional survey, the HCPs were inter- used for severe cases of acute and chronic pain. Drops viewed in person to understand the preference of different antispasmodics available in Indian pharmaceutical market. The interviewed HCPs included Graduates/general practitioners (MBBS), Postgraduates (MD) and Super specialist (DM/MD, DNB). The postgraduates were either physician or pediatrician while the super specialists were gastroenterologists. The preference of usage of tablet or injection in acute/chronic spasmodic pain according it severity of condition, perceptions about attributes (efficacy, quick onset of action, prolonged relief, ease of admin- istration) of different antispasmodic -for mulations, medicine recall (spontaneous Fig 2: Use of oral formulation (n=157) or injection (n=152) in acute or aided) of antispasmodic preparations, spasmodic pain

The Indian Practitioner q Vol.68 No.5. May 2015 33 Original Article

called by more than 70% HCPs included dicyclomine plus paracetamol, camylofin plus diclofenac, mefenamic acid plus dicyclomine and drotaverine. Camylofin plus paracetamol followed by dicyclomine plus paracetamol and drotaverine were ranked as number one by 24%, 17% and 14% HCPs respectively. Overall camylofin plus paracetamol tablet is the most commonly used preparation for Fig 3: Use of oral formulation (n=157) or injection (n=152) in chronic spasmodic pain spasmodic conditions. The most common in- are mostly recommended for mild acute and chronic pain dication for the use of camylofin plus paracetamol is ab- with higher recommendation by pediatricians in chronic dominal spasmodic pain. For dysmenorrhea, mefenamic cases of spasmodic pain. The preference of oral therapy acid plus dicyclomine and camylofin plus paracetamol versus injection based on the severity of spasmodic pain each are used by 35% of HCPs. The indications for oral is shown in figure 2 and figure 3. In mild acute spasmodic antispasmodic formulation are shown in table 1. pain oral formulation is used by 58% of HCPs while injec- Spasmodic condition (abdominal/stomach pain) and tion is not used in mild pain. On the contrary, in severe dysmenorrhoea are the most preferred aliments for ca- acute spasmodic pain, injection is preferred by 55% HCPs mylofin plus paracetamol while for camylofin plus diclof- versus 26% practitioners who prefer to use oral medica- enac the top two indications are abdominal pain and gall tion (figure 2). bladder problem. In mild and moderate chronic spasmodic pain, almost Dicylcomine plus paracetamol combination is com- half of the HCPs use oral formulation of antispasmodic monly used for abdominal pain, intestinal colic, abdomi- medication for the management of pain. Injection of anti- nal colic, gastric pain and duodenal ulcer. Dysmenorrhoea spasmodic medicine is used by 53% of HCPs to manage severe chronic spasmodic pain (figure 90% 3). 80% 80% Injection (67%) is most com- 67% monly preferred for better effi- 70% cacy followed by tablet (37%), 60% 58% syrup (15%) and drops (11%). A total of 80% HCPs use injec- 50% 46% Tablet/Capsule tions for quick onset of action. 40% 37% 38% Injection Tablets provide prolonged relief and are easy to adminis- 30% 27% 28% Drops 25% 28%

ter according to 46% and 58% % of HCPs 20% Syrup HCPs respectively (figure 4). 15% 16% 11% 11% 13% Camylofin plus paracetamol 10% 9% was the most common anti- 0% spasmodic preparation re- Efficacy Quick onset Prolonged Easy to called (91% HCPs). The other of action relief administer antispasmodic preparations re- Fig 4: Perception about attributes of different antispasmodic formulations (n=171)

34 The Indian Practitioner q Vol.68 No.5. May 2015 Original Article % of HCPs

Camylofin+ Dicyclomine+ Mefenamic Drotavarine Camylofin+ Drotavarine+ Dicyclomine Hyosine Dicyclomine+ Camylofin paracetamol paracetamol acid+ diclofenac mefenamic simethicone dicyclomine acid Fig 5: Medicine recall among HCPs (n=171) is the most common indication for mefenamic acid plus dysmenorrhea and abdominal spasm 7% HCPs use ca- dicylomine. Gallbladder problem and gastritis are the top mylofin injection while dicyclomine injection is used by two indications for preference of drotaverine. 11% HCPs for intestinal colic and 7% HCPs for gall blad- Overall prescriptions for drotaverine plus paracetamol, der problem. drotaverine plus mefenamic acid, dicylomine plus diclof- Discussion enac and hyosine are less. Duodenal ulcer and gallblad- Antispasmodics also known as spasmolytics agent der problem are the two top most aliments for use of relieve spasmodic pain by different mechanisms. Some drotaverine plus paracetamol. Intestinal colic, abdominal agents are direct smooth muscle relaxants while some act colic, duodenal ulcer and bowel irregularity are the most by blocking cholinergic action or calcium channels.8 common ailments for use of drotavarine plus mefenamic acid. Hyoscine is most commonly preferred for gastric In this cross-sectional survey, HCPs from four differ- pain, renal and binary colic and gastritis. ent clinical disciplines were interviewed by a third party to avoid bias in the outcomes or survey responses. The Abdominal pain with accompanied by gastrointesti- survey participants included general practitioners, con- nal disorder, para umbilical pain and colic pain are the sulting physicians, gastroenterologists and pediatricians. most common indications for the use of dicylomine plus Close to three forth survey participants were general diclofenac (Table 1). practitioners and consulting physicians while one fifth Dysmenorrhea and spasmodic conditions are the two of the participants were pediatricians. Patients with spas- most common indications for camylofin injection where- modic pain are treated by all surveyed participants. The as gallbladder problem and intestinal colic are the two survey participants reported that acute spasmodic pain is most common indications for dicylomine injection. For more commonly encountered compared to chronic spas-

30%

25% 24% 20% 20% 18% 18% 17% 15% 15% 14% 14% 13%13% 12% Rank 1 11% 10% 10% 9%

% of HCPs 8% 8% 8% 6% 7% Rank 2 5% 5% 4% Rank 3 0% Camylofin+ Camylofin+ Dicyclomine+ Mefenamic Drotavarine Drotavarine + Hyosine paracetamol diclofenac Paracetamol acid + Mefenamic dicyclomine acid

Fig 6: Preference of molecule (n=171)

The Indian Practitioner q Vol.68 No.5. May 2015 35 Original Article

Table 1: Indications for oral formulation (n=171) Camylo Camylo Dicyclo Mefenamic Drota Drota Drota Hyoscine Dicyclo ﬁn + ﬁn + mine + acid + verine verine + verine + mine + Paraceta Diclo Paraceta Dicyclo Paraceta Mefena Diclofenac mol fenac mol mine mol mic acid Spasmodic 53% 19% 20% 31% 19% 7% 6% 4% 8% condition (Abdominal/sto mach pain) Dysmenorrhea 35% 9% 9% 35% 5% 2% 1% 3%

Abdominal pain 23% 9% 10% 14% 13% 4% 3% 1% 6% with GI disorder Pain in 23% 7% 11% 12% 5% 4% 5% 4% 6% paraumbilical region Bowel 20% 5% 7% 15% 9% 4% 6% 3% 1% irregularity Duodenal ulcer 19% 4% 12% 8% 12% 8% 6% 2% 3%

Gastritis 18% 6% 10% 9% 14% 4% 2% 5% 5%

Active phase of 17% 6% 11% 10% 9% 4% 4% 2% 4% labor Renal and 17% 8% 11% 10% 9% 4% 5% 5% 3% biliary colic Intestinal colic 15% 9% 12% 13% 11% 2% 7% 1% 5%

Abdominal colic 14% 9% 12% 13% 12% 3% 7% 4% 5%

Gall bladder 14% 11% 3% 9% 16% 7% 4% 3% 4% problem Gastric pain 13% 9% 12% 11% 12% 4% 4% 6% 5%

Peptic ulcer 11% 9% 10% 8% 13% 4% 5% 4% 3%

modic pain. This could be possibly due to the fact that, tions resulting in acute abdominal spasm, genitourinary acute pain because of its fast onset and severe nature is spasm or in labor and diagnostic and therapeutic abdom- not often ignored by the patients or relatives and they of- inal procedures, where smooth muscle spasm could be a ten seek healthcare assistance for these conditions. There problem.5 was no much difference in the number of patients with Interestingly, guidelines have neither recommended acute spasmodic pain seen by pediatricians versus other nor disapproved the use of antispasmodics in treatment specialties. of renal stone,9 gall stone related disease,10 or dysmenor- Acute abdominal pain sometimes is very severe and rhea.11 However, the results of our survey show routine requires urgent medical attention.2 Injections of antispas- usage of antispasmodics in various conditions. 5 modic are often used in acute spasmodic conditions es- Camylofin dihydrochloride is a selective PDE- pecially severe pain. Severe acute or chronic spasmodic 4 enzyme inhibitor available as Anafortan in India.12 pain is treated with injection by more than half of the Camylofin dihydrochloride is also used in combination HCPs, according to the results of this survey. Parenteral with other analgesics such as paracetamol or diclofenac.13 antispasmodic is used for achieving rapid onset of action Out of all antispasmodic preparations used, camylofin 5 with good efficacy. Our survey results showed that injec- plus paracetamol was recalled by almost nine out of ten tion of antispasmodic medicine is preferred by close to HCPs. Medicine recall may be affected by different fac- two third of HCPs for better efficacy while majority use tors such as frequency of medical representative’s visit it for fast onset of pain relief. The conventional formu- to the doctor, type and intensity of promotional activity lations such as tablets are easy to administer and hence or personal experience of the physician in his/her prac- preferred by close to sixty percent HCPs. Good tolerabil- tice. In terms of ranking the prescription, camylofin plus ity is another criteria for the use in wide range of condi- paracetamol was ranked as number one by almost one

36 The Indian Practitioner q Vol.68 No.5. May 2015 Original Article quarter of the HCPs. Overall camylofin plus paracetamol Pharmacol Res 2001;21:21-9 tablet was found to be the most commonly used prepara- 7. El-Sherif AE, Foda R, Norlen LJ, Yahia H. Treatment tion for spasmodic conditions. The different indications of renal colic by prostaglandin synthetase inhibitors for which antispasmodics are used included spasmodic and avafortan (analgesic antispasmodic). Br J Urol condition (Abdominal/stomach pain), dysmenorrhoea, 1990;66:602-5 Abdominal pain with GI disorder, pain in para - umbili- 8. Annaházi A, Róka R, Rosztóczy A, Wittmann T. Role cal region, bowel irregularity, peptic ulcer, gastritis/gas- of antispasmodics in the treatment of irritable bowel tric pain, active phase of labor, renal colic, biliary colic syndrome. World J Gastroenterol 2014 May 28; 20(20): and intestinal/abdominal colic. The results of this survey 6031-6043 could be useful for clinicians to understand the overall prescription pattern of antispasmodic agents and decide 9. Pearle MS, Goldfarb DS, Assimos DG, Curhan G, a strategy for selecting an antispasmodic agent. Denu-Ciocca JD, Matlaga BR, et al. Medical management of kidney stones: AUA Guideline. https://www. Survey based research has several limitations.14 In our auanet.org/common/pdf/education/clinical-guidance/ survey, due to convenient sampling, the estimate bias Medical-Management-of-Kidney-Stones.pdf accessed could be possible. The sample surveyed may not be the on 13th May 2015 true representation of the complete population in real world. Secondly, there is a possibility of social desirability 10. Alam HB, Demehri FR, Chong ST, Kronick SL, bias, because respondents may try to show give favorable Repaskey WT, Rice MD, et al, Evaluation and man- responses. agement of gallstone-related diseases in non-pregnant adults. Guidelines for clinical care inpatient. http:// Conclusion www.med.umich.edu/1info/FHP/practiceguides/gall- Pain is most common indication in clinical prac- stone/Gallstonefinal.pdf accessed on 13th May 2015 tice. Among spasmodic pain, patient with acute pain 11. Lefebvre G, Pinsonneault O, Antao V, Black A, Burnett seek medical attention more often than in chronic pain. M, Feldman K, et al. Primary dysmenorrhea consen- Antispasmodics are routinely used in the management sus guideline. JOGC. 2005;169:1117-1130 of spasmodic conditions. Camylofin plus paracetamol is 12. Kaur Sarbhjit , Bajwa S.K., Kaur Parmjit, Surinder B. most commonly recalled and preferred antispasmodic To compare the effect of camylofin dihydrochloride formulation for the management of spasmodic conditions (Anafortin) with combination of valethamate bromide by the surveyed participants. (Epidosin) and hyoscine butyl-N-bormide (Buscopan) References on cervical dilation. Journal of Clinical and Diagnostic 1. Tytgat GN. Hyoscine butylbromide: a review of its Research. 2013 Sept, Vol-7(9): 1897-1899 use in the treatment of abdominal cramping and pain. 13. Kokilambigai KS, Lakshmi KS. Camylofin Drugs 2007;67:1343-57 Dihydrochloride-A review of analytical methods. 2. Kulkarni SK, Patil C. Modulatory effect of diclofenac International Journal of Pharmacy and Pharmaceutical on antispasmodic effect of pitofenone in choliner- Sciences 2014;6:36-37 gic spasm. Indian Journal of Experimental biology. 14. Mutha AS, Mutha SA, Baghel PJ, Patil RJ, Bhagat SB, 2004;42:567-569 Patel SB, et al. A knowledge, attitudes and practices 3. Lacy BE, Wang F, Bhowal S, Schaefer E; study group. survey regarding sex, contraception and sexually On-demand hyoscine butylbromide for the treatment transmitted diseases among commerce college- stu of self-reported functional cramping abdominal pain. dents in Mumbai. Journal of Clinical and Diagnostic Scan J Gastroenterol 2013;48:926-35 Research. 2014;8:14-18. 4. Dash A, Maiti R, Akantappa Bandakkanavar TK, 9 Arora P. Intramuscular drotaverine and diclofenac in acute renal colic: a comparative study of analgesic efficacy and safety. Pain Med 2012;13:466-71 5. Tytgat GN. Hyoscine butylbromide - a review on its parenteral use in acute abdominal spasm and as an aid in abdominal diagnostic and therapeutic procedures. Curr Med Res Opin 2008;24:3159-73 6. de los Santos AR, Zmijanovich R, Perez Macri S, Marti ML, Di Girolamo G. Antispasmodic/analgesic associations in primary dysmenorrhea double-blind crossover placebo-controlled clinical trial. Int J Clin

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